A EPA
EPA Document# EPA-740-R-25-001
January 2025
United States Office of Chemical Safety and
Environmental Protection Agency Pollution Prevention
Risk Evaluation for Diisononyl Phthalate
(DINP)
CASRNs: 28553-12-0 and 68515-48-0
(Representative Structure)
January 2025
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TABLE OF CONTENTS
ACKNOWLEDGEMENTS 9
EXECUTIVE SUMMARY 10
1 INTRODUCTION 15
1.1 Scope of the Risk Evaluation 15
1.1.1 Life Cycle and Production Volume 16
1.1.2 Conditions of Use Included in the Risk Evaluation 20
1.1.2.1 Conceptual Models 27
1.1.3 Populations and Durations of Exposure Assessed 32
1.1.3.1 Potentially Exposed and Susceptible Subpopulations 32
1.2 Organization of the Risk Evaluation 32
2 CHEMISTRY AND FATE AND TRANSPORT OF DINP 34
2.1 Summary of Physical and Chemical Properties 34
2.2 Summary of Environmental Fate and Transport 34
3 RELEASES AND CONCENTRATIONS OF DINP IN THE ENVIRONMENT 36
3.1 Approach and Methodol ogy 36
3.1.1 Manufacturing, Processing, Industrial and Commercial 36
3.1.1.1 Crosswalk of Conditions of Use to Occupational Exposure Scenarios 36
3.1.1.2 Description of DINP Use for Each OES 39
3.1.2 Estimating the Number of Release Days per Year for Facilities in Each OES 39
3.1.3 Daily Release Estimation 42
3.1.4 Consumer (Down-the-Drain) 42
3.2 Summary of Environmental Releases 43
3.2.1 Manufacturing, Processing, Industrial and Commercial 43
3.2.2 Weight of Scientific Evidence Conclusions for Environmental Releases from Industrial and
Commercial Sources 49
3.2.3 Strengths, Limitations, Assumptions, and Key Sources of Uncertainty for the Environmental
Release Assessment 58
3.3 Summary of Concentrations of DINP in the Environment 58
3.3.1 Weight of Scientific Evidence Conclusions 60
3.3.1.1 Surface Water 60
3.3.1.2 Ambient Air - Air to Soil Deposition 61
4 HUMAN HEALTH RISK ASSESSMENT 62
4.1 Summary of Human Exposures 63
4.1.1 Occupational Exposures 63
4.1.1.1 Approach and Methodol ogy 63
4.1.1.2 Summary of Number of Workers and ONUs 67
4.1.1.3 Summary of Inhalation Exposure Assessment 68
4.1.1.4 Summary of Dermal Exposure Assessment 71
4.1.1.5 Weight of Scientific Evidence Conclusions for Occupational Exposure 73
4.1.1.5.1 Strengths, Limitations, Assumptions, and Key Sources of Uncertainty for the
Occupational Exposure Assessment 83
4.1.2 Consumer Exposures 84
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4.1.2.1 Summary of Consumer and Indoor Dust Exposure Scenarios and Modeling
Approach and Methodology 84
4.1.2.2 Modeling Dose Results by COU for Consumer and Indoor Dust 92
4.1.2.3 Monitoring Concentrations of DINP in the Indoor Environment 106
4.1.2.4 Indoor Aggregate Dust Monitoring and Modeling Comparison 109
4.1.2.5 Weight of Scientific Evidence Conclusions for Consumer Exposure Ill
4.1.2.5.1 Strength, Limitations, Assumptions, and Key Sources of Uncertainty for the
Consumer Exposure Assessment 112
4.1.3 General Population Exposures 122
4.1.3.1 General Population Screening Level Exposure Assessment Results 125
4.1.3.2 Daily Intake Estimates for the U.S. Population Using NHANES Urinary
Biomonitoring Data 128
4.1.3.1 Overall Confidence in General Population Screening Level Exposure Assessment... 130
4.1.4 Human Milk Exposures 130
4.1.5 Aggregate and Sentinel Exposure 131
4.2 Summary of Human Health Hazard 132
4.2.1 Background 132
4.2.2 Non-cancer Human Health Hazards 132
4.2.3 Cancer Human Health Hazards 134
4.3 Human Health Risk Characterization 136
4.3.1 Risk Assessment Approach 136
4.3.1.1 Estimation of Non-cancer Risks 137
4.3.1.2 Estimation of Non-cancer Aggregate Risks 138
4.3.2 Risk Estimates for Workers 138
4.3.2.1 Application of Adhesives and Sealants 138
4.3.2.1.1 Overview of Risk Estimates 138
4.3.2.1.2 Overview of Exposure Data 139
4.3.2.1.3 Risk Characterization of COUs 140
4.3.2.2 Application of Paints and Coatings 141
4.3.2.2.1 Overview of Risk Estimates 141
4.3.2.2.2 Overview of Exposure Data 142
4.3.2.2.3 Risk Characterization of COUs 143
4.3.2.3 PVC Plastics and Non-PVC Material Compounding 144
4.3.2.3.1 Overview of Risk Estimates 144
4.3.2.3.2 Overview of Exposure Data 144
4.3.2.3.3 Risk Characterization of COUs 144
4.3.2.4 PVC Plastics and Non-PVC Material Converting 145
4.3.2.4.1 Overview of Risk Estimates 145
4.3.2.4.2 Overview of Exposure Data 145
4.3.2.4.3 Risk Characterization of COUs 146
4.3.2.5 Recycling and Disposal 146
4.3.2.5.1 Overview of Risk Estimates 146
4.3.2.5.2 Overview of Exposure Data 147
4.3.2.5.3 Risk Characterization of COUs 147
4.3.2.6 Fabrication and Final Use of Products or Articles 147
4.3.2.6.1 Overview of Risk Estimates 147
4.3.2.6.2 Overview of Exposure Data 148
4.3.2.6.3 Risk Characterization of COUs 148
4.3.2.7 Distribution in Commerce 149
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4.3.2.8 OESs/COUs without Dust or Mist Generation 149
4.3.2.9 Overall Confidence in Worker Risks 150
4.3.3 Risk Estimates for Consumers 159
4.3.3.1 Overall Confidence in Consumer Risks 162
4.3.4 Risk Estimates for General Population 176
4.3.5 Risk Estimates for Potentially Exposed or Susceptible Subpopulations 176
4.3.6 Cumulative Risk Considerations 177
5 ENVIRONMENTAL RISK ASSESSMENT 178
5.1 Summary of Environmental Exposures 178
5.2 Summary of Environmental Hazards 180
5.3 Environmental Risk Characterization 181
5.3.1 Risk Assessment Approach 181
5.3.2 Risk Estimates for Aquatic and Terrestrial Species 183
5.3.3 Overall Confidence and Remaining Uncertainties Confidence in Environmental Risk
Characterization 187
6 UNREASONABLE RISK DETERMINATION 190
6.1 Human Health 193
6.1.1 Populations and Exposures EPA Assessed for Human Health 194
6.1.2 Summary of Human Health Effects 194
6.1.3 Basis for Unreasonable Risk to Human Health 195
6.1.4 Workers 196
6.1.5 Consumers 198
6.1.6 General Population 199
6.2 Environment 200
6.2.1 Populations and Exposures EPA Assessed for the Environment 200
6.2.2 Summary of Environmental Effects 201
6.2.3 Basis for No Unreasonable Risk of Injury to the Environment 201
6.3 Additional Information Regarding the Basis for the Unreasonable Risk Determination 202
REFERENCES 211
APPENDICES 224
Appendix A KEY ABBREVIATIONS AND ACRONYMS 224
Appendix B REGULATORY AND ASSESSMENT HISTORY 226
B. 1 Federal Laws and Regulations 226
B.2 State Laws and Regulations 228
B.3 International Laws and Regulations 228
B.4 Assessment History 229
Appendix C LIST OF SUPPLEMENTAL AND TECHNICAL SUPPORT DOCUMENTS 232
Appendix D UPDATES TO THE DINP CONDITIONS OF USE TABLE 235
Appendix E CONDITIONS OF USE DESCRIPTIONS 245
E. 1 Manufacturing - Domestic Manufacturing 245
E.2 Manufacturing - Importing 245
E.3 Processing - Incorporation into Formulation, Mixture, or Reaction Product - Heat Stabilizer
and Processing Aid in Basic Organic Chemical Manufacturing 246
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E.4 Processing - Incorporation into Formulation, Mixture, or Reaction Product - Plasticizers
(Adhesives Manufacturing; Custom Compounding of Purchased Resin; Paint and Coating
Manufacturing; Plastic Material and Resin Manufacturing; Synthetic Rubber Manufactring;
Wholesale and Retail Trade; All Other Chemical Product and Preparation Manufacturing;
Ink, Toner, and Colorant Manufacturing [Including Pigment]) 246
E.5 Processing - Incorporation into Articles - Plasticizers (Toys, Playground and Sporting
Equipment Manufacturing; Plastics Products Manufacturing; Rubber Product
Manufacturing; Wholesale and Retail Trade; Textiles, Apparel, and Leather Manufacturing;
Electical Equipment, Appliance and Component Manufacturing; Ink, Toner, and Colorant
Products Manufacturing [Including Pigment]) 248
E.6 Processing - Other Uses - Miscellaneous Processing (Petroleum Refineries; Wholesale and
Retail Trade) 249
E.7 Processing - Repackaging - Plasticizer (All Other Chemical Product and Preparation
Manufacturing; Wholesale and Retail Trade, Laboratory Chemicals Manufacturing) 249
E.8 Processing - Recycling 250
E.9 Distribution in Commerce 250
E.10 Industrial Uses - Adhesive and Sealant Chemicals - Adhesive and Sealant Chemicals
(Sealant (Barrier) in Machinery Manufacturing); Computer and Electronic Product
Manufacturing; Electrical Equipment, Appliance, and Component Manufacturing; and
Adhesion/Coesion Promoter in Transportation Equipment Manufacturing) 250
E. 11 Industrial Uses - Construction, Paint, Electrical, and Metal Products -
Building/Construction Materials (Roofing, Pool Liners, Window Shades, Flooring, Water
Supply Piping) 251
E.12 Industrial Uses - Construction, Paint, Electrical, and Metal Products - Paints and Coatings. 251
E. 13 Industrial Use - Other Uses - Hydraulic Fluids 252
E. 14 Industrial Use - Other Uses - Pigment (Leak Detection) 252
E. 15 Industrial Uses - Other Uses- Automotive Articles 252
E.16 Commercial Use - Construction, Paint, Electrical, and Metal Products - Adhesives and
Sealants 253
E. 17 Commercial Use - Construction, Paint, Electrical, and Metal Products - Plasticizer in
Building/Construction Materials (Roofing, Pool Liners, Window Shades, Water Supply
Piping); Construction and Building Materials Covering Large Surface Areas; Including
Paper Articles; Metal Articles; Stone, Plaster, Cement, Glass, and Ceramic Articles 254
E.18 Commercial Use - Construction, Paint, Electrical, and Metal Products - Electrical and
Electronic Products 254
E.19 Commercial Use - Construction, Paint, Electrical, and Metal Products - Paints and Coatings255
E.20 Commercial Use - Furnishing, Cleaning, Treatment/Care Products - Foam Seating and
Bedding Products; Furniture and Furnishings Including Plastic Articles (Soft); Leather
Articles 255
E.21 Commercial Use - Furnishing, Cleaning, Treatment/Care Products - Air Care Products 256
E.22 Commercial Use - Furnishing, Cleaning, Treatment/Care Products - Floor
Coverings/Plasticizer in Construction and Building Materials Covering Large Surface Areas
Including Stone, Plaster, Cement, Glass, and Ceramic Articles; Fabrics, Textiles, and
Apparel(Vinyl Tiles, Resilient Flooring, PVC-Backed Carpeting) 256
E.23 Commercial Use - Furnishing, Cleaning, Treatment/Care Products - Fabric, Textile, and
Leather Products (Apparel and Footwear Care Products) 256
E.24 Commercial Use - Packaging, Paper, Plastic, and Hobby Products - Arts, Crafts, and Hobby
Materials 257
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E.25 Commercial Use - Packaging, Paper, Plastic, and Hobby Products - Ink, Toner, and
Colorant Products 257
E.26 Commercial Use - Packaging, Paper, Plastic, and Hobby Products - Packaging, Paper,
Plastic, Hobby Products (Packaging (Excluding Food Packaging), Including Rubber
Articles; Plastic Articles (Hard); Plastic Articles (Soft) 258
E.27 Commercial Use - Packaging, Paper, Plastic, and Hobby Products - Plasticizer (Plastic and
Rubber Products; Tool Handles, Flexible Tubes, Profiles and Hoses) 258
E.28 Commercial Use - Packaging, Paper, Plastic, and Hobby Products - Toys, Playground, and
Sporting Equipment 259
E.29 Commercial Use - Solvents (for Cleaning or Degreasing) 259
E.30 Commercial Use - Other Uses - Laboratory Chemicals 259
E.31 Commercial Use - Other Use - Automotive Articles 259
E.32 Consumer Use - Construction, Paint, Electrical, and Metal Products - Adhesives and
Sealants 260
E.33 Consumer Use - Construction, Paint, Electrical, and Metal Products - Building Construction
Materials (Wire and Cable Jacketing, Wall Coverings, Roofing, Pool Applications, Water
Supply Piping, etc.) 260
E.34 Consumer Use - Construction, Paint, Electrical, and Metal Products - Electrical and
Electronic Products 261
E.35 Consumer Use - Construction, Paint, Electrical, and Metal Products - Paints and Coatings . 261
E.36 Consumer Use - Furnishing, Cleaning, Treatment/Care Products - Foam Seating and
Bedding Products; Furniture and Furnishings Including Plastic Articles (Soft); Leather
Articles 262
E.37 Consumer Use - Furnishing, Cleaning, Treatment/Care Products - Floor
Coverings/Plasticizer in Construction and Building Materials Covering Large Surface Areas
Including Stone, Plaster, Cement, Glass, and Ceramic Articles; Fabrics, Textiles, and
Apparel (inyl Tiles, Resilient Flooring, PVC-Backed Carpeting) 262
E.38 Consumer Use - Furnishing, Cleaning, Treatment/Care Products - Air Care Products 263
E.39 Consumer Use - Furnishing, Cleaning, Treatment/Care Products - Fabric, Textile, and
Leather Products (Apparel and Footwear Care Products) 263
E.40 Consumer Use - Packaging, Paper, Plastic, Hobby Products - Arts, Crafts, and Hobby
Materials 264
E.41 Consumer Use - Packaging, Paper, Plastic, Hobby Products - Ink, Toner, and Colorant
Products 264
E.42 Consumer Use - Packaging, Paper, Plastic, Hobby Products - Other Articles with Routine
Direct Contact During Normal Use Including Rubber Articles; Plastic Articles (Hard); Vinyl
Tape; Flexible Tubes; Profiles; Hoses 264
E.43 Consumer Use - Packaging, Paper, Plastic, Hobby Products - Packaging (Excluding Food
Packaging), Including Rubber Articles; Plastic Articles (Hard); Plastic Articles (Soft) 265
E.44 Consumer Use - Packaging, Paper, Plastic, Hobby Products - Toys, Playground, and
Sporting Equipment 265
E.45 Consumer Use - Other - Novelty Articles 265
E.46 Consumer Use - Other Use - Automotive Articles 266
E.47 Disposal 266
Appendix F OCCUPATIONAL EXPOSURE VALUE DERIVATION 267
F. 1 Occupational Exposure Value Calculations 267
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LIST OF TABLES
Table 1-1. Categories and Subcategories of Use and Corresponding Exposure Scenario in the Risk
Evaluation for DINP 21
Table 2-1. Physical and Chemical Properties of DINP 34
Table 3-1. Crosswalk of COUs to Assessed OESs 37
Table 3-2. Description of the Function of DINP for Each OES 39
Table 3-3. Generic Estimates of Number of Operating Days per Year for Each OES 40
Table 3-4. Summary of EPA's Daily Release Estimates for Each OES and EPA's Overall Confidence in
these Estimates 44
Table 3-5. Summary of Overall Confidence in Environmental Release Estimates by OES 50
Table 3-6. Summary of High-End DINP Concentrations in Various Environmental Media from
Environmental Releases 60
Table 4-1. Summary of Exposure Monitoring and Modeling Data for OESs 65
Table 4-2. Summary of Total Number of Workers and ONUs Potentially Exposed to DINP for Each
OES 67
Table 4-3. Summary of Average Adult Worker Inhalation Exposure Results for Each OES 70
Table 4-4. Summary of Average Adult Worker Dermal Exposure Results for Each OES 72
Table 4-5. Summary of Assumptions, Uncertainty, and Overall Confidence in Exposure Estimates by
OES 74
Table 4-6. Summary of Consumer COUs, Exposure Scenarios, and Exposure Routes 86
Table 4-7. Weight of Scientific Evidence Conclusions for Indoor Dust Ingestion Exposure 108
Table 4-8. Comparison Between Modeled and Monitored Daily Dust Intake Estimates for DINP 110
Table 4-9. Weight of Scientific Evidence Summary Per Consumer COU 116
Table 4-10. Exposure Scenarios Assessed in General Population Screening Level Analysis 124
Table 4-11. General Population Surface Water and Drinking Water Exposure Summary 126
Table 4-12. Fish Ingestion for Adults in Tribal Populations Summary 127
Table 4-13. General Population Ambient Air to Soil Deposition Exposure Summary 128
Table 4-14. Daily Intake Values and MOEs for DINP Based on Urinary Biomonitoring from the 2017 to
2018 NHANES Cycle 129
Table 4-15. Non-cancer HECs and HEDs Used to Estimate Risks 134
Table 4-16. Exposure Scenarios, Populations of Interest, and Hazard Values 136
Table 4-17. Occupational Aggregate Risk Summary Table 151
Table 4-18. Consumer Risk Summary Table 163
Table 5-1. Relevant Exposure Pathway to Receptors and Corresponding Risk Assessment (Qualitative)
for the DINP Environmental Risk Characterization 183
Table 5-2. DINP Evidence Table Summarizing Overall Confidence Derived for Environmental Risk
Characterization 189
Table 6-1. Supporting Basis for the Risk Determination for Human Health (Occupational COUs) 203
LIST OF FIGURES
Figure 1-1. TSCA Existing Chemical Risk Evaluation Process 15
Figure 1-2. Risk Evaluation Document Summary Map 16
Figure 1-3. DINP Life Cycle Diagram 18
Figure 1-4. Percentage of DINP Production Volume by Use 19
Figure 1-5. DINP Conceptual Model for Industrial and Commercial Activities and Uses: Potential
Exposure and Hazards 28
Figure 1-6. DINP Conceptual Model for Consumer Activities and Uses: Potential Exposures and
Hazards 29
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Figure 1-7. DINP Conceptual Model for Environmental Releases and Wastes: General Population
Hazards 30
Figure 1-8. DINP Conceptual Model for Environmental Releases and Wastes: Ecological Exposures and
Hazards 31
Figure 3-1. An Overview of How EPA Estimated Daily Releases for Each OES 42
Figure 4-1. Approaches Used for Each Component of the Occupational Assessment for Each OES 64
Figure 4-2. Acute Dose Rate for DINP from Ingestion, Inhalation, and Dermal Exposure Routes in
Infants Aged Less than 1 Year and Toddlers Aged 1 to 2 Years 95
Figure 4-3. Acute Dose Rate of DINP from Ingestion, Inhalation, and Dermal Exposure Routes in
Preschoolers Aged 3 to 5 Years and Middle Childhood Aged 6 to 10 Years 96
Figure 4-4. Acute Dose Rate of DINP from Ingestion, Inhalation, and Dermal Exposure Routes in
Young Teens Aged 11 to 15 Years and for Teenagers and Young Adults Aged 16 to 20
Years 98
Figure 4-5. Acute Dose Rate of DINP from Ingestion, Inhalation, and Dermal Exposure Routes in
Adults Aged 21 Years or Older 99
Figure 4-6. Intermediate Dose Rate for DINP from Inhalation Exposure Route in Bystander Infants
Aged Less than 1 Year and Toddlers Aged 1 to 2 Years 100
Figure 4-7. Intermediate Dose Rate for DINP from Inhalation Exposure Route in Bystander Preschoolers
Aged 3 to 5 Years and Middle Childhood Aged 6 to 10 Years 100
Figure 4-8. Intermediate Dose Rate of DINP from Inhalation and Dermal Exposure Routes in Young
Teens Aged 11 to 15 Years and for Teenagers and Young Adults Aged 16 to 20 Years 100
Figure 4-9. Intermediate Dose Rate of DINP from Inhalation and Dermal Exposure Routes in Adults
Aged 21 Years and Older 101
Figure 4-10. Chronic Dose Rate for DINP from Ingestion, Inhalation, and Dermal Exposure Routes in
Infants Aged Less than 1 Year and Toddlers Aged 1 to 2 Years 102
Figure 4-11. Chronic Dose Rate of DINP from Ingestion, Inhalation, and Dermal Exposure Routes in
Preschoolers Aged 3 to 5 Years and Middle Childhood Aged 6 to 10 Years 103
Figure 4-12. Chronic Dose Rate of DINP from Ingestion, Inhalation, and Dermal Exposure Routes in
Young Teens Aged 11 to 15 Years and in Teenagers and Young Adults Aged 16 to 20
Years 104
Figure 4-13. Chronic Dose Rate of DINP from Ingestion, Inhalation, and Dermal Exposure Routes in
Adults Aged 21 Years and Older 105
Figure 4-14. Potential Human Exposure Pathways to DINP for the General Population 123
Figure 5-1. Trophic Transfer of DINP in Aquatic and Terrestrial Ecosystems 180
LIST OF APPENDIX TABLES
Table_Apx B-l. Federal Laws and Regulations 226
Table_Apx B-2. State Laws and Regulations 228
Table_Apx B-3. International Laws and Regulations 228
Table_Apx B-4. Assessment History of DINP 229
Table Apx D-l. Additions and Name Changes to Categories and Subcategories of COUs Based on CDR
Reporting and Stakeholder Engagement 235
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ACKNOWLEDGEMENTS
The Assessment Team gratefully acknowledges the participation, input, and review comments from U.S.
Environmental Protection Agency (EPA or the Agency) Office of Pollution Prevention and Toxics
(OPPT) and Office of Chemical Safety and Pollution Prevention (OCSPP) senior managers and science
advisors. The Agency is also grateful for assistance from EPA contractors ERG (Contract No.
68HERD20A0002); ICF (Contract No. 68HERC19D0003 and 68HERD22A0001); and SRC, Inc.
(Contract No. 68HERH19D0022).
Special acknowledgement is given for the contributions of technical experts from EPA's Office of
Research and Development (ORD) and Office of Pesticide Programs (OPP), including Christopher
Corton and Gregory Akerman for their technical review of EPA's cancer mode of action analysis and
Jeff Gift and Geoffrey Collin Peterson for their benchmark dose modeling support.
Docket
Supporting information can be found in the public docket, Docket ID (EPA.-H.Q-OPPT-2018-0436).
Disclaimer
Reference herein to any specific commercial products, process, or service by trade name, trademark,
manufacturer, or otherwise does not constitute or imply its endorsement, recommendation, or favoring
by the United States Government.
Authors: Anthony Luz (Assessment Lead and Human Health Hazard Assessment Lead), Christopher
Green (Assessment Lead), Brandall Ingle-Carlson (Assessment Lead), Maiko Arashiro (General
Population Exposure Assessment Lead), Jennifer Brennan (Environmental Hazard Assessment Lead),
Laura Krnavek (Consumer and Indoor Dust Exposure Assessment Lead), J. Aaron Murray and Yashfin
Mahid (Engineering Assessment Leads), Ryan Sullivan and Juan Bezares Cruz (Physical and Chemical,
and Fate Assessment Leads), Todd Coleman (Risk Determination Lead), Collin Beachum (Branch
Chief), Ana Corado (Branch Chief), John Allran, Randall Bernot, Emily Griffin, Bryan Groza,
Christelene Horton, Kiet Ly, Rachel McAnallen, Andrew Middleton, Carolyn Mottley, Mark Myer,
Catherine Ngo, Ashley Peppriell, Brianne Raccor, Andrew Sayer, and Dyllan Taylor
Contributors: Azah Abdalla-Mohamed, Sabrina Alam, Ballav Aryal, Amy Benson, Odani Bowen,
Marcella Card, Nicholas Castaneda, Maggie Clark, Jone Corrales, Daniel DePasquale, Patricia Fontenot,
Ross Geredien, Myles Hodge, Annie Jacob, June Kang, Grace Kaupas, Roger Kim, Yadi Lopez, Rony
Arauz Melendez, Kelsey Miller, Maxwell Sail, Abhilash Sasidharan, Alex Smith, Kelley Stanfield, Cory
Strope, Sailesh Surapureddi, Abigail Ulmer, Joseph Valdez, Leora Vegosen, Susanna Wegner, and Jason
Wight
Technical Support: Mark Gibson, Hillary Hollinger, and S. Xiah Kragie
This risk evaluation and associated technical support documents were reviewed and cleared for
release by OPPT and OCSPP leadership.
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EXECUTIVE SUMMARY
Background
The U.S. Environmental Protection Agency (EPA or the Agency) has evaluated the health and
environmental risks of the chemical diisononyl phthalate (DINP) under section 6 of the Toxic
Substances Control Act (TSCA). In this risk evaluation, EPA has determined that DINP presents an
unreasonable risk of injury to human health under the conditions of use (COUs). Of the 47 COUs
that EPA evaluated, 4 COUs have risk estimates that raise concerns for workers' exposure to DINP,
including Industrial and Commercial use of adhesives and sealants, and Industrial and Commercial use
of paints and coatings. These four COUs represent about 3 percent of the U.S. production volume of
DINP. In its risk evaluation, EPA's protective, screening-level approaches demonstrated that uses of
DINP under TSCA do not pose risk to the environment, the general population, or consumers. The
Science Advisory Committee on Chemicals (SACC) peer reviewed the draft diisodecyl phthalate
(DIDP) risk evaluation and draft DINP environmental and human health hazard assessments during its
July 2024 meeting. This finalized risk evaluation takes into consideration input from the public as well
as independent, expert peer review advice provided by the SACC.
In 2019, EPA received a request, pursuant to TSCA and its implementing regulations, from ExxonMobil
Chemical Company through the American Chemistry Council's High Phthalates Panel to conduct a
TSCA risk evaluation for DINP. EPA determined that the request met the regulatory criteria and
requirements and granted the request in 2019.
DINP is used primarily as a plasticizer to manufacture flexible polyvinyl chloride (PVC). It is also used
to make building and construction materials; automotive articles; and other commercial and consumer
products, including adhesives and sealants, paints and coatings, and electrical and electronic products—
all of which are considered TSC A COUs. Workers may be exposed to DINP when making these
products or otherwise using DINP in the workplace. When it is manufactured or used to make products,
DINP can be released into the water, where because of its physical and chemical properties, most will
end up in the sediment at the bottom of lakes and rivers. If released into the air, DINP will attach to dust
particles and be deposited on land or into water. Indoors, DINP has the potential over time to come out
of products and adhere to dust particles. If it does, people could inhale or ingest dust that contains DINP.
Manufacturers report DINP production volumes through the TSCA Chemical Data Reporting (CDR)
rule under two associated CAS Registry Numbers (CASRNs). The production volume for CASRN
28553-12-0 in 2015 was between 100 to 250 million pounds (lb) and decreased to 50 to 100 million lb in
2019 based on the latest 2020 CDR data. The production volume for CASRN 68515-48-0 in 2015
ranged between 100 to 250 million lb and changed to between 100 million and 1 billion lb in 2019, also
based on the latest 2020 CDR data. EPA describes production volumes as a range to protect confidential
business information.
Laboratory animal studies have been conducted to study DINP for a range of cancer and non-cancer
effects on exposed people. After reviewing the available studies, the Agency concluded that oral
exposure to DINP can cause adverse developmental effects and non-cancer liver toxicity in experimental
animal models. For humans, exposure to DINP may lead to adverse effects on the developing male
reproductive system—what is known as phthalate syndrome. Notably, assessments by Health Canada,
U.S. Consumer Product Safety Commission (U.S. CPSC), European Chemicals Agency (ECHA),
European Food Safety Authority (EFSA), and the Australian National Industrial Chemicals Notification
and Assessment Scheme (NICNAS) have reached similar conclusions regarding the effects of DINP on
development and the liver.
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EPA is including DINP in its forthcoming cumulative risk assessment (CRA) along with five other
phthalate chemicals that also cause adverse effects on laboratory animals consistent with phthalate
syndrome. Notably, assessments by Health Canada, U.S. CPSC, ECHA, andNICNAS have also
conducted CRAs of phthalates based on these chemicals' shared ability to cause phthalate syndrome.
Furthermore, independent, expert peer reviewers endorsed EPA's proposal to conduct a CRA of
phthalates under TSCA during the May 2023 meeting of the SACC because doing so represents the best
available science. EPA has not yet accounted for its cumulative phthalate risk assessment nor taken into
consideration cumulative phthalate exposure in its risk calculations for DINP. However, based on the
Draft Technical Support Document for the Cumulative Risk Analysis ( 24a). EPA does not
expect the cumulative risk estimates to support any significant changes to risk conclusions for DINP.
The Agency is issuing a draft cumulative risk assessment for public comment and peer review, which
will be followed by a final cumulative assessment that incorporates DINP.
EPA also reviewed the studies that investigated DINP's potential to cause cancer in laboratory animals
and concluded that DINP can cause liver cancer in rats and mice. However, liver cancer in these rodents
occurred at higher doses than observed for other non-cancer effects on the liver and the developing male
reproductive system. Therefore, evaluating and protecting human health from non-cancer risks
associated with exposure to DINP will also be protective of cancer effects.
Past assessments of DINP undertaken by other regulatory agencies that addressed a broad range of uses
have concluded that DINP does not pose risk to human health or the environment based on its
concentration in those products and the environment. Notably, the 2014 U.S. CPSC risk assessment—
which included consideration of exposure from children's products as well as from other sources such as
personal care products, diet, consumer products, and the environment—concluded that DINP exposure
comes primarily from diet for women, infants, toddlers, and children, which is a source of exposure that
is not by law subject to TSCA' jurisdiction.
In this risk evaluation, EPA only evaluated risks resulting from exposure to DINP from or within
facilities that use, manufacture, or process DINP under industrial and/or commercial COUs subject to
TSCA and the products resulting from such manufacture and processing. Human or environmental
exposure to DINP through uses that are not subject to TSCA (e.g., cosmetics, medical devices, and food
contact materials) were not evaluated or taken into account by EPA in reaching its determination of
unreasonable risk to injury of human health. Thus, although the Agency is determining in this risk
evaluation that four specific TSCA COUs significantly contribute to its unreasonable risk finding for
DINP, this determination cannot be extrapolated to form conclusions about uses of DINP that are not
subject to TSCA and that EPA did not evaluate.
Determining Unreasonable Risk to Human Health
EPA's TSCA existing chemical risk evaluations must determine whether a chemical substance does or
does not present unreasonable risk under its COUs. Although the unreasonable risk must be informed by
science, the Agency, in making the finding of presents unreasonable risk, also considers risk-related
factors as described in the recently revised risk evaluation framework rule. Risk-related factors beyond
the levels of DINP that can cause specific health effects include but are not limited to the type of health
effect under consideration; the reversibility of the health effect being evaluated; exposure-related
considerations (e.g., duration, magnitude, frequency of exposure); population exposed (including any
susceptible subpopulations); and EPA's confidence in the information used to inform the hazard and
exposure values. These considerations must be included as part of a pragmatic and holistic evaluation of
hazard and exposure to DINP. If an estimate of risk for a specific scenario exceeds the standard risk
Page 11 of 269
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benchmarks, then the formal determination of whether those risks significantly contribute to the
unreasonable risk of DINP under TSCA must be both case-by-case and context-driven.
EPA evaluated the risks to people from being exposed to DINP at work, indoors, and outdoors. In its
human health evaluation, the Agency used a combination of screening level and more refined
approaches to assess how people might be exposed to DINP through breathing or ingesting dust or other
particulates—as well as through skin contact. In determining whether DINP presents an unreasonable
risk of injury to human health, as required under TSCA, EPA incorporated the following potentially
exposed and susceptible subpopulations (PESS) into its assessment: women of reproductive
age/pregnant women, infants, children and adolescents, people who frequently use consumer products
and/or articles containing high concentrations of DINP, people exposed to DINP in the workplace, and
tribes and subsistence fishers whose diets include large amounts of fish. These subpopulations are PESS
because some have greater exposure to DINP per body weight (e.g., infants, children, adolescents) or
due to age-specific behaviors (e.g., mouthing of toys, wires, and erasers by infants and children), while
some people may experience DINP exposure from multiple sources or experience higher exposure than
others.
EPA also evaluated exposure to DINP for people living in communities in close proximity to facilities
with TSCA releases—including exposure from incidental dermal contact or ingestion of surface waters,
ingestion of fish from surface waters, and soil ingestion and dermal soil contact resulting from air to soil
deposition of DINP. EPA did not estimate inhalation exposure to DINP from ambient air for people
living in close proximity to facilities with TSCA releases because ambient air was not expected to be a
pathway of concern for DINP, because DINP is not persistent in the air and rapidly partitions to
sediment, soil, and surface water. EPA's robust scientific analysis shows DINP to not result in
unreasonable risk to consumers or the general population, including PESS, except for those exposed to
DINP at work for the previously noted four COUs.
The four COUs that EPA identified as significantly contributing to unreasonable risk from DINP to
workers include those that led to exposures to average adults and female workers of reproductive age in
scenarios in which unprotected workers used spray adhesives and sealants or paints and coatings that
contain DINP. This is because doing so could create high concentrations of DINP in mist that an
unprotected worker could inhale.
Considerations and Next Steps
EPA evaluated a total of 47 TSCA COUs for DINP. The Agency is determining that only the following
four COUs significantly contribute to the unreasonable risk of DINP via exposures to unprotected
workers:
• Industrial use - adhesives and sealant chemicals (sealant [barrier] in machinery manufacturing;
computer and electronic product manufacturing; electrical equipment, appliance, component
manufacturing, and adhesion/cohesion promoter in transportation equipment manufacturing);
• Industrial use - construction, paint, and metal products - paints and coatings;
• Commercial use - construction, paint, electrical, and metal products - adhesives and sealants;
and
• Commercial use - construction, paint, electrical, and metal products - paints and coatings.
For the remaining 43 COUs, EPA has determined that they do not significantly contribute to the
unreasonable risk:
• Manufacturing - domestic manufacturing;
Page 12 of 269
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Manufacturing - importing;
Processing - incorporation into a formulation, mixture, or reaction product - heat stabilizer and
processing aid in basic organic chemical manufacturing;
Processing - incorporation into a formulation, mixture, or reaction product - plasticizers
(adhesives manufacturing, custom compounding of purchased resin; paint and coating
manufacturing; plastic material and resin manufacturing; synthetic rubber manufacturing;
wholesale and retail trade; all other chemical product and preparation manufacturing; ink, toner,
and colorant manufacturing [including pigment]);
Processing - incorporation into an article - plasticizers (toys, playground and sporting equipment
manufacturing; plastics products manufacturing; rubber product manufacturing; wholesale and
retail trade; textiles, apparel, and leather manufacturing; electrical equipment, appliance, and
component manufacturing; ink, toner, and colorant manufacturing [including pigment]);
Processing - other uses - miscellaneous processing (petroleum refineries; wholesale and retail
trade);
Processing - repackaging - plasticizer (all other chemical product and preparation
manufacturing; wholesale and retail trade; laboratory chemicals manufacturing);
Processing - recycling;
Distribution in commerce;
Industrial use - construction, paint, electrical, and metal products - building/construction
materials (roofing, pool liners, window shades, flooring, water supply piping);
Industrial use - other uses - hydraulic fluids;
Industrial use -other uses - pigment (leak detection);
Industrial use - other - automotive articles;
Commercial use - construction, paint, electrical, and metal products - plasticizer in
building/construction materials (roofing, pool liners, window shades, water supply piping);
construction and building materials covering large surface areas, including paper articles; metal
articles; stone, plaster, cement, glass, and ceramic articles;
Commercial use - construction, paint, electrical, and metal products - electrical and electronic
products;
Commercial use - furnishing, cleaning, treatment/care products - foam seating and bedding
products; furniture and furnishings including plastic articles (soft); leather articles;
Commercial use - furnishing, cleaning, treatment/care products - air care products;
Commercial use - furnishing, cleaning, treatment/care products - floor coverings; plasticizer in
construction and building materials covering large surface areas including stone, plaster, cement,
glass, and ceramic articles; fabrics, textiles and apparel (vinyl tiles, resilient flooring, PVC-
backed carpeting);
Commercial use - furnishing, cleaning, treatment/care products - fabric, textile, and leather
products (apparel and footwear care products);
Commercial use - packaging, paper, plastic, hobby products - arts, crafts, and hobby materials;
Commercial use - packaging, paper, plastic, hobby products - ink, toner, and colorant products;
Commercial use - packaging, paper, plastic, hobby products - packaging, paper, plastic, hobby
products (packaging [excluding food packaging], including rubber articles; plastic articles [hard];
plastic articles [soft]);
Commercial use - packaging, paper, plastic, hobby products - plasticizer (plastic and rubber
products; tool handles, flexible tubes, profiles, and hoses);
Commercial use - packaging, paper, plastic, hobby products - toys, playground, and sporting
equipment;
Commercial use - solvents (for cleaning or degreasing) - solvents (for cleaning or degreasing);
Page 13 of 269
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• Commercial use - other uses - laboratory chemicals;
• Commercial use - other - automotive articles;
• Consumer use - construction, paint, electrical, and metal products - adhesives and sealants;
• Consumer use - construction, paint, electrical, and metal products - plasticizer in
building/construction materials (roofing, pool liners, window shades, water supply piping, etc.);
• Consumer use - construction, paint, electrical, and metal products - electrical and electronic
products;
• Consumer use - construction, paint, electrical, and metal products - paints and coatings;
• Consumer use - furnishing, cleaning, treatment/care products - floor coverings/plasticizer in
construction and building materials covering large surface areas including stone, plaster, cement,
glass, and ceramic articles; fabrics, textiles and apparel (vinyl tiles, resilient flooring, PVC-
backed carpeting)
• Consumer use - furnishing, cleaning, treatment/care products - foam seating and bedding
products; furniture and furnishings including plastic articles (soft); leather articles;
• Consumer use - furnishing, cleaning, treatment/care products - air care products;
• Consumer use - furnishing, cleaning, treatment/care products - fabric, textile, and leather
products (apparel and footwear care products);
• Consumer use - packaging, paper, plastic, hobby products - arts, crafts, and hobby materials;
• Consumer use - packaging, paper, plastic, hobby products - ink, toner, and colorant products;
• Consumer use - packaging, paper, plastic, hobby products - other articles with routine direct
contact during normal use including rubber articles; plastic articles (hard); vinyl tape; flexible
tubes; profiles; hoses;
• Consumer use - packaging, paper, plastic, hobby products - packaging (excluding food
packaging), including rubber articles; plastic articles (hard); plastic articles (soft);
• Consumer use - packaging, paper, plastic, hobby products - toys, playground, and sporting
equipment;
• Consumer use - other - novelty articles;
• Consumer use - other - automotive articles; and
• Disposal.
This risk evaluation was released for public comment. Notably, the draft DIDP risk evaluation and draft
DINP environmental and human health hazard assessments were peer reviewed by SACC in July 2024.
The entire draft DINP risk evaluation package was not subject to peer review by SACC at that time
because EPA applied similar approaches and methodologies for assessing exposure for both the DIDP
and DINP risk evaluations, while the human health hazard approaches differed across the two risk
evaluations. This final DINP risk evaluation takes into consideration input from the public and
recommendations received from SACC. In this risk evaluation, EPA has determined that DINP
presents an unreasonable risk of injury to human health. As a next step, EPA will initiate regulatory
action to mitigate the unreasonable risk.
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1 INTRODUCTION
EPA has evaluated diisononyl phthalate (DINP) pursuant to section 6(b) of the Toxic Substances
Control Act (TSCA). DINP is a common chemical name for the category of chemical substances that
includes the following substances: 1,2-benzene-dicarboxylic acid, 1,2-diisononyl ester (CASRN 28553-
12-0) and 1,2-benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich (CASRN 68515-48-0).
Both CASRNs contain mainly C9 dialkyl phthalate esters. DINP is primarily used as a plasticizer in
polyvinyl chloride (PVC) in consumer, commercial, and industrial applications—although it is also used
in adhesives, sealants, paints, coatings, rubbers, and non-PVC plastics as well as for other applications.
Section 1.1 summarizes the scope of the DINP risk evaluation and provides information on production
volume, a life cycle diagram (LCD), TSCA conditions of use (COUs), and conceptual models used for
DINP. Section 1.2 presents the organization of this risk evaluation.
Figure 1-1 describes the major inputs, phases, and outputs/components of the TSCA risk evaluation
process, from scoping to releasing the final risk evaluation.
Inputs
Existing Laws, Regulations,
and Assessments
• Use Document
Public Comments
Public Comments on
Draft Scope Document
Analysis Plan
Testing Results
Data Evaluation Process
Data Integration
Public Comments on
Draft RE
• Peer Review Comments
on Draft RE
Phase
Outputs
Figure 1-1. TSCA Existing Chemical Risk Evaluation Process
1.1 Scope of the Risk Evaluation
EPA evaluated risk to human and environmental populations for DINP. Specifically for human
populations, the Agency evaluated risk to (1) workers and occupational non-users (ONUs) via inhalation
routes; (2) workers via dermal routes; (3) ONUs via dermal routes for occupational exposure scenarios
(OESs) in mists and dusts; (4) consumers via inhalation, dermal, and oral routes; and (5) bystanders via
the inhalation route. Additionally, EPA incorporated the following potentially exposed and susceptible
populations (PESS) into its assessment—women of reproductive age/pregnant women, infants, children
and adolescents, people who frequently use consumer products and/or articles containing high-
concentrations of DINP, people exposed to DINP in the workplace, and tribes and subsistence fishers
whose diets include large amounts of fish. As described further in Section 4.1.3, using a screening level
analysis EPA assessed risks to the general population, which considered risk from exposure to DINP via
oral ingestion of surface water, drinking water, fish, and soil from air to soil deposition. For
environmental populations, EPA evaluated risk to aquatic species via water, sediment, and air as well as
risk to terrestrial species via air, soil, sediment, and water.
Page 15 of 269
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The DINP risk evaluation comprises a series of technical support documents. Each technical support
document contains sub-assessments that inform adjacent, "downstream" technical support documents. A
basic diagram showing the layout and relationship of these assessments is provided below in Figure 1-2.
High-level summaries of each relevant technical support document are presented in this risk evaluation.
Detailed information for each technical support document can be found in the corresponding documents.
Appendix C incudes a list and citations for all technical support documents and supplemental files
included in the risk evaluation for DINP.
These technical support documents leveraged the data and information sources already identified in the
Final Scope of the Risk Evaluation for Di-isononyl Phthalate (DINP) ( 1,2-Benzene-dicarboxylic acid,
1,2-diisononyl ester, and 1,2-Benzenedicarboxylic acid, di-C8-10-branched alky I esters, C9-rich);
CASRNs 28553-12-0 and 68515-48-0 (also called the "final scope for DINP" or "final scope document)
(U.S. EPA. 2021c). OPPT conducted a comprehensive search for "reasonably available information" to
identify relevant DINP data for use in the risk evaluation. The approach used to identify specific
relevant risk assessment information was discipline-specific and is detailed in Systematic Review
Protocol for Diisononyl Phthalate (DINP) (U.S. EPA. 2025aa). or as otherwise noted in the relevant
technical support documents (TSDs; see also Appendix C).
Cancer Human Health
Hazard Assessment
Non-cancer Human Health
Hazard Assessment
Includes biological PESS
Physical Chemistry
Assessment
Fate Assessment
Human Exposure Assessments
Environmental Media and
General Population
Exposure Assessment
Environmental Release
and Occupational
Exposure Assessment
Consumer and Indoor
Dust Exposure
Assessment
Include exposure PESS
Environmental
Exposure Assessment
Risk Evaluation
Conditions of Use
Human Health
Risk Characterization
Includes PESS
Environmental Risk
Characterization
Unreasonable
Risk Determination
Environmental
Hazard Assessment
Chemical-specific systematic review protocol and data extraction files
Figure 1-2. Risk Evaluation Document Summary Map
1.1.1 Life Cycle and Production Volume
The LCD shown in Figure 1-3 depicts the COUs that are within the scope of the risk evaluation, during
various life cycle stages, including manufacturing, processing, distribution, use (industrial, commercial,
consumer), and disposal. The LCD has been updated since its original inclusion in the final scope
document, with consolidated and/or expanded processing and use steps. A complete list of updates and
explanations of the updates made to COUs for DINP from the final scope document and draft risk
evaluation to this final risk evaluation is provided in Appendix D. The information in the LCD is
Page 16 of 269
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grouped according to the Chemical Data Reporting (CDR) processing codes and use categories
(including functional use codes for industrial uses and product categories for industrial and commercial
uses). The CDR Rule under TSCA section 8(a) (see 40 CFR part 711) requires U.S. manufacturers
(including importers) to provide EPA with information on the chemicals they manufacture or import into
the United States. EPA collects CDR data approximately every 4 years with the latest collections with
available data occurring in 2006, 2012, 2016, and 2020.
EPA included descriptions of the industrial, commercial, and consumer use categories identified from
the 2020 CDR in the LCD (Figure 1-3) ( 2020b). The descriptions provide a brief overview of
the use category; the Environmental Release and Occupational Exposure Assessment for Diisononyl
Phthalate ( >025r) contains more detailed descriptions (e.g., process descriptions, worker
activities, process flow diagrams, equipment illustrations) for each manufacturing, processing, use, and
disposal category.
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MFG/IMPORT
Manufacture
(Including Import)
PROCESSING
Incorporation into formulation, mixture, or reaction product
Heat stabilizer and processing aid in basic organic chemical
manufacturing; Plasticizers (adhesives manufacturing; custom
compounding of purchased resin; paint and coating
manufacturing; plastic material and resin manufacturing;
synthetic rubber manufacturing; wholesale and retail trade; all
other chemical product and preparation manufacturing;
pigments)
Incorporation into article
Plasticizers (playground and sporting equipment manufacturing;
plastics products manufacturing; rubber product manufacturing;
wholesale and retail trade; textiles, apparel, and leather
manufacturing; electrical equipment, appliance, and component
manufacturing; transportation equipment manufacturing; ink.
toner, and colorant manufacturing (including pigment))
Other uses
Miscellaneous processing (petroleum refineries; wholesale, and
retail trade)
Repackaging
Plasticizer (all other chemical product and preparation
manufacturing; wholesale and retail trade; laboratory chemicals
manufacturing)
X>
INDUSTRI AL, COMMERCIAL, CONSUMER USES
K>
Adhesive and sealant chemicals
(e.g.. machinery manufacturing; computer and electronic product
manufacturing; transportation equipment manufacturing)
Automotive, fuel, agriculture, outdoor use products
(e.g., automotive products, other than fluids)
Construction, paint, electrical, and metal products
(e.g.. building/construction materials (roofing, pool liners,
window shades); adhesives and sealants; paints and coatings;
electrical and electronic products)
Furnishing, cleaning, treatment/care products
(e.g., foam seating and bedding; leather articles; air care
products; fabrics, textiles and apparel (vinyl tiles, resilient
flooring, PVC-backed carpeting); floor coverings)
Packaging, paper, plastic, and hobby products
(e.g., arts, crafts, and hobby materials; ink, toner, and colorant
products; plastic and rubber products; tool handles, flexible
tubes, profiles, and hoses; toys, playground, and sporting
equipment)
Miscellaneous uses
(e.g.. laboratory chemicals; hydraulic fluids; pigment (leak
detection); solvents (for cleaning or degreasing))
Recycling
RELEASES AND
WASTE DISPOSAL
See Conceptual Model
for Environmental
Releases and Wastes
~
~
~
Manufacture
(including import)
Processing
Uses
Figure 1-3. DINP Life Cycle Diagram
See Table 1-1 for categories and subcategories of COUs. Activities related to distribution (e.g., loading, unloading) will be considered throughout the
DINP life cycle, as well as qualitatively through a single distribution scenario.
Page 18 of 269
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The production volume for CASRN 28553-12-0 in 2015 was between 100 to 250 million pounds (lb)
and decreased to 50 to 100 million lb in 2019 based on the 2020 CDR data. The production volume
range for CASRN 68515-48-0 in 2015 was between 100 to 250 million lb and changed to between 100
million and 1 billion lb in 2019 based on the latest 2020 CDR data. EPA described production volumes
as a range to protect production volume data claimed as confidential business information (CBI). For the
2016 and 2020 CDR cycle, collected data included the company name, volume of each chemical
manufactured/imported, the number of workers at each site, and information on whether the chemical
was used in the commercial, industrial, and/or consumer sector(s).
The production volumes for the most recently available CDR reporting year (2019) are split between
two CASRNs based on the method of manufacture. Due to facility CBI claims on manufacture and
import volumes, EPA presents the known production volume of DINP as a range. For both CASRN
28553-12-0 and CASRN 68515-48-0, production volume information from known sites with known
production volumes was insufficient to reduce the uncertainty in total CASRN production volumes due
to most sites reporting their production volume as CBI. For example, 23 sites reported importing or
manufacturing DINP under CASRN 28553-12-0; however, only 13 sites reported a non-CBI production
volume, totaling a combined 29 million lb. In contrast, the CDR national production volume was 50 to
100 million lb, leaving 21 to 71 million lb of DINP unaccounted for. The known production volume gap
was larger for CASRN 68515-48-0. Only two of the seven import/manufacturing sites provided their
production volumes as non-CBI (combined total of 2 million lb), representing only 2 to 0.2 percent of
the total estimated DINP production volume of 100 million to 1 billion lb. As a result, EPA attributed
more than 97 percent of the total DINP manufacturing and import volume to reporting sites that claimed
their production volumes as CBI. Consequently, EPA could not specify production volumes for each
OES based on CDR data and instead relied on industry submitted data from the American Chemistry
Council (ACC) and the EU Risk Assessment to estimate the relative percentages of DINP used in most
OES. In Figure 1-4, the OES in the "Other" category include all smaller use case OES, including paints
and coatings, adhesives and sealants, laboratory chemicals, and other formulations, mixtures, or reaction
products. Due to the limitations discussed above, Figure 1-4 may not accurately reflect actual DINP use,
and each OES may comprise a smaller or larger percentage of the overall production volume of DINP.
DINP Uses (% of Production Volume)
2.55% 2.55%
¦ Non-PVC Materials
¦ PVC Plastics
¦ Other (Adhesives and Sealants; Paints and Coatings; Laboratory Chemicals; Other Formulations, Mixtures, and Reaction
Products)
Figure 1-4. Percentage of DINP Production Volume by Use
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1.1.2 Conditions of Use Included in the Risk Evaluation
The final scope for DINP (U.S. EPA. 202 lc) identified and described the life cycle stages, categories,
and subcategories that comprise TSCA COUs that EPA planned to consider in the risk evaluation. All
COUs for DINP included in this risk evaluation are reflected in the LCD (Figure 1-3) and conceptual
models (Section 1.1.2.1). Table 1-1 below presents all COUs for DINP.
In the risk evaluation, EPA made updates to the COUs listed in the final scope document (U.S. EPA.
2| ) and draft risk evaluation of DINP. These updates reflect EPA's improved understanding of the
COUs based on further outreach, public comments, and updated industry code names under the CDR for
2020. Updates included (1) additions and clarification of COUs based on new reporting in CDR for
2020 or information received from stakeholders, (2) consolidation of redundant COUs from the
processing lifestage based on inconsistencies found in CDR reporting for DINP processing and uses as
well as communications with stakeholders about the use of DINP in industry, and (3) correction of typos
or edits for consistency. A complete list of updates and explanations of the updates made to COUs for
DINP from the final scope document and draft risk evaluation to this completed risk evaluation is
provided in Appendix D. Table 1-1 presents the revised COUs that were included and evaluated in the
risk evaluation for DINP. Appendix E contains descriptions of each COU. In this risk evaluation, EPA
has updated the COU table and described any changes made in either the COU table or the titles of the
COU's provided in Appendix D.
Page 20 of 269
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Table 1-1. Categories and Subcategories of Use and Corresponding Exposure Scenario in the Risk Evaluation for DINP
Life Cycle Stage"
Category''
Subcategory of Use"'
Reference(s)
(CASRN 28553-12-0)
Reference(s)
(CASRN 68515-48-0)
Manufacturing
Domestic
manufacturing
Domestic manufacturing^
(U.S. EPA. 2019a. c)
(U.S. EPA, 2019a. c)
Importing
Importing^
(U.S. EPA. 2019a. c)
(U.S. EPA. 2019a. c)
Processing
Incorporation
in formulation,
mixture, or
reaction
product
Heat stabilizer and processing aid in basic organic
chemical manufacturing
(U.S. EPA. 2020a. 2019a)
Plasticizers (adhesives manufacturing, custom
compounding of purchased resin; paint and coating
manufacturing; plastic material and resin
manufacturing; synthetic rubber manufacturing;
wholesale and retail trade; all other chemical product
and preparation manufacturing; ink, toner, and
colorant manufacturing [including pigment])
(U.S. EPA. 2020a. 2019a)
EPA -HO -OPPT-2018-0436-
0019; EPA-HO-OPPT-
(U.S. EPA. 2020a. 2019a:
Polvone. 2018: Silver Fern
Chemical Inc.. 2015) EPA-
2018-043c 001 S
HO-OPPT-2018-043 6-0019
Incorporation
into articles
Plasticizers (toys, playground and sporting equipment
manufacturing; plastics products manufacturing;
rubber product manufacturing; wholesale and retail
trade; textiles, apparel, and leather manufacturing;
electrical equipment, appliance, and component
manufacturing; ink, toner, and colorant manufacturing
[including pigment])
(U.S. EPA. 2020a. 2019a:
O'Sullivan Films Inc., 2016)
(U.S. EPA. 2020a. 2019a:
Polvone. 2018) EPA-HO-
EPA -HO -OPPT-2018-0436-
OPPT-2018-043 6-0019
00IS ' (1 s (JO-OPPT-
2018-0436-0019
Other uses
Miscellaneous processing (petroleum refineries;
wholesale and retail trade)
(U.S. EPA. 2020a. 2016)
(U.S. EPA. 2020a. 2019a.
2016)
Repackaging
Plasticizer (all other chemical product and preparation
manufacturing; wholesale and retail trade; laboratory
chemicals manufacturing)
(U.S. EPA. 2020a: TCI
America, 2019:1
2019a)
(U.S. EPA. 2019a)
Recycling
Recycling
(U.S. EPA, 2019a)
Distribution in
Commerce
Distribution in
commerce
Distribution in commerce
Page 21 of 269
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Life Cycle Stage"
Category''
Subcategory of Use"'
Reference(s)
(CASRN 28553-12-0)
Reference(s)
(CASRN 68515-48-0)
Adhesive and
sealant
chemicals
Adhesive and sealant chemicals (sealant (barrier) in
machinery manufacturing; computer and electronic
product manufacturing; electrical equipment,
appliance, component manufacturing, and
adhesion/cohesion promoter in transportation
equipment manufacturing)d
(U.S. EPA. 2020a; Tremco.
2019; U.S. EPA. 2019a. c)
(U.S. EPA. 2019c)
Construction,
Building/construction materials (roofing, pool liners,
window shades, flooring, water supply piping)''
(U.S. EPA. 2019c)
(U.S. EPA. 2019c)
Industrial Use
paint,
electrical, and
metal products
Paints and coatings^
(Freeman Manufacturing
and SuddIv Company,
2018) EPA-HO-OPPT-
2018-0436-0032
EPA-HO-OPPT-2018-0436-
0032
Hydraulic fluids
EPA -HO -OPPT-2018-0436-
0019
EPA-HO-OPPT-2018-0436-
0019
Other uses
Pigment (leak detection)
(U.S. EPA. 2019c)
EPA -HO -OPPT-2018-0436-
0019
(U.S. EPA. 2019c)
EPA-HO-OPPT-2018-0436-
0019
Automotive articles
(U.S. EPA. 2019c)
(U.S. EPA. 2019c)
Adhesives and sealants^
(U.S. EPA. 2020a. 2019c;
3M.: )
(U.S. EPA. 2019c)
Commercial Use
Construction,
paint,
electrical, and
metal products
Plasticizer in building/construction materials (roofing,
pool liners, window shades, water supply piping);
construction and building materials covering large
surface areas, including paper articles; metal articles;
stone, plaster, cement, glass, and ceramic articles^
(U.S. EPA. 2020a. 2019a. c)
(U.S. EPA. 2019a. c)
Electrical and electronic products^
(U.S. EPA. 2020a. 2019a. c)
(U.S. EPA. 2020a. 2019a. c)
Paints and coatings^
(U.S. EPA. 2020a. 2019c)
(U.S. EPA. 2019c)
Furnishing,
cleaning,
treatment/care
products
Foam seating and bedding products; furniture and
furnishings including plastic articles (soft); leather
articles
( :HPP. 2023; U.S.
EPA. 2019a; U.S. CPSC.
2015) EPA-HO-OPPT-
2018-0436-0046; EPA-HO-
( >P. 2023; U.S. EPA.
2020a. 2019a; U.S. CPSC.
2015)
EPA-HO-OPPT-2018-0436-
Page 22 of 269
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Life Cycle Stage"
Category''
Subcategory of Use"'
Reference(s)
(CASRN 28553-12-0)
Reference(s)
(CASRN 68515-48-0)
Commercial Use
Furnishing,
cleaning,
treatment/care
products
OPPI-2018-0436-0047;
EPA -HO -OPPT-2018-0436-
0048; EPA-HO-OPPT-
2018-0436-0049; EPA-HO-
OPPT-2018-0436-0050
0046; EPA-HO-OPPT-2018-
0436-0047; EPA-HO-OPPT-
2018-0436-0048; EPA-HO-
OPPT-2018-0436-0049;
EPA-HO-OPPT-2018-0436-
0050
Air care products
(Rustic Escentuals, 2015)
Floor coverings; plasticizer in construction and
building materials covering large surface areas
including stone, plaster, cement, glass, and ceramic
articles; fabrics, textiles and apparel (vinyl tiles,
resilient flooring, PVC-backed carpeting) d
( :HPP. 2023: U.S.
EPA. 2020a. 2019c)
(v»» «'PP. 2023: U.S. EPA.
2019a. c)
Fabric, textile, and leather products (apparel and
footwear care products)
( :HPP. 2023: U.S.
EPA. 2019a)
(v»» «'PP. 2023: U.S. EPA.
2020a. 2019a)
Packaging,
paper, plastic,
hobby products
Arts, crafts, and hobby materials
(U.S. EPA. 202Id)
(U.S. EPA. 202Id)
Ink, toner, and colorant products^
( :HPP.2023:Evonik
Industries. 2019; U.S. EPA.
( >P. 2023; U.S. EPA.
2019c: Polvone. .VIS) ( rs
2019c: Porelon. 2007) EPA-
HO-OPPI-2018-0436-0055
HO-OPPT-2018-0436-0055
Packaging, paper, plastic, hobby products (packaging
[excluding food packaging], including rubber articles;
plastic articles [hard]; plastic articles [soft])
(U.S. EPA. 2020a)
(U.S. EPA. 2020a)
Plasticizer (plastic and rubber products; tool handles,
flexible tubes, profiles, and hoses)d
(U.S. EPA. 2020a. 2019a. c)
(U.S. EPA. 2019a. c)
Toys, playground, and sporting equipment^
( :HPP. 2023; U.S.
EPA. 2019a. c)
(mi «'PP. 2023; U.S. EPA.
2019a. c)
Solvents (for
cleaning or
degreasing)
Solvents (for cleaning or degreasing)
(CCW. 2020: Green
Mountain International.
2008)
Other uses
Laboratory chemicals
(Sigma Aldricli, 2024; Soex
EPA-HO-OPPT-2018-0504-
Certioreo LLC. 2019; TCI
0019
Page 23 of 269
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Life Cycle Stage"
Category''
Subcategory of Use"'
Reference(s)
(CASRN 28553-12-0)
Reference(s)
(CASRN 68515-48-0)
Commercial Use
Other uses
America. 2019; Solvents
and Petroleum Service,
2009)
EPA -HO -OPPT-2018-0504-
0019
Automotive articles
(Siema Aldricli, 2024; Soex
CertioreD LLC, 2019; TCI
America. 2019; I
2019c; Solvents and
Petroleum Service, 2009)
(U.S. EPA. 2019c)
Consumer Use
Construction,
paint,
electrical, and
metal products
Adhesives and sealants^
(U.S. EPA, 2019a. c)
(U.S. EPA. 2019a. c)
Building construction materials (wire and cable
jacketing, wall coverings, roofing, pool applications,
water supply piping, etc.) d
( :HPP. 2023; U.S.
EPA. 2020a. 2019a. c)
(v»» «'PP. 2023; U.S. EPA.
2019a. c)
Electrical and electronic products^
(U.S. EPA. 2019a. c)
(U.S. EPA. 2020a. 2019a. c)
Paint and coatings^
(U.S. EPA. 2019a. c)
(U.S. EPA. 2019a. c)
Furnishing,
cleaning,
treatment/care
products
Foam seating and bedding products; furniture and
furnishings including plastic articles (soft); leather
articles
( :,HPP. 2023; U.S.
EPA. 2019a; U.S. CPSC.
2015)
EPA -HO -OPPT-2018-0436-
0046; EPA-HO-OPPT-
2018-042 10-
OPPT-2018-0436-0048;
EPA -HO -OPPT-2018-0436-
0049; EPA-HO-OPPT-
2018-0436-0050
( >P. 2023; U.S. EPA.
2019a; U.S. CPSC. 2015)
EPA-HO-OPPT-2018-0436-
0046; EPA-HO-OPPT-2018-
0436-0047; EPA-HO-OPPT-
2018-0436-0048; EPA-HO-
OPPT-2018-0436-0049;
EPA-HO-OPPT-2018-0436-
0050
Floor coverings; plasticizer in construction and
building materials covering large surface areas
including stone, plaster, cement, glass, and ceramic
articles; fabrics, textiles and apparel (vinyl tiles,
resilient flooring, PVC-backed carpeting)''
( :HPP. 2023; U.S.
EPA. 2019a. c)
(v»» «'PP. 2023; U.S. EPA.
2019a. c)
Air care products
(Rustic Escentuals, 2015)
Page 24 of 269
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Life Cycle Stage"
Category''
Subcategory of Use"'
Reference(s)
(CASRN 28553-12-0)
Reference(s)
(CASRN 68515-48-0)
Consumer Use
Fabric, textile, and leather products (apparel and
footwear care products)''
( : HPP. 2023: U.S.
EPA. 2020a. 2019a)
(m> «'PP. 2023: U.S. EPA.
2019a)
Packaging,
paper, plastic,
hobby products
Arts, crafts, and hobby materials
(U.S. EPA. 2021d)
(U.S. EPA. 2021d)
Ink, toner, and colorant products^
( : HPP. 2023; Evonik
Industries, 2019; U.S. EPA,
2019c: Porelon. 2007)
EPA-HO-OPPI-2018-0436-
0055
( >P. 2023; U.S. EPA.
2019c)
EPA-HO-OPPT-2018-0436-
0055
Other articles with routine direct contact during
normal use including rubber articles; plastic articles
(hard); vinyl tape; flexible tubes; profiles; hoses''
(U.S. EPA. 2019a. c)
(U.S. EPA. 2020a. 2019a. c)
Packaging (excluding food packaging), including
rubber articles; plastic articles (hard); plastic articles
(soft)
(U.S. EPA. 2020a)
Toys, playground, and sporting equipment^
( : HPP. 2023: U.S.
EPA. 2019a. c)
(m> «'PP. 2023: U.S. EPA.
2019a. c)
Other uses
Novelty articles
(U.S. EPA. 2019c: Stabile.
2013)
(U.S. EPA. 2019c: Stabile.
2013)
Automotive articles
(U.S. EPA. 2019c)
(U.S. EPA. 2019c)
Disposal
Disposal
Disposal
" Life Cycle Stage Use Definitions (40 CFR 711.3)
- "Industrial use" means use at a site at which one or more chemicals or mixtures are manufactured (including imported) or processed.
- "Commercial use" means the use of a chemical or a mixture containing a chemical (including as part of an article) in a commercial enterprise providing saleable
goods or services.
- "Consumer use" means the use of a chemical or a mixture containing a chemical (including as part of an article, such as furniture or clothing) when sold to or
made available to consumers for their use.
- Although EPA has identified both industrial and commercial uses here for purposes of distinguishing scenarios in this document, the Agency interprets the
authority over "any manner or method of commercial use" under TSCA section 6(a)(5) to reach both.
b These categories of COUs appear in the life cycle diagram, reflect CDR codes, and broadly represent COUs of DINP in industrial and/or commercial settings.
c These subcategories reflect more specific COUs of DINP.
d Circumstances on which ACC HPP is requesting that EPA conduct a risk evaluation. DINP is no longer processed into toys at concentrations greater than 0.1%
(processing into articles); however, EPA will evaluate risk from toys already in commerce that contain DINP and newer toys that may contain up to 0.1% DINP. In
addition, DINP processing into playground and sporting equipment is ongoing.
Page 25 of 269
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Life Cycle Stage"
Category''
Subcategory of Use"'
Reference(s)
(CASRN 28553-12-0)
Reference(s)
(CASRN 68515-48-0)
e In the final scope document, EPA added the following TSCA COUs: processing aids not otherwise listed (mixed metal stabilizer); and foam seating and bedding
products, air care products, furniture and furnishings not covered elsewhere (EPA-HO-OPPT-2018-0436-0028). Due to additional information from stakeholder
outreach, public comments, and further research, the following COU was removed after the publication of the draft scope document: personal care products.
Page 26 of 269
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1.1.2.1 Conceptual Models
The conceptual model in Figure 1-5 presents the exposure pathways, exposure routes, and hazards to
human populations from industrial and commercial activities and uses of DINP. There is potential for
exposures to workers and/or ONUs via inhalation and via dermal contact. The conceptual model also
includes potential ONU dermal exposure to DINP in mists and dusts deposited on surfaces. EPA
evaluated activities resulting in exposures associated with distribution in commerce (e.g., loading,
unloading) throughout the various life cycle stages and COUs (e.g., manufacturing, processing,
industrial use, commercial use, and disposal), as well as qualitatively through a single distribution
scenario.
Figure 1-6 presents the conceptual model for consumer activities and uses, Figure 1-7 presents general
population exposure pathways and hazards for environmental releases and wastes, and Figure 1-8
presents the conceptual model for ecological exposures and hazards from environmental releases and
wastes.
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Industrial and Commercial Exposure Pathway Exposure Route Populations Hazards
Activities / Uses"
Figure 1-5. DINP Conceptual Model for Industrial and Commercial Activities and Uses: Potential Exposure and Hazards
11 Some products are used in both commercial and consumer applications. See Table 1-1 for categories and subcategories of COUs.
h Fugitive air emissions are emissions that are not routed through a stack and include fugitive equipment leaks from valves, pump seals, flanges,
compressors, sampling connections and open-ended lines; evaporative losses from surface impoundment and spills; and releases from building ventilation
systems.
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CONSUMER ACTIVITIES/
USES
EXPOSURE
PATHWAYS
EXPOSURE
ROUTES
POPULATIONS
EXPOSED
HAZARDS
Construction, paint electrical, and
metal products
Furnishing, cleaning, treatment care
products
Packaging, paper, plastic, hobby
products
(iquid Article A
Product J
Solid Article
Product
Other uses
Hazards potentially
associated with scute.
Intermediate, and
chronic exposures
Key:
Dash Arrow
Solid Arrow
Pathways and routes that were assessed liquid product and articles
Pathways and routes that were assessed all products and articles
Consumer Handiing of Disposal and
Waste
Wastewater, Liquid Wastes and Solid
~ Wastes (See Environmental Releases
Conceptual Models)
Figure 1-6. DINP Conceptual Model for Consumer Activities and Uses: Potential Exposures and Hazards
The conceptual model presents the exposure pathways, exposure routes, and hazards to human populations from consumer activities and uses of DINP.
Page 29 of 269
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RELEASES AND WASTES FROM INDUSTRIAL ,
COMMERCIAL / CONSUMER USES
EXPOSURE PATHWAYS
EXPOSURE ROUTES
POPULATIONS
HAZARDS
Wastewater or
Liquid Wastes
Solid Wastes
Liquid Wastes
Industrial Pre-
-~ Treatment or
Industrial WWT
Indirect discharge
t
POTW
£
Hazardous and
-~ Municipal Waste
Landfill
Hazardous and
—~ Municipal Waste
Incinerators
OiT-&ite Waste
Transfer
Recycling. Other
Treatment
Hazards Potentially
Associated with Lifetime
Cancer and'or Non-Cancer
Chronic Exposures
Key:
Gray Text and Arrow
Solid Arrow
Pathways and routes that were not assessed
Pathways and routes that were further assessed
Emissions to Air
Figure 1-7. DINP Conceptual Model for Environmental Releases and Wastes: General Population Hazards
The conceptual model presents the exposure pathways, exposure routes, and hazards to human populations from releases and wastes from industrial,
commercial, and/or consumer uses of DINP.
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RELEASES AND WASTES FROM INDUSTRIAL
C OMMERCIAL! CONSXTJER USES
EXPOSURE PATHWAYS
POPULATIONS
EXPOSED
HAZARDS
Figure 1-8. DINP Conceptual Model for Environmental Releases and Wastes: Ecological Exposures and Hazards
The conceptual model presents the exposure pathways, exposure routes, and hazards to ecological receptors from releases and wastes from industrial,
commercial, and/or consumer uses of DINP.
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1.1.3 Populations and Durations of Exposure Assessed
Based on the conceptual models presented in Section 1.1.2.1, EPA evaluated risk to environmental and
human populations. Environmental risks were evaluated for acute and chronic exposure scenarios for
aquatic and terrestrial species, as appropriate. Human health risks were evaluated for acute,
intermediate, and chronic exposure scenarios, as applicable based on reasonably available exposure and
hazard data as well as the relevant populations for each. Human populations assessed include
• workers, including average adults and women of reproductive age;
• ONUs, including average adults;
• consumers, including infants (<1 year), toddlers (1-2 years), children (3-5 and
young teens (11-15 years), teenagers (16-20 years), and adults (21+ years);
• bystanders, including infants (<1 year), toddlers (1-2 years), and children (3-5
and
• general population, including infants, children, youth, and adults.
1.1.3.1 Potentially Exposed and Susceptible Subpopulations
TSCA section 6(b)(4)(A) requires that risk evaluations "determine whether a chemical substance
presents an unreasonable risk of injury to health or the environment, without consideration of costs or
other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible
subpopulation identified as relevant to the risk evaluation by the Administrator, under the conditions of
use." TSCA section 3(12) states that "the term 'potentially exposed or susceptible subpopulation'
[PESS] means a group of individuals within the general population identified by the Administrator who,
due to either greater susceptibility or greater exposure, may be at greater risk than the general population
of adverse health effects from exposure to a chemical substance or mixture, such as infants, children,
pregnant women, workers, the elderly, or overburdened communities."
This risk evaluation considers PESS throughout the human health risk assessment (Section 4), including
throughout the exposure assessment, hazard identification, and dose-response analysis supporting this
assessment. EPA incorporated the following PESS into its assessment: women of reproductive
age/pregnant women, infants, children and adolescents, people who frequently use consumer products
and/or articles containing high concentrations of DINP, people exposed to DINP in the workplace, and
tribes and subsistence fishers whose diets include large amounts of fish. These subpopulations are PESS
because some have greater exposure to DINP per body weight (e.g., infants, children, adolescents) or
due to age-specific behaviors (e.g., hand-to-mouth ingestion from synthetic leather furniture by infants
and children assessed in the consumer exposure scenarios), while some experience aggregate or sentinel
exposures.
Section 4.3.5 summarizes (1) how PESS were incorporated into the risk evaluation through
consideration of potentially increased exposures and/or potentially increased biological susceptibility;
and (2) additional sources of uncertainty related to consideration of PESS.
1.2 Organization of the Risk Evaluation
This risk evaluation for DINP includes five additional major sections, and several appendices, including:
• Section 2 summarizes basic physical and chemical characteristics as well as the fate and
transport of DINP.
• Section 3 includes an overview of releases and concentrations of DINP in the environment.
6-10 years),
and 6-10 years);
Page 32 of 269
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• Section 4 presents the human health risk assessment, including the exposure, hazard, and risk
characterization based on the COUs. It includes a discussion of PESS based on both greater
exposure and/or susceptibility, as well as a description of aggregate and sentinel exposures.
Section 4 also discusses assumptions and uncertainties and how they potentially impact the
strength of the evidence of risk evaluation.
• Section 5 provides a discussion and analysis of the environmental risk assessment, including the
environmental exposure, hazard, and risk characterization based on the COUs for DINP. It also
discusses assumptions and uncertainties and how they potentially impact the strength of the
evidence of risk evaluation.
• Section 6 presents EPA's determination of whether the chemical presents an unreasonable risk to
human health or the environment as a whole chemical approach and under the assessed COUs.
• Appendix A provides a list of key abbreviations and acronyms used throughout this risk
evaluation.
• Appendix B provides a brief summary of the federal, state, and international regulatory history of
DINP.
• Appendix C incudes a list and citations for all TSDs and supplemental files included in the risk
evaluation for DINP.
• Appendix D provides a summary of updates made to COUs for DINP from the final scope
document to this risk evaluation.
• Appendix E provides descriptions of the DINP COUs evaluated by EPA.
• Appendix F provides the occupational exposure value for DINP that was derived by EPA.
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2 CHEMISTRY AND FATE AND TRANSPORT OF DINP
Physical and chemical properties determine the behavior and characteristics of a chemical that inform its
condition of use, environmental fate and transport, potential toxicity, exposure pathways, routes, and
hazards. Environmental fate and transport includes environmental partitioning, accumulation,
degradation, and transformation processes. Environmental transport is the movement of the chemical
within and between environmental media such as air, water, soil, and sediment. Thus, understanding the
environmental fate of DINP informs the specific exposure pathways as well as potential human and
environmental exposed populations that EPA considered in this risk evaluation.
Sections 2.1 and 2.2 summarize the physical and chemical properties and environmental fate and
transport of DINP, respectively. See the Physical Chemistry Assessment for Diisononyl Phthalate
(DINP) (U.S. EPA. 2025v) and Fate Assessment for Diisononyl Phthalate (DINP) ( 2025s)
provide further details.
2.1 Summary of Physical and Chemical Properties
EPA gathered and evaluated physical and chemical property data and information according to the
process described in the Systematic Review Protocol for Diisononyl Phthalate (DINP) (U.S. EPA.
2025aa). During the evaluation of DINP, EPA considered both measured and estimated physical and
chemical property data/information summarized in Table 2-1, as applicable. Information on the full,
extracted dataset is available in the Data Quality Evaluation and Data Extraction Information for
Physical and Chemical Properties for Diisononyl Phthalate (DINP) ( 2025j_).
Table 2-1. Physical and Chemical Properties of DINP
Property
Selected Value(s)
Reference(s)
Data Quality
Rating
Molecular formula
C26H42O4
Molecular weight
418.62 g/mol
Physical form
Clear Liquid
fNLM. 2015)
High
Melting point
l
00
0
O
CO'Neil. ..Oi 0
High
Boiling point
>400 °C
( )
High
Density
0.97578 g/cm3
(De Lorenzi et al. 1998)
High
Vapor pressure
5.40E-07 mmHg
( )
High
Water solubility
0.00061 mg/L
(Letinski et al.. 2002)
High
Octanol:water partition
coefficient (log Kow)
8.8
( )
High
Octanol:air partition
coefficient (log Koa)
11.9 (EPI Suite™)
( 2017)
High
Henry's Law constant
9.14E-05 atmm3/mol at 25 °C
(Cousins and Mackav. 2000)
High
Flash point
213 °C
CO'Neil. 2013)
High
Autoflammability
400 °C
(H n \ .01 )
High
Viscosity
77.6 cP
( )
High
2.2 Summary of Environmental Fate and Transport
Reasonably available environmental fate data—including biotic and abiotic biodegradation rates,
removal during wastewater treatment, volatilization from lakes and rivers, and organic carbon:water
partition coefficient (log Koc)—are the parameters used in the risk evaluation. In assessing the
environmental fate and transport of DINP, EPA considered the full range of results from the available
Page 34 of 269
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highest quality data sources obtained during systematic review. Information on the full extracted dataset
is available in the Data Quality Evaluation and Data Extraction Information for Environmental Fate
and Transport for Diisononyl Phthalate (DINP) ( ?25h). Other fate estimates were based on
modeling results from EPI Suite™ (U.S. EPA. 20121 a predictive tool for physical and chemical
properties and environmental fate estimation.
DINP is considered ubiquitous in various environmental media due to its presence in both point and
non-point source discharges from industrial and conventional wastewater treatment effluents, biosolids,
and sewage sludge, storm water runoff, and landfill leachate (Net et at.. 2015). As an isomeric mixture,
the fate and transport properties of DINP can be difficult to classify. EPA evaluated the reasonably
available information to characterize the environmental fate and transport of DINP, the key points of the
Fate Assessment for Diisononyl Phthalate (DINP) ( :5s) are summarized below.
Given the consistent results from numerous high-quality studies, there is robust evidence that DINP
• Is expected to undergo significant direct photolysis and will rapidly degrade in the atmosphere
(ti/2 = 8.5 hours).
• Is expected to degrade rapidly via direct and indirect photolysis.
• Is not expected to appreciably hydrolyze under environmental conditions.
• Is expected to have environmental biodegradation half-life in aerobic environments on the order
of days to weeks.
• Is not expected to be subject to long range transport.
• Is expected to transform in the environment via biotic and abiotic processes to form
monoisononyl phthalate, isononanol, and phthalic acid.
• Is expected to show strong affinity and sorption potential for organic carbon in soil and sediment.
• Will be removed at rates greater than 94 percent in conventional wastewater treatment systems.
• When released to air, will not likely exist in gaseous phase, but will show strong affinity for
adsorption to particulate matter.
• Is likely to be found in, and accumulate in, indoor dust.
As a result of limited studies identified, there is moderate confidence that DINP
• Is not expected to biodegrade under anoxic conditions and may have high persistence in
anaerobic soils and sediments.
• Has limited bioaccumulation potential in fish in the water column.
• Has limited bioaccumulation potential in benthic organisms exposed to sediment with elevated
concentrations of DINP proximal to continual sources of release.
• Is expected to be removed in conventional water treatment systems both in the treatment process,
and via reduction by chlorination and chlorination byproducts in post-treatment storage and
drinking water conveyance.
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3 RELEASES AND CONCENTRATIONS OF DINP IN THE
ENVIRONMENT
EPA estimated environmental releases and concentrations of DINP. Section 3.1 describes the approach
and methodology for estimating releases. Section 3.2 presents estimates of environmental releases and
Section 3.3 presents the approach and methodology for estimating environmental concentrations as well
as a summary of concentrations of DINP in the environment.
3.1 Approach and Methodology
At the time of this risk evaluation, releases of DINP have not been reported to programmatic databases
including Discharge Monitoring Report (DMR) or National Emissions Inventory (NEI). Although DINP
was added to the Toxics Release Inventory (TRI) in 2023 (; 39), releases of DINP to this
database were not available at the time of this drat risk evaluation. Therefore, EPA utilized models to
estimate environmental releases for each OES. This section provides an overview of the approach and
methodology for assessing releases to the environment from industrial, commercial, and consumer uses.
Specifically, Sections 3.1.1 through 3.1.3 describe the approach and methodology for estimating releases
to the environment from industrial and commercial uses, and Section 3.1.4 describes the approach and
methodology for assessing down-the-drain releases from consumer uses.
3.1.1 Manufacturing, Processing, Industrial and Commercial
This subsection describes the grouping of manufacturing, processing, industrial and commercial COUs
into OESs as well as the use of DINP within each OES. Specifically, Section 3.1.1.1 provides a
crosswalk of COUs to OESs and Section 0 provides descriptions for the use of DINP within each OES.
3.1.1.1 Crosswalk of Conditions of Use to Occupational Exposure Scenarios
EPA categorized the COUs listed in Table 1-1 into OESs. Table 3-1 provides a crosswalk between the
COUs and OESs. Each OES is developed based on a set of occupational activities and conditions such
that similar occupational exposures and environmental releases are expected from the use(s) covered
under that OES. For each OES, EPA provided occupational exposure and environmental release results,
which are expected to be representative of the entire population of workers and sites for the given OES
in the United States. In some cases, EPA defined only a single OES for multiple COUs, while in other
cases the Agency developed multiple OESs for a single COU. EPA made this determination by
considering variability in release and use conditions and whether the variability required discrete
scenarios or could be captured as a distribution of exposures. The Environmental Release and
Occupational Exposure Assessment for Diisononyl Phthalate (DINP) (U.S. EPA. 2025r) provides
further information on specific OESs.
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Table 3-1. Crosswalk of COUs to Assessed OESs
Life Cycle
Stage
Category
Subcategory
OES
Manufacturing
Domestic
manufacturing
Domestic manufacturing
Manufacturing
Importing
Importing
Import and repackaging
Repackaging
Plasticizer (all other chemical product and preparation manufacturing;
wholesale and retail trade; laboratory chemicals manufacturing)
Import and repackaging
Other uses
Miscellaneous processing (petroleum refineries; wholesale and retail trade)
Incorporation into other formulations, mixtures, or
reaction products
Incorporation into
formulation,
mixture, or
reaction product
Heat stabilizer and processing aid in basic organic chemical manufacturing
Incorporation into other formulations, mixtures, or
reaction products
Processing
Plasticizers (adhesives manufacturing, custom compounding of purchased
resin; paint and coating manufacturing; plastic material and resin
manufacturing; synthetic rubber manufacturing; wholesale and retail trade;
all other chemical product and preparation manufacturing; ink, toner, and
colorant manufacturing [including pigment])
Incorporation into adhesives and sealants;
Incorporation into paints and coatings;
Incorporation into other formulations, mixtures, or
reaction products; PVC material compounding;
Non-PVC material compounding
Incorporation into
articles
Plasticizers (playground and sporting equipment manufacturing;
plastics products manufacturing; rubber product manufacturing; wholesale
and retail trade; textiles, apparel, and leather manufacturing; electrical
equipment, appliance, and component manufacturing; ink, toner, and
colorant manufacturing [including pigment])
PVC plastics converting;
Non-PVC material converting
Recycling
Recycling
Recycling
Disposal
Disposal
Disposal
Disposal
Distribution in
Commerce
Distribution in
commerce
Distribution in commerce
Distribution in commerce
Adhesive and
sealant chemicals
Adhesive and sealant chemicals (sealant (barrier) in machinery
manufacturing; computer and electronic product manufacturing; electrical
equipment, appliance, component manufacturing; and adhesion/cohesion
promoter in transportation equipment manufacturing)
Application of adhesives and sealants
Industrial Uses
Construction,
paint, electrical,
Building/construction materials (roofing, pool liners, window shades,
flooring, water supply piping)
Fabrication or use of final product or articles
and metal
products
Paints and coatings
Application of paints and coatings
Hydraulic fluids
Use of lubricants and functional fluids
Other uses
Pigment (leak detection)
Application of paints and coatings
Automotive articles
Fabrication or use of final product or article
Page 37 of 269
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Life Cycle
Stage
Category
Subcategory
OES
Construction,
paint, electrical,
and metal
products
Adhesives and sealants
Application of adhesives and sealants
Plasticizer in building/construction materials (roofing, pool liners, window
shades, water supply piping); construction and building materials covering
large surface areas, including paper articles; metal articles; stone, plaster,
cement, glass, and ceramic articles
Fabrication or use of final product or articles
Electrical and electronic products
Fabrication or use of final product or articles
Paints and coatings
Application of paints and coatings
Foam seating and bedding products; furniture and furnishings including
plastic articles (soft); leather articles
Fabrication or use of final product or articles
Furnishing,
cleaning,
treatment/care
products
Air care products
Incorporation into other formulations, mixtures, or
reaction products
Commercial
Use
Floor coverings; plasticizer in construction and building materials covering
large surface areas including stone, plaster, cement, glass, and ceramic
articles; fabrics, textiles and apparel (vinyl tiles, resilient flooring, PVC-
backed carpeting)
Fabrication or use of final product or articles
Fabric, textile, and leather products (apparel and footwear care products)
Fabrication or use of final product or articles
Arts, crafts, and hobby materials
Fabrication or use of final product or articles
Ink, toner, and colorant products
Application of paints and coatings
Packaging, paper,
plastic, hobby
products
Packaging, paper, plastic, hobby products (packaging [excluding food
packaging], including rubber articles; plastic articles [hard]; plastic articles
[soft])
Fabrication or use of final product or articles
Plasticizer (plastic and rubber products; tool handles, flexible tubes,
profiles, and hoses)
Fabrication or use of final product or articles
Toys, playground, and sporting equipment
Fabrication or use of final product or articles
Other uses
Laboratory chemicals
Use of laboratory chemicals
Automotive articles
Fabrication or use of final product or article
Solvents (for
cleaning or
degreasing)
Solvents (for cleaning or degreasing)
Use of lubricants and functional fluids
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3.1.1.2 Description of DINP Use for Each OES
After EPA characterized the OESs for the occupational exposure assessment of DINP, the occupational
uses of DINP for all OESs were summarized. Brief summaries of the uses of DINP for all OESs are
presented in Table 3-2.
Table 3-2. Description of the Function of DINP for Each OES
OES
Role/Function of DINP
Manufacturing
DINP is typically produced through the reaction of phthalic anhydride
and isononyl alcohol using an acid catalyst. The first form is
manufactured from a C9 alcohol, which is n-butene-based while the
second form is manufactured from a C8-C10 alcohol fraction.
Import and repackaging
DINP is imported domestically for use and/or may be repackaged before
shipment to formulation sites.
PVC plastics compounding
DINP is used in PVC plastics to increase flexibility.
PVC plastics converting
DINP is used in PVC plastics to increase flexibility.
Incorporation into adhesives and
sealants
DINP is a plasticizer in adhesive and sealant products for industrial and
commercial use.
Incorporation into paints and
coatings
DINP is a plasticizer in paint and coating products for industrial and
commercial use.
Incorporation into other
formulations, mixtures, or reaction
products, not covered elsewhere
DINP is incorporated into products, such as cleaning solvents, penetrants,
and printing inks.
Non-PVC material compounding
DINP is used in non-PVC polymers, such as polyurethane resin, rubber
erasers, and synthetic rubber.
Non-PVC material converting
DINP is used in non-PVC polymers, such as polyurethane resin, rubber
erasers, and synthetic rubber.
Application of adhesives and
sealants
Industrial and commercial sites apply DINP-containing adhesives and
sealants using roll or bead application methods. Products may also be
applied using a syringe, caulk gun, or spray gun.
Application of paints and coatings
Commercial sites apply DINP-containing paints and coatings using roll,
brush, trowel, and spray application methods.
Use of laboratory chemicals
DINP is a laboratory chemical used for laboratory analyses in solid and
liquid forms.
Use of lubricants and functional
fluids
DINP is incorporated into lubricants and functional fluids in both
commercial and industrial processes.
Recycling and disposal
Upon manufacture or use of DINP-containing products, residual chemical
is disposed and released to air, wastewater, or disposal facilities. A
fraction of PVC plastics is recycled either in-house or at PVC recycling
facilities for continuous compounding of new PVC material.
Fabrication and final use of
products or articles
DINP is found in a wide array of different final articles not found in other
OES including floor matting, erasers, glass filaments, and wall coverings.
3.1.2 Estimating the Number of Release Days per Year for Facilities in Each OES
Based on the limited reasonably available data on the number of release days for the majority of the
OESs, EPA developed generic estimates of the number of operating days (days/year) for facilities in
each OES, as presented in Table 3-3. Generally, EPA does not have information on the number of
Page 39 of 269
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operating days for facilities; however, EPA used generic scenarios (GSs) or emission scenario
documents (ESDs) to assess the number of operating days for a given OES. EPA estimated average
daily releases for facilities by assuming that the number of release days is equal to the number of
operating days.
Table 3-3. Generic Estimates of Number of Operating Days per Year for Each OES
OES
Operating Days
(days/year)
Basis
Manufacturing
180
EPA assumed the number of operating days and release days equals
180 days/per year, based on industry-provided information on
operating davs (ExxonMobil 2022b).
Import and
repackaging
208 to 260
The 2022 Chemical Repackaging GS estimated the total number of
operating days based on the shift lengths of operators over the course
of a full year, or 174-260 days/year. Shift lengths include 8, 10, or 12
hour/day shifts. Release estimates that EPA assessed using Monte
Carlo modeling (see Environmental Release and Occupational
Exposure Assessment for Diisononvl Phthalate (DINP) (U.S. EPA.
2025 r)) used a 50th to 95th percentile ranse of 208-260 davs/vear
0 5- I l* \ 1022).
Incorporation into
adhesives and
sealants
250
EPA assumed year-round site operation, considering a 2-week
downtime, totaling 250 days/year.
Incorporation into
paints and coatings
250
EPA assumed year-round site operation, considering a 2-week
downtime, totaling 250 days/year.
Incorporation into
other formulations,
mixtures, and
reaction products
not covered
elsewhere
250
EPA assumed year-round site operation, considering a 2-week
downtime, totaling 250 days/year.
PVC plastics
compounding
223 to 254
The 2014 Plastic Compounding GS and 2021 plastic compounding
revised GS estimated the number of operating days as 148-264
days/year. Release estimates that EPA assessed using Monte Carlo
modeling (see Environmental Release and Occupational Exposure
Assessment for Diisononvl Phthalate (DINP) (U.S. EPA. 2025 r)) used
a 50th to 95th percentile ranee of 223-254 davs/vear (U.S. EPA,
202If. 2014c).
PVC plastics
converting
219 to 251
The 2021 Revised Draft GS on the Use of Additives in the
Thermoplastics Converting Industry estimated the number of operating
days as 138 to 253 days/year. Release estimates that EPA assessed
using Monte Carlo modeling (see Environmental Release and
Occupational Exposure Assessment for Diisononyl Phthalate (DINP)
(U.S. EPA. 2025r)) used a 50th to 95th percentile ranse of 219-251
davs/vear (U.S. EPA, 2021s).
Non-PVC material
compounding
234 to 280
The 2014 Plastic Compounding GS, 2021 Plastic Compounding
Revised GS, and the 2020 Specific Emission Release Category
(SpERC) Factsheet on Rubber Production and Processing estimated
the total number of operating days as 148-300 days/year. Release
estimates that EPA assessed using Monte Carlo modeling (see
Environmental Release and Occupational Exposure Assessment for
Page 40 of 269
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OES
Operating Days
(days/year)
Basis
Diisononvl Phthalate (DINP) (U.S. EPA, 2025 r)) used a 50th to 95th
percentile ranse of 234-280 davs/vear (U.S. EPA. 202if; ESIG.
2020b; U.S. EPA. 2014c)
Non-PVC material
converting
219 to 251
The 2021 Revised Draft GS on the Use of Additives in the
Thermoplastics Converting Industry estimated the number of operating
days as 137-254 days/year. Release estimates that EPA assessed using
Monte Carlo modeling (see Environmental Release and Occupational
Exposure Assessment for Diisononvl Phthalate (DINP) (U.S. EPA.
2025 r)) used a 5 0th to 95th percentile ranse of 219-251 davs/vear
0 5- I l* \ 2021s).
Application of
adhesives and
sealants
232 to 325
Based on several end use products categories, the 2015 ESD on the
Use of Adhesives estimated the total number of operating days as 50-
365 days/year. Release estimates that EPA assessed using Monte Carlo
modeling (Environmental Release and Occupational Exposure
Assessment for Diisononvl Phthalate (DINP) (U.S. EPA. 2025 r)) used
a 50th to 95th percentile range of 232-325 davs/vear (OECD. 2015b).
Application of
paints and coatings
257 to 287
EPA assessed the total number of operating days based on the 2011
ESD on Radiation Curable Coatings, Inks and Adhesives, the 2011
ESD on Coating Application via Spray-Painting in the Automotive
Finishing Industry, the 2004 GS on Spray Coatings in the Furniture
Industry, and the SpERC Factsheet for Industrial Application of
Coatings and Inks by Spraying. These sources estimated the total
number of operating days as 225-300 days/year. Release estimates
that EPA assessed using Monte Carlo modeling (Environmental
Release and Occupational Exposure Assessment for Diisononyl
Phthalate (DINP) (U.S. EPA, 2025r)) used a 50th to 95th percentile
ranse of 257-287 davs/vear (ESIG. 2020a; OECD. 2011a. b; U.S.
EPA. 2004b).
Use of laboratory
chemicals
Liquid: 235 to
258
Solid: 260
The 2023 Use of Laboratory Chemicals GS estimated the total number
of operating days based on the shift lengths of operators over the
course of a full year as 174-260 days/year. Shift lengths include 8, 10,
or 12 hour/day shifts. Release estimates that EPA assessed using
Monte Carlo modeling (Environmental Release and Occupational
Exposure Assessment for Diisononvl Phthalate (DINP) (U.S. EPA,
2025 r)) used a 50th to 95th percentile ranse of 235-258 davs/vear
0 5- I l* \ 2023f).
Use of lubricants
and functional
fluids
2 to 4
EPA assumed 1-4 changeouts per year based on identified product
data for different types of hydraulic fluids and the ESD on the
Lubricant and Lubricant Additives. EPA assumed each changeout
occurs over one day. Release estimates that EPA assessed using Monte
Carlo modeling used a 50th to 95th percentile range of 2-4 days/year
( CD, 2004b).
Recycling and
disposal
Recycling: 223
to 254
EPA estimated recycling and disposal releases separately. For the PVC
recycling OES, the 2014 Plastic Compounding GS and 2021 Plastic
Compounding Revised GS estimated the number of operating days as
148-264 days/year. Release estimates that EPA assessed using Monte
Carlo modeling (see Environmental Release and Occupational
Exposure Assessment for Diisononvl Phthalate (DINP) (U.S. EPA.
2025 r)) used a 50th to 95th percentile range of 223-254 days/year
Page 41 of 269
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OES
Operating Days
(days/year)
Basis
(U.S. EPA. 2021f. 2014c). EPA evaluated disposal releases within the
assessments for each OES. The Agency provided operating days for
individual OES in this table.
Fabrication and
final use of
products or articles
250
EPA assumed year-round site operation, considering a 2-week
downtime, totaling 250 days/year. However, EPA was not able to
perform a quantitative release assessment for this OES, because the
release parameters were unknown and unquantifiable.
3.1.3 Daily Release Estimation
For each OES, EPA estimated daily releases to each media of release using CDR, GSs, and ESDs, EPA
published models, and the previously published European Union DINP Risk Assessment, as shown in
Figure 3-1. Generally, EPA used 2020 CDR data (U.S. EPA. 2020a) and the 2003 EUDINP Risk
Assessment (ECJRC. 2003b) to estimate annual releases. Where available, EPA used GSs or ESDs for
applicable OES to estimate the associated number of release days. Where available, EPA used 2020
CDR, 2020 U.S. County Business Practices, and Monte Carlo modeling data to estimate the number of
sites using DINP within an OES. Generally, information for reporting sites in CDR was sufficient to
accurately characterize each reporting site's OES. Thq Environmental Release and Occupational
Exposure Assessment for Diisononyl Phthalate (DINP) (U.S. EPA. 2025r) describes EPA's approach
and methodology for estimating daily releases and provides detailed facility level results for each OES.
For each OES, EPA estimated DINP releases to each release media applicable to that OES. For DINP,
EPA assumed that releases occur to water, air, or land (i.e., disposal to land).
Figure 3-1. An Overview of How EPA Estimated Daily Releases for Each OES
CDR = Chemical Data Reporting; ESD = emission scenario document; GS = generic scenario
3.1.4 Consumer (Down-the-Drain)
EPA evaluated down-the-drain releases of DINP for consumer COUs qualitatively. Although EPA
acknowledges that there may be DINP releases to the environment via the cleaning and disposal of
adhesives, sealants, paints, lacquers, and coatings, the Agency did not quantitatively assess down-the-
drain and disposal scenarios of consumer products due to limited information from monitoring data, or
modeling tools but provides a qualitative assessment using physical and chemical properties in this
Page 42 of 269
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section. See EPA's Consumer and Indoor Dust Exposure Assessment for Diisononyl Phthalate (DINP)
( 2025b) for further details. Adhesives, sealants, paints, lacquers, and coatings can be disposed
down-the-drain while consumer users wash their hands, brushes, sponges, and other product applying
tools. In addition, these products can be disposed of when users no longer have use for them or have
reached the product shelf life and taken to landfills. All other solid products and articles in Table 4-6 can
be removed and disposed in landfills, or other waste handling locations that properly manage the
disposal of products like adhesives, sealants, paints, lacquers, and coatings. A range of drinking water
treatment removal rates from 79 percent to over 96 percent removal was observed in (Shi et at.. 2012).
and even with the use of 79 percent, all drinking water exposures resulted in minimal human exposure
and subsequent risk, see the DINP Exposure Media Concentration and General Population Technical
Support Document, ( )25q). DINP affinity to organic material and low water solubility and
log Kow suggest that DINP in down-the-drain water is expected to mainly partition to suspended solids
present in water. Also, the available information suggest that the use of flocculants and filtering media
could potentially help remove DINP during drinking water treatment by sorption into suspended organic
matter, settling, and physical removal.
3.2 Summary of Environmental Releases
3.2.1 Manufacturing, Processing, Industrial and Commercial
EPA combined its estimates for total production volume, release days, number of facilities, and hours of
release per day to estimate a range of daily releases for each OES. Table 3-4 presents a summary of
these ranges across facilities. See the Environmental Release and Occupational Exposure Assessment
for Diisononyl Phthalate (DINP) ( 25r) for additional detail on deriving the overall
confidence score for each OES. EPA was not able to estimate releases for the fabrication and final use of
products or articles OES due to the lack of reasonably available process-specific and DINP-specific
data; however, EPA expects releases from this OES to be small compared to other upstream uses (see
Section 3.14.3 of ( 2Q25r) for further description).
Page 43 of 269
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Table 3-4. Summary of EPA's Daily Release Estimates for Each PES and EPA's Overall Confidence in these Estimates
OES
Estimated Daily
Release across Sites
(kg/site-dav)
Type of Discharge," Air
Emission,6 or Transfer for
Estimated Release
Frequency across Sites
(Days) d
Number of Facilities'
Weight of
Scientific
Evidence
Rating^
Sou rccs
Central
Tendencv
High-End
Disposal'
Central
Tendency
High-End
1.66E-06
3.78E-06
Fugitive Air
2.23E-01
Stack Air
CDR, Peer-
2.05E-01
3.70E-01
Wastewater to Onsite treatment or
Discharge to POTW
180
1 - Gehring Montgomery,
Warminster, PA
Moderate
reviewed
literature
5.13
5.34
Onsite Wastewater Treatment,
Incineration, or Landfill
(GS/ESD)
2.16
3.75
Landfill
1.80E-06
3.95E-06
Fugitive Air
1.16E01
1.73E01
Stack Air
CDR, Peer-
Manufacturing
1.01E01
2.26E01
Wastewater to Onsite Treatment or
Discharge to POTW
180
3 generic sites
Moderate
reviewed
literature
2.35E02
3.50E02
Onsite Wastewater Treatment,
Incineration, or Landfill
(GS/ESD)
1.00E02
2.38E02
Landfill
4.44E-06
7.92E-06
Fugitive Air
2.76E02
4.80E02
Stack Air
CDR, Peer-
2.31E02
6.08E02
Wastewater to Onsite Treatment or
reviewed
Discharge to POTW
180
2 generic sites
Moderate
literature
5.61E03
9.75E03
Onsite Wastewater Treatment,
Incineration, or Landfill
(GS/ESD)
8.69E02
Landfill
1.57E-08
2.90E-08
Fugitive Air
1 - Henkel Louisville,
Louisville, KY
Moderate
1.47
1.70
Wastewater to Onsite Treatment,
Discharge to POTW, or Landfill
208
260
9.70E-08
1.02E-07
Fugitive Air
1 - Formosa Global
Solutions, Livingston, NJ
2.03
2.52
Wastewater to Onsite Treatment,
Discharge to POTW, or Landfill
208
260
Moderate
CDR, Peer-
Import and
1.00E-07
1.06E-07
Fugitive Air
1 - Chemspec,
Uniontown, OH
reviewed
repackaging
5.80
7.17
Wastewater to Onsite Treatment,
Discharge to POTW, or Landfill
208
260
Moderate
literature
(GS/ESD)
1.01E-07
1.07E-07
Fugitive Air
6.89
8.52
Wastewater to Onsite Treatment,
1 - Harwick Standard
discharge to POTW, or Landfill
208
260
Distribution Corp. Akron,
OH
Moderate
Page 44 of 269
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OES
Import and
repackaging
Estimated Daily
Release across Sites
(kjj/site-day)
Type of Discharge," Air
Emission,6 or Transfer for
Disposal'
Estimated Release
Frequency across Sites
(Days) d
Number of Facilities'
Weight of
Scientific
Evidence
Sou rccs
CDR, Peer-
reviewed
literature
(GS/ESD)
7.75E-08
1.07E-07
Fugitive Air
208
260
1 - Silver Fern Chemical,
Seattle, WA
Moderate
1.12E01
1.38E01
Wastewater to Onsite Treatment,
Discharge to POTW, or Landfill
1.04E-07
1.12E-07
Fugitive Air
208
260
1 - MAK Chemicals Inc.
Clifton, NJ
Moderate
1.12E01
1.39E01
Wastewater to Onsite Treatment,
Discharge to POTW, or Landfill
5.13E-08
6.71E-08
Fugitive Air
208
260
1 - Mercedes Benz,
Vance AL
Moderate
1.62E01
2.00E01
Wastewater to Onsite Treatment,
Discharge to POTW, or Landfill
5.55E-08
7.38E-08
Fugitive Air
208
260
1 - Univar Solutions,
Redmond, WA
Moderate
2.75E01
3.40E01
Wastewater to Onsite Treatment,
Discharge to POTW, or Landfill
1.22E-07
1.41E-07
Fugitive Air
208
260
1 - Belt Concepts of
America, Spring Hope,
NC
Moderate
3.45E01
4.26E01
Wastewater to Onsite Treatment,
Discharge to POTW, or Landfill
1.29E-07
1.53E-07
Fugitive Air
208
260
1 - Tribute Energy Inc.,
Houston, TX
Moderate
4.37E01
5.40E01
Wastewater to Onsite Treatment,
Discharge to POTW, or Landfill
6.15E-08
8.39E-06
Fugitive Air
208
260
1 - Geon Performance
Solutions LLC,
Louisville, KY
Moderate
4.38E01
5.41E01
Wastewater to Onsite Treatment,
Discharge to POTW, or Landfill
1.54E-07
1.97E-07
Fugitive Air
208
260
1 - Cascade Columbia
Distribution
Moderate
7.75E01
9.59E01
Wastewater to Onsite Treatment,
Discharge to POTW, or Landfill
5.10E-07
9.15E-07
Fugitive Air
208
260
1 - Alac International Inc.
New York, NY
Moderate
1.16E03
1.42E03
Wastewater to Onsite Treatment,
Discharge to POTW, or Landfill
1.93E-07
3.79E-07
Fugitive Air
208
260
10 generic sites
Moderate
2.07E02
3.51E02
Wastewater to Onsite Treatment,
Discharge to POTW, or Landfill
2.77E-06
7.88E-06
Fugitive Air
208
260
5 generic sites
Moderate
4.94E03
9.58E03
Wastewater to Onsite Treatment,
Discharge to POTW, or Landfill
Page 45 of 269
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OES
Estimated Daily
Release across Sites
(kjj/site-day)
Type of Discharge," Air
Emission,6 or Transfer for
Disposal'
Estimated Release
Frequency across Sites
(Days) d
Number of Facilities'
Weight of
Scientific
Evidence
Sou rccs
PVC plastics
compounding
3.30E01
1.46E02
Fugitive or Stack Air
223
254
110-215 generic sites
Moderate
CDR, Peer-
reviewed
literature
(GS/ESD)
8.23E01
2.74E02
Fugitive Air, Wastewater,
Incineration, or Landfill
4.28E2
6.81E02
Wastewater, Incineration, or
Landfill
1.09E02
1.64E02
Wastewater
2.23E01
1.11E02
Incineration or Landfill
PVC plastics
converting
1.58
6.94
Fugitive or Stack Air
219
251
2,386-4,662 generic sites
Moderate
CDR, Peer-
reviewed
literature
(GS/ESD)
3.92
1.30E01
Fugitive Air, Wastewater,
Incineration, or Landfill
1.54E01
2.35E01
Wastewater, Incineration, or
Landfill
5.14
7.85
Wastewater
1.43E01
2.27E01
Incineration or Landfill
Non-PVC material
compounding
5.47E01
2.15E02
Fugitive or Stack Air
234
280
5-9 generic sites
Moderate
CDR, Peer-
reviewed
literature
(GS/ESD)
4.77
1.86E01
Fugitive Air, Wastewater,
Incineration, or Landfill
1.20E03
2.60E03
Wastewater, Incineration, or
Landfill
1.11E02
1.86E02
Wastewater
7.96E01
2.81E02
Incineration or Landfill
Non-PVC material
converting
1.39
5.72
Fugitive or Stack Air
219
251
122-190 generic sites
Moderate
CDR, Peer-
reviewed
literature
(GS/ESD)
1.37E-01
5.22E-01
Fugitive Air, Wastewater,
Incineration, or Landfill
9.65
1.76E01
Wastewater, Incineration, or
Landfill
2.77
5.32
Wastewater
9.23
1.93E01
Incineration or Landfill
Incorporation into
adhesives and sealants
5.19E-09
1.78E-08
Fugitive Air
250
15-59 generic sites
Moderate
CDR, Peer-
reviewed
literature
(GS/ESD)
4.97E-09
4.10E-08
Stack Air
3.60E01
7.51E01
Wastewater, Incineration, or
Landfill
Incorporation into
paints and coatings
2.29E-06
2.06E-05
Fugitive Air
250
4-23 generic sites
Moderate
CDR, Peer-
reviewed
literature
(GS/ESD)
9.15E-09
8.24E-08
Stack Air
3.00E02
1.01E03
Wastewater, Incineration, or
Landfill
Page 46 of 269
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OES
Estimated Daily
Release across Sites
(kjj/site-day)
Type of Discharge," Air
Emission,6 or Transfer for
Disposal'
Estimated Release
Frequency across Sites
(Days) d
Number of Facilities'
Weight of
Scientific
Evidence
Sou rccs
Incorporation into
other formulations,
mixtures, and reaction
products not covered
elsewhere
9.35E-08
3.16E-07
Fugitive Air
250
1-7 generic sites
Moderate
CDR, Peer-
reviewed
literature
(GS/ESD)
7.83E-08
5.81E-07
Stack Air
8.64E02
2.68E03
Wastewater, Incineration, or
Landfill
Application of paints
and coatings
with overspray
controls
[no overspray
controls]
1.06E-08
[1.06E-08]
2.71E-08
[2.71E-08]
Fugitive Air
257
287
145-792 generic sites
[145-795 generic sites]
Moderate
CDR, Peer-
reviewed
literature
(GS/ESD)
2.64
[1.661
8.25
[4.471
Stack Air
[Unknown]
2.55E01
[2.65E01]
7.84E01
[8.22E01]
Wastewater, Incineration, or
Landfill
Application of
adhesives and sealants
4.97E-09
1.30E-08
Fugitive or Stack Air
232
325
345-2,383 generic sites
Moderate
CDR, Peer-
reviewed
literature
(GS/ESD)
1.48
6.46
Wastewater, Incineration, or
Landfill
Use of laboratory
chemicals
high conc. liquid
[low conc. liquid]
1.98E-09
[2.38E—12]
3.35E-09
[3.82E-121
Fugitive or Stack Air
235
[260]
258
[260]
586^1,912 generic sites
[36,873 generic sites]
Moderate
CDR, Peer-
reviewed
literature
(GS/ESD)
1.96
[2.74E-02]
3.68
[2.75E-02]
Wastewater, Incineration, or
Landfill
Use of laboratory
chemicals - solid
1.55E-04
4.34E-04
Stack Air
260
36,873
Moderate
2.74E-02
2.75E-02
Wastewater, Incineration, or
Landfill
Use of lubricants and
functional fluids
7.27E01
2.69E02
Wastewater
2
4
7,033-48,659 generic
sites
Moderate
CDR, Peer-
reviewed
literature
(GS/ESD)
3.19E01
1.30E02
Landfill
1.18
6.27
Recycling
2.64E01
1.39E02
Fuel Blending (Incineration)
Page 47 of 269
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Estimated Dailv
Type of Discharge," Air
Estimated Release
Weight of
OES
Release across Sites
Emission,6 or Transfer for
Frequency across Sites
Number of Facilities'
Scientific
Sou rccs
(kjj/site-day)
Disposal'
(Days) d
Evidence
4.33E-02
8.67E-01
Stack Air
223
254
58 generic sites
CDR, Peer-
reviewed
literature
(GS/ESD)
3.46
6.30
Fugitive Air, Wastewater,
CDR, Peer-
Recycling
Incineration, or Landfill
223
254
58 generic sites
Moderate
reviewed
literature
(GS/ESD)
1.46
3.19
Wastewater
223
254
58 generic sites
CDR, Peer-
reviewed
literature
(GS/ESD)
"Direct discharge to surface water; indirect discharge to non-POTW; indirect discharge to POTW
h Emissions via fugitive air or stack air, or treatment via incineration
c Transfer to surface impoundment, land application, or landfills
''Where available, EPA used industry provided information, ESDs, or GSs to estimate the number of release days for each COU.
' Where available. EPA used 2020 CDR (U.S. EPA. 20203). 2020 U.S. Countv Business Practices (U.S. Census Bureau. 20221 and Monte Carlo models to estimate the
number of sites that use DINP for each COU.
' See Section 3.2.2 for details on EPA's determination of the weight of scientific evidence rating.
Page 48 of 269
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3.2.2 Weight of Scientific Evidence Conclusions for Environmental Releases from
Industrial and Commercial Sources
For each OES, EPA considered the assessment approach, the quality of the data and models, and the
uncertainties in the assessment results to determine a level of confidence for the environmental release
estimates. Table 3-5 provides EPA's weight of scientific evidence rating for each OES.
EPA integrated numerous evidence streams across systematic review and non-systematic review sources
to develop environmental estimates for DINP. The Agency made a judgment based on the weight of
scientific evidence to support the release estimates based on the strengths, limitations, and uncertainties
associated with the release estimates. EPA described this judgment using the following confidence
descriptors: robust, moderate, slight, or indeterminate.
In determining the strength of the overall weight of scientific evidence, EPA considered factors that
increase or decrease the strength of the evidence supporting the release estimate (whether measured or
estimated), including quality of the data/information, relevance of the data to the release scenario
(including considerations of temporal and spatial relevance), and the use of surrogate data when
appropriate. In general, higher rated studies (as determined through data evaluation) increase the weight
of scientific evidence when compared to lower rated studies, and EPA gave preference to chemical- and
scenario-specific data over surrogate data (e.g., data from a similar chemical or scenario). For example,
a conclusion of moderate weight of scientific evidence is appropriate where there is measured release
data from a limited number of sources, such that there is a limited number of data points that may not
cover most or all the sites within the OES. A conclusion of slight weight of scientific evidence is
appropriate where there is limited information that does not sufficiently cover all sites within the COU,
and the assumptions and uncertainties are not fully known or documented. See EPA's Draft Systematic
Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances, Version 1.0: A Generic
TSCA Systematic Review Protocol with Chemical-Specific Methodologies ( 021a) (also
called the "Draft Systematic Review Protocol") for additional information on weight of scientific
evidence conclusions.
Table 3-5 summarizes EPA's overall weight of scientific evidence conclusions for its release estimates
for each OES. In general, modeled data had data quality ratings of medium. As a result, for releases that
used GSs/ESDs, the weight of scientific conclusion was moderate, when used in tandem with Monte
Carlo modeling.
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Table 3-5. Summary of Overall Confidence in Environmental Release Estimates by PES
OES
Weight of Scientific Evidence Conclusion in Release Estimates
Manufacturing
EPA found limited chemical specific data for the manufacturing OES and assessed environmental releases using models and model
parameters derived from CDR. the 2023 Methodology for Estimating Environmental Releases from Sampling Wastes (U.S. EPA, 2023c).
and sources identified through systematic review (including industry supplied data). EPA used EPA/OPPT models combined with Monte
Carlo modeling to estimate releases to the environment, with media of release assessed using assumptions from EPA/OPPT models and
industry supplied data. EPA believes the strength of the Monte Carlo modeling approach is that variation in model input values and a range
of potential release values are more likely to capture actual releases than a discrete value. Additionally, Monte Carlo modeling uses a large
number of data points (simulation runs) and considers the full distributions of input parameters. EPA used facility-specific DINP
manufacturing volumes for all facilities that reported this information to CDR and DINP-specific operating parameters derived using data
with a high data quality ranking from a current U.S. manufacturing site to provide more accurate estimates than the generic values provided
by the EPA/OPPT models.
The primary limitation of EPA's approach is the uncertainty in the representativeness of release estimates toward the true distribution of
potential releases. In addition, EPA lacks DINP facility production volume data for some DINP manufacturing sites that claim this
information as CBI for the purposes of CDR reporting; therefore, throughput estimates for these sites are based on the CDR reporting
threshold of 25,000 lb (i.e., not all potential sites represented) and an annual DINP production volume range that spans an order of
magnitude. Additional limitations include uncertainties in the representativeness of the industry-provided operating parameters and the
generic EPA/OPPT models for all DINP manufacturing sites.
Based on this information, EPA concluded that the weight of scientific evidence for this assessment is moderate, and the assessment
provides a plausible estimate of releases considering the strengths and limitations of the reasonably available data.
Import and
repackaging
EPA found limited chemical specific data for the import and repackaging OES and assessed releases to the environment using the
assumptions and values from the Chemical Repackaging GS. which the systematic review process rated high for data aualitv (U.S. EPA.
2022). EPA also referenced the 2023 Methodology for Estimating Environmental Releases from Sampling Wastes (U.S. EPA, 2023c) and
used EPA/OPPT models combined with Monte Carlo modeling to estimate releases to the environment. EPA assessed the media of release
using assumptions from the ESD and EPA/OPPT models. EPA believes the strength of the Monte Carlo modeling approach is that variation
in model input values and a range of potential release values are more likely to capture actual releases at sites than a discrete value.
Additionally, Monte Carlo modeling uses a high number of data points (simulation runs) and the full distributions of input parameters. EPA
used facility specific DINP import volumes for all facilities that reported this information to CDR.
The primary limitation of EPA's approach is the uncertainty in the representativeness of estimated release values toward the true distribution
of potential releases at all sites in this OES. Specifically, because the default values in the ESD are generic, there is uncertainty in the
representativeness of these generic site estimates in characterizing actual releases from real-world sites that import and repackage DINP. In
addition, EPA lacks DINP facility import volume data for some CDR-reporting import and repackaging sites that claim this information as
CBI; therefore, throughput estimates for these sites are based on the CDR reporting threshold of 25,000 lb (i.e., not all potential sites
represented) and an annual DINP production volume range that spans an order of magnitude.
Based on this information, EPA concluded that the weight of scientific evidence for this assessment is moderate, and the assessment
provides a plausible estimate of releases, considering the strengths and limitations of the reasonably available data.
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Incorporation into
adhesives and
sealants
EPA found limited chemical specific data for the incorporation into adhesives and sealants OES and assessed releases to the environment
using the ESD on the Formulation of Adhesives. which has a high data aualitv rating based on the systematic review process fOECD. 2009).
EPA used EPA/OPPT models combined with Monte Carlo modeling to estimate releases to the environment and assessed the media of
release using assumptions from the ESD and EPA/OPPT models. EPA believes the strength of the Monte Carlo modeling approach is that
variation in model input values and a range of potential release values are more likely to capture actual releases at sites than a discrete value.
Monte Carlo modeling also considers a large number of data points (simulation runs) and the full distributions of input parameters.
Additionally, EPA used DINP-specific data on concentrations in adhesive and sealant products in the analysis to provide more accurate
estimates than the generic values provided by the ESD. EPA based the production volume for the OES on use rates cited in an ACC report
(ACC, 2020). which references the 2003 EURisk Assessment Report (ECJRC, 2003b) for expected U.S. DINP use rates per use scenario.
The primary limitation of EPA's approach is the uncertainty in the representativeness of estimated release values toward the true distribution
of potential releases at all sites in this OES. Specifically, the default values in the ESD may not be representative of actual releases from
real-world sites that incorporate DINP into adhesives and sealants. In addition, EPA lacks data on DINP-specific facility production volume
and number of formulation sites; therefore, EPA based throughput estimates on CDR which has a reporting threshold of 25,000 lb (i.e., not
all potential sites represented) and an annual DINP production volume range that spans an order of magnitude. The respective share of DINP
use for each OES (as presented in the EU Risk Assessment Report) may differ from actual conditions adding additional uncertainty to
estimated releases.
Based on this information, EPA concluded that the weight of scientific evidence for this assessment is moderate, and the assessment
provides a plausible estimate of releases, considering the strengths and limitations of the reasonably available data.
Incorporation into
paints and coatings
EPA found limited chemical specific data for the incorporation into paints and coatings OES and assessed releases to the environment using
the Draft GS for the Formulation of Waterborne Coatings, which has a medium data aualitv rating based on systematic review (U.S. EPA,
20143). EPA used EPA/OPPT models combined with Monte Carlo modeling to estimate releases to the environment and assessed the media
of release using assumptions from the GS and EPA/OPPT models. EPA believes the strength of the Monte Carlo modeling approach is that
variation in model input values and a range of potential release values are more likely to capture actual releases than a discrete value. Monte
Carlo modeling also considers a large number of data points (simulation runs) and the full distributions of input parameters. Additionally,
EPA used DINP-specific data on concentrations in paint and coating products to provide more accurate estimates of DINP concentrations
than the generic values provided by the GS. EPA based the production volume for the OES on rates cited in an ACC report (ACC, 2020).
which references the 2003 EU Risk Assessment Report (ECJRC, 2003b) for expected U.S. DINP use rates per use scenario.
The primary limitation of EPA's approach is the uncertainty in the representativeness of estimated release values toward the true distribution
of potential releases at all sites in this OES. Specifically, the generic default values in the GS are specific to waterborne coatings and may
not be representative of releases from real-world sites that incorporate DINP into paints and coatings, particularly for sites formulating other
coating types (e.g., solvent-borne coatings). In addition, EPA lacks data on DINP-specific facility production volume and number of
formulation sites; therefore, EPA based throughput estimates on CDR which has a reporting threshold of 25,000 lb (i.e., not all potential
sites represented) and an annual DINP production volume range that spans an order of magnitude. The share of DINP use for each OES
presented in the EU Risk Assessment Report may differ from actual conditions adding some uncertainty to estimated releases.
Based on this information, EPA concluded that the weight of scientific evidence for this assessment is moderate, and the assessment
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provides a plausible estimate of releases, considering the strengths and limitations of the reasonably available data.
Incorporation into
other formulations,
mixtures, and
reaction products
not covered
elsewhere
EPA found limited chemical specific data for the incorporation into other formulations, mixtures, and reaction products not covered
elsewhere OES and assessed releases to the environment using the Draft GS for the Formulation of Waterborne Coatings, which has a
medium data aualitv ratine based on the systematic review process CU.S. EPA. 2014a). EPA used EPA/OPPT models combined with Monte
Carlo modeling to estimate releases to the environment, and media of release using assumptions from the GS and EPA/OPPT models. EPA
believes the strength of the Monte Carlo modeling approach is that variation in model input values and a range of potential release values are
more likely to capture actual releases than discrete values. Monte Carlo modeling also considers a large number of data points (simulation
runs) and the full distributions of input parameters. Additionally, EPA used DINP-specific data on concentrations in other formulations,
mixtures, and reaction products in the analysis to provide more accurate estimates than the generic values provided by the GS. The safety
and product data sheets that EPA obtained these values from have high data quality ratings based on the systematic review process. EPA
based the production volume for the OES on rates cited bv in an ACC report (ACC, 2020). which references the 2003 EURisk Assessment
Report (ECJRC, 2003b) for expected U.S. DINP use rates per use scenario.
The primary limitation of EPA's approach is the uncertainty in the representativeness of estimated release values toward the true distribution
of potential releases at all sites in this OES. Specifically, the generic default values in the ESD are based on the formulation of paints and
coatings and may not represent releases from real-world sites that incorporate DINP into other formulations, mixtures, or reaction products.
In addition, EPA lacks data on DINP-specific facility production volumes and number of formulation sites; therefore, EPA based the
throughput estimates on CDR which has a reporting threshold of 25,000 lb (i.e., not all potential sites represented) and an annual DINP
production volume range that spans an order of magnitude. Finally, the share of DINP use for each OES presented in the EU Risk
Assessment Report may differ from actual conditions adding some uncertainty to estimated releases.
Based on this information, EPA concluded that the weight of scientific evidence for this assessment is moderate, and the assessment
provides a plausible estimate of releases, considering the strengths and limitations of the reasonably available data.
PVC plastics
compounding
EPA found limited chemical specific data for the PVC plastics compounding OES and assessed releases to the environment using the
Revised Draft GS for the Use of Additives in Plastic Compounding, which has a medium data quality rating based on systematic review
(U.S. EPA. 202If). EPA used EPA/OPPT models combined with Monte Carlo modeling to estimate releases to the environment, and media
of release using assumptions from the GS and EPA/OPPT models. EPA believes the strength of the Monte Carlo modeling approach is that
variation in model input values and a range of potential release values are more likely to capture actual releases than discrete values. Monte
Carlo modeling also considers a large number of data points (simulation runs) and the full distributions of input parameters. Additionally,
EPA used DINP-specific data on concentrations in different DINP-containing PVC plastic products and PVC-specific additive throughputs
in the analysis. These data points are more accurate than the generic values provided by the GS. The safety and product data sheets that EPA
obtained these values from have high data quality ratings based on systematic review. EPA based production volumes for the OES on rates
cited in an ACC report (ACC, 2020). which references the 2003 EU Risk Assessment Report (ECJRC, 2003b) for the expected U.S. DINP
use rates per use scenario.
The primary limitation of EPA's approach is the uncertainty in the representativeness of estimated release values toward the true distribution
of potential releases at all sites in this OES. Specifically, the generic default values in the ESD consider all types of plastic compounding and
may not represent releases from real-world sites that compound DINP into PVC plastic raw material. In addition, EPA lacks data on DINP-
specific facility production volumes and number of compounding sites; therefore, EPA estimated throughput based on CDR which has a
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reporting threshold of 25,000 lb (i.e., not all potential sites represented) and an annual DINP production volume range that spans an order of
magnitude. The respective share of DINP use for each OES presented in the EU Risk Assessment Report may differ from actual conditions
adding some uncertainty to estimated releases.
Based on this information, EPA concluded that the weight of scientific evidence for this assessment is moderate, and the assessment
provides a plausible estimate of releases, considering the strengths and limitations of the reasonably available data.
PVC plastics
converting
EPA found limited chemical specific data for the PVC plastics converting OES and assessed releases to the environment using the Revised
Draft GS on the Use of Additives in the Thermoplastics Converting Industry, which has a medium data quality rating based on systematic
review CU.S. 1 21a). EPA used EPA/OPPT models combined with Monte Carlo modeling to estimate releases to the environment, and
media of release using assumptions from the GS and EPA/OPPT models. EPA believes the strength of the Monte Carlo modeling approach
is that variation in model input values and a range of potential release values is more likely to capture actual releases than discrete values.
Monte Carlo also considers a large number of data points (simulation runs) and the full distributions of input parameters. Additionally, EPA
used DINP-specific data on concentrations in different DINP-containing PVC plastic products and PVC-specific additive throughputs in the
analysis. These data provide more accurate estimates than the generic values provided by the GS. The safety and product data sheets that
EPA used to obtain these values have high data quality ratings based on systematic review. EPA based the production volume for the OES
on rates cited in an ACC report (ACC, 2020). which references the 2003 EU Risk Assessment Report (ECJRC. 2003b) for the expected U.S.
DINP use rates per use scenario.
The primary limitation of EPA's approach is the uncertainty in the representativeness of estimated release values toward the true distribution
of potential releases at all sites in this OES. Specifically, the generic default values in the ESD are based on all types of thermoplastics
converting sites and processes and may not represent actual releases from real-world sites that convert DINP-containing PVC raw material
into PVC articles using a variety of methods, such as extrusion or calendaring. In addition, EPA lacks data on DINP-specific facility
production volume and number of converting sites; therefore, EPA estimated throughput based on CDR which has a reporting threshold of
25,000 lb (i.e., not all potential sites represented) and an annual DINP production volume range that spans an order of magnitude. The
respective share of DINP use for each OES presented in the EU Risk Assessment Report may differ from actual conditions adding some
uncertainty to estimated releases.
Based on this information, EPA concluded that the weight of scientific evidence for this assessment is moderate, and the assessment
provides a plausible estimate of releases, considering the strengths and limitations of the reasonably available data.
Non-PVC material
compounding
EPA found limited chemical specific data for the non-PVC material compounding OES and assessed releases to the environment using the
Revised Draft GS for the Use of Additives in Plastic Compounding and the ESD on Additives in the Rubber Industry. Both sources have a
medium data aualitv ratine based on the systematic review process CU.S. EPA. 2021f; OECD. 2004a). EPA used EPA/OPPT models
combined with Monte Carlo modeling to estimate releases to the environment, and media of release using assumptions from the GS, ESD,
and EPA/OPPT models. EPA believes the strength of the Monte Carlo modeling approach is that variation in model input values and a range
of potential release values are more likely to capture actual releases than discrete values. Monte Carlo modeling also considers a large
number of data points (simulation runs) and the full distributions of input parameters. Additionally, EPA used DINP-specific concentration
data for different DINP-containing rubber products in the analysis. These data provide more accurate estimates than the generic values
provided by the GS and ESD. The safety and product data sheets that EPA obtained these values from have high data quality ratings based
on systematic review. EPA based the production volume for the OES on rates cited in an ACC report (ACC. 2020). which references the
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2003 EU Risk Assessment Report (ECJRC, 2003b) for expected U.S. DINP use rates per use scenario.
The primary limitation of EPA's approach is the uncertainty in the representativeness of estimated release values toward the true distribution
of potential releases at all sites in this OES. Specifically, the generic default values in the GS and ESD are based on all types of plastic
compounding and rubber manufacturing, and the DINP-specific concentration data only consider rubber products. As a result, these values
may not be representative of actual releases from real-world sites that compound DINP into non-PVC material. In addition, EPA lacks data
on DINP-specific facility production volumes and number of compounding sites; therefore, EPA estimated throughput based on CDR which
has a reporting threshold of 25,000 lb (i.e., not all potential sites represented) and an annual DINP production volume range that spans an
order of magnitude. The respective share of DINP use for each OES presented in the EU Risk Assessment Report may differ from actual
conditions adding some uncertainty to estimated releases.
Based on this information, EPA concluded that the weight of scientific evidence for this assessment is moderate, and the assessment
provides a plausible estimate of releases, considering the strengths and limitations of the reasonably available data.
Non-PVC material
converting
EPA found limited chemical specific data for the non-PVC material converting OES and assessed releases to the environment using the
Revised Draft GS on the Use of Additives in the Thermoplastics Converting Industry and the ESD on Additives in the Rubber Industry.
Both documents have a medium data quality ratine based on systematic review (U.S. EPA, 2021a; OECD, 2004a). EPA used EPA/OPPT
models combined with Monte Carlo modeling to estimate releases to the environment, and media of release using assumptions from the GS,
ESD, and EPA/OPPT models. EPA believes the strength of the Monte Carlo modeling approach is that variation in model input values and a
range of potential release values are more likely to capture actual releases than discrete values. Monte Carlo modeling also considers a large
number of data points (simulation runs) and the full distributions of input parameters. Additionally, EPA used DINP-specific data on
concentrations in different DINP-containing rubber products in the analysis. These data provide more accurate estimates than the generic
values provided by the GS and ESD. The safety and product data sheets that EPA obtained these values from have high data quality ratings
based on the systematic review process. EPA based the production volume for the OES on rates cited in an ACC report (ACC. 2020). which
references the 2003 EU Risk Assessment Report (ECJRC, 2003b) for expected U.S. DINP use rates per use scenario.
The primary limitation of EPA's approach is the uncertainty in the representativeness of estimated release values toward the true distribution
of potential releases at all sites in this OES. Specifically, the generic default values in the GS and ESD consider all types of plastic
converting and rubber manufacturing sites, and the DINP-specific concentration data only considers rubber products. As a result, these
generic site estimates may not represent actual releases from real-world sites that convert DINP-containing, non-PVC material into finished
articles. In addition, EPA lacks data on DINP-specific facility production volumes and number of converting sites; therefore, EPA based
throughput estimates on values from industry SpERC documents, CDR data (which has a reporting threshold of 25,000 lb (i.e., not all
potential sites represented), and an annual DINP production volume range that spans an order of magnitude. The share of DINP use for each
OES presented in the EU Risk Assessment Report may differ from actual conditions adding some uncertainty to estimated releases.
Based on this information, EPA concluded that the weight of scientific evidence for this assessment is moderate, and the assessment
provides a plausible estimate of releases, considering the strengths and limitations of the reasonably available data.
Application of
adhesives and
sealants
EPA found limited chemical specific data for the application of adhesives and sealants OES and assessed releases to the environment using
the ESD on the Use of Adhesives. which has a medium data quality ratine based on systematic review (OECD, 2015a). EPA used
EPA/OPPT models combined with Monte Carlo modeling to estimate releases to the environment, and media of release using assumptions
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from the ESD and EPA/OPPT models. EPA believes the strength of the Monte Carlo modeling approach is that variation in model input
values and a range of potential release values are more likely to capture actual releases than discrete values. Monte Carlo modeling also
considers a large number of data points (simulation runs) and the full distributions of input parameters. Additionally, EPA used DINP-
specific data on concentration and application methods for different DINP-containing adhesives and sealant products in the analysis. These
data provide more accurate estimates than the generic values provided by the ESD. The safety and product data sheets from which these
values were obtained have high data quality ratings from the systematic review process. EPA based production volumes for the OES on rates
cited in an ACC report (ACC, 2020), which references the 2003 EU Risk Assessment Report (ECJRC, 2003b) for expected U.S. DINP use
rates per use scenario.
The primary limitation of EPA's approach is the uncertainty in the representativeness of estimated release values toward the true distribution
of potential releases at all sites in this OES. Specifically, the generic default values in the ESD may not represent releases from real-world
sites that incorporate DINP into adhesives and sealants. In addition, EPA lacks data on DINP-specific facility use volumes and number of
use sites; therefore, EPA based throughput estimates on values from industry SpERC documents, CDR data (which has a reporting threshold
of 25,000 lb (i.e., not all potential sites represented), and an annual DINP production volume range that spans an order of magnitude. The
respective share of DINP use for each OES as presented in the EU Risk Assessment Report may differ from actual conditions adding some
uncertainty to estimated releases.
Based on this information, EPA concluded that the weight of scientific evidence for this assessment is moderate, and the assessment
provides a plausible estimate of releases, considering the strengths and limitations of reasonably available data.
Application of
paints and coatings
EPA found limited chemical specific data for the application of paints and coatings OES and assessed releases to the environment using the
ESD on the Application of Radiation Curable Coatings, Inks and Adhesives, the GS on Coating Application via Spray Painting in the
Automotive Refinishing Industry, and the GS on Spray Coatings in the Furniture Industry. These documents have a medium data quality
ratine based on the systematic review process CU.S. EPA. 2014b; OECD. 201 lb; U.S. EPA. 2004cY EPA used EPA/OPPT models combined
with Monte Carlo modeling to estimate releases to the environment. EPA assessed media of release using assumptions from the ESD, GS,
and EPA/OPPT models and a default assumption that all paints and coatings are spray applied. EPA believes the strength of the Monte Carlo
modeling approach is that variation in model input values and a range of potential release values are more likely to capture actual releases
than discrete values. Monte Carlo modeling also considers a large number of data points (simulation runs) and the full distributions of input
parameters. Additionally, EPA used DINP-specific data on DINP concentration and paint/coating application methods for different DINP-
containing paints and coatings in the analysis. These data provide more accurate estimates than the generic values provided by the GS and
ESDs. The safety and product data sheets that EPA obtained these values from have high data quality ratings based on the systematic review
process. EPA based production volumes for these OES on rates cited in an ACC report (ACC, 2020). which references the 2003 EU Risk
Assessment Report (ECJRC, 2003b) for expected U.S. DINP use rates per use scenario.
The primary limitation of EPA's approach is the uncertainty in the representativeness of estimated release values toward the true distribution
of potential releases at all sites in this OES. Specifically, the generic default values in the GS and ESDs may not represent releases from
real-world sites that incorporate DINP into paints and coatings. Additionally, EPA assumes spray applications of the coatings, which may
not be representative of other coating application methods. In addition, EPA lacks data on DINP-specific facility use volumes and number of
use sites; therefore, EPA based throughput estimates on values from industry SpERC documents, CDR data (which has a reporting threshold
of 25,000 lb (i.e., not all potential sites represented), and an annual DINP production volume range that spans an order of magnitude. The
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share of DINP use for each OES presented in the EU Risk Assessment Report may differ from actual conditions adding some uncertainty to
estimated releases.
Based on this information, EPA concluded that the weight of scientific evidence for this assessment is moderate, and the assessment
provides a plausible estimate of releases, considering the strengths and limitations of reasonably available data.
Use of laboratory
chemicals
EPA found limited chemical specific data for the Use of Laboratory Chemicals OES and assessed releases to the environment using the
Draft GS on the Use of Laboratory Chemicals, which has a high data aualitv ratine based on systematic review (U.S. EPA. 2023:0. EPA
used EPA/OPPT models combined with Monte Carlo modeling to estimate releases to the environment, and media of release using
assumptions from the GS and EPA/OPPT models for solid and liquid DINP-containing laboratory chemicals. EPA believes the strength of
the Monte Carlo modeling approach is that variation in model input values and a range of potential release values are more likely to capture
actual releases than discrete values. Monte Carlo modeling also considers a large number of data points (simulation runs) and the full
distributions of input parameters. EPA used SDSs from identified, DINP-containing laboratory products to inform product concentration and
material states.
EPA believes the primary limitation to be the uncertainty in the representativeness of values toward the true distribution of potential
releases. In addition, EPA lacks data on DINP-containing laboratory chemical throughputs and number of laboratories; therefore, EPA based
the number of laboratories and throughput estimates on stock solution throughputs from the Draft GS on the Use of Laboratory Chemicals
and on CDR reporting thresholds. Additionally, because no entries in CDR indicate a laboratory use case, and there were no other sources to
estimate the volume of DINP used in this OES, EPA developed a high-end bounding estimate based on the CDR reporting threshold, which
by definition over-estimates the average release case.
Based on this information, EPA concluded that the weight of scientific evidence for this assessment is moderate, and the assessment
provides a plausible estimate of releases, considering the strengths and limitations of reasonably available data.
Use of lubricants
and functional
fluids
EPA found limited chemical specific data for the Use of Lubricants and Functional Fluids OES and assessed releases to the environment
using the ESD on the Lubricant and Lubricant Additives, which has a medium data aualitv ratine based on systematic review (OECD,
2004b). EPA used EPA/OPPT models combined with Monte Carlo modeling to estimate releases to the environment, and media of release
using assumptions from the ESD and EPA/OPPT models. EPA believes the strength of the Monte Carlo modeling approach is that variation
in model input values and a range of potential release values are more likely to capture actual releases than discrete values. Monte Carlo
modeling also considers a large number of data points (simulation runs) and the full distributions of input parameters. EPA did not identify
any DINP-containing lubricants and functional fluids for use in Monte Carlo analysis. Therefore, EPA used products containing DIDP as
surrogate to develop concentration and use data for the analysis. These data provide more accurate estimates than the generic values
provided by the ESD. The safety and product data sheets that EPA used to obtain these values have high data quality ratings based on
systematic review. EPA based production volumes for the OES on rates cited in an ACC report (ACC. 2020). which references the 2003 EU
Risk Assessment Report (ECJRC. 2003b) for expected U.S. DINP use rates per use scenario.
The primary limitation of EPA's approach is the uncertainty in the representativeness of estimated release values toward the true distribution
of potential releases at all sites in this OES. Specifically, the generic default values in the ESD may not represent releases from real-world
sites using DINP-containing lubricants and functional fluids. In addition, EPA lacks information on facility use rates of DINP-containing
products and number of use sites; therefore, EPA estimated the number of sites and throughputs based on CDR, which has a reporting
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threshold of 25,000 lb (i.e., not all potential sites represented), and an annual DINP production volume range that spans an order of
magnitude. The respective share of DINP use for each OES presented in the EU Risk Assessment Report may differ from actual conditions
adding some uncertainty to estimated releases. Furthermore, EPA lacks chemical-specific information on DINP concentrations in lubricants
and functional fluids and relied on surrogate data. Actual concentrations may differ adding some uncertainty to estimated releases.
Based on this information, EPA concluded that the weight of scientific evidence for this assessment is moderate, and the assessment
provides a plausible estimate of releases in consideration of the strengths and limitations of reasonably available data.
Fabrication and
final use of
products or articles
No data were available to estimate releases for this OES and there were no suitable surrogate release data or models. Releases for this OES
are described qualitatively.
Recycling and
disposal
EPA found limited chemical specific data for the recycling and disposal OES. EPA assessed releases to the environment from recycling
activities using the Revised Draft GS for the Use of Additives in Plastic Compounding as surrogate for the recycling process. The GS has a
medium data aualitv ratine based on systematic review CU.S. EPA. 2021:0. EPA used EPA/OPPT models combined with Monte Carlo
modeling to estimate releases to the environment, and media of release using assumptions from the GS and EPA/OPPT models. EPA
believes the strength of the Monte Carlo modeling approach is that variation in model input values and a range of potential release values are
more likely to capture actual releases than discrete values. Monte Carlo modeling also considers a large number of data points (simulation
runs) and the full distributions of input parameters. Additionally, EPA used DINP-specific data on DINP concentrations in different PVC
plastic products in the analysis to provide more accurate estimates than the generic values provided by the GS. The safety and product data
sheets that EPA used to obtain these values have high data quality ratings based on systematic review. EPA referenced the Quantification
and Evaluation of Plastic Waste in the United States, which has a medium quality rating based on systematic review (Milbrandt et aL 2022).
to estimate the rate of PVC recycling in the U.S. and applied it to the DINP PVC market share to define an approximate recycling volume of
DINP-containing PVC.
The primary limitation of EPA's approach is the uncertainty in the representativeness of estimated release values toward the true distribution
of potential releases at all sites in this OES. Specifically, the generic default values in the GS represent all types of plastic compounding sites
and may not represent sites that recycle PVC products that contain DINP. In addition, EPA lacks DINP-specific data on PVC recycling rates
and facility production volumes; therefore, EPA based throughput estimates on PVC plastics compounding data and U.S. PVC recycling
rates, which are not specific to DINP, and may not accurately reflect current U.S. recycling volumes.
Based on this information, EPA concluded that the weight of scientific evidence for this assessment is moderate, and the assessment still
provides a plausible estimate of releases, considering the strengths and limitations of the reasonably available data.
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3.2.3 Strengths, Limitations, Assumptions, and Key Sources of Uncertainty for the
Environmental Release Assessment
Manufacturers and importers of DINP submit CDR data to EPA if they meet reporting threshold
requirements. Sites are only required to load production data into CDR if their yearly production volume
exceeds 25,000 lb. Sites can claim their production volume as CBI, further limiting the production
volume information in CDR. As a result, some sites that produce or use DINP may not be included in
the CDR dataset and the total production volume for a given OES may be under or overestimated. The
extent to which sites that are not captured in the CDR reports release DINP into the environment is
unknown. The media of release for these sites is also unknown.
CDR information on the downstream use of DINP at facilities is also limited; therefore, there is some
uncertainty as to the production volume attributed to a given OES. For OES with limited CDR data,
EPA used a 2003 DINP Risk Assessment published by the European Union, Joint Research Centre and a
DINP report presented by ACC to determine approximate production volumes (ECJRC. 2003b). The
ACC report indicates that the use rate of DINP in the United States is similar to the production volume
in the European Union (ACC. 2020). EPA calculated the production volume for a given OES as the use
rate percentage of the total production volume for the relevant OES as defined in the EU risk
assessment. For non-polymer use cases, the EU risk assessment assesses a total production volume
percentage of 2.61 percent across all uses. EPA spilt this percentage equally between paint/coating,
adhesive/sealant, and other formulation use cases. Due to these uncertainties, the total production
volume attributed to a given OES may be under or overestimated.
Furthermore, DINP releases at each site may vary from day to day, such that on any given day the actual
daily release rate may be higher or lower than the estimated average daily release rate.
• Use of Census Bureau for Number of Facilities - In some cases, EPA estimated the maximum
number of facilities for a given OES using data from the U.S. Census. In such cases, EPA
determined the maximum number of sites for use in Monte Carlo modeling from industry data
from the U.S. Census Bureau, County and Business Patterns dataset ( ;nsus Bureau. 2022).
• Uncertainties Associated with Number of Release Days Estimate - For most OES, EPA
estimated the number of release days using data from GSs, ESDs, or Specific Emission Release
Category (SpERC) factsheets. In such cases, EPA used applicable sources to estimate a range of
release days over the course of an operating year. Due to uncertainty in DINP-specific facility
operations, release days may be under or overestimated.
• Uncertainties Associated with DINP-Containing Product Concentrations - In most cases,
the number of identified products for a given OES were limited. In such cases, EPA estimated a
range of possible DINP concentrations for products in the OES. However, the extent to which
these products represent all DINP-containing products within the OES is uncertain. For OES
with little-to-no product data, EPA estimated DINP concentrations from GSs or ESDs. Due to
these uncertainties, the average product concentrations may be under or overestimated.
3.3 Summary of Concentrations of DINP in the Environment
Based off the environmental release assessment summarized in Section 3.2 and presented in EPA's
Environmental Release and Occupational Exposure Assessment for Diisononyl Phthalate (DINP) (U.S.
25r), DINP is expected to be released to the environment via air, water, biosolids, and disposal
to landfills. Environmental media concentrations were quantified in ambient air, soil from ambient air
deposition, surface water, and sediment. Additional analysis of surface water used as drinking water was
conducted for the Human Health Risk Assessment (Section 4). Given the physical and chemical
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properties and fate parameters of DINP (Section 2), concentrations of DINP in soil and groundwater
from releases to biosolids and landfills were not quantified. Instead, DINP in soil and groundwater are
discussed qualitatively. EPA relied on its fate assessment to determine which environmental pathways to
consider for its screening level analysis of environmental exposure and general population exposure.
Details on the environmental partitioning and media assessment can be found in Fate Assessment for
DiisononylPhthalate (DINP) ( 25s) and its use for determining pathways to assess are
detailed in Environmental Exposure Assessment for Diisononyl Phthalate (DINP) ( *025o).
Briefly, based on DINP's fate parameters, EPA anticipated DINP to be predominantly in water, soil, and
sediment, with DINP in soils attributable to air to soil deposition and land application of biosolids.
Therefore, the Agency quantitatively assessed concentrations of DINP in surface water, sediment, and
soil from air to soil deposition. Ambient air concentrations were quantified for the purpose of estimating
soil concentrations from air to soil deposition but was not used for the exposure assessment as DINP
was not assumed to be persistent in the air (ti/2 = 5.36-8.5 hours (\ v < < \ , < ,ertsirisopon et at..
2009)) and partitioning analysis showed DINP partitions primarily to soil, compared to air, water, and
sediment, even in air releases. Soil concentration of DINP from land applications were not quantitatively
assessed in the screening level analysis as DINP was expected to have limited persistence potential and
mobility in soils receiving biosolids.
Further detail on the screening level assessment of each environmental pathway can be found in EPA's
Environmental Media and General Population Screening for Diisononyl Phthalate (DINP) (U.S. EPA.
2Q25q). Screening level assessments are useful when there is little location- or scenario-specific
information available. Because of limited environmental monitoring data and lack of reasonably
available location data for DINP releases, EPA began its environmental and general population exposure
assessment with a screening level approach using the highest modeled environmental media
concentrations for the environmental pathways expected to be of greatest concern. Details on the use of
screening level analyses in exposure assessment can be found in EPA's Guidelines for Human Exposure
Assessment ( ).
In addition to considering the most likely environmental pathways for DINP exposure based on the fate
properties of DINP, EPA considered the highest potential environmental media concentrations for the
purpose of a screening level analysis. The highest environmental media concentrations were estimated
using the release estimates for an OES associated with a COU that paired with conservative assumption
of environmental conditions resulted in the greatest modeled concentration of DINP in a given
environmental media type. Therefore, EPA did not estimate environmental concentrations of DINP
resulting from all OES presented in Table 3-1. The OES resulting in the highest environmental
concentration of DINP varied by environmental media as shown in Table 3-6.
High-end concentrations of DINP in surface water and soil from air to soil deposition were estimated for
the purpose of risk screening for environmental exposure described in EPA's Environmental Exposure
Assessment for Diisononyl Phthalate (DINP) ( 025 o) and for general population exposure
described in EPA's Environmental Media and General Population Screening for Diisononyl Phthalate
(DINP) ( 25q). Ambient air concentrations were quantified to estimate soil concentrations
from air to soil deposition. However, ambient air concentrations themselves were not used for the
environmental or general population exposure as it was not expected to be an exposure pathway of
concern. Table 3-6 summarizes the highest concentrations of DINP estimated in different environmental
media based on releases to the environment from various OES associated with COUs. This means that
the Manufacturing OES yielded the highest water concentrations using a 7Q10 flow (the lowest 7-day
average flow that occurs [on average] once every 10 years) while the Use of lubricants and functional
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fluids OES yielded the highest water concentration using a 30Q5 flow (the lowest 30-day average flow
that occurs [on average] once every 5 years) compared to any other OES. The Non-PVC plastic
compounding OES yielded the highest soil concentration from air to soil deposition. The summary table
also indicates whether the high-end estimate was used for environmental exposure assessment or general
population exposure assessment. For the screening level analysis, if the high-end environmental media
concentrations did not result in potential environmental or human health risk, no further OESs were
assessed. For the surface water component of this screening analysis, only the OES resulting in the
highest estimated sediment concentrations was carried forward to the environmental risk assessment
(Manufacturing), and only the OES resulting in the highest estimated water column concentrations was
carried forward to the human health risk assessment (Use of lubricants and functional fluids).
Table 3-6. Summary of High-End DINP Concentrations in Various Environmental Media from
Environmental Releases
OES
Release
Media
Environmental Media
DINP
Concentration
Environmental or
General Population
Manufacturing
Water
Total Water Column (7Q10)
24,000 ng/L
Environmental
Benthic Pore Water (7Q10)
10,100 ng/L
Environmental
Benthic Sediment (7Q10)
126,000 mg/kg
Environmental
Use of lubricants
and functional
fluids
Water
Surface Water (30Q5)
9,350 ng/L
General Population
Surface Water (Harmonic Mean)
8,100 (ig/L
General Population
Non-PVC plastic
compounding
Fugitive Air
Soil (Air to Soil Deposition 100 m)
1,460 jxg/kg
General Population
Soil (Air to Soil Deposition 1,000 m)
40 (ig/kg
Environmental
"Table 3-1 provides the crosswalk of OES to COUs.
3.3.1 Weight of Scientific Evidence Conclusions
Detailed discussion of the strengths, limitations, and sources of uncertainty for modeled environmental
media concentration leading to a weight of scientific evidence conclusion can be found in EPA's
Environmental Media and General Population Screening for Diisononyl Phthalate (DINP) (U.S. EPA.
2025q). However, the weight of scientific evidence conclusion is summarized below for the modeled
concentrations for surface water and of soil from ambient air to soil deposition.
3.3.1.1 Surface Water
Due to the lack of reasonably available release data for facilities discharging DINP to surface waters,
releases were modeled, and the high-end estimate for each COU was applied for surface water
modeling. Additionally, due to a lack of reasonably available site-specific release information, a generic
distribution of hydrologic flows was developed from facilities which had been classified under relevant
NAICS codes, and which had National Pollutant Discharge Elimination System (NPDES) permits. The
flow rates selected from the generated distributions coupled with high-end (95th percentile) release
scenarios, resulted in moderate modeled concentrations. EPA has moderate confidence in the modeled
concentrations as being representative of actual releases, with a slight bias toward over-estimation, but
robust confidence that no surface water release scenarios exceed the concentrations presented in this
evaluation. Other model inputs were derived from reasonably available literature collected and
evaluated through EPA's systematic review process for TSCA risk evaluations. All monitoring and
experimental data included in this analysis were from articles rated medium or high quality from this
process.
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The high-end modeled concentrations in the surface water and sediment identified through systematic
review exceeded the highest values available from monitoring studies by more than three orders of
magnitude. This confirms EPA's expectation that modeled concentrations presented herein are biased
toward overestimation, to be applied as a screening level evaluation for use in environmental and
general population exposure assessment.
3.3.1.2 Ambient Air - Air to Soil Deposition
Similar to the surface water analysis, due to the lack of reasonably available release data, releases were
modeled using generic scenarios and the high-end estimates for each COU was applied for ambient air
modeling. With moderate confidence in the release data detailed in Environmental Release and
Occupational Exposure Assessment for Diisononyl Phthalate (DINP) (U.S. EPA. 2025r) and
conservative assumptions used for modeled air dispersion and particle distribution inputs, EPA has
slight confidence in the air and deposition concentrations modeled based on EPA estimated releases
being representative of actual releases, but for the purpose of a risk screening level assessment, EPA has
robust confidence that its modeled releases usedfor estimating air to soil deposition is appropriately
conservative for a screening level analysis.
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4 HUMAN HEALTH RISK ASSESSMENT
DINP - Human Health Risk Assessment (Section 4):
Key Points
EPA evaluated all reasonably available information to support human health risk characterization of
DINP for workers, ONUs, consumers, bystanders, and the general population. Exposures to workers,
ONUs, consumers, bystanders, and the general population are described in Section 4.1. Human health
hazards are described in Section 4.2. Human health risk characterization is described in Section 4.3.
Exposure Key Points
• EPA assessed inhalation and dermal exposures for workers and ONUs, as appropriate, for each
COU (Section 4.1.1). However, the primary route of exposure was inhalation.
• EPA assessed inhalation, dermal, and oral exposures for consumers and bystanders, as appropriate,
for each COU (Section 4.1.2) in scenarios that represent a range of use patterns and behaviors. The
primary route of exposure was inhalation.
• EPA assessed oral and dermal exposures for the general population, as appropriate, via surface
water, drinking water, soil, and fish ingestion for tribal populations and determined that all
exposures assessed for the general population were not of concern (Sections 4.1.30 and 4.3.4). The
Agency did not assess inhalation exposure to DINP from ambient air for the general population
because ambient air is not expected to be a pathway of concern for DINP. This is because DINP is
not persistent in the air and rapidly partitions to sediment, soil, and surface water.
Hazard Key Points
• EPA identified liver and developmental toxicity as the most sensitive and robust non-cancer
hazards associated with oral exposure to DINP in experimental animal models (Section 4.2).
• A non-cancer POD of 12 mg/kg-day was selected to characterize non-cancer risks for acute and
intermediate durations of exposure. A total uncertainty factor of 30 was selected for use as the
benchmark margin of exposure.
• A non-cancer POD of 3.5 mg/kg-day was selected to characterize non-cancer risks for chronic
durations of exposure. A total uncertainty factor of 30 was selected for use as the benchmark
margin of exposure.
• DINP has been shown to cause liver cancer in experimental studies of rats and mice; however, liver
cancer in rodents occurred at higher doses than observed for other non-cancer effects on the liver
and the developing male reproductive system. Therefore, evaluating and protecting human health
from non-cancer risks associated with exposure to DINP will also be protective of cancer effects.
Risk Assessment Key Points
• Dermal and ingestion exposures were not a risk driver for any duration of exposure or population.
• Inhalation exposures drive acute, intermediate, and chronic non-cancer risks to workers in
occupational settings (Section 4.3.2).
• Inhalation exposures drive chronic non-cancer risks to consumers (Section 4.3.3).
• No potential non-cancer risk was identified for the general population (Section 4.3.4).
• EPA considered combined exposure across all routes of exposure for each individual occupational
and consumer COU to calculate aggregate risks (Sections 4.3.2 and 4.3.3).
• EPA is including DINP in its cumulative risk assessment along with five other phthalate
chemicals. EPA has not yet accounted for its cumulative phthalate risk assessment nor taken
into consideration cumulative phthalate exposure in its risk calculations; however, EPA does
not expect the risk estimates to support any significant changes to risk estimates or risk
conclusions (Section 4.3.6).
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4.1 Summary of Human Exposures
4.1.1 Occupational Exposures
The following subsections briefly describe EPA's approach to assessing occupational exposures and
provide exposure assessment results for each OES. As stated in the Final Scope of the Risk Evaluation
for Diisononyl Phthalate (DINP) ( 21c\ EPA evaluated exposures to workers and ON Us
via the inhalation route, including incidental ingestion of inhaled dust, and exposures to workers via the
dermal route associated with the manufacturing, processing, use, and disposal of DINP. Also, EPA
assessed dermal exposure to workers and ONUs from mist and dust deposited on surfaces. The
Environmental Release and Occupational Exposure Assessment for Diisononyl Phthalate (DINP) (
»25r) provides additional details on the development of approaches and the exposure assessment
results.
4.1.1.1 Approach and Methodology
As described in the Final Scope of the Risk Evaluation for Diisononyl Phthalate (DINP) (
2 ), EPA distinguished exposure levels among potentially exposed employees for workers and
ONUs. In general, the primary difference between workers and ONUs is that workers may handle DINP
and have direct contact with the DINP, while ONUs work in the general vicinity of DINP but do not
handle DINP. Where possible, for each COU, EPA identified job types and categories for workers and
ONUs.
As discussed in Section 3.1.1.1, EPA established OESs to assess the exposure scenarios more
specifically within each COU, and Table 3-1 provides a crosswalk between COUs and OESs. EPA
identified relevant inhalation exposure monitoring data for some of the OESs. EPA evaluated the quality
of this monitoring data using the data quality review evaluation metrics and the rating criteria described
in the 2021 Draft Systematic Review Protocol ( 2021a). EPA assigned an overall quality level
of high, medium, or low to the relevant data. In addition, the Agency established an overall confidence
level for the data when integrated into the occupational exposure assessment. EPA considered the
assessment approach, the quality of the data and models, as well as uncertainties in assessment results to
assign an overall confidence level of robust, moderate, or slight.
Where monitoring data were reasonably available, EPA used these data to characterize central tendency
and high-end inhalation exposures (see also Figure 4-1). Where no inhalation monitoring data were
available, but inhalation exposure models were reasonably available, the Agency estimated central
tendency and high-end exposures using only modeling approaches. If both inhalation monitoring data
and exposure models were reasonably available, EPA presented central tendency and high-end
exposures using both. For inhalation exposure to dust in occupational settings, EPA used the Generic
Model for Central Tendency and High-End Inhalation Exposure to Total and Respirable Particulates Not
Otherwise Regulated (PNOR) ( 32le). In all cases of occupational dermal exposure to DINP,
EPA used a flux-limited dermal absorption model to estimate both high-end and central tendency dermal
exposures for workers in each OES, as described in the Environmental Release and Occupational
Exposure Assessment for Diisononyl Phthalate (DINP) ( )25r).
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Figure 4-1. Approaches Used for Each Component of the Occupational Assessment for Each OES
CDR = Chemical Data Reporting; GS = generic scenario; ESD = emission scenario document; BLS = Bureau of
Labor Statistics; PNOR = particulates not otherwise regulated
For inhalation and dermal exposure routes, EPA provided occupational exposure results representative
of central tendency and high-end exposure conditions. The central tendency is expected to represent
occupational exposures in the center of the distribution for a given COU. For risk evaluation, EPA used
the 50th percentile (median), mean (arithmetic or geometric), mode, or midpoint value of a distribution
to represent the central tendency scenario. Although the Agency preferred to provide the 50th percentile
of the distribution, if the full distribution was unknown, EPA used either the mean, mode, or midpoint of
the distribution to represent the central tendency depending on the statistics available for the
distribution. The high-end exposure is expected to represent occupational exposures that occur at
probabilities above the 90th percentile, but below the highest exposure for any individual (U.S. EPA
1992). For risk evaluation, EPA provided high-end results at the 95th percentile. If the 95th percentile
was not reasonably available, the Agency used a different percentile greater than or equal to the 90th
percentile but less than or equal to the 99th percentile—depending on the statistics available for the
distribution. If the full distribution is not known and the preferred statistics are not reasonably available,
EPA estimated a maximum or bounding estimate in lieu of the high-end. Table 4-1 provides a summary
of whether monitoring data were reasonably available for each OES, and if data were available, the
number of data points and quality of that data. Table 4-1 also provides EPA's overall confidence rating
and whether the Agency used modeling to estimate inhalation and dermal exposures for workers.
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Table 4-1. Summary of Exposure Monitoring and Modeling Data for OESs
Inhalation Exposure
Dermal Exposure
Monitoring
Modeling
Weight of Seientitle
Modeling
Weight of Scientific
OES
Evidence Conclusion
Evidence Conclusion
Worker
# Data
Points
ONU
# Data
Points
Data
Quality
Worker
ONU
Worker
ONU
Worker
ONU
Worker
ONU
Ratings
Manufacturing
V
12
V
1
High
X
X
Moderate to
Robust
Moderate
l/
X
Moderate
N/A
Import/
V
12"
V
1"
High
X
X
Moderate
Moderate
l/
X
Moderate
N/A
repackaging
Incorporation into
V
2b
V
lb
High
X
X
Moderate
Moderate
l/
X
Moderate
N/A
adhesives and
sealants
Incorporation into
V
2b
V
lb
High
X
X
Moderate
Moderate
l/
X
Moderate
N/A
paints and
coatings
Incorporation into
V
2 b
V
1b
High
X
X
Moderate
Moderate
l/
X
Moderate
N/A
other
formulations,
mixtures, and
reaction products
not covered
elsewhere
PVC plastics
V
2
V
1
High
V
V
Moderate
Moderate
l/
l/
Moderate
Moderate
compounding
PVC plastics
V
2
V
1
High
V
V
Moderate
Moderate
l/
l/
Moderate
Moderate
converting
Non-PVC material
V
2 b
V
1b
High
V
V
Moderate
Moderate
t/
Moderate
Moderate
compounding
Non-PVC material
V
2 b
V
1b
High
V
V
Moderate
Moderate
t/
Moderate
Moderate
converting
Application of
X
N/A
X
N/A
N/A
V
V
Moderate
Moderate
t/
Moderate
Moderate
adhesives and
sealants
Application of
X
N/A
X
N/A
N/A
V
V
Moderate
Moderate
l/*
V
Moderate
Moderate
paints and
coatings
Use of laboratory
V
12 "
V
1"
High
V
V
Moderate
Moderate
i/
Moderate
Moderate
chemicals
Use of lubricants
V
12"
V
1
High
X
X
Moderate
Moderate
X.
Moderate
N/A
Page 65 of 269
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OES
Inhalation Exposure
Dermal Exposure
Monitoring
Modeling
Weight of Scientific
Evidence Conclusion
Modeling
Weight of Scientific
Evidence Conclusion
Worker
# Data
Points
ONU
# Data
Points
Data
Quality
Ratings
Worker
ONU
Worker
ONU
Worker
ONU
Worker
ONU
and functional
fluids
Fabrication and
final use of
products or
articles
X
N/A
X
N/A
N/A
V
V
Moderate
Moderate
Moderate
Moderate
Recycling and
disposal
X
N/A
X
N/A
N/A
V
V
Moderate
Moderate
1/
l/"
Moderate
Moderate
" Inhalation monitoring data for exposure to vapors from the Manufacturing OES were used as surrogate data for OES where inhalation exposure comes from vapor
generating-activities only.
b Inhalation monitoring data for exposure to vapors from the PVC plastics compounding/converting OES were used as surrogate data for OESs where inhalation
exposure to vapor might occur during the heating and cooling plastic and non-plastic polymer materials.
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4.1.1.2 Summary of Number of Workers and ONUs
The Environmental Release and Occupational Exposure Assessment for Diisononyl Phthalate (DINP)
( 2025r) provides a summary of the estimates for the total exposed workers and ONUs for
each OES. To prepare these estimates, EPA first attempted to identify relevant North American
Industrial Classification (NAICS) codes for each OES. For these NAICS codes, the Standard
Occupational Classification (SOC) codes from the Bureau of Labor Statistics (BLS) were used to
classify SOC codes as either workers or ONUs. EPA assumed that all other SOC codes represent
occupations where exposure is unlikely. The Agency also estimated the total number facilities associated
with the relevant NAICS codes based on data from the U.S. Census Bureau. To estimate the average
number of potentially exposed workers and ONUs per site, the total number of workers and ONUs were
divided by the total number of facilities. Lastly, using estimates of the number of facilities using DINP,
the total number of workers and ONUs potentially exposed to DINP for each OES were estimated. The
Environmental Release and Occupational Exposure Assessment for Diisononyl Phthalate (DINP) (U.S.
25r) provides additional details on the approach and methodology for estimating the number of
facilities using DINP and the number of potentially exposed workers and ONUs.
Table 4-2 summarizes the number of facilities and total number of exposed workers for all OESs. For
scenarios in which the results are expressed as a range, the low-end of the range represents the central
tendency result, and the upper end of the range represents the high-end result.
Table 4-2. Summary of Total Number of Workers and ONUs Potentially Exposed to DINP for
Each OES
OES
Total Exposed
Workers"
Total Exposed
ONUs
Number of
Facilities"
Notes
Manufacturing
116-258
53-118
3-6
Number of workers and ONU estimates
based on the BLS and U.S. Census
Bureau data (IIS. BLS. 2016: U.S.
Census Bureau, 2015).
Import/repackaging
32-35
11-12
29-32
Number of workers and ONU estimates
based on the BLS and U.S. Census
Bureau data (U.S. BLS. 2016; U.S.
Census Bureau, 2015).
Incorporation into
adhesives and sealants
425-1,672
187-736
15-59
Number of workers and ONU estimates
based on the BLS and U.S. Census
Bureau data (U.S. BLS. 2016: U.S.
Census Bureau, 2015).
Incorporation into
paints and coatings
72-415
21-119
4-23
Number of workers and ONU estimates
based on the BLS and U.S. Census
Bureau data (U.S. BLS, 2016; U.S.
Census Bureau, 2015).
Incorporation into
other formulations,
mixtures, and reaction
products not covered
elsewhere
22-153
10-71
1-7
Number of workers and ONU estimates
based on the BLS and U.S. Census
Bureau data (U.S. BLS, 2016; U.S.
Census Bureau, 2015).
PVC plastics
compounding
3,022-5,907
1,328-2,595
110-215
Number of workers and ONU estimates
based on the BLS and U.S. Census
Bureau data (U.S. BLS, 2016; U.S.
Census Bureau, 2015).
Page 67 of 269
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OES
Total Exposed
Workers"
Total Exposed
ONUs
Number of
Facilities"
Notes
PVC plastics
converting
43,777-85,536
12,389-24,206
2,386-4,662
Number of workers and ONU estimates
based on the BLS and U.S. Census
Bureau data (U.S. BLS. 2016: U.S.
Census Bureau, 2015).
Non-PVC material
compounding
74-132
13-23
5-9
Number of workers and ONU estimates
based on the BLS and U.S. Census
Bureau data (U.S. BLS. 2016: U.S.
Census Bureau, 2015).
Non-PVC material
converting
1,793-2,793
307-477
122-190
Number of workers and ONU estimates
based on the BLS and U.S. Census
Bureau data (U.S. BLS, 2016: U.S.
Census Bureau, 2015).
Application of
adhesives and sealants
18,576-
128,306
5,885-40,646
345-2,383
Number of workers and ONU estimates
based on the BLS and U.S. Census
Bureau data (U.S. BLS, 2016: U.S.
Census Bureau, 2015).
Application of paints
and coatings
1,790-9,817
915-5,016
145-795
Number of workers and ONU estimates
based on the BLS and U.S. Census
Bureau data (U.S. BLS, 2016: U.S.
Census Bureau, 2015).
Use of laboratory
chemicals
(liquid)
564-4,724
5,070-42,499
586-4,912
Number of workers and ONU estimates
based on the BLS and U.S. Census
Bureau data (U.S. BLS, 2016: U.S.
Census Bureau, 2015).
Use of laboratory
chemicals
(solid)
35,463
319,026
36,873
Number of workers and ONU estimates
based on the BLS and U.S. Census
Bureau data (U.S. BLS, 2016: U.S.
Census Bureau, 2015).
Use of lubricants and
functional fluids
617,370-
4,271,378
151,950-
1,051,294
7,033-48,659
Number of workers and ONU estimates
based on the BLS and U.S. Census
Bureau data (U.S. BLS, 2016: U.S.
Census Bureau, 2015).
Fabrication and final
use of products or
articles
N/A
Number of sites data was unavailable for
this OES.
Recycling and disposal
377
216
58
Number of workers and ONU estimates
based on the BLS and U.S. Census
Bureau data (U.S. BLS, 2016: U.S.
Census Bureau, 2015).
" EPA's approach and methodology for estimating the number of facilities using DINP and the number of workers and
ONUs potentially exposed to DINP can be found in the Environmental Release and Occupational Exposure Assessment
for Diisononvl Phthalate (DINP) (US. EPA. 2025r)
4.1.1.3 Summary of Inhalation Exposure Assessment
Table 4-3 presents a summary of inhalation exposure results based on monitoring data and exposure
modeling for each OES. This table provides a summary of the 8- and 10-hour time-weighted average (8-
or 10-hour TWA) inhalation exposure estimates, as well as the acute dose (AD), the intermediate
average daily dose (IADD), and the chronic average daily dose (ADD). The Environmental Release and
Occupational Exposure Assessment for Diisononyl Phthalate (DINP) ( 25r) provides
exposure results for females of reproductive age and ONUs. That TSD also provides additional details
Page 68 of 269
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regarding AD, IADD, and ADD calculations along with EPA's approach and methodology for
estimating inhalation exposures.
Page 69 of 269
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Table 4-3. Summary of Average Adult Worker Inhalation Exposure Results for Each PES
OES
Inhalation Estimates (Average Adult Worker)
Vapor/Mist 8- or 110-
hour] TWA (mg/mJ)
PNOR 8-hour
TWA (mg/mJ)
AD
(mg/kg/dav)
IADD
(mg/kg/day)
ADD
(mg/kg/dav)
HE
CT
HE
CT
HE
CT
HE
CT
HE
CT
Manufacturing
6.9E-02
3.5E-02
-
-
8.6E-03
4.3E-03
6.3E-03
3.2E-03
4.3E-03
2.1E-03
Import/repackaging
6.9E-02
3.5E-02
-
-
8.6E-03
4.3E-03
6.3E-03
3.2E-03
5.9E-03
2.5E-03
Incorporation into adhesives and sealants
[5.0E-04]
[2.5E-04]
-
-
7.8E-05
3.9E-05
5.7E-05
2.9E-05
5.4E-05
2.7E-05
Incorporation into paints and coatings
[5.0E-04]
[2.5E-04]
-
-
7.8E-05
3.9E-05
5.7E-05
2.9E-05
5.4E-05
2.7E-05
Incorporation into other formulations,
mixtures, and reaction products not covered
elsewhere
[5.0E-04]
[2.5E-04]
7.8E-05
3.9E-05
5.7E-05
2.9E-05
5.4E-05
2.7E-05
PVC plastics compounding
[5.0E-04]
[2.5E-04]
2.1
0.10
0.26
1.3E-02
0.19
9.5E-03
0.18
7.9E-03
PVC plastics converting
[5.0E-04]
[2.5E-04]
2.1
0.10
0.26
1.3E-02
0.19
9.5E-03
0.18
7.8E-03
Non-PVC material compounding
[5.0E-04]
[2.5E-04]
1.9
9.2E-02
0.24
1.2E-02
0.17
8.5E-03
0.16
7.4E-03
Non-PVC material converting
[5.0E-04]
[2.5E-04]
1.9
9.2E-02
0.24
1.2E-02
0.17
8.5E-03
0.16
6.9E-03
Application of adhesives and sealants - spray
application
18
1.4
-
-
2.2
0.17
1.6
0.12
1.5
0.11
Application of adhesives and sealants - non-
spray application
[5.0E-04]
[2.5E-04]
-
-
7.8E-05
3.9E-05
5.7E-05
2.9E-05
5.4E-05
2.5E-05
Application of paints and coatings - spray
application
8.8
0.68
-
-
1.1
8.4E-02
0.81
6.2E-02
0.76
5.8E-02
Application of paints and coatings - non-spray
application
[5.0E-04]
[2.5E-04]
-
-
7.8E-05
3.9E-05
5.7E-05
2.9E-05
5.4E-05
2.7E-05
Use of laboratory chemicals - liquid
6.9E-02
3.5E-02
-
-
8.6E-03
4.3E-03
6.3E-03
3.2E-03
5.9E-03
2.8E-03
Use of laboratory chemicals - solid
-
-
8.1E-02
5.7E-03
1.0E-02
7.1E-04
7.4E-03
5.2E-04
6.9E-03
4.9E-04
Use of lubricants and functional fluids
6.9E-02
3.5E-02
-
-
8.6E-03
4.3E-03
1.2E-03
2.9E-04
9.5E-05
2.4E-05
Fabrication and final use of products or articles
-
-
0.81
9.0E-02
0.10
1.1E-02
7.4E-02
8.3E-03
6.9E-02
7.7E-03
Recycling and disposal
-
-
1.6
0.11
0.20
1.4E-02
0.14
9.9E-03
0.13
8.2E-03
Page 70 of 269
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4.1.1.4 Summary of Dermal Exposure Assessment
Table 4-4 presents a summary of dermal exposure results, which are based on both empirical dermal
absorption data and dermal absorption modeling estimation efforts. This table provides a summary of
the Acute Potential Dose Rate (APDR) for occupational dermal exposure estimates, as well as the AD,
IADD, and Chronic ADD. The Environmental Release and Occupational Exposure Assessment for
Diisononyl Phthalate (DINP) (U ,S. EPA. 2025f) provides exposure results for females of reproductive
age and ONUs. That TSD also provides additional details regarding AD, IADD, and ADD calculations
along with EPA's approach and methodology for estimating dermal exposures.
Page 71 of 269
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Table 4-4. Summary of Average Adult Worker Dermal Exposure Results for Each PES
OES
Dermal Estimates (Average Adult Worker)
Exposure Type
APDR
(mg/day)
AD
(mg/kg/day)
IADD
(mg/kg/day)
ADD
(mg/kg/day)
Liquid
Solid
HE
CT
HE
CT
HE
CT
HE
CT
Manufacturing
X
12
6.2
0.16
7.8E-02
0.11
5.7E-02
7.7E-02
3.8E-02
Import/repackaging
X
12
6.2
0.16
7.8E-02
0.11
5.7E-02
0.11
4.4E-02
Incorporation into adhesives and sealants
X
12
6.2
0.16
7.8E-02
0.11
5.7E-02
0.11
5.3E-02
Incorporation into paints and coatings
X
12
6.2
0.16
7.8E-02
0.11
5.7E-02
0.11
5.3E-02
Incorporation into other formulations, mixtures,
and reaction products not covered elsewhere
X
12
6.2
0.16
7.8E-02
0.11
5.7E-02
0.11
5.3E-02
PVC plastics compounding
X
X
12
6.2
0.16
7.8E-02
0.11
5.7E-02
0.11
4.8E-02
PVC plastics converting
X
4.9E-02
2.5E-02
6.2E-04
3.1E-04
4.5E-04
2.3E-04
4.2E-04
1.8E-04
Non-PVC material compounding
X
X
12
6.2
0.16
7.8E-02
0.11
5.7E-02
0.11
5.0E-02
Non-PVC material converting
X
4.9E-02
2.5E-02
6.2E-04
3.1E-04
4.5E-04
2.3E-04
4.2E-04
1.8E-04
Application of adhesives and sealants - spray &
non-spray applications
X
12
6.2
0.16
7.8E-02
0.11
5.7E-02
0.11
5.0E-02
Application of paints and coatings - spray & non-
spray applications
X
12
6.2
0.16
7.8E-02
0.11
5.7E-02
0.11
5.3E-02
Use of laboratory chemicals - liquid
X
12
6.2
0.16
7.8E-02
0.11
5.7E-02
0.11
5.0E-02
Use of laboratory chemicals - solid
X
4.9E-02
2.5E-02
6.2E-04
3.1E-04
4.5E-04
2.3E-04
4.2E-04
2.1E-04
Use of lubricants and functional fluids
X
12
6.2
0.16
7.8E-02
2.1E-02
5.2E-03
1.7E-03
4.3E-04
Fabrication and final use of products or articles
X
4.9E-02
2.5E-02
6.2E-04
3.1E-04
4.5E-04
2.3E-04
4.2E-04
2.1E-04
Recycling and disposal
X
4.9E-02
2.5E-02
6.2E-04
3.1E-04
4.5E-04
2.3E-04
4.2E-04
1.9E-04
Page 72 of 269
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4.1.1.5 Weight of Scientific Evidence Conclusions for Occupational Exposure
Judgment on the weight of scientific evidence is based on the strengths, limitations, and uncertainties
associated with the release estimates. The Agency considers factors that increase or decrease the
strength of the evidence supporting the exposure estimate—including quality of the data/information,
applicability of the exposure data to the COU (including considerations of temporal and locational
relevance), and the representativeness of the estimate for the whole industry. The best professional
judgment is summarized using the descriptors of robust, moderate, slight, or indeterminant, in
accordance with the Draft Systematic Review Protocol ( s21a). For example, a conclusion of
moderate weight of scientific evidence is appropriate where there is measured exposure data from a
limited number of sources, such that there is a limited number of data points that may not be
representative of worker activities or potential exposures. A conclusion of slight weight of scientific
evidence is appropriate where there is limited reasonably available information that does not sufficiently
cover all potential exposures within the COU, and the assumptions and uncertainties are not fully known
or documented. See the Draft Systematic Review Protocol ( 21a) for additional information
on weight of scientific evidence conclusions. Table 4-5 provides a summary of EPA's overall
confidence in its occupational exposure estimates for each of the OESs assessed.
Page 73 of 269
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Table 4-5. Summary of Assumptions, Uncertainty, and Overall Confidence in Exposure Estimates by PES
OES
Weight of Scientific Evidence Conclusion in Exposure Estimates
Manufacturing
EPA considered the assessment approach, the quality of the data, and uncertainties in assessment results to determine a weight of scientific
evidence conclusion for the full-shift TWA inhalation exposure estimates for the Manufacturing OES. The primary strength is the use of
personal breathing zone (PBZ) directly applicable monitoring data, which are preferrable to other assessment approaches such as modeling
or the use of occupational exposure limits (OELs). EPA used PBZ air concentration data to assess inhalation exposures, with the data
source having a high data aualitv rating from the systematic review process (ExxonMobil. 2022a). Data from these sources were DINP-
specific from a DINP manufacturing facility, though it is uncertain whether the measured concentrations accurately represent the entire
industry. A further strength of the data is that it was compared against an EPA developed Monte Carlo model and the data points from
ExxonMobil were found to be more protective.
The primary limitations of these data include the uncertainty of the representativeness of these data toward the true distribution of
inhalation concentrations in this scenario, that the data come from one industry-source, and that 100% of the data for both workers and
ONUs from the source were reported as below the limit of detection (LOD). EPA also assumed 8 exposure hours per day and 180 exposure
davs per vear based on a manufacturing site reporting half-vear DINP campaign runs (ExxonMobil. 2022b); it is uncertain whether this
captures actual worker schedules and exposures at that and other manufacturing sites.
Based on these strengths and limitations, EPA has concluded that the weight of scientific evidence for this assessment is moderate to robust
and provides a plausible estimate of exposures.
Import and
repackaging
EPA used surrogate monitoring data from a DINP manufacturing facility to estimate worker inhalation exposures due to limited data
available for import and repackaging inhalation exposures. The primary strength is the use of monitoring data, which are preferrable to
other assessment approaches such as modeling or the use of OELs. EPA used PBZ air concentration data to assess inhalation exposures,
with the data source having a high data aualitv rating from the systematic review process (ExxonMobil 2022a). Data from these sources
were DINP-specific from a DINP manufacturing facility, though it is uncertain whether the measured concentrations accurately represent
the entire industry.
The primary limitations of these data include the uncertainty of the representativeness of these data toward this OES and the true
distribution of inhalation concentrations in this scenario; that the data come from one industry-source; and that 100% of the data for both
workers and ONUs from the source were reported as below the LOD. EPA also assumed 8 exposure hours per day and 250 exposure days
per year based on continuous DINP exposure each working day for a typical worker schedule; it is uncertain whether this captures actual
worker schedules and exposures.
Based on these strengths and limitations, EPA has concluded that the weight of scientific evidence for this assessment is moderate and
provides a plausible estimate of exposures.
Incorporation into
adhesives and
sealants
EPA used surrogate monitoring data from a PVC converting facility to estimate worker inhalation exposures due to limited data. The
primary strength is the use of monitoring data, which are preferrable to other assessment approaches such as modeling or the use of OELs.
EPA used compiled PBZ concentration data from one study to assess inhalation exposures. Worker and ONU PBZ data are for oil mist
exposures to DINP at a PVC roofing manufacturing site (Irwin, 2022). The data source has a high data quality rating from the systematic
Page 74 of 269
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OES
Weight of Scientific Evidence Conclusion in Exposure Estimates
review process.
The primary limitation of this data include the uncertainty of the representativeness of the monitoring data, as the data are specific to a
PVC plastic converting facility, and it is uncertain whether the measured concentrations accurately represent the incorporation into
adhesives and sealants. Another limitation is that the data comes from a singular source, and that the data for both workers and ONUs were
reported as below the LOD. Monitoring data points were based on a 10-hour TWA with annual exposure of 200 davs/vear (Irwin. 2022): it
is uncertain whether this captures actual worker schedules and exposures for the entire industry.
Based on these strengths and limitations, EPA has concluded that the weight of scientific evidence for this assessment is moderate and
provides a plausible estimate of exposures.
Incorporation into
paints and
coatings
EPA used surrogate monitoring data from a PVC converting facility to estimate worker inhalation exposures due to limited data. The
primary strength is the use of monitoring data, which are preferrable to other assessment approaches such as modeling or the use of OELs.
EPA used compiled PBZ concentration data from one study to assess inhalation exposures. Worker and ONU PBZ data are for oil mist
exposures to DINP at a PVC roofing manufacturing site (Irwin, 2022). The data source has a high data quality rating from the systematic
review process.
The primary limitation of this data include the uncertainty of the representativeness of the monitoring data, as the data are specific to a
PVC plastic converting facility, and it is uncertain whether the measured concentrations accurately represent the incorporation into paints
and coatings. Another limitation is that the data comes from a singular source and that the majority of the data for both workers and ONUs
were reported as below the LOD. Monitoring data points were based on a 10-hour TWA with annual exposure of 200 davs/vear (Irwin.
2022): it is uncertain whether this captures actual worker schedules and exposures for the entire industry.
Based on these strengths and limitations, EPA has concluded that the weight of scientific evidence for this assessment is moderate and
provides a plausible estimate of exposures.
Incorporation into
other
formulations,
mixtures, and
reaction products
not covered
elsewhere
EPA used surrogate monitoring data from a PVC converting facility to estimate worker inhalation exposures due to limited data. The
primary strength is the use of monitoring data, which are preferrable to other assessment approaches such as modeling or the use of OELs.
EPA used compiled PBZ concentration data from one study to assess inhalation exposures. Worker and ONU PBZ data are for oil mist
exposures to DINP at a PVC roofing manufacturing site (Irwin. 2022). The data source has a high data aualitv rating from the systematic
review process.
The primary limitation of this data include the uncertainty of the representativeness of the monitoring data, as the data are specific to a
PVC plastic converting facility, and it is uncertain whether the measured concentrations accurately represent the incorporation into other
formulations, mixtures, and reaction products not covered elsewhere. Another limitation is that the data comes from a singular source and
that the majority of the data for both workers and ONUs were reported as below the LOD. Monitoring data points were based on a 10-hour
TWA with annual exposure of 200 davs/vear (Irwin. 2022): it is uncertain whether this captures actual worker schedules and exposures for
the entire industry.
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OES
Weight of Scientific Evidence Conclusion in Exposure Estimates
Based on these strengths and limitations, EPA has concluded that the weight of scientific evidence for this assessment is moderate and
provides a plausible estimate of exposures.
PVC plastics
compounding
EPA considered the assessment approach, the quality of the data, and the uncertainties in the assessment results to determine a weight of
scientific evidence conclusion for the 8-hour TWA inhalation exposure estimates for PVC plastics compounding. EPA used monitoring
data from a single combined plastics compounding and converting site to estimate worker inhalation exposures to vapor. This source
provided both worker and ONU exposures (Irwin. 2022). The primary strength of this approach is that it uses monitoring data specific to
this OES, which is preferrable to other assessment approaches, such as modeling or the use of OELs. Additionally, the data is also well
characterized and the study sampled a variety of work areas and has a high data quality rating from the systematic review process. EPA
also expects compounding activities to generate dust from solid PVC plastic products; therefore, EPA incorporated the Generic Model for
Central Tendency and High-End Inhalation Exposure to Total and Respirable Particulates Not Otherwise Regulated (PNORj (U.S. EPA.
202 le) into the assessment to estimate worker inhalation exposures to solid particulate. A strength of the model is that the respirable PNOR
range was refined using OSHA Chemical Exposure Health Data (CEHD) datasets, which EPA tailored to the plastics industry and the
resulting dataset contains 237 discrete sample data points. The systematic review process rated the source high for data aualitv (OSHA.
2020). EPA estimated the highest expected concentration of DINP in plastic using industry provided data on DINP concentration in PVC
plastic. These data were also rated high for data quality in the systematic review process.
The primary limitations of these data include uncertainty in the representativeness of the vapor monitoring data and the PNOR model in
capturing the true distribution of inhalation concentrations for this OES. Additionally, the vapor monitoring dataset consisted of just two
datapoints for workers and one for ONUs and 100% of the datapoints were reported as below the LOD. The OSHA CEHD dataset used in
the PNOR model is not specific to DINP. Finally, EPA also assumed 8 exposure hours per day and 223-250 exposure days per year based
on continuous DINP exposure during each working day for a typical worker schedule with the exposure day representing the 50th-95th
percentile. It is uncertain whether this assumption captures actual worker schedules and exposures.
Based on these strengths and limitations, EPA has concluded that the weight of scientific evidence for this assessment is moderate and
provides a plausible estimate of exposures.
PVC plastics
converting
EPA considered the assessment approach, the quality of the data, and the uncertainties in the assessment results to determine a weight of
scientific evidence conclusion for the 8-hour TWA inhalation exposure estimates for PVC plastics converting. EPA used monitoring data
from a single combined plastics compounding and converting site to estimate worker inhalation exposures to vapor. This source provided
both worker and ONU exposures (Irwin. 2022). The primary strength is this approach is that it uses monitoring data specific to this OES.
which is preferrable to other assessment approaches such as modeling or the use of OELs. Additionally, the study data is well
characterized, sampled from a variety of work areas, and has a high data quality rating from the systematic review process. EPA also
expects converting activities to generate dust from solid PVC plastic products; therefore, EPA incorporated the PNOR model into the
assessment to estimate worker inhalation exposures to solid particulate. A strength of the model is that the respirable PNOR range was
refined using OSHA CEHD datasets, which EPA tailored to the plastics industry and the resulting dataset contains 237 discrete sample data
points. The systematic review process rated the source high for data aualitv COSH A. 2020). EPA estimated the highest expected
concentration of DINP in plastic using industry provided data on DINP concentration in PVC plastic. These data were also rated high for
data quality in the systematic review process.
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OES
Weight of Scientific Evidence Conclusion in Exposure Estimates
The primary limitations of these data include uncertainty in the representativeness of the vapor monitoring data and the PNOR model in
capturing the true distribution of inhalation concentrations for this OES. Additionally, the vapor monitoring dataset consisted of just two
datapoints for workers and one for ONUs and 100% of the datapoints were reported as below the LOD. The OSHA CEHD dataset used in
the PNOR model is not specific to DINP. Finally, EPA also assumed 8 exposure hours per day and 219-250 exposure days per year based
on continuous DINP exposure during each working day for a typical worker schedule with the exposure days representing the 50th-95th
percentile. It is uncertain whether this assumption captures actual worker schedules and exposures.
Based on these strengths and limitations, EPA has concluded that the weight of scientific evidence for this assessment is moderate and
provides a plausible estimate of exposures.
Non-PVC
material
compounding
EPA used surrogate monitoring data from a PVC converting facility to estimate worker inhalation exposures to vapor and PNOR model to
estimate worker inhalation exposures to particulates. Non-PVC material compounding vapor inhalation exposures were estimated using
study data from a single combined plastics compounding and converting site. The source provided worker and ONU exposures to
vapor/mist and only worker exposures to dust (Irwin, 2022). The primary strength is the use of monitoring data for a similar OES. which
are preferrable to other assessment approaches such as modeling or the use of OELs. Additionally, the data is also well characterized and
the study sampled a variety of work areas and has a high data quality rating from the systematic review process. EPA also expects
compounding activities to generate dust from solid PVC plastic products; therefore, EPA incorporated the PNOR model into the
assessment to estimate worker inhalation exposures to solid particulate. A strength of the model is that the respirable PNOR range was
refined using OSHA CEHD datasets, which EPA tailored to the plastics industry and the resulting dataset contains 237 discrete sample data
points. The systematic review process rated the source high for data quality (OSHA, 2020). EPA estimated the highest expected
concentration of DINP in plastic using industry provided data on DINP concentration in PVC plastic. These data were also rated high for
data quality in the systematic review process.
The primary limitations of these data include uncertainty in the representativeness of the vapor monitoring data and the PNOR model in
capturing the true distribution of inhalation concentrations for this OES. Additionally, the vapor monitoring dataset consisted of just two
datapoints for workers and one for ONUs and 100% of the datapoints were reported as below the LOD. The OSHA CEHD dataset used in
the PNOR model is not specific to DINP. Finally, EPA also assumed 8 exposure hours per day and 234-250 exposure days per year based
on continuous DINP exposure during each working day for a typical worker schedule with the exposure days representing the 50th-95th
percentile of exposure. It is uncertain whether this assumption captures actual worker schedules and exposures.
Based on these strengths and limitations, EPA has concluded that the weight of scientific evidence for this assessment is moderate and
provides a plausible estimate of exposures.
Non-PVC
material
converting
EPA used surrogate monitoring data from a PVC converting facility to estimate worker inhalation exposures to vapor and the PNOR model
to estimate worker inhalation exposures to particulates. Non-PVC material converting vapor inhalation exposures were estimated using
study data from a single combined plastics compounding and converting site. The source provided worker and ONU exposures to
vapor/mist and only worker exposures to dust (Irwin, 2022). The primary strength is the use of monitoring data for a similar OES. which
are preferrable to other assessment approaches such as modeling or the use of OELs. Additionally, the data is also well characterized and
the study sampled a variety of work areas and has a high data quality rating from the systematic review process. EPA also expects
compounding activities to generate dust from solid PVC plastic products; therefore, the PNOR model was use in the assessment to estimate
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OES
Weight of Scientific Evidence Conclusion in Exposure Estimates
worker inhalation exposures to solid particulate. A strength of the model is that the respirable PNOR range was refined using OSHA
CEHD datasets, which EPA tailored to the plastics industry and the resulting dataset contains 237 discrete sample data points. The
systematic review process rated the source high for data aualitv COSH A. 2020). EPA estimated the highest expected concentration of DINP
in plastic using industry provided data on DINP concentration in PVC plastic. These data were also rated high for data quality in the
systematic review process.
The primary limitations of these data include uncertainty in the representativeness of the vapor monitoring data and the PNOR model in
capturing the true distribution of inhalation concentrations for this OES. Additionally, the vapor monitoring dataset consisted of just two
datapoints for workers and one for ONUs and 100% of the datapoints were reported as below the LOD. The OSHA CEHD dataset used in
the PNOR model is not specific to DINP. Finally, EPA also assumed 8 exposure hours per day and 219-250 exposure days per year based
on continuous DINP exposure during each working day for a typical worker schedule with the exposure days representing the 50th-95th
percentile of exposure. It is uncertain whether this assumption captures actual worker schedules and exposures.
Based on these strengths and limitations, EPA has concluded that the weight of scientific evidence for this assessment is moderate and
provides a plausible estimate of exposures.
Application of
adhesives and
sealants
For inhalation exposure from spray application, EPA used surrogate monitoring data from the ESD on Coating Application via Spray-
Painting in the Automotive Refinishing Industry (OECD, 201 la), which the systematic review process rated high for data aualitv. For
inhalation exposure from non-spray application, EPA estimated vapor inhalation exposures using DINP monitoring data from PVC
compounding and converting (Irwin. 2022). which the systematic review process rated high for data aualitv. EPA used SDSs and product
data sheets from identified DINP-containing adhesives and sealant products to identify product concentrations.
The primary limitation is the lack of DINP-specific monitoring data for the application of adhesives and sealants. For the spray application
scenario, data outlined in the ESD on Coating Application via Spray-Painting in the Automotive Refinishing Industry is representative of
the level of mist exposure that could be expected at a typical work site for the given spray application method, but the data are not specific
to DINP. For the non-spray application scenario, vapor exposure from volatilization is estimated using DINP-specific data, but for a
different scenario which imposes uncertainty. EPA only assessed mist exposures to DINP over a full 8-hour work shift to estimate the level
of exposure, though other activities may result in vapor exposures other than mist and application duration may be variable depending on
the job site. EPA assessed a high end of 232-250 days of exposure per year based on workers applying coatings on every working day,
however, application sites may use DINP-containing coatings at much lower or variable frequencies. The exposure days represent the 50th-
95th percentile range of exposure days per year.
Based on these strengths and limitations, EPA has concluded that the weight of scientific evidence for this assessment is moderate and
provides a plausible estimate of exposures.
Application of
paints and
coatings
For inhalation exposure from spray application, EPA used surrogate monitoring data from the ESD on Coating Application via Spray-
Painting in the Automotive Refinishing Industry (OECD, 201 la), which the systematic review process rated high for data aualitv. For
inhalation exposure from non-spray application, EPA estimated vapor inhalation exposures using DINP monitoring data from PVC
compounding and converting (Irwin. 2022). which the systematic review process rated high for data quality. EPA used SDSs and product
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Weight of Scientific Evidence Conclusion in Exposure Estimates
data sheets from identified DINP-containing products to identify product concentrations.
The primary limitation is the lack of DINP-specific monitoring data for the application of paints and coatings. For the spray application
scenario, data outlined in the ESD on Coating Application via Spray-Painting in the Automotive Refinishing Industry is representative of
the level of mist exposure that could be expected at a typical work site for the given spray application method, but the data are not specific
to DINP. For the non-spray application scenario, vapor exposure from volatilization is estimated using DINP-specific data, but for a
different scenario which imposes uncertainty. EPA only assessed mist exposures to DINP over a full 8-hour work shift to estimate the level
of exposure, though other activities may result in vapor exposures other than mist and application duration may be variable depending on
the job site. EPA assessed 250 days of exposure per year based on workers applying coatings on every working day, however, application
sites may use DINP-containing coatings at much lower or variable frequencies.
Based on these strengths and limitations, EPA has concluded that the weight of scientific evidence for this assessment is moderate and
provides a plausible estimate of exposures.
Use of laboratory
chemicals
EPA used surrogate monitoring data from a DINP manufacturing facility to estimate worker vapor inhalation exposures, and the PNOR
model was used to characterize worker particulate inhalation exposures. The primary strength is the use of monitoring data, which are
preferrable to other assessment approaches such as modeling or the use of OELs. EPA used PBZ air concentration data to assess inhalation
exposures, with the data source having a high data aualitv rating from the systematic review process (ExxonMobil. 2022a).
EPA incorporated the PNOR model into the assessment to estimate worker inhalation exposures to solid particulate. A strength of the
model is that the respirable PNOR range was refined using OSHA CEHD datasets, which EPA tailored to the plastics industry and the
resulting dataset contains 33 discrete sample data points. The systematic review process rated the source high for data aualitv (OSHA,
2020). EPA estimated the highest expected concentration of DINP in identified DINP-containing products applicable to this OES. These
data were also rated high for data quality in the systematic review process.
The primary limitations of these data include uncertainty in the representativeness of the vapor monitoring data and the PNOR model in
capturing the true distribution of inhalation concentrations for this OES; that the vapor monitoring data come from one industry-source; and
that 100% of the data for both workers and ONUs from the source were reported as below the LOD; and that the OSHA CEHD dataset
used in the PNOR model is not specific to DINP. EPA also assumed 8 exposure hours per day and 235-250 exposure days per year based
on continuous DINP exposure each working day for a typical worker schedule; it is uncertain whether this captures actual worker schedules
and exposures. The exposure days represent the 50th-95th percentile range of exposure days per year.
Based on these strengths and limitations, EPA has concluded that the weight of scientific evidence for this assessment is moderate and
provides a plausible estimate of exposures.
Use of lubricants
and functional
fluids
EPA used surrogate monitoring data from a DINP manufacturing facility to estimate worker inhalation exposures due to limited data. The
primary strength is the use of monitoring data, which are preferrable to other assessment approaches such as modeling or the use of OELs.
EPA used PBZ air concentration data to assess inhalation exposures, with the data source having a high data quality rating from the
systematic review process (ExxonMobil. 2022a). Data from this source are DINP-specific and from a DINP manufacturing facility.
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OES
Weight of Scientific Evidence Conclusion in Exposure Estimates
The primary limitations of these data include the uncertainty of the representativeness of these data toward this OES and the true
distribution of inhalation concentrations in this scenario; that the data come from one industry-source; and that 100% of the data for both
workers and ONUs from the source were reported as below the LOD. EPA also assumed 8 exposure hours per day and 2 to 4 exposure
days per year based on a typical equipment maintenance schedule; it is uncertain whether this captures actual worker schedules and
exposures.
Based on these strengths and limitations, EPA has concluded that the weight of scientific evidence for this assessment is moderate and
provides a plausible estimate of exposures
Fabrication and
final use of
products or
articles
EPA considered the assessment approach, the quality of the data, and uncertainties in assessment results to determine a weight of scientific
evidence conclusion for the 8-hour TWA inhalation exposure estimates. EPA utilized the PNOR model to estimate worker inhalation
exposure to solid particulate. A strength of the model is that the respirable PNOR range was refined using OSHA CEHD datasets, which
EPA tailored to the plastics industry and the resulting dataset contains 272 discrete sample data points. The systematic review process rated
the source high for data quality (OSHA, 2020). EPA estimated the highest expected concentration of DINP in plastic using industry
provided data on DINP concentration in PVC plastic. These data were also rated high for data quality in the systematic review process.
The primary limitation is the uncertainty in the representativeness of values toward the true distribution of potential inhalation exposures.
Additionally, the representativeness of the CEHD dataset and the identified DINP concentrations in plastics for this specific fabrication and
final use of products or articles is uncertain. EPA lacks facility and DINP-containing product fabrication and use rates, methods, and
operating times and EPA assumed 8 exposure hours per day and 250 exposure days per year based on continuous DINP exposure each
working day for a typical worker schedule; it is uncertain whether this captures actual worker schedules and exposures.
Based on these strengths and limitations, EPA has concluded that the weight of scientific evidence for this assessment is moderate and
provides a plausible estimate of exposures.
Recycling and
disposal
EPA considered the assessment approach, the quality of the data, and uncertainties in assessment results to determine a weight of scientific
evidence conclusion for the 8-hour TWA inhalation exposure estimates. EPA utilized the PNOR model to estimate worker inhalation
exposure to solid particulate. A strength of the model is that the respirable PNOR range was refined using OSHA CEHD datasets, which
EPA tailored to the plastics industry and the resulting dataset contains 130 discrete sample data points. The systematic review process rated
the source high for data aualitv COSH A. 2020). EPA estimated the highest expected concentration of DINP in plastic using industry
provided data on DINP concentration in PVC plastic. These data were also rated high for data quality in the systematic review process.
The primary limitation is the uncertainty in the representativeness of values toward the true distribution of potential inhalation exposures.
Additionally, the representativeness of the CEHD dataset and the identified DINP concentrations in plastics for this specific fabrication and
final use of products or articles is uncertain. EPA lacks facility and DINP-containing product fabrication and use rates, methods, and
operating times and EPA assumed 8 exposure hours per day and 223-250 exposure days per year based on continuous DINP exposure each
working day for a typical worker schedule; it is uncertain whether this captures actual worker schedules and exposures. The exposure days
represent the 50th-95th percentile range of exposure days per year.
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OES
Weight of Scientific Evidence Conclusion in Exposure Estimates
Based on these strengths and limitations, EPA has concluded that the weight of scientific evidence for this assessment is moderate and
provides a plausible estimate of exposures.
Dermal - liquids
EPA used in vivo rat absorption data for neat DINP (Midwest Research Institute, 1983) to estimate occupational dermal exposures to
workers since exposures to the neat material or concentrated formulations are possible for occupational scenarios. Because rat skin
generally has greater permeability than human skin (Scott et aL 1987). the use of in vivo rat absorption data is considered to be a
conservative assumption. Also, it is acknowledged that variations in chemical concentration and co-formulant components affect the rate of
dermal absorption. However, it is assumed that absorption of the neat chemical serves as a reasonable upper bound across chemical
compositions and the data received a medium rating through EPA's systematic review process.
For occupational dermal exposure assessment, EPA assumed a standard 8-hour workday and that the chemical is contacted at least once per
day. Because DINP has low volatility and low absorption, it is possible that the chemical remains on the surface of the skin after a dermal
contact until the skin is washed. Therefore, absorption of DINP from occupational dermal contact with materials containing DINP may
extend up to 8 hours per day (U S ). For average adult workers, the surface area of contact was assumed equal to the area of
one hand (i.e., 535 cm2), or two hands (i.e., 1.070cm2). for central tendency exposures, or high-end exposures, respectively (U.S. EPA,
2 ). The standard sources for exposure duration and area of contact received high ratings through EPA's systematic review process.
The occupational dermal exposure assessment for contact with liquid materials containing DINP was based on dermal absorption data for
the neat material, as well as standard occupational inputs for exposure duration and area of contact, as described above. Based on the
strengths and limitations of these inputs, EPA has concluded that the weight of scientific evidence for this assessment is moderate and
provides a plausible estimate of occupational dermal exposures.
Dermal - solids
EPA used dermal modeling of aaueous materials (U.S. EPA. 2023a. 2004a) to estimate occupational dermal exposures of workers and
ONUs to solid materials. The modeling approach for determining the aqueous permeability coefficient was used outside the range of
applicability given the physical and chemical properties of DINP. Also, it is acknowledged that variations in chemical concentration and
co-formulant components affect the rate of dermal absorption. However, it is assumed that the aqueous absorption of a saturated solution of
DINP serves as a reasonable upper bound for the potential dermal absorption of DINP from solid matrices, and the modeling approach
received a medium rating through EPA's systematic review process.
For modeling potential dermal exposure levels from solids containing DINP, EPA used the maximum value of water solubility from
available data (NLM, 2015; Howard et al., 1985). These data sources for water solubility all received high ratings through EPA's
systematic review process. By using the maximum value of water solubility from available data, rather than a water solubility value near
the low-end of available data, EPA is providing a protective assessment for human health.
For occupational dermal exposure assessment, EPA assumed a standard 8-hour workday and that the chemical is contacted at least once per
day. Because DINP has low volatility and low absorption, it is possible that the chemical remains on the surface of the skin after a dermal
contact until the skin is washed. Therefore, absorption of DINP from occupational dermal contact with materials containing DINP may
extend up to 8 hours per day (U S ). For average adult workers, the surface area of contact was assumed equal to the area of
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OES
Weight of Scientific Evidence Conclusion in Exposure Estimates
one hand (i.e., 535 cm2), or two hands (i.e., 1.070cm2). for central tendency exposures, or high-end exposures, respectively (U.S. EPA,
2 ). The standard sources for exposure duration and area of contact received high ratings through EPA's systematic review process.
The occupational dermal exposure assessment for contact with solid materials containing DINP was based on dermal absorption modeling
of aqueous DINP with the maximum value for aqueous solubility identified through systematic review, as well as standard occupational
inputs for exposure duration and area of contact, as described above. Based on the strengths and limitations of these inputs, EPA has
concluded that the weight of scientific evidence for this assessment is moderate and provides a protective but plausible estimate of
occupational dermal exposures.
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4.1.1.5.1 Strengths, Limitations, Assumptions, and Key Sources of Uncertainty for
the Occupational Exposure Assessment
EPA assigned overall confidence descriptions of high, medium, or low to the exposure assessments,
based on the strength of the underlying scientific evidence. When the assessment is supported by robust
evidence, the Agency's overall confidence in the exposure assessment is high; when supported by
moderate evidence, EPA's overall confidence is medium; when supported by slight evidence, the
Agency's overall confidence is low.
Strengths
The exposure scenarios and exposure factors underlying the inhalation and dermal assessment are
supported by moderate to robust evidence. Occupational inhalation exposure scenarios were informed
by moderate or robust sources of surrogate monitoring data or GSs/ESDs used to model the inhalation
exposure concentration. Exposure factors for occupational inhalation exposure include duration of
exposure, body weight, and breathing rate, all of which were informed by moderate to robust data
sources.
A strength of the modeling assessment includes the consideration of variable model input parameters as
opposed to using a single static value. Parameter variation increases the likelihood that the true
occupational inhalation exposures fall within the range of modeled estimates. An additional strength is
that all data that EPA used to inform the modeling parameter distributions have overall data quality
ratings of either high or medium from the Agency's systematic review process. Strengths associated
with dermal exposure assessment are described in Table 4-5.
Limitations
The principal limitation of the inhalation monitoring data is uncertainty in the representativeness of the
data, as there is limited exposure monitoring data in the literature for some scenarios. Additionally,
differences in work practices and engineering controls across sites can introduce variability and limit the
representativeness of the monitoring data. The age of the monitoring data can also introduce uncertainty
due to differences in workplace practices and equipment used at the time the monitoring data were
collected compared to those currently in use. A limitation of the modeling methodologies is that model
input data from GSs/ESDs are generic for the OESs and not specific to the use of DINP within the
OESs. Limitations associated with dermal exposure assessment are described in Table 4-5.
Assumptions
To analyze the inhalation monitoring data, EPA categorized each data point as either "worker" or
"ONU." These categorizations are based on descriptions of worker job activity provided in the literature
and the Agency's judgment. Exposures for ONUs can vary substantially and exposure levels for the
"ONU" category will have high variability depending on the specific work activity performed.
EPA calculated ADD values assuming workers and ONUs are regularly exposed during their entire
working lifetime, which likely results in an overestimate. Individuals may change jobs during the course
of their career such that they are no longer exposed to DINP and the actual ADD values become lower
than the estimates presented. Assumptions associated with dermal exposure assessment are described in
Table 4-5.
Uncertainties
EPA addressed variability in inhalation models by identifying key model parameters and applying
statistical distributions that mathematically define the parameter's variability. The Agency defined
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statistical distributions for parameters using documented statistical variations where available. Where
the statistical variation was unknown, EPA made assumptions to estimate the parameter distribution
using available literature data, such as GSs and ESDs. However, there is uncertainty as to the
representativeness of the parameter distributions because these data are often not specific to sites that
use DINP. In general, the effects of these uncertainties on the exposure estimates are unknown, as the
uncertainties may result in either overestimation or underestimation of exposures depending on the
actual distributions of each of the model input parameters. Uncertainties associated with dermal
exposure assessment are described in Table 4-5.
There are several uncertainties surrounding the estimated number of workers potentially exposed to
DINP. First, BLS' OES employment data for each industry/occupation combination are only available at
the 3-, 4-, or 5-digitNAICS level, rather than the full 6-digitNAICS level. This lack of granularity could
result in an overestimate of the number of exposed workers if some 6-digit NAICS are included in the
less granular BLS estimates but are not likely to use DINP for the assessed applications. EPA addressed
this issue by refining the OES estimates using total employment data from the U.S. Census' Statistics of
U.S. Businesses (SUSB). However, this approach assumes that the distribution of occupation types
(SOC codes) in each 6-digit NAICS is equal to the distribution of occupation types at the parent 5-digit
NAICS level. If the distribution of workers in occupations with DINP exposure differs from the overall
distribution of workers in each NAICS, then this approach will result in inaccuracy.
4.1.2 Consumer Exposures
The following subsections briefly describe EPA's approach to assessing consumer exposures and
provide exposure assessment results for each COU. The Consumer and Indoor Dust Exposure
Assessment for Diisononyl Phthalate (DINP) ( 025b) provides additional details on the
development of approaches and the exposure assessment results. The consumer exposure assessment
TSD evaluated exposures from individual COUs while the indoor dust assessment TSD used a subset of
consumer articles with large surface area and presence in indoor environments to garner COU-specific
contributions to the total exposures from dust.
4.1.2.1 Summary of Consumer and Indoor Dust Exposure Scenarios and Modeling
Approach and Methodology
Consumer products or articles containing DINP were matched with the identified consumer COUs.
Table 4-6 summarizes the consumer exposure scenarios by COU for each product example(s), the
exposure routes, which scenarios are also used in the indoor dust assessment, and whether the analysis
was done qualitatively or quantitatively. The indoor dust assessment uses consumer products
information for selected articles with the goal of recreating the indoor environment. The subset of
consumer articles used in the indoor dust assessment were selected for their potential to have large
surface area for dust collection, roughly larger than 1 m2
When a quantitative analysis was conducted, exposure from the consumer COUs was estimated by
modeling. Exposure via inhalation and ingestion routes were modeled using EPA's Consumer Exposure
Model (CEM) Version 3.2 ( )23a) and dermal exposures were done using a computational
framework implemented within a spreadsheet environment. For each exposure route, EPA used the 10th
percentile, average, and 95th percentile value of an input parameter (e.g., weight fraction, surface area)
where possible to characterize low, medium, and high exposure for a given COU. Should only a range
be reported as the minimum, average, and maximum, EPA used these for the low, medium, and high,
respectively. See Consumer and Indoor Dust Exposure Assessment for Diisononyl Phthalate (DINP)
( 2025b) for details about the consumer modeling approaches, sources of data, model
parameterization, and assumptions.
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Exposure via the inhalation route occurs from inhalation of DINP gas-phase emissions or when DINP
partitions to suspended particulate from direct use or application of products and articles. Exposure via
the dermal route can occur from direct contact with products and articles. Exposure via ingestion
depends on the product or article use patterns. It can occur via direct mouthing {i.e., directly putting
product in mouth) in which the person can ingest settled dust with DINP or directly ingest DINP from
the product. Additionally, ingestion of suspended dust can occur when DINP migrates from product to
dust or partitions from gas-phase to suspended dust.
EPA made some adjustments to match CEM's lifestages to those listed in both the Centers for Disease
Control and Prevention (CDC) guidelines (CDC. 2021) and I'J'A's A Framework for Assessing Health
Risks of Exposures to Children ( .006). CEM lifestages are re-labeled from this point forward
as follows:
• Adult (21+ years) —~ Adult
• Youth 2 (16-20 years) —~ Teenager
• Youth 1 (11-15 years) —~ Young teen
• Child 2 (6-10 years) —~ Middle childhood
• Child 1 (3-5 years) —~ Preschooler
• Infant 2(1-2 years) —~ Toddler
• Infant 1 (<1 year) —~ Infant
EPA assessed acute, intermediate, and chronic exposures to DINP from consumer COUs. For the acute
dose rate calculations, an averaging time of 1 day is used representing the maximum time-integrated
dose over a 24-hour period during the exposure event. The chronic dose rate is calculated iteratively at a
30-second interval during the first 24 hours and every hour after that for 60 days. Intermediate dose is
the exposure to continuous or intermittent (depending on product) use during a 30-day period, which is
roughly a month. Professional judgment and product use descriptions were used to estimate events per
day and per month/year for the calculation of the intermediate/chronic dose.
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Table 4-6. Summary of Consumer CPUs, Exposure Scenarios, and Exposure Routes
Consumer COU
Category
Consumer COL Subcategory
Product/Article
Exposure Scenario and
Route
Evaluated Routes
Inhalation
Dermal
Ingestion
Qualitative /
Quantitative^
Suspended
Dust
Settled
Dust
6J3
s
2
3
O
s
Construction, paint,
electrical, and metal
products
Adhesives and sealants
Adhesive foam
Use of product in DIYe
large-scale home repair
activities. Direct contact
during use; inhalation of
emissions during use
%/
%/
X
X
X
Quantitative
Construction, paint,
electrical, and metal
products
Adhesives and sealants
Adhesives for small
repairs
Use of product in DIYe
small-scale home repair
activities. Direct contact
during use
X
%/
X
X
X
Quantitative
Construction, paint,
electrical, and metal
products
Adhesives and sealants
Automotive adhesives
Use of product in DIYe
small-scale auto repair.
Direct contact during use;
inhalation of emissions
%/
%/
X
X
X
Quantitative
Construction, paint,
electrical, and metal
products
Adhesives and sealants
Caulking compounds
Use of product in DIYe
home repair activities.
Direct contact during use;
inhalation of emissions
during use
%/
%/
X
X
X
Quantitative
Construction, paint,
electrical, and metal
products
Adhesives and sealants
Polyurethane injection
resin
Use of product in DIYe
home repair activities.
Direct contact during use;
inhalation of emissions
during use
%/
%/
X
X
X
Quantitative
Construction, paint,
electrical, and metal
products
Adhesives and sealants
Roofing adhesives
Use of product in DIYe
home repair. Direct contact
during use; inhalation of
emissions during use
%/
%/
X
X
X
Quantitative
Construction, paint,
electrical, and metal
Building construction materials
(wire and cable jacketing, wall
Roofing membranes
(also fabrics and film)
Direct contact while
repairing or maintenance
Xd
%/
X
X
X
Quantitative
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Consumer COU
Consumer COU Subcategory
Product/Article
Exposure Scenario and
Evaluated Routes
products
coverings, roofing, pool
applications, water supply
piping, etc.)
Construction, paint,
electrical, and metal
products
Building construction materials
(wire and cable jacketing, wall
coverings, roofing, pool
applications, water supply
piping, etc.)
Electrical tape, spline
Direct contact during
application.
X
%/
X
X
X
Quantitative
Construction, paint,
electrical, and metal
products
Building construction materials
(wire and cable jacketing, wall
coverings, roofing, pool
applications, water supply
piping, etc.)
PVC pipes
Direct contact while
repairing or maintenance
and drinking water
ingestion
X
%/
%/ b
Quantitative
Construction, paint,
electrical, and metal
products
Electrical and Electronic
Products
Wire insulation
Direct contact, inhalation
of emissions / ingestion of
dust adsorbed chemical,
mouthing by children
%/ a
%/
%/ a
%/ a
X
Quantitative
Construction, paint,
electrical, and metal
products
Paints and coatings
Lacquer sealer spray
(large project)
Application of product in
house via spray. Direct
contact during use;
inhalation of emissions
during use
%/
%/
X
X
X
Quantitative
Construction, paint,
electrical, and metal
products
Paints and coatings
Paint and lacquer
spray (small project)
Application of product in
house via spray. Direct
contact during use;
inhalation of emissions
during use
%/
%/
X
X
X
Quantitative
Furnishing, cleaning,
treatment/care products
Foam seating and bedding
products; furniture and
furnishings (furniture and
furnishings including plastic
articles (soft); leather articles)
Foam cushions
Direct contact, inhalation
of emissions / ingestion of
dust adsorbed chemical
%/ a
%/
%/ a
%/ a
X
Quantitative
Furnishing, cleaning,
treatment/care products
Foam seating and bedding
products; furniture and
furnishings (furniture and
furnishings including plastic
articles (soft); leather articles)
Indoor furniture
Direct contact during use;
inhalation of emissions /
ingestion of airborne
particulate; ingestion by
mouthing
V a
%/
%>' a
%>' a
Quantitative
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Consumer COU
Consumer COU Subcategory
Product/Article
Exposure Scenario and
Evaluated Routes
Furnishing, cleaning,
treatment/care products
Foam seating and bedding
products; furniture and
furnishings (furniture and
furnishings including plastic
articles (soft); leather articles)
Outdoor furniture
Direct contact during use
Xd
V
X
X
X
Quantitative
Furnishing, cleaning,
treatment/care products
Foam seating and bedding
products; furniture and
furnishings (furniture and
furnishings including plastic
articles (soft); leather articles)
Truck awning
Direct contact during use
Xd
%/
X
X
X
Quantitative
Furnishing, cleaning,
treatment/care products
Floor coverings/Plasticizer in
construction and building
materials covering large surface
areas including stone, plaster,
cement, glass, and ceramic
articles; fabrics, textiles, and
apparel (vinyl tiles, resilient
flooring, PVC-backed carpeting)
Carpet backing tiles
Direct contact, inhalation
of emissions / ingestion of
dust adsorbed chemical
V a
%/
V a
V a
X
Quantitative
Furnishing, cleaning,
treatment/care products
Floor coverings/Plasticizer in
construction and building
materials covering large surface
areas including stone, plaster,
cement, glass, and ceramic
articles; fabrics, textiles, and
apparel (vinyl tiles, resilient
flooring, PVC-backed carpeting)
Solid (resilient) vinyl
flooring tiles
Direct contact, inhalation
of emissions / ingestion of
dust adsorbed chemical
•%/ a
%/
•%/ a
•%/ a
X
Quantitative
Furnishing, cleaning,
treatment/care products
Floor coverings/Plasticizer in
construction and building
materials covering large surface
areas including stone, plaster,
cement, glass, and ceramic
articles; fabrics, textiles, and
apparel (vinyl tiles, resilient
flooring, PVC-backed carpeting)
Specialty wall
coverings
Direct contact during
installation (teenagers and
adults) and while in place;
inhalation of emissions /
ingestion of dust adsorbed
chemical
%/ a
%/
%/ a
%/ a
X
Quantitative
Furnishing, cleaning,
treatment/care products
Floor coverings/Plasticizer in
construction and building
materials covering large surface
areas including stone, plaster,
Wallpaper
Direct contact during
installation (teenagers and
adults) and while in place;
inhalation of emissions /
%/ a
%/
%/ a
%/ a
X
Quantitative
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Consumer COU
Consumer COU Subcategory
Product/Article
Exposure Scenario and
Evaluated Routes
cement, glass, and ceramic
articles; fabrics, textiles, and
apparel (vinyl tiles, resilient
flooring, PVC-backed carpeting)
ingestion of dust adsorbed
chemical
Furnishing, cleaning,
treatment/care products
Air care products
Oil fragrances
(making homemade
product)
Direct dermal while DIY
project (making of a
product)
%¦>'*
X
X
X
Quantitative
Furnishing, cleaning,
treatment/care products
Fabric, textile, and leather
products (apparel and footwear
care products)
Clothing
Direct contact during use
Xc
%¦>'*
X
X
X
Quantitative
Furnishing, cleaning,
treatment/care products
Fabric, textile, and leather
products (apparel and footwear
care products)
Footwear, steering
wheel covers, bags
Direct contact during use
Xc
%¦>'*
X
X
X
Quantitative
Packaging, paper,
plastic, hobby products
Arts, crafts, and hobby materials
Rubber eraser
Direct contact during use;
rubber particles may be
inadvertently ingested
during use. Eraser may be
mouthed by children
Xc
%¦>'*
X
X
Quantitative
Packaging, paper,
plastic, hobby products
Arts, crafts, and hobby materials
Crafting resin
Direct contact and
inhalation of emissions
during use
%¦>'*
X
X
X
Quantitative
Packaging, paper,
plastic, hobby products
Arts, crafts, and hobby materials
Hobby cutting board
Direct contact during use
X
%¦>'*
X
X
X
Quantitative
Packaging, paper,
plastic, hobby products
Ink, toner, and colorant products
No consumer products
identified
Current products were not
identified. Foreseeable uses
were matched with the
lacquers, and paints (small
projects) because similar
use patterns are expected.
See lacquers, and paints (small and
large projects)
Packaging, paper,
plastic, hobby products
Other articles with routine direct
contact during normal use
including rubber articles; plastic
articles (hard); vinyl tape;
flexible tubes; profiles; hoses
Shower curtain
Direct contact during use.
See routine contact
scenario inhalation of
emissions / ingestion of
dust adsorbed chemical
while hanging in place
%>' a
%>' a
%>' a
X
Quantitative
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Consumer COU
Consumer COU Subcategory
Product/Article
Exposure Scenario and
Evaluated Routes
Packaging, paper,
plastic, hobby products
Other articles with routine direct
contact during normal use
including rubber articles; plastic
articles (hard); vinyl tape;
flexible tubes; profiles; hoses
Work gloves, pet
chewy toys, garden
hose, cell phone
cover, tarpaulin
Direct contact during use.
X
X
X
X
Quantitative
Packaging, paper,
plastic, hobby products
Packaging (excluding food
packaging), including rubber
articles; plastic articles (hard);
plastic articles (soft)
PVC soap packaging
Direct contact during use.
X
%¦>'*
X
X
X
Quantitative
Packaging, paper,
plastic, hobby products
Toys, Playground, and Sporting
Equipment
Children's toys
(legacy)
Collection of toys. Direct
contact during use;
inhalation of emissions /
ingestion of airborne
particulate; ingestion by
mouthing
%>' a
%¦>'*
%>' a
%>' a
%¦>'*
Quantitative
Packaging, paper,
plastic, hobby products
Toys, Playground, and Sporting
Equipment
Children's toys (new)
Collection of toys. Direct
contact during use;
inhalation of emissions /
ingestion of airborne PM;
ingestion by mouthing
%/ a
%¦>'*
%/ a
%/ a
%¦>'*
Quantitative
Packaging, paper,
plastic, hobby products
Toys, Playground, and Sporting
Equipment
Sporting mats
Direct contact during use,
inhalation of emissions /
ingestion of dust adsorbed
chemical while hanging in
place
%>' a
%¦>'*
%>' a
%>' a
X
Quantitative
Other uses
Novelty articles
Adult toys
Direct contact during use,
ingestion by mouthing
Xc
%¦>'*
X
X
Quantitative
Other uses
Automotive articles
Car mats
Direct contact during use.
See routine contact
scenario inhalation of
emissions / ingestion of
dust adsorbed chemical
%>' a
%¦>'*
%>' a
%>' a
X
Quantitative
Disposal
Disposal
Down the drain
products and articles
Down the drain and
releases to environmental
media
X
X
X
X
X
Qualitative
Page 90 of 269
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Consumer COU
Consumer COU Subcategory
Product/Article
Exposure Scenario and
Evaluated Routes
Disposal
Disposal
Residential end-of-life
disposal, product
demolition for
disposal
Product and article end-of-
life disposal and product
demolition for disposal
Qualitative
»* Scenario is considered either qualitatively or quantitatively in this assessment.
•>>''" Scenario used in the indoor dust exposure assessment TSD. These indoor dust articles scenarios consider the surface area from multiple articles such as toys and wire
insulation, while furniture, curtains, flooring, and wallpaper already have large surface areas. For these articles dust can deposit and contribute to significantly larger
concentration of dust than single small articles.
*/b Scenario was assessed for drinking water ingestion in Section 6 in the Environmental Media and General Population Exposure for Diisononyl Phthalates (DINP), (U.S. EPA,
2025q) TSD.
* Scenario was deemed unlikely based on low volatility and small surface area, likely negligible gas and particle phase concentration for inhalation, low possibility of mouthing
based on product use patterns and targeted population age groups, and/or low possibility of dust on surface due to barriers or low surface area for dust ingestion.
*c Scenario was deemed unlikely based on low volatility and small surface area and likely negligible gas and suspended particle phase concentration.
Outdoor use with significantly higher ventilation minimizes inhalation.
e Do-it-yourself
•^Quantitative applies to green check marks and qualitative applies to red "x" marks for the routes that were deemed unlikely or assessed qualitatively using physical and
chemical properties (Disposal).
Page 91 of 269
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Inhalation and Ingestion Exposure Routes Modeling Approaches
Key parameters for articles modeled in CEM 3.2 are summarized in detail in Section 2 in Consumer and
Indoor Dust Exposure Assessment for Diisononyl Phthalate (DINP) (U.S. EPA. 2025b). Calculations,
sources, input parameters, and results are also available in the consumer exposure TSD. Generally, and
when possible, model parameters were determined based on specific articles identified in this
assessment and CEM defaults were only used where specific information was not available. A list of
some of the most important input parameters for exposure from articles and products is included below:
• weight fraction (articles and products);
• density (articles and products);
• duration of use (products);
• frequency of use for chronic, acute, and intermediate (products);
• product mass used (products);
• article surface area (articles);
• chemical migration rate to saliva (articles);
• area mouthed (articles); and
• use environment volume (articles and products).
For each exposure route, EPA used the 10th percentile, average, and 95th percentile value of an input
parameter (e.g., weight fraction, surface area, etc.) to characterize low, medium, and high exposure,
where possible and according to condition of use. Should only a range be reported, the Agency used the
minimum and maximum of the range as the low and high values, with the average of the minimum and
maximum used for the medium scenario. Each input in the list was parameterized according to the
article data found via systematic review or provided by CEM if article-specific parameters were not
available, or as an assumption based on article use descriptions by manufactures—always leaning on the
health protective values. For example, the chemical migration rate of DINP was estimated based on data
compiled in a review published by the Denmark Environmental Protection Agency in 2016 (Danish
). For all scenarios, the near-field modeling option was selected to account for a small
personal breathing zone (PBZ) around the user during product use in which concentrations are higher,
rather than employing a single well-mixed room. A near-field volume of 1 m3 was selected.
Dermal Exposure Routes Modeling Approaches
Dermal modeling was done outside of CEM. The use of the CEM model for dermal absorption, which
relies on total concentration rather than aqueous saturation concentration, would greatly overestimate
exposure to DINP in liquid and solid products and articles. See ( 025b) and (U.S. EPA.
2025c) for more details. The dermal dose of DINP associated with use of both liquid products and solid
articles was calculated in a spreadsheet outside of CEM. See Consumer Exposure Analysis for
Diisononyl Phthalate (DINP) ( 25c) for details. For each product or article, high, medium,
and low exposure scenarios were developed. Values for duration or dermal contact and area of exposed
skin were determined based on reasonably expected use for each item. In addition, high, medium, and
low estimates for dermal flux (liquid products) or absorption (solid products) were calculated and
applied in the corresponding scenario. Key parameters for the dermal model are shown in Section 2.3 in
( 2025b).
4.1.2.2 Modeling Dose Results by COU for Consumer and Indoor Dust
This section summarizes the dose estimates from inhalation, ingestion, and dermal exposure to DINP in
consumer products and articles. Detailed tables of the dose results for acute, intermediate, and chronic
exposures are available in Section 4 of Consumer and Indoor Dust Exposure Assessment for Diisononyl
Phthalate (DINP) ( 2025b) as well as the DINP Consumer Risk Calculator (U.S. EPA.
2025d).
Page 92 of 269
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Acute, Intermediate, and Chronic Dose Rate Results, Conclusions, and Data Patterns
Figure 4-2 to Figure 4-13 summarizes modeling results for the high, medium, and low acute dose rate
(ADR) for dermal, ingestion, and inhalation for infants, children, teenagers, and adults. The chronic
average daily dose (CADD) and intermediate figures resulted in the same data patterns as the acute
doses (see Section 4 in (II 2025b) for each lifestage for data patterns and discussion). Only
three product examples under the Construction, paint, electrical, and metal products; adhesives and
sealants COU were candidates (intermittent or consecutive monthly use) for intermediate exposure
scenarios.
Some products and articles did not have dose results because the product or article was not targeted for
that lifestage or exposure route. Among the younger lifestages, less than 10 years, dermal exposure
doses were higher followed by ingestion via mouthing and inhalation. For teens and adults, dermal
contact was a strong driver of exposure to DINP, with the dose received being generally higher (purple
bars in figures) than to the dose received from exposure via inhalation or ingestion. The spread of values
estimated for each product or article reflects the aggregate effects of variability and uncertainty in key
modeling parameters for each item; acute dose rate for some products/articles covers a larger range than
others primarily due to a wider distribution of DINP weight fraction values, chemical migration rates for
mouthing exposures, and behavioral factors such as duration of use or contact time and mass of product
used as described in Section 2 in ( 25b). Key differences in exposures among lifestages
include designation as product user or bystander; behavioral differences such as mouthing durations,
hand-to-mouth contact times, and time spent on the floor; and dermal contact expected from touching
specific articles, which may not be appropriate for some lifestages.
In addition to assessing users of various lifestages EPA consider bystanders exposures to consumer
products and articles where applicable. Bystanders are people who are not in direct use or application of
the product but who can be exposed to DINP by proximity to the use of the product via inhalation of
gas-phase emissions or suspended dust. All bystander scenarios were assessed for children under 10
years for products that are not targeted for the use of children under 10 and assessed as users for older
than 11 years because the products can be used by children 11 and older. People older than 11 years can
also be bystanders; however, the user scenarios utilize inputs that would result in larger exposure doses
and thus the bystander scenarios would have lower risk estimates. Bystander scenarios and COUs
include (1) Construction, paint, electrical, and metal products; adhesives and sealants; and (2)
Construction, paint, electrical, and metal products; paints and coatings.
For the assessment of indoor dust exposures and estimating contribution to dust from individual COUs,
EPA recreated plausible indoor environment using consumer products and articles commonly present in
indoor spaces inhalation exposure from toys, carpet backing, vinyl flooring tiles, indoor furniture, foam
cushions, in-place wallpaper, specialty wall coverings, shower curtains, sporting mats, car mats, and
wire insulation include a consideration of dust collected on the surface of a relatively large area. These
can include flooring, furniture, and wallpaper, but also multiple toys and wires collecting dust with
DINP and subsequent inhalation and ingestion. All lifestages assessed under the indoor dust exposure
scenarios are considered users of the articles being assessed.
Acute Dose Results for Infants, Toddlers, Preschoolers, and Middle Childhood (<10 Years)
Figure 4-2 and Figure 4-3 show all exposure routes for infants (<1 year old) to 10-year-old children.
Dose result patterns were very similar for the same products or articles and routes of exposure across
these three lifestages (see DINP Consumer Risk Calculator ( 325d) doses per lifestage). EPA
averaged the three lifestages into one dose result for all in Figure 4-2 and Figure 4-3. Ingestion route
acute dose results in the figure show the sum of all ingestion scenarios (mouthing, suspended dust, and
Page 93 of 269
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surface dust). Inhalation exposure from toys, flooring, carpet backing, indoor furniture, cushions,
wallpaper, shower curtains, and wire insulation include a consideration of dust collected on the surface,
settled dust, of a relatively large area, like flooring and wallpaper, but also multiple toys and wires
collecting dust with DINP and subsequent inhalation and ingestion.
Compared to all exposure routes inhalation is the highest dose per product and articles, except for new
children's toys and wire insulation ingestion via mouthing. The highest ADR estimated for these
lifestages was for inhalation of suspended dust exposure to carpet backing, children's toys, indoor
furniture, wallpaper and coverings, vinyl flooring, sports mats, and wire insulation. Inhalation of DINP -
contaminated dust is an important contributor to indoor exposures. Inhalation doses of adhesives and
lacquers for this lifestages represent bystander exposures, which is a person in the proximity of someone
else using such products. These products inhalation doses are overall lower than the articles used for
indoor inhalation of suspended dust.
Ingestion of DINP has the overall second highest doses. For articles assessed for mouthing, such as toys,
furniture, wire insulation, and rubber erasers exposure from mouthing is expected to have a larger
impact in the overall ingestion dose. Mouthing tendencies decrease or cease entirely for children 6 to 10
years. Ingestion of DINP via mouthing of legacy and new toy have similar high-intensity use doses
because the same chemical migration rates were used for all scenarios. However, it is noteworthy that
the concentration of DINP in new toys is below the range of values used to derive the chemical
migration rates and it is likely that the high-intensity use mouthing exposure estimates are not
representative of actual doses that would be received from these items. Articles that were not assessed
for mouthing were assessed for ingestion of settled and suspended dust, in which the settled dust
exposures tend to be larger than ingestion from suspended dust (see Section 4.3 and Table 4-4 in (U.S.
25b) for indoor settled dust ingestion exposure results).
The dermal ADR is the lowest dose in comparison to inhalation and ingestion per product and articles,
except for cushions. The dermal assessment of cushions considered direct contact like that of furniture,
which may be an overestimation. The ADR range is similar for shower curtains, flooring, wallpaper and
specialty coverings, and wire insulation, because of similar contact patterns and frequencies, and from
using the same dermal flux rates.
Page 94 of 269
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Adhesive Foam
Automotive Adhesives
Car mats
i Inhalation A Low Exposure Scenario
Ingestion () Medium Exposure Scenario
Dermal V High Exposure Scenario
Carpet Backing
Caulking Compounds
Children's toys (legacy)
Children's toys (new)
Clothing
Crafting Resin
Foam Cushions'
Indoor Furniture
V
0 A
V
Outdoor Furniture
Paint/Lacquer (Large Project)
Paint/Lacquer (Small Project)
Roofing Adhesives
Rubber Eraser
Shower Curtain
Small Articles with Potential for
Semi-Routine Contact
Specialty Wall Coverings (In-Place)
Sports Mats
Vinyl Flooring
Wallpaper (In Place)
Wire Insulation
10"'
A
0 A
V o A
V
0 A
10--
10-'
0.001
o.oi
o.i
10
ADR ((ig/kg/day) in Infant and Toddler Users and Bystanders
\
V o A
v^r a
100
Figure 4-2. Acute Dose Rate for DINP from Ingestion, Inhalation, and Dermal Exposure Routes
in Infants Aged Less than 1 Year and Toddlers Aged 1 to 2 Years
Page 95 of 269
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Adhesive Foam
Automotive Adhesives
Car mats
i Inhalation A Low Exposure Scenario
Ingestion (} Medium Exposure Scenario
Dermal V High Exposure Scenario
Carpet Backing
Caulking Compounds
Children's toys (legacy)
Children's toys (new)
Clothing
Crafting Resin
Foam Cushions^
Indoor Furniture
Mobile Phone Covers
Outdoor Furniture
Paint/Lacquer (Large Project)
Paint/Lacquer (Small Project)
Roofing Adhesives
Rubber Eraser
Shower Curtain
Small Articles with Potential for
Semi-Routine Contact
Specialty Wall Coverings (In-Place)
Sports Mats
Vinyl Flooring
Wallpaper (In Place)
Wire Insulation
10"'
0 A
XB0&
^A
V
v 0
*
^0r\
^ A
0 a
V 0 A
V
0 A
V o A
V 0
ltr3 io"^ o.ooi o.oi o.i l
ADR (ng/kg/day) in Child Users and Bystanders
10
gm
100
Figure 4-3. Acute Dose Rate of DIM* from Ingestion, Inhalation, and Dermal Exposure Routes
Preschoolers Aged 3 to 5 Years and Middle Childhood Aged 6 to 10 Years
Page 96 of 269
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Young Teens, Teenagers, Young Adults, and Adults (11—21 Years and 21+ Years)
Figure 4-4 and Figure 4-5 show all exposure routes for young teens (11-15 years) to adults above 21
years old. Dose result patterns were very similar for the same products or articles and routes of exposure
across young teens, teenagers and young adults, aged 11 to 20 years (see DINP Consumer Risk
Calculator (U.S. EPA. 2025d) doses per lifestage). EPA averaged two lifestages 11 to 20 years, except
adults that have added exposures to adult toys. The acute dose rate for some products/articles covers a
larger range than others primarily due to a wider distribution of weight fraction values for those
examples. Inhalation exposure as a bystander for these lifestages were not targeted for adhesives and
lacquers for small projects. Young adults (aged 16-20 years) can use these products in similar capacity
as adults during do-it-yourself (DIY) projects and as bystanders; hence this lifestage was modeled as a
user of the product rather than a bystander. Users have higher doses when considering direct contact and
use. Dermal exposure resulted in the highest doses overall, for DIY products such as adhesives, paints,
lacquers, scented oils, except for paints for large projects in which inhalation exposure was higher likely
because of the use of spray paints and the volatilization of the paint and subsequent inhalation of mist
and droplets.
For articles considered in the indoor assessment inhalation and ingestion of suspended and settled dust
doses were higher than dermal, which decreases significantly. Ingestion via mouthing is either not
considered or significantly lower which is expected due to a decrease or ceased in mouthing behavior.
Mouthing tendencies decrease significantly for theses lifestages; thus, most scenarios do not estimate
exposure via mouthing. Mouthing is still an important exposure route for adult toys and teenagers and
adults. Ingestion of settled dust is the only ingestion pathway for other products and articles other than
adult toys, which suggests that indoor dust ingestion and inhalation are an important contributor to DINP
exposures.
Page 97 of 269
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Adhesive Foam
Adhesives for Small Repairs
Adult Toys*
Automotive Adhesives
Caulking Compounds
Clothing
Crafting Resin
Mobile Phone Covers
Outdoor Furniture
Polyurethane Injection Resin
Scented Oil
Shower Curtain
Small Articles with Potential for
Semi-Routine Contact
Specialty Wall Coverings (In-Place)
Wallpaper (In Place)
¦ Inhalation A Low Exposure Scenario
Ingestion () Medium Exposure Scenario
¦ Dermal V High Exposure Scenario
Foam Cushions-^ q ^
Indoor Furniture
vO*
Carpet Backing
M>A
Children's toys (legacy)
0 A
Children's toys (new) ^
0
V 0 A
Paint/Lacquer (Large Project)
Paint/Lacquer (Small Project) *
Roofing Adhesives
Roofing Membrane
Rubber Eraser
^0 A
\a0*
V OA
Specialty Wall Coverings (Installation)
Sports Mats
V 0 A
*0*
Truck Awning
Vinyl Flooring
0 A
V 0 a
Wallpaper (Installation)
Wire Insulation
V 0 A
10'6 10"5 10"4 0.001 0.01 0.1 1 10
ADR (ng/kg/day) in Teen Users and Bystanders
•Mouthing exposure modeled for Teenagers (16-20 years old) only
Figure 4-4. Acute Dose Rate of DINP from Ingestion, Inhalation, and Dermal Exposure Routes
Young Teens Aged 11 to 15 Years and for Teenagers and Young Adults Aged 16 to 20 Years
Page 98 of 269
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Adhesive Foam
Adhesives for Small Repairs
Carpet Backing
Caulking Compounds
Children's toys (legacy)
Children's toys (new)
Clothing
Crafting Resin
Foam Cushions-^
Indoor Furniture
Mobile Phone Covers
Outdoor Furniture
Paint/Lacquer (Large Project)
Paint/Lacquer (Small Project)
Polyurethane Injection Resin
Roofing Adhesives
Roofing Membrane
Rubber Eraser
Scented Oil
Shower Curtain
Small Articles with Potential for
Semi-Routine Contact
Specialty Wall Coverings (In-Place)
Specialty Wall Coverings (Installation)
Sports Mats
Truck Awning
Vinyl Flooring
Wallpaper (In Place)
Wallpaper (Installation)
Wire Insulation
¦ Inhalation A Low Exposure Scenario
Ingestion () Medium Exposure Scenario
Dermal V High Exposure Scenario
Adult Toys
V o A
Automotive Adhesives
¦0"*
Car mats
*
0 A
V 0 A
safe
v0 A
0 A
V 0 A
0 A
V o A
V 0 A
10-4 0.001 0.01 0.1 1
ADR (ng/kg/day) in Adult Users and Bystanders
Figure 4-5. Acute Dose Rate of DINP from Ingestion, Inhalation, and Dermal Exposure Routes
Adults Aged 21 Years or Older
Page 99 of 269
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Intermediate Dose Results for All Lifestages
Only automotive adhesives and construction adhesives qualified to be used in intermediate scenarios
because according to manufacture product use description repeated use can be expected within a 30-day
period. Based on manufacturer use description and professional judgement/assumption, these products
may be used repeatedly within a 30-day period depending on projects. Infants to childhood lifestages do
not have dermal doses as these products are not targeted for their use and application. However, starting
from young teens through adults, it is possible that these lifestages can use automotive and construction
adhesives in home renovation projects or other hobbies. Infants to middle childhood lifestages are
considered bystanders when these products are in use and are exposed via inhalation. Direct dermal
contact has a larger dose than inhalation for the uses during application. See Figure 4-6 through Figure
4-9 for intermediate dose visual representation.
Inhalation A Low Exposure Scenario
Ingestion (} Medium Exposure Scenario
Dermal V High Exposure Scenario
Adhesive Foam
Automotive Adhesives
Intermediate Daily Dose (ng/kg/day) in Infant and Toddler Users and Bystanders
Figure 4-6. Intermediate Dose Rate for DINP from Inhalation Exposure Route in Bystander
Infants Aged Less than 1 Year and Toddlers Aged 1 to 2 Years
Adhesive Foam
Automotive Adhesives
10"'
• Inhalation A Low Exposure Scenario
Ingestion () Medium Exposure Scenario
Dermal V High Exposure Scenario
M
icP icr o.ooi
Intermediate Daily Dose (ng/kg/day) in Child Users and Bystanders
o.oi
Figure 4-7. Intermediate Dose Rate for DINP from Inhalation Exposure Route in Bystander
Preschoolers Aged 3 to 5 Years and Middle Childhood Aged 6 to 10 Years
Adhesive Foam
' Inhalation A Low Exposure Scenario
Ingestion () Medium Exposure Scenario
Dermal V High Exposure Scenario
r,
Adhesives for Small Repairs
Automotive Adhesives
10'6 10'5 10"4 0.001 0.01 0.1 1
Intermediate Daily Dose (ng/kg/day) in Teen Users and Bystanders
Figure 4-8. Intermediate Dose Rate of DINP from Inhalation and Dermal Exposure Routes in
Young Teens Aged 11 to 15 Years and for Teenagers and Young Adults Aged 16 to 20 Years
Page 100 of 269
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Adhesive Foam
i Inhalation A Low Exposure Scenario
Ingestion (} Medium Exposure Scenario
Dermal V High Exposure Scenario
MM
r6 io"5 io"4 o.ooi o.oi o.i j
L
Intermediate Daily Dose (^ig/kg/day) in Adult Users and Bystanders
Figure 4-9. Intermediate Dose Rate of DINP from Inhalation and Dermal Exposure Routes in
Adults Aged 21 Years and Older
Chronic Dose Results for All Lifestages
Data patterns are illustrated in figures after the table and includes summary descriptions of the patterns
by exposure route and population or lifestage. The following set of figures (Figure 4-10 to Figure 4-13)
show chronic average daily dose data for all products and articles modeled in all lifestages. For each
lifestage, figures are provided that show CADD estimated from exposure via inhalation, ingestion
(aggregate of mouthing, suspended dust ingestion, and settled dust ingestion), and dermal contact. The
chronic average daily dose figures resulted in similar overall data patterns as the acute doses.
Page 101 of 269
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Car mats
'Inhalation A Low Exposure Scenario
Ingestion () Medium Exposure Scenario
Dermal V High Exposure Scenario
Carpet Backing
Caulking Compounds
Children's toys (legacy)
Children's toys (new)
Clothing
Crafting Resin
Foam Cushions*
Indoor Furniture
V
0 A
^>A
Outdoor Furniture
Paint/Lacquer (Large Project)
Paint/Lacquer (Small Project)
Roofing Adhesives
Rubber Eraser
Shower Curtain
Small Articles with Potential for
Semi-Routine Contact
Specialty Wall Coverings (In-Place)
Sports Mats
Vinyl Flooring
Wallpaper (In Place)
Wire Insulation
10"'
^0 A
0 A
V o A
0 A
V 0 A
A
10-
10"
0.001
0.01
0.1
10
CADD (pg/kg/day) in Infant and Toddler Users and Bystanders
100
Figure 4-10. Chronic Dose Rate for DINP from Ingestion, Inhalation, and Dermal Exposure
Routes in Infants Aged Less than 1 Year and Toddlers Aged 1 to 2 Years
Page 102 of 269
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Car mats
¦ Inhalation A Low Exposure Scenario
Ingestion () Medium Exposure Scenario
Dermal V High Exposure Scenario
Carpet Backing
Caulking Compounds
Children's toys (legacy)
Children's toys (new)
Clothing
Crafting Resin
Foam Cushions
Indoor Furniture
Mobile Phone Covers
Outdoor Furniture
Paint/Lacquer (Large Project)
Paint/Lacquer (Small Project)
Roofing Adhesives
Rubber Eraser
Shower Curtain
V
Small Articles with Potential for
Semi-Routine Contact
Specialty Wall Coverings (In-Place)
Sports Mats
Vinyl Flooring
Wallpaper (In Place)
Wire Insulation
10"'
0 A
\*>A
V
A
W
V o
v o
A
v 0 A
v 0 a
v
0 A
V 0 A
V o
icr
10
o.ooi
o.oi
o.i
10
CADD (ng/kg/day) in Child Users and Bystanders
100
Figure 4-11. Chronic Dose Rate of DINP from Ingestion, Inhalation, and Dermal Exposure Routes
in Preschoolers Aged 3 to 5 Years and Middle Childhood Aged 6 to 10 Years
Page 103 of 269
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Adult Toys
Caulking Compounds
Children's toys (legacy)
Children's toys (new)
Clothing
Crafting Resin
Foam Cushions^
Indoor Furniture
Mobile Phone Covers
Outdoor Furniture
Paint/Lacquer (Large Project)
Paint/Lacquer (Small Project)
Polyurethane Injection Resin
Roofing Adhesives
Rubber Eraser
Scented Oil
Shower Curtain
Small Articles with Potential for'
Semi-Routine Contact
Specialty Wall Coverings (In-Place)
Sports Mats
Vinyl Flooring
Wallpaper (In Place)
Wire Insulation
1(P
0 A
v A
^*te
V 0 A
V 0 A
ltr-
10-
0.001 0.01 0.1 1
CADD ((jg/kg/day) in Teen Users and Bystanders
•Mouthing exposure modeled for Teenagers (16-20 years old) only
10
Figure 4-12. Chronic Dose Rate of DINP from Ingestion, Inhalation, and Dermal Exposure Routes
in Young Teens Aged 11 to 15 Years and in Teenagers and Young Adults Aged 16 to 20 Years
Page 104 of 269
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Adult Toys
Car mats
Carpet Backing
Caulking Compounds
Children's toys (legacy)
Children's toys (new)
Clothing
Crafting Resin
¦ Inhalation A Low Exposure Scenario
Ingestion Q Medium Exposure Scenario
Dermal V High Exposure Scenario
V 0 A
1
c
I
\m
v 0
A
«
O
>
Foam Cushionsv
0 A
Indoor Furniture
Mobile Phone Covers
Outdoor Furniture
Paint/Lacquer (Large Project)
Paint/Lacquer (Small Project)
Polyurethane Injection Resin
Shower Curtain
Small Articles with Potential for
Semi-Routine Contact
V 0 A
^0*
Roofing Adhesives
Rubber Eraser
Scented Oil
^ A
Specialty Wall Coverings (In-Place)
V
0 A
—
Sports Mats
V 0 A
Vinyl Flooring
V
0 A
Wallpaper (In Place)
V 0
A
Wire Insulation
V 0 A
CADD (ng/kg/day) in Adult Users and Bystanders
Figure 4-13. Chronic Dose Rate of DINP from Ingestion, Inhalation, and Dermal Exposure Routes
in Adults Aged 21 Years and Older
Page 105 of 269
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4.1.2.3 Monitoring Concentrations of DINP in the Indoor Environment
For the indoor exposure assessment, EPA considered modeling and monitoring data. This section
describes indoor dust monitoring data exclusively while modeling data and approaches are summarized
in Sections 4.1.2.1 and 4.1.2.2. Modeling data used in indoor dust assessment originated from the
consumer exposure assessment to reconstruct major indoor sources of DINP into dust and obtain COU-
and product-specific exposure estimates for ingestion and inhalation.
Monitoring data are expected to represent aggregate exposure to DINP in dust resulting from all sources
present in a home or other indoor environments like gyms for sporting mats and car for car mats.
Although it is not a good indicator of individual contributions of specific COUs, it provides a real-world
indicator of total exposure through dust. The monitoring data considered are from residential dust
samples from studies conducted in the United States. Measured DINP concentrations were compared to
determine consistency among datasets. The monitoring studies and assumptions made to estimate
exposure are described in detail in Section 3.2 of the Consumer and Indoor Dust Exposure Assessment
for Diisononyl Phthalate (DINP) ( 25b).
Indoor Dust Monitoring Data
A total of 38 studies were identified as containing measured DINP concentrations in dust during
systematic review. Of these, three studies were identified as containing U.S. data on residential
measured DINP concentrations in dust (Hammel et at.. I , Dodson et at.. 201 ; c.hin et at.. 2014). The
remaining 35 studies measured DINP dust concentrations in non-residential buildings, such as offices,
schools, businesses, and day cares, did not present original data and/or were not conducted in the United
States. The studies that contained residential DINP dust monitoring data were compared to identify
similarities and differences in sampled population and sampling methods. Evaluating the sampled
population and sampling methods across studies was important to determine whether the residential
monitoring data were conducted on broadly representative populations {i.e., not focused on a particular
subpopulation).
Of the three studies that were identified as containing United States data on residential measured DINP
concentrations, two had small sample sizes and sampled subpopulations that were not necessarily
broadly representative of the U.S. population. Ham m el et al. was the only U.S. study identifying
DINP concentrations in residential dust that was not focused on a particular subpopulation. That study
collected paired house dust, hand wipe, and urine samples from 203 children aged 3 to 6 years from 190
households in Durham, North Carolina, between 2014 and 2016. That study also analyzed product use
and presence of materials in individual houses. The households were participants in the Newborn
Epigenetics Study (NEST), a prospective pregnancy cohort study that was conducted between 2005 and
2011. Participants were recontacted and invited to participate in a follow-up study on phthalate and
SVOC exposure, which was titled the Toddlers' Exposure to SVOCs in the Indoor Environment
(TESIE) Study. This study involved home visits conducted between 2014 and 2016. DINP
measurements from the Hammel study reported 188 samples concentrations ranging from
no detects to 788 |ig/g with a median of 79 |ig/g and a detection frequency of 96 percent.
The data on DINP concentrations were used with body weight data representative of the U.S. population
taken from the Exposure Factors Handbook ( ) and estimated daily dust intake rates
taken from (Ozkavnak et al.. 2022) to derive an estimate of daily DINP intake in residential dust per
kilogram body weight, dose (see Section 4.2 in ( 25b) for further information).
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Strengths, Limitations, Assumptions, and Key Sources of Uncertainty for the Indoor Dust Monitoring
Data
There are several potential challenges in interpreting available indoor dust monitoring data, which are
listed below:
• Samples may have been collected at exposure times or for exposure durations not expected to be
consistent with a presumed hazard based on a specified exposure time or duration.
• Samples may have been collected at a time or location when there were multiple sources of
DINP that included "non-TSCA" uses (e.g., cosmetics, medical devices, and food contact
materials).
• None of the identified monitoring data contained source apportionment information that could be
used to determine the fraction of DINP in dust samples that resulted from a particular TSCA or
non-TSCA COU.
• Activity patterns may differ according to demographic categories (e.g., stay at home/work from
home individual vs. an office worker), which can affect exposures especially to articles that
continually emit a chemical of interest.
Other considerations like specific household construction approaches, peoples' use and activity patterns,
and some indoor environments may have more ventilation than others, which may change across
seasons.
The DINP concentrations in indoor dust were derived from Hammel et al. (2019). In this study, 190
households from the TESIE study conducted between 2014 and 2016 in Durham, North Carolina, were
vacuum sampled for indoor residential dust. Study participants were recruited from participants in an
existing pregnancy cohort study, and the demographics of the study population matched those of the
Durham population. Residents were asked to refrain from vacuuming or otherwise cleaning hard
surfaces within the home for 2 days prior to sampling, and dust sampling was conducted by study
technicians according to an internationally recognized sampling method ( 001). Samples were
taken from a single room in each home, which was identified as the room in which the child(ren)
residing in the home spent the most time. The study identifies these rooms as typically playrooms or
living rooms. A key assumption made in this analysis is that dust concentrations in playrooms and living
rooms are representative of those in the remainder of the home. It is possible that sampling biases were
introduced by the choice of study location, by the choice to include only households that contain
children, and by differences among the households that chose to participate in the study. Differences in
consumer behaviors, housing type and quality, tidiness, and other variables that affect DINP
concentrations in household dust are possible between participating households and the general
population.
Body weights were taken from the Exposure Factors Handbook ( 201 la), which were derived
from the NHANES 1999 to 2006 dataset. The NHANES studies were designed to obtain a nationally
representative dataset for the United States and include weight adjustment for oversampling of certain
groups (children, adolescents 12-19 years, persons 60+ years of age, low-income persons, African
Americans, and Mexican Americans). Body weights were aggregated across lifestages and averaged by
sex. In general, body weights have increased in the United States since 2006 (CDC. ), which may
lead to an underestimate of body weight in this analysis. This would lead to an overestimate of DINP
dose per unit body weight, because actual body weights in the U.S. population may be larger than those
assumed in this analysis.
There are several potential challenges in interpreting available indoor dust monitoring data, which
include the following:
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• Samples may have been collected at exposure times or for exposure durations not expected to be
consistent with a presumed hazard based on a specified exposure time or duration.
• Samples may have been collected at a time or location when there were multiple sources of
DINP that included non-TSCA COUs, like household dust with skin residue exposed to DINP-
containing cosmetics.
• None of the identified monitoring data contained source apportionment information that could be
used to determine the fraction of DINP in dust samples that resulted from a particular TSCA or
non-TSCA COU. Therefore, these monitoring data represent background concentrations of DINP
and are an estimate of aggregate exposure from all residential sources.
• Activity patterns may differ according to demographic categories (e.g., stay at home/work from
home individual vs an office worker) that can affect exposures especially to articles that
continually emit a chemical of interest.
• Some indoor environments may have more ventilation than others, which may change across
seasons.
Weight of Scientific Evidence Conclusions for Indoor Dust Monitoring Data
The weight of scientific evidence for the indoor dust exposure assessment of DINP (Table 4-7) is
dependent on studies that include indoor residential dust monitoring data. Only studies that included
indoor dust samples taken from residences were included for data extraction. In the case of DINP, three
studies were identified as containing data on residences in the United States. Of these three, one study
was selected for use in the indoor dust monitoring assessment as described in (Hammel et at.. 2019).
This study was rated high quality per the exposure systematic review criteria.
Table 4-7. Weight of Scientific Evidence Conclusions for Indoor Dust Ingestion Exposure
Scenario
Confidence in
Data Used "
Confidence in Model Inputs
Weight of Scientific
Evidence Conclusion
Body
Weighth
Dust Ingestion
Rate c
Indoor exposure to
residential dust via
ingestion
Robust
Robust
Moderate
Robust
a Hammel et al. (2019)
h U.S. EPA (2011a)
c Ozkavnak et al. (2022)
Table 4-7 presents the assessor's level of confidence in the data quality of the input datasets for
estimating dust ingestion from monitoring data, including the DINP dust monitoring data themselves,
the estimates of U.S. body weights, and the estimates of dust ingestion rates, according to the following
rubric:
• Robust confidence means the supporting weight of scientific evidence outweighs the
uncertainties to the point that the assessor has decided that it is unlikely that the uncertainties
could have a significant effect on the exposure estimate.
• Moderate confidence means the supporting scientific evidence weighed against the uncertainties
is reasonably adequate to characterize exposure estimates, but uncertainties could have an effect
on the exposure estimate.
• Slight confidence means the assessor is making the best scientific assessment possible in the
absence of complete information. There may be significant uncertainty in the underlying data
that needs to be considered.
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These confidence conclusions were derived from a combination of systematic review {i.e., the quality
determinations for individual studies) and the assessor's professional judgment. Taken as a whole, with
robust confidence in the DINP concentration monitoring data in indoor residential dust from Hammel et
al. (20191 robust confidence in body weight data from the Exposure Factors Handbook U.S. EPA.
(201 la), and moderate confidence in dust intake data from Ozkavnak et al. (2022). EPA has assigned a
weight of scientific evidence rating of robust confidence in our estimates of daily DINP intake rates
from ingestion of indoor dust in residences (Table 4-7).
4.1.2.4 Indoor Aggregate Dust Monitoring and Modeling Comparison
Aggregate Indoor Dust Exposure Approach and Methodology for Modeling Data
Given the complexity of source apportionment in exposure assessment for chemicals in indoor dust,
EPA considered the available modeling and monitoring data to estimate the aggregate exposures to
DINP that may occur via dust in a typical indoor environment. Modeling data used in indoor dust
assessment originated from the consumer exposure assessment, Section 4.1.2.2, to reconstruct major
indoor sources of DINP into dust and obtain COU and product specific exposure estimates for ingestion
and inhalation—although only ingestion of settled dust was used in the monitoring and modeling
comparison. The monitoring data considered, described in Section 4.2 in ( 25b) and in
Section 4.1.2.3 of this risk evaluation, are from residential settled dust samples from studies conducted
in countries with comparable standards of living to the United States. Detailed descriptions of the indoor
dust approaches and methodologies are available in Section 4.1.2 of the Consumer and Indoor Dust
Exposure Assessment for Diisononyl Phthalate (DINP) ( >25b).
For the modeling indoor dust assessment, EPA identified article specific information by COU to
construct relevant and representative exposure scenarios from the consumer assessment, Sections 4.1.2.1
and 4.1.2.2. Although most of the exposure scenarios for articles used in this indoor assessment were
modeled in CEM for inhalation, ingestion of suspended and settled dust, mouthing, and dermal (see
Section 4.1.2.1), only ingestion of settled dust exposures was used to compare with monitoring data
because that was the information type reported in those monitoring studies. Exposure to DINP via
ingestion of dust was assessed for all articles expected to contribute significantly to dust concentrations
due to high surface area (exceeding ~1 m2) for either a single article or collection of like articles as
appropriate, including
• wallpaper;
• specialty wall coverings;
• wire insulation;
• foam cushions;
• solid vinyl flooring tiles;
• carpet backing tiles;
• indoor furniture;
• car mats;
• shower curtains;
• sporting mats; and
• children's toys, both legacy and new.
Of the above list of articles, specialty coverings, car mats, and sporting mats are not expected to be
commonly found in homes. Furthermore, because the monitoring data are exclusively for residential
locations, EPA did not include these in the modeling aggregate comparison with monitoring data.
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Modeling and Monitoring Indoor Dust Ingestion Exposure Comparison
The dose estimates for indoor dust from the CEM model are larger than those indicated by the
monitoring approach. Table 4-8 compares the sum of the chronic dose central tendency for indoor dust
ingestion from CEM outputs for all COUs to the central tendency predicted daily dose from the
monitoring approach. Because monitoring intake rates were only assessed for settled dust ingestion, the
comparison between monitoring and modeling only includes settled dust ingestion estimates.
Table 4-8. Comparison Between Modeled and Monitored Daily Dust Intake Estimates for DINP
Lifestage
Daily DINP Intake
Estimate from Dust,
Hg/kg-day,
Modeled Exposure"
Daily DINP Intake
Estimate from Dust,
Hg/kg-day,
Monitoring Exposure*
Margin of
Difference
(Modeled +
Monitoring)
Infant (<1 Year)
31.03
0.25c
124.1
Toddler (1-2 Years)
38.42
0.16
240.2
Preschooler (3-5 Years)
43.38
0.080
542.3
Middle Childhood (6-10 Years)
15.22
0.064
237.9
Young Teen (11-15 Years)
8.52
0.032
266.4
Teenager (16-20 Years)
6.76
0.012
563.5
Adult (21+ Years)
3.03
0.0034^
990.0
11 Sum of chronic doses for indoor dust ingestion for the "medium" intake scenario for all COUs modeled in
CEM.
h Central tendency estimate of daily dose for indoor dust ingestion from monitoring data.
c Weighted average by month of monitored lifestages from birth to 12 months.
''Weighted average by year of monitored lifestages from 21 to 80 years.
The sum of DINP intakes from dust in CEM modeled scenarios were, in all cases, considerably higher
than those predicted by the monitoring approach. The difference between the two approaches ranged
from 124 times in infants less than 1 year old, to a high of 990 times in adults 21 years and older. These
discrepancies partially stem from differences in the exposure assumptions of the CEM model vs. the
assumptions made when estimating daily dust intakes in Ozkavnak et al. (2022). Dust intakes in
Ozkavnak et al. (2022) decline rapidly as a person ages due to behavioral factors, including walking
upright instead of crawling, cessation of exploratory mouthing behavior, and a decline in hand-to-mouth
events. This age-mediated decline in dust intake, which is more rapid for the Ozkavnak et al. (2022)
study than in CEM, partially explains why the margin of difference between the modeled and
monitoring results grows larger with age. Another source of the margin between the two approaches is
the assumption that the sum of the indoor dust sources in the CEM modeled scenario is representative of
items found in typical indoor residences. It is likely that individual residences have varying assortments
and amounts of the products and articles that are sources of DINP, resulting in lower and higher
exposures.
In the indoor dust modeling assessment, EPA reconstructed the scenario using consumer articles as the
source of DINP in dust. CEM modeling parameters and inputs for dust ingestion can partially explain
the differences between modeling and monitoring estimates. For example, surface area, indoor
environment volume, and ingestion rates by lifestage were selected to represent common use patterns.
CEM calculates DINP concentration in small particles (respirable particles) and large particles (dust)
that are settled on the floor or surfaces. The model assumes these particles bound to DINP are available
via incidental dust ingestion and estimates exposure based on a daily dust ingestion rate and a fraction of
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the day that is spent in the zone with the DINP-containing dust. The use of a weighted dust
concentration can also introduce discrepancies between monitoring and modeling results.
Indoor Dust Exposure Assessment Conclusions
For the indoor exposure assessment, EPA considered modeling and monitoring data. Monitoring data
are expected to represent aggregate exposure to DINP in dust resulting from all sources present in a
home. Although not a good indicator of individual contributions of specific COUs, monitoring data
provide a real-world indicator of total exposure through dust. For the modeling assessment of indoor
dust exposures and estimating contribution to dust from individual COUs, EPA recreated plausible
indoor environments using consumer products and articles commonly present in indoor spaces. This
included inhalation exposure from toys, flooring, synthetic leather furniture, wallpaper, and wire
insulation as well as consideration of dust collected on the surface of a relatively large area (e.g.,
flooring, furniture, wallpaper), but also multiple toys and wires collecting dust with DINP and
subsequent inhalation and ingestion. Note that other non-residential environments can contain these
articles, including daycares, offices, malls, schools, and other public indoor spaces. The indoor
consumer articles exposure scenarios were modeled with stay-at-home parameters, which consider use
patterns similar or higher than those in other indoor environments. Therefore, EPA concludes that
exposures to similar articles in other indoor environments are included in the residential assessment as a
health protective upper bound scenario.
Given the wide discrepancies between monitoring and modeling of DINP in indoor dust, EPA concluded
that there is too much uncertainty in this analysis to support derivation of risk estimates for aggregate
indoor dust exposure. Despite the robust confidence evaluation of the monitoring assessment, a risk
estimate based on these data was not derived. Instead, they were used as a comparator to show that the
modeled DINP exposure estimates were health protective relative to residential monitored exposures
(Table 4-8). This comparison was a key input to having robust confidence in the overall health
protectiveness of EPA's exposure assessment for ingestion of DINP in indoor dust. The individual COU
scenarios had a moderate to robust confidence in the dose results and protectiveness of parameters used.
Thus, the COU scenarios of the articles used in the indoor assessment were utilized in risk estimate
calculations.
4.1.2.5 Weight of Scientific Evidence Conclusions for Consumer Exposure
Key sources of uncertainty for evaluating exposure to DINP in consumer goods and strategies to address
those uncertainties are described in detail in Section 5.1 of Consumer and Indoor Dust Exposure
Assessment for Diisononyl Phthalate (DINP) Q x \ \\ . 025b). Generally, designation of robust
confidence suggests thorough understanding of the scientific evidence and uncertainties. The supporting
weight of scientific evidence outweighs the uncertainties to the point where it is unlikely that the
uncertainties could have a significant effect on the exposure estimate. The designation of moderate
confidence suggests some understanding of the scientific evidence and uncertainties. More specifically,
the supporting scientific evidence weighed against the uncertainties is reasonably adequate to
characterize exposure estimates. The designation of slight confidence is assigned when the weight of
scientific evidence may not be adequate to characterize the scenario. Furthermore, in cases when an
assessor is making the best scientific assessment possible in the absence of complete information, there
are additional uncertainties that may need to be considered. Although the uncertainty for some of the
scenarios and parameters ranges from slight to robust, the overall confidence to use the results for risk
characterization ranges from moderate to robust, depending on COU scenario. The basis for the
moderate to robust confidence in the overall exposure estimates is a balance between using parameters
that will represent various populations use patterns and lean on protective assumptions that are not
excessive or unreasonable.
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4.1.2.5.1 Strength, Limitations, Assumptions, and Key Sources of Uncertainty for
the Consumer Exposure Assessment
The exposure assessment of chemicals from consumer products and articles has inherent challenges due
to many sources of uncertainty in the analysis, including variations in product formulation, patterns of
consumer use, frequency, duration, and application methods. Variability in environmental conditions
may also alter physical and/or chemical behavior of the product or article. Table 4-9 summarizes the
overall uncertainty per COU, and a discussion of rationale used to assign the overall uncertainty. The
subsections ahead of the table describe sources of uncertainty for several parameters used in consumer
exposure modeling that apply across COUs and provide an in depth understanding of sources of
uncertainty and limitations and strengths within the analysis. The confidence to use the results for risk
characterization ranges from moderate to robust (Table 4-9).
Product Formulation and Composition
Variability in the formulation of consumer products—including changes in ingredients, concentrations,
and chemical forms—can introduce uncertainty in exposure assessments. In addition, data were
sometimes limited for weight fractions of DINP in consumer goods. EPA obtained DINP weight
fractions in various products and articles from material safety data sheets, databases, and existing
literature. Where possible, EPA obtained multiple values for weight fractions for similar products or
articles. The lowest value was used in the low exposure scenario, the highest value in the high exposure
scenario, and the average of all values in the medium exposure scenario. EPA decreased uncertainty in
exposure and subsequent risk estimates in the high, medium, and low intensity use scenarios by
capturing the weight fraction variability as well as obtaining a better characterization of the products and
articles varying composition within one COU. Overall weight fraction confidence is moderate for
products/articles with only one source and robust for products/articles with more than one source.
Product Use Patterns
Consumer use patterns like frequency of use, duration of use, and methods of application are expected to
differ. Where possible, high, medium, and low default values from CEM 3.2's prepopulated scenarios
were selected for mass of product used, duration of use, and frequency of use. In instances where no
prepopulated scenario was appropriate for a specific product, low, medium, and high values for each of
these parameters were estimated based on the manufacturers' product descriptions. EPA decreased
uncertainty by selecting use pattern inputs that represent product and article use descriptions and
furthermore capture the range of possible use patterns in the high to low intensity use scenarios.
Exposure and risk estimates are considered representative of product use patterns and well characterized.
Most use patterns overall confidence is rated robust.
Article Surface Area
The surface area of an article directly affects the potential for DINP emissions to the environment. For
each article modeled for inhalation exposure, low, medium, and high estimates for surface area were
calculated Section 2 in ( )25bY This approach relied on manufacturer-provided dimensions
where possible, or values from EPA's Exposure Factors Handbook for floor and wall coverings. For
small items that might be expected to be present in a home in significant quantities, such as insulated
wires and children's toys, aggregate values were calculated for the cumulative surface area for each type
of article in the indoor environment. Overall confidence in surface area is moderate for articles like
wires because there is less understanding of the number of wires exposed to collect dust and the great
variability that is expected may not be well represented. Overall confidence in surface area is robust for
articles like furniture, wall coverings, flooring, toys, and shower curtains because there is a good
understanding of the presence and dimensions in indoor environments.
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Human Behavior
CEM 3.2 has three different activity patterns: stay-at-home; part-time out-of-the home (daycare, school,
or work); and full-time out-of-the-home. The activity patterns were developed based on the
Consolidated Human Activity Database (CHAD). For all products and articles modeled, the stay-at-
home activity pattern was chosen as it is the most protective assumption.
Mouthing durations are a source of uncertainty in human behavior. The data used in this assessment are
based on a study in which parents observed children (n = 236) ages 1 month to 5 years of age for 15
minutes each session and 20 sessions in total (Smith and Norris. 2003). There was considerable
variability in the data due to behavioral differences among children of the same lifestage. For instance,
while children aged 6 to 9 months had the highest average mouthing duration for toys at 39 minutes per
day, the minimum duration was 0 minutes and the maximum was 227 minutes per day. The observers
noted that the items mouthed were made of plastic roughly 50 percent of the mouthing time, but this not
limited to soft plastic items likely to contain significant plasticizer content. In another study, 169
children aged 3 months to 3 years were monitored by trained observers for 12 sessions at 12 minutes
each (Greene. 2002). They reported mean mouthing durations ranging from 0.8 to 1.3 minutes per day
for soft plastic toys and 3.8 to 4.4 minutes per day for other soft plastic objects (except pacifiers). Thus,
it is likely that the mouthing durations used in this assessment provide a health protective estimate for
mouthing of soft plastic items likely to contain DINP.
Modeling Tool
Confidence in the model used considers whether the model has been peer reviewed, as well as whether it
is being applied in a manner appropriate to its design and objective. For example, the model used (CEM
3.2) has been peer reviewed, is publicly available, and has been applied in a manner intended by
estimating exposures associated with uses of household products and/or articles. This also considers the
default values data source(s) such as building and room volumes, interzonal ventilation rates, and air
exchange rates. Overall confidence in the proper use of CEM for consumer exposure modeling is robust.
Dermal Modeling for DINP
Experimental dermal data was identified via the systematic review process to characterize consumer
dermal exposures to liquids or mixtures and formulations containing DINP. EPA has moderate
understanding of the scientific evidence and the uncertainties, while the supporting scientific evidence
against the uncertainties is reasonably adequate to characterize exposure estimates. The confidence in
dermal exposure to liquid products model used in this assessment is moderate.
EPA identified only one set of experimental data related to the dermal absorption of neat DINP
(Midwest Research Institm 5)- This dermal absorption study was conducted in vivo using male
F344 rats. There have been additional studies conducted to determine the difference in dermal
absorption between rat skin and human skin. Specifically, Scott (1987) examined the difference in
dermal absorption between rat skin and human skin for four different phthalates {i.e., dimethyl phthalate
[DMP], diethyl phthalate [DEP], dibutyl phthalate [DBP], and diethylhexyl phthalate [DEHP]) using in
vitro dermal absorption testing. Results from the in vitro dermal absorption experiments showed that rat
skin was more permeable than human skin for all four phthalates examined. For example, rat skin was
up to 30 times more permeable than human skin for DEP while rat skin was up to 4 times more
permeable than human skin for DEHP. Although there is uncertainty regarding the magnitude of
difference between dermal absorption through rat skin vs. human skin for DINP, EPA is confident that
the in vivo dermal absorption data using male F344 rats (Midwest Research Institute. 1983) provide an
upper bound of dermal absorption of DINP based on the findings of Scott (1987).
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Another source of uncertainty regarding the dermal absorption of DINP from products or formulations
stems from the varying concentrations and co-formulants that exist in products or formulations
containing DINP. For purposes of this risk evaluation, EPA assumes that (1) the absorptive flux of neat
DINP measured from in vivo rat experiments serves as an upper bound of potential absorptive flux of
chemical into and through the skin for dermal contact with all liquid products or formulations, and (2)
that the modeled absorptive flux of aqueous DINP serves as an upper bound of potential absorptive flux
of chemical into and through the skin for dermal contact with all solid products. However, dermal
contact with products or formulations that have lower concentrations of DINP might exhibit lower rates
of flux since there is less material available for absorption. Conversely, co-formulants or materials
within the products or formulations may lead to enhanced dermal absorption, even at lower
concentrations. Therefore, it is uncertain whether the products or formulations containing DINP would
result in decreased or increased dermal absorption. Based on the available dermal absorption data for
DINP, EPA has made assumptions that result in exposure assessments that are the most human health
protective in nature.
Experimental dermal data were not identified via the systematic review process to estimate dermal
exposures to solid products or articles containing DINP and a modeling approach was used to estimate
exposures. EPA has a slight confidence in the dermal exposure to solid products or articles modeling
approach. It is assumed that the aqueous absorption of a saturated solution of DINP serves as a
reasonable upper bound for the potential dermal absorption of DINP from solid matrices, and the
modeling approach received a medium rating through EPA's systematic review process. For modeling
potential dermal exposure levels from solids containing DINP, EPA used the maximum value of water
solubility from available data (NLM. .01 "i; Howard et at.. 1985). These data sources for water solubility
all received high ratings through EPA's systematic review process. By using the maximum value of
water solubility from available data, rather than a water solubility value near the low-end of available
data, EPA is providing a protective assessment for human health.
Lastly, EPA notes that there is uncertainty with respect to the modeling of dermal absorption of DINP
from solid matrices or articles. Because there were no available data related to the dermal absorption of
DINP from solid matrices or articles, the Agency has assumed that dermal absorption of DINP from
solid objects would be limited by aqueous solubility of DINP. Therefore, to determine the maximum
steady-state aqueous flux of DINP, EPA utilized the CEM ( 23 a) to first estimate the
steady-state aqueous permeability coefficient of DINP. The estimation of the steady-state aqueous
permeability coefficient within CEM ( '23a) is based on quantitative structure-activity
relationship (QSAR) model presented by ten Berge (2009). which considers chemicals with log (Kow)
ranging from -3.70 to 5.49 and molecular weights ranging from 18 to 584.6. The molecular weight of
DINP falls within the range suggested by ten Berge (2009). but the log (Kow) of DINP exceeds the range
suggested by ten Berge (2009). Therefore, there is uncertainty regarding the accuracy of the QSAR
model used to predict the steady-state aqueous permeability coefficient for DINP.
Modeling Parameters for DINP Chemical Migration
For chemical migration rates to saliva, existing data were highly variable both within and between
studies. This indicates the significant level of uncertainty for the chemical migration rate as it may also
differ even among similar items due to variations in chemical makeup and polymer structure. As such,
an effort was made to choose DINP migration rates likely to be representative of broad classes of items
that comprise consumer COUs produced with different manufacturing processes and material
formulations. There is no consensus on the correct value to use for this parameter in past assessments of
DINP. The 2003 EU Risk Assessment for DINP used a migration rate of 53.4 |ig/cm2/h selected from
the highest individual estimate from a 1998 study by the Netherlands National Institute for Public Health
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and the Environment (RIVM) (ECJRC. 2003b; RIV 8). The RIVM study measured DINP in
saliva of 20 adult volunteers biting and sucking four PVC disks with a surface of 10 cm2. Average
migration to saliva from the samples tested were 8.4, 14, 4, and 9.6 |ig/cm2/h, and there was
considerable variability in the results. In a more recent report, ECHA compiled and evaluated new
evidence on human exposure to DINP, including chemical migration rates (ECHA.. 2013). They
concluded that chemical migration rate of 14 [j,g/cm2/h was likely to be representative of a "typical
mouthing scenario" and a migration rate of 45 ug/cm2/h was a reasonable worst-case estimate of this
parameter. The "typical" value was determined by compiling in vivo migration rate data from existing
studies (Niino et at.. 2003; Sueita et at.. 2003; Fiala et at.. 2000; Meuling et at.. 2000; Chen. 1998;
RIVM. 1998). The "worst case" value was midway between the two highest individual measurements
among all the studies (the higher of which was used in the 2003 EU risk assessment).
However, a major limitation of all existing data is that DINP weight fractions for products tested in
mouthing studies skew heavily towards relatively high weight fractions (30-60%) and measurements for
weight fractions less than 15 percent are very rarely represented in the dataset. Thus, it is unclear
whether these migration rate values are applicable to consumer goods with low (<15%) weight fractions
of DINP, where rates might be lower than represented by "typical" or worst-case values determined by
existing datasets. As such, based on available data for chemical migration rates of DINP to saliva, the
range of values used in this assessment (1.6, 13.3, and 44.8 |ig/cm2/h) are considered likely to capture
the true value of the parameter.
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Table 4-9. Weight of Scientific Evidence Summary Per Consumer CPU
Consumer COU
Category and
Subcategory
Weight of Scientific Evidence
Overall Confidence
Construction, paint,
electrical, and metal
products; Adhesives and
sealants
Six different scenarios were assessed under this COU for products with differing use patterns for which
each scenario had varying number of identified product examples (in parenthesis): adhesives for small
repairs (2), adhesive foam (1), automotive adhesives (4), caulking compounds (5), polyurethane injection
resin (1), and roofing adhesives (2). The six scenarios and the products within capture the variability in
product formulation in the high, medium, and low intensity use estimates. The modeling input for roofing
adhesives chronic duration events per year was selected as an extremely conservative input for the
screening approach used in this assessment, while other inputs are considered representative. The chronic
inhalation and dermal events per year input result in a low confidence for roofing adhesives scenarios and
the overall confidence in this inhalation and dermal scenario is moderate because there is a relatively
good understanding of the overestimation from using 365 events per year for the chronic duration. The
overall confidence in this COU inhalation exposure estimate for the other products is robust because the
CEM default parameters represent actual use patterns and location of use.
For dermal exposure EPA used a dermal flux approach, which was estimated based on DINP in vivo
dermal absorption in rats. An overall moderate confidence in dermal assessment of adhesives was
assigned. Uncertainties about the difference between human and rat skin absorption increase uncertainty.
However, other parameters like frequency and duration of use, and surface area in contact are well
understood and representative.
Inhalation for adhesives
for small repairs, adhesive
foam, automotive
adhesives, caulking
compounds, polyurethane
injection resin - Robust
Inhalation for roofing
adhesives - Moderate
Dermal - Moderate
Construction, paint,
electrical, and metal
products; Building
construction materials
(wire and cable jacketing,
wall coverings, roofing,
pool applications, water
supply piping, etc.)
Two different scenarios were assessed under this COU for four articles with differing use patterns for
which each scenario had varying number of identified article examples (in parenthesis): roofing
membranes (1) and electrical tape, spline (4). Of these two scenarios roofing membranes were assessed
for dermal exposures only because outdoor inhalation and ingestion would have low exposure potential.
When available more than one article input parameters capture the variability in product formulations in
the high, medium, and low intensity use estimates. The overall confidence in this COU inhalation and
dust ingestion exposure estimate is moderate because although the CEM default parameters represent
actual use patterns and location of use.
Dermal absorption estimate based on the assumption that dermal absorption of DINP from solid objects
would be limited by aqueous solubility of DINP. EPA has slight confidence for solid objects because the
high uncertainty in the assumption of partitioning form solid to liquid and subsequent dermal absorption
is not well characterized. However, other parameters like frequency and duration of use, and surface area
in contact are well understood and representative, making the overall confidence of moderate in a health
protective estimate.
Inhalation, Dust Ingestion,
and Dermal - Moderate
Construction, paint,
electrical, and metal
One article was identified for this COU, wire insulation. Inhalation, dust ingestion, mouthing, and dermal
exposures were assessed for this article. Inhalation and ingestion of dust scenarios were built to represent
indoor presence of this article and therefore this scenario is an aggregate assessment of multiple wire
Inhalation, Dust Ingestion,
Mouthing, and Dermal -
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Consumer COU
Category and
Subcategory
Weight of Scientific Evidence
Overall Confidence
products; Electrical and
electronic products
insulations, while mouthing and dermal exposures can only be assessed for the contact area with the
article and the frequency and duration of the contact. The weight fraction data used had a large range
resulting in higher variability due to changing formulation approaches. The high, medium, and low
intensity use scenarios capture the high variability in article formulation. The overall confidence in this
COU inhalation and dust ingestion exposure estimate is moderate. Although CEM default parameters are
expected to be representative of the use patterns and location of use there are larger uncertainties in the
aggregated surface area used. In addition, for dermal and mouthing the overall confidence is also
moderate from uncertainties from the solid article to dermal and saliva migration approaches and
frequency and durations of the exposure.
Moderate
Construction, paint,
electrical, and metal
products; Paints and
coatings
Two different scenarios were assessed under this COU for products with differing use patterns for which
each scenario had varying number of identified product examples (in parenthesis): paint/lacquer (large
project) (1) and paint/lacquer (small project) (2). The two scenarios and the products within capture the
variability in product formulation in the high, medium, and low intensity use estimates. The overall
confidence in this COU inhalation exposure estimate is robust because the CEM default parameters
represent actual use patterns and location of use.
For dermal exposure EPA used a dermal flux approach, which was estimated based on DINP in vivo
dermal absorption in rats. An overall moderate confidence in dermal assessment of adhesives was
assigned. Uncertainties about the difference between human and rat skin absorption increase uncertainty.
However, other parameters like frequency and duration of use, and surface area in contact are well
understood and representative.
Inhalation - Robust
Dermal - Moderate
Foam seating and
bedding products;
furniture and furnishings
(furniture and furnishings
including plastic articles
[soft]; leather articles)
Four different scenarios were assessed under this COU for various articles with differing use patterns for
which each scenario had varying number of identified article examples (in parenthesis): foam cushions
(1), indoor furniture (2), outdoor furniture (1), and truck awnings (1). The outdoor furniture and truck
awnings were assessed for dermal exposure only because outdoor inhalation and ingestion would have
low exposure potential. Foam cushions and indoor furniture scenarios estimated inhalation, ingestion, and
dermal exposures. Foam cushions and indoor furniture scenarios capture potential exposures to their
presence in indoor environments. The articles input parameters capture the variability in product
formulations and possible surface area present in indoor environments in the high, medium, and low
intensity use estimates. The overall confidence in this COU inhalation and dust ingestion exposure
estimate is robust because the CEM default parameters represent actual use patterns and location of use,
and the estimated surface area for foam cushions and furniture is well characterized and representative of
indoor furniture dimensions.
Migration of DINP from product to saliva approach has an overall confidence of moderate due to
uncertainties from article formulation differences, but the mouthing parameters and durations are well
characterized, resulting in an overall moderate confidence for a health protective estimate.
Inhalation and Dust
Ingestion - Robust
Dermal - Moderate
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Consumer COU
Category and
Subcategory
Weight of Scientific Evidence
Overall Confidence
Dermal absorption estimate based on the assumption that dermal absorption of DINP from solid objects
would be limited by aqueous solubility of DINP. EPA has slight confidence for solid objects because the
high uncertainty in the assumption of partitioning form solid to liquid and subsequent dermal absorption
is not well characterized. However, other parameters like frequency and duration of use, and surface area
in contact are well understood and representative, making the overall confidence of moderate in a health
protective estimate.
Furnishing, cleaning,
treatment/care products;
Floor coverings/
Plasticizer in construction
and building materials
covering large surface
areas including stone,
plaster, cement, glass,
and ceramic articles;
fabrics, textiles, and
apparel (vinyl tiles,
resilient flooring, PVC-
backed carpeting)
Four different scenarios were assessed under this COU for various articles with differing use patterns for
which each scenario had varying number of identified article examples (in parenthesis): carpet backing
(3), vinyl tiles (flooring) (4), specialty wall coverings (3), wallpaper (1). These four scenarios were
assessed for dermal, inhalation, and dust ingestion exposures. These articles capture potential dust
inhalation and ingestion in indoor environments. The articles input parameters capture the variability in
product formulations and possible surface area present in indoor environments in the high, medium, and
low intensity use estimates. The overall confidence in this COU inhalation and dust ingestion exposure
estimate is robust because the CEM default parameters represent actual use patterns and location of use
and the estimated surface area is well characterized and represents a wide range of plausible uses.
Dermal absorption estimate based on the assumption that dermal absorption of DINP from solid objects
would be limited by aqueous solubility of DINP. EPA has slight confidence for solid objects because the
high uncertainty in the assumption of partitioning form solid to liquid and subsequent dermal absorption
is not well characterized. However, other parameters like frequency and duration of use, and surface area
in contact are well understood and representative, making the overall confidence of moderate in a health
protective estimate.
Inhalation and Dust
Ingestion - Robust
Dermal - Moderate
Furnishing, cleaning,
treatment/care products;
Air care products
Two different scenarios were assessed under this COU for one product, scented oil with differing use
patterns: scented oil DIY and scented oil in homemade burning candle. The two scenarios capture the
variability in product formulation in the high, medium, and low intensity use estimates. The overall
confidence in this COU inhalation exposure estimate is robust because the CEM default parameters
represent actual use patterns and location of use.
Dermal absorption estimate based on the assumption that dermal absorption of DINP from solid objects
would be limited by aqueous solubility of DINP. EPA has slight confidence for solid objects because the
high uncertainty in the assumption of partitioning form solid to liquid and subsequent dermal absorption
is not well characterized. However, other parameters like frequency and duration of use, and surface area
in contact are well understood and representative, making the overall confidence of moderate in a health
protective estimate.
Inhalation - Robust
Dermal - Moderate
Furnishing, cleaning,
Two different scenarios were assessed under this COU for various articles with differing use patterns for
Dermal - Moderate
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Consumer COU
Category and
Subcategory
Weight of Scientific Evidence
Overall Confidence
treatment/care products;
Fabric, textile, and
leather products (apparel
and footwear care
products)
which each scenario had varying number of identified article examples (in parenthesis): clothing (2) and
small articles with potential for routine contact (4). These two scenarios were assessed for dermal
exposures. Dermal absorption estimate based on the assumption that dermal absorption of DINP from
solid objects would be limited by aqueous solubility of DINP. Slight was selected for solid objects
because the high uncertainty in the assumption of partitioning form solid to liquid and subsequent dermal
absorption is not well characterized. However, other parameters like frequency and duration of use, and
surface area in contact are well understood and representative, making the overall confidence in a health
protective estimate moderate.
Packaging, paper, plastic,
hobby products; Arts,
crafts, and hobby
materials
Three different scenarios were assessed under this COU for various products with differing use patterns
for which each scenario had varying number of identified product examples (in parenthesis): rubber
eraser (2), crafting resin (4), and hobby cutting board (1). The hobby cutting board was assessed for
dermal contact only because inhalation and ingestion would have low exposure potential for such small
surface area product. The scenarios for crafting resin and rubber eraser and the products within capture
the variability in product formulation in the high, medium, and low intensity use estimates. The overall
confidence in this COU inhalation exposure estimate is robust because the CEM default parameters
represent actual use patterns and location of use.
For dermal exposure EPA used a dermal flux approach, which was estimated based on DINP in vivo
dermal absorption in rats. An overall moderate confidence in dermal assessment of adhesives was
assigned. Uncertainties about the difference between human and rat skin absorption increase uncertainty.
However, other parameters like frequency and duration of use, and surface area in contact are well
understood and representative.
Inhalation and Ingestion -
Robust
Dermal - Moderate
Packaging, paper, plastic,
hobby products; Ink,
toner, and colorant
products
See Construction, paint, electrical, and metal products; Paints and coatings COU. Current products were
not identified. Foreseeable uses were matched with the lacquers, and paints (small and large projects)
because similar use patterns are expected.
Inhalation - Robust
Dermal - Moderate
Packaging, paper, plastic,
hobby products; Other
articles with routine
direct contact during
normal use including
rubber articles; plastic
articles (hard); vinyl tape;
flexible tubes; profiles;
hoses
Two different scenarios were assessed under this COU for various products and articles with differing use
patterns for which each scenario had varying number of identified examples (in parenthesis): shower
curtains (1) and small articles with potential for semi-routine contact (5). The small articles with potential
for semi-routine contact was assessed for dermal contact only because inhalation and ingestion would
have low exposure potential for such small surface area products. The scenario for shower curtains is an
indoor exposure assessment and it captures possible variability in product formulation in the high,
medium, and low intensity use estimates. The overall confidence in this indoor COU inhalation and dust
ingestion exposure estimate is robust because the CEM default parameters represent actual use patterns
and location of use.
Inhalation and Ingestion -
Robust
Dermal - Moderate
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Consumer COU
Category and
Subcategory
Weight of Scientific Evidence
Overall Confidence
Dermal absorption estimate based on the assumption that dermal absorption of DINP from solid objects
would be limited by aqueous solubility of DINP. EPA has slight confidence for solid objects because the
high uncertainty in the assumption of partitioning form solid to liquid and subsequent dermal absorption
is not well characterized. However, other parameters like frequency and duration of use, and surface area
in contact are well understood and representative, making the overall confidence of moderate in a health
protective estimate.
Packaging, paper, plastic,
hobby products;
Packaging (excluding
food packaging),
including rubber articles;
plastic articles (hard);
plastic articles (soft)
One scenario was built for this COU for PVC soap packaging. This scenario was assessed for dermal only
as inhalation and dust ingestion is unlikely for to be significant for the surface area of this article. Dermal
absorption estimate based on the assumption that dermal absorption of DINP from solid objects would be
limited by aqueous solubility of DINP. Slight was selected for solid objects because the high uncertainty
in the assumption of partitioning form solid to liquid and subsequent dermal absorption is not well
characterized. However, other parameters like frequency and duration of use, and surface area in contact
are well understood and representative, making the overall confidence in a health protective estimate
moderate.
Dermal - Moderate
Packaging, paper, plastic,
hobby products; Toys,
playground, and sporting
equipment
Three different scenarios were assessed under this COU for various articles with differing use patterns:
sports mats, legacy and non-compliant children's toys, and new children's toys. Inhalation, dust
ingestion, mouthing, and dermal were assessed for all three scenarios with varying use patterns and
inputs. The high, medium, and low intensity scenarios capture variability and provide a range of
representative use patterns. The overall confidence in this COU inhalation and dust ingestion exposure
estimate is robust because the CEM default parameters represent actual use patterns and location of use.
The overall confidence in this COU mouthing and dermal exposure assessment is robust. The mouthing
parameters used like duration and surface area for infants to children are very well understood, while
older groups have less specific information because mouthing behavior is not expected. The chemical
migration value is DINP specific and only source of uncertainty are related to article formulation and
chemical migration dynamics, which may not be very well characterized, but by assessing high, medium,
and low intensity scenarios EPA captures that source of uncertainty and increases confidence in the
estimates by using representative scenarios.
Dermal absorption estimate based on the assumption that dermal absorption of DINP from solid objects
would be limited by aqueous solubility of DINP. EPA has slight confidence for solid objects because the
high uncertainty in the assumption of partitioning form solid to liquid and subsequent dermal absorption
is not well characterized. However, other parameters like frequency and duration of use, and surface area
in contact are well understood and representative, making the overall confidence of moderate in a health
protective estimate.
Inhalation, Dust Ingestion,
and Mouthing - Robust
Dermal - Moderate
Other uses; Novelty
articles
One scenario was built for this COU for adult toys. This scenario was assessed for dermal only as
inhalation and dust ingestion is unlikely for to be significant for the surface area of this article. Dermal
Dermal - Moderate
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Consumer COU
Category and
Subcategory
Weight of Scientific Evidence
Overall Confidence
absorption estimate based on the assumption that dermal absorption of DINP from solid objects would be
limited by aqueous solubility of DINP. Slight was selected for solid objects because the high uncertainty
in the assumption of partitioning form solid to liquid and subsequent dermal absorption is not well
characterized. However, other parameters like frequency and duration of use, and surface area in contact
are well understood and representative, making the overall confidence in a health protective estimate
moderate.
Other uses; Automotive
articles
This COU was assessed with one indoor scenario for one type of article. The scenario for car mats
captures variability in product formulation in the high, medium, and low intensity use estimates. The
overall confidence in this indoor COU inhalation and dust ingestion exposure estimate is robust because
the CEM default parameters represent actual use patterns and location of use.
Dermal absorption estimate based on the assumption that dermal absorption of DINP from solid objects
would be limited by aqueous solubility of DINP. EPA has slight confidence for solid objects because the
high uncertainty in the assumption of partitioning form solid to liquid and subsequent dermal absorption
is not well characterized. However, other parameters like frequency and duration of use, and surface area
in contact are well understood and representative, making the overall confidence of moderate in a health
protective estimate.
Inhalation and Ingestion -
Robust
Dermal - Moderate
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4.1.3 General Population Exposures
General population exposures occur when DINP is released into the environment and the environmental
media is then a pathway for exposure. As described in the Environmental Release and Occupational
Exposure Assessment for Diisononyl Phthalate (DINP) ( >25r\ releases of DINP are
expected in air, water, and disposal to landfills. Figure 4-14 provides a graphic representation of where
and in which media DINP is estimated to be found due to environmental releases and the corresponding
route of exposure for the general population.
EPA took a screening level approach to assess DINP exposure for the general population. Screening
level assessments are useful when there is little location- or scenario-specific information available. EPA
began its DINP general population exposure assessment using a screening level approach because of
limited environmental monitoring data for DINP and lack of location data for DINP releases. A
screening level analysis relies on conservative assumptions, including default input parameters for
modeling exposure, to assess exposures that would be expected to be on the high-end of the expected
exposure distribution. Details on the use of screening level analyses in exposure assessment can be
found in EPA's Guidelines for Human Exposure Assessment (U.S. EPA. 2019b).
The Agency evaluated the reasonably available information for releases of DINP from facilities that use,
manufacture, or process DINP under industrial and/or commercial COUs subject to TSCA regulations
detailed in the Environmental Release and Occupational Exposure Assessment for Diisononyl Phthalate
(DINP) ( 25r). As described in Section 3.3, using the release data, EPA modeled predicted
concentrations of DINP in surface water, sediment, drinking water, and soil from air to soil deposition in
the United States. Table 3-6 summarizes the high-end DINP concentrations in environmental media
from environmental releases. The reasoning for assessing different pathways qualitatively or
quantitatively is discussed briefly in Section 3.3 and additional detail can be found in Environmental
Media and General Population Screening for Diisononyl Phthalate (DINP) ( 2025q).
Page 122 of 269
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HIA'i
Air
ff Ambient Air
Inhalation
Landfills
(Industrial or
Muncipal)
Wastewater
Facility
VMA
Drinking
Water
Treatment
Bathing
Water
Dermal.
Inhalation
-ys-
Water
Recreation
Oral. Dermal
| Sediment |
Figure 4-14. Potential Human Exposure Pathways to DINP for the General Population
Potential routes of exposure are shown in italics under each potential pathway of exposure.
High-end estimates of DINP concentrati on in the various environmental media presented in Table 3-6
and the Environmental Media and General Population Screening for Diisononyl Phthalate (DINP) (U.S.
EPA. 2025c) were used for screening level purposes in the general population exposure assessment.
EPA's Guidelines for Human Exposure Assessment (U.S. EPA, 2019b) defines high-end exposure
estimates as a "plausible estimate of individual exposure for those individuals at the upper end of an
exposure distribution, the intent of which is to convey an estimate of exposure in the upper range of the
distribution while avoiding estimates that are beyond the true distribution." If risk is not found for these
individuals with high-end exposure, no risk is anticipated for central tendency exposures, which is
defined as "an estimate of individuals in the middle of the distribution." Plainly, if there is no risk for an
individual identified as having the potential for the highest exposure associated with a COU for a given
pathway of exposure, then that pathway was determined not to be a pathway of concern and not pursued
further. If any pathways were identified as a pathway of concern for the general population, further
exposure assessments for that pathway would be conducted to include higher tiers of modeling when
available, refinement of exposure estimates, and exposure estimates for additional subpopulations and
OESs/COUs.
Identifying individuals at the upper end of an exposure distribution included consideration of high-end
exposure scenarios defined as those associated with the industrial and commercial releases from a COU
and OES that resulted in the highest environmental media concentrations. As described in Section 3.3,
EPA focused on estimating high-end concentrations of DINP from the largest estimated releases for the
purpose of its screening level assessment for environmental and general population exposures. This
means that the Agency considered the environmental concentration of DINP in a given environmental
media resulting from the OES that had the highest release compared to any other OES for the same
releasing media. Release estimates from OESs resulting in lower environmental media concentrations
were not considered for this screening level assessment. Additionally, individuals with the greatest
intake rate of DINP per body weight were considered to be those at the upper end of the exposure.
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Table 4-10 summarizes the high-end exposure scenarios that were considered in the screening level
analysis, including the lifestage assessed as the most potentially exposed population based on intake rate
and body weight. Table 4-10 also indicates which pathways were evaluated quantitatively or
qualitatively. Exposure was assessed quantitatively only when environmental media concentrations were
quantified for the appropriate exposure scenario. For example, exposure from soil or groundwater
resulting from DINP release to the environment via biosolids or landfills was not quantitatively assessed
because DINP concentrations to the environment from biosolids and landfills were not quantified. Due
to the high confidence in the biodegradation rates and physical and chemical data, there is robust
confidence that in soils receiving DINP will not be mobile and will have low persistence potential.
There is also robust confidence that DINP is unlikely to be present in landfill leachates. However,
exposure was still assessed qualitatively for exposures potentially resulting from biosolids and landfills.
Further details on the screening level approach and exposure scenarios evaluated by EPA for the general
population are provided in the Environmental Media and General Population Screening for Diisononyl
Phthalate (DINP) (I v << \ . '.'Jhj.). Selected OESs represent those resulting in the highest modeled
environmental media concentrations, for the purpose of a screening-level analysis.
Table 4-10. Exposure Scenarios Assessed in General Population Screening Level Analysis
OES''
Exposure
Pathway
Exposure
Route
Exposure Scenario
Lifestage
Analysis (Quantitative
or Qualitative)
All
Biosolids
No specific exposure scenarios were assessed
Qualitative
All
Landfills
No specific exposure scenarios were assessed
Qualitative
Use of
lubricants and
functional
fluids
Surface
Water
Dermal
Dermal exposure to DINP in
surface water during
swimming
Adults
(21+ years)
Quantitative
Oral
Incidental ingestion of DINP
in surface water during
swimming
Youths
(11-15
years)
Quantitative
Use of
lubricants and
functional
fluids
Drinking
Water
Oral
Ingestion of drinking water
Infants (<1
year)
Quantitative
All
Fish
Ingestion
Oral
Ingestion of fish for general
population
Adults
(21+ years)
Quantitative
Ingestion of fish for
subsistence fishers
Adults
(21+ years)
Quantitative
Ingestion of fish for tribal
populations
Adults
(21+ years)
Quantitative
Non-PVC
plastic
compounding
Ambient Air
Oral
Ingestion of DINP in soil
resulting from air to soil
deposition
Infants and
Children
(6 months to
12 years)
Quantitative
Dermal
Dermal exposure to DINP in
soil resulting from air to soil
deposition
Infants and
Children
(6 months to
12 years)
Quantitative
"Table 3-1 provides the crosswalk of OES to COUs
EPA also considered biomonitoring data, specifically urinary biomonitoring data from CDC's
NHANES, to estimate exposure using reverse dosimetry (see Section 10.2 of EPA's Environmental
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Media and General Population Screening for Diisononyl Phthalate (DINP) ( 2025q)Y
Reverse dosimetry modeling is a powerful tool for estimating exposure but does not distinguish between
routes or pathways of exposure nor does it allow for source apportionment (i.e., exposure from TSCA
COUs cannot be isolated from non-TSCA uses). Instead, reverse dosimetry provides an estimate of the
total dose (or aggregate exposure) responsible for the measured biomarker. Therefore, intake doses
estimated using reverse dosimetry are not directly comparable to the exposure estimates from the
various environmental media presented in this assessment. However, the total intake dose estimated
from reverse dosimetry can help contextualize the exposure estimates from exposure pathways outlined
in Table 4-10 as being potentially underestimated or overestimated.
4.1.3.1 General Population Screening Level Exposure Assessment Results
Land Pathway
EPA evaluated general population exposures via the land pathway (i.e., application of biosolids,
landfills) qualitatively. Due to low water solubility (6.1 x 1CT4 mg/L) and affinity for sorption to soil and
organic constituents in soil (log Koc = 5.5), DINP is unlikely to migrate to groundwater via runoff after
land application of biosolids. Additionally, the half-life of 28 to 52 days in aerobic soils (
2025s) indicates that DINP will have low persistence potential in the aerobic environments associated
with freshly applied biosolids. Because the physical and chemical properties of DINP indicate that it is
unlikely to migrate from land applied biosolids to groundwater via runoff, EPA did not model
groundwater concentrations resulting from land application of biosolids.
Although there is limited measured data on DINP in landfill leachates, the data suggest that DINP is
unlikely to be present in the leachate. Further, the small amounts of DINP that could potentially be in
landfill leachates will have limited mobility and are unlikely to infiltrate groundwater due to the high
affinity of DINP for organic compounds that would be present in receiving soil and sediment.
Interpretation of the high-quality physical and chemical property data also suggest that DINP is unlikely
to be present in landfill leachate. Therefore, EPA concludes that further assessment of DINP in landfill
leachate is not needed.
Surface Water Pathway - Incidental Ingestion and Dermal Contact from Swimming
EPA conducted modeling of releases to surface water at the point of release (i.e., in the immediate
receiving waterbody receiving the effluent) to assess the expected resulting environmental media
concentrations from TSCA COUs. EPA conducted modeling with the U.S. EPA's Variable Volume
Water Model with Point Source Calculator Tool (VVWM-PSC) both to estimate concentrations of DINP
within surface water as well as settled sediment in the benthic region of streams. Releases associated
with the Use of lubricants and functional fluids OES resulted in the highest total water column
concentrations— with water concentrations of 9,350 |ig/L without wastewater treatment and 187 |ig/L
when run under an assumption of 98 percent wastewater treatment removal efficiency (Table 4-11).
Both treated and untreated scenarios were assessed due to uncertainty about the prevalence of
wastewater treatment from discharging facilities and to demonstrate the hypothetical disparity in
exposures between treated and untreated effluent in the generic release scenarios. COUs mapped to this
OES are shown in Table 3-1. These water column concentrations were used to estimate the ADR from
dermal exposure and incidental ingestion of DINP while swimming for adults (21+ years) and youth
(11-15 years). Exposure scenarios leading to the highest modeled ADR are shown in Table 4-11.
For the purpose of a screening level assessment, EPA used a margin of exposure (MOE) approach using
high-end exposure estimates to determine if exposure pathways were pathways of concern for potential
non-cancer risks. MOEs for general population exposure through dermal exposure and incidental
ingestion during swimming ranged from 240 to 247 for scenarios assuming no wastewater treatment and
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from 12,000 to 12,300 for scenarios assuming 98 percent wastewater treatment removal efficiency
(compared to a benchmark of 30) (Table 4-11). Based on a screening level assessment, risk for non-
cancer health effects is not expectedfor the surface water pathway; therefore, the surface water
pathway is not considered to be a pathway of concern to DINP for the general population.
Surface Water Pathway - Drinking Water
For the drinking water pathway, modeled surface water concentrations were used to estimate drinking
water exposures. For screening level purposes, only the OES scenario resulting in the highest modeled
surface water concentrations, Use of lubricants and functional fluids, was included in the drinking water
exposure analysis. COUs mapped to this OES are shown in Table 3-1. EPA evaluated drinking water
scenarios that assumed (1) a wastewater treatment removal efficiency of 98 percent, (2) no further
drinking water treatment, and (3) a scenario that assumed a wastewater treatment removal efficiency of
98 percent as well as a conservative drinking water treatment removal rate of 79 percent (Table 4-11).
ADR and ADD values from drinking water exposure to DINP were calculated for various age groups
but the most exposed lifestage, infants (birth to <1 year), is shown below. Exposure scenarios leading to
the highest ADR and ADD are shown in Table 4-11.
MOEs for general population exposure through drinking water exposure were 322,000 and 1,530,000 for
the drinking water scenario with an assumed wastewater treatment removal and an additional
assumption of drinking water treatment, respectively, for the lifestage {i.e., infants) with the highest
exposure (compared to a benchmark of 30) (Table 4-11). Based on screening level analysis, risk for non-
cancer health effects is not expected for the drinking water pathway; therefore, the drinking water
pathway is not considered to be a pathway of concern to DINP for the general population.
Table 4-11. General Population Surface Water and Drinking Water Exposure Summary
OES"
Water Column
Concentrations
Incidental Dermal
Su rfacc Waterh
Incidental Ingestion
Surface Water'
Drinking Water''
30Q5 Cone.
(Mg/L)
ADRpot
(mg/kg-
day)
Acute MOE
(Benchmark
MOE = 30)
ADRpot
(mg/kg-
day)
Acute MOE
(Benchmark
MOE = 30)
ADRpot
(mg/kg-
day)
Acute MOE
(Benchmark
MOE = 30)
Use of lubricants and
functional fluids
Without Wastewater
Treatment
9,350
4.85E-02
247
5.00E-02
240
N/A
N/A
Use of lubricants and
functional fluids
With Wastewater
Treatment
187
9.71E-04
12,300
1.00E-03
12,000
3.7E-05
322,000
Use of lubricants and
functional fluids
With Wastewater and
Drinking Water
Treatment
0.26
N/A
N/A
N/A
N/A
7.8E-06
1,530,000
" Table 3-1 provides a crosswalk of industrial and commercial COUs to OES.
b Most exposed age group: Adults (21+ years)
c Most exposed age group: Youths (11-15 years)
d Most exposed age group: Infants (birth to <1 year)
Fish Ingestion
Surface water concentrations for DINP associated with a particular COU were modeled using VVWM-
PSC by COU/OES water release as described in Section 3.3.1.1. However, modeled surface water
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concentrations exceeded the estimates of the water solubility limit for DINP (approximately 6.1 /10 4
mg/L) by five to eight orders of magnitude based on 7Q10 flow conditions (see Physical Chemistry
Assessment for Diisononyl Phthalate (DINP) ( 025v)). Additionally, as described in the
Environmental Exposure Assessment for Diisononyl Phthalate ( )25o\ based on the sorption
and physical and chemical properties, DINP within suspended solids is not expected to be bioavailable.
Therefore, DINP concentrations in fish is calculated in the Environmental Exposure Assessment for
Diisononyl Phthalate (DINP) ( 25o) and based on a solubility and a predicted
bioconcentration factor (BCF). For estimating exposure to humans from fish ingestion, calculating fish
concentration using a bioaccumulation factor (BAF) is preferred because it considers the animal's
uptake of a chemical from both diet and the water column. Therefore, EPA estimated fish tissue
concentrations for estimating exposure to humans from fish ingestion using DINP's water solubility
limit and a BAF. In addition, the Agency calculated fish tissue concentrations using the highest
measured DINP concentrations in surface water. Details on the calculated fish tissue concentrations can
be found in Section 7 of the Environmental Media and General Population Screening for Diisononyl
Phthalate (DINP) (U.S. EPA. 2025q).
Using the estimated fish tissue concentrations, EPA evaluated exposure and potential risk to DINP
through fish ingestion for adults in the general population, adult subsistence fishers, and adult tribal
populations. Children were not considered for reasons explained in Sections 7.2 and 7.3 of the
Environmental Media and General Population Screening for Diisononyl Phthalate (DINP) (U.S. EPA.
2025q). Exposure estimates were the highest for tribal populations because of their elevated fish
ingestion rates compared to the general population and subsistence fisher populations. As such, tribal
populations represent the sentinel exposure scenario. Risk estimates calculated from the water solubility
limit of DINP as surface water concentration were three to six orders of magnitude above its non-cancer
risk benchmark using both the current and heritage fish ingestion rate (Table 4-12). Using the highest
measured DINP levels from a stormwater catchment area in Sweden as the surface water concentration,
risk estimates for tribal populations were still one to three orders of magnitude above its corresponding
benchmark for both fish ingestion rates. Exposure estimates based on conservative values such as
surface water concentration from a stormwater catchment area still resulted in risk estimates that exceed
their benchmarks. Therefore, these results indicate that fish ingestion is not a pathway of concern for
DINP for tribal members, subsistence fishers, or the general population.
Table 4-12. Fish Ingestion for Adults in Tribal Populations Summary
Calculation Method
Current Mean Ingestion Rate
(Benchmark MOE = 30)
Heritage Ingestion Rate
(Benchmark MOE = 30)
ADR/ADD
(mg/kg-day)
Acute
MOE
Chronic
MOE
ADR/ADD
(mg/kg-day)
Acute
MOE
Chronic
MOE
Water solubility limit
(6.10E-04 mg/L)
3.46E-05
1,4200,000
434,000
2.64E-04
186,000
56,900
Monitored surface water
concentration from
stormwater catchment area
(8.50E-02 mg/L)
4.82E-03
10,200
3,110
3.67E-02
1,330
408
Ambient Air Pathway - Air to Soil Deposition
EPA used the American Meteorological Society (AMS)/EPA Regulatory Model (AERMOD) to estimate
ambient air concentrations and air deposition of DINP from EPA estimated releases. The highest
modelled 95th percentile annual ambient air and soil concentrations across all release scenarios were
Page 127 of 269
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4.Ox 102 |ig/m3 and 1.46 mg/kg at 100 m from the releasing facility for the Non-PVC plastic
compounding OES, based on the high-end meteorology and rural land category scenario in AERMOD
(Table 3-6). COUs mapped to this OES are shown in Table 3-1. Non-PVC plastic compounding was the
only OES assessed for the purpose of a screening level assessment as it was the OES associated with the
highest ambient air concentration. Next, using conservative exposure assumptions for infants and
children (aged 6 months to <12 years), EPA estimated the ADR for soil ingestion and the dermal
absorbed dose (DAD) for soil dermal contact to be 0.018 and 0.0487 mg/kg-day. EPA did not estimate
inhalation exposure to ambient air because it was not expected to be a pathway of concern (see Section 9
of Environmental Media and General Population Screening for Diisononyl Phthalate (DINP) (U.S.
EPA. 2025q) for more details).
Using the highest modeled 95th percentile air concentration, ADR, and DAD, MOEs for general
population exposure through a combined soil ingestion and dermal soil contact is 180 for acute and 53
for chronic (Table 4-13) (compared to a benchmark of 30). Based on risk screening results, risk for non-
cancer health effects are not expectedfor the ambient air pathway; therefore, the ambient air pathway is
not considered to be a pathway of concern to DINP for the general population.
Table 4-13. General Population Ambient Air to Soil Deposition Exposure Summary
OESfl
Soil Ingestion
(Benchmark MOE = 30)
Dermal Soil Contact
(Benchmark MOE = 30)
Soil
Concentration6
(mg/kg)
ADD
(mg/kg-day)
MOEc
Soil
Concentration6
(mg/kg)
DAD
(mg/kg-day)
MOEc
Non-PVC
plastic
compounding
1.46
0.018
180
(acute)
53
(chronic)
1.46
0.0487
180
(acute)
53
(chronic)
"Table 3-1 provides a crosswalk of industrial and commercial COUs to OES.
h Air and soil concentrations are 95th percentile at 100 m from the emitting facility.
c MOE for soil ingestion and dermal contact represent aggregated exposure.
4.1.3.2 Daily Intake Estimates for the U.S. Population Using NHANES Urinary
Biomonitoring Data
EPA used a screening level approach to calculate sentinel exposures to the general population from
TSCA releases. EPA also analyzed urinary biomonitoring data from the CDC's NHANES dataset to
provide context for aggregate exposures in the U.S. non-institutionalized civilian population. Reverse
dosimetry was used to calculate estimated daily intake of DINP using NHANES reported urinary
concentrations for three metabolites of DINP: mono-isononyl phthalate (MiNP) (measured in the
1999-2018 NHANES cycles), mono-oxoisononyl phthalate (MONP) (measured in the 2017-2018
NHANES cycle), and mono-(carboxyoctyl) phthalate (MCOP) (measured in the 2005-2018 NHANES
cycles). Urinary MiNP, MONP, and MCOP levels reported in the most recent NHANES survey {i.e.,
2017-2018) were used to calculate daily intake values for various demographic groups reported within
NHANES (Table 4-14). Median daily intake estimates across demographic groups ranged from 0.6 to
1.7 |ig/kg-day, while 95th percentile daily intake estimates ranged from 3.4 to 8.1 |ig/kg-day. The
highest daily intake value estimated was for female children (6-11 years old) and was 8.1 |ig/kg-day at
the 95th exposure percentile. Detailed results of the NHANES analysis can be found in Section 10.2 of
EPA's Environmental Media and General Population Screening for Diisononyl Phthalate (DINP) (U.S.
EPA. 2025a).
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Using 50th and 95th percentile daily intake values calculated from reverse dosimetry, EPA calculated
MOEs ranging from 2,300 to 5,800 at the 50th percentile and 430 to 1,030 at the 95th percentile across
demographic groups using the chronic point of departure (POD; i.e., an HED of 3,500 |ig/kg-day) based
on liver toxicity (Table 4-14). The lowest calculated MOE of 430 was for female children (6-11 years),
based on the 95th percentile exposure estimate. All calculated MOEs at the 50th and 95th percentiles
were above the benchmark of 30, indicating that aggregate exposure to DINP does not pose a risk to the
non-institutionalized, U.S. civilian population. At this time, EPA has not yet completed its cumulative
phthalate risk assessment where multiple phthalates will be considered. As discussed further in Section
4.3.6, the Agency is issuing a draft cumulative risk assessment for public comment and peer review,
which will be followed by a final cumulative assessment that incorporates DINP.
General population exposure estimates calculated herein from exposure to ambient air, surface water,
fish ingestion, and soil from TSCA releases are not directly analogous to daily intake values estimated
via reverse dosimetry from NHANES. Although NHANES may be used to provide context for
aggregate exposures in the U.S. population, it is not expected to capture exposures from specific TSCA
COUs that may result in high-dose exposure scenarios (e.g., occupational exposures to workers), as
compared to EPA's general population exposure assessment which evaluates sentinel exposures for
specific exposure scenarios corresponding to TSCA releases. However, as a screening level analysis,
media specific general population exposure estimates calculated herein were compared to daily intake
values calculated using reverse dosimetry of NHANES biomonitoring data. Comparison of the values
shows that many of the exposure estimates resulting from incidental dermal contact or ingestion of
surface water (assuming no wastewater treatment) (Table 4-11), ingestion of fish for adults in tribal
populations (assuming heritage ingestion rate) (Table 4-12), and soil ingestion and dermal soil contact
resulting from air to soil deposition of DINP (Table 4-13) from sentinel exposure scenarios exceed the
total daily intake values estimated using NHANES (Table 4-14).
Exposure estimates for the general population via ambient air, surface water, and drinking water
resulting from TSCA releases quantified in this document are likely overestimates. This is because
exposure estimates from individual pathways exceed the total intake values calculated from NHANES
measured—even at the 95th percentile of the U.S. population for all ages. Furthermore, this is consistent
with the U.S. CPSC's conclusion that DINP exposure comes primarily from diet for women, infants,
toddlers, and children and that the outdoor environment is not a major source of exposure to DINP (U.S.
CPSC, 2014). Thus, although the general population exposure estimates calculated using a screening
level approach likely represent an overestimation of exposure, in no case did MOEs for these sentinel
exposures exceed the benchmark MOE of 30, indicating no needfor further refinement.
Table 4-14. Daily Intake Values and MOEs for DINP Based on Urinary Biomonitoring from the
2017 to 2018 NHANES Cycle
Demographic
50th Percentile
Daily Intake
(95% CI)
(jig/kg-day)
95th Percentile
Daily Intake
(95% CI)
(jig/kg-day)
50th Percentile
MOE
(Benchmark = 30)
95th Percentile
MOE
(Benchmark = 30)
All
0.6 (0.6-0.7)
4 (3.3-4.8)
5,800
875
Females
0.7 (0.6-0.7)
4.4 (3-5.9)
5,000
800
Males
0.6 (0.6-0.7)
3.6(2.7-4.6)
5,800
970
White non-Hispanic
0.6 (0.6 - 0.7)
3.6(2.5-4.8)
5,800
970
Black non-Hispanic
0.6 (0.6-0.7)
4.5 (2.9-6.2)
5,800
780
Mexican-American
0.6 (0.6-0.7)
4.8 (2.1-7.5)
5,800
730
Page 129 of 269
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Other Race
0.7 (0.6-0.8)
4.7(2.1-7.3)
5,000
740
Above Poverty Level
0.7 (0.6-0.8)
7.1 (3.9-10.2)
5,000
490
Below Poverty Level
0.6 (0.6-0.7)
3.7(2.9-4.6)
5,800
950
3-5 years
1.5 (1.4-1.6)
5.7(0.2-11.2)
2,300
610
6-11 years
1 (0.9-1.2)
6.2 (3.3-9.1)
3,500
560
12-15 years
0.7 (0.5-0.8)
5.2 (-1.1 to 11.5)
5,000
670
16-49 years
0.7 (0.6-0.7)
4 (1.9-6.2)
5,000
875
16+ years
0.6 (0.6-0.6)
3.5 (2.7-4.4)
5,800
1,000
Males 3-5 years
1.4 (1.3-1.6)
4.8 (-4.7 to 14.4)
2,500
730
Males 6-11 years
1 (0.8-1.2)
3.4(1.1-5.7)
3,500
1,030
Males 12-15 years
0.6 (0.5-0.8)
AT
5,800
740
Males 16-49 years
0.6 (0.6-0.7)
3.4 (2-4.9)
5,800
1,030
Males 16+years
0.6 (0.5-0.6)
3.4 (2.4-4.4)
5,800
1,030
Females 3-5 years
1.5 (1.3-1.7)
7.4 (-0.7 to 15.5)
2,300
470
Females 6-11 years
1 (0.9-1.2)
8.1fl
3,500
430
Females 12-15 years
0.7 (0.4-0.9)
5.2"
5,000
670
Females 16-49 years
0.7 (0.6-0.8)
5.6(2-9.3)
5,000
630
Females 16+ years
0.6 (0.6-0.7)
3.6(1.8-5.4)
5,800
970
a95% confidence intervals (CI) could not be calculated due to small sample size or a standarc
error of zero.
4.1.3.1 Overall Confidence in General Population Screening Level Exposure
Assessment
The weight of scientific evidence supporting the general population exposure estimate is decided based
on the strengths, limitations, and uncertainties associated with the exposure estimates, which are
discussed in detail for ambient air, surface water, drinking water, and fish ingestion in the
Environmental Media and General Population Screening for Diisononyl Phthalate (DINP) (U.S. EPA.
2025q). EPA summarized its weight of scientific evidence using confidence descriptors: robust,
moderate, slight, or indeterminate. The Agency used general considerations (i.e., relevance, data quality,
representativeness, consistency, variability, and uncertainties) as well as chemical-specific
considerations for its weight of scientific evidence conclusions.
EPA determined robust confidence in its qualitative assessment of biosolids and landfills. For its
quantitative assessment, the Agency modeled exposure due to various general population exposure
scenarios resulting from different pathways of exposure. Exposure estimates utilized high-end inputs for
the purpose of risk screening. When available, monitoring data was compared to modeled estimates to
evaluate overlap, magnitude, and trends. EPA has robust confidence that modeled releases used are
appropriately conservative for a screening level analysis. Therefore, the Agency has robust confidence
that no exposure scenarios will lead to greater doses than presented in this evaluation. Despite slight and
moderate confidence in the estimated values themselves, confidence in exposure estimates capturing
high-end exposure scenarios was robust given that many of the modeled values exceeded those of
monitored values and exceeded total daily intake values calculated from NHANES biomonitoring data,
adding to confidence that exposure estimates captured high-end exposure scenarios.
4.1.4 Human Milk Exposures
Infants are a potentially susceptible subpopulation because of their higher exposure per body weight,
immature metabolic systems, and the potential for chemical toxicants to disrupt sensitive developmental
Page 130 of 269
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processes, among other reasons. Reasonably available information from studies of experimental animal
models also indicates that DINP is a developmental toxicant ( J025u). EPA considered
exposure and hazard information, as well as pharmacokinetic models, to determine the most
scientifically supportable appropriate approach to evaluate infant exposure to DINP from human milk
ingestion (U.S. EPA. 2025qY
Although no U.S. biomonitoring studies investigated the presence of DINP or its metabolites in human
milk, EPA identified nine studies from foreign countries that did. The highest measured concentration
and the high-end milk ingestion rate was used to estimate infant exposure to DINP through human milk
ingestion. Despite these conservative inputs, non-cancer risk estimates exceeded their corresponding
benchmarks for both intermediate and chronic exposure.
Furthermore, no human health studies have evaluated only lactational exposure from quantified levels of
DINP in milk. Uncertainties in the toxic moiety for DINP and the limited half-life data of its metabolites
in the human body that are both sensitive and specific also precluded modeling human milk
concentrations by COUs. Overall, EPA concluded that the most scientifically supportable approach is to
not model milk concentrations. The Agency instead used human health hazard values that are based on
gestational exposure and biomonitoring data that aggregates exposure to estimate risks to a nursing
infant. Further discussion of the human milk pathway is provided in the Environmental Media and
General Population Exposure for Diisononyl Phthalate (DINP) ( !025q).
4.1.5 Aggregate and Sentinel Exposure
TSCA section 6(b)(4)(F)(ii) (15 U.S.C. 2605(b)(4)(F)(ii)) requires EPA, in conducting a risk evaluation,
to describe whether aggregate and sentinel exposures under the COUs were considered and the basis for
their consideration.
EPA defines aggregate exposure as "the combined exposures to an individual from a chemical substance
across multiple routes and across multiple pathways (40 CFR 702.33)." For the DINP risk evaluation,
the Agency considered aggregate risk across all routes of exposure for each individual consumer and
occupational COU evaluated for acute, intermediate, and chronic exposure durations. As described in
Section 5.1 of the Non-cancer Human Health Hazard Assessment for DINP (U.S. EPA. 2Q25u\ EPA
considers it possible to aggregate risks across exposure routes because the PODs are based on systemic
effects {i.e., developmental and liver toxicity) and because the Agency conducted route-to-route
extrapolation of the PODs derived from oral studies for use in the dermal and inhalation risk
calculations. EPA did not consider aggregate exposure for the general population because, as described
in Section 4.1.3, the Agency employed a risk screen approach for the general population exposure
assessment. Based on results from the risk screen, no pathways of concern {i.e., ambient air, surface
water, drinking water, fish ingestion) to DINP exposure were identified for the generation population.
EPA did analyze urinary biomonitoring data from the CDC's NHANES dataset, which provides an
estimate of non-attributable {i.e., cannot distinguish between TSCA and non-TSCA exposures)
aggregate exposure to DINP for the U.S. civilian population (Section 4.1.3.2).
EPA did not consider aggregate exposure scenarios across COUs because the Agency did not find any
evidence to support such an aggregate analysis, such as statistics of populations using certain products
represented across COUs, or workers performing tasks across COUs. However, EPA considered
combined exposure across all routes of exposure for each individual occupational and consumer COU to
calculate aggregate risks (Sections 4.3.2 and 4.3.3).
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EPA defines sentinel exposure as "the exposure to a chemical substance that represents the plausible
upper bound of exposure relative to all other exposures within a broad category of similar or related
exposures (40 CFR 702.33)." In terms of this risk evaluation, EPA considered sentinel exposures by
considering risks to populations who may have upper bound exposures; for example, workers and ONUs
who perform activities with higher exposure potential, or consumers who have higher exposure potential
or certain physical factors like body weight or skin surface area exposed. EPA characterized high-end
exposures in evaluating exposure using both monitoring data and modeling approaches. Where
statistical data are available, EPA typically uses the 95th percentile value of the available dataset to
characterize high-end exposure for a given COU. For general population and consumer exposures, EPA
occasionally characterized sentinel exposure through a "high-intensity use" category based on elevated
consumption rates, breathing rates, or user-specific factors.
4.2 Summary of Human Health Hazard
4.2.1 Background
This section briefly summarizes the human health hazards of DINP. Additional information on the non-
cancer and cancer human health hazards of DINP are provided in the Non-cancer Human Health Hazard
Assessment for Diisononyl Phthalate (DINP) ( 025u) and Cancer Human Health Hazard
Assessment for Diisononyl Phthalate (DINP) ( 025a). which were peer reviewed by the
SACC during the July 30 to August 1, 2024, SACC meeting ( 2024b).
4.2.2 Non-cancer Human Health Hazards
EPA identified developmental, liver, and kidney toxicity as the most sensitive and robust non-cancer
hazards associated with oral exposure to DINP in experimental animal models. Liver, kidney, and
developmental toxicity were also identified as the most sensitive and robust non-cancer effects
following oral exposure to DINP by the U.S. Consumer Product Safety Commission ( >C. 2014).
Health Canada (ECCC/HC. 2020). European Chemicals Agency (ECHA. 2013). European Food Safety
Authority (EFSA. 2019). and the Australian National Industrial Chemicals Notification and Assessment
Scheme fNICNAS. 2015b).
To calculate non-cancer risks from oral to DINP for acute and intermediate durations of exposure in the
risk evaluation of DINP, EPA selected a NOAEL of 50 mg/kg-day and a benchmark dose (BMD) 95
percent lower confidence limit (BMDL) associated with a benchmark response (BMR) of 5 percent
(BMDLs) of 49 mg/kg-day. The NOAEL was derived from a gestational exposure study of rats that
reported decreased fetal testicular testosterone content and increased incidence of multinucleated
gonocytes (MNGs) in the testes of fetal rats (Clewell et at.. 2013). The BMDL5 was derived through
meta-regression analysis and BMD modeling of fetal testicular testosterone data from two prenatal
exposure studies of rats by the National Academies of Sciences, Engineering, and Medicine (NA.SEM.
2017). Using allometric body weight scaling to the three-quarter power (I v H \ 101 I. the NOAEL
of 50 mg/kg-day and BMDL5 of 49 mg/kg-day were converted to a human equivalent dose (HED) of 12
mg/kg-day. As discussed in the Non-cancer Human Health Hazard Assessment for Diisononyl Phthalate
(DINP) ( 25u) several additional developmental toxicity studies of DINP provide similar,
although less-sensitive, candidate points of departure (PODs), which further support EPA's decision to
use the selected HED of 12 mg/kg-day for decreased fetal testicular testosterone production. The
Agency has performed 3/4 body weight scaling to yield the HED and is applying the animal to human
extrapolation factor {i.e., interspecies extrapolation; UFa) of 3x and a human variability extrapolation
factor {i.e., intraspecies extrapolation; UFh) of 10x. Thus, a total uncertainty factor (UF) of 30x is
applied for use as the benchmark MOE. Based on the strengths, limitations, and uncertainties discussed
in the Non-cancer Human Health Hazard Assessment for Diisononyl Phthalate (DINP) (U.S. EPA.
Page 132 of 269
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2025u), EPA has robust overall confidence in the POD based on fetal testicular testosterone for use in
characterizing risk from exposure to DINP for acute and intermediate exposure scenarios. For purposes
of assessing non-cancer risks, the selected POD is considered most applicable to women of reproductive
age/pregnant women, male infants, and male children. Use of this POD to assess risk for other age
groups (e.g., adult males) is conservative.
To calculate non-cancer risks from oral exposure to DINP for chronic durations of exposure in the risk
evaluation of DINP, EPA selected a NOAEL of 15 mg/kg-day from a 2-year study of F344 rats based on
liver toxicity. More specifically, liver toxicity in the key study (Lington et ai. 1997; Bio/dynamics.
1986) was characterized by increased liver weight, increased serum alanine aminotransferase (ALT),
aspartate aminotransferase (AST), alkaline phosphatase (ALP), and histopathological findings (e.g.,
spongiosis hepatis, focal necrosis). EPA considers the observed liver effects to be adverse and relevant
for extrapolating human risk from chronic exposures ( 1002a). The Agency has performed 3/4
body weight scaling to yield an HED of 3.5 mg/kg-day and is applying the animal to human
extrapolation factor (i.e., interspecies extrapolation; UFa) of 3x and an within human variability
extrapolation factor (i.e., intraspecies extrapolation; UFh) of 10x. Thus, a total UF of 30x is applied for
use as the benchmark MOE. Overall, based on the strengths, limitations, and uncertainties discussed in
the Non-cancer Human Health Hazard Assessment for Diisononyl Phthalate (DINP) ( Q25u).
EPA has robust overall confidence in the POD based on hepatic outcomes for use in characterizing risk
from exposure to DINP for chronic exposure scenarios.
As discussed in Appendix I of the Non-cancer Human Health Hazard Assessment for Diisononyl
Phthalate (DINP) (U.S. EPA. 2025u). the selected chronic POD is considered most applicable to male
and female adult workers, adult consumers and adult members of the general population that may be
exposed chronically to DINP through work, regular contact with consumer products and/or articles
containing DINP, or through TSCA releases of DINP to the environment. Use of the chronic POD for
assessing risk to infants and children may be conservative and may not be relevant. The chronic POD is
based on liver effects dependent and independent of PPARa activation. As discussed in EPA's Cancer
Human Health Hazard Assessment for Diisononyl Phthalate (DINP) ( 25a). there is
evidence to suggest humans are less sensitive than rats to liver effects associated with PPARa activation,
while the PPARa -independent effects (i.e., spongiosis hepatis) are most prevalent in the livers of aging
rats.
No data were reasonably available for the dermal or inhalation routes that were suitable for deriving
route-specific PODs. Therefore, EPA used the acute/intermediate and chronic oral PODs to evaluate
risks from dermal exposure to DINP. Differences in absorption will be accounted for in dermal exposure
estimates in the risk evaluation for DINP. For the inhalation route, EPA extrapolated the oral HED to an
inhalation human equivalent concentration (HEC) using a human body weight and breathing rate
relevant to a continuous exposure of an individual at rest ( 4). Table 4-15 summarizes the
oral HED and inhalation HEC values selected by EPA to estimate non-cancer risk from
acute/intermediate and chronic exposure to DINP in this risk evaluation.
Page 133 of 269
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Table 4-15. Non-cancer HECs and HEDs Used to Estimate Risks
Exposure
Scenario
Target
Organ
System
Species
Du ration
POD
(mg/kg-
day)
Effect
HEC
(mg/m3)
[ppm|
HED
(mg/
kg-day)
Benchmark
MOE
Reference
Acute,
Intermediate
Develop-
mental
Rat
5 to 14 days
throughout
gestation
bmdl5
= 49"
NOAEL
= 50 b
| fetal
testicular
testosterone, t
incidence of
MNGs
63
[3.7]
12 c
UFa= 3
UFh=10
Total UF=30
(NASEM.
2017;
Clewell et
al. 2013)
Chronic
Liver
Rat
2 years
NOAEL
= 15
t liver weight,
t serum
chemistry,
histopathology
d e
19
[1.1]
3.5
UFa= 3
UFh=10
Total UF=30
(Lington et
al. 1997;
Bio/dynamic
s. 1986)
BMDL = benchmark dose lower limit; HEC = human equivalent concentration; HED = human equivalent dose; MOE =
margin of exposure; NOAEL = no observable adverse effect level; POD = point of departure; UF = uncertainty factor
" The BMDL5 was derived by NASEM (2017) through meta-regression and BMD modeling of fetal testicular testosterone
data from two studies of DINP with rats (Boberg et al.. 2011; Hannas et al.. 2011). R code suDDorting NASEM's meta-
regression and BMD analysis of DINP is mibliclv available through GitHiib.
b The NOAEL was derived from the gestational c\do sure studv conducted bv Clewell et al. ("2013). which suDDorts a
NOAEL of 50 mg/kg-day based decreased fetal testicular testosterone and increased incidence of MNGs.
c The BMDL5 of 49 mg/kg-day and NOAEL of 50 mg/kg-day both support an HED of 12 mg/kg-day.
''Liver toxicity included increased relative liver weight, increased serum chemistry (i.e., AST, ALT, ALP), and
histopathologic findings (e.g., focal necrosis, spongiosis hepatis) inF344 rats following 2 years of dietary exposure to
DINP (Lington et al.. 1"" ; fx.Vdvnamics. 1986).
e The Lington et al. study presents a portion of the data from a larger good laboratory practice (GLP)-certified study by
Bio/dvnamics (1986).
4.2.3 Cancer Human Health Hazards
DINP has been evaluated for carcinogenicity in two 2-year dietary studies of F344 rats (Covamce Labs.
1998b; Lingtonetal. one 1 -year dietary study of SD rats (Bio/dynamics. 1987). and one 2-year
dietary study of B6C3F1 mice (Covamce Labs. 1998a). Across available studies, statistically significant
increases in renal tubule cell carcinomas, mononuclear cell leukemia (MNCL), and hepatocellular
adenomas and carcinomas have been observed. As discussed further below (and in U.S. EPA (2025a)).
EPA does not consider the renal tubule cell carcinomas observed only in male rats to occur through a
human relevant MO A, and there is significant scientific uncertainty associated with MNCL in F344 rats.
Therefore, EPA focused its cancer dose-response assessment to hepatocellular adenomas and
carcinomas.
Kidney Tumors
A slight, but statistically significant increase in renal tubule cell carcinomas was observed in high-dose
(637 mg/kg-day) male (but not female) F344 rats in one study (Covance Labs. 1998b). while a non-
statistically significant increase in renal tubule cell carcinomas was observed in male (but not female)
F344 rats in a second study (Lington et al.. 1997). Renal tubule carcinomas have not been observed in
female SD or F344 rats or mice of either sex. Much of the available literature supports an a2U-globulin
MOA to explain the incidences of renal tubule cell carcinomas observed only in male rats exposed
chronically to DINP. EPA does not consider kidney tumors arising through a a2u-globulin MOA to be
human relevant (U.S. EPA. 1991a). Therefore, EPA did not consider it appropriate to derive quantitative
estimates of cancer hazard for data on kidney tumors observed in these studies. The SACC supported
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EPA's conclusion that kidney tumors produced by DINP are due to a a2u-globulin MO A and are not
relevant to humans ( »24b).
Mononuclear Cell Leukemia
The incidence of MNCL was significantly elevated in male and female F344 rats exposed to DINP in
the diet at doses as low as 152 to 359 mg/kg-day when compared to study control animals in two
independent carcinogenicity studies (Covance Labs. 1998b; Lington et at.. 1997). Inconsistent with
findings from the two chronic studies of F344 rats, MNCL was not observed in male or female SD rats
treated with up to 553 to 672 mg/kg-day DINP for 2 years (Bio/dynamics. 1987) or male and female
B6C3F1 mice treated with up to 1,560 to 1,888 mg/kg-day DINP for two years (Covance Labs. 1998a).
As discussed further in EPA's Cancer Human Health Hazard Assessment for Diisononyl Phthalate
(DINP) ( 25a), there are several sources of scientific uncertainty associated with MNCL.
First, MNCL is a spontaneously occurring neoplasm of the hematopoietic system that reduces lifespan
and is one of the most common tumor types occurring at a high background rate in the F344 strain of rat
(also referred to as Fisher rat leukemia because it is so common) (Thomas et at.. 2007). Historical
control data from the National Toxicology Program (NTP) have demonstrated an increase in the
spontaneous background incidence of MNCL in untreated male and female F344 rats from 7.9 and 2.1
percent in males and females, respectively, in 1971 to 52.5 and 24.2 percent in males and females,
respectively, from 1995 through 1998 (Thomas et at.. 2007). Spontaneous incidence of MNCL in other
strains of rat appear to be rare. Brix et al. (2005) report the incidence of MNCL in female Harlan SD rats
to be 0.5 percent in NTP 2-year studies. Further, MNCL does not appear to occur naturally in mice
(Thomas et al.. 2007). The F344/N strain of rat was used in NTP 2-year chronic and carcinogenicity
bioassays for nearly 30 years (King-Herbert et al.. 2010; King-Herbert and Thayer. 2006). However, in
the early 2000s NTP stopped using the F344/N strain of rat in large part because of high background
incidence of MNCL and testicular Ley dig cell tumors that confounded bioassay interpretation. NTP
subsequently replaced the F344 strain of rats with the Harlan Sprague Dawley strain (King-Herbert et
al.. 2010; King-Herbert and Thayer. 2006).
Given the high and variable background rate of MNCL in F344 rats, it is important to consider
concurrent control data, historical control data, and time to onset of MNCL to assist in determining
whether observed increases in MNCL are treatment-related. Historical control data from the laboratories
conducting the studies of DINP is not available—although there is some limited evidence available that
indicates that time to onset of MNCL was shorter in DINP-treated animals compared to concurrent
controls. Another source of uncertainty is lack of MO A information for induction of MNCL in F344
rats. The MOA for induction of MNCL in F344 rats is unknown. Lack of MO A information makes it
difficult to determine human relevancy. There is additional uncertainty related to the human correlate to
MNCL in F344 rats. Therefore, the significance of MNCL and its biological relevance for human cancer
risk remains uncertain. Other regulatory agencies have also considered the human relevance of MNCL.
Generally, other agencies such as Australia NICNAS (2012) Health Canada (EC/HC. 2015a). U.S.
CPSC (2010). and EC HA (2013) have concluded that MNCL observed in F344 rats is not human
relevant or has unclear human relevance and refrained from using MNCL to predict cancer risk in
humans.
Overall, the SACC recommended that "the observation of an increased incidence of MNCL in a chronic
bioassay employing the Fisher 344 rat should not be considered a factor in the determination of the
cancer classification..and "Most Committee members agreed that given the material presented in a
retrospective review, MNCL and Ley dig Cell Tumors, among other tumor responses in F344 rat
carcinogenicity studies lack relevance in predicting human carcinogenicity (Maronpot et al., 2016)"
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( 2024b). Consistent with the recom m en dati on s of the SACC, EPA is not considering MNCL
as a factor in the determination of the cancer classification for DINP any further.
Liver Tumors
Across available studies, treatment-related hepatocellular adenomas and carcinomas have consistently
been observed in F344 and SD rats as well as B6C3F1 mice. Existing assessments of DINP by U.S.
CPSC (2014. 20101 Health Canada (ECCC/HC. 2020; EC/HC. 2015a: Health Canada 20151 ECHA
(20131 and NICNAS ( ) have postulated that DINP causes liver tumors in rats and mice through a
peroxisome proliferator-activated receptor alpha (PPARa) MOA. Consistent with EPA Guidelines for
Carcinogen Risk Assessment ( ?5a) and the IPC S Mode of Action Framework (IPCS. 2007).
EPA further evaluated the postulated PPARa MOA for liver tumors as well as evidence for other
plausible MO As for DINP.
Although some uncertainties remain, there is strong evidence to support the postulated, non-genotoxic,
PPARa MOA. Under the Guidelines for Carcinogen Risk Assessment ( )05al EPA
determined that DINP is Not Likely to be Carcinogenic to Humans at doses below levels that do not
result in PPARa activation (key event 1 in the postulated MOA). Further, the non-cancer chronic POD
(NOAEL/LOAEL of 15/152 mg/kg-day based on non-cancer liver effects (see EPA's Non-cancer
Human Health Hazard Assessment for Diisononyl Phthalate (DINP) (U.S. EPA. 2025u)) will adequately
account for all chronic toxicity—including carcinogenicity—which could potentially result from
exposure to DINP. Therefore, the non-cancer chronic POD of 15 mg/kg-day is considered protective of
PPARa activation and carcinogenicity.
4.3 Human Health Risk Characterization
4.3.1 Risk Assessment Approach
The exposure scenarios, populations of interest, and toxicological endpoints used for evaluating risks
from acute, short-term/intermediate, and chronic/lifetime exposures are summarized in Table 4-16.
Table 4-16. Exposure Scenarios, Populations of Interest, and Hazard Values
Workers
Male and female adolescents and adults (16+ years old) and females of reproductive age directly
working with DINP under light activity (breathing rate of 1.25 m3/h)
Exposure Durations
• Acute - 8 hours for a single workday
• Intermediate - 8 hours per workday for 22 days per 30-day period
• Chronic - 8 hours per workday for 250 days per year for 31 or 40 working years
Exposure Routes
• Inhalation and dermal
Occupational Non-users
Male and female adolescents and adults (16+ years old) indirectly exposed to DINP within the
same work area as workers (breathing rate of 1.25 m3/h)
Exposure Durations
• Acute, Intermediate, and Chronic - same as workers
Exposure Routes
• Inhalation, dermal (mist and dust deposited on surfaces)
Consumers
Male and female infants (<1 year), toddlers (1-2 years), children (3-5 years and 6-10 years),
young teens (11-15 years), teenagers (16-20 years) and adults (21+ years) exposed to DINP
through product or articles use
Exposure Durations
Population of Interest
and Exposure Scenario
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• Acute - 1 day exposure
• Intermediate - 30 days per year
• Chronic - 365 days per year
Exposure Routes
• Inhalation, dermal, and oral
Bystanders
Male and female infants (<1 year), toddlers (1-2 years), and children (3-5 years and 6-10 years)
incidentally exposed to DINP through product use
Exposure Durations
• Acute - 1 day exposure
• Intermediate - 30 days per year
• Chronic - 365 days per year
Exposure Routes
• Inhalation
General Population
Male and female infants, children, youth, and adults exposed to DINP through drinking water,
surface water, soil from air to soil deposition, and fish ingestion
Exposure Durations
• Acute - Exposed to DINP continuously for a 24-hour period
• Chronic - Exposed to DINP continuously up to 78 years
Exposure Routes - Inhalation, dermal, and oral (deoendine on exposure scenario)
Health Effects,
Concentration and
Time Duration
Non-cancer Acute/Intermediate Value
Sensitive health effect: Developmental toxicity (i.e., reduced fetal testicular testosterone content)
HEC Daily, continuous = 63 mg/m3 (3.7 ppm)
HED Daily =12 mg/kg-day; dermal and oral
Total UF (benchmark MOE) = 30 (UFA = 3; UFH = 10)
EPA considers the non-cancer acute/intermediate values based on developmental toxicity to be
most directly applicable to women of reproductive age/pregnant women, male infants, and male
children. Use of this hazard value to calculate risks for other age groups (e.g., adult males) is
conservative.
Non-cancer Chronic Value
Sensitive health effect: Liver toxicity
HEC Daily, continuous =19 mg/m3 (1.1 ppm)
HED Daily = 3.5 mg/kg-day; dermal and oral
Total UF (benchmark MOE) = 30 (UFA = 3; UFH = 10)
EPA considers the non-cancer chronic values based on liver toxicity to be more directly applicable
to adult workers, adult consumers, and adult members of the general population. Use of this
hazard value to calculate risks for other age groups (e.g., infants and children) is conservative.
4.3.1.1 Estimation of Non-cancer Risks
EPA used an MOE approach to identify potential non-cancer risks for individual exposure routes {i.e.,
oral, dermal, inhalation). The MOE is the ratio of the non-cancer POD divided by a human exposure
dose. Acute, short-term, and chronic MOEs for non-cancer inhalation and dermal risks were calculated
using Equation 4-1.
Equation 4-1. Margin of Exposure Calculation
Non — cancer Hazard Value (POD)
M0E ~ Human Exposure
Where:
MOE
Non-cancer Hazard Value (POD) =
Margin of exposure for acute, short-term, or chronic
risk comparison (unitless)
HEC (mg/m3) or HED (mg/kg-day)
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Human Exposure = Exposure estimate (mg/m3 or mg/kg-day)
MOE risk estimates may be interpreted in relation to benchmark MOEs. Benchmark MOEs are typically
the total UF for each non-cancer POD. The MOE estimate is interpreted as a possible human health risk
of concern if the MOE estimate is less than the benchmark MOE {i.e., the total UF). On the other hand,
if the MOE estimate is equal to or exceeds the benchmark MOE, the risk is not considered to be of
concern and mitigation is not needed. Typically, the larger the MOE, the more unlikely it is that a
non-cancer adverse effect occurs relative to the benchmark. When determining whether a chemical
substance presents unreasonable risk to human health or the environment, calculated risk estimates are
not "bright-line" indicators of unreasonable risk, and EPA has the discretion to consider other risk-
related factors in addition to risks identified in the risk characterization.
4.3.1.2 Estimation of Non-cancer Aggregate Risks
As described in Section 4.1.5, EPA considered aggregate risk across all routes of exposure for each
individual consumer and occupational COU evaluated for acute, intermediate, and chronic exposure
durations. To identify potential non-cancer risks for aggregate exposure scenarios for workers (Section
4.3.2) and consumers (Section 4.3.3), EPA used the total MOE approach ( 01). For the total
MOE approach, MOEs for each exposure route of interest in the aggregate scenario must first be
calculated. The total MOE for the aggregate scenario can then be calculated using Equation 4-2.
Equation 4-2. Total Margin of Exposure Calculation
1
Total MOE = jjj
MOE0rai MOEDermai MOEInhaiation
Where:
Total MOE = Margin of exposure for aggregate scenario (unitless)
MOEorai = Margin of exposure for oral route (unitless)
MOEDermai = Margin of exposure for dermal route (unitless)
MOEinhdation = Margin of exposure for inhalation route (unitless)
Total MOE risk estimates may be interpreted in relation to benchmark MOEs, as described in the
preceding Section 4.3.1.1.
4.3.2 Risk Estimates for Workers
Risk estimates for workers from inhalation and dermal exposures, as well as aggregated exposures, are
shown in Table 4-17. This section provides discussion and characterization of risk estimates for workers,
including females of reproductive age and ONUs, for the various OESs and COUs.
4.3.2.1 Application of Adhesives and Sealants
4.3.2.1.1 Overview of Risk Estimates
For the spray application of adhesives and sealants, inhalation exposure from mist generation is
expected to be the dominant route of exposure; however, for the non-spray application of adhesives and
sealants, inhalation exposure is expected to be minimal compared to the dermal route of exposure.
Therefore, EPA distinguished exposure estimates between spray and non-spray application of adhesive
and sealant products containing DINP. In support of this, MOEs for high-end acute, intermediate, and
chronic inhalation exposure from the spray application scenario ranged from 2.1 to 7.4 for average adult
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workers and women of reproductive age, while high-end dermal MOEs ranged from 33 to 114
(benchmark = 30). For central tendency of the spray scenario, MOEs for the same populations and
exposure scenarios ranged from 30 to 97 for inhalation exposure and 71 to 228 for dermal exposure.
MOEs for high-end acute, intermediate, and chronic inhalation exposure from the non-spray application
scenario ranged from 59,215 to 209,455 for average adult workers and women of reproductive age,
while high-end dermal MOEs ranged from 33 to 114. For central tendency of the non-spray scenario,
MOEs for the same populations and exposure scenarios ranged from 127,618 to 418,909 for inhalation
exposure and 71 to 228 for dermal exposure.
Aggregation of inhalation and dermal exposures led to negligible differences in MOEs when compared
to MOE estimates from the dominant route of exposure alone (inhalation is dominant for spray
scenarios, dermal is dominant for non-spray scenarios). Also, it is important to note that there were large
variations between the central tendency and high-end estimates of worker inhalation exposure, which are
largely due to the range of potential product concentrations as described in the section below.
4.3.2.1.2 Overview of Exposure Data
For spray application of adhesives and sealants, EPA relied on mist monitoring data from the ESD on
Coating Application via Spray-Painting in the Automotive Refinishing Industry (OE i), which
showed that the central tendency {i.e., 50th percentile) of mist concentrations from automotive
refinishing was 3.38 mg/m3 and the high-end {i.e., 95th percentile) was 22.1 mg/m3. These mist
concentration data were derived from a variety of industrial and commercial automotive refinishing
scenarios {e.g., different gun types, booth configurations, spray durations), but all scenarios considered
in the ESD commonly used the spray application of auto refinishing coatings. Although the tasks
evaluated for mist concentrations varied in duration with the 95th percentile of spray times among tasks
being 141 minutes, EPA assumed that these mist concentrations may be persistent in an environment
where spraying occurs throughout all or most of the workday. The more highly pressurized spray guns
generally lead to higher inhalation exposure levels, while less pressurized spray guns generally lead to
lower inhalation exposure levels. The same trend is expected for dermal exposure. Specifically, high-
pressure spray applications are more likely to lead to higher levels of dermal exposure, and low-pressure
spray guns are more likely to lead to lower levels of dermal exposure. However, there are a variety of
factors other than spray equipment type that affect exposure levels, such as spray booth ventilation
configuration, product concentration, and spray duration.
High-end levels of exposure represent scenarios where one or more factors are contributing to unusually
elevated exposure levels, whereas central tendency levels of exposure represent more typical levels of
exposure for scenarios where there are few factors contributing to increased exposure. There is
uncertainty regarding the particular combination of factors that would lead to high-end levels of
exposure. Also, there was one study noted in the EU Risk Assessment for DIDP (2003a) that measured
concentrations of DEHP, DIDP, and DINP during spray coating or spread coating in an automobile
factory. Specifically, the study by King (1996) showed inhalation exposure levels that ranged from 0 to
0.11 mg/m3 for DEHP, DIDP, and DINP, according to the 2003 EU Risk Assessment for DIDP.
However, EPA has been unable to locate this study to determine key study details including sample
duration, concentration of DINP in coating materials, type of equipment and application methods
examined. Without access to the study, EPA has low confidence in integrating the results from King
(il'Ils) into the risk evaluation of DINP.
For non-spray application of adhesives and sealants, mist generation is not expected, and EPA assumed
that vapor generation during use would be similar to the vapor exposure experienced during the
incorporation of DINP into adhesive and sealant products. Specifically, EPA estimated vapor inhalation
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exposures using surrogate monitoring data for DINP use during PVC plastics compounding at a PVC
roofing manufacturing site (Irwin. 2022). All inhalation datapoints were below the detection limit;
therefore, EPA assessed high-end exposure using the detection limit and central tendency exposure
using half the detection limit.
Regarding product concentrations, the various commercial adhesive and sealant products considered are
summarized in Appendix F of the Environmental Release and Occupational Exposure Assessment for
DiisononylPhthalate (DINP) ( 25r). There are also two industrial adhesive and sealant
products (i.e., Tremco JS443 A & B) listed in Appendix F of the Environmental Release and
Occupational Exposure Assessment for Diisononyl Phthalate (DINP). Both products have similar DINP
concentrations to the commercial products identified. The central tendency product concentration was
chosen as the mode of available product concentrations (i.e., 10 wt%) and the high-end product
concentration was chosen as 95th percentile of available product concentrations (i.e., 40 wt%). Because
there were significant differences between central tendency and high-end values for the mist exposure
concentration and the product concentration, which are both inputs to the inhalation exposure
distribution for the spray application scenario, there was a larger range of potential inhalation exposures
for the spray application of adhesives and sealants.
4.3.2.1.3 Risk Characterization of COUs
The range of exposure estimates shown in Table 4-17 for Application of adhesives and sealants - spray
application are potentially reflective of industrial or commercial operations where adhesives and sealants
are applied using spray methods {i.e., Industrial COU: Adhesive and sealant chemicals; Commercial
COU: Adhesives and sealants). As described in the section above, EPA assumed that task-based mist
concentrations may be persistent throughout the entirety of a workday for exposure estimation, which is
realistic but on the conservative end of expected exposure duration for spray coating scenarios. The
central tendency estimates of the spray application scenario represent the mode of available product
concentrations and the mist concentration from the 50th percentile of the data presented in the ESD on
Coating Application via Spray-Painting in the Automotive Refinishing Industry (QE t), and
these levels of exposure are expected to be typical for standard working conditions where workers are
spray applying adhesive and sealant products containing DINP for up to 8 hours per day. However, it is
noted that there are several factors that affect exposure levels related to the spray application of adhesive
and sealant chemicals including spray equipment type, spray booth ventilation configuration, product
concentration, and spray duration. High-end levels of exposure may occur if one or more of these factors
contribute to elevated levels of exposure; however, there is uncertainty regarding the conditions
associated with high-end exposures.
Because the high-end risk estimates are based on high-end mist concentration levels, high-end product
concentration, and high-end exposure duration, the high-end risk values presented in Table 4-17 for
Application of adhesives and sealants - spray application may overestimate exposures for typical
working conditions. EPA does expect spray application of adhesive and sealant products based on public
feedback regarding the industrial and commercial applications of adhesives and sealants containing
phthalates (EPA-HQ-OPPT-2024-0073-0069). Specifically, public comments indicate there are
phthalate-containing adhesive/sealant products with concentrations up to 30 percent, and these products
are intended for high-volume, low-pressure spray for tank linings and large areas. For a 2-hour spraying
task with HVLP equipment and 30 percent product concentration, mist levels exceeding 16 mg/m3 (i.e.,
92nd percentile of the distribution of mist monitoring data) would result in risk values below the
benchmark MOE. For an 8-hour workday spent spraying with HVLP equipment and 30 percent product
concentration, mist levels exceeding 4 mg/m3 (i.e., 56th percentile of the distribution of mist monitoring
data) would result in risk values below the benchmark MOE. Although there is uncertainty in the
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relevance of a high-end exposure estimate that is based on all high-end input values, the two spray
scenarios described above {i.e., 2- and 8-hour spray duration of 30% product with HVLP equipment)
may be relevant based on the expected product use.
Although most worker exposures to DINP through spray application of adhesives and sealants are
expected to be closer to the central tendency exposure values for this COU, a confluence of a subset of
variables {e.g., low ventilation, high-pressure spray) would result in risk below the benchmark. While
most workers are not expected to experience these conditions, they are considered plausible and
expected for an acute 1-day exposure.
Based on the reasonably available information, the range of exposure estimates shown in Table 4-17 for
Application of adhesives and sealants - non-spray application are believed to be reflective of industrial
or commercial operations where adhesives and sealants are applied using non-spray methods {i.e.,
Industrial COU: Adhesive and sealant chemicals; Commercial COU: Adhesives and sealants). The
adhesive and sealant products containing DINP that were identified by EPA during systematic review
and summarized in Appendix F of Environmental Release and Occupational Exposure Assessment for
Diisononyl Phthalate (DINP) ( 25r) are not intended for spray application. More
specifically, the products are to be applied through non-spray methods such as bead, brush, or roll
applications. The exposure and risk estimates associated with non-spray application scenarios for
adhesives and sealants containing DINP show low variability between central tendency and high-end,
and the range of exposure estimates are expected to be representative of various non-spray application
scenarios for adhesive and sealant chemicals containing DINP.
4.3.2.2 Application of Paints and Coatings
4.3.2.2.1 Overview of Risk Estimates
For the spray application of paints and coatings, inhalation exposure from mist generation is expected to
be the dominant route of exposure; however, for the non-spray application of paints and coatings,
inhalation exposure is expected to be minimal compared to the dermal route of exposure. Therefore,
EPA distinguished exposure estimates between spray and non-spray application of paint and coating
products containing DINP. In support of this, MOEs for high-end acute, intermediate, and chronic
inhalation exposure from the spray application scenario ranged from 4.2 to 15 for average adult workers
and women of reproductive age, while high-end dermal MOEs ranged from 33 to 114 (benchmark = 30).
For central tendency of the spray scenario, MOEs for the same populations and exposure scenarios
ranged from 55 to 194 for inhalation exposures and 66 to 228 for dermal exposures. MOEs for high-end
acute, intermediate, and chronic inhalation exposure from the non-spray application scenario ranged
from 59,215 to 209,455 for average adult workers and women of reproductive age, while high-end
dermal MOEs ranged from 33 to 114. For central tendency of the non-spray scenario, MOEs for the
same populations and exposure scenarios ranged from 118,429 to 418,909 for inhalation exposure and
71 to 228 for dermal exposure.
Aggregation of inhalation and dermal exposures led to negligible differences in MOEs when compared
to MOE estimates from the dominant route of exposure alone (inhalation is dominant for spray
scenarios, dermal is dominant for non-spray scenarios). Also, it is important to note that there were large
variations between the central tendency and high-end estimates of worker inhalation exposure, which is
largely due to the range of potential product concentrations as described in the section below.
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4.3.2.2.2 Overview of Exposure Data
For spray application of paints and coatings, EPA relied on mist monitoring data from the ESD on
Coating Application via Spray-Painting in the Automotive Refinishing Industry (OE t), which
showed that the central tendency {i.e., 50th percentile) of mist concentrations from automotive
refinishing was 3.38 mg/m3 and the high-end {i.e., 95th percentile) was 22.1 mg/m3. These mist
concentration data were derived from a variety of industrial and commercial automotive refinishing
scenarios {e.g., different gun types and booth configurations), but all scenarios considered in the ESD
commonly used the spray application of auto refinishing coatings. Although the tasks evaluated for mist
concentrations varied in time, with the 95th percentile of spray times among tasks being 141 minutes,
EPA assumed that these mist concentrations may be persistent in an environment where spraying occurs
throughout all or most of the workday. The more highly pressurized spray guns generally lead to higher
inhalation exposure levels, and less pressurized spray guns generally lead to lower inhalation exposure
levels. The same trend is expected for dermal exposure. Specifically, high-pressure spray applications
are more likely to lead to higher levels of dermal exposure, and low-pressure spray guns are more likely
to lead to lower levels of dermal exposure. However, there are a variety of factors other than spray
equipment type that affect exposure levels, such as spray booth ventilation configuration, product
concentration, and spray duration.
High-end levels of exposure represent scenarios where one or more factors are contributing to unusually
elevated exposure levels, whereas central tendency levels of exposure represent more typical levels of
exposure for scenarios where there are few factors contributing to increased exposure. There is
uncertainty regarding the particular combination of factors that would lead to high-end levels of
exposure. Also, there was one study noted in the EU Risk Assessment for DIDP (2003a) that measured
concentrations of DEHP, DIDP, and DINP during spray coating or spread coating in an automobile
factory. Specifically, the study by King (1996) showed inhalation exposure levels that ranged from 0 to
0.11 mg/m3 for DEHP, DIDP, and DINP, according to the 2003 EU Risk Assessment for DIDP.
However, EPA has been unable to locate this study to determine key study details including sample
duration, concentration of DINP in coating materials, type of equipment and application methods
examined. Without access to the study, EPA has low confidence integrating the results from King
(i_™§) into the risk evaluation of DINP.
For non-spray application of paints and coatings, mist generation is not expected and EPA assumed that
vapor generation during use would be similar to the vapor exposure experienced during the
incorporation of DINP into paint and coating products. Specifically, EPA estimated vapor inhalation
exposures using surrogate monitoring data for DINP use during PVC plastics compounding at a PVC
roofing manufacturing site (Irwin. 2022). All inhalation datapoints were below the detection limit,
therefore EPA assessed high-end exposure using the detection limit and central tendency exposure using
half the detection limit.
Regarding product concentrations, the various commercial paint and coating products considered are
summarized in Appendix F of the Environmental Release and Occupational Exposure Assessment for
DiisononylPhthalate (DINP) ( 25r). There is also one paint and coating product {i.e.,
Freeman 90 - Burnt Orange Pattern Coating) that is listed as an Industrial COU in Table 1-1, and this
product has a similar range of potential DINP concentrations to the commercial products identified. EPA
used the mode product concentration {i.e., 5%) to represent the central tendency product concentration
and the upper bound product concentration {i.e., 20%) to represent the high-end product concentration.
Due to the differences between central tendency and high-end values for the mist exposure concentration
and the product concentration, which are both inputs to the inhalation exposure distribution of the spray
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application scenario, there was a larger range of potential inhalation exposures for the spray application
of paints and coatings.
4.3.2.2.3 Risk Characterization of COUs
The range of exposure estimates shown in Table 4-17 for Application of paints and coatings - spray
application are potentially reflective of industrial or commercial operations where paints and coatings
are applied using spray methods {i.e., Industrial COU: Paints and coatings; Commercial COU: Paints
and coatings). As described in the section above, EPA assumed that task-based mist concentrations may
be persistent throughout the entirety of a workday for exposure estimation, which is realistic but on the
conservative end of expected exposure duration for spray coating scenarios. The central tendency
estimates of the spray application scenario represent the mode of available product concentrations and
the mist concentration from the 50th percentile of the data presented in the ESD on Coating Application
via Spray-Painting in the Automotive Refinishing Industry COECD. 201 la), and these levels of exposure
are expected to be typical for standard working conditions where workers are spray applying paint and
coating products containing DINP for up to 8 hours per day. However, it is noted that there are several
factors that affect exposure levels related to the spray application of paint and coating chemicals,
including spray equipment type, spray booth ventilation configuration, product concentration, and spray
duration. High-end levels of exposure may occur if one or more of these factors contribute to elevated
levels of exposure; however, there is uncertainty regarding the conditions associated with high-end
exposures.
Because the high-end risk estimates are based on high-end mist concentration levels, high-end product
concentration, and high-end exposure duration, the high-end risk values presented in Table 4-17 for
Application of paints and coatings - spray application may overestimate exposures for typical working
conditions. However, there were public comments indicating that there are phthalate-containing
automotive undercoating products with plasticizer concentrations up to 9 percent CEPA-HQ-OPPT-
2024-0073-0069). For a 2-hour spraying task with a paint/coating product containing 9 percent DINP,
mist levels exceeding 53 mg/m3 would result in risk values below the benchmark MOE, which is well
beyond the expected level of mist exposure for spray coating applications. However, for an 8-hour
workday spent spraying with a paint/coating product containing 9 percent DINP, mist levels exceeding
13.3 mg/m3 {i.e., 91st percentile of the distribution of mist monitoring data) would result in risk values
below the benchmark MOE. These two spray scenarios described above {i.e., 2- and 8-hour spray
duration of 9% product) seem relevant based on the expected product use; however, these scenarios
show that the mist concentrations that would result in risk values below the benchmark MOE would be
at a high level {i.e., >90th percentile of mist concentration data for an 8-hour period).
Although most worker exposures to DINP through spray application of paints and coatings are expected
to be closer to the central tendency exposure values for this COU, a confluence of a subset of variables
{e.g., low ventilation, high-pressure spray, etc.) would result in risk below the benchmark. While most
workers are not expected to experience these conditions, they are considered plausible and expected for
an acute 1-day exposure.
The COUs identified for DINP also indicate commercial use of paint and coating products containing
DINP. The commercial paint and coating products that were identified through the risk evaluation
process and summarized in Appendix F of Environmental Release and Occupational Exposure
Assessment for Diisononyl Phthalate (DINP) ( 025r) are generally applied through low-
pressure hand pump sprayers, small volume spray cans, and buff coating applications. The occupational
applications of paints and coatings through spray equipment are reflected by the exposure and risk
estimates for Application of paints and coatings - spray application shown in Table 4-17, as described in
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the paragraph above, and the occupational applications of paints and coatings through non-spray
methods such as brush or roll application are reflected by the range of exposure and risk estimates for
Application of paints and coatings - non-spray application shown in Table 4-17. The exposure and risk
estimates associated with non-spray application scenarios for paints and coatings containing DINP show
low variability between central tendency and high-end, and the range of exposure estimates are expected
to be representative of various non-spray application scenarios for paint and coating chemicals
containing DINP. These non-spray application estimates are relevant for industrial or commercial uses
of paint and coating products that are not spray applied {i.e., Industrial COUs: Paints and coatings;
Pigment [leak detection]; and Commercial COUs: Paints and coatings; Ink, toner, and colorant
products).
4.3.2.3 PVC Plastics and Non-PVC Material Compounding
4.3.2.3.1 Overview of Risk Estimates
For PVC plastics compounding and non-PVC material compounding, inhalation exposure from dust
generation is expected to be the dominant route of exposure. In support of this, for PVC plastics
compounding, MOEs for high-end acute, intermediate, and chronic inhalation exposure ranged from 17
to 62 for average adult workers and women of reproductive age, while high-end dermal MOEs ranged
from 33 to 114 (benchmark = 30). Similarly, for non-PVC material compounding MOEs for high-end
acute, intermediate, and chronic inhalation exposure ranged from 20 to 70 for average adult workers and
women of reproductive age, while high-end dermal MOEs ranged from 33 to 114. For central tendency,
MOEs for the same population and exposure scenarios ranged from 400 to 1,261 for inhalation exposure
and 80 to 228 for dermal exposures during PVC plastics compounding and 428 to 1,418 for inhalation
exposure and 70 to 228 for dermal exposures during non-PVC material compounding. The reason for the
large variation between high-end and central tendency is described in the section below.
4.3.2.3.2 Overview of Exposure Data
EPA estimated worker inhalation exposures using monitoring data for vapor exposures at a PVC roofing
manufacturing site (Irwin. 2022) and the Generic Model for Central Tendency and High-End Inhalation
Exposure to Total and Respirable Particulates Not Otherwise Regulated (PNOR) for dust exposures
( 202le). EPA did not have a robust dataset for vapor exposures, with all monitoring data
below the limit of detection (LOD); therefore, EPA assessed high-end vapor exposures at the LOD and
central tendency vapor exposures at half of the LOD. For inhalation exposures to particulate, EPA
determined the 50th and 95th percentiles of the surrogate dust data from facilities with NAICS codes
starting with 326 (Plastics and Rubber Manufacturing). EPA multiplied these dust concentrations by the
maximum product concentrations provided by industry for PVC {i.e., 45%) and non-PVC {i.e., 40%)
products, respectively, to conservatively estimate DINP particulate concentrations in the air. The
differences in the central tendency and high-end dust concentrations led to significant differences
between the central tendency and high-end risk estimates. Although the PNOR {i.e., dust) concentration
data provides a reliable range of dust concentrations that a worker may experience in the compounding
industry, the composition of workplace dust is uncertain. The exposure and risk estimates are based on
the assumption that the concentration of DINP in workplace dust is the same as the concentration of
DINP in PVC plastics or non-PVC materials, respectively. However, it is likely that workplace dust
contains a variety of constituents and that the concentration of DINP in workplace dust is less than the
concentration of DINP in PVC or non-PVC products.
4.3.2.3.3 Risk Characterization of COUs
Although the dust monitoring data from the PNOR model are based on a robust dataset, there is
uncertainty regarding the concentration of DINP in workplace dust. Specifically, it was assumed that the
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concentration of DINP in workplace dust is equal to that in PVC or non-PVC products for both high-end
and central tendency estimates. However, the concentration of DINP in workplace dust is likely much
lower than the concentrated product due to the presence of other constituents. Further, it was noted
during the public comment period (EPA-HQ-QF 24-0073-0069) that liquid plasticizers are
generally added to dry mixtures during the compounding process, and any dust generated would come
from the dry material rather than the plasticizer.
Inhalation exposure from dust generation is expected to be the dominant route of exposure, although
dermal and aggregate exposures were also assessed. Chronic inhalation risk estimates for workers were
below the benchmark MOE at the high-end for PVC and non-PVC compounding scenarios, and
aggregated risk estimates were below the benchmark MOE at the high-end for PVC compounding
scenarios. However, high-end estimates of inhalation exposure are based on high-end dust levels and
high-end product concentration (i.e., 45% for PVC and 40% for non-PVC), which likely overestimate
worker exposures due to the conservatism of the input values. Central tendency estimates of inhalation
exposure are based on central tendency dust levels but also high-end product concentration (i.e., 45% for
PVC and 40% for non-PVC), which leads to a conservative assessment of worker central tendency
exposure.
Therefore, due to the uncertainty regarding DINP concentrations in workplace dust and potential
overestimation at the high-end, central tendency values of exposure are expected to be more reflective of
worker exposures within the COUs covered under the PVC plastics compounding and Non-PVC
material compounding OESs (i.e., Processing COUs: Plasticizers [custom compounding of purchased
resin; plastic material and resin manufacturing; synthetic rubber manufacturing]).
4.3.2.4 PVC Plastics and Non-PVC Material Converting
4.3.2.4.1 Overview of Risk Estimates
For PVC plastics converting and non-PVC material converting, inhalation exposure from dust
generation is expected to be the dominant route of exposure. In support of this, for PVC plastics
converting, MOEs for high-end acute, intermediate, and chronic inhalation exposure ranged from 17 to
62 for average adult workers and women of reproductive age, while high-end dermal MOEs for the
same populations and exposure scenarios ranged from 8,309 to 28,960 (benchmark = 30). Similarly,
non-PVC material converting MOEs for high-end acute, intermediate, and chronic inhalation exposure
ranged from 20 to 70 for average adult workers and women of reproductive age, while high-end dermal
MOEs for the same populations and exposure scenarios ranged from 8,309 to 28,960. For central
tendency, MOEs for the same population and exposure scenarios ranged from 407 to 1,261 for
inhalation exposure and 18,970 to 57,590 for dermal exposures during PVC plastics converting and 458
to 1,418 for inhalation exposure and 18,970 to 57,590 for dermal exposures during non-PVC material
converting. Aggregation of inhalation and dermal exposures led to negligible differences in MOEs when
compared to estimates from inhalation exposure alone.
4.3.2.4.2 Overview of Exposure Data
EPA estimated worker inhalation exposures using monitoring data for vapor exposures at a PVC roofing
manufacturing site ("Irwin. 2022) and the Generic Model for Central Tendency and High-End Inhalation
Exposure to Total and Respirable Particulates Not Otherwise Regulated (PNOR) for dust exposures
( 202 le). EPA did not have a robust dataset for vapor exposures with all monitoring data
existing below the LOD; therefore, the Agency assessed high-end exposure as the LOD and the central
tendency as half of the LOD to represent potential exposures from vapor. For inhalation exposure to
PNOR, EPA determined the 50th and 95th percentiles of the surrogate dust release data taken from
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facilities with NAICS codes starting with 326 (Plastics and Rubber Manufacturing). EPA multiplied
these dust concentrations by the maximum product concentrations provided by industry for PVC {i.e.,
45%) and non-PVC {i.e., 40%) products, respectively, to conservatively estimate DINP particulate
concentrations in the air. The differences in the central tendency and high-end dust concentrations led to
significant differences between the central tendency and high-end risk estimates. Although the PNOR
{i.e., dust) concentration data provides a reliable range of dust concentrations that a worker may
experience in the compounding industry, the composition of workplace dust is uncertain. The exposure
and risk estimates are based on the assumption that the concentration of DINP in workplace dust is the
same as the concentration of DINP in PVC plastics or non-PVC materials, respectively. However, it is
likely that workplace dust contains a variety of constituents and that the concentration of DINP in
workplace dust is less than the concentration of DINP in PVC or non-PVC products.
4.3.2.4.3 Risk Characterization of COUs
Although the dust monitoring data from the PNOR model are based on a robust dataset, there is
uncertainty regarding the concentration of DINP in workplace dust. Specifically, it was assumed that the
concentration of DINP in workplace dust is equal to that in PVC or non-PVC products for both high-end
and central tendency estimates. However, the concentration of DINP in workplace dust is likely much
lower than the concentrated product due to the presence of other constituents. Further, it was noted
during the public comment period (EPA-HQ-QF 24-0073-0069) that liquid plasticizers are
generally added to dry mixtures during the compounding process, and any dust generated would come
from the dry material rather than the plasticizer.
Inhalation exposure from dust generation is expected to be the dominant route of exposure, though
dermal and aggregate exposures were also assessed. Chronic inhalation risk estimates were below the
benchmark MOE at the high-end for PVC and non-PVC converting scenarios. However, high-end
estimates of inhalation exposure are based on high-end dust levels and high-end product concentration
{i.e., 45%) for PVC and 40% for non-PVC), which likely overestimate worker exposures due to the
conservatism of the input values. Central tendency estimates of inhalation exposure are based on central
tendency dust levels, but also high-end product concentration {i.e., 45% for PVC and 40% for non-
PVC), which leads to a conservative assessment of worker central tendency exposure.
Therefore, due to the uncertainty regarding DINP concentrations in workplace dust and potential
overestimation at the high-end, central tendency values of exposure are expected to be more reflective of
worker exposures within the COUs covered under the PVC plastics compounding and Non-PVC
material compounding OESs {i.e., Processing COUs: Plasticizers [playground and sporting equipment
manufacturing; plastics products manufacturing; rubber product manufacturing; wholesale and retail
trade; textiles, apparel, and leather manufacturing; electrical equipment, appliance, and component
manufacturing; transportation equipment manufacturing; ink, toner, and colorant manufacturing
(including pigments)]).
4.3.2.5 Recycling and Disposal
4.3.2.5.1 Overview of Risk Estimates
For recycling and disposal of DINP containing materials, the inhalation exposure from dust generation is
expected to be the dominant route of exposure. In support of this, MOEs for high-end acute,
intermediate, and chronic inhalation exposure ranged from 23 to 83 for average adult workers and
women of reproductive age, while high-end dermal MOEs for the same populations and exposure
scenarios ranged from 8,309 to 28,960 (benchmark = 30). The central tendency MOEs for the same
populations and exposure scenarios ranged from 18,630 to 57,920 for dermal exposure and 384 to 1,212
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for inhalation exposure. Aggregation of inhalation and dermal exposures led to negligible differences in
risk when compared to risk estimates from inhalation exposure alone. The large variations between the
central tendency and high-end estimates of worker inhalation exposures are described in the section
below.
4.3.2.5.2 Overview of Exposure Data
EPA estimated worker inhalation exposures using the Generic Model for Central Tendency and High-
End Inhalation Exposure to Total and Respirable Particulates Not Otherwise Regulated (PNOR) for dust
exposures ( 1021 e). Regarding the dominant route of exposure, inhalation exposure of PNOR,
the Agency determined the 50th and 95th percentiles of the surrogate dust release data taken from
facilities with NAICS codes starting with 56 (Administrative and Support and Waste Management and
Remediation Services). EPA multiplied these dust concentrations by the industry provided maximum
DINP concentration in PVC (i.e., 45%) to estimate DINP particulate concentrations in the air. Therefore,
the differences in the central tendency and high-end dust concentrations led to significant differences
between the central tendency and high-end risk estimates. Although the PNOR (i.e., dust) concentration
data provides a reliable range of dust concentrations that a worker may experience in the recycling and
disposal industry, the composition of workplace dust is uncertain. The exposure and risk estimates are
based on the assumption that the concentration of DINP in workplace dust is the same as the maximum
concentration of DINP in PVC plastics. However, it is likely that workplace dust contains a variety of
constituents and that the concentration of DINP in workplace dust is less than the concentration of DINP
in recycled or disposed products or articles.
4.3.2.5.3 Risk Characterization of COUs
Although the dust monitoring data from the PNOR model are based on a robust dataset, there is
uncertainty regarding the concentration of DINP in workplace dust. Specifically, it was assumed that the
concentration of DINP in workplace dust is equal to that in PVC products (i.e., 45%) for both high-end
and central tendency estimates. Because the concentration of DINP in workplace dust is likely much
lower than the concentrated product due to the presence of other constituents, the range of inhalation
exposure values may overestimate exposures for typical working conditions. Also, dermal exposures to
solids containing DINP are estimated to be minimal at both high-end and central tendency levels.
Inhalation exposure from dust generation is expected to be the dominant route of exposure, although
dermal and aggregate exposures were also assessed. Chronic inhalation risk estimates were below the
benchmark MOE at the high-end. However, high-end estimates of inhalation exposure are based on
high-end dust levels and high-end product concentration for PVC (i.e., 45%), which likely overestimate
worker exposures due to the conservatism of the input values. Central tendency estimates of inhalation
exposure are based on central tendency dust levels, but also high-end product concentration for PVC
(i.e., 45%), which leads to a conservative assessment of worker central tendency exposure.
Therefore, due to the uncertainty regarding DINP concentrations in workplace dust and potential
overestimation at the high-end, central tendency values of exposure are expected to be more reflective of
worker exposures within the COUs covered under the Recycling and Disposal OESs (i.e., Industrial
COUs: Recycling and Disposal).
4.3.2.6 Fabrication and Final Use of Products or Articles
4.3.2.6.1 Overview of Risk Estimates
For fabrication and final use of products or articles, inhalation exposure from dust generation is expected
to be the dominant route of exposure. In support of this, MOEs for high-end acute, intermediate, and
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chronic inhalation exposure ranged from 46 to 162 for average adult workers and women of
reproductive age, while high-end dermal MOEs for the same populations and exposure scenarios ranged
from 8,309 to 28,960 (benchmark = 30). The central tendency MOEs for the same populations and
exposure scenarios ranged from 16,618 to 57,920 for dermal exposure and 411 to 1,455 for inhalation
exposure. Aggregation of inhalation and dermal exposures led to negligible differences in risk when
compared to risk estimates from inhalation exposure alone. The large variations between the central
tendency and high-end estimates of worker inhalation exposures are described in the section below.
4.3.2.6.2 Overview of Exposure Data
EPA estimated worker inhalation exposures using the Generic Model for Central Tendency and High-
End Inhalation Exposure to Total and Respirable Particulates Not Otherwise Regulated (PNOR) for dust
exposures ( 1021 e). For inhalation exposure to PNOR, the Agency determined the 50th and
95th percentiles of the surrogate dust release data taken from facilities with NAICS codes starting with
337 (Furniture and Related Product Manufacturing). EPA multiplied these dust concentrations by the
industry provided maximum DINP concentration in PVC (i.e., 45%) to estimate DINP particulate
concentrations in the air. Therefore, the differences in the central tendency and high-end dust
concentrations led to significant differences between the central tendency and high-end risk estimates.
Although the PNOR (i.e., dust) concentration data provides a reliable range of dust concentrations that a
worker may experience in the fabrication industry, the composition of workplace dust is uncertain. The
exposure and risk estimates are based on the assumption that the concentration of DINP in workplace
dust is the same as the maximum concentration of DINP in PVC plastics. However, it is likely that
workplace dust contains a variety of constituents and that the concentration of DINP in workplace dust
is less than the concentration of DINP in final products or articles.
4.3.2.6.3 Risk Characterization of COUs
Although the dust monitoring data from the PNOR model are based on a robust dataset, there is
uncertainty regarding the concentration of DINP in workplace dust. Specifically, it was assumed that the
concentration of DINP in workplace dust is equal to that in PVC products (i.e., 45%) for both high-end
and central tendency estimates. Because the concentration of DINP in workplace dust is likely much
lower than the concentrated product due to the presence of other constituents, the range of inhalation
exposure values may overestimate exposures for typical working conditions. Also, dermal exposures to
solids containing DINP are estimated to be minimal at both high-end and central tendency levels.
Inhalation exposure from dust generation is expected to be the dominant route of exposure, though
dermal and aggregate exposures were also assessed. However, high-end estimates of inhalation exposure
are based on high-end dust levels and high-end product concentration for PVC (i.e., 45%), which likely
overestimate worker exposures due to the conservatism of the input values. Central tendency estimates
of inhalation exposure are based on central tendency dust levels, but also high-end product concentration
for PVC (i.e., 45%), which leads to a conservative assessment of worker central tendency exposure.
Therefore, due to the uncertainty regarding DINP concentrations in workplace dust and potential
overestimation at the high-end, central tendency values of exposure are expected to be more reflective of
worker exposures within the COUs covered under the Fabrication and final use of products or articles
OES (i.e., Industrial COUs: Automotive products, other than fluids; Building/construction materials
(roofing, pool liners, window shades, flooring, water supply piping). Commercial COUs: Automotive
products, other than fluids; Plasticizer in building/construction materials (roofing, pool liners, window
shades, water supply piping); Construction and building materials covering large surface areas,
including paper articles, metal articles, stone, plaster, cement, glass, and ceramic articles; Electrical and
electronic products; Foam seating and bedding products; Floor coverings; Fabrics, textiles and apparel
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(vinyl tiles, resilient flooring, PVC-backed carpeting); Fabric, textile, and leather products (apparel and
footwear care products); Furniture and furnishings (furniture & furnishings including plastic articles
[soft]; leather articles); Plasticizer (plastic and rubber products; tool handles, flexible tubes, profiles, and
hoses); Toys, playground, and sporting equipment), Packaging, paper, plastic, hobby products
(packaging [excluding food packaging], including rubber articles; plastic articles [hard]; plastic articles
[soft]) (see also Appendix E).
4.3.2.7 Distribution in Commerce
Distribution in commerce includes transporting DINP or DINP-containing products between work sites
or to final use sites as well as loading and unloading from transport vehicles. Individuals in occupations
that transport DINP-containing products (e.g., truck drivers) or workers who load and unload transport
trucks may encounter DINP or DINP-containing products.
Worker activities associated with distribution in commerce (e.g., loading, unloading) are not expected to
generate mist or dust, similar to other COUs such as Manufacturing and Import. Therefore, inhalation
exposures to workers during distribution in commerce are expected to be from the vapor phase only.
Dermal contact with the neat material or concentrated formulations may occur during activities
associated with distribution in commerce, also similar to COUs such as Manufacturing and Import.
While some worker activities associated with distribution in commerce are similar to COUs such as
manufacturing or import, it is expected that workers involved in distribution in commerce spend less
time exposed to DINP than workers in manufacturing or import facilities since only part of the workday
is spent in an area with potential exposure. In conclusion, occupational exposures associated with the
Distribution in commerce COU are expected to be less than other OESs/COUs without dust or mist
Generation, such as manufacturing or import, and the COU is captured in the subsection below.
4.3.2.8 OESs/COUs without Dust or Mist Generation
Due to the low vapor pressure of DINP, inhalation exposures from vapor-generating activities, without
dust or mist generation, are shown to be quite low. Analysis of each OES relied on either direct or
surrogate vapor monitoring data, and resulting worker risk estimates were far above the benchmark
MOE of 30 (i.e., high-end inhalation MOEs for the OESs listed below were >536 for all assessed
populations and exposure duration). Also, due to the long alkyl chain length of DINP, the rate of dermal
absorption of DINP is quite slow, which leads to low dermal exposure potential. For all of the below
OES the MOE for dermal exposure to DINP, liquid and solid, ranges from greater than 33 for high-end
and greater than 66 for central tendency. Aggregation of inhalation and dermal exposures led to
negligible differences in risk when compared to risk estimates from each exposure alone. Therefore, any
OES or COU where inhalation exposure to DINP comes only from vapor-generating activities is not
expected to lead to significant worker exposures, and such uses are summarized below.
OESs where inhalation exposure comes from vapor-generating activities only are provided below:
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• Manufacturing; Import and repackaging; Incorporation into adhesives and sealants;
Incorporation into paints and coatings; Incorporation into other formulations, mixtures, and
reaction products not covered elsewhere; Use of laboratory chemicals - liquids; Use of lubricants
and functional fluids; and Distribution in commerce.
• Although there is dust generation expected during the OES for Use of laboratory chemicals -
solids, the industry provided maximum DINP concentration is very low {i.e., 3%), which leads to
very low levels of potential worker inhalation exposure similar to that of vapor-generating
activities.
COUs where inhalation exposure comes from vapor-generating activities only are provided below:
• Industrial: Domestic manufacturing; Import; Repackaging (all other chemical product and
preparation manufacturing; wholesale and retail trade; laboratory chemicals manufacturing);
Miscellaneous processing (petroleum refineries, wholesale, and retail trade); Heat stabilizer and
processing aid in basic organic chemical manufacturing; Plasticizer (adhesives manufacturing;
paint and coating manufacturing; All other chemical product and preparation manufacturing;
Wholesale and retail trade; ink, toner, and colorant manufacturing (including pigment),
Hydraulic fluids
• Commercial: Laboratory chemicals; Air care products; Solvents (for cleaning or degreasing)
• Distribution in Commerce
Table 4-17 summarizes the risk estimates discussed above for all OESs and COUs. Section 4.1.1
presents the occupational exposure assessment. The risk summary below is based on the most sensitive
non-cancer endpoints for each scenario {i.e., acute non-cancer, intermediate non-cancer, and chronic
non-cancer).
4.3.2.9 Overall Confidence in Worker Risks
As described in Section 4.1.1.5 and the Environmental Release and Occupational Exposure Assessment
for DiisononylPhthalate (DINP) ( 25r). EPA has moderate to robust confidence in the
assessed inhalation and dermal OESs (Table 4-5) and robust confidence in the non-cancer PODs
selected to characterize risk from acute, intermediate, and chronic duration exposures to DINP (see
Section 4.2 and (U ,S. EPA. 2025uV). For purposes of assessing non-cancer risks for workers, the
selected acute/intermediate POD based on developmental toxicity is considered most applicable to
female workers of reproductive age, while the chronic POD based on liver toxicity is considered
applicable to female workers of reproductive age and average adult workers. Use of the
acute/intermediate POD to calculate risks for other age groups {e.g., average adult workers) is
conservative. Overall, EPA has moderate to robust confidence in the risk estimates calculated for worker
and ONU inhalation and dermal exposure scenarios. Sources of uncertainty associated with these
occupational COUs are discussed above in Section 4.3.2.
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Table 4-17. Occupational Aggregate Risk Summary Table
Life Cycle
Stage/ Category
Subcategory
OES
Population
Exposure
Level
Inhalation Risk Estimates
(Benchmark MOE = 30)
Dermal Risk Estimates
(Benchmark MOE = 30)
Aggregate Risk Estimates
(Benchmark MOE = 30)
Acute
Intermed.
Chronic
Acute
Intermed.
Chronic
Acute
Intermed.
Chronic
Manufacturing -
Domestic
Manufacturing
Domestic
manufacturing
Manufacturing
Worker: Average
Adult Worker
High-End
1,391
1,897
823
77
105
45
73
99
43
Central
Tendency
2,783
3,794
1,646
154
210
91
146
199
86
Worker: Female of
Reproductive Age
High-End
1,260
1,718
745
84
114
50
79
107
46
Central
Tendency
2,519
3,435
1,490
167
228
99
157
214
93
ONU
High-End
2,783
3,794
1,646
N/A
N/A
N/A
2,783
3,794
1,646
Central
Tendency
2,783
3,794
1,646
N/A
N/A
N/A
2,783
3,794
1,646
Manufacturing -
Importing
Importing
Import and
repackaging
Worker: Average
Adult Worker
High-End
1,391
1,897
592
77
105
33
73
99
31
Central
Tendency
2,783
3,794
1,424
154
210
79
146
199
75
Worker: Female of
Reproductive Age
High-End
1,260
1,718
536
84
114
36
79
107
33
Processing -
Repackaging
Plasticizer (all other
chemical product and
preparation
manufacturing;
wholesale and retail
trade; laboratory
chemicals
manufacturing)
Central
Tendency
2,519
3,435
1,289
167
228
86
157
214
80
ONU
High-End
2,783
3,794
1,185
N/A
N/A
N/A
2,783
3,794
1,185
Central
Tendency
2,783
3,794
1,424
N/A
N/A
N/A
2,783
3,794
1,424
Processing -
Incorporation
into formulation,
mixture, or
reaction product
Plasticizers
(adhesives
manufacturing)
Incorporation
into adhesives
and sealants
Worker: Average
Adult Worker
High-End
153,600
209,455
65,408
77
105
33
77
105
33
Central
Tendency
307,200
418,909
130,816
154
210
66
154
210
65
Worker: Female of
Reproductive Age
High-End
139,056
189,622
59,215
84
114
36
84
114
36
Central
Tendency
278,112
379,244
118,429
167
228
71
167
228
71
ONU
High-End
153,600
209,455
65,408
N/A
N/A
N/A
153,600
209,455
65,408
Central
Tendency
307,200
418,909
130,816
N/A
N/A
N/A
307,200
418,909
130,816
Processing -
Incorporation
into
formulation,
mixture, or
reaction
product
Plasticizers (paint
and coating
manufacturing; ink,
toner, and colorant
manufacturing
(including
pigment))
Incorporation
into paints and
coatings
Worker: Average
Adult Worker
High-End
153,600
209,455
65,408
77
105
33
77
105
33
Central
Tendency
307,200
418,909
130,816
154
210
66
154
210
65
Worker: Female
of Reproductive
Age
High-End
139,056
189,622
59,215
84
114
36
84
114
36
Central
Tendency
278,112
379,244
118,429
167
228
71
167
228
71
ONU
High-End
153,600
209,455
65,408
N/A
N/A
N/A
153,600
209,455
65,408
Central
Tendency
307,200
418,909
130,816
N/A
N/A
N/A
307,200
418,909
130,816
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Lite Cycle
Stage/ Category
Subcategory
OES
Population
Exposure
Level
Inhalation Risk Estimates
(Benchmark MOE = 30)
Dermal Risk Estimates
(Benchmark MOE = 30)
Aggregate Risk Estimates
(Benchmark MOE = 30)
Miscellaneous
High-End
153,600
209,455
65,408
77
105
33
77
105
33
Processing -
Other uses
processing
(petroleum
refineries;
wholesale and retail
trade)
Worker: Average
Adult Worker
Heat stabilizer and
Central
307,200
418,909
130,816
154
210
66
154
210
65
processing aid in
Incorporation
into other
formulations,
mixtures, and
reaction
products not
covered
elsewhere
Tendency
Processing -
Incorporation
into
basic organic
chemical
manufacturing
Worker: Female
of Reproductive
High-End
139,056
189,622
59,215
84
114
36
84
114
36
formulation,
Plasticizers
Age
Central
278,112
379,244
118,429
167
228
71
167
228
71
mixture, or
(wholesale and
Tendency
reaction
retail trade; all other
High-End
153,600
209,455
65,408
N/A
N/A
N/A
153,600
209,455
65,408
product
chemical product
and preparation
manufacturing)
Commercial
ONU
Central
307,200
418,909
130,816
N/A
N/A
N/A
307,200
418,909
130,816
Use -
Furnishing,
cleaning,
treatment/
Air care products
Tendency
care products
Processing -
Incorporation
into
formulation,
mixture, or
reaction
product
Worker: Average
Adult Worker
High-End
45
62
19
77
105
33
29
39
12
Plasticizers (custom
compounding of
purchased resin;
plastic material and
resin
manufacturing)
Central
Tendency
925
1,261
441
154
210
73
132
180
63
PVC plastics
compounding
Worker: Female
High-End
41
56
17
84
114
36
28
38
12
of Reproductive
Age
Central
Tendency
837
1,142
400
167
228
80
140
190
67
High-End
922
1,257
393
39,024
53,215
16,618
901
1,228
385
ONU
Central
Tendency
925
1,261
441
39,024
53,215
18,630
903
1,232
431
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Lite Cycle
Stage/ Category
Subcategory
OES
Population
Exposure
Level
Inhalation Risk Estimates
(Benchmark MOE = 30)
Dermal Risk Estimates
(Benchmark MOE = 30)
Aggregate Risk Estimates
(Benchmark MOE = 30)
Processing -
Incorporation
into articles
Plasticizers
(playground and
sporting equipment
manufacturing;
plastics products
manufacturing;
wholesale and retail
trade; textiles,
apparel, and leather
manufacturing;
electrical
equipment,
appliance, and
component
manufacturing; ink,
toner, and colorant
manufacturing
[including
pigment!)
PVC plastics
converting
Worker: Average
Adult Worker
High-End
45
62
19
19,512
26,608
8,309
45
62
19
Central
Tendency
925
1,261
450
39,024
53,215
18,970
903
1,232
439
Worker: Female
of Reproductive
Age
High-End
41
56
17
21,237
28,960
9,044
41
56
17
Central
Tendency
837
1,142
407
42,475
57,920
20,647
821
1,120
399
ONU
High-End
922
1,257
393
39,024
53,215
16,618
901
1,228
385
Central
Tendency
925
1,261
450
39,024
53,215
18,970
903
1,232
439
Processing -
Incorporation
into
formulation,
mixture, or
reaction
product
Plasticizers (custom
compounding of
purchased resin;
plastic material and
resin
manufacturing;
synthetic rubber
manufacturing)
Non-PVC
material
compounding
Worker: Average
Adult Worker
High-End
51
70
22
77
105
33
31
42
13
Central
Tendency
1,040
1,418
473
154
210
70
134
183
61
Worker: Female
of Reproductive
Age
High-End
46
63
20
84
114
36
30
41
13
Central
Tendency
941
1,284
428
167
228
76
142
194
65
ONU
High-End
1,036
1,413
441
39,024
53,215
16,618
1,010
1,377
431
Central
Tendency
1,040
1,418
473
39,024
53,215
17,754
1,013
1,381
461
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Lite Cycle
Stage/ Category
Subcategory
OES
Population
Exposure
Level
Inhalation Risk Estimates
(Benchmark MOE = 30)
Dermal Risk Estimates
(Benchmark MOE = 30)
Aggregate Risk Estimates
(Benchmark MOE = 30)
Processing -
Incorporation
into articles
Plasticizers
(playground and
sporting equipment
manufacturing;
plastics products
manufacturing;
rubber product
manufacturing;
wholesale and retail
trade; textiles,
apparel, and leather
manufacturing;
electrical
equipment,
appliance, and
component
manufacturing; ink,
toner, and colorant
manufacturing
[including
pigment!)
Non-PVC
material
converting
Worker: Average
Adult Worker
High-End
51
70
22
19,512
26,608
8,309
51
69
22
Central
Tendency
1,040
1,418
506
39,024
53,215
18,970
1,013
1,381
492
Worker: Female
of Reproductive
Age
High-End
46
63
20
21,237
28,960
9,044
46
63
20
Central
Tendency
941
1,284
458
42,475
57,920
20,647
921
1,256
448
ONU
High-End
1,036
1,413
441
39,024
53,215
16,618
1,010
1,377
431
Central
Tendency
1,040
1,418
506
39,024
53,215
18,970
1,013
1,381
492
Industrial Uses
- Adhesives
and sealants
Adhesive and
sealant chemicals
Application of
adhesives and
sealants - spray
application
Average Adult
Worker
High-End
5.4
7.4
2.3
77
105
33
5.1
6.9
2.2
Central
Tendency
71
97
33
154
210
71
49
66
22
Commercial
uses -
Construction,
paint, electrical,
and metal
products
Adhesives and
sealants
Female of
Reproductive
Age
High-End
4.9
6.7
2.1
84
114
36
4.6
6.3
2.0
Central
Tendency
64
88
30
167
228
77
47
63
21
ONU
High-End
71
97
30
154
210
66
49
66
22
Central
Tendency
71
97
33
154
210
71
49
66
22
Industrial uses
- Adhesives
and Sealants
Adhesive and
sealant chemicals
Application of
adhesives and
sealants - non-
spray
application
Worker: Average
Adult Worker
High-End
153,600
209,455
65,408
77
105
33
77
105
33
Central
Tendency
307,200
418,909
140,966
154
210
71
154
210
71
Worker: Female
of Reproductive
Age
High-End
139,056
189,622
59,215
84
114
36
84
114
36
Central
Tendency
278,112
379,244
127,618
167
228
77
167
228
77
Commercial
uses -
Construction,
paint, electrical,
and metal
products
Adhesives and
sealants
ONU
High-End
153,600
209,455
65,408
N/A
N/A
N/A
153,600
209,455
65,408
Central
Tendency
307,200
418,909
140,966
N/A
N/A
N/A
307,200
418,909
140,966
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Lite Cycle
Stage/ Category
Subcategory
OES
Population
Exposure
Level
Inhalation Risk Estimates
(Benchmark MOE = 30)
Dermal Risk Estimates
(Benchmark MOE = 30)
Aggregate Risk Estimates
(Benchmark MOE = 30)
Industrial Uses
Worker: Average
Adult Worker
High-End
11
15
4.6
77
105
33
9.5
13
4.1
- Construction,
paint, electrical,
Central
Tendency
142
194
61
154
210
66
74
101
31
and metal
products
Application of
paints and
coatings - spray
application
Worker: Female
of Reproductive
Age
High-End
9.8
13
4.2
84
114
36
8.8
12
3.7
Commercial
uses -
Paints and coatings
Central
Tendency
129
176
55
167
228
71
73
99
31
construction,
High-End
142
194
61
154
210
66
74
101
31
paint, electrical,
and metal
products
ONU
Central
Tendency
142
194
61
154
210
66
74
101
31
Industrial uses
Worker: Average
High-End
153,600
209,455
65,408
77
105
33
77
105
33
- Construction,
Adult Worker
paint, electrical,
and metal
products
Paints and coatings
Commercial
Uses -
Construction,
paint, electrical,
and metal
products
Application of
paints and
coatings - non-
spray
application
Industrial uses
Pigment (leak
- Other uses
detection)
Central
Tendency
307,200
418,909
130,816
154
210
66
154
210
65
Worker: Female
High-End
139,056
189,622
59,215
84
114
36
84
114
36
of Reproductive
Age
Central
Tendency
278,112
379,244
118,429
167
228
71
167
228
71
High-End
153,600
209,455
65,408
N/A
N/A
N/A
153,600
209,455
65,408
Commercial
Ink, toner, and
Central
307,200
418,909
130,816
N/A
N/A
N/A
307,200
418,909
130,816
Uses -
Packaging,
paper, plastic,
hobby products
colorant products
ONU
Tendency
Worker: Average
Adult Worker
High-End
1,391
1,897
592
77
105
33
73
99
31
Use of
laboratory
chemicals -
liquid
Central
Tendency
2,783
3,794
1,261
154
210
70
146
199
66
Commercial
Laboratory
chemicals
Worker: Female
High-End
1,260
1,718
536
84
114
36
79
107
33
Uses - Other
uses
of Reproductive
Age
Central
Tendency
2,519
3,435
1,141
167
228
76
157
214
71
High-End
2,783
3,794
1,185
N/A
N/A
N/A
2,783
3,794
1,185
ONU
Central
Tendency
2,783
3,794
1,261
N/A
N/A
N/A
2,783
3,794
1,261
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Lite Cycle
Stage/ Category
Subcategory
OES
Population
Exposure
Level
Inhalation Risk Estimates
(Benchmark MOE = 30)
Dermal Risk Estimates
(Benchmark MOE = 30)
Aggregate Risk Estimates
(Benchmark MOE = 30)
Worker: Average
Adult Worker
High-End
1,185
1,616
505
19,512
26,608
8,309
1,117
1,524
476
Use of
laboratory
chemicals -
solid
Central
Tendency
16,842
22,967
7,172
39,024
53,215
16,618
11,765
16,043
5,010
Commercial
Laboratory
chemicals
Worker: Female
High-End
1,073
1,463
457
21,237
28,960
9,044
1,021
1,393
435
Uses - Other
uses
of Reproductive
Age
Central
Tendency
15,247
20,792
6,493
42,475
57,920
18,087
11,220
15,300
4,778
High-End
16,842
22,967
7,172
39,024
53,215
16,618
11,765
16,043
5,010
ONU
Central
Tendency
16,842
22,967
7,172
39,024
53,215
16,618
11,765
16,043
5,010
Commercial
Solvents (for
Worker: Average
Adult Worker
High-End
1,391
10,435
37,029
77
577
2,047
73
547
1,940
Uses - Solvents
(for cleaning or
cleaning or
degreasing)
Central
Tendency
2,783
41,739
148,116
154
2,308
8,189
146
2,187
7,760
degreasing)
Use of
Worker: Female
High-End
1,260
9,447
33,523
84
628
2,228
79
589
2,089
lubricants and
of Reproductive
Central
2,519
37,787
134,091
167
2,512
8,913
157
2,355
8,358
Industrial uses
functional fluids
Age
Tendency
- Other uses
Hydraulic fluids
High-End
2,783
20,870
74,058
N/A
N/A
N/A
2,783
20,870
74,058
ONU
Central
Tendency
2,783
41,739
148,116
N/A
N/A
N/A
2,783
41,739
148,116
Industrial Uses
Automotive
High-End
119
162
50
19,512
26,608
8,309
118
161
50
- Automotive,
fuel,
products, other than
fluids
agriculture,
outdoor use
products
Industrial Uses
Building/
Central
1,067
1,455
454
39,024
53,215
16,618
1,038
1,416
442
- Automotive,
construction
Fabrication and
Tendency
fuel,
agriculture,
outdoor use
materials (roofing,
pool liners, window
shades, flooring,
final use of
products or
articles
Worker: Average
Adult Worker
products
water supply piping)
Industrial Uses
Automotive
- Automotive,
fuel,
products, other than
fluids
agriculture,
outdoor use
products
Page 156 of 269
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Lite Cycle
Stage/ Category
Subcategory
OES
Population
Exposure
Level
Inhalation Risk Estimates
(Benchmark MOE = 30)
Dermal Risk Estimates
(Benchmark MOE = 30)
Aggregate Risk Estimates
(Benchmark MOE = 30)
Plasticizer in
building/
construction
materials (roofing,
pool liners, window
shades, water
Commercial
uses -
Construction,
paint, electrical,
and metal
products
supply piping);
construction and
building materials
covering large
surface areas,
including paper
articles; metal
articles; stone,
plaster, cement,
glass, and ceramic
articles
High-End
107
146
46
21,237
28,960
9,044
107
146
45
Electrical and
electronic products
Foam seating and
Fabrication and
bedding products;
furniture and
furnishings
including plastic
articles (soft);
leather articles
Final Use of
Products or
Articles
Worker: Female
of Reproductive
Age
Floor coverings;
plasticizer in
construction and
Commercial
building materials
Uses -
Furnishing,
cleaning,
treatment/
covering large
surface areas
including stone,
plaster, cement,
care products
glass, and ceramic
articles; fabrics,
textiles, and apparel
(vinyl tiles, resilient
flooring, PVC-
backed carpeting)
Central
Tendency
966
1,317
411
42,475
57,920
18,087
944
1,288
402
Fabric, textile, and
leather products
(apparel and
footwear care
products)
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Lite Cycle
Stage/ Category
Subcategory
OES
Population
Exposure
Level
Inhalation Risk Estimates
(Benchmark MOE = 30)
Dermal Risk Estimates
(Benchmark MOE = 30)
Aggregate Risk Estimates
(Benchmark MOE = 30)
Arts, crafts, and
hobby materials
Commercial
Use:
Packaging,
paper, plastic,
hobby products
Packaging, paper,
plastic, hobby
products (packaging
[excluding food
packaging],
including rubber
articles; plastic
articles [hard];
plastic articles
rsofti)
Fabrication and
Final Use of
Products or
Articles
ONU
High-End
1,067
1,455
454
39,024
53,215
16,618
1,038
1,416
442
Plasticizer (plastic
and rubber products;
tool handles,
flexible tubes,
profiles, and hoses)
Central
Tendency
1,067
1,455
454
39,024
53,215
16,618
1,038
1,416
442
Toys, playground,
and sporting
equipment
Worker: Average
Adult Worker
High-End
61
83
26
19,512
26,608
8,309
61
83
26
Processing -
Recycling
Recycling
Central
Tendency
889
1,212
424
39,024
53,215
18,630
869
1,185
415
Recycling and
Disposal
Worker: Female
High-End
55
75
23
21,237
28,960
9,044
55
75
23
Disposal -
Disposal
of Reproductive
Age
Central
Tendency
805
1,097
384
42,475
57,920
20,277
790
1,077
377
Disposal
High-End
889
1,212
379
39,024
53,215
16,618
869
1,185
371
ONU
Central
Tendency
889
1,212
424
39,024
53,215
18,630
869
1,185
415
Page 158 of 269
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4.3.3 Risk Estimates for Consumers
Table 4-18 summarizes the dermal, inhalation, ingestion, and aggregate MOEs used to characterize non-
cancer risk for acute, intermediate, and chronic exposure to DINP and presents these values for all
lifestages for each COU. A screening level assessment for consumers considers high-intensity exposure
scenarios risk estimates and it relies on conservative assumptions to assess exposures that would be
expected to be on the high-end of the expected exposure distribution. Using the high-intensity risk
estimates will assist in developing health protective approaches. MOEs for high-intensity exposure
scenarios are shown for all consumer COUs, while MOEs for medium-intensity exposure scenarios are
shown only for COUs with high-intensity MOEs close to the benchmark of 30 {i.e., Construction, paint,
electrical, and metal products: Adhesives and sealants; Furnishing, cleaning, treatment/care products:
Floor coverings/Plasticizer in construction and building materials covering large surface areas including
stone, plaster, cement, glass, and ceramic articles; fabrics, textiles and apparel (vinyl tiles, resilient
flooring, PVC-backed carpeting); Furnishing, cleaning, treatment/care products: Furniture and
furnishings (furniture and furnishings including plastic articles [soft]); leather articles. Table 4-18 also
provides MOEs for the modeling indoor exposure assessment.
The main objective in reconstructing the indoor environment using consumer products and articles
commonly present in indoor spaces is to calculate exposure and risk estimates by COU, and by product
and article from indoor dust ingestion and inhalation. EPA identified article-specific information by
COU to construct relevant and representative exposure scenarios. Exposure to DINP via ingestion of
dust was assessed for all articles expected to contribute significantly to dust concentrations due to high
surface area (exceeding ~1 m2) for either a single article or collection of like articles as appropriate.
Articles included in the indoor environment assessment included: carpet backing, vinyl flooring,
specialty wall coverings, foam cushions, indoor furniture, car mats, sports mats, wallpaper, synthetic
leather furniture, shower curtains, children's toys, both legacy and new, and wire insulation. COUs
associated with articles included in the indoor environment assessment are indicated with "**" in Table
4-18.
Of note, the risk summary below is based on the most sensitive non-cancer endpoint for all relevant
duration scenarios {i.e., developmental toxicity for acute and intermediate durations; liver toxicity for
the chronic duration). MOEs for all high-, medium- and low-intensity exposure scenarios for all COUs
are described in the Consumer Risk Calculator for Diisononyl Phthalate (DINP) ( 325d).
COUs with MOEs for High-Intensity Exposure Scenarios Ranging from 37 to 44,000,000,000
All consumer COUs and product/article examples, except for roofing adhesives, carpet backing, vinyl
flooring, in-place wallpaper, and indoor furniture (discussed more below), resulted in MOEs for high-
intensity exposure scenarios ranging from 37 for chronic aggregate exposure to DINP from legacy
children's toys for infants (less than one) to 44,000,000,000 for acute duration ingestion of suspended
dust from foam cushions for adults (21+ years) (Table 4-18). Variability in MOEs for these high-
intensity exposure scenarios results from use of different exposure factors for each COU and
product/article example that led to different estimates of exposure to DINP. Additional variability in
MOEs resulting from acute/intermediate exposures and chronic exposures results from use of a POD of
12 mg/kg-day (developmental toxicity) for acute and intermediate durations and a POD of 3.5 mg/kg-
day liver toxicity) for chronic durations. As described in the Consumer and Indoor Exposure Assessment
for Diisononyl Phthalate (DINP) ( 25b) and Non-cancer Human Health Hazard Assessment
for Diisononyl Phthalate (DINP) ( 25u), EPA has moderate to robust confidence in the
exposure estimates and robust confidence in the non-cancer hazard value used to estimate non-cancer
risk for these COUs.
Page 159 of 269
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Construction, Paint, Electrical, and Metal Products: Adhesives and Sealants
Six different product scenarios were assessed under this COU for products with differing use patterns.
For example, adhesives for small repairs, adhesive foams, automotive adhesives, and caulking
compounds all are used indoors, while polyurethane injection resin and roofing adhesives are used
outdoors. Outdoor uses inhalation exposure is not expected to be significant due to a combination of
small surface area, amount of product used, weight fraction, and large ventilation rate, however, for
roofing adhesives the expected surface area, amount of product used, and weight fraction are
significantly larger than other adhesives. Thus, EPA assessed inhalation exposures. Of the six product
scenarios assessed for this COU, only use of roofing adhesives resulted in MOEs less than 30. Roofing
adhesives chronic high-intensity use exposure route assessment for dermal and inhalation resulted in
MOEs of 47 to 52 and 41 to 61, respectively, for users aged 11 years to adults (21+ years), while high-
intensity chronic aggregate MOEs ranged from 22 to 27 for users aged 11 years to adults (21+ years).
MOEs for chronic medium-intensity roofing adhesive use scenarios for dermal and inhalation exposure
routes were 190 to 210 and 69 to 100, respectively, for users aged 11 years to adults (21+ years), while
aggregate MOEs ranged from 51 to 66 for users aged 11 years to adults (21+ years).
For the high-intensity scenario, inhalation and dermal exposure routes contribute equally to aggregate
risk indicating that for higher weight fraction roofing adhesive products used chronically for long
duration projects, 8 hours or longer, and relatively high amounts of the product can be used in that
duration, 18,000 g/event, there is a possibility of health risks from dermal and inhalation exposures.
However, it is noteworthy that the chronic duration modeling effort used an extremely conservative
events per year input, 365 events per year, in the screening assessment approach, for both high and
medium intensity use scenarios while all other inputs are considered representative. Because of this
extremely conservative input for events per year for the chronic duration estimate, EPA assigned a
moderate confidence in the overall estimate and recommends the consideration of the high and medium
intensity use scenario MOEs. Although one extreme and unlikely high intensity use scenario exceeded
the MOE benchmark, the medium intensity use scenario did not exceed the MOE benchmark. Further
refinement of the high and medium intensity use scenario with a smaller events per year input would
result in MOEs similar or higher to those in the medium and low intensity use scenarios that were not in
exceedance of the benchmark.
The six assessed exposure scenarios and the products within capture the high variability in adhesive
product formulation and are represented in the high, medium, and low intensity use estimates. The
overall confidence in this COU inhalation exposure estimate is robust for all adhesives except roofing
adhesives because the CEM default parameters are representative of actual use patterns and location of
use. Roofing adhesives inhalation estimates were assigned a moderate overall confidence because the
events per year input was extremely conservative and unlikely to be representative of actual uses. For
dermal exposure EPA used a dermal flux approach, which was estimated based on DINP in vivo dermal
absorption in rats. An overall moderate confidence in dermal assessment of adhesives was assigned.
Uncertainties about the difference between human and rat skin absorption increase uncertainty.
However, other parameters like frequency and duration of use, and surface area in contact are well
understood and representative.
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Furnishing, Cleaning, Treatment/Care Products: Floor Coverings/Plasticizer in Construction and
Building Materials Covering Large Surface Areas Including Stone, Plaster, Cement, Glass, and
Ceramic Articles; Fabrics, Textiles, and Apparel (Vinyl Tiles, Resilient Flooring, PVC-Backed
Carpeting)
Six different scenarios were assessed under this COU for various articles with differing use patterns for
which each scenario had varying number of identified article examples (in parenthesis): carpet backing
(3), flooring vinyl tiles (4), specialty wall coverings (both in-place and installation) (3), wallpaper (both
in-place and installation) (1). All these scenarios, except installation scenarios, mimic the presence of
these articles in indoor environments ranging from low- to high-intensity uses based on the surface area
in indoor environments, in addition to weight fraction ranges identified. Of the scenarios evaluated,
carpet backing, vinyl tiles, and in-place wallpaper had chronic MOEs less than 30, indicating possible
chronic risks to consumers. Chronic high-intensity dermal and ingestion MOEs range from 88,000 to
580,000 and 140 to 3,300, respectively, for carpet backing, vinyl tiles, and in-place wallpaper—
indicating little potential for dermal or ingestion risk for either exposure route alone. Chronic high and
medium- intensity inhalation MOEs for all three articles range from 17 to 29 and 31 to 46, respectively,
for infants and toddlers (2 years) for carpet backing, and for infants to preschoolers (5 years) for vinyl
flooring tiles and wallpaper. The MOE values increase with increasing age due to changes in inhalation
rate to body weight ratios; thus, leading to decreasing exposure with increasing lifestage age.
Aggregate risk from dermal, ingestion, and inhalation exposures to DINP for all three articles was also
considered. Inhalation exposure was the primary contributor to aggregate risk for all three articles, while
exposure through ingestion was a minor contributor to aggregate risk {i.e., aggregate MOEs were 1-3
units less than the MOEs for inhalation route alone for high-intensity scenarios) and the contribution of
dermal exposure to aggregate risk estimates was negligible. Chronic high- and medium-intensity
aggregate MOEs for the carpet backing scenario ranged from 25 to 30 and 36 to 44, respectively, for
infants to preschoolers (5 years). Similarly, chronic high- and medium-intensity aggregate MOEs ranged
from 16 to 30 and 29 to 54, respectively, for infants to children aged 6 to 10 years for the vinyl flooring
scenario, and 16 to 29 and 32 to 62, respectively, for infants to children aged 6 to 10 years for the in-
place wallpaper scenario. The difference in MOEs between carpet backing and vinyl flooring tiles and
wallpaper scenarios is mainly driven by weight fractions. Carpet backing weight fractions for the high
intensity use scenario was 16 percent while vinyl flooring was 25 percent and wallpaper was 26 percent.
The difference among these three articles high to medium intensity use scenarios is driven by surface
area, 200 to 100 m2 from high- to medium-intensity use scenario, as well as weight fraction.
In these article inhalation scenarios DINP is released into the gas-phase, the article inhalation scenario
tracks chemical transport between the source, air, airborne and settled particles, and indoor sinks by
accounting for emissions, mixing within the gas phase, transfer to particulates by partitioning, removal
due to ventilation, removal due to cleaning of settled particulates and dust to which DINP has
partitioned, and sorption or desorption to/from interior surfaces. The emissions from the wallpaper were
modeled with a single exponential decay model. This means that chronic and acute exposure duration
scenario uses the same emissions/air concentration data based on the weight fraction but have different
averaging times for the air concentration used. The acute data uses concentrations for a 24-hour period
at the peak, while the chronic data was averaged over the entire 1-year period. Because air
concentrations for most of the year are significantly lower than the peak value, the air concentration
used in chronic dose calculations is lower than acute. The overall confidence in this COU inhalation and
dust ingestion exposure estimate is robust because the CEM default parameters represent actual use
patterns and location of use, and the estimated surface area is well characterized and represents a wide
range of plausible uses.
Page 161 of 269
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Indoor Dust
Exposure to DINP via ingestion of dust was assessed for all articles expected to contribute significantly
to dust concentrations due to high surface area (exceeding ~1 m2) for either a single article or collection
of like articles as appropriate, including wallpaper, specialty wall coverings, wire insulation, foam
cushions, solid vinyl flooring tiles, carpet backing tiles, indoor furniture, car mats, shower curtains,
sporting mats, and children's toys, both legacy and new. In a screening assessment, EPA considered the
aggregation of chronic dust ingestion doses, see Section 4.1.2.4. The highest dose from Table 4-8 was
for preschoolers, aged 3 to 5 years and resulted in an MOE of 81. Furthermore, by aggregating all indoor
articles in the previous list, see Consumer Risk Calculator for DiisononylPhthalate (DINP) (U.S. EPA.
2025d), the highest aggregated dose was for preschoolers aged 3 to 5 years, and the MOE for that dose
was 43. All other doses were lower and would have resulted in larger MOEs.
4.3.3.1 Overall Confidence in Consumer Risks
As described in Section 4.1.2 and in more technical details in the Consumer and Indoor Exposure
Assessment for Diisononyl Phthalate (DINP) ( 025b). EPA has moderate and robust
confidence in the assessed inhalation, ingestion, and dermal consumer exposure scenarios. The exposure
doses used to estimate risk relied on conservative, health-protective inputs and parameters that are
considered representative of a wide selection of use patterns. Sources of uncertainty associated with the
three consumer COUs with MOEs less than 30 are discussed above in Section 4.3.3. As discussed above
in Section 4.3.3, EPA calculated chronic MOEs less than 30 for infants (<1 year), toddlers (1-2 years),
preschoolers (3-5 years) and middle aged children (6-10 years) for three consumer COUs—but did not
calculate any chronic MOEs less than 30 for young teens (11-15 years), teenagers (16-20 years) or
adults (21+ years). Although EPA has robust confidence in the chronic non-cancer POD selected to
characterize risk from chronic duration exposure to DINP, EPA considers the selected chronic POD to
be most directly applicable to male and female adult consumers (Section 4.2.2). Use of the chronic POD
for assessing risk to infants and children may be conservative and may not be relevant. The chronic POD
is based on liver effects dependent and independent of PPARa activation.
As discussed in EPA's Cancer Human Health Hazard Assessment for Diisononyl Phthalate (DINP)
( 2025a). there is evidence to suggest humans are less sensitive than rats to liver effects
associated with PPARa activation, while the PPARa-independent effects {i.e., spongiosis hepatis) are
most prevalent in the livers of aging rats. As discussed further in Appendix I of the of the Non-cancer
Human Health Hazard Assessment for Diisononyl Phthalate (DINP) ( Z5u). EPA
considered several other PODs more directly applicable for assessing chronic risk to the infant and child
lifestages based on developmental effects. This includes the acute/intermediate POD of 12 mg/kg-day
based on reduced fetal testicular testosterone and a POD of 15 mg/kg-day (derived from a BMDLs of 65
mg/kg-day for reduced offspring body weight in a two-generation study of reproduction), which was the
most sensitive candidate chronic POD considered for DINP that is more directly applicable to infants
and children. As can be seen from Table 4-18, use of the more sensitive acute/intermediate POD of 12
mg/kg-day to calculate chronic risks from exposure to DINP for infants and children would result in
MOEs of 53 or higher for all consumer exposure scenarios discussed above in Section 4.3.3.
Page 162 of 269
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Table 4-18. Consumer Risk Summary Table
Lite Cycle Stage:
COU: Subcategory
Product or
Article
Duration
Exposure
Route
Exposure
Scenario
(H, M, L) a
Lifestage (years)
(Benchmark MOE = 30)
Infant
(<1 Year)
Toddler
(1-2 Years)
Preschooler
(3-5 years)
Middle
Childhood
(6-10 years)
Young
Teen
(11-15 years)
Teenagers
(16-20 years)
Adults
(21+years)
Consumer Uses:
Other uses:
Automotive articles
Car Mats
(** - Part of
indoor
exposure
scenario)
Acute
Dermal
H
-
-
-
-
4,500,000
5,000,000
4,600,000
Ingestion**
H
710,000
590,000
530,000
1,400,000
2,500,000
3,100,000
6,200,000
Inhalation**
H
28,000
30,000
37,000
53,000
75,000
87,000
110,000
Aggregate
H
27,000
29,000
35,000
51,000
72,000
83,000
110,000
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
-
-
-
-
9,300,000
10,000,000
9,500,000
Ingestion**
H
240,000
200,000
180,000
480,000
830,000
1,000,000
2,100,000
Inhalation**
H
9,600
10,000
12,000
18,000
25,000
30,000
37,000
Aggregate
H
9,200
9,500
11,000
17,000
24,000
29,000
36,000
Consumer Uses:
Construction, paint,
electrical, and metal
products: Adhesives
and sealants
Adhesive Foam
(f = MOE for
bystander
scenario)
Acute
Dermal
H
-
-
-
-
160
180
170
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
f 61,000
f65,000
f80,000
f 110,000
78,000
100,000
110,000
Aggregate
H
-
-
-
-
160
180
170
Intermed.
Dermal
H
-
-
-
-
4,900
5,300
5,000
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
f 1,800,000
f2,000,000
f2,400,000
f3,400,000
2,300,000
3,000,000
3,400,000
Aggregate
H
-
-
-
-
4,900
5,300
5,000
Chronic
-
-
-
-
-
-
-
-
-
Consumer Uses:
Construction, paint,
electrical, and metal
products: Adhesives
and sealants
Adhesives for
Small Repairs
Acute
Dermal
H
-
-
-
-
6,500
7,100
6,600
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
-
-
-
-
-
-
-
Intermed.
Dermal
H
-
-
-
-
190,000
210,000
200,000
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
-
-
-
-
-
-
-
Chronic
-
-
-
-
-
-
-
-
-
Consumer Uses:
Construction, paint,
electrical, and metal
products: Adhesives
and sealants
Automotive
Adhesives
(f = MOE for
bystander
scenario)
Acute
Dermal
H
-
-
-
-
3,200
3,500
3,300
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
f 17,000
f 18,000
f23,000
f33,000
39,000
47,000
57,000
Aggregate
H
-
-
-
-
3,000
3,300
3,100
Intermed.
Dermal
H
-
-
-
-
97,000
110,000
100,000
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
f520,000
f550,000
f680,000
f980,000
1,200,000
1,400,000
1,700,000
Aggregate
H
-
-
-
-
90,000
102,000
94,000
Chronic
-
-
-
-
-
-
-
-
-
Page 163 of 269
-------
Lite Cycle Stage:
COU: Subcategory
Product or
Article
Duration
Exposure
Route
Exposure
Scenario
(H, M, L) "
Lifestage (years)
(Benchmark MOE = 30)
Infant
(<1 Year)
Toddler
(1-2 Years)
Preschooler
(3-5 years)
Middle
Childhood
(6-10 years)
Young
Teen
(11-15 years)
Teenagers
(16-20 years)
Adults
(21+years)
Consumer Uses:
Construction, paint,
electrical, and metal
products: Adhesives
and sealants
Caulking
Compounds
(f " MOE for
bystander
scenario)
Acute
Dermal
H
-
-
-
-
6,500
7,100
6,600
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
f50,000
f53,000
f65,000
f93,000
130,000
150,000
180,000
Aggregate
H
-
-
-
-
6,200
6,800
6,400
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
-
-
-
-
13,000
15,000
14,000
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
f860
f910
f 1,100
f 1,600
1,900
2,300
2,800
Aggregate
H
-
-
-
-
1,700
2,000
2,300
Consumer Uses:
Construction, paint,
electrical, and metal
products: Adhesives
and sealants
Polyurethane
Injection Resin
Acute
Dermal
H
-
-
-
-
160
180
170
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
-
-
-
-
-
-
-
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
-
-
-
-
47
52
48
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
-
-
-
-
-
-
-
Consumer Uses:
Construction, paint,
electrical, and metal
products: Adhesives
and sealants
Roofing
Adhesives
(f = MOE for
bystander
scenario)
Acute
Dermal
H
-
-
-
-
160
180
170
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
f26,000
f28,000
f34,000
f42,000
14,000
19,000
21,000
Aggregate
H
-
-
-
-
160
180
170
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
-
-
-
-
47
52
48
M
-
-
-
-
190
210
190
Ingestion
H
-
-
-
-
-
-
-
M
-
-
-
-
-
-
-
Inhalation
H
f 130
f 130
f 170
f200
41
56
61
M
f 130
f 130
f 170
f240
69
92
100
Aggregate
H
-
-
-
-
22
27
27
M
-
-
-
-
51
64
66
Page 164 of 269
-------
Lite Cycle Stage:
COU: Subcategory
Product or
Article
Duration
Exposure
Route
Exposure
Scenario
(H, M, L) "
Lifestage (years)
(Benchmark MOE = 30)
Infant
(<1 Year)
Toddler
(1-2 Years)
Preschooler
(3-5 years)
Middle
Childhood
(6-10 years)
Young
Teen
(11-15 years)
Teenagers
(16-20 years)
Adults
(21+years)
Consumer Uses:
Construction, paint,
electrical, and metal
products: Building
construction
materials (wire and
cable jacketing, wall
coverings, roofing,
pool applications,
water supply piping,
etc.)
Roofing
Membrane
Acute
Dermal
H
-
-
-
-
80,000
88,000
82,000
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
-
-
-
-
-
-
-
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
-
-
-
-
-
-
-
-
-
Consumer Uses:
Construction, paint,
electrical, and metal
products: Building
construction
materials (wire and
cable jacketing, wall
coverings, roofing,
pool applications,
water supply piping,
etc.)
PVC pipes
Acute
Dermal
H
75,000
88,000
100,000
130,000
160,000
180,000
160,000
Ingestion
H
Scenario was assessed for drinking water ingestion in Section 6 in the Environmental Media and General
Population Exposure for DiisononvlPhthalates (DINP), (U.S. EPA, 2025q) technical support document
Inhalation
H
-
-
-
-
-
-
-
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
22,000
26,000
30,000
37,000
47,000
51,000
48,000
Ingestion
H
Scenario was assessed for drinking water ingestion in Section 6 in the Environmental Media and General
Population Exposure for Diisononvl Phthalates (DINP), (U.S. EPA, 202 5q) technical support document
Inhalation
H
-
-
-
-
-
-
-
Consumer Uses:
Construction, paint,
electrical, and metal
products: Electrical
and electronic
products
Wire Insulation
(** - Part of
indoor
exposure
scenario)
Acute
Dermal
H
850,000
1,000,000
1,200,000
1,400,000
1,800,000
2,000,000
1,900,000
Ingestion**
H
500
820
1,200
32,000
57,000
72,000
160,000
Inhalation**
H
1,400
1,500
1,900
2,700
3,800
4,500
5,500
Aggregate
H
370
530
740
2,500
3,600
4,200
5,300
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
250,000
290,000
340,000
420,000
530,000
580,000
540,000
Ingestion**
H
150
240
360
11,000
19,000
24,000
53,000
Inhalation**
H
470
500
610
880
1,200
1,500
1,800
Aggregate
H
110
160
230
810
1,100
1,400
1,700
Page 165 of 269
-------
Lite Cycle Stage:
COU: Subcategory
Product or
Article
Duration
Exposure
Route
Exposure
Scenario
(H, M, L) "
Lifestage (years)
(Benchmark MOE = 30)
Infant
(<1 Year)
Toddler
(1-2 Years)
Preschooler
(3-5 years)
Middle
Childhood
(6-10 years)
Young
Teen
(11-15 years)
Teenagers
(16-20 years)
Adults
(21+years)
Consumer Uses:
Construction, paint,
electrical, and metal
products: Paints and
coatings
Paint/Lacquer
(Large Project)
(f " MOE for
bystander
scenario)
Acute
Dermal
H
-
-
-
-
78,000
85,000
80,000
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
f26,000
f28,000
f34,000
f42,000
14,000
19,000
21,000
Aggregate
H
-
-
-
-
12,000
16,000
17,000
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
-
-
-
-
23,000
25,000
23,000
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
f650
f690
f850
f 1,000
210
280
310
Aggregate
H
-
-
-
-
210
280
310
Consumer Uses:
Construction, paint,
electrical, and metal
products: Paints and
coatings
Paint/Lacquer
(Small Project)
(f " MOE for
bystander
scenario)
Acute
Dermal
H
-
-
-
-
650
710
660
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
f 10,000
f 11,000
f 13,000
f 19,000
18,000
23,000
27,000
Aggregate
H
-
-
-
-
630
690
640
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
-
-
-
-
1,300
1,500
1,400
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
f270
f290
f350
f500
520
640
760
Aggregate
H
-
-
-
-
370
450
490
Consumer Uses:
Furnishing, cleaning,
treatment/care
products: Air care
products
Scented Oil
Acute
Dermal
H
-
-
410
510
650
710
660
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
-
-
-
-
-
-
-
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
-
-
-
-
1,300
1,500
1,400
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
-
-
-
-
-
-
-
Consumer Uses:
Furnishing, cleaning,
treatment/care
products: Fabric,
textile, and leather
products (apparel
and footwear care
products)
Clothing
Acute
Dermal
H
1,000
1,100
1,200
1,500
1,800
2,000
2,100
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
-
-
-
-
-
-
-
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
2,000
2,300
2,500
3,100
3,700
4,000
4,200
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
-
-
-
-
-
-
-
Page 166 of 269
-------
Lite Cycle Stage:
COU: Subcategory
Product or
Article
Duration
Exposure
Route
Exposure
Scenario
(H, M, L) "
Lifestage (years)
(Benchmark MOE = 30)
Infant
(<1 Year)
Toddler
(1-2 Years)
Preschooler
(3-5 years)
Middle
Childhood
(6-10 years)
Young
Teen
(11-15 years)
Teenagers
(16-20 years)
Adults
(21+years)
Consumer Uses:
Furnishing, cleaning,
treatment/care
products: Floor
coverings/Plasticizer
in construction and
building materials
covering large
surface areas
including stone,
plaster, cement,
glass, and ceramic
articles; fabrics,
textiles and apparel
(vinyl tiles, resilient
flooring, PVC-
backed carpeting)
Carpet Backing
(** - Part of
indoor
exposure
scenario)
Acute
Dermal
H
300,000
350,000
410,000
510,000
640,000
700,000
660,000
M
850,000
1,000,000
1,200,000
1,400,000
1,800,000
2,000,000
1,900,000
Ingestion**
H
960
780
690
2,000
3,500
4,400
9,900
M
1,400
1,100
1,000
2,900
5,100
6,400
14,000
Inhalation**
H
82
87
110
150
220
250
320
M
120
130
160
220
320
370
460
Aggregate
H
76
78
95
140
210
240
310
M
110
120
140
200
300
350
450
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
88,000
100,000
120,000
150,000
190,000
200,000
190,000
M
250,000
290,000
340,000
420,000
530,000
580,000
540,000
Ingestion**
H
320
260
230
650
1,200
1,500
3,300
M
470
380
330
950
1,700
2,100
4,800
Inhalation**
H
27 (92)4
29 (98)4
35 (120)4
50
72
84
100
M
39
42
51
73
100
120
150
Aggregate
H
25 (85)4
26 (88)4
30 (104)4
46
68
80
97
M
36 (124)4
38
44
68
94
110
150
Consumer Uses:
Furnishing, cleaning,
treatment/care
products: Floor
coverings/Plasticizer
in construction and
building materials
covering large
surface areas
including stone,
plaster, cement,
glass, and ceramic
articles; fabrics,
textiles and apparel
(vinyl tiles, resilient
flooring, PVC-
backed carpeting)
Specialty Wall
Coverings (In-
Place)
(** = Part of
indoor
exposure
scenario)
Acute
Dermal
H
850,000
1,000,000
1,200,000
1,400,000
1,800,000
2,000,000
1,900,000
Ingestion**
H
2,100
1,700
1,500
4,200
7,500
9,500
21,000
Inhalation**
H
180
190
230
330
470
550
690
Aggregate
H
170
170
200
310
440
520
670
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
250,000
290,000
340,000
420,000
530,000
580,000
540,000
Ingestion**
H
690
560
490
1,400
2,500
3,200
7,100
Inhalation**
H
58
62
76
110
150
180
230
Aggregate
H
53
56
66
100
140
170
220
Page 167 of 269
-------
Lite Cycle Stage:
COU: Subcategory
Product or
Article
Duration
Exposure
Route
Exposure
Scenario
(H, M, L) "
Lifestage (years)
(Benchmark MOE = 30)
Infant
(<1 Year)
Toddler
(1-2 Years)
Preschooler
(3-5 years)
Middle
Childhood
(6-10 years)
Young
Teen
(11-15 years)
Teenagers
(16-20 years)
Adults
(21+years)
Consumer Uses:
Furnishing, cleaning,
treatment/care
products: Floor
coverings/plasticizer
in construction and
building materials
covering large
surface areas
including stone,
plaster, cement,
glass, and ceramic
articles; fabrics,
textiles and apparel
(vinyl tiles, resilient
flooring, PVC-
backed carpeting)
Specialty Wall
Coverings
(Installation)
Acute
Dermal
H
-
-
-
-
-
-
-
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
-
-
-
-
-
-
-
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
-
-
-
-
-
-
-
-
-
Consumer Uses:
Furnishing, cleaning,
treatment/care
products: Floor
coverings/plasticizer
in construction and
building materials
covering large
surface areas
including stone,
plaster, cement,
glass, and ceramic
articles; fabrics,
textiles and apparel
(vinyl tiles, resilient
flooring, PVC-
backed carpeting)
Vinyl Flooring
(** - Part of
indoor
exposure
scenario)
Acute
Dermal
H
300,000
350,000
410,000
510,000
640,000
700,000
660,000
M
850,000
1,000,000
1,200,000
1,400,000
1,800,000
2,000,000
1,900,000
Ingestion**
H
620
500
440
1,300
2,200
2,800
6,300
M
1,100
890
790
2,200
4,000
5,000
11,000
Inhalation**
H
53
56
69
98
140
160
200
M
94
99
120
180
250
290
360
Aggregate
H
49
50
60
91
130
150
190
M
87
89
100
170
240
270
350
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
88,000
100,000
120,000
150,000
190,000
200,000
190,000
M
250,000
290,000
340,000
420,000
530,000
580,000
540,000
Ingestion**
H
200
170
150
420
750
940
2,100
M
370
290
260
740
1,300
1,700
3,700
Inhalation**
H
17 (59)4
18 (63)4
22 (77)4
32 (111)4
46
53
67
M
31
33
40
58
82
95
120
Aggregate
H
16 (54)4
16 (56)4
19 (67)4
30 (103)4
43
50
65
M
29 (97)4
30 (101)4
35 (119)4
54
77
90
120
Page 168 of 269
-------
Lite Cycle Stage:
COU: Subcategory
Product or
Article
Duration
Exposure
Route
Exposure
Scenario
(H, M, L) "
Lifestage (years)
(Benchmark MOE = 30)
Infant
(<1 Year)
Toddler
(1-2 Years)
Preschooler
(3-5 years)
Middle
Childhood
(6-10 years)
Young
Teen
(11-15 years)
Teenagers
(16-20 years)
Adults
(21+years)
Consumer Uses:
Furnishing, cleaning,
treatment/care
products: Floor
coverings/plasticizer
in construction and
building materials
covering large
surface areas
including stone,
plaster, cement,
glass, and ceramic
articles; fabrics,
textiles and apparel
(vinyl tiles, resilient
flooring, PVC-
backed carpeting)
Wallpaper (in-
place)
(** = Part of
indoor
exposure
scenario)
Acute
Dermal
H
850,000
1,000,000
1,200,000
1,400,000
1,800,000
2,000,000
1,900,000
M
2,400,000
2,800,000
3,300,000
4,100,000
5,100,000
5,600,000
5,200,000
Ingestion**
H
600
480
430
1,200
2,200
2,700
6,100
M
1,300
1,000
910
2,600
4,600
5,800
13,000
Inhalation**
H
51
54
67
96
140
160
200
M
110
110
140
200
290
340
420
Aggregate
H
47
49
58
89
130
150
190
M
100
99
120
190
270
320
410
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
250,000
290,000
340,000
420,000
530,000
580,000
540,000
M
700,000
820,000
950,000
1,200,000
1,500,000
1,600,000
1,500,000
Ingestion**
H
200
160
140
410
720
910
2,000
M
420
340
300
860
1,500
1,900
4,300
Inhalation**
H
17 (57)4
18 (61)4
22 (75)4
31 (108)4
44
52
65
M
35 (122)4
38
46
67
94
110
140
Aggregate
H
16 (53)4
16 (55)4
19 (65)4
29 (100)4
41
49
63
M
32 (112)4
34 (116)4
40
62
88
100
140
Consumer Uses:
Furnishing, cleaning,
treatment/care
products: Floor
coverings/plasticizer
in construction and
building materials
covering large
surface areas
including stone,
plaster, cement,
glass, and ceramic
articles; fabrics,
textiles and apparel
(vinyl tiles, resilient
flooring, PVC-
backed carpeting)
Wallpaper
(Installation)
Acute
Dermal
H
-
-
-
-
40,000
44,000
41,000
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
-
-
-
-
-
-
-
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
-
-
-
-
-
-
-
-
Page 169 of 269
-------
Lite Cycle Stage:
COU: Subcategory
Product or
Article
Duration
Exposure
Route
Exposure
Scenario
(H, M, L) "
Lifestage (years)
(Benchmark MOE = 30)
Infant
(<1 Year)
Toddler
(1-2 Years)
Preschooler
(3-5 years)
Middle
Childhood
(6-10 years)
Young
Teen
(11-15 years)
Teenagers
(16-20 years)
Adults
(21+years)
Consumer Uses:
Furnishing, cleaning,
treatment/care
products: Foam
seating and bedding
products; furniture
and furnishings
(furniture and
furnishings
including plastic
articles (soft);
leather articles)
Foam Cushions
(** = Part of
indoor
exposure
scenario)
Acute
Dermal
H
1,000
1,100
1,200
1,500
1,800
2,000
2,100
Ingestion**
H
100,000,000
110,000,000
130,000,000
190,000,000
270,000,000
320,000,000
400,000,000
Inhalation**
H
-
-
-
-
-
-
-
Aggregate
H
1,000
1,100
1,200
1,500
1,800
2,000
2,100
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
290
330
360
440
530
580
600
Ingestion**
H
34,000,000
36,000,000
44,000,000
64,000,000
90,000,000
110,000,000
130,000,000
Inhalation**
H
-
-
-
-
-
-
-
Aggregate
H
290
330
360
440
530
580
600
Consumer Uses:
Furnishing, cleaning,
treatment/care
products: Foam
seating and bedding
products; furniture
and furnishings
(furniture and
furnishings
including plastic
articles [soft];
leather articles)
Indoor
Furniture
(** = Part of
indoor
exposure
scenario)
Acute
Dermal
H
1,000
1,100
1,200
1,500
1,800
2,000
2,100
M
8,800
21,000
26,000
34,000
44,000
48,000
46,000
Ingestion**
H
440
660
860
6,500
12,000
15,000
33,000
M
2,000
2,300
2,900
14,000
25,000
32,000
71,000
Inhalation**
H
150
160
190
270
390
450
560
M
310
330
410
590
840
980
1,200
Aggregate
H
101
115
138
221
312
359
436
M
260
285
354
557
798
932
1,151
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
290
330
360
440
530
580
600
M
2,600
6,000
7,600
9,900
13,000
14,000
13,000
Ingestion**
H
130
200
260
2,200
3,900
4,900
11,000
M
620
720
910
4,700
8,300
11,000
23,000
Inhalation**
H
48
51
63
90
130
150
190
M
100
110
130
190
270
320
400
Aggregate
H
31 (107)4
36 (123)4
44
72
102
116
142
M
83
94
112
179
256
304
382
Page 170 of 269
-------
Lite Cycle Stage:
COU: Subcategory
Product or
Article
Duration
Exposure
Route
Exposure
Scenario
(H, M, L) "
Lifestage (years)
(Benchmark MOE = 30)
Infant
(<1 Year)
Toddler
(1-2 Years)
Preschooler
(3-5 years)
Middle
Childhood
(6-10 years)
Young
Teen
(11-15 years)
Teenagers
(16-20 years)
Adults
(21+years)
Consumer Uses:
Furnishing, cleaning,
treatment/care
products: Foam
seating and bedding
products; furniture
and furnishings
(furniture and
furnishings
including plastic
articles [soft];
leather articles)
Outdoor
Furniture
Acute
Dermal
H
8,000
9,000
9,900
12,000
15,000
16,000
17,000
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
-
-
-
-
-
-
-
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
4,100
4,600
5,100
6,100
7,400
8,100
8,500
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
Consumer Uses:
Furnishing, cleaning,
treatment/care
products: Foam
seating and bedding
products; furniture
and furnishings
(furniture and
furnishings
including plastic
articles [soft];
leather articles)
Truck Awning
Acute
Dermal
H
-
-
-
-
910,000
990,000
930,000
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
-
-
-
-
-
-
-
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
-
-
-
-
1,900,000
2,000,000
1,900,000
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
Consumer Uses:
Packaging, paper,
plastic, hobby
products: Arts,
crafts, and hobby
materials
Crafting Resin
Acute
Dermal
H
-
-
-
-
650
710
660
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
9,100
9,700
12,000
17,000
16,000
20,000
24,000
Aggregate
H
-
-
-
-
630
690
640
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
-
-
-
-
1,300
1,500
1,400
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
190
200
240
350
370
450
540
Aggregate
H
-
-
-
-
290
350
390
Page 171 of 269
-------
Lifestage (years)
Lite Cycle Stage:
COU: Subcategory
Product or
Article
Exposure
Route
Exposure
(Benchmark MOE
= 30)
Duration
Scenario
(H, M, L) "
Infant
(<1 Year)
Toddler
(1-2 Years)
Preschooler
(3-5 years)
Middle
Childhood
(6-10 years)
Young
Teen
(11-15 years)
Teenagers
(16-20 years)
Adults
(21+years)
Dermal
H
430,000
500,000
580,000
720,000
910,000
990,000
930,000
Acute
Ingestion
H
-
-
1,400
2,300
-
-
-
Consumer Uses:
Inhalation
H
-
-
-
-
-
-
-
Packaging, paper,
plastic, hobby
products: Arts,
crafts, and hobby
materials
Aggregate
H
-
-
1,400
2,300
-
-
-
Rubber Eraser
Intermed.
-
-
-
-
-
-
-
-
-
Dermal
H
120,000
150,000
170,000
210,000
260,000
290,000
270,000
Chronic
Ingestion
H
-
-
400
680
-
-
-
Inhalation
H
-
-
-
-
-
-
-
Aggregate
H
-
-
400
680
-
-
-
Dermal
H
75,000
88,000
100,000
130,000
160,000
180,000
160,000
Consumer Uses:
Small Articles
with Potential
for semi-
routine contact
Acute
Ingestion
H
-
-
-
-
-
-
-
Packaging, paper,
plastic, hobby
products: Arts,
crafts, and hobby
materials
Inhalation
H
-
-
-
-
-
-
-
Intermed.
-
-
-
-
-
-
-
-
-
Dermal
H
22,000
26,000
30,000
37,000
47,000
51,000
48,000
Chronic
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
-
-
-
-
-
-
-
Consumer Uses:
Packaging, paper,
plastic, hobby
products: Ink, toner,
and colorant
Current products were not identified. Foreseeable uses were matched with the lacquers, and paints (small projects) because similar use patterns are expected.
products
Page 172 of 269
-------
Lite Cycle Stage:
COU: Subcategory
Product or
Article
Duration
Exposure
Route
Exposure
Scenario
(H, M, L) "
Lifestage (years)
(Benchmark MOE = 30)
Infant
(<1 Year)
Toddler
(1-2 Years)
Preschooler
(3-5 years)
Middle
Childhood
(6-10 years)
Young
Teen
(11-15 years)
Teenagers
(16-20 years)
Adults
(21+years)
Consumer Uses:
Packaging, paper,
plastic, hobby
products: Other
articles with routine
direct contact during
normal use including
rubber articles;
plastic articles
(hard); vinyl tape;
flexible tubes;
profiles; hoses
Shower Curtain
(** = Part of
indoor
exposure
scenario)
Acute
Dermal
H
850,000
1,000,000
1,200,000
1,400,000
1,800,000
2,000,000
1,900,000
Ingestion**
H
33,000
27,000
24,000
68,000
120,000
150,000
340,000
Inhalation**
H
1,000
1,100
1,300
1,900
2,700
3,100
3,900
Aggregate
H
970
1,100
1,200
1,800
2,600
3,000
3,800
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
250,000
290,000
340,000
420,000
530,000
580,000
540,000
Ingestion**
H
11,000
9,000
7,900
23,000
40,000
51,000
110,000
Inhalation**
H
330
350
430
620
880
1,000
1,300
Aggregate
H
320
340
410
600
860
980
1,300
Consumer Uses:
Packaging, paper,
plastic, hobby
products: Other
articles with routine
direct contact during
normal use including
rubber articles;
plastic articles
(hard); vinyl tape;
flexible tubes;
profiles; hoses
Small Articles
with Potential
for semi-
routine contact
Acute
Dermal
H
75,000
88,000
100,000
130,000
160,000
180,000
160,000
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
-
-
-
-
-
-
-
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
22,000
26,000
30,000
37,000
47,000
51,000
48,000
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
Consumer Uses:
Packaging, paper,
plastic, hobby
products: Packaging
(excluding food
packaging),
including rubber
articles; plastic
articles (hard);
plastic articles (soft)
Small Articles
with Potential
for semi-
routine contact
Acute
Dermal
H
75,000
88,000
100,000
130,000
160,000
180,000
160,000
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
-
-
-
-
-
-
-
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
22,000
26,000
30,000
37,000
47,000
51,000
48,000
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
-
-
-
-
-
-
-
Page 173 of 269
-------
Lite Cycle Stage:
COU: Subcategory
Product or
Article
Duration
Exposure
Route
Exposure
Scenario
(H, M, L) "
Lifestage (years)
(Benchmark MOE = 30)
Infant
(<1 Year)
Toddler
(1-2 Years)
Preschooler
(3-5 years)
Middle
Childhood
(6-10 years)
Young
Teen
(11-15 years)
Teenagers
(16-20 years)
Adults
(21+years)
Consumer Uses:
Packaging, paper,
plastic, hobby
products: Toys,
playground, and
sporting equipment
Children's toys
(legacy)
(** = Part of
indoor
exposure
scenario)
Acute
Dermal
H
120,000
140,000
170,000
210,000
260,000
290,000
-
Ingestion**
H
300
930
1,400
9,800
17,000
22,000
49,000
Inhalation**
H
200
210
260
370
530
610
760
Aggregate
H
120
170
220
360
500
590
750
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
36,000
42,000
49,000
61,000
77,000
84,000
-
Ingestion**
H
88
280
430
3,200
5,800
7,300
16,000
Inhalation**
H
65
69
85
120
170
200
250
Aggregate
H
37
55
71
120
170
190
250
Consumer Uses:
Packaging, paper,
plastic, hobby
products: Toys,
playground, and
sporting equipment
Children's toys
(new)
(** = Part of
indoor
exposure
scenario)
Acute
Dermal
H
120,000
140,000
170,000
210,000
260,000
290,000
-
Ingestion**
H
320
1,200
2,400
410,000
730,000
920,000
2,100,000
Inhalation**
H
8,300
8,800
11,000
16,000
22,000
26,000
32,000
Aggregate
H
310
1,000
1,900
14,000
20,000
23,000
32,000
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
36,000
42,000
49,000
61,000
77,000
84,000
-
Ingestion**
H
93
350
690
140,000
240,000
310,000
680,000
Inhalation**
H
2,700
2,900
3,500
5,100
7,200
8,400
11,000
Aggregate
H
90
310
570
4,600
6,400
7,500
11,000
Consumer Uses:
Packaging, paper,
plastic, hobby
products: Toys,
playground, and
sporting equipment
Sports Mats
(** - Part of
indoor
exposure
scenario)
Acute
Dermal
H
300,000
350,000
410,000
510,000
640,000
700,000
660,000
Ingestion**
H
22,000
18,000
16,000
45,000
80,000
100,000
230,000
Inhalation**
H
1,000
1,100
1,400
1,900
2,800
3,200
4,000
Aggregate
H
950
1,000
1,300
1,800
2,700
3,100
3,900
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
150,000
180,000
210,000
260,000
330,000
360,000
340,000
Ingestion**
H
7,300
5,900
5,200
15,000
27,000
34,000
75,000
Inhalation**
H
340
360
440
640
900
1,100
1,300
Aggregate
H
320
340
410
610
870
1,100
1,300
Consumer Uses:
Other uses: Novelty
articles
Adult Toys
Acute
Dermal
H
-
-
-
-
-
2,000,000
1,900,000
Ingestion
H
-
-
-
-
-
180
200
Inhalation
H
-
-
-
-
-
-
-
Aggregate
H
-
-
-
-
-
180
200
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
-
-
-
-
-
580,000
540,000
Ingestion
H
-
-
-
-
-
51
57
Inhalation
H
-
-
-
-
-
-
-
Aggregate
H
-
-
-
-
-
51
57
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Lite Cycle Stage:
COU: Subcategory
Product or
Article
Duration
Exposure
Route
Exposure
Scenario
(H, M, L) "
Lifestage (years)
(Benchmark MOE = 30)
Infant
(<1 Year)
Toddler
(1-2 Years)
Preschooler
(3-5 years)
Middle
Childhood
(6-10 years)
Young
Teen
(11-15 years)
Teenagers
(16-20 years)
Adults
(21+years)
"Exposure scenario intensities include high (H), medium (M), and low (L).
4 As discussed above in Section 4.3.3.1 and in more detail in Appendix I of the Non-cancer Human Health Hazard Assessment for Diisononvl Phthalate (DINP) (IIS, EPA, 2025uX EPA
considers the chronic POD based on liver toxicity to be most directly applicable to male and female adult consumers. Use of the chronic POD for assessing chronic risks to infants and
children may be conservative and may not be relevant. Chronic MOEs shown in parentheses were calculated using the acute/intermediate POD of 12,000 (ig/kg-day based on reduced fetal
testicular testosterone, which is the most sensitive POD identified by EPA that is more directly applicable for assessing chronic risks from exposure to DINP for infants and children.
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4.3.4 Risk Estimates for General Population
As described in the Environmental Media and General Population Screening for Diisononyl Phthalate
(DINP) ( 25q) and Section 4.1.3, EPA employed a screening level approach for general
population exposures for DINP releases associated with TSCA COUs. EPA evaluated surface water,
drinking water, fish ingestion, and ambient air pathways quantitatively, and land pathways {i.e., landfills
and application of biosolids) qualitatively. For pathways assessed quantitatively, high-end estimates of
DINP concentration in the various environmental media were used for screening level purposes. EPA
used an MOE approach using high-end exposure estimates to determine whether an exposure pathway
had potential non-cancer risks. High-end exposure estimates were defined as those associated with the
industrial and commercial releases from a COU and OES that resulted in the highest environmental
media concentrations. If there is no risk for an individual identified as having the potential for the
highest exposure, associated with a COU for a given pathway of exposure, then that pathway was
determined not to be a pathway of concern and not pursued further. If any pathways were identified as a
pathway of concern for the general population, further exposure assessments for that pathway would be
conducted to include higher tiers of modeling when available and exposure estimates for additional
subpopulations and COUs. However, using a screening level approach described in Section 4.1.3, no
pathways of exposure were identified as pathways of concern for the general population.
4.3.5 Risk Estimates for Potentially Exposed or Susceptible Subpopulations
EPA considered PESS throughout the exposure assessment and throughout the hazard identification and
dose-response analysis supporting the DINP risk evaluation.
Some population group lifestages may be more susceptible to the health effects of DINP exposure. As
discussed in Section 4.2 and in EPA's Non-cancer Human Health Hazard Assessment for Diisononyl
Phthalate (DINP) ( 2025u). exposure to DINP causes developmental toxicity in experimental
animal models and therefore women of reproductive age/pregnant women, infants, children and
adolescents are considered to be susceptible subpopulations. These susceptible lifestages were
considered throughout the risk evaluation. For example, women of reproductive age were evaluated for
occupational exposures to DINP for each COU (Section 4.3.2) and infants (<1 year), toddlers (1-2
years), and middle school children (6-10 years) were evaluated for exposure to DINP through consumer
products and articles (Section 4.3.3). The non-cancer POD for DINP selected by EPA for use in risk
characterization is based on the most sensitive developmental effect {i.e., reduced fetal testicular
testosterone production) observed and is expected to be protective of susceptible subpopulations.
Additionally, EPA used a value of 10 for the UFh to account for human variability. The Risk
Assessment Forum, in A Review of the Reference Dose and Reference Concentration Processes,
discusses some of the evidence for choosing the default factor of 10 when data are lacking—including
toxicokinetic and toxicodynamic factors as well as greater susceptibility of children and elderly
populations (U.S. EPA. 2002b).
The available data suggest that some groups or lifestages have greater exposure to DINP. This includes
people exposed to DINP at work, those who frequently use consumer products and/or articles containing
high-concentrations of DINP, those who may have greater intake of DINP per body weight {e.g., infants,
children, adolescents), and those exposed to DINP through certain age-specific behaviors {e.g.,
mouthing of toys, wires, and erasers by infants and children, and hand-to-mouth ingestion from
synthetic leather furniture) leading to greater exposure. EPA accounted for these populations with
greater exposure in the DINP risk evaluation as follows:
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• EPA evaluated a range of OESs for workers and ONUs, including high-end exposure scenarios
for women of reproductive age (a susceptible subpopulation) and average adult workers.
• EPA evaluated a range of consumer exposure scenarios, including high-intensity exposure
scenarios for infants and children (susceptible subpopulations). These populations had greater
intake per body weight and exposure due to age-specific behaviors (e.g., mouthing of toys, wires,
and erasers by infants and children).
• EPA evaluated a range of general population exposure scenarios, including high-end exposure
scenarios for infants and children (susceptible subpopulations). These populations had greater
intake per body weight.
• EPA evaluated exposure of children to DINP through use of legacy and new toys.
• EPA evaluated exposure to DINP through fish ingestion for subsistence fishers and tribal
populations.
• EPA aggregated occupational inhalation and dermal exposures for each COU for women of
reproductive age (a susceptible subpopulation) and average adult workers.
• EPA aggregated consumer inhalation, dermal, and oral exposures for each COU for infants and
children (susceptible subpopulations).
4.3.6 Cumulative Risk Considerations
In accordance with EP A's Draft Proposed Approach for Cumulative Risk Assessment of High-Priority
and a Manufacturer-Requested Phthalate under the Toxic Substances Control Act ( Z023b)
and in agreement with SACC peer-review comments (U.S. EPA. 2023d). EPA is including DINP in its
cumulative risk assessment along with five other phthalate chemicals that also cause effects on
laboratory animals consistent with a disruption of androgen action and development of phthalate
syndrome. For DINP and other toxicologically similar phthalates, the Agency considers acute duration
exposures during the critical window of development most relevant for a disruption of androgen action
based on reduced fetal testicular testosterone.
In this risk evaluation, EPA identified chronic risk for several individual consumer and occupational
COUs based on non-cancer liver toxicity, which is not a health outcome under consideration as part of
the Agency's phthalate cumulative risk assessment. EPA did not identify any risk for the general
population or for consumers from acute or intermediate exposures to individual DINP COUs based on
reduced fetal testicular testosterone, while high-end acute, intermediate, and chronic risk was identified
for two occupational COUs (i.e., Industrial use of adhesives and sealants; Industrial use of paints and
coatings). EPA has not yet accounted for its cumulative phthalate risk assessment nor taken into
consideration cumulative phthalate exposure in its risk calculations; however, based on the draft
cumulative risk analysis TSD ( 24a). the Agency does not expect the risk estimates to
support any significant changes to risk estimates or risk conclusions.
EPA is issuing a draft cumulative risk assessment for public comment and peer review, which will be
followed by a final cumulative assessment that incorporates DINP.
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5 ENVIRONMENTAL RISK ASSESSMENT
DINP - Environmental Risk Assessment (Section 5):
Key Points
EPA evaluated the reasonably available information for environmental exposures and hazard to
ecological receptors following releases of DINP to surface water and air deposition of DINP to soil.
• EPA expects the main environmental exposure pathway for DINP are releases to surface water
with subsequent deposition to sediment.
• The OES with the highest environmental media concentrations in surface water or wastewater
and fugitive or stack air release was manufacturing.
• Although the conservative nature of the VVWM-PSC and AERMOD outputs resulted in
reduced confidence for the environmental media concentrations in surface water, sediment,
and soil, EPA has robust confidence that the modeled environmental media concentrations do
not underestimate real exposures to ecological receptors.
• Hazard data for aquatic invertebrates and algae indicated no acute or chronic exposure toxicity
up to and exceeding the limit of DINP water solubility. Because chronic hazard data for fish
indicated inconsistent effects and/or lack of dose-response below limit of solubility, no hazard
threshold was established for fish chronically exposed to DINP. No toxicity was observed
from hazard studies with bulk sediment or pore water acute or chronic exposures to sediment-
dwelling organisms.
• A trophic transfer analysis explored potential DINP exposures to terrestrial mammals through
their diet via the water to sediment pathway for semi-aquatic terrestrial mammals and by the
soil pathway for other terrestrial mammals, with releases to surface water representing the
major source.
• Dietary exposure estimates from trophic transfer based on either biomonitoring literature
values or COU/OES-based modeled biota concentrations did not exceed the hazard value for
representative mammalian species. Therefore, EPA did not pursue further quantitative
analyses for these pathways.
• Empirical toxicity data for rats were used to estimate a toxicity reference value (TRV) for
terrestrial mammals at 139 of mg/kg-bw/day.
• A qualitative risk characterization supports that EPA's determination that there is no risk for
all pathways assessedfor exposure to ecological receptors. The Agency has robust confidence
in the determination of no risk to aquatic receptors and moderate confidence in the
determination of no risk to terrestrial receptors. In cases where EPA lacked reasonably
available hazard data (e.g., avian and terrestrial plants), risk to those receptors from DINP
environmental releases was indeterminate.
5.1 Summary of Environmental Exposures
EPA evaluated the reasonably available information for environmental exposures of DINP to aquatic
and terrestrial species. The Agency expects the main environmental exposure pathway for DINP is to be
released to surface water with subsequent deposition to sediment. The ambient air exposure pathway
was also assessed for its limited contribution via deposition to soil. DINP exposure to aquatic species via
surface water and sediment were modeled to estimate concentrations from the COU/OES that resulted in
the highest environmental media concentrations. EPA calculated concentrations of DINP in
representative organisms (Figure 5-1) for a screening level trophic transfer analysis using modelled
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sediment concentrations from VVWM-PSC. Based on a water solubility limit of 6.1 /10 4 mg/L and the
predicted BCF of 5.2 L/kg, the modelled concentration of DINP in fish was 3,2/ 10 3 mg/kg, which was
one order of magnitude lower than the highest DINP concentrations reported in aquatic biota in the peer-
reviewed literature. In a lower trophic level organism, mussel, DINP concentration modeled using a
BAF of 209.8 was 0.128 mg/kg-bw for the highest releasing DINP COU/OES. Exposure to terrestrial
species through soil via air deposition was also assessed using the AERMOD model. DINP is not
considered bioaccumulative; however, within the aquatic environment, relevant environmental
exposures are possible through incidental ingestion of sediment while feeding and/or ingestion of food
items that have become contaminated due to uptake from sediment.
Exposure through diet was assessed through a trophic transfer analysis with representative species,
which estimated the transfer of DINP from soil through the terrestrial food web as well as from surface
water and sediment through the aquatic food web via releases to surface waters. Within the aquatic
ecosystem, the highest COU/OES estimate (Non-PVC material compounding) resulted in modeled
DINP exposure concentration at least three orders of magnitude greater than measured DINP
concentrations in sediment, filter feeding mussels, and fish from the published literature. These
modeling predictions also resulted in a maximum calculated DINP dietary exposure for mink of 62.7
mg/kg-bw/day, which was least three orders of magnitude greater than calculated DINP dietary exposure
in an aquatic-dependent mammal based on the maximum measured concentrations reported from the
published literature. Mink DINP dietary exposure rates using VVWM-PSC modeled DINP in sediment
with P75 and P90 7Q10 flows were 0.88 mg DINP/kg-bw/day and 0.1 mg DINP/kg-bw/day,
respectively. The inclusion of modeled sediment concentrations of DINP from varying percentile 7Q10
flow rates allowed for this analysis to demonstrate an array of dietary exposure rates of DINP for a
representative mammal based on low flow conditions across the distribution of flow data from NAICS
codes comprising the COU/OES with the highest release to surface water and sediment. In terrestrial
ecosystems, the highest COU/OES estimate (Non-PVC materials compounding) resulted in DINP
exposure concentrations comparable to the maximum measured soil concentrations from the published
literature (0.03 mg/kg).
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Figure Legend
Partitioning/Transportation
~ Low
Moderate
High
FIR = 0.55
Figure 5-1. Trophic Transfer of DINP in Aquatic and Terrestrial Ecosystems
5.2 Summary of Environmental Hazards
EPA evaluated the reasonably available information for environmental hazard endpoints associated with
DINP exposure to ecological receptors in aquatic and terrestrial ecosystems. In total, the Agency
reviewed 46 references and determined that 35 references had high or medium data quality. These
references included acute and chronic exposures via water, soil, sediment, and food.
Experimental aquatic hazard data were available from studies of the effects from acute exposures of
DINP on five fish species, one amphibian species, five aquatic invertebrate species, and two algal
species. Three fish species were represented in chronic exposure DINP feeding studies. Results from
standard laboratory tests suggest that DINP has low hazard potential in aquatic species. Few consistent
adverse effects on survival, growth, development, or reproduction were observed in acute and chronic
exposure duration tests at concentrations up to and exceeding the DINP solubility and saturation limits.
In terrestrial habitats, a TRY of 139 mg/kg-bw/d was derived for the chronic exposure effects of DINP
on a generalized terrestrial mammal. One study of earthworm survival and reproduction found no
hazards at the maximum experimental soil concentration of 1,000 mg/kg dw DINP. No toxicity studies
on avian or terrestrial plant species were identified.
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5.3 Environmental Risk Characterization
5.3.1 Risk Assessment Approach
The environmental risk characterization of DINP was conducted to evaluate whether the potential
releases of DINP into the environment exceed the DINP concentrations that result in hazardous effects
to aquatic and terrestrial organisms. EPA first characterized risk based upon the COU/OES and
associated environmental media with the highest estimated concentrations for a given pathway. Then, if
this exposure concentration did not exceed the hazard thresholds harmful to organisms, the Agency
based the risk determination on this maximum exposure scenario to be most inclusive and protective by
encompassing the other exposure COUs/OESs associated with lower estimated environmental media
concentrations.
DINP concentrations within surface water, sediment, and soil are potential exposure pathways to aquatic
and terrestrial species (U.S. EPA. 2025q). EPA assessed DINP concentrations in surface water,
sediment, and soil via modeling (VVWM-PSC and AERMOD, respectively) to represent COU-based
DINP releases. Using COU/OES-specific estimated days of release, the highest release distribution of
COU/OES-specific annual releases to surface water were assessed under multiple flow assumptions
(P50 and P90) in VVWM-PSC to generate modeled environmental concentrations for surface water and
sediment ( 025q). The median (P50) 7Q10 flow rate was applied as a conservative low flow
condition across the modeled releases and refined analyses were conducted for the scenarios resulting in
the greatest environmental concentrations by applying the 90th percentile (P90) flow metrics from the
distribution, which were expected to be more representative of the flow conditions associated with high-
end releases. Air deposition of DINP to soil was modeled to represent COU-based releases to air using
AERMOD with conservative parameters and assumptions ( 25q).
In evaluating the environmental hazard of DINP, a weight of evidence approach was used to (1)
determine whether aquatic and terrestrial organisms had documented hazard, and (2) qualitatively
evaluate risk from DINP for organisms which demonstrated hazard. A qualitative risk assessment for
terrestrial species was conducted because no hazard threshold was established for aquatic organisms
exposed to DINP up to and exceeding the solubility in water within the reasonably available published
literature that was assigned overall quality determinations of high and medium through EPA's
systematic review procedures ( 25aa). Similarly, the hazard evidence for benthic organisms
exposed to DINP demonstrated no hazard. The weight of scientific evidence of these data demonstrates
that DINP has few hazardous effects in aquatic and benthic species under environmental conditions in
which DINP may persist in water (e.g., up to and exceeding the limit of solubility). Similarly, in cases
where effects in aquatic species were observed at low water concentrations or in dietary exposures to
aquatic species, the evidence for hazardous effects are expected was inconsistent and not dose-response
dependent. Despite no reasonably available studies of DINP hazard in wildlife, a TRV was derived from
laboratory rodent studies to obtain a threshold dose concentration to represent hazard for terrestrial
mammals. The TRV was used as a hazard effect threshold for dietary transfers through trophic levels in
food webs (i.e., trophic transfer) from water and soil media releases ("I ; S 1 V \ 2025o).
The OES with the highest environmental media release to surface water or wastewater was
Manufacturing and for and fugitive or stack air release it was the Non-PVC plastic compounding OES.
For COUs with water-based releases, sediment concentrations modeled using VVWM-PSC resulted in
the highest DINP concentration for the Manufacturing OES at 126,000 mg/kg ( 025q).
Deposition of DINP from air to soil was modeled via AERMOD resulting in a maximum daily
deposition rate of 2.5 xlO-1 g/m2-day at 100 m from a facility, based on higher-end meteorology and a
rural land category scenario ( I025o). Using these maximum modeled deposition rates from
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fugitive and stack releases, the high-end concentration of DINP in soil from modeled air to soil
deposition at 100 m from a hypothetical release site for the Non-PVC plastics compounding OES was
1.46 mg/kg (U.S. EPA. 2025o).
Lack of reasonably available information on plant and avian hazard data precluded EPA's ability to
designate hazard thresholds for these taxa. However, previous risk assessments provided insight into
DINP hazard for terrestrial plants. Environment Canada's State of the Science report on DINP (EC/HC.
2015a) summarized previous terrestrial hazard studies and found adverse effects for seed germination
(lowest-observed-effect concentration [LOEC]) with lettuce {Lactuca sativa) at a nominal test
concentration of 3,000 mg/kg dw soil and a no-observed-effect concentration (NOEC) of 1,000 mg/kg
dw soil. The narrative indicated that analytically verified concentrations were confirmed to be near
nominal concentrations. The EC/HC summary also reported a 28-day seed germination and growth
study with a lettuce NOEC of 1,387 mg/kg dw soil and a LOEC exceeding 1,387 mg/kg dw soil
(EC/HC. 2015a). EPA did not have access to the terrestrial plant hazard studies summarized within
Environment Canada's State of the Science report on DINP (EC/HC. 2015a). The resulting NOAELs
from these study summaries are three orders of magnitude greater than the highest modeled value for air
to soil deposition from Non-PVC plastic compounding OES. Additionally, the NOAELs in terrestrial
plants are four orders of magnitude greater than the highest DINP soil concentrations reported within
reasonably available literature from monitoring studies (range 1.3/10 3 mg/kg dw to 0.17 mg/kg dw)
(Huang et at.. 2019; Trail et at.. 2015; Zhang et at.. ..01 Liu et at.. 2010; Zeng et at.. 2009; Zeng et at..
2008; Vikels0e et at.. 2002).
Hazard values from a low confidence analog, DEHP, allow for comparisons between tissue and egg
concentrations from reasonably available biomonitoring studies in the absence of avian hazard data on
DINP. Within birds, an egg injection study in chicken indicated a behavioral impact associated with
chick imprinting at the highest DEHP concentration of 100 mg/kg (Abdul-Ghani et at..: ). DEHP
exposures of 45 days within the diet (gavage) quail (Coturnix coturnix coturnix) have demonstrated
histological based alterations of cardiac tissue at DEHP concentrations of 500 mg/kg-bw/day and
kidneys at 250 mg/kg-bw/day (Wane et at.. 2020; Wane et at.. 2019). Mackintosh et al. (2004) reported
DINP and DEHP concentrations within liver tissue of a marine avian species, surf scooter (Melanitta
perspicillata), at a mean of 0.005 mg/kg and 0.005 mg/kg wet weight, respectively. Although no
reasonably available data report measurement of DINP within bird eggs, two papers do report DEHP
within eggs as a com pari son to this egg injection study. Schwarz et al. (2016) collected samples from
failed peregrine falcon eggs within Germany as part of a large survey of pollutants within eggs.
Concentrations of DEHP within peregrine falcon eggs Schwarz et al. (2016) were reported as "traces of
DEHP" with no concentration reported within the study (detection limit reported as 0.001 mg/kg dw).
A more comprehensive study on environmental pollutants within egg samples was conducted on seabird
species within coastal Norway (Huber et al.. 2015). Concentrations of DEHP recorded within pooled
eggs of the European herring gull (Larus argentatus) were between 0.011 to 0.024 mg/kg ww and 0.003
to 0.042 mg/kg ww in European shag eggs (Phalacrocorax aristotelis aristotelis) (Huber et al.. 2015).
These measured phthalate concentrations found in eggs of wild bird populations are four orders of
magnitude lower than that used in the laboratory administered injection treatment of 100 mg/kg DEHP
in species chicken eggs by Abdul-Ghani et al. (2012). Additionally, Mackintosh et al. (2004) determined
Food-Web Magnification Factors (FWMF) for phthalates and polychlorinated biphenyls using 18
aquatic species (including one avian species) that represented approximately 4 trophic levels and found
trophic dilution for both DIDP and DINP with FWMFs of 0.44 and 0.46, respectively. Taken together,
data from environmental monitoring and biomonitoring indicate limited intersection of exposure from
DINP at the hazard concentrations described.
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DINP is expected to have a low potential for bioaccumulation and biomagnification in aquatic
organisms (Blair et al.. 2009; McConnell. 2007; Mackintosh et al.. 2004). Monitored concentrations of
DINP within differing aquatic taxa reflect dilution across trophic levels (McConnell 2007; Mackintosh
et al.. 2004). DINP exposure to terrestrial organisms occurs primarily through diet via the sediment
pathway for semi-aquatic terrestrial mammals followed by the soil pathway for soil invertebrates and
terrestrial mammals, with releases to surface water representing an exposure pathway of concern. Risk
estimates for dietary exposure pathways to aquatic-dependent mammals and terrestrial mammals as
receptors were qualitatively and not quantitatively evaluated because even with conservative
assumptions, dietary DINP exposures were orders of magnitude less than the identified mammalian
hazard threshold (TRV) (U.S. EPA. 2025p).
5.3.2 Risk Estimates for Aquatic and Terrestrial Species
EPA expects the main environmental exposure pathways for DINP to be (1) releases to surface water
and subsequent deposition to sediment and (2) limited dispersal from fugitive and stack air release
deposition to soil. Risks of DINP exposure to organisms in the environment were qualitatively evaluated
based upon comparisons between surface water and air-to-soil exposure pathways and DINP hazard (or
lack of hazard) in aquatic and terrestrial organisms. A summary of relevant exposure pathways to
receptors and resulting qualitative risk estimates are presented in Table 5-1.
Table 5-1. Relevant Exposure Pathway to Receptors and Corresponding Risk Assessment
(Qualitative) for the DINP Environmental Risk Characterization
Exposure Pathway
Receptor
Risk Assessment
Surface water
Aquatic species
No risk
Surface water, sediment
Aquatic species; aquatic dependent
mammal
No risk17
Air deposition to surface water,
sediment
Aquatic species; aquatic dependent
mammal
No risk17
Air deposition to soil
Terrestrial mammal
No risk17
Landfill to surface water, sediment
Aquatic species
No risk
Aggregate media of release (water,
incineration, or landfill)
Aquatic dependent mammal
No risk
Landfill to surface water, sediment
Aquatic dependent mammal
No risk
Biosolids
Terrestrial mammal
No risk
11 Screening level trophic transfer analysis conducted by producing exposure estimates from the high-end
exposure scenarios defined as those associated with the industrial and commercial releases from a COU and
OES that resulted in the highest environmental media concentrations and presented within U.S. EPA (2025o).
Empirical toxicity data for rats and mice were used to estimate a TRV for terrestrial mammals at 139
mg/kg-bw/day.
DINP is expected to partition primarily to soil and sediment, regardless of the compartment of
environmental release (U.S. EPA. 2025s). DINP is not expected to undergo long-range transport and is
expected to be found predominantly in sediments near point sources, with a decreasing trend in sediment
concentrations downstream due to DINP's strong affinity and sorption potential for organic carbon in
soil and sediment. Transport of DINP is further limited by its low water solubility (6.1 x 10~4 mg/L)
which in combination with high sorption coefficients indicate that freely dissolved and bioavailable
concentrations would be reduced due to strong sorption to suspended solids (Mackintosh et al.. 2006).
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Although DINP is predicted to have an overall environmental half-life of 35 days, DINP is expected to
have a low biodegradation potential within low oxygen conditions indicating longer persistence within
subsurface sediments and soils ( 025s).
Additional evidence indicates that DINP is not persistent within other exposure pathways. Within air,
DINP is expected to have an atmospheric half-life of 5.36 hours. The potential removal of DINP via
wastewater treatment was modeled using STPWIN™, an EPI Suite™ module that estimates chemical
removal in sewage treatment plants, predicting greater than 93 percent removal of DINP in wastewater
by sorption to sludge (U.S. EPA. 2025s).
The landscape of hazard data for DINP provides information for qualitative risk assessment connecting
relevant exposure pathways to aquatic and terrestrial organisms. DINP demonstrated no consistent
aquatic toxicity for the population-level endpoints of survival and reproduction up to and beyond the
limit of solubility under both acute and chronic exposure durations ( 025p). Thus, with no
observed hazard to aquatic organisms, EPA has determined that there is no risk from DINP
environmental exposures in sediment or surface waters (Table 5-1). In no circumstances did dietary
exposures in the surface water, sediment, and air to soil pathways exceed the definitive hazard threshold
for terrestrial mammals. EPA has robust confidence in the qualitative risk evaluation for aquatic
receptors and moderate confidence in the qualitative risk evaluation for terrestrial receptors. In cases
where EPA lacked reasonably available hazard data (e.g., avian and terrestrial plants), risk is
indeterminate.
Surface Water
Hazard data for fish, aquatic invertebrates, and algae indicated no acute or chronic toxicity up to and
exceeding the limit of water solubility leading to robust confidence that DINP poses little hazard to these
organisms ( 2025p). The fate and transport of DINP in surface water are governed by water
solubility, organic carbon partitioning coefficients, and volatility—although volatilization is not
expected to be a significant source of loss of DINP from surface water ( 025s). DINP has a
low water solubility of 6.1 x 10~4 mg/L but is likely to form a colloidal suspension and may be detected
in surface water at higher concentrations (EC/HC. 2015b). These DINP colloidal suspensions are
unlikely to be bioavailable to aquatic organisms via absorption across respiratory surfaces or ingestion.
Concentrations of DINP above the aqueous solubility of 6.1 x 10~4 mg/L are not uncommon in
monitoring studies proximal to releases of DINP to surface water (Wen et at.. 2018). EPA has robust
confidence in the reasonably available information of DINP concentrations within surface waters (e.g.,
up to 85 |.ig/L (U.S. EPA. 2025o)) that were all orders of magnitude lower than unbounded hazard
estimates at concentrations up to and above the water solubility limit. Because no hazard effects of
DINP on aquatic organisms through acute or chronic water exposures were evident, EPA has robust
confidence in the determination that DINP exposure poses no risk to aquatic organisms via surface water
exposures.
Surface Water and Sediment Exposure Pathway
During DINP releases to surface water bodies, greater than 92 percent of DINP is expected to partition
to both suspended and benthic sediments ( )25s). The OES with the highest environmental
media release to surface water was Manufacturing. Modeled environmental media concentrations
resulting from this OES were assessed as worst-case (conservative) exposures to organisms (
2025o). The highest concentrations of DINP in sediment modeled by VVWM-PSC were from the
Manufacturing OES that were almost three orders of magnitude higher than the highest sediment
concentrations (212 mg/kg in Sweden) reported within the literature ( 2025p). No hazard
effects of sediment DINP to sediment dwelling animals were documented in the literature (
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2025p). For example, effects on mortality and development within the benthic invertebrate, Chironomus
tentans, were not observed from 10-day DINP laboratory exposures up to the highest measured sediment
concentration of 2,630 mg/kg, which were comparable to modeled concentrations (Call et at.. 2001).
Thus, EPA has robust confidence in the determination that DINP exposure poses no risk to sediment
dwelling animals.
The potential hazardous effects of a DINP pathway from surface water to an aquatic dependent mammal
were explored using a trophic transfer analysis of DINP food web exposure and comparing it to the
hazard threshold (TRV) to terrestrial mammals (139 mg/kg bw/d). DINP has low bioaccumulation
potential in aquatic and terrestrial organisms, and no apparent biomagnification across trophic levels in
the aquatic food web (U.S. EPA. 2025s). Thus, the trophic transfer analysis included documented
bioconcentration estimates and the most conservative assumptions for DINP diet transfer through the
ingestion of sediment. The high-end sediment concentration modeled by VVWM-PSC was from the
Manufacturing OES and was used in this trophic transfer analysis for dietary exposure to fish and to an
aquatic-dependent mammal (U.S. EPA. 2025o). The highest modeled sediment concentration yielded
values for potential dietary exposure of DINP to aquatic dependent mammals were 0.02 mg/kg bw/d and
were lower than the TRV of 139 mg/kg bw/d ( 025o). Based on the conservative VVWM-
PSC outputs for surface water and sediment shown in ( 2025o), the COlJs/OESs based water
releases of DINP are not expected to produce environmental concentrations leading to hazardous effects
within aquatic dependent wildlife. EPA has moderate confidence in the modeled values in sediment, and
in animal diets, but because the models used the most conservative assumptions, the Agency has robust
confidence that the analyses are protective of the organisms and has determined that DINP poses no risk
to aquatic dependent animals via dietary exposures.
Based on the weight of scientific evidence for DINP within the environment, lack of bioaccumulation/
biomagnification, and hazard value for an aquatic dependent mammal, qualitative analysis indicates that
reaching a daily rate of 139 mg/kg-day is unlikely and was not reached—even with conservative
modeling and trophic transfer assumptions.
The reasonably available literature monitoring DINP within surface water and sediment includes
collections from suspected point sources, landfills, and urbanized areas, which builds confidence in the
role of monitored concentrations for this analysis. Therefore, DINP exposure within surface water and
sediment are not expected to produce hazardous effects within aquatic organisms and represent lack of
risk based on available hazard and monitoring data.
Air Deposition to Water, Sediment
The concentrations of DINP in sediment and surface water modeled from air deposition of the highest
releasing COU/OES are lower than the highest NOEC values reported within several hazard studies for
aquatic invertebrates and vertebrates in the water column, benthic invertebrates, and aquatic plants and
algae. Therefore, COU/OES based fugitive and stack air releases of DINP and subsequent deposition to
surface water and sediment are not expected to produce environmental concentrations leading to
hazardous effects within aquatic organisms.
Air Deposition to Soil
Modeling results indicate a rapid decline in DINP concentrations from air deposition to soil. The PVC
plastics compounding OES resulted in the highest fugitive release of DINP with daily deposition rates to
soil at 100, 1,000, and 5,000 m of 1.8, 5.1xl0~2, and 2.4><10~3 mg/kg, respectively. Because DINP has
low bioaccumulation potential ( 325s) and biodilutes (Mackintosh et at.. 2004). the transfer
of DINP through a food web is expected to dilute in each trophic level and this is less than the amount
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deposited to soil. These modeled daily deposition rates from 100 m and 5,000 m from a release source
are two to five orders of magnitude below the mammalian TRV value of 139 mg/kg-bw/day. One study
of earthworms and DINP indicated aNOEC of 1,000 mg/kg, which demonstrates no hazardous effects
within this soil invertebrate—even when testing DINP to very high concentrations compared to
available monitoring information in soil (range 1.3xl0~3 mg/kg dw to 0.17 mg/kg dw) (Huang et at..
2019; Trail et at.. 2015; Zhang et at.. -01 Liu et at.. 2010; Zeng et at.. 2009; Zeng et at.. 2008;
Vikels0e et at.. 2002). The highest modeled DINP concentration within soil at 1,000 from a fugitive
release is five orders of magnitude below the NOEC of 1,387 mg/kg dw soil from a 28-day seed
germination and growth study summarized within Environment Canada's State of the Science report on
DINP (EC/HC. 2015a). Therefore, COU/OES based fugitive and stack air releases of DINP and
subsequent deposition to soil are not expected to produce environmental concentrations leading to
hazardous effects within soil invertebrates or terrestrial mammals. EPA has robust confidence in the
determination that DINP exposure poses no risk to terrestrial animals due to the lack of hazard effects to
an invertebrate and low soil exposure concentrations that do not exceed a TRV to mammals.
Landfill (to Surface Water, Sediment)
Due to its low water solubility (6.1 x 10~4 mg/L) and affinity for organic carbon (log Koc = 5.5), DINP is
expected to be present at low concentrations in landfill leachate. Concentrations of DINP in landfill
leachates outside of the United States ranged from 1 to 70 |ig/L (Duyar et at.. 2021; Katmykova et at..
2013). Furthermore, any DINP that may present in landfill leachates will not be mobile in receiving soils
and sediments due to its high affinity for organic carbon. Sediments near a landfill in Sweden were
found to have a DINP concentration of 290 |ig/kg (Cousins et at.. 2007). For comparison, the same study
reported that sediment taken from background lakes had DINP concentrations below the detection limit
of 100 |ig/kg for all samples and reported that sediments from urban locations had DINP concentrations
ranging from below detection to 3,400 |ig/kg (Cousins et at.. 2007). These concentrations were well
below NOEC values for aquatic sediment organisms and below concentrations that might be expected to
transfer up the food web via trophic transfer and potentially affect terrestrial mammals at the estimated
TRV of 139 mg/kg-bw/day. DINP is not likely to be persistent in groundwater/subsurface environments
unless anoxic conditions exist. As a result, the evidence presented indicates that DINP migration from
landfills to surface water and sediment is limited and not likely to result in hazardous effects or pose risk
to aquatic and terrestrial organisms.
Biosolids
EPA did not pursue using generic release scenarios to model potential DINP concentrations in biosolids
because the high-end release scenarios were not considered to be applicable to the evaluation of land
application of biosolids. One monitoring report conducted in Sweden reported concentration of DINP in
sludge from sewage treatment plants ranging 19.0 to 51.0 mg/kg (Cousins et at.. 2007). Two additional
studies reported DINP concentrations in biosolids of 3.80 to 8.03 mg/kg and 4.3 to 24.9 mg/kg
(Armstrong et at.. 2018; ECJRC. 2003a). The half-life of 28 to 52 days in aerobic soils ( 5)
indicates that DINP is not persistent in the aerobic environments associated with freshly applied
biosolids. High-end releases from industrial facilities are unlikely to be released directly to municipal
wastewater treatment plants without pretreatment or to be directly land applied following on-site
treatment at the industrial facility itself. In comparison to hazard values, the highest reported DINP
concentrations within biosolids from reasonably available literature are two orders of magnitude below
the read-across NOEC value within earthworms of 1,000 mg/kg from a 28-day exposure and one order
of magnitude below a daily hazard threshold for mammals of 139 mg/kg-bw/day. The highest reported
DINP concentrations within biosolids are also two orders of magnitude below the NOEC of 1,387 mg/kg
dw soil from a 28-day seed germination and growth study summarized within Environment Canada's
State of the Science report on DINP (EC/HC. 2015a). The combination of factors such as biodegradation
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(SRC. 1983) and the weight of evidence supporting a lack of bioaccumulation and biomagnifi cation
(Mackintosh et al. 2004; ECJRC. 2003a; Gob as et al. 2003) supports this qualitative assessment that
potential DINP concentrations in biosolids do not present concentrations able to produce hazardous
effects within soil invertebrates or terrestrial mammals.
Distribution in Commerce
EPA evaluated activities resulting in exposures associated with distribution in commerce (e.g., loading,
unloading) throughout the various life cycle stages and COUs (e.g., manufacturing, processing,
industrial use, commercial use, disposal) rather than a single distribution scenario. Data were not
reasonably available for the Agency to assess risks to the environment from environmental releases and
exposures related to distribution of DINP in commerce as a single OES. However, most of the releases
from this COU/OES are expected to be captured within the releases of other COUs/OESs because most
of the activities (loading, unloading) generating releases from distribution of commerce are release
points of other COUs/OESs.
Aggregate Media of Release
COUs/OESs with aggregated media of release, where the environmental release assessment did not
provide individual release estimates associated within singular release media, are represented in Table 1-
1 in Environmental Release and Occupational Exposure Assessment for Diisononyl Phthalate (DINP)
( 2025r). Specifically, these COUs/OESs detailed fugitive air and stack air releases in addition
to water releases as an aggregate of "wastewater, incineration, or landfill" rather than water or
wastewater only. All aggregate COUs/OESs have annual release per site (kg/site-year) values lower than
Non-PVC plastic compounding.
5.3.3 Overall Confidence and Remaining Uncertainties Confidence in Environmental
Risk Characterization
Environmental risk characterization evaluated confidence from environmental exposures and
environmental hazards. Exposure confidence is detailed within Environmental Media and General
Population Screening for Diisononyl Phthalate (DINP) ( )25q)). represented by modeled
and monitored data. Trophic transfer confidence is represented by evidence type as reported in U.S. EPA.
(2025o). Environmental Exposure Assessment for Diisononyl Phthalate (DINP). Hazard confidence was
represented by evidence type as reported previously in '20250). Environmental Hazard
Assessment for Diisononyl Phthalate (DINP). The following confidence determinations for risk
characterization inputs are robust confidence for the aquatic evidence and moderate confidence for
terrestrial evidence (Table 5-2).
Exposure
Conservative approaches within both environmental media modeling (e.g., AERMOD, VVWM-PSC)
and the screening level trophic transfer analysis likely overrepresent DINP ability to transfer among the
trophic levels; however, this increases confidence that risks are not underestimated. Due to the lack of
reasonably available release data for facilities discharging DINP to surface waters, releases were
modeled and the high-end estimate for each COU was applied for surface water modeling. Additionally,
due to lack of site-specific release information, a generic distribution of hydrologic flows was developed
from facilities which had been classified under relevant NAICS codes, and which had NPDES permits.
The flow rates selected from these generated distributions represented conservative low flow rates.
When coupled with high-end release scenarios, these low flow rates result in high modeled
concentrations. Additional scenarios were modelled with the median (e.g., faster) flow rates resulting in
sediment concentrations within the same order of magnitude to measured concentrations, increasing
EPA's confidence that risks were not underestimated. Although reported measured concentrations for
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ambient air found in the peer-reviewed and gray literature from the systematic review are within range
of the ambient air modeled concentrations from AERMOD for some scenarios, the highest modeled
concentrations of DINP in ambient air were at least two orders of magnitude higher than any monitored
value—providing more confidence that the modelling exercise was conservative and protective.
Monitored DINP concentrations within soil, surface water, and sediment were evaluated and used to
represent potential DINP exposures within a screening level trophic transfer analysis concurrently with
the previously described modeled data for the same environmental media. All monitoring and
experimental data included in this analysis were assigned overall quality determination of medium or
high with an overall moderate confidence in evidence from monitored data from published literature.
Aquatic Species
The overall confidence in the risk characterization for the aquatic assessment is robust. Studies used for
the aquatic environmental hazard assessment consisted of 19 studies with an overall quality
determination of high or medium. Consistently, no effects were observed up to the highest DINP
concentration tested within all aquatic hazard studies. As detailed within Section 5.3.2, monitoring data
from published literature report DINP concentrations within surface water and sediment lower than the
highest NOEC values presented among several hazard studies for aquatic invertebrates and vertebrates
in the water column, benthic invertebrates in the sediment, and aquatic plants and algae, which
collectively provides more confidence in the risk characterization.
Terrestrial Species
There is moderate confidence in the risk characterization inputs for the terrestrial risk characterization.
For the terrestrial assessment for mammals, EPA assigned an overall quality determination of high or
medium to 12 acceptable toxicity studies used as surrogates for terrestrial mammals. Moderate
confidence in hazard was assigned for terrestrial invertebrates due to the use of an earthworm study with
a single but high test dose; however, the study found no deleterious effects of DINP at concentrations up
to 1,000 mg/kg dw soil (ExxonMobil. 2010). The fate properties discussed in >25si in
conjunction with the previous qualitative risk characterization for terrestrial species (Section 5.3.2).
increase confidence that DINP concentrations at or above 1,000 mg/kg in the soil are not
environmentally relevant.
A hazard threshold was identified for mammals in the form of a TRV, permitting the use of a screening
level trophic transfer analysis to compare potential environmental concentrations and dietary uptake of
DINP with a daily rate of oral uptake that produces hazard under experimental conditions.
Several conservative approaches incorporated within the screening level trophic transfer analysis likely
overrepresent DINP ability to accumulate at higher trophic levels; however, this increases confidence
that risks are not underestimated. Exposure pathways with aquatic-dependent mammals and terrestrial
mammals as receptors were not examined further because, even with conservative assumptions, dietary
DINP exposure concentrations from this analysis are not equal to or greater than the TRV. These results
align with previous studies indicating that DINP has low bioaccumulation potential and will not
biomagnify as summarized within U.S. EPA (2025s). The utilization of both modeled and monitored
data as a comparative approach with similar results increases confidence that dietary exposure of DINP
does not reach concentrations that would cause hazard effects within mammals.
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Table 5-2. DINP Evidence Table Summarizing Overall Confidence Derived for Environmental
Risk Characterization
Types of Evidence
Exposure
Hazard
Trophic
Transfer
Risk
Characterization
Confidence
Aquatic
Acute aquatic assessment
++ VVWM-PSCfl
+ AERMOD6
Tcncslr
+ + +
N/A
Robust
Chronic aquatic assessment
+ +
N/A
Chronic benthic assessment
+ + +
N/A
Alijal assessment
al
\'\
Chronic avian assessment
N/A
N/A
N/A
Indeterminate
Chronic mammalian assessment
++ VVWM-PSCfl
+ AERMOD
+ +
+ +
Moderate
Terrestrial invertebrates
+ AERMOD
+ +
N/A
Moderate
Terrestrial plant assessment
N/A
N/A
N/A
Indeterminate
a EPA conducted modeling with the EPA's WWM-PSC tool (PSC), to estimate concentrations of DINP within
surface water and sediment.
b EPA used AERMOD to estimate ambient air concentrations and air deposition of DINP from EPA-estimated
releases.
+ + + Robust confidence suggests thorough understanding of the scientific evidence and uncertainties. The supporting
weight of scientific evidence outweighs the uncertainties to the point where it is unlikely that the uncertainties could
have a significant effect on the risk estimate.
+ + Moderate confidence suggests some understanding of the scientific evidence and uncertainties. The supporting
scientific evidence weighed against the uncertainties is reasonably adequate to characterize risk estimates.
+ Slight confidence is assigned when the weight of scientific evidence may not be adequate to characterize the
scenario, and when the assessor is making the best scientific assessment possible in the absence of complete
information. There are additional uncertainties that may need to be considered.
N/A Indeterminant corresponds to entries in evidence tables where information is not available within a specific
evidence consideration.
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6 UNREASONABLE RISK DETERMINATION
TSCA section 6(b)(4) requires EPA to conduct a risk evaluation to determine whether a chemical
substance presents an unreasonable risk of injury to health or the environment, without consideration of
costs or other non-risk factors, including an unreasonable risk to a PESS identified by EPA as relevant to
the risk evaluation, under the COUs.
EPA has determined that DINP presents an unreasonable risk of injury to human health, under the
COUs. Four out of 47 total industrial or commercial COUs, representing about 3 percent of the U.S.
production volume of DINP (see Section 1.1.1), significantly contribute to the unreasonable risk of
DINP due to the risk to workers. EPA did not identify risk to consumers or general population from any
of the COUs that would contribute to the unreasonable risk determination for DINP. Furthermore, the
Agency did not identify risk of injury to the environment that would contribute to the unreasonable risk
determination for DINP. This unreasonable risk determination is based on the information in previous
sections of this risk evaluation, the appendices, and the TSDs included with this risk evaluation in
accordance with TSCA section 6(b). This unreasonable risk determination and the underlying evaluation
is consistent with the best available science (TSCA section 26(h)) and based on the weight of scientific
evidence (TSCA section 26(i)), and (3) relevant implementing regulations in 40 CFR part 702, including
the amendments to the procedures for chemical risk evaluation rule (89 FR 37028; May 3, 2024).
EPA will initiate risk management for DINP by applying one or more of the requirements under TSCA
section 6(a) to the extent necessary so that DINP no longer presents an unreasonable risk. The risk
management requirements will likely focus on those COUs that significantly contribute to the
unreasonable risk. However, under TSCA section 6(a), EPA is not limited to regulating the specific
COUs found to significantly contribute to unreasonable risk and may select from among a suite of risk
management options related to manufacture, processing, distribution in commerce, commercial use, and
disposal to address the unreasonable risk. For instance, EPA may regulate upstream COUs (e.g.,
processing, distribution in commerce) to address downstream COUs that significantly contribute to
unreasonable risk (e.g., consumer use)—even if the upstream COUs are not significant contributors to
the unreasonable risk. EPA would also consider whether such risk may be prevented or reduced to a
sufficient extent by action taken under another federal law, such that referral to another agency under
TSCA section 9(a) or use of another Agency-administered authority to protect against such risk pursuant
to TSCA section 9(b) may be appropriate.
EPA notes that human or environmental exposures to DINP through uses not attributable to TSCA
COUs (e.g., food, food contact materials, cosmetics, medical devices, and pharmaceuticals) were not
evaluated by the Agency or taken into account in reaching this determination of unreasonable risk of
injury to human health, because these uses are excluded from TSCA's definition of chemical substance.
EPA's finding for DINP should not be extrapolated to conclusions about uses of DINP that are not
subject to TSCA and that the Agency did not evaluate.
Although EPA is not making a determination of unreasonable risk based on sources not attributable to
COUs, the Agency did analyze urinary biomonitoring data from the CDC's NHANES dataset, which
provides an estimate of non-attributable (i.e., cannot distinguish between TSCA and non-TSCA
exposures) aggregate exposure to DINP for the U.S. civilian population (Section 4.1.3.2). Results of this
analysis of NHANES biomonitoring data are discussed in Section 6.1.6 for the general population. In
addition, EPA included DINP in its draft cumulative risk analysis TSD along with five other
toxicologically similar phthalate chemicals (i.e., DEHP, DBP, DIBP, BBP, and DCHP) that are also
being evaluated under TSCA (U.S. EPA. 2024a). Based on the Draft Technical Support Document for
the Cumulative Risk Analysis of Di(2-ethylhexyl) Phthalate (DEHP), Dibutyl Phthalate (DBP), Butyl
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Benzyl Phthalate (BBP), Diisobutyl Phthalate (DIBP), Dicyclohexyl Phthalate (DCHP), and Diisononyl
Phthalate (DINP) Under the Toxic Substances Control Act (TSCA) ( 024a). the Agency has
considered the draft cumulative risk (i.e., human health risks related to exposures to multiple phthalates)
in this final DINP unreasonable risk determination and concluded that based on the reasonably available
information, the draft cumulative risk analysis is not expected to change any of the conclusions of this
risk determination. More information on the cumulative risk considerations is provided in Section 4.3.6.
The COUs evaluated for DINP are listed in Table 1-1. EPA has determined that the following COUs
significantly contribute to the unreasonable risk:
• Industrial use - adhesives and sealant chemicals (sealant (barrier) in machinery manufacturing;
computer and electronic product manufacturing; electrical equipment, appliance, component
manufacturing, and adhesion/cohesion promoter in transportation equipment manufacturing);
• Industrial use - construction, paint, and metal products - paints and coatings;
• Commercial use - construction, paint, electrical, and metal products - adhesives and sealants;
and
• Commercial use - construction, paint, electrical, and metal products - paints and coatings.
EPA has determined that the following COUs do not significantly contribute to the unreasonable risk:
• Manufacturing - domestic manufacturing;
• Manufacturing - importing;
• Processing - incorporation into a formulation, mixture, or reaction product - heat stabilizer and
processing aid in basic organic chemical manufacturing;
• Processing - incorporation into a formulation, mixture, or reaction product - plasticizers
(adhesives manufacturing, custom compounding of purchased resin; paint and coating
manufacturing; plastic material and resin manufacturing; synthetic rubber manufacturing;
wholesale and retail trade; all other chemical product and preparation manufacturing; ink, toner,
and colorant manufacturing [including pigment]);
• Processing - incorporation into an article - plasticizers (toys, playground and sporting equipment
manufacturing; plastics products manufacturing; rubber product manufacturing; wholesale and
retail trade; textiles, apparel, and leather manufacturing; electrical equipment, appliance, and
component manufacturing; ink, toner, and colorant manufacturing [including pigment]);
• Processing - other uses - miscellaneous processing (petroleum refineries; wholesale and retail
trade);
• Processing - repackaging - plasticizer (all other chemical product and preparation
manufacturing; wholesale and retail trade; laboratory chemicals manufacturing);
• Processing - recycling;
• Distribution in commerce;
• Industrial use - construction, paint, electrical, and metal products - building/construction
materials (roofing, pool liners, window shades, flooring, water supply piping);
• Industrial use - other uses - hydraulic fluids;
• Industrial use -other uses - pigment (leak detection);
• Industrial use - other - automotive articles;
• Commercial use - construction, paint, electrical, and metal products - plasticizer in
building/construction materials (roofing, pool liners, window shades, water supply piping);
construction and building materials covering large surface areas, including paper articles; metal
articles; stone, plaster, cement, glass, and ceramic articles;
• Commercial use - construction, paint, electrical, and metal products - electrical and electronic
products;
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Commercial use - furnishing, cleaning, treatment/care products - foam seating and bedding
products; furniture and furnishings including plastic articles (soft); leather articles;
Commercial use - furnishing, cleaning, treatment/care products - air care products;
Commercial use - furnishing, cleaning, treatment/care products - floor coverings; plasticizer in
construction and building materials covering large surface areas including stone, plaster, cement,
glass, and ceramic articles; fabrics, textiles and apparel (vinyl tiles, resilient flooring, PVC-
backed carpeting);
Commercial use - furnishing, cleaning, treatment/care products - fabric, textile, and leather
products (apparel and footwear care products);
Commercial use - packaging, paper, plastic, hobby products - arts, crafts, and hobby materials;
Commercial use - packaging, paper, plastic, hobby products - ink, toner, and colorant products;
Commercial use - packaging, paper, plastic, hobby products - packaging, paper, plastic, hobby
products (packaging [excluding food packaging], including rubber articles; plastic articles [hard];
plastic articles [soft]);
Commercial use - packaging, paper, plastic, hobby products - plasticizer (plastic and rubber
products; tool handles, flexible tubes, profiles, and hoses);
Commercial use - packaging, paper, plastic, hobby products - toys, playground, and sporting
equipment;
Commercial use - solvents (for cleaning or degreasing) - solvents (for cleaning or degreasing);
Commercial use - other uses - laboratory chemicals;
Commercial use - other - automotive articles;
Consumer use - construction, paint, electrical, and metal products - adhesives and sealants;
Consumer use - construction, paint, electrical, and metal products - plasticizer in
building/construction materials (roofing, pool liners, window shades, water supply piping, etc.);
Consumer use - construction, paint, electrical, and metal products - electrical and electronic
products;
Consumer use - construction, paint, electrical, and metal products - paints and coatings;
Consumer use - furnishing, cleaning, treatment/care products - floor coverings/plasticizer in
construction and building materials covering large surface areas including stone, plaster, cement,
glass, and ceramic articles; fabrics, textiles and apparel (vinyl tiles, resilient flooring, PVC-
backed carpeting)
Consumer use - furnishing, cleaning, treatment/care products - foam seating and bedding
products; furniture and furnishings including plastic articles (soft); leather articles;
Consumer use - furnishing, cleaning, treatment/care products - air care products;
Consumer use - furnishing, cleaning, treatment/care products - fabric, textile, and leather
products (apparel and footwear care products);
Consumer use - packaging, paper, plastic, hobby products - arts, crafts, and hobby materials;
Consumer use - packaging, paper, plastic, hobby products - ink, toner, and colorant products;
Consumer use - packaging, paper, plastic, hobby products - other articles with routine direct
contact during normal use including rubber articles; plastic articles (hard); vinyl tape; flexible
tubes; profiles; hoses;
Consumer use - packaging, paper, plastic, hobby products - packaging (excluding food
packaging), including rubber articles; plastic articles (hard); plastic articles (soft);
Consumer use - packaging, paper, plastic, hobby products - toys, playground, and sporting
equipment;
Consumer use - other - novelty articles;
Consumer use - other - automotive articles; and
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• Disposal.
Whether EPA makes a determination of unreasonable risk for a particular chemical substance under
TSCA depends upon risk-related factors beyond exceedance of benchmarks, such as the endpoint under
consideration, the reversibility of effect, exposure-related considerations (e.g., duration, magnitude,
frequency of exposure, population exposed—including PESS), and the confidence in the information
used to inform the hazard and exposure values. This unreasonable risk determination explains how the
Agency considered these risk related factors in the determination.
For some COUs, EPA integrated reasonably available information in a qualitative risk characterization
using professional judgement of read-across evidence. The qualitative analyses are a best estimate of
what the Agency expects given the weight of scientific evidence. For COUs evaluated quantitatively, as
described in the risk characterization, EPA also considered how the central tendency and high-end risk
estimates represented the risk related factors, and the Agency based the risk determination on the risk
estimate that best represented the COU. EPA also considered, where relevant, the Agency's analyses on
aggregate exposures. Additionally, in the risk evaluation, EPA describes the weight of scientific
evidence supporting the human health and environmental assessments in terms of strength such as
robust, moderate, or slight. Robust confidence suggests thorough understanding of the scientific
evidence and uncertainties, and that the supporting weight of scientific evidence outweighs the
uncertainties to the point where it is unlikely that the uncertainties could have a significant effect on the
risk. Moderate confidence suggests some understanding of the scientific evidence and uncertainties, and
the supporting scientific evidence weighed against the uncertainties is reasonably adequate to
characterize the risk. Slight confidence is assigned when the weight of scientific evidence may not be
adequate to characterize the risk and when the Agency is making the best scientific assessment possible
in the absence of complete information.
This risk evaluation discusses important assumptions and key sources of uncertainty in the risk
characterization, and these are described in more detail in the respective weight of scientific evidence
conclusion sections for fate and transport, environmental release, environmental exposures,
environmental hazards, and human health hazards. It also includes overall confidence and remaining
uncertainties sections for human health and environmental risk characterization.
In the DINP unreasonable risk determination, EPA has considered risk estimates with an overall
confidence rating of slight, moderate, or robust. In general, the Agency makes an unreasonable risk
determination based on risk estimates that have an overall confidence rating of moderate or robust—
because those confidence ratings indicate the scientific evidence is adequate to characterize risk despite
uncertainties or is such that it is unlikely the uncertainties could have a significant effect on the risk
estimates.
6.1 Human Health
Calculated non-cancer risk estimates (margins of exposure or MOEs1) can provide a risk profile of
DINP by presenting a range of estimates for different health effects for different COUs. When
characterizing the risk to human health from occupational exposures during risk evaluation under TSCA,
1 EPA derives non-cancer MOEs by dividing the non-cancer POD (HEC [mg/m3] or HED [mg/kg-day]) by the exposure
estimate (mg/m3 or mg/kg-day). Section 4.3.1 has additional information on the risk assessment approach for human health.
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EPA conducts baseline assessments of risk and makes its determination of unreasonable risk that does
not assume use of respiratory protection or other personal protective equipment (PPE2). Making
unreasonable risk determinations based on the baseline assessment should not be viewed as an indication
that the Agency believes there are no occupational safety protections in place at any location. Rather, it
reflects EPA's recognition that unreasonable risk may exist for subpopulations of workers that may be
highly exposed. The Agency making an unreasonable risk determination based on the absence of PPE
should not be viewed as an indication that other federal, state, and local regulations pertaining to PPE
use are not adequate. EPA published its position on the use of PPE in developing risk evaluations in its
procedures for chemical risk evaluation rule under TSCA Federal Register notice on May 3, 2024 (FRL-
8529-02-OCSPP).
An MOE that is less than the benchmark MOE is a starting point for informing a determination of
unreasonable risk of injury to health, based on non-cancer effects. It is important to emphasize that these
calculated risk estimates alone are not bright-line indicators of unreasonable risk. In the risk
determination, as described in the procedures for chemical risk evaluation rule (89 FR 37028; May 3,
2024), EPA considers risk-related factors beyond exceedance of benchmarks.
6.1.1 Populations and Exposures EPA Assessed for Human Health
EPA has evaluated risk to workers—including ONUs, female workers of reproductive age, and
adolescent and adult workers (>16 years); consumer users and bystanders, including infants and children;
and the general population, including infants and children and people who consume fish—using
reasonably available monitoring and modeling data for inhalation and dermal exposures, as applicable.
EPA has evaluated risk from inhalation and dermal exposure of DINP to workers, inhalation exposure to
ONUs, and for relevant COUs—dermal exposure to ONUs from contact with mist or dust deposited on
surfaces containing DINP. The Agency has evaluated risk from inhalation, dermal, and oral-exposure to
consumer users. For relevant COUs, the Agency has evaluated risk from inhalation exposure to
bystanders and dermal exposures where bystanders, including children, could have exposures from the
products or articles that contain DINP, such as wallpaper. Finally, EPA also evaluated risk from
exposures from surface water, drinking water, fish ingestion, ambient air, and land pathways {i.e.,
landfills and application of biosolids) to the general population.
Descriptions of the data used for human health exposure and human health hazards are provided in
Sections 4.1 and 4.2, respectively, in this risk evaluation. Uncertainties for overall exposures and
hazards are presented in this risk evaluation, the Consumer and Indoor Exposure Assessment for
Diisononyl Phthalate (DINP) ( 25b). and the Environmental Release and Occupational
Exposure Assessment for Diisononyl Phthalate (DINP) (U. 2025r), and all are considered in this
unreasonable risk determination.
6.1.2 Summary of Human Health Effects
EPA has determined that the unreasonable risk presented by DINP is due to
2 It should be noted that, in some cases, baseline conditions may reflect certain mitigation measures, such as engineering
controls, in instances where exposure estimates are based on monitoring data at facilities that have engineering controls in
place.
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• non-cancer effects (developmental toxicity) in female workers of reproductive age from acute
inhalation exposures;
• non-cancer effects (liver effects) in female workers of reproductive age from chronic aggregate
exposures; and
• non-cancer effects (liver effects) in workers from chronic aggregate exposures
With respect to health endpoints upon which EPA has based this unreasonable risk determination, the
Agency has robust overall confidence in the non-cancer developmental toxicity POD (fetal testicular
testosterone) for use in characterizing risk from exposure to DINP for acute and intermediate exposure
scenarios. The acute and intermediate POD is considered most applicable to women of reproductive
age/pregnant women, male infants, and male children. The developmental toxicity POD was not
considered in the risk determination of other age groups (e.g., adult males). In addition, EPA has robust
overall confidence in the POD based on liver effects for use in characterizing risk from exposure to
DINP for chronic exposure scenarios. The liver effects chronic POD is considered most applicable to
male and female adult workers, adult consumers, and adult members of the general population who may
have chronic exposures to DINP through work, regular contact with consumer products and/or articles
containing DINP, or through TSCA releases of DINP to the environment. However, use of the chronic
POD for assessing risk to infants and children was not considered in the risk determination because the
effects (spongiosis hepatis) are most prevalent in the livers of aging rats.
With respect to cancer effects, EPA reviewed the studies that investigated DINP's potential to cause
cancer in laboratory animals and concluded that DINP can cause liver cancer in rats and mice. However,
liver cancer in rats and mice occurred at higher doses than observed for other non-cancer effects on the
liver and the developing male reproductive system. Therefore, evaluating and protecting human health
from non-cancer risks associated with exposure to DINP will also be protective of cancer effects.
EPA's exposure and overall risk characterization confidence levels are summarized in Section 4.3, with
specific confidence levels presented in Sections 4.3.2.9 (occupational exposure) and 4.3.3.1 (consumer
exposure). Additionally, health risk estimates can be found in Section 4.3.2 (workers, including ONUs),
Section 4.3.3 (consumers and bystanders), Section 4.3.4 (general population), and Section 4.3.5 (PESS).
Again, the benchmarks are not bright lines and EPA has discretion to consider other risk-related factors
when concluding whether a COU significantly contributes to the unreasonable risk of the chemical
substance.
6.1.3 Basis for Unreasonable Risk to Human Health
In developing the exposure and hazard assessments for DINP, EPA analyzed reasonably available
information to ascertain whether some human populations may have greater exposure and/or
susceptibility than the general population to the hazard posed by DINP. For the DINP risk evaluation,
EPA identified the following groups as PESS: people who are expected to have greater exposure to
DINP at work; people who frequently use consumer products and/or articles containing high
concentrations of DINP; people who may have greater intake of DINP per body weight (e.g., infants,
children, adolescents); people exposed to DINP through certain age-specific behaviors (e.g., mouthing
of toys, wires, and erasers by infants and children and hand-to-mouth ingestion from synthetic leather
furniture assessed in the consumer exposure scenarios); people using toys before restrictions were in
place, leading to greater exposure; and subsistence fishers and tribal populations whose diets include
large amounts of fish. Additionally, EPA identified people who may have greater susceptibility to the
health effects of DINP as PESS, including women of reproductive age/pregnant women, infants,
children, and adolescents. The aggregate and high-end risk estimates reflect expected risk to PESS. A
full PESS analysis and the risk estimates that represent their risk can be found in Section 4.3.5.
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Risk estimates based on high-end exposure levels (e.g., 95th percentile, or high intensity scenarios) are
generally intended to cover individuals with sentinel exposure whereas risk estimates based on the
central tendency exposure are intended to cover average or typical exposure. However, because EPA
was able to calculate risk estimates for PESS groups in this assessment (e.g., female workers of
reproductive age, infants, and children), EPA generally used the central tendency risk estimates to
represent the average or typical exposure of the PESS group as the basis of the unreasonable risk
determination for DINP. The use of either central tendency or high-end risk estimates for workers to
make a determination of unreasonable risk is based on which one of the risk estimates for a COU, based
on the reasonably available information, best represent a typical scenario and process within the COU.
To determine the risk to consumers EPA considered high-intensity exposure levels. For example, high-
intensity consumer indoor dust exposure scenarios assumed that people are in their homes for longer
periods than the medium- or lower-intensity scenarios. The parameters were varied between the high-,
medium-, and low-intensity scenarios; for example, exposure duration (8 vs. 2 hours for high vs. low,
respectively, for applying roofing adhesives, hanging wallpaper and for using indoor furniture). Health
parameters were also adjusted for each population, such as inhalation rates used per lifestage.
Additionally, as explained in Sections 3.3, 4.1.3, 4.3.4, and 5.1, EPA used a screening level approach in
this risk evaluation using conservative environmental release estimates for occupational COUs with the
highest releases to determine whether there is risk to the environment and the general population. Thus,
for the environment, EPA only considered high-end exposure levels.
Additionally, the Agency aggregated exposures across routes for workers, including ONUs, and
consumers for COUs with quantitative risk estimates. For most occupational COUs, aggregation of
inhalation and dermal exposures led to negligible differences (<10%) in risk estimates when the
aggregate risk estimated was compared to the inhalation risk estimate, which was the dominant route.
Inhalation exposure is the dominant route for occupational scenarios where mists or dusts are generated,
and dermal exposure is the dominant route for occupational scenarios where mists or dusts are not
generated. For consumers, dermal, oral, and inhalation routes were aggregated. More information on
how EPA characterized sentinel and aggregate risks is provided in Section 4.1.5.
6.1.4 Workers
EPA analyzed mist or dust concentration inhalation exposure in the occupational scenarios using a TWA
for a typical 8-hour shift (Table 4-3). Separate estimates of central tendency and high-end inhalation and
dermal exposures were made for average adult (16+ years old) workers, female workers of reproductive
age, and ONUs, as appropriate.
Non-cancer risk estimates were calculated from acute, intermediate, and chronic exposures. These terms
are in reference to the duration of exposure to DINP. For most OESs, acute refers to an exposure
timeframe of one 8-hour workday, intermediate refers to an exposure timeframe of 22 workdays, 8 hours
per day, and chronic refers to an exposure timeframe of 250 days per year for 31 to 40 years (8 hours per
day).
EPA analyzed the individual COUs using both central tendency or high-end estimates for workers,
including ONUs, based on the parameters and assumptions used in the OESs used to evaluate each
COU. For the majority of COUs evaluated, risk was not indicated at the high-end or central tendency
estimates for inhalation exposure to workers, including ONUs. Risk was not indicated at the high-end or
central tendency estimates for dermal exposure to workers, including ONUs for any of the COUs
assessed. For those four COUs that had risk indicated at the high-end for workers after aggregation of
the individual routes (inhalation, dermal) of exposure, these four COUs represent scenarios where
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conservative assumptions used in the calculations for workers inhaling dust containing DINP are
contributing to unusually elevated risk estimates. For example, the MOEs represent total PNOR (i.e.,
dust) concentrations that contain a variety of constituents besides DINP, and a conservative assumption
that the amount of plasticizer in dust is equal to the weight fraction of plasticizer in the PVC product or
article. Furthermore, it was noted by a public comment (EPA-HQ-OPPT-2024-0073-0069) that liquid
plasticizers are generally added to dry mixtures during the compounding process, and any dust generated
would come from the dry material rather than the plasticizer.
Based on the occupational risk estimates and related risk factors, EPA has determined that the following
four COUs significantly contribute to the unreasonable risk presented by DINP to workers, specifically
female workers of reproductive age due to acute inhalation exposure:
• Industrial use - adhesives and sealant chemicals (sealant (barrier) in machinery manufacturing;
computer and electronic product manufacturing; electrical equipment, appliance, component
manufacturing, and adhesion/cohesion promoter in transportation equipment manufacturing);
• Industrial use - construction, paint, and metal products - paints and coatings;
• Commercial use - construction, paint, electrical, and metal products - adhesives and sealants;
and
• Commercial use - construction, paint, electrical, and metal products - paints and coatings.
These four COUs have MOEs below the benchmark of 30 at the high-end estimates of acute inhalation
exposure—mainly because of the use of spray applications and mist generation. In general, exposures to
DINP through spray applications are expected to be closer to the central tendency risk estimates for
these four COUs, due to the exposure scenario inputs and parameters used in the risk evaluation (e.g.,
low ventilation, high-pressure spray, concentrations of DINP, total volume of product used). The risk
estimates for the spray application scenarios at the central tendency would result in risk estimates above
the benchmark MOE; however, the high-end risk estimates represent situations that are reasonably
expected to occasionally occur for an acute 1-day exposure. In addition, the endpoint considered for
acute exposures (offspring loss) is relevant only for female workers of reproductive age. Therefore, EPA
did not identify risk to average adult workers or ONUs on the basis of high-end acute, intermediate, and
chronic inhalation exposures or aggregated acute exposures that would contribute to the unreasonable
risk of DINP. However, at the central tendency, two of the four COUs (the industrial and commercial
adhesives and sealants) have chronic aggregate MOEs that still indicate risk, so EPA has determined that
these two COUs would significantly contribute to the unreasonable risk of DINP for all workers due to
chronic aggregate exposure. Based on these considerations, EPA has determined that these four COUs
significantly contribute to the unreasonable risk of DINP due to acute inhalation exposures for female
workers of reproductive age, and two of the four COUs are due to chronic aggregate exposure for all
workers. Sections 4.1.1 and 4.3.2, provide more details regarding the inputs and parameters used in the
exposure scenarios and the consideration of central tendency or high-end risk estimates.
Distribution in Commerce
EPA qualitatively evaluated the distribution in commerce COU. Worker activities associated with
distribution in commerce (e.g., loading, unloading) are not expected to generate mist or dust, similar to
other COUs such as domestic manufacturing. Dermal contact with the neat material or concentrated
formulations may occur during activities associated with distribution in commerce is also similar to
COUs such as domestic manufacturing. Therefore, occupational exposures associated with the
distribution in commerce COU are expected to be less than the domestic manufacturing COU (which
does not significantly contribute to the unreasonable risk of DINP); thus, EPA has determined that
distribution in commerce does not significantly contribute to the unreasonable risk of DINP. Section
4.3.2.7 provides more details.
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In the overall occupational assessment, EPA has moderate to robust confidence in the assessed
inhalation and dermal OESs and robust confidence in the non-cancer PODs selected to characterize risk
from acute, intermediate, and chronic duration exposures to DINP. Overall, the Agency has moderate to
robust confidence in the risk estimates calculated for worker and ONU inhalation and dermal exposure
scenarios. More information on EPA's confidence in these risk estimates and the uncertainties
associated with them can be found in Section 4.3.2.9.
6.1.5 Consumers
Based on the consumer risk estimates and related risk factors, EPA has determined that consumer COUs
do not significantly contribute to the unreasonable risk of DINP. Although EPA considered MOEs that
were below the benchmark for one consumer COU: Consumer use - construction, paint, electrical, and
metal products - adhesives and sealants, the Agency is finding that this COU does not contribute
significantly to the unreasonable risk. Further information is provided below.
When applicable, such as the assessment of the Packaging, paper, plastic, hobby products - toys,
playground, and sporting equipment COU, oral exposure to DINP was evaluated through the mouthing
of articles during use. EPA notes that the Consumer Product Safety Improvement Act of 2008 banned
the use of DINP at concentrations of greater than 0.1 percent in children's toys and childcare articles in
2008 for certain articles. The U.S. CPSC subsequently finalized a ban in 2018 for all remaining articles.
EPA expects that the use of toys and childcare articles manufactured or processed prior to the bans in
2008 and 2018, respectively, and thus potentially containing DINP concentration greater than 0.1
percent may still be occurring.
The acute, intermediate (where assessed), and chronic inhalation risk estimates for bystanders do not
indicate risk for the COUs assessed. Dermal and oral exposures were assessed for non-cancer risks for
consumers only because bystanders would not be expected to be exposed within any consumer COUs.
Non-cancer risk estimates for consumers and bystanders were calculated from acute, intermediate
(where assessed), and chronic exposures. For a given consumer exposure scenario, acute exposure refers
to the timeframe of 1 day, intermediate refers to an exposure timeframe of 30 days, and chronic refers to
a timeframe of 365 days. Professional judgment and product use descriptions were used to estimate the
intermediate timeframe.
For Construction, paint, electrical, and metal products - adhesives and sealants, chronic, high-intensity
aggregate risk estimates were below the benchmark of 30. The risk estimate for young teens (11-15
years) was 22, and the risk estimate for teenagers (16-20 years) and adults (21+ years) was 27. EPA
identified two roofing adhesion products with weight fractions ranging from 30 to 31 percent and used
31 percent for the high-intensity model. However, for this COU, EPA modeled a well-ventilated, indoor
area for roofing adhesives because, although inhalation exposures outdoors are generally expected to be
negligible, the size of a typical roofing project and the high weight fraction of DINP in identified roofing
adhesive products was such that the Agency did not consider the potential for outdoor exposures to be
negligible. However, while one extreme and unlikely high intensity use scenario exceeded the MOE
benchmark for the three age groups mentioned above (where EPA estimated aggregate risk assuming
dermal contact [inside of two palms] with the adhesive during 365 roofing projects in a single year), the
medium intensity use scenario did not exceed the MOE benchmark. Further refinement of the high
intensity use scenario with a smaller events per year input would result in MOEs similar or higher to
those in the medium and low intensity use scenarios. Therefore, EPA determined that the consumer
COU, Construction, paint, electrical, and metal products - adhesives and sealants, in an outdoors or a
well-ventilated indoor setting, does not significantly contribute to the unreasonable risk of DINP.
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The overall confidence in the exposure doses used to estimate risk ranges from moderate to robust. EPA
has robust confidence in the non-cancer POD selected to characterize risk from acute, intermediate, and
chronic duration exposures to DINP. The Agency has moderate to robust confidence in the assessed
inhalation, ingestion, and dermal consumer exposure scenarios (Section 4.3.3.1). More information on
EPA's confidence in these risk estimates and the uncertainties associated with them can be found in this
risk evaluation as well as the Consumer and Indoor Dust Exposure Assessment for Diisononyl Phthalate
(DINP) (U.S. EPA. 2025bY
6.1.6 General Population
Based on a screening level exposure assessment using releases from manufacturing, processing, and
industrial uses of DINP, and related risk factors, EPA did not identify risk to the general population for
non-cancer effects that would contribute to the unreasonable risk of DINP. For further information, see
Section 4.1.3.1.
Due to DINP's low water solubility, affinity for sorption to soil and organic constituents in soil, and
considering the half-life in aerobic soils, DINP is unlikely to migrate from land applied biosolids to
groundwater via runoff and is unlikely to be present in landfill leachate or be mobile in soils. For these
reasons, biosolids and landfill were evaluated qualitatively. As such, EPA does not expect general
population exposure to DINP to occur via the land pathway; therefore, the Agency does not expect there
to be risk to the general population from the land pathway.
EPA used the highest possible DINP concentration in surface water due to facility release to
quantitatively evaluate the risk to the general population from exposure to DINP from drinking water or
incidental ingestion and dermal contact during recreational swimming. The Agency took the high-end
exposure estimates associated with the COU with the highest total water column concentration to
calculate an MOE. Because that MOE did not indicate non-cancer risk, based on this screening level
assessment, risk for non-cancer health effects is not expected for the surface water pathway for the
general population.
Risk estimates for fish ingestion generated at concentrations of DINP at both the water solubility limit
and at the highest measured concentrations in surface water did not indicate risk to tribal populations. As
tribal populations are considered to represent the sentinel exposure scenario because of their elevated
fish ingestion rates compared to the general population and subsistence fisher population, it can be
extrapolated that, based on these results, fish ingestion is also not considered a pathway of concern for
risk to subsistence fishers and the general population.
EPA also considered concentrations of DINP in ambient air and soil deposition of DINP from air.
Inhalation exposure was not assessed because DINP is not persistent in the air and partitions primarily to
soil. Therefore, ambient air it is not expected to be an exposure pathway of concern to DINP for the
general population (Section 4.1.3). The Agency used the OES that provided the highest modeled 95th
percentile annual ambient air and air deposition concentrations for DINP to calculate exposure due to
ingestion or contact with DINP in soil and used conservative exposure assumptions for infants and
children (ages 6 months to <12 years). MOEs based on these conservative estimates were above the
benchmark of 30 (MOEs for general population exposure through a combined soil ingestion and dermal
soil contact is 180 for acute and 53 for chronic). Therefore, based on this screening level analysis, risk
for non-cancer health effects is not expected for the ambient air pathway for the general population.
EPA has robust confidence in its qualitative assessment of biosolids and landfills. Due to the high
confidence in the biodegradation rates and physical and chemical data, there is robust confidence that in
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soils receiving DINP it will not be mobile and will have low persistence potential, and there is robust
confidence that DINP is unlikely to be present in landfill leachates.
For its quantitative assessment for risk to the general population, EPA modeled exposure due to various
general population exposure scenarios resulting from different pathways of exposure. Exposure
estimates utilized high-end inputs for the purpose of risk screening. When available, monitoring data
was compared to modeled estimates to evaluate overlap, magnitude, and trends. EPA has robust
confidence that modeled releases used are appropriately conservative for a screening level analysis.
Therefore, the Agency has robust confidence that no exposure scenarios will lead to greater doses than
presented in this evaluation. More information on EPA's confidence in its assessment and the associated
uncertainties can be found in Section 4.1.3.1.
6.2 Environment
EPA did not identify risk of injury to the environment that would contribute to the unreasonable risk
determination for DINP. EPA compared the highest release estimates to environmental media for a
given pathway with the hazard values for aquatic and terrestrial organisms. If the exposure for the COU
with the highest amount of environmental release {i.e., the COU with the highest environmental
exposures, the most conservative exposure estimates) did not exceed the hazard threshold for aquatic or
terrestrial organisms, it was determined that exposures due to releases from other COUs would not lead
to environmental risk. Qualitative risk characterization indicates that EPA does not expect risk for all
pathways assessed for exposure to ecological receptors. Expected lack of risk to aquatic and terrestrial
receptors was assigned moderate confidence except in cases where the Agency lacked reasonably
available hazard data {e.g., avian species and terrestrial plants). Because of the lack of reasonably
available information, EPA is not identifying risk to avian and terrestrial plant receptors.
6.2.1 Populations and Exposures EPA Assessed for the Environment
EPA quantitatively determined DINP concentrations in surface water, sediment, and soil. However, the
Agency did not quantitatively evaluate exposures to aquatic organisms and terrestrial species. The use of
a qualitative analysis of exposure for DINP to aquatic organisms and terrestrial species was chosen due
to the fact that (1) DINP does not persist in environmental media, (2) hazard thresholds were not
identified for some receptors, and (3) DINP environmental exposures were consistently below the
concentrations tested within hazard studies indicating a lack of environmental toxicity for this
compound.
EPA expects the main environmental exposure pathway for aquatic species to be releases to surface
water and subsequent deposition to sediment. Releases to ambient air and subsequent deposition to
water and sediment also have a limited contribution to environmental exposure for aquatic organisms.
EPA determined that DINP is expected to have a low potential for bioaccumulation and
biomagnification in aquatic organisms. As detailed in Section 5.3.2, monitoring data from published
literature report DINP concentrations within surface water and sediment lower than the highest NOEC
values presented among several hazard studies for aquatic invertebrates and vertebrates in the water
column, benthic invertebrates in the sediment, and aquatic plants and algae.
EPA expects that DINP has a low bioconcentration and biomagnification potential across trophic levels.
DINP exposure to terrestrial organisms occurs primarily through diet via the sediment pathway for semi-
aquatic terrestrial mammals followed by the soil pathway for soil invertebrates and terrestrial mammals,
with releases to surface water representing an exposure pathway of concern. Direct exposure of DINP to
terrestrial receptors via air was not assessed quantitatively because dietary exposure was determined to
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be the driver of exposure to wildlife; however, air deposition of DINP to soil, sediment, and surface
water were modeled to represent COU-based releases to air.
In general, EPA has an overall robust confidence in environmental releases for acute and chronic aquatic
assessments, chronic benthic assessments, and algal assessments and moderate confidence in
environmental releases for chronic mammalian assessment and terrestrial invertebrates. Although the
conservative nature of model outputs resulted in slight confidence for the environmental media
concentrations in surface water, sediment, and soil, there is robust confidence that the modeled
environmental media concentrations do not underestimate exposure to ecological receptors, as noted in
Table 5-2 of this risk evaluation. EPA has also determined an indeterminate confidence in chronic avian
and terrestrial plant assessments as there is a lack of reasonably available hazard data, and the Agency is
not identifying risk to avian and terrestrial plant receptors. Because terrestrial hazard data for DINP were
not available for birds or mammalian species, studies in earthworms (and rats to develop a TRV) were
used to derive hazard values for mammalian species.
6.2.2 Summary of Environmental Effects
EPA qualitatively assessed risk via release to surface water and subsequent deposition to sediment, as
well as the ambient air exposure pathway for its limited contribution via deposition to soil, water, and
sediment and has identified
• no adverse effects to aquatic organisms up to and exceeding the limit of water solubility;
• no adverse effects to aquatic dependent mammals; and
• no adverse effects to terrestrial mammals.
EPA evaluated activities resulting in exposures associated with distribution in commerce (e.g., loading,
unloading) throughout the various life cycle stages and COUs (e.g., manufacturing, processing,
industrial use, commercial use, disposal) rather than a single distribution scenario. EPA expects that
environmental releases from distribution in commerce will be similar or less than the exposure estimates
from the COUs evaluated that did not exceed hazard to ecological receptors; therefore, the Agency has
determined that distribution in commerce also would not result in exposures that significantly contribute
to the unreasonable risk of DINP.
EPA evaluated down-the-drain releases of DINP for consumer COUs qualitatively. Although the
Agency acknowledges that there may be DINP releases to the environment via the cleaning and disposal
of adhesives, sealants, paints, lacquers, and coatings, EPA did not quantitatively assess down-the-drain
and disposal scenarios of consumer products due to limited information from monitoring data, or
modeling tools. However, the consideration of the physical and chemical properties of DINP allows the
Agency to conduct a qualitative assessment. DINP affinity to organic material and low water solubility
and log Kow suggest that DINP in down-the-drain water is expected to mainly partition to suspended
solids present in water. Also, the use of flocculants and filtering media could potentially help remove
DINP during conventional drinking water treatment. Therefore, EPA does not expect risk to the
environment from down-the-drain releases associated with the consumer COUs.
6.2.3 Basis for No Unreasonable Risk of Injury to the Environment
Based on the risk evaluation for DINP—including the risk estimates, the environmental effects of DINP,
the exposures, physical and chemical properties of DINP, and consideration of uncertainties—EPA does
not identify risk of injury to the environment that would contribute to the unreasonable risk
determination for DINP.
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For aquatic organisms, surface water and subsequent deposition to sediment were determined to be the
drivers of exposure, but EPA does not expect these pathways to contribute significantly to unreasonable
risk to the environment. The Agency does not expect exposure to DINP via water, land, or dietary
pathways to contribute significantly to unreasonable risk to the environment. EPA's overall
environmental risk characterization confidence levels varied and are summarized in the Environmental
Exposure Assessment for Diisononyl Phthalate (DINP) ( |25o).
6.3 Additional Information Regarding the Basis for the Unreasonable Risk
Determination
Table 6-1 summarizes the basis for this unreasonable risk determination of injury to human health and
the environment presented in this risk evaluation. In these tables, a checkmark (•/) indicates how the
COU significantly contributes to the unreasonable risk by identifying the type of effect (e.g., non-cancer
for human health) and the exposure route to the population or receptor that results in such contribution.
As explained in Section 6, for this unreasonable risk determination, EPA considered the effects of DINP
to human health at the central tendency and high-end, as well as effects of DINP to human health from
the exposures associated from the TSCA COUs, risk estimates, and uncertainties in the analysis.
Checkmarks in Table 6-1 represents risk at the high-end (for COUs with acute durations of spray
application) and central tendency exposure level as discussed in Section 6.1.
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Table 6-1. Supporting Basis for the Risk Determination for Human Health (Occupational CPUs)
l.ilV C \cle
SiihciiU'jion
Populiilion
l'l\|)UMIIV
Anile Non-
Ink'niK'diiik'
Chronic Non-
S(;i»e
Roiile
c;inccr
Non-ciinccr
Ciincor
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Domestic
Domestic manufacturing
Worker: Female of
Reproductive Age
Inhalation
manufacturing
Dermal
Aggregate
ONU
Inhalation
Manufacturing
Aggregate
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Importing
Importing
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Aggregate
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Heat stabilizer and processing aid in basic
Worker: Female of
Reproductive Age
Inhalation
organic chemical manufacturing
Dermal
Aggregate
Incorporation in
formulation,
mixture, or
reaction product
ONU
Inhalation
Processing
Aggregate
Worker: Average
Adult Worker
Inhalation
Plasticizers (adhesives manufacturing,
Dermal
custom compounding of purchased resin;
paint and coating manufacturing; plastic
material and resin manufacturing; synthetic
rubber manufacturing; wholesale and retail
trade; all other chemical product and
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
preparation manufacturing; ink, toner, and
Inhalation
colorant manufacturing [including
ONU
Dermal
pigment])
Aggregate
Page 203 of 269
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l.ilV < \cle
S(;i»e
('silcgon
SiihciiU'jion
Populiilion
l'l\|)UMIIV
Roiile
Anile Non-
c;inccr
Ink'niK'diiik'
Non-ciinccr
Chronic Non-
Ciincor
Processing
Incorporation
into articles
Plasticizers (toys, playground and sporting
equipment manufacturing;
plastics products manufacturing; rubber
product manufacturing; wholesale and
retail trade; textiles, apparel, and leather
manufacturing; electrical equipment,
appliance, and component manufacturing;
ink, toner, and colorant manufacturing
[including pigment])
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Dermal
Aggregate
Other uses
Miscellaneous processing (petroleum
refineries; wholesale and retail trade)
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Aggregate
Repackaging
Plasticizer (all other chemical product and
preparation manufacturing; wholesale and
retail trade; laboratory chemicals
manufacturing)
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Aggregate
Recycling
Recycling
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
Page 204 of 269
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l.ilV < \cle
S(;i»e
('silcgon
SiihciiU'jion
Populiilion
l'l\|)UMIIV
Roiile
Anile Non-
c;inccr
Ink'niK'diiik'
Non-ciinccr
Chronic Non-
Ciincor
Processing
Recycling
Recycling
ONU
Inhalation
Dermal
Aggregate
Distribution in
Commerce
Distribution in
commerce
Distribution in Commerce
Assessed qualitatively
Industrial Use
Adhesive and
sealant
chemicals
Adhesive and sealant chemicals (sealant
(barrier) in machinery manufacturing;
computer and electronic product
manufacturing; electrical equipment,
appliance, component manufacturing, and
adhesion/cohesion promoter in
transportation equipment manufacturing)
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
~
Worker: Female of
Reproductive Age
Inhalation
~
Dermal
Aggregate
~
~
ONU
Inhalation
Dermal
Aggregate
~
Construction,
paint, electrical,
and metal
products
Building/construction materials (roofing,
pool liners, window shades, flooring, water
supply piping)
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
Paints and coatings
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
~
Dermal
Aggregate
~
ONU
Inhalation
Dermal
Aggregate
Other uses
Hydraulic fluids
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Page 205 of 269
-------
l.ilV < \cle
S(;i»e
('silcgon
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Populiilion
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c;inccr
Ink'niK'diiik'
Non-ciinccr
Chronic Non-
Ciincor
Industrial Use
Other uses
Aggregate
ONU
Inhalation
Aggregate
Pigment (leak detection)
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Aggregate
Automotive articles
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Dermal
Aggregate
Commercial
Use
Construction,
paint, electrical,
and metal
products
Adhesives and sealants
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
~
Worker: Female of
Reproductive Age
Inhalation
~
Dermal
Aggregate
~
V
ONU
Inhalation
Dermal
Aggregate
~
Plasticizer in building/construction
materials (roofing, pool liners, window
shades, water supply piping); construction
and building materials covering large
surface areas, including paper articles;
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Page 206 of 269
-------
l.ilV < \cle
S(;i»e
('silcgon
SiihciiU'jion
Populiilion
l'l\|)UMIIV
Roiile
Anile Non-
c;inccr
Ink'niK'diiik'
Non-ciinccr
Chronic Non-
Ciincor
Commercial
Use
Construction,
paint, electrical,
and metal
products
metal articles; stone, plaster, cement, glass,
and ceramic articles''
Aggregate
ONU
Inhalation
Dermal
Aggregate
Electrical and electronic products
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Dermal
Aggregate
Paints and coatings
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
~
Dermal
Aggregate
~
ONU
Inhalation
Dermal
Aggregate
Furnishing,
cleaning,
treatment/care
products
Foam seating and bedding products;
furniture and furnishings including plastic
articles (soft); leather articles
Foam seating and bedding products;
furniture and furnishings including plastic
articles (soft); leather articles
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Dermal
Aggregate
Air care products
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Inhalation
Page 207 of 269
-------
l.ilV C \cle
SiihciiU'jion
Populiilion
l'l\|)UMIIV
Anile Non-
Ink'niK'diiik'
Chronic Non-
S(;i»e
Roiile
c;inccr
Non-ciinccr
Ciincor
Reproductive Age
Dermal
Aggregate
ONU
Inhalation
Aggregate
Worker: Average
Adult Worker
Inhalation
Dermal
Floor coverings; plasticizer in construction
Aggregate
and building materials covering large
surface areas including stone, plaster,
cement, glass, and ceramic articles; fabrics,
textiles and apparel (vinyl tiles, resilient
flooring, PVC-backed carpeting
Worker: Female of
Reproductive Age
Inhalation
Dermal
Furnishing,
cleaning,
treatment/care
Aggregate
Inhalation
ONU
Dermal
products
Aggregate
Worker: Average
Adult Worker
Inhalation
Commercial
Dermal
Use
Aggregate
Fabric, textile, and leather products
(apparel and footwear care products))
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
Inhalation
ONU
Dermal
Aggregate
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Packaging,
paper, plastic,
hobby products
Arts, crafts, and hobby materials
Dermal
Aggregate
Inhalation
ONU
Dermal
Aggregate
Ink, toner, and colorant products
Worker: Average
Inhalation
Adult Worker
Dermal
Page 208 of 269
-------
l.ilV < \cle
S(;i»e
('silcgon
SiihciiU'jion
Populiilion
l'l\|)UMIIV
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Anile Non-
c;inccr
Ink'niK'diiik'
Non-ciinccr
Chronic Non-
Ciincor
Commercial
Use
Packaging,
paper, plastic,
hobby products
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Aggregate
Packaging, paper, plastic, hobby products
(packaging (excluding food packaging),
including rubber articles; plastic articles
(hard); plastic articles [soft])
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Dermal
Aggregate
Plasticizer (plastic and rubber products;
tool handles, flexible tubes, profiles, and
hoses)
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Dermal
Aggregate
Toys, playground, and sporting equipment
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Dermal
Aggregate
Solvents (for
cleaning or
Solvents (for cleaning or degreasing)
Worker: Average
Adult Worker
Inhalation
Dermal
Page 209 of 269
-------
l.ilV < \cle
S(;i»e
SiihciiU'jion
Populiilion
l'l\|)UMIIV
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c;inccr
Ink'niK'diiik'
Non-ciinccr
Chronic Non-
Ciincor
Commercial
Use
degreasing)
Solvents (for cleaning or degreasing)
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Aggregate
Other uses
Laboratory chemicals
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Dermal
Aggregate
Automotive articles
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Dermal
Aggregate
Disposal
Disposal
Disposal
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Dermal
Aggregate
Page 210 of 269
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Z025p). Environmental Hazard Assessment for Diisononyl Phthalate (DINP). Washington,
DC: Office of Pollution Prevention and Toxics.
Z025q). Environmental Media and General Population Screening for Diisononyl Phthalate
(DINP). Washington, DC: Office of Pollution Prevention and Toxics.
E025r). Environmental Release and Occupational Exposure Assessment for Diisononyl
Phthalate (DINP) Washington, DC: Office of Pollution Prevention and Toxics.
Page 222 of 269
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2025s). Fate Assessment for Diisononyl Phthalate (DINP). Washington, DC: Office of
Pollution Prevention and Toxics.
2025t). Fish Ingestion Risk Calculator for Diisononyl Phthalate (DINP). Washington, DC:
Office of Pollution Prevention and Toxics.
2025u). Non-cancer Human Health Hazard Assessment for Diisononyl Phthalate (DINP)
Washington, DC: Office of Pollution Prevention and Toxics.
2Q25v). Physical Chemistry Assessment for Diisononyl Phthalate (DINP). Washington, DC:
Office of Pollution Prevention and Toxics.
2025w). Risk Calculator for Occupational Exposures for Diisononyl Phthalate (DINP)
Washington, DC: Office of Pollution Prevention and Toxics.
2025x1 Surface Water Human Exposure Risk Calculator for Diisononyl Phthalate (DINP)
for P50 Flow Rates. Washington, DC: Office of Pollution Prevention and Toxics.
2Q25v). Surface Water Human Exposure Risk Calculator for Diisononyl Phthalate (DINP)
for P75 Flow Rates. Washington, DC: Office of Pollution Prevention and Toxics.
2025z). Surface Water Human Exposure Risk Calculator for Diisononyl Phthalate (DINP)
for P90 Flow Rates. Washington, DC: Office of Pollution Prevention and Toxics.
2025aa). Systematic Review Protocol for Diisononyl Phthalate (DINP) Washington, DC:
Office of Pollution Prevention and Toxics.
>01). German Protocol VDI4300 Part 8 — Measurement of indoor air pollution: Sampling of
house dust. (VDI 4300 Blatt 8). Berlin, Germany: Beuth Verlag.
https://www.vdi.de/fileadmin/paees/vdi de/redakteure/richtlinien/inhaltsverzeichnisse/(
pdf
Vikels0e >msen. M; Carlsen. L. (2002). Phthalates and nonylphenols in profiles of differently
dressed soils. Sci Total Environ 296: 105-116. http://dx.doi.org/10.1016/80048-9697(02)00063-3
Wang. H; Guan. TO: Sun. IX; Talukder. M; Huang. YO; Li. YH: Li. JL. (2020). Di-(2-ethylhexyl)
phthalate induced nephrotoxicity in quail (Coturnix japonica) by triggering nuclear xenobiotic
receptors and modulating the cytochrome P450 system. Environ Pollut 261: 114162.
http://dx.doi.on 10 101 i ^nvpol.2Q_^ I I 11 .
Warn (2019). Modulation of heat-shock response is
associated with di (2-ethylhexyl) phthalate (DEHP)-induced cardiotoxicity in quail (Coturnix
japonica). Chemosphere 214: 812-820. http://dx.doi.org/10.1016/i.chemosphere..O I \ 10 002
Wen. ZD; Huativ v i »\N i in t Shat^ \\ \ 1 11 Song. KS.
(2018). Phthalate esters in surface water of Songhua River watershed associated with land use
types, Northeast China. Environ Sci Pollut Res Int 25: 7688-7698.
http://dx.doi.on
t (m i \U> 1 1 lu. M; Sun 1 u;i j no. D; Zeng. Z. (2008). Phthalate esters
(PAEs): Emerging organic contaminants in agricultural soils in peri-urban areas around
Guangzhou, China. Environ Pollut 156: 425-434. http://dx.doi.org 10 101 | envpol.200s 01 0 1^
Zeng. F: Cui. K; Xie. Z: Wu. L: Luo. D; Chen. L: Lin. Y: Liu. M: Sun. G. (2009). Distribution of
phthalate esters in urban soils of subtropical city, Guangzhou, China. J Hazard Mater 164: 1171-
1178. http://dx.doi.org/ jhazMat.2008.09.029
Zhan\ \ Wang. P; Wang. L; Sun bao. J; Zhang. H; Du. N. (2015). The influence of facility
agriculture production on phthalate esters distribution in black soils of northeast China. Sci Total
Environ 506-507: 118-125. http://dx.doi.org/10.1016/i.scitotenv.201 I 10 0 ^
Page 223 of 269
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APPENDICES
Appendix A KEY ABBREVIATIONS AND ACRONYMS
ADD
Average daily dose
ADC
Average daily concentration
AERMOD
American Meteorological Society/EPA Regulatory Model
BLS
Bureau of Labor Statistics
CASRN
Chemical Abstracts Service Registry Number
CBI
Confidential business information
CDR
Chemical Data Reporting
CEHD
Chemical Exposure Health Data
CEM
Consumer Exposure Model
CFR
Code of Federal Regulations
COU
Condition of use
CPSC
Consumer Product Safety Commission
DEHP
Diethylhexyl phthalate
DIDP
Diisodecyl phthalate
DINP
Diisononyl phthalate
DIY
Do-it-yourself
DMR
Discharge Monitoring Report
EPA
Environmental Protection Agency (or the Agency)
ESD
Emission scenario document
EU
European Union
FDA
Food and Drug Administration
FFDCA
Federal Food, Drug, and Cosmetic Act
GS
Generic scenario
Koc
Soil organic carbon: water partitioning coefficient
Kow
Octanol: water partition coefficient
HEC
Human equivalent concentration
HED
Human equivalent dose
IADD
Intermediate average daily dose
IR
Ingestion rate
LCD
Life cycle diagram
LOD
Limit of detection
LOEC
Lowest-ob served-effect concentration
Log Koc
Logarithmic organic carbon: water partition coefficient
Log Kow
Logarithmic octanol: water partition coefficient
MOE
Margin of exposure
NAICS
North American Industry Classification System
NHANES
National Health and Nutrition Examination Survey
NICNAS
National Industrial Chemicals Notification and Assessment Scheme
NOAEL
No-observed-adverse-effect level
NOEC
No-observed-effect -concentration
NPDES
National Pollutant Discharge Elimination System
NTP
National Toxicology Program
OCSPP
Office of Chemical Safety and Pollution Prevention
OECD
Organisation for Economic Co-operation and Development
OEL
Occupational exposure limit
Page 224 of 269
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OES
Occupational exposure scenario
ONU
Occupational non-user
OPPT
Office of Pollution Prevention and Toxics
OSHA
Occupational Safety and Health Administration
PBZ
Personal breathing zone
PEL
Permissible exposure limit (OSHA)
PESS
Potentially exposed or susceptible subpopulations
PNOR
Particulates not otherwise regulated
POD
Point of departure
POTW
Publicly owned treatment works
PPARa
Peroxisome proliferator activated receptor alpha
PVC
Polyvinyl chloride
SACC
Science Advisory Committee on Chemicals
SDS
Safety data sheet
SOC
Standard Occupational Classification
SpERC
Specific Emission Release Category
TRV
Toxicity reference value
TSCA
Toxic Substances Control Act
TSD
Technical support document
TWA
Time-weighted average
UF
Uncertainty factor
U.S.
United States
VVWM-PSC
Variable Volume Water Model with Point Source Calculator Tool
7Q10
The lowest 7-day average flow that occurs (on average) once every 10 years
30Q5
The lowest 30-day average flow that occurs (on average) once every 5 years
Page 225 of 269
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Appendix B REGULATORY AND ASSESSMENT HISTORY
B.l Federal Laws and Regulations
Table Apx B-l. Federal Laws and Regulations
Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
1 !l' \ Mlllllk's ICUIlljlliiills
Toxic Substances Control
Act (TSCA) - section 8(a)
The TSCA section 8(a) CDR Rule
requires manufacturers (including
importers) to give EPA basic exposure-
related information on the types,
quantities, and uses of chemical
substances produced domestically and
imported into the United States.
DINP manufacturing (including importing),
processing, and use information is reported
under the CDR rule (85 FR 5081620122.
April 9, 2020).
TSCA - section 8(b)
EPA must compile, keep current, and
publish a list (the TSCA Inventory) of
each chemical substance manufactured
(including imported) or processed for
commercial purposes in the United States.
1,2-Benzenedicarboxylic acid, 1,2-
diisononyl ester (CASRN 28553-12-0) and
1,2-benzenedicarboxylic acid, di-C8-10-
branched alkyl esters, C9-rich (CASRN
68515-48-0)) were on the initial TSCA
Inventory and therefore were not subject to
EPA's new chemicals review process under
TSCA section 5 ( )9, March 29,
1995).
TSCA - section 8(e)
Manufacturers (including importers),
processors, and distributors must
immediately notify EPA if they obtain
information that supports the conclusion
that a chemical substance or mixture
presents a substantial risk of injury to
health or the environment.
Four substantial risk reports were received
for CASRN 28553-12-0 and 8 substantial
risk reports were received for CASRN
68515-48-0 (1991-1998) (U.S. EPA,
ChemView. Accessed March 1, 2024).
TSCA - section 4
Provides EPA with authority to issue
rules, enforceable consent agreements,
and orders requiring manufacturers
(including importers) and processors to
test chemical substances and mixtures.
Two chemical data submissions from test
rules received for CASRN 28553-12-0 for
biodegradation (U.S. EPA, ChemView.
Accessed March 1, 2024).
Federal Food, Drug, and
Cosmetic Act (FFDCA) -
section 408
FFDCA governs the allowable residues of
pesticides in food. Section 408 of the
FFDCA provides EPA with the authority
to set tolerances (rules that establish
maximum allowable residue limits), or
exemptions from the requirement of a
tolerance, for pesticide residues (including
inert ingredients) on food. Prior to issuing
a tolerance or exemption from tolerance,
EPA must determine that the pesticide
residues permitted under the action are
"safe." Section 408(b) of the FFDCA
defines "safe" to mean a reasonable
certainty that no harm will result from
aggregate exposures (which includes
CASRN 28553-12-0 is approved for non-
food use (InertFinder, Accessed March 1,
2024).
Page 226 of 269
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
dietary exposures from food and drinking
water as well as nonoccupational
exposures) to the pesticide. Pesticide
tolerances or exemptions from tolerance
that do not meet the FFDCA safety
standard are subject to revocation under
FFDCA section 408(d) or (e). In the
absence of a tolerance or an exemption
from tolerance, a food containing a
pesticide residue is considered adulterated
and may not be distributed in interstate
commerce.
Clean Water Act (CWA)
- sections 301, 304, 306,
307, and 402
CWA section 307(a) established a list of
toxic pollutants or combination of
pollutants under the CWA. The statute
specifies a list of families of toxic
pollutants also listed in the Code of
Federal Regulations at 40 CFR 401.15.
The "priority pollutants" specified by
those families are listed in 40 CFR part
423 Appendix A. These are pollutants for
which best available technology effluent
limitations must be established on either a
national basis through rules (sections
301(b), 304(b), 307(b), 306) or on a case-
by-case best professional judgement basis
in NPDES permits, see section
402(a)(1)(B). EPA identifies the best
available technology that is economically
achievable for that industry after
considering statutorily prescribed factors
and sets regulatory requirements based on
the performance of that technology.
As a phthalate ester, DINP is designated as
a toxic pollutant under section 307(a)(1) of
the CWA, and as such is subject to effluent
limitations.
Note - even if not specified as a toxic
pollutant, unless it is a conventional
pollutant - it is also subject to effluent
limitations based on Best Available
Technology Economically Achievable
(BAT). All pollutants except conventional
pollutants are subject to BAT.
Comprehensive
Environmental Response,
Compensation and
Liability Act (CERCLA)
Authorizes EPA to promulgate regulations
designating as hazardous substances those
substances which, when released into the
environment, may present substantial
danger to the public health or welfare or
the environment.
As a phthalate ester, DINP is designated as
a hazardous substance under CERCLA. No
reportable quantity is assigned to the generic
or broad class (40 CFR 302.4).
Oilier I'cdcial sUilulcs ivuulalions
Federal Food, Drug, and
Cosmetic Act (FFDCA)
Provides the U.S. Food and Drug
Administration (FDA) with authority to
oversee the safety of food, drugs, and
cosmetics, except residues of pesticides in
food are regulated by EPA under FFDCA
section 408 (discussed above where
applicable).
CASRN 28553-12-0 is listed as an Indirect
Additive used in Food Contact Substances
(21 CFR 178.3740).
Consumer Product Safety
Improvement Action of
2008 (CPSIA)
Under section 108 of the Consumer
Product Safety Improvement Act of 2008
(CPSIA), CPSC prohibits the manufacture
Children's toys and childcare articles that
contain concentrations of >0.1% of DINP
are prohibited. The interim prohibition on
Page 227 of 269
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
for sale, offer for sale, distribution in
commerce or importation of eight
phthalates in toys and childcare articles at
concentrations >0.1%: DEHP, DBP, BBP,
DINP, DIBP, DPENP, DHEXP and
DCHP.
the use of DINP in children's toys and child
care articles (15 U.S.C. 2057(c), August 14,
2008) became permanent in the final rule
and was expanded to prohibit all children's
toys (not just those that can be placed in a
child's mouth) and child care articles that
contain concentrations >0.1% of DINP (16
CFR oart 1307. October 27. 2017).
B.2 State Laws and Regulations
Table Apx B-2. State
^aws and Regulations
State Actions
Description of Action
State Right-to-Know
Acts
Pennsylvania (P.L. 734, No. 159 and 34 Pa. Code section 323) includes phthalate
esters on the hazardous substance list as an environmental hazard but does not
specifically list DINP.
Chemicals of High
Concern to Children
Several states have adopted reporting laws for chemicals in children's products
containing DINP (CASRN 28553-12-0), including Minnesota (Toxic Free Kids Act
Minn. Stat. 116.9401 to 116.9407), Oregon (Toxic-Free Kids Act, Senate Bill 478,
2015), Vermont (18 V.S.A. section 1776), and Washington State (Wash. Admin.
Code 173-334-130).
Other
California listed DINP on Proposition 65 in 2013 due to potential to cause cancer.
(Cal Code Regs. Title 27, section 27001).
DINP (CASRN 28553-12-0) is listed as a Candidate Chemical under California's
Safer Consumer Products Program (Health and Safety Code section 25252 and
25253).
California lists DINP as a designated priority chemical for biomonitoring (California
SB 1379).
Minnesota designated DINP (28553-12-0) as a chemical of high concern (Toxic Free
Kids Act Minn. Stat. 116.9401 to 116.9407.
B.3 International Laws and Regulations
Table Apx B-3. International Laws and Regulations
Country/Organization
Requirements and Restrictions
Canada
CASRNs 28553-12-0 and 68515-48-0 are on the Canadian Domestic Substances List
(Government of Canada. Managing substances in the environment. Substances
search. Database accessed May 18, 2020).
European Union
CASRN 28553-12-0 (EC/List no.: 249-079-5) and CASRN 68515-48-0 (EC/List no.:
271-090-9) are registered for use in the EU (European Chemicals Agency (ECHA)
database. Accessed March 1, 2024).
DINP was added to the Annex XVII of REACH (Conditions of restriction)
Page 228 of 269
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Country/Organization
Requirements and Restrictions
(European Union Chemical Agency [ECHA] database. Accessed March 1, 2024).
In 2006, a restriction of sale and use of toys and childcare articles which can be
placed in the mouth by children containing 0.1% or more CASRN 28553-12-0 and
CASRN 68515-48-0 was added to Annex XVII of regulation (EC) No 1907/2006 -
REACH (Registration, Evaluation, Authorization and Restriction of Chemicals).
(European Chemicals Agency [ECHA] database, accessed February 28, 2024).
Australia
CASRNs 28553-12-0 and 68515-48-0 were assessed under Human Health Tier II of
the Inventory Multi-Tiered Assessment and Prioritisation (IMAP). (National
Industrial Chemicals Notification and Assessment Scheme [NICNAS], 2015,
Diisononyl phthalates and related compounds: Human health tier II assessment.
Accessed January 27, 2021).
CASRNs 28553-12-0 and 68515-48-0 are listed on the Chemical Inventory and
subject to secondary notifications when importing or manufacturing the chemical in
Australia (Australian Inventory of Industrial Chemicals database. Accessed January
27, 2021).
Japan
CASRNs 28553-12-0 and 68515-48-0 are regulated in Japan under the following
legislation:
• Act on the Evaluation of Chemical Substances and Regulation of Their
Manufacture, etc. (Chemical Substances Control Law [CSCL]) CASRN
68515-48-0 is also regulated under the following legislation:
• Act on Confirmation, etc. of Release Amounts of Specific Chemical
Substances in the Environment and Promotion of Improvements to the
Management Thereof
(National Institute of Technology and Evaluation [NITE] Chemical Risk Information
Platform [CHIRP]. Accessed March 1, 2024).
Countries with
occupational exposure
limits
Occupational exposure limits for CASRN 28553-12-0 are as follows:
• Denmark: 3 mg/m3 (8-hour) and 6 mg/m3 (short-term);
• Ireland: 5 mg/m3 (8-hour);
• New Zealand: 5 mg/m3 (8-hour);
• South Africa Mining: 5 mg/m3 (8-hour); and
• United Kingdom: 5 mg/m3 (8-hour).
(GESTIS International limit values for chemical agents [Occupational exposure
limits, OELs] database. Accessed February, 28, 2024).
B.4 Assessment History
Table Apx B-4. Assessment History of DINP
Authoring Organization
Publication
I S LIW puhliciilions
U.S. EPA, Office of Pollution Prevention and Toxics
(OPPT)
Technical Review of Diisononyl Phthalate (Final
Assessment) (U.S. EPA, 2023e)
Revised Technical Review of Diisononyl Phthalate
Page 229 of 269
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Authoring Organization
Publication
(US,EPA,2005b)
Oilier I S.-based organi/alions
U.S. Consumer Product Safety Commission (U.S.
CPSC)
Chronic Hazard Panel on Phthalates and Phthalate
Alternatives Final Report (With Appendices) (U.S.
CPSC. 2014)
Toxicity Review of Diisononyl Phthalate (DINP) (U.S.
CPSC. 2010)
Report to the U.S. Consumer Product Safety
Commission by the Chronic Hazard Advisory Panel on
Diisononvl Phthalate (DINP) (U.S. CPSC. 2001)
National Toxicology Program (NTP), Center for the
Evaluation of Risks to Human Reproduction (CERHR),
National Institute of Health (NIH)
NTP-CERHR Monograph on the Potential Human
Reproductive and Developmental Effects of Di-
isononvl Phthalate (DINP) (NTP-CERHR. 2003)
Office of Environmental Health Hazard Assessment
(OEHHA), California Environmental Protection
Agency
Evidence of the Carcinogenicity of Diisononyl
Phthalate (DINP) (Tomar et ah, 2013)
IllkTIUlllOlial
European Union, European Chemicals Agency (ECHA)
Committee for Risk Assessment (RAC) Opinion
proposing harmonised classification and labelling at
EU level of 1,2-Benzenedicarboxylic acid, di-C8-10-
branched alkylesters, C9- rich; [1] di-"isononyl"
ohthalate: 121 IDINPI (ECHA. 2018)
Evaluation of New Scientific Evidence Concerning
DINP and DIDP (ECHA. 2013)
European union risk assessment report: DINP (ECB,
2003)
European Food Safety Authority (EFSA)
Update of the Risk Assessment of Di-butylphthalate
(DBP), Butyl-benzyl-phthalate (BBP), Bis(2-
ethylhexyl)phthalate (DEHP), Di-isononylphthalate
(DINP) and Diisodecylphthalate (DIDP) for Use in
Food Contact Materials (EFSA. 2019)
Opinion of the scientific panel on food additives,
flavourings, processing aids and materials in contact
with food (AFC) on a request from the commission
related to di-isononylphthalate (DINP) for use in food
contact materials. Question N° EFSA-q-2003-194
(EFSA. 2005)
Government of Canada, Environment Canada, Health
Canada
Screening Assessment: Phthalate Substance Grouping
(ECCC/HC. 2020)
State of the science report: Phthalate substance
grouping 1,2-Benzenedicarboxylic acid, diisononyl
ester; 1,2-Benzenedicarboxylic acid, di-C8-10-
Page 230 of 269
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Authoring Organization
Publication
branched alkyl esters, C9-rich (Diisononyl Phthalate;
DINP). Chemical Abstracts Service Registry Numbers:
28553-12-0 and 68515-48-0 (EC/HQ 2015a)
National Industrial Chemicals Notification and
Assessment Scheme (NICNAS), Australian
Government
Diisononyl phthalates and related compounds: Human
health tier II assessment ("NICNAS. 2015a)
Priority existing chemical assessment report no. 35:
Diisononvl phthalate (NICNAS, 2012)
Phthalates hazard compendium: A summary of
physicochemical and human health hazard data for 24
ortho-phthalate chemicals ("NICNAS. 2008)
Page 231 of 269
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Appendix C LIST OF SUPPLEMENTAL AND TECHNICAL
SUPPORT DOCUMENTS
Appendix C incudes a list and citations for all supplemental documents included in the Risk Evaluation
for DINP.
Associated Systematic Review Protocol and Data Quality Evaluation and Data Extraction
Documents - Provide additional detail and information on systematic review methodologies used as
well as the data quality evaluations and extractions criteria and results.
Systematic Review Protocol for Diisononyl Phthalate (DINP) ( 25aa) - In lieu of an
update to the Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical
Substances, also referred to as the "2021 Draft Systematic Review Protocol" ( '2la), this
systematic review protocol for the Risk Evaluation for DINP describes some clarifications and
different approaches that were implemented than those described in the 2021 Draft Systematic
Review Protocol in response to (1) SACC comments, (2) public comments, or (3) to reflect
chemical-specific risk evaluation needs. This supplemental file may also be referred to as the "DINP
Systematic Review Protocol."
Data Quality Evaluation and Data Extraction Information for Physical and Chemical Properties for
Diisononyl Phthalate (DINP) ( 25}) - Provides a compilation of tables for the data
extraction and data quality evaluation information for DINP. Each table shows the data point, set, or
information element that was extracted and evaluated from a data source that has information
relevant for the evaluation of physical and chemical properties.
Data Quality Evaluation and Data Extraction Information for Environmental Fate and Transport for
Diisononyl Phthalate (DINP) ( 25h) - Provides a compilation of tables for the data
extraction and data quality evaluation information for DINP. Each table shows the data point, set, or
information element that was extracted and evaluated from a data source that has information
relevant for the evaluation for environmental fate and transport.
Data Quality Evaluation and Data Extraction Information for Environmental Release and
Occupational Exposure for Diisononyl Phthalate (DINP) (I v << \ . Provides a
compilation of tables for the data extraction and data quality evaluation information for DINP. Each
table shows the data point, set, or information element that was extracted and evaluated from a data
source that has information relevant for the evaluation of environmental release and occupational
exposure.
Data Quality Evaluation and Data Extraction Information for Dermal Absorption for Diisononyl
Phthalate (DINP) (U.S. EPA. 2025g) - Provides a compilation of tables for the data extraction and
data quality evaluation information for DINP. Each table shows the data point, set, or information
element that was extracted and evaluated from a data source that has information relevant for the
evaluation for dermal absorption.
Data Quality Evaluation Information for General Population, Consumer, and Environmental
Exposure for Diisononyl Phthalate (DINP) (U.S. EPA. 20251) - Provides a compilation of tables for
the data quality evaluation information for DINP. Each table shows the data point, set, or
information element that was evaluated from a data source that has information relevant for the
evaluation of general population, consumer, and environmental exposure.
Page 232 of 269
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Data Extraction Information for General Population, Consumer, and Environmental Exposure for
Diisononyl Phthalate (DINP) ( 25D - Provides a compilation of tables for the data
extraction for DINP. Each table shows the data point, set, or information element that was extracted
from a data source that has information relevant for the evaluation of general population, consumer,
and environmental exposure.
Data Quality Evaluation Information for Human Health Hazard Epidemiology for Diisononyl
Phthalate (DINP) ( !5n) - Provides a compilation of tables for the data quality
evaluation information for DINP. Each table shows the data point, set, or information element that
was evaluated from a data source that has information relevant for the evaluation of epidemiological
information.
Data Quality Evaluation Information for Human Health Hazard Animal Toxicology for Diisononyl
Phthalate (DINP) ( 15m) - Provides a compilation of tables for the data quality
evaluation information for DINP. Each table shows the data point, set, or information element that
was evaluated from a data source that has information relevant for the evaluation of human health
hazard animal toxicity information.
Data Quality Evaluation Information for Environmental Hazardfor Diisononyl Phthalate (DINP)
( 2025k) - Provides a compilation of tables for the data quality evaluation information for
DINP. Each table shows the data point, set, or information element that was evaluated from a data
source that has information relevant for the evaluation of environmental hazard toxicity information.
Data Extraction Information for Environmental Hazard and Human Health Hazard Animal
Toxicology and Epidemiology for Diisononyl Phthalate (DINP) ( '025e) - Provides a
compilation of tables for the data extraction for DINP. Each table shows the data point, set, or
information element that was extracted from a data source that has information relevant for the
evaluation of environmental hazard and human health hazard animal toxicology and epidemiology
information.
Associated Technical Support Documents (TSDs) - Provide additional details and information on
exposure, hazard, and risk assessments.
Physical Chemistry Assessment for Diisononyl Phthalate (DINP) ( 25v).
Fate Assessment for Diisononyl Phthalate (DINP) ( :5s).
Environmental Release and Occupational Exposure Assessment for Diisononyl Phthalate (DINP)
( 2025r).
Consumer and Indoor Exposure Assessment for Diisononyl Phthalate (DINP) (\ c< « i1 \ 2025bl
Environmental Media and General Population Screening for Diisononyl Phthalate (DINP) (U.S.
25q).
Environmental Exposure Assessment for Diisononyl Phthalate (DINP) ( 025o).
Environmental Hazard Assessment for Diisononyl Phthalate (DINP) ( 25p).
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Non-cancer Human Health Hazard Assessment for Diisononyl Phthalate (DINP) ( 025u).
Cancer Human Health Hazard Assessment for Diisononyl Phthalate (DINP) ( s25a).
Consumer Exposure Analysis for Diisononyl Phthalate (DINP) ( 025c).
Consumer Risk Calculator for Diisononyl Phthalate (DINP) ( E025d).
Risk Calculator for Occupational Exposures for Diisononyl Phthalate (DINP) ( J025w).
Fish Ingestion Risk Calculator for Diisononyl Phthalate (DINP) ( 2025f)
Surface Water Human Exposure Risk Calculator for Diisononyl Phthalate (DINP) for P50 Flow
Rates ( 025x).
Surface Water Human Exposure Risk Calculator for Diisononyl Phthalate (DINP) for P75 Flow
Rates (U.S. EPA. 2025vY
Surface Water Human Exposure Risk Calculator for Diisononyl Phthalate (DINP) for P90 Flow
Rates ( 025z).
Page 234 of 269
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Appendix D UPDATES TO THE DINP CONDITIONS OF USE
TABLE
After the final scope (1 c. IV \ 20 J I h), EPA received updated submissions under the 2020 CDR
reported data. In addition to new submissions received under the 2020 CDR, the reporting name codes
changed for the 2020 CDR reporting cycle. Therefore, the Agency is amending the description of certain
DINP COUs based on those new submissions and new reporting name codes. Also, EPA received
information from stakeholders about other uses of DINP. TableApx D-l summarizes the changes to the
COUs based on the new reporting codes in the 2020 CDR and any other new information since the
publication of the final scope and draft risk evaluation.
Table Apx D-l. Additions and Name Changes to Categories and Subcategories of COUs Based on
CDR Reporting and Stakeholder Engagement
Life Cycle
Stage and
Category
Original Subcategory in
the Final Scope
Document
Occurred Change
Revised Subcategory in the 2025 Risk
Evaluation
Processing;
Processing as a
reactant
Plasticizers; Plastic
material and resin
manufacturing; Processing
aids not otherwise listed
(e.g., mixed metal
stabilizer); Rubber product
manufacturing; Synthetic
rubber manufacturing
Consolidated category and
associated subcategories under
either "processing,
incorporation into article" or
"processing, incorporation
into formulation, mixture, or
reaction products" based on
further consultations with the
submitters of the manufacturer
requested risk evaluation
(ACC HPP. 2023).
Processing - Incorporation in formulation,
mixture, or reaction product - Plasticizers
(adhesives manufacturing, custom
compounding of purchased resin; paint and
coating manufacturing; plastic material and
resin manufacturing; synthetic rubber
manufacturing; wholesale and retail trade;
all other chemical product and preparation
manufacturing; ink, toner, and colorant
manufacturing (including pigment))
And
Processing - Incorporation into articles -
Plasticizers (playground and sporting
equipment manufacturing; plastics products
manufacturing; rubber product
manufacturing; wholesale and retail trade;
textiles, apparel, and leather manufacturing;
electrical equipment, appliance, and
component manufacturing; ink, toner, and
colorant manufacturing [including pigment])
Processing,
Incorporation into
articles
Textiles, apparel, and
leather manufacturing
Consolidated subcategory into
"processing, incorporation
into articles, plasticizer" to
avoid duplication based on
updates to CDR reporting.
Processing - Incorporation into articles -
Plasticizers (playground and sporting
equipment manufacturing; plastics products
manufacturing; rubber product
manufacturing; wholesale and retail trade;
textiles, apparel, and leather manufacturing;
electrical equipment, appliance, and
component manufacturing; ink, toner, and
colorant manufacturing [including pigment])
Processing,
Incorporation into
articles
Electrical equipment,
appliance, and component
manufacturing
Consolidated into "processing,
incorporation into articles,
plasticizer" COU to avoid
duplication.
Processing - Incorporation into articles -
Plasticizers (playground and sporting
equipment manufacturing; plastics products
manufacturing; rubber product
manufacturing; wholesale and retail trade;
textiles, apparel, and leather manufacturing;
electrical equipment, appliance, and
component manufacturing; ink, toner, and
Page 235 of 269
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Life Cycle
Stage and
Category
Original Subcategory in
the Final Scope
Document
Occurred Change
Revised Subcategory in the 2025 Risk
Evaluation
colorant manufacturing [including pigment])
Processing,
Incorporation into
articles
Plasticizers (e.g., toys,
playground, and sporting
equipment manufacturing)
Consolidated COUs and
updated to include CDR
reporting during the 2020
CDR reporting cycle: added
"plastics products
manufacturing; rubber product
manufacturing; wholesale and
retail trade; textiles, apparel,
and leather manufacturing;
electrical equipment,
appliance, and component
manufacturing; transportation
equipment manufacturing; ink,
toner, and colorant
manufacturing (including
pigment))
Processing - Incorporation into articles -
Plasticizers (toys, playground and sporting
equipment manufacturing; plastics products
manufacturing; rubber product
manufacturing; wholesale and retail trade;
textiles, apparel, and leather manufacturing;
electrical equipment, appliance, and
component manufacturing; ink, toner, and
colorant manufacturing [including pigment])
Processing,
Incorporation into
articles
Finishing agents (e.g., all
other chemical products
and preparation
manufacturing)
Consolidated subcategory
based on review of CDR
reports to other processing
COUs.
Processing - Other uses - Miscellaneous
processing (petroleum refineries; wholesale
and retail trade)
Processing,
Incorporation in
formulation,
mixture, or
reaction product
Adhesives and sealants
chemicals (e.g., adhesive
and sealant manufacturing;
construction; wholesale
and retail trade)
Consolidated into "processing,
incorporation in formulation,
mixture, or reaction product,
plasticizer" COU to remove
duplication and to reflect the
functional use of DINP in
these sectors as a plasticizer.
Processing - Incorporation in formulation,
mixture, or reaction product - Plasticizers
(adhesives manufacturing, custom
compounding of purchased resin; paint and
coating manufacturing; plastic material and
resin manufacturing; synthetic rubber
manufacturing; wholesale and retail trade;
all other chemical product and preparation
manufacturing; ink, toner, and colorant
manufacturing [including pigment])
Processing,
Incorporation in
formulation,
mixture, or
reaction product
Laboratory Chemicals
Consolidated into the
"processing, repackaging"
COU, since DINP is not being
reformulated and is being used
as a technical standard or
reference reagent.
Processing - Repackaging - Plasticizer (all
other chemical product and preparation
manufacturing; wholesale and retail trade;
laboratory chemicals manufacturing)
Processing,
Incorporation in
formulation,
mixture, or
reaction product
Intermediates (e.g.,
adhesive manufacturing;
all other chemical
products and preparation
manufacturing; plastic
material and resin
manufacturing)
Updated based on 2020 CDR
reporting cycle and
communication with
stakeholders who confirmed
DINP is used as a processing
aid rather than as an
intermediate (ACC HPP.
2023). Removed
"Intermediate" and
consolidated adhesive
manufacturing; all other
chemical products and
preparation manufacturing;
plastic material and resin
manufacturing with other
processing COUs."
Processing - Incorporation in formulation,
mixture, or reaction product - Plasticizers
(adhesives manufacturing, custom
compounding of purchased resin; paint and
coating manufacturing; plastic material and
resin manufacturing; synthetic rubber
manufacturing; wholesale and retail trade;
all other chemical product and preparation
manufacturing; ink, toner, and colorant
manufacturing [including pigment])
Page 236 of 269
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Life Cycle
Stage and
Category
Original Subcategory in
the Final Scope
Document
Occurred Change
Revised Subcategory in the 2025 Risk
Evaluation
Processing,
Incorporation in
formulation,
mixture, or
reaction product
Plasticizers (e.g., adhesive
manufacturing; custom
compounding of
purchased resin; paint and
coating manufacturing;
plastic product
manufacturing; plastic
material and resin
manufacturing; synthetic
rubber manufacturing;
transportation equipment
manufacturing; wholesale
and retail trade)
Consolidated and updated
COUs; based on review of
CDR reports and downstream
uses. Removed "plastic
products manufacturing,"
since DINP is being
formulated into a plastic
material or resin first, before
being incorporated into
articles, i.e., plastic products.
Added "all other chemical
product and preparation
manufacturing; ink, toner, and
colorant manufacturing
[including pigment])"
Processing - Incorporation in formulation,
mixture, or reaction product - Plasticizers
(adhesive manufacturing; custom
compounding of purchased resin; paint and
coating manufacturing; plastic material and
resin manufacturing; synthetic rubber
manufacturing; wholesale and retail trade;
all other chemical product and preparation
manufacturing; ink, toner, and colorant
manufacturing [including pigment])
Processing,
Incorporation in
formulation,
mixture, or
reaction product
Processing aids, not
otherwise listed (e.g., all,
other basic organic
chemical manufacturing;
furniture and related
product manufacturing)
Consolidated into "processing,
incorporation in formulation,
mixture, or reaction product,
plasticizer" COU to remove
duplication, and added "Heat
stabilizer and processing aid in
basic organic chemical
manufacturing" to reflect
updates to CDR reporting
codes during the 2020 CDR
reporting cycle."
Processing - Incorporation in formulation,
mixture, or reaction product - Heat stabilizer
and processing aid in basic organic chemical
manufacturing
Processing,
Incorporation in
formulation,
mixture, or
reaction product
Process regulators (e.g.,
paint and coating
manufacturing)
Consolidated into "processing,
incorporation in formulation,
mixture, or reaction product,
plasticizer" COU to remove
duplication and reflect updates
to CDR reporting codes during
the 2020 CDR reporting cycle.
Processing - Incorporation in formulation,
mixture, or reaction product - Plasticizers
(adhesives manufacturing, custom
compounding of purchased resin; paint and
coating manufacturing; plastic material and
resin manufacturing; synthetic rubber
manufacturing; wholesale and retail trade;
all other chemical product and preparation
manufacturing; ink, toner, and colorant
manufacturing [including pigment])
Processing,
Incorporation in
formulation,
mixture, or
reaction product
Not known or reasonably
ascertainable (e.g.,
petroleum refineries)
Consolidated into "processing,
other uses, miscellaneous
processing" COU to include
other sectors from CDR
reporting during the 2020
CDR reporting cycle.
Processing - Other uses - Miscellaneous
processing (petroleum refineries; wholesale
and retail trade)
Processing,
Incorporation in
formulation,
mixture, or
reaction product
Viscosity adjusters (e.g.,
wholesale and retail trade)
Consolidated into "processing,
incorporation in formulation,
mixture, or reaction product,
plasticizer" COU to remove
duplication, and reflect
updates to CDR reporting
codes during the 2020 CDR
reporting cycle.
Processing - Incorporation in formulation,
mixture, or reaction product - Plasticizers
(adhesives manufacturing, custom
compounding of purchased resin; paint and
coating manufacturing; plastic material and
resin manufacturing; synthetic rubber
manufacturing; wholesale and retail trade;
all other chemical product and preparation
manufacturing; ink, toner, and colorant
manufacturing [including pigment])
Page 237 of 269
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Life Cvclc
Original Subcategory in
Revised Subcategory in the 2025 Risk
Evaluation
Stage and
Category
the Final Scope
Document
Occurred Change
Processing, Other
uses
N/A
Added category and
subcategory to reflect updates
from 2020 CDR reporting
cycle.
Processing - Other uses - Miscellaneous
processing (petroleum refineries; wholesale
and retail trade)
Repackaging
Repackaging
Updated subcategory to show
specific examples of where
repackaging is used by various
industries.
Processing - Repackaging - Plasticizer (all
other chemical product and preparation
manufacturing; wholesale and retail trade;
laboratory chemicals manufacturing)
Industrial uses,
Adhesive and
sealant chemicals
Adhesive and sealant
chemicals
Updated to reflect 2020 CDR
reporting cycle and
consolidate sectors for which
DINP's functional use is as an
adhesive, sealant, or barrier.
Added "(sealant (barrier) in
machinery manufacturing;
computer and electronic
product manufacturing;
electrical equipment,
appliance, component
manufacturing, and
adhesion/cohesion promoter in
transportation equipment
manufacturing)"
Industrial uses - Adhesive and sealant
chemicals - Adhesive and sealant chemicals
(sealant (barrier) in machinery
manufacturing; computer and electronic
product manufacturing; electrical equipment,
appliance, component manufacturing, and
adhesion/cohesion promoter in
transportation equipment manufacturing)
Industrial uses,
plasticizer
Plasticizer
Consolidated into both
"processing, incorporation
into an article" and
"processing, incorporation
into a formulation, mixture, or
reactant product" based on
Agency research and
communication with
stakeholders fACC HPP.
2023).
Processing - Incorporation in formulation,
mixture, or reaction product - Plasticizers
(adhesives manufacturing, custom
compounding of purchased resin; paint and
coating manufacturing; plastic material and
resin manufacturing; synthetic rubber
manufacturing; wholesale and retail trade;
all other chemical product and preparation
manufacturing; ink, toner, and colorant
manufacturing [including pigment])
And
Processing - Incorporation into articles -
Plasticizers (playground and sporting
equipment manufacturing; plastics products
manufacturing; rubber product
manufacturing; wholesale and retail trade;
textiles, apparel, and leather Manufacturing;
electrical equipment, appliance, and
component manufacturing; ink, toner, and
colorant manufacturing [including pigment])
Industrial use,
automotive, fuel,
agriculture,
outdoor use
products
Automotive care products
Updated subcategory to clarify
the COU does not include uses
already covered under other
COUs and to clarify it does
not include agricultural, fuel,
or outdoor products.
Industrial Uses - Other Uses - Automotive
articles
Page 238 of 269
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Life Cycle
Stage and
Category
Original Subcategory in
the Final Scope
Document
Occurred Change
Revised Subcategory in the 2025 Risk
Evaluation
Industrial uses,
Construction,
paint, electrical,
and metal
products
Adhesives and sealants
Consolidated the subcategory
with the "industrial use,
adhesive and sealants" COU.
Industrial uses - Adhesive and sealant
chemicals - Adhesive and sealant chemicals
(sealant (barrier) in machinery
manufacturing; computer and electronic
product manufacturing; electrical equipment,
appliance, component manufacturing, and
adhesion/cohesion promoter in
transportation equipment manufacturing)
Industrial uses,
Construction,
paint, electrical,
and metal
products
Building/construction
materials not covered
elsewhere (e.g., roofing)
Updated to reflect 2020 CDR
reporting cycle and
consolidate examples of
subcategories for more
specificity in examples rather
than the broader "not covered
elsewhere" subcategory.
Industrial uses - Construction, paint,
electrical, and metal products -
Building/construction materials (roofing,
pool liners, window shades, flooring, water
supply piping)
Industrial Use,
Other Uses
N/A
Added subcategory based on
review of the manufacturer
requested risk evaluation and
additional information from
stakeholder meetings (EPA-
HO-OPPT-2018-0436-0019).
Industrial Use - Other Uses - Hydraulic
fluids
Industrial Use,
Other Uses
N/A
Added subcategory based on
review of the manufacturer
requested risk evaluation and
additional information from
stakeholder meetings (EPA-
HO-OPPT-2018-0436-0019).
Industrial Use - Other Uses - Pigment (leak
detection)
Commercial use,
automotive fuel,
agriculture,
outdoor use
products
N/A
Updated subcategory to clarify
the COU does not include uses
already covered under other
COUs and to clarify it does
not include agricultural, fuel,
or outdoor products.
Commercial use - Other use - Automotive
articles
Commercial use,
Construction,
paint, electrical,
and metal
products
Building/construction
materials not covered
elsewhere (e.g., roofing)
Updated to reflect 2020 CDR
reporting cycle and
consolidate examples of
subcategories to provide more
specific examples rather than
the broader "not covered
elsewhere" subcategory and
added "Plasticizer in
building/construction
materials (roofing);
construction and building
materials covering large
surface areas, including paper
articles; metal articles; stone,
plaster, cement, glass, and
ceramic articles"
Commercial use - Construction, paint,
electrical, and metal products - Plasticizer in
building/construction materials (roofing);
construction and building materials covering
large surface areas, including paper articles;
metal articles; stone, plaster, cement, glass,
and ceramic articles
Commercial use,
Furnishing,
cleaning,
treatment/care
products
Foam seating and bedding
products
Updated to reflect the 2020
CDR reporting cycle. Added
"furniture and furnishings
including plastic articles
(soft); leather articles"
Commercial use - Furnishing, cleaning,
treatment/care products - Foam seating and
bedding products; furniture and furnishings
including plastic articles (soft); leather
articles
Page 239 of 269
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Life Cycle
Stage and
Category
Original Subcategory in
the Final Scope
Document
Occurred Change
Revised Subcategory in the 2025 Risk
Evaluation
Commercial use,
Furnishing,
cleaning,
treatment/care
products
Cleaning and furniture
care products
Consolidated in commercial
use, furnishing, cleaning,
treatment/care products, foam
seating and bedding products,
furniture and furnishings
including plastic articles
(soft); leather articles"
subcategory based on review
of CDR reports and Agency
research on the use of DINP in
cleaning and furniture care
products. The CDR reference
that previously supported this
use was corrected by the
submitter.
Commercial use - Furnishing, cleaning,
treatment/care products - Foam seating and
bedding products; furniture and furnishings
including plastic articles (soft); leather
articles
Commercial use,
Furnishing,
cleaning,
treatment/care
products
Floor coverings
Updated to reflect the 2020
CDR reporting cycle. Added
"Plasticizer in construction
and building materials
covering large surface areas
including stone, plaster,
cement, glass, and ceramic
articles; fabrics, textiles and
apparel (vinyl tiles, resilient
flooring, PVC-backed
carpeting)."
Commercial use - Furnishing, cleaning,
treatment/care products - Floor coverings;
plasticizer in construction and building
materials covering large surface areas
including stone, plaster, cement, glass, and
ceramic articles; fabrics, textiles and apparel
(vinyl tiles, resilient flooring, PVC-backed
carpeting)
Commercial use,
Furnishing,
cleaning,
treatment/care
products
Fabric, textile, and leather
products not covered
elsewhere
Updated to reflect the 2020
CDR reporting cycle for more
specificity in examples rather
than the broader "not covered
elsewhere" subcategory and
added "(apparel and footwear
care products)."
Commercial use - Furnishing, cleaning,
treatment/care products - Fabric, textile, and
leather products (apparel and footwear care
products)
Commercial use,
Furnishing,
cleaning,
treatment/care
products
Furniture and furnishings
not covered elsewhere
Consolidated in commercial
use, furnishing, cleaning,
treatment/care products, foam
seating and bedding products,
furniture and furnishings
including plastic articles
(soft); leather articles"
subcategory.
Commercial use - Furnishing, cleaning,
treatment/care products - Foam seating and
bedding products; furniture and furnishings
including plastic articles (soft); leather
articles
Commercial use,
Packaging, paper,
plastic, hobby
products
Plastic and rubber
products
Updated to better reflect the
2020 CDR reporting cycle.
Added "packaging, paper,
plastic hobby products
(packaging [excluding food
packaging], including rubber
articles; plastic articles [hard]
plastic articles [soft])."
Commercial use - Packaging, paper, plastic,
hobby products - Packaging, paper, plastic,
hobby products (packaging [excluding food
packaging], including rubber articles; plastic
articles [hard]; plastic articles [soft])
Commercial use,
Packaging, paper,
plastic, hobby
products
N/A
Added subcategory based on
additional information and
communications with
stakeholders (EPA-HO-OPPT-
2018-0436-0055) (ACC HPP.
Commercial use - Packaging, paper, plastic,
hobby products - Ink, toner, and colorant
products
Page 240 of 269
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Life Cvclc
Original Subcategory in
Revised Subcategory in the 2025 Risk
Evaluation
Stage and
Category
the Final Scope
Document
Occurred Change
2023).
Commercial use,
Packaging, paper,
plastic, hobby
products
N/A
Added subcategory to better
reflect the 2020 CDR
reporting cycle.
Commercial use - Packaging, paper, plastic,
hobby products -Plasticizer (plastic and
rubber products; tool handles, flexible tubes,
profiles, and hoses)
Commercial use,
Packaging, paper,
plastic, hobby
products
Plastic and rubber
products not covered
elsewhere (e.g., tool
handles, flexible tubes,
profiles, and hoses)
Consolidated under
"plasticizer" subcategory with
more specific examples rather
than the broader "not covered
elsewhere."
Commercial use - Packaging, paper, plastic,
hobby products - Plasticizer (plastic and
rubber products; tool handles, flexible tubes,
profiles, and hoses)
Commercial use,
Construction,
paint, electrical,
and metal
products
Building/construction
materials not covered
elsewhere
Updated with more specificity
in examples rather than the
broader "not covered
elsewhere" Subcategory.
Commercial use - Construction, paint,
electrical, and metal products - Plasticizer in
building/construction materials (roofing,
pool liners, window shades, water supply
piping); construction and building materials
covering large surface areas, including paper
articles; metal articles; stone, plaster,
cement, glass, and ceramic articles
Commercial Use,
Other Uses
Hydraulic fluids
Redesignated this commercial
use as an industrial use based
on review of the manufacturer
requested risk evaluation and
additional information from
stakeholder meetings (EPA-
HO-OPPT-2018-0436-0019).
Industrial use - Other uses - Hydraulic
fluids
Commercial Use,
Other Uses
Pigment (leak detection)
Redesignated this commercial
use as an industrial use based
on review of the manufacturer
requested risk evaluation and
additional information from
stakeholder meetings (EPA-
HO-OPPT-2018-0436-0019).
Industrial use - Other uses - Pigment (leak
detection)
Consumer use,
automotive fuel,
agriculture,
outdoor use
products
Automotive care products
Updated subcategory to reflect
the 2020 CDR reporting cycle
and align with DIDP final risk
evaluation.
Consumer use - Other use - Automotive
articles
Consumer use,
Automotive, fuel,
agriculture,
outdoor use
products
Electrical and electronic
products
Consolidated with the
Construction, paint, electrical,
and metal products.
Consumer use - Construction, paint,
electrical, and metal products - Electrical
and electronic products
Consumer use,
Construction,
paint, electrical,
and metal
products
Building construction
materials not covered
elsewhere (e.g., wire and
cable jacketing, vinyl tiles,
resilient flooring, PVC-
backed carpeting, wall
coverings, roofing, pool
applications, etc.)
Updated with more specific
examples rather than the
broader "not covered
elsewhere... vinyl tiles,
resilient." flooring, PVC-
backed carpeting."
Consumer use - Construction, paint,
electrical, and metal products - Building
construction materials (wire and cable
jacketing, wall coverings, roofing, pool
applications, water supply piping, etc.)
Page 241 of 269
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Life Cycle
Stage and
Category
Original Subcategory in
the Final Scope
Document
Occurred Change
Revised Subcategory in the 2025 Risk
Evaluation
Consumer use,
Furnishing,
cleaning,
treatment/care
products
Foam seating and bedding
products
Updated based on the 2020
CDR reporting cycle. Added
"(furniture and furnishings
including plastic articles
(soft); leather articles)
Consumer use - Furnishing, cleaning,
treatment/care products - Foam seating and
bedding products; furniture and furnishings
including plastic articles (soft); leather
articles
Consumer use,
Furnishing,
cleaning,
treatment/care
products
Floor coverings
Updated based on the 2020
CDR reporting cycle. Added
"Plasticizer in construction
and building materials
covering large surface areas
including stone, plaster,
cement, glass, and ceramic
articles; fabrics, textiles and
apparel (vinyl tiles, resilient
flooring, PVC-backed
carpeting)"
Consumer use - Furnishing, cleaning,
treatment/care products - Floor coverings;
plasticizer in construction and building
materials covering large surface areas
including stone, plaster, cement, glass, and
ceramic articles; fabrics, textiles and apparel
(vinyl tiles, resilient flooring, PVC-backed
carpeting)
Consumer use,
Furnishing,
cleaning,
treatment/care
products
Fabric, textile, and leather
products not covered
elsewhere
Consolidated with "fabric,
textile, and leather products"
subcategory in the same life
cycle stage and category.
Consumer use - Furnishing, cleaning,
treatment/care products - Fabric, textile, and
leather products (apparel and footwear care
products)
Consumer use,
Furnishing,
cleaning,
treatment/care
products
Furniture and furnishings
not covered elsewhere
Consolidated in "foam seating
and bedding products;
furniture and furnishings
(furniture and furnishings
including plastic articles
(soft); leather articles)"
subcategory within the same
category."
Consumer use - Furnishing, cleaning,
treatment/care products - Foam seating and
bedding products; furniture and furnishings
including plastic articles (soft); leather
articles
Furnishing,
cleaning,
treatment/care
products
Cleaning and furniture
care products
Consolidated in "consumer
use, furnishing, cleaning,
treatment/care products, foam
seating and bedding products,
furniture and furnishings
including plastic articles
(soft); leather articles"
subcategory based on review
of CDR reports and Agency
research on the use of DINP in
cleaning and furniture care
products. The CDR reference
that previously supported this
use was corrected by the
submitter.
Consumer use - Furnishing, cleaning,
treatment/care products - Foam seating and
bedding products; furniture and furnishings
including plastic articles (soft); leather
articles
Consumer use,
Packaging, paper,
plastic, hobby
products
Plastic and rubber
products
Updated subcategory to better
reflect 2020 CDR reporting
codes.
Consumer use - Packaging, paper, plastic,
hobby products - Packaging (excluding food
packaging), including rubber articles; plastic
articles (hard); plastic articles (soft)
Consumer use,
Packaging, paper,
plastic, hobby
products
Plastic and rubber
products not covered
elsewhere (e.g., textiles,
apparel, and leather; vinyl
tape; flexible tubes;
profiles; hoses)
Updated subcategory to better
reflect 2020 CDR reporting
codes.
Consumer use - Packaging, paper, plastic,
hobby products - Other articles with routine
direct contact during normal use including
rubber articles; plastic articles (hard); vinyl
tape; flexible tubes; profiles; hoses
Page 242 of 269
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Life Cycle
Stage and
Category
Original Subcategory in
the Final Scope
Document
Occurred Change
Revised Subcategory in the 2025 Risk
Evaluation
Consumer use,
Packaging, paper,
plastic, hobby
products
Paper products
Consolidated in "consumer
use, packaging, paper, plastic,
hobby products, packaging
(excluding food packaging). .
." subcategory to better reflect
2020 CDR reporting codes.
Consumer use - Packaging, paper, plastic,
hobby products - Packaging (excluding food
packaging), including rubber articles; plastic
articles (hard); plastic articles (soft)
Consumer use,
Other
N/A
Added category and
subcategory based on
additional information and
Asencv research (Stabile.
2013).
Consumer use - Other - Novelty articles
As indicated in the TableApx D-l, the changes are based on close examination of the CDR reports,
including the 2020 CDR reports that were received after the scope was completed, additional research
on the COUs, additional comments from stakeholders, and overall systematic review of the use
information.
When developing this risk evaluation, EPA concluded that some subcategories of the COUs listed in the
final scope (U.S. EPA. 2021b) were redundant and consolidation was needed to avoid evaluation of the
same COU multiple times. The Agency concluded that there were some instances where subcategory
information on the processing and uses of DINP was misreported by CDR reporters based on outreach
with stakeholders. For these instances, EPA recategorized the activity described in the COU listed in the
scope to fit the description of the COU included in this risk evaluation. Finally, the Agency determined
that wording changes were needed to accurately describe COUs. Therefore, as described in Table Apx
D-l, EPA has made changes to COUs for the risk evaluation.
In addition, EPA did further analysis of the following COUs, which resulted in the changes already
presented on the table which warrant further explanation because these COUs were changed
significantly between the final scope and the risk evaluation:
• "Industrial use -plasticizer" was consolidated into both "processing, incorporation into an
article" and "processing, incorporation into a formulation, mixture, or reactant product" based on
Agency research and communication with stakeholders (ACC HPP. 2023). EPA believes that
this consolidation and recategorization more accurately represents the use of DINP as a
plasticizer in various processing stages by industry.
• "Commercial use - hydraulic fluid' was redesignated as "Industrial use - hydraulic fluid' based
on review of the manufacturer requested risk evaluation and additional information from
stakeholder meetings (< " \ i IQ-QPPT-201 \ 0 1- 001' }. EPA believes that this recategorization
better represents the Department of Defense (DoD) referenced presence of DINP in hydraulic
fluids better than commercial as any DoD use would be considered industrial rather than
commercial. DoD was the only reference for this use.
• "Commercial use pigment (leak detection/' was redesignated as "Industrial use pigment
(leak detection)" based on review of the manufacturer requested risk evaluation and additional
information from stakeholder meetings (< " \ i iQ-O"" I _ 01 \ 0 I'- 00 rs). EPA believes that
this recategorization better represents the DoD referenced presence of DINP in leak detection
fluids (as a pigment) better than commercial as any DoD use would be considered industrial
rather than commercial. DoD was the only reference for this use.
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"Consumer use - novelty articles'' was added to the risk evaluation based on Agency research
into the use of various phthalate in adult sex toys {i.e., novelty articles). EPA was unaware of this
use during development of the scope and is therefore adding it during the development of the risk
evaluation to ensure that it is assessed appropriately given the evidence the Agency has cited on
DINP being used in these types of products.
Processing, Processing as a reactant, "plasticizers; plastic material and resin manufacturing;
processing aids not otherwise listed (e.g., mixed metal stabilizer); rubber product
manufacturing; synthetic rubber manufacturing" were all removed because as part of the
outreach with the manufacturer requested risk evaluation submitters it was determined that DINP
is not used as a reactant. Although reported in the CDR for various reporting cycles as a reactant,
the Agency has consolidated all of those reported reactant uses of DINP under other processing
COUs that more accurately reflect the uses.
Consumer uses, Other uses, "Novelty products" subcategory was edited to "Novelty articles'' to
clarify that "articles" as defined by 40 CFR part 751 were assessed under this COU.
For the Commercial uses and Consumer uses, Automotive, fuel, agriculture, outdoor use
products, Automotive products, other than fluids" COUs, the category and subcategory was
edited. The category "Automotive, fuel, agriculture, outdoor use products" was edited to " Other
uses" to reflect that this use was not reported to the CDR in either the 2016 or 2020 CDR cycles
The subcategory of "Automotive products other than fluids" was changed to "Automotive
articles" This was to clarify that "articles" as defined by 40 CFR part 751 were assessed under
this COU.
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Appendix E CONDITIONS OF USE DESCRIPTIONS
The following descriptions are intended to include examples of uses, so as not to exclude other activities
that may also be included in the COUs of the chemical substance. To better describe the COU, EPA
considered CDR submissions from the last two CDR cycles for DINP (CASRN 28553-12-0 and CASRN
68515-48-0), and the COU descriptions reflect what the Agency identified as the best fit for that
submission. Examples of articles, products, or activities are included in the following descriptions to
help describe the COU but are not exhaustive. EPA uses the terms "articles" and "products" or product
mixtures in the following descriptions and is generally referring to articles and products as defined by 40
CFR part 751. There may be instances where the terms are used interchangeably by a company or
commenters, or by EPA in reference to a code from the CDR reports which are referenced (e.g., "plastic
products manufacturing" or "fabric, textile, and leather products". The Agency will clarify as needed
when these references are included throughout the COU descriptions below.
E.l Manufacturing - Domestic Manufacturing
Domestic manufacture means to manufacture or produce DINP within the Unites States. For purposes of
the DINP risk evaluation, this includes the extraction of DINP from a previously existing chemical
substance or complex combination of chemical substances and loading and repackaging (but not
transport) associated with the manufacturing and/or production of DINP.
At a typical manufacturing site, DINP is formed through the reaction of phthalic anhydride and isononyl
alcohol using an acid catalyst. DINP is manufactured in two forms. The first form, CASRN 28553-12-0,
is manufactured from a C9 alcohol, which is n-butene based. The second form, CASRN 68515-48-0, is
manufactured from a C8-C 10 alcohol fraction (ExxonMobil. 2022b). Typical manufacturing operations
consist of reaction, followed by a crude filtration, where the product is distilled or separated, and final
filtration. Manufacturing operations may also include quality control sampling of the DINP product.
Additionally, manufacturing operations include equipment cleaning/reconditioning and product
transport to other areas of the manufacturing facility or offsite shipment for downstream processing or
use (ExxonMobil. 2022b). This COU includes the typical manufacturing process and any other similar
production of DINP.
Examples of CDR Submissions
In the 2016 CDR cycle, two CDR companies reported domestic manufacturing of DINP (CASRN
28553-12-0); and two companies reported domestic manufacturing of DINP (CASRN 68553-12-0) with
all manufacturers producing a liquid.
In the 2020 CDR cycle, two CDR companies reported domestic manufacturing of DINP (CASRN
68553-12-0); and one CDR company reported domestic manufacturing of DINP (CASRN 28553-12-0)
with all manufacturers producing a liquid.
E.2 Manufacturing - Importing
Import refers to the import of DINP into the customs territory of the United States. This COU includes
loading/unloading and repackaging (but not transport) associated with the import of DINP. In general,
chemicals may be imported into the United States in bulk via water, air, land, and intermodal shipments.
These shipments take the form of oceangoing chemical tankers, railcars, tank trucks, and intermodal
tank containers (U.S. EPA. 2021c). Imported DINP is shipped in either dry powder/crystal pellets/solid
form or liquid form with concentrations ranging from 1 to 100 percent DINP (U.S. EPA. 2020a).
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Examples of CDR Submissions
In the 2016 CDR cycle, 16 CDR companies reported importation of DINP (CASRN 28553-12-0) with
every company importing DINP as a liquid except one who imported pellets/large crystals. Three of
these companies reported importation for the purposes of repackaging in various industries. In 2016,
four CDR companies reported importation of DINP (CASRN 68515-48-0) with each importing a liquid.
In the 2020 CDR cycle, 20 CDR companies reported importation of DINP (CASRN 28553-12-0) with
every company importing liquid except one who imported pellets/large crystals. Two of these companies
reported importation for the purposes of repackaging in various industries. In 2020, three CDR
companies reported importation of DINP (CASRN 68515-48-0) with each importing a liquid.
E.3 Processing - Incorporation into Formulation, Mixture, or Reaction
Product - Heat Stabilizer and Processing Aid in Basic Organic
Chemical Manufacturing
This COU refers to the preparation of a product; that is, the incorporation of DINP into formulation,
mixture, or a reaction product which occurs when a chemical substance is added to a product (or product
mixture), after its manufacture, for distribution in commerce. In this case, processing of DINP into a
product that for use as a heat stabilizer in basic organic chemical manufacturing.
Examples of CDR Submissions
In the 2016 CDR cycle one company reported the use of DINP (CASRN 28553-12-0) as an intermediate
and heat stabilizer in all other chemical product and preparation manufacturing.
The 2016 and 2012 CDRs report use of DINP as an intermediate in basic organic chemical
manufacturing, which implies that DINP is used as a feedstock in the production of another chemical via
a chemical reaction in which DINP is consumed to form the product. EPA's use report determined that
there are some reports that list DINP as an intermediate and process regulator in Nordic countries (U.S.
2Id). However, EPA does not expect DINP to be consumed in chemical reactions; rather, it will
be incorporated into the formulation. Therefore, EPA is removing the "intermediate" from this COU
description—although those uses reported as "intermediate" in CDR will be considered under this COU.
E.4 Processing - Incorporation into Formulation, Mixture, or Reaction
Product - Plasticizers (Adhesives Manufacturing; Custom
Compounding of Purchased Resin; Paint and Coating Manufacturing;
Plastic Material and Resin Manufacturing; Synthetic Rubber
Manufacturing; Wholesale and Retail Trade; All Other Chemical
Product and Preparation Manufacturing; Ink, Toner, and Colorant
Manufacturing [Including Pigment])
This COU refers to the preparation of a product; that is, the incorporation of DINP into formulation,
mixture, or a reaction product that occurs when a chemical substance is added to a product (or product
mixture) after its manufacture, for distribution in commerce—in this case as a plasticizer in various
industrial sectors, specifically to provide flexibility to PVC. In manufacturing of plastic material and
resin through non-PVC and PVC compounding, DINP is blended into polymers. Compounding involves
the mixing of the polymer with the plasticizer and other chemical such as, fillers and heat stabilizers.
The plasticizer needs to be absorbed into the particle to impart flexibility to the polymer. For PVC
compounding, compounding occurs through mixing of ingredients to produce a powder (dry blending)
or a liquid (Plastisol blending). The most common process for dry blending involves heating the
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ingredients in a high intensity mixer and transfer to a cold mixer. The Plastisol blending is done at
ambient temperature using specific mixers that allow for the breakdown of the PVC agglomerates and
the absorption of the plasticizer into the resin particle.
EPA is aware that DINP may be incorporated into PVC plastisol inks, toners, and colorants, including
pigments (ACC HPP. 20231
Examples of CDR Submissions
In the 2016 CDR cycle one company reported the use of DINP as a plasticizer in custom compounding
of purchased resin (CASRN 68515-48-0 and CASRN 28553-12-0); one company reported the use of
DINP as an plasticizer in synthetic rubber manufacturing (CASRN 28553-12-0); one company reported
the use of DINP as an plasticizer in custom compounding of purchased resin and paint and coating
manufacturing (CASRN 68515-48-0); several companies reported the use of DINP as a plasticizer in
plastic material and resin manufacturing (CASRN 28553-12-0); and one company reported the use of
DINP as a plasticizer in wholesale and retail trade (CASRN 68515-48-0). In 2016 one company reported
incorporation into a formulation - plasticizer in adhesive manufacturing (CASRN 28553-12-0).
In the 2020 CDR cycle, two companies reported the use of DINP as an plasticizer in custom
compounding of purchased resin (CASRN 68515-48-0); two companies reported the use of DINP as an
plasticizer in custom compounding of purchased resin, paint and coating manufacturing, and synthetic
rubber manufacturing (CASRN 28553-12-0); one company reported the use of DINP as a plasticizer in
plastic material and resin manufacturing (CASRN 68515-48-0); two companies reported the use of
DINP as a plasticizer in plastic material and resin manufacturing (CASRN 28553-12-0); another
reported the use of DINP as an plasticizer in wholesale and retail trade (CASRN 68515-48-0 and
CASRN 28553-12-0). Another company reported the use of DINP as a plasticizer in rubber product
manufacturing (CASRN 28553-12-0), but the activity included in this report represents the
manufacturing of rubber products where DINP is added to an article, and therefore it is better
represented under the processing incorporation into articles COU. One company reported the use of
DINP as a reactant - plasticizer in all other chemical product and preparation manufacturing (CASRN
68515-48-0), but since EPA does not expect DINP to be consumed in chemical reactions, this activity
fits better under this COU. A company reported the use of DINP as a plasticizer in plastics product
manufacturing (CASRN 68515-48-0) and another reported the use of DINP as a plasticizer in plastics
product manufacturing (CASRN 28553-12-0)—but these activities related to manufacturing plastic
products where DINP is added to an article are better represented under the processing - incorporation
into an article COU. One company reported incorporation of DINP into formulation, mixture or reaction
product for transportation equipment manufacturing (CASRN 28553-12-0), but based on the available
information regarding the use of DINP in this sector, the report was referring to incorporating DINP into
adhesive and sealant formulations, which are then used in transportation equipment manufacturing in an
industrial setting, therefore, transportation equipment manufacturing is not included in this COU
description. Rather, the activity described by the CDR report is included under industrial uses - adhesive
and sealant chemicals in transportation equipment manufacturing.
Also in the 2020 CDR cycle, one company reported incorporation of DINP into a formulation -
adhesives and sealants in adhesive manufacturing (CASRN 28553-12-0), and another reported
incorporation into a formulation - plasticizer in adhesive manufacturing (CASRN 28553-12-0).
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E.5 Processing - Incorporation into Articles - Plasticizers (Toys,
Playground and Sporting Equipment Manufacturing; Plastics
Products Manufacturing; Rubber Product Manufacturing; Wholesale
and Retail Trade; Textiles, Apparel, and Leather Manufacturing;
Electrical Equipment, Appliance and Component Manufacturing; Ink,
Toner, and Colorant Products Manufacturing [Including Pigment])
This COU refers to the preparation of an article; that is, the incorporation of DINP into articles, meaning
DINP becomes a component of the article, after its manufacture, for distribution in commerce. In this
case, DINP is present in a raw material such as rubber or plastic that contains a mixture of plasticizers
and other additives, and this COU refers to the manufacturing of PVC and non-PVC articles using those
raw materials. PVC articles are manufactured after the formation of a raw material that can contain a
mixture of plasticizer and other additives. The raw material is converted by processes such as
calendaring, extrusion, injection molding, and plastisol spread coating (EPA-HQ-OPPT-2018-0435-
0022. EPA-HQ-QPPT-2018-0436-0032). DINP also is an additive in inks, which are then incorporated
into textiles and articles (EPA-HO-OPPT-2Q18-0435-00221
According to information provided to EPA, plastisol technology or film calendaring technology is used
in the production of plastic and rubber products such as textiles, apparel, and leather; vinyl tape; flexible
tubes; profiles; hoses ( 3 HPP. 2023). Additionally, ACT provided examples of sporting equipment
containing DINP. This COU refers to the processing of DINP into the sporting equipment articles.
This COU also includes the possibility of the processing of DINP; that is, forming, shaping, or cutting
articles containing DINP, in toy manufacturing since toys could contain up to 0.1 percent of DINP. (The
CPSC has a regulatory limit of no more than 0.1% for DINP concentration in toys.) Additionally, it is
possible that DINP could be incorporated into playground equipment manufacturing due to its use as a
plasticizer in PVC and non-PVC articles that may be components of playground equipment.
DINP is incorporated as a general-purpose plasticizer in various textiles including vinyl clothing (e.g.,
raincoats, boots, and gloves) which would be expected to be used across industrial, commercial, and
consumer applications (A.CC HPP. 2019). PVC articles are manufactured after the formation of a raw
material that can contains a mixture of plasticizer and other additives. Also, this use was reported in the
2016 CDR reporting cycle by one company (CASRN 68515-48-0). EPA expects that the use of DINP in
textiles, apparel, and leather manufacturing is associated with PVC applications in these durable vinyl
products. EPA expects that the commercial use of substances containing DINP to produce foam seating
and bedding would occur through spray and/or mix applications, and then cutting and molding of foam
products of pre-formed products that contain DINP for their final commercial form.
According to the Manufacturer Request for Risk Evaluation Diisononyl Phthalate (DINP), DINP is
incorporated as a general-purpose plasticizer in electrical and electronic products which would be
expected to be used across industrial, commercial, and consumer applications (A.CC HPP. 2019)
Electrical equipment and products typically have PVC components or are manufactured with PVC (e.g.,
wire jacketing, etc.). PVC articles are manufactured after the formation of a raw material that can
contains a mixture of plasticizer and other additives. EPA found that DINP (CASRN 68515-48-0) was
used in extrusion for wire and cable and in the manufacture of computer, electronic, electrical equipment
in other countries ( 202Id).
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Examples of CDR Submissions
In the 2016 CDR cycle, two companies reported the use of DINP (CASRN 68515-48-0) as a plasticizer
in plastic products manufacturing; various companies reported the use of DINP (CASRN 28553-12-0) as
a plasticizer in plastic products manufacturing; and two companies reported the use of DINP (CASRN
28553-12-0) as a plasticizer in rubber product manufacturing.
In the 2020 CDR cycle, one company reported the use of DINP (CASRN 68515-48-0) as a plasticizer in
plastic products manufacturing; another reported the use of DINP (CASRN 28553-12-0) as a plasticizer
in plastic products manufacturing; another reported the use of DINP (CASRN 28553-12-0) as a
plasticizer in rubber product manufacturing; another reported the use of DINP (CASRN 28553-12-0) as
a plasticizer in wholesale and retail trade. Another company reported the use of DINP (CASRN 28553-
12-0) in adhesive and sealant chemicals in transportation equipment manufacturing, based on the
understanding of how DINP is used in the transportation sector, the activity represented by this CDR
report is included under industrial uses of adhesives and sealants chemicals in transportation equipment
manufacturing. And another company reported the use of DINP (CASRN 28553-12-0) as a plasticizer in
both plastic material and resin manufacturing and synthetic rubber manufacturing; however, this CDR
report seems to describe the incorporation of DINP into a formulation, mixture, or reaction product
COU and therefore this DINP's use in plastic material and resin manufacturing and synthetic rubber
manufacturing was included in that COU.
E.6 Processing - Other Uses - Miscellaneous Processing (Petroleum
Refineries; Wholesale and Retail Trade)
This COU refers to the preparation of a product; that is, the incorporation of DINP into formulation,
mixture, or a reaction product which occurs when DINP is added to a product (or product mixture) after
its manufacture, for distribution in commerce; or the preparation of an article—meaning DINP becomes
a component of the article, after its manufacture, for distribution in commerce. In this case, petroleum
refineries are processing DINP for the purposes of plasticizing various applications.
In the 2016 and 2020 CDR cycles, one company reported processing DINP (CASRN 68515-48-0) in
petroleum refineries and rubber product manufacturing; another company reported processing DINP
(CASRN 28553-12-0) in wholesale and retail trade.
E.7 Processing - Repackaging - Plasticizer (All Other Chemical Product
and Preparation Manufacturing; Wholesale and Retail Trade,
Laboratory Chemicals Manufacturing)
Repackaging refers to the preparation of DINP for distribution in commerce in a different form, state, or
quantity than originally received or stored by various industrial sectors, including chemical product and
preparation manufacturing, wholesale and retail trade, and laboratory chemicals manufacturing. This
COU includes the transferring of DINP from a bulk container into smaller containers. This COU would
not apply to the relabeling or redistribution of a chemical substance without removing the chemical
substance from the original container it was supplied in.
Examples of CDR Submissions
In the 2016 CDR cycle, one company reported repackaging DINP (CASRN 28553-12-0) as a plasticizer
in wholesale and retail trade.
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In the 2020 CDR cycle, one company reported repackaging DINP as a plasticizer in all other chemical
product and preparation manufacturing, while another company reported repackaging DINP (CASRN
28553-12-0) in wholesale and retail trade.
Repackaging DINP as a laboratory chemical was not reported in the 2016 or 2020 reporting cycles.
However, EPA identified products containing DINP sold as a liquid for research purposes only and not
intended for use as drugs, food additives, households, or pesticides (T srica. 2019).
E.8 Processing - Recycling
This COU refers to the process of treating generated waste streams {i.e., which would otherwise be
disposed of as waste), containing DINP, that are collected, either on-site or at a third-party site, for
commercial purpose. DINP is primarily recycled industrially in the form of DINP-containing PVC waste
streams, including roofing membranes, vinyl window frame profiles, and carpet squares. New PVC can
be manufactured from recycled and virgin materials at the same facility. Some (ENF Plastic. 2024)
estimate a total of 228 plastics recyclers operating in the United States of which 58 accept PVC wastes
for recycling. It is unclear if the total number of sites includes some or all circular recycling sites—
facilities where new PVC can be manufactured from recycled and virgin materials on the same site. EPA
notes that although DINP was not reported for recycling in the 2016 or 2020 CDR reporting periods,
EPA is assuming that recycling waste streams could contain DINP.
E.9 Distribution in Commerce
For purposes of assessment in this risk evaluation, distribution in commerce consists of the
transportation associated with the moving of DINP or DINP-containing products between sites
manufacturing, processing, or recycling DINP or DINP-containing products, or to final use sites, or for
final disposal of DINP or DINP-containing products. More broadly under TSCA, "distribution in
commerce" and "distribute in commerce" are defined under TSCA section 3(5).
E.10 Industrial Uses - Adhesive and Sealant Chemicals - Adhesive and
Sealant Chemicals (Sealant (Barrier) in Machinery Manufacturing);
Computer and Electronic Product Manufacturing; Electrical
Equipment, Appliance, and Component Manufacturing; and
Adhesion/Cohesion Promoter in Transportation Equipment
Manufacturing)
This COU refers to DINP as it is used in various industrial sectors as a component of adhesive or sealant
mixtures, meaning the use of DINP after it has already been incorporated into an adhesive and/or sealant
product or mixture, as opposed to when it is used upstream, {e.g., when DINP is processed into the
adhesive and sealant formulation).
Examples of CDR Submissions
In the 2016 CDR cycle, one company reported the use of DINP (CASRN 28553-12-0) for use as an
adhesive and sealant chemical in adhesive manufacturing.
In the 2020 CDR cycle, one company reported the use of DINP (CASRN 28553-12-0) for use as a
barrier sealant in machinery manufacturing, computer and electronic product manufacturing, and
electrical equipment, appliance, and component manufacturing. In 2020 another company reported the
use of DINP (CASRN 28553-12-0) as an adhesive and sealant in transportation equipment
manufacturing.
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According to the Manufacturer Request for Risk Evaluation Diisononyl Phthalate (DINP), less than 5
percent of DINP is used in non-PVC applications such as those associated with adhesives and sealants
(ACC HPP. ). With respect to transportation equipment manufacturing, it should be noted that
DINP is used in various automotive adhesive and sealant applications such as window glazing, doors,
acrylic plastisol sealants in wheel wells (ACC H ). And DINP is used in various transportation
equipment manufacturing specific adhesives and sealants ( 202Id). EPA expects that these
sealants would be used on exterior as well as interior applications in this sector.
EPA identified several examples of transportation (or automotive) adhesive and sealant products (U.S.
2 Id). Some of these products appear to have been discontinued or reformulated and may no
longer contain DINP. EPA expects that many of these products would be used on the exterior or the
vehicle to prevent moisture or water penetrating the dry areas of the equipment.
EPA expects that these adhesives and sealants are likely to be manually and robotically applied through
various different methods including spraying and rolling depending on the application.
E.ll Industrial Uses - Construction, Paint, Electrical, and Metal Products -
Building/Construction Materials (Roofing, Pool Liners, Window
Shades, Flooring, Water Supply Piping)
This COU refers to the use of DINP in various industrial sectors as a component of building/
construction material, including roofing, pool liner, and window shade products. This is a use of DINP
after it has already been incorporated into a plastic product or mixture, as opposed to when it is used
upstream (e.g., when DINP is processed into a product or an article).
DINP is used in roofing materials in industrial applications. This COU was included in the Manufacturer
Request for Risk Evaluation Diisononyl Phthalate (DINP) due to DINP's use as a general-purpose
plasticizer for PVC in various building and construction applications which includes roofing (ACC HPP.
2019). EPA has been unable to identify DINP is any specific roofing products but expects that due to the
general-purpose use as plasticizer, DINP are likely to be used in roofing membranes, sealants, or other
adhesives associated with roofing systems, although the sealants and adhesives used with roofing
systems would be covered under the adhesives and sealants COU. EPA identified one product which
appears to be a penetration sealant for flashing or roofing systems; however, EPA was unable to
determine if this is strictly used in industrial, commercial, or consumer applications (U.S. EPA. 202 Id).
ACC also notes that DINP can be used in window shades, flooring, roofing, pool liners, and wall
coverings (ACC. 2024). A public commenter for the draft risk evaluation for DINP noted that DINP is
also used in water supply piping which could be used for industrial, commercial, and consumer
applications (EPA~H.Q~QPPT~2018-0436-0095).
This COU was not reported in the 2016 or 2020 CDR cycles.
E.12 Industrial Uses - Construction, Paint, Electrical, and Metal Products -
Paints and Coatings
This COU refers to DINP as it is used in various industrial sectors as a component of industrial paints
and coatings. This is a use of DINP after it has already been incorporated into a paint or coating product
or mixture, as opposed to when it is used upstream (e.g., when DINP is processed into the paint or
coating formulation).
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According to information provided to EPA, approximately five percent of DINP in the United States is
used in adhesives, caulks & sealants, inks & paints with the predominate use in these sectors as being
"industrial" in nature within the printing and metal coating industry (EPA-HQ-QPPT-2018-0436-0032).
EPA expects that the industrial application of these paints and coatings would take place on structural
steel or during fabrication of structural components that would later be installed by commercial
contractors. Other industrially applied products are lacquer-based coatings made up of heat-resistant
resins to withstand the chemicals and heat encountered with most air-set and cold-set binders used in the
foundry industry ( nan Manufacturing and Supply Company. 2018). This COU would include
underbody coatings applied in an industrial scenario. EPA expects that these products would be applied
in the industrial sector; however, notes that it is possible for these products to be purchased by
commercial users and applied in the commercial sector as well.
This COU was not reported in the 2016 or 2020 CDR reporting cycles.
E.13 Industrial Use - Other Uses - Hydraulic Fluids
This COU is referring to the use of DINP as a component of hydraulic fluids in the defense industry.
This is a use of DINP after it has already been incorporated into a hydraulic fluid, as opposed to when it
is used upstream (e.g., when DINP is processed into the hydraulic fluid).
DoD recommended that EPA include the use of DINP in hydraulic fluid and lubricant oils (
) There is limited information and data other than the communication from DoD
in support of this COU. EPA will consider distribution of these types of products to DoD under the
distribution in commerce or repackaging COUs.
This use was not reported to EPA in the 2016 or 2020 CDR cycles.
E.14 Industrial Use - Other Uses - Pigment (Leak Detection)
This COU is referring to the use of DINP in pigments involved with leak detection equipment in the
defense industry. This is a use of DINP after it has already been incorporated into a leak detection
product or mixture, as opposed to when it is used upstream (e.g., when DINP is processed into the leak
detection product).
EPA notes that DoD confirmed that EPA should look at the use of DINP containing pigments as they are
used in leak detector products in DoD activities ( EPA will consider
distribution these types of products to DoD under the distribution in commerce or repackaging COUs.
This use was not reported to EPA in the 2016 or 2020 CDR cycles.
E.15 Industrial Uses - Other Uses- Automotive Articles
This COU refers to the use of DINP in the automobile manufacturing sector as a component in various
automotive articles. This is a use of DINP after it has already been incorporated into a plastic product or
mixture, as opposed to when it is used upstream (e.g., when DINP is processed into a product).
DINP is used in automotive articles for various industrial uses. The Manufacturer Request for Risk
Evaluation Diisononyl Phthalate (DINP) notes that DINP is used in automotive care products; EPA was
unable to identify any specific automotive articles, that contained DINP. However, the American
Chemistry Council's website details the use of high phthalates, such as DINP, in automobile interiors,
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vinyl seat covers, and interior trim because it can prevent degradation of these components (ACC.
2024).
This COU was not reported in the 2016 or 2020 CDR cycles.
E.16 Commercial Use - Construction, Paint, Electrical, and Metal Products
- Adhesives and Sealants
This COU is referring to the commercial use of DINP in adhesives and sealants. This is a use of DINP -
containing adhesives and sealants in a commercial setting, such as a business or at a job site, as opposed
to upstream use of DINP (e.g., when DINP containing products are used in the manufacturing of the
construction products) or use in an industrial setting.
Workers in a commercial setting generally apply adhesives and sealants that already have DINP
incorporated as a plasticizer. Adhesives and sealants (which could also be fillers and putties) are highly
malleable materials used to repair, smooth over or fill minor cracks in holds and buildings. EPA expects
that commercial applications of adhesives and sealants containing DINP would occur using non-
pressurized methods based on products identified in the marketplace. According to the Manufacturer
Request for Risk Evaluation Diisononyl Phthalate (DINP) less than five percent of DINP is used in non-
PVC applications such as those associated with adhesives and sealants.
EPA identified several commercially available (denoted as being possibly industrial, commercial, or
consumer viable) adhesive products which contain DINP at various concentrations. These adhesive and
sealants are commonly applied using a syringe, caulk gun, or are spread on a surface using a trowel.
DINP is also used in various automotive care product applications EPA expects that the use of these
types of products would occur in commercial applications; however, the Agency notes that this product
are likely to be sourced by DIY consumers through various online vendors.
EPA also identified several automotive adhesives that are likely to be used in industrial/commercial/
consumer applications (U.S. EPA. 202 Id). The expected users of products under this category would be
expected to apply these products through spray, roll, and brush/caulk on applications depending on the
desired end use.
Examples of CDR Submissions
In the 2016 CDR cycle, three companies reported the use of DINP (CASRN 28553-12-0) in adhesives
and sealants.
In the 2020 CDR cycle, one company reported the use of DINP (CASRN 28553-12-0) in adhesives and
sealants and one company reported the use of DINP (CASRN 28553-12-0) as a plasticizer in adhesives
and sealants.
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E.17 Commercial Use - Construction, Paint, Electrical, and Metal Products
- Plasticizer in Building/Construction Materials (Roofing, Pool Liners,
Window Shades, Water Supply Piping); Construction and Building
Materials Covering Large Surface Areas; Including Paper Articles;
Metal Articles; Stone, Plaster, Cement, Glass, and Ceramic Articles
This COU is referring to the commercial use of DINP in commercial sectors associated with
construction products that contain DINP as a plasticizer. This is a use of DINP-containing construction
materials such as roofing, pool liners, and window shades in commercial applications, such as at a
business or at a job site, as opposed to upstream use of DINP (e.g., when DINP is processed into the
construction material) or use in an industrial setting.
This COU was included in the Manufacturer Request for Risk Evaluation Diisononyl Phthalate (DINP)
due to DINP's use as a general-purpose plasticizer for PVC in various building and construction
applications that includes roofing (A.CC HPP. 2019). EPA has been unable to identify DINP in any
specific roofing products but expects that due to the general-purpose use as plasticizer, DINP is likely to
be used in roofing membranes, sealants, or other adhesives associated with roofing systems. The Agency
identified a penetration sealant for flashing or roofing systems; however, EPA was unable to determine
if this is strictly used in industrial, commercial, or consumer applications ( 2 Id). The
Agency expects that commercial applications of construction and building materials such as roofing
containing DINP would occur using non-pressurized methods based on products identified in the
marketplace. EPA expects that workers can install in window shades, flooring, roofing, pool liners, and
wall coverings that already have DINP incorporated (ACC. 2024). A public commenter for the draft risk
evaluation for DINP noted that DINP is also used in water supply piping which could be used for
industrial, commercial, and consumer applications ( .Q-OPPT-2018-0436-0095).
Examples of CDR Submissions
In the 2016 CDR cycle, four companies reported the use of DINP (CASRN 28553-12-0) in
building/construction materials not covered elsewhere.
In the 2020 CDR cycle, one company reported the use of DINP (CASRN 28553-12-0) in
building/construction materials not covered elsewhere and three companies reported the use of DINP
(CASRN 28553-12-0) as a plasticizer in construction and building materials covering large surface
areas, including paper articles; metal articles; stone, plaster, cement, glass, and ceramic articles.
E.18 Commercial Use - Construction, Paint, Electrical, and Metal Products
- Electrical and Electronic Products
This COU is referring to the commercial use of DINP already incorporated as a plasticizer in electrical
and electronic products.
The Manufacturer Request for Risk Evaluation Diisononyl Phthalate (DINP) states that DINP is used as
a general-purpose plasticizer for PVC used in building a construction, particularly wire associated with
electronic products (ACC HEP. 2019). This COU describes the workers handling the electric products,
wiring, etc. and related insulation during installation and use that may have DINP incorporated into the
products. The users of products under this category would be expected to apply these products through
hand contact with the wire and electronic components through various commercial applications.
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Examples of CDR Submissions
In the 2016 CDR cycle, two companies reported the use of DINP (CASRN 28553-12-0) as a plasticizer
in electrical and electronic products, and one company reported the use of DINP (CASRN 68515-48-0)
as a plasticizer in electrical and electronic products.
In the 2020 CDR cycle, one company reported the use of DINP (CASRN 28553-12-0) as a plasticizer in
electrical and electronic products, and another company reported the use of DINP (CASRN 68515-48-0)
as a plasticizer in electrical and electronic products.
E.19 Commercial Use - Construction, Paint, Electrical, and Metal Products
- Paints and Coatings
This COU is referring to the commercial use of DINP already incorporated as a plasticizer in paints and
coatings.
DINP is used in a variety of paint and coating products, often used as a surfactant in paints and coatings.
The Manufacturer Request for Risk Evaluation Diisononyl Phthalate (DINP) reports use of DINP in
consumer paints and coatings (A.CC HPP. 2019). EPA expects that these products would be purchased
by commercial operations and applied by professional contractors in various commercial settings. EPA
also expects that some of these products are likely to be used for industrial applications; however, they
would be available and used in smaller scale commercial settings for similar purposes (e.g., corrosion
and water protection on structural components, residential construction). This COU would include
underbody coatings applied in a commercial scenario.
EPA also notes that this COU was not reported to the CDR in 2016 or 2020 cycles.
E.20 Commercial Use - Furnishing, Cleaning, Treatment/Care Products -
Foam Seating and Bedding Products; Furniture and Furnishings
Including Plastic Articles (Soft); Leather Articles
This COU is referring to the commercial use of DINP already incorporated in foam seating and bedding
products and furnishings. EPA understands that DINP has been used in foam seating and bedding
products as well as furniture (including plasticized vinyl seats) at concentrations by weight of at least 30
percent but less than 60 percent ( 202Id). The Agency also notes that this COU was included
in the Manufacturer Request for Risk Evaluation Diisononyl Phthalate (DINP) due to DINP's use as a
plasticizer to impart flexibility to PVC applications (ACC HPP. 2019). EPA was unable to find any
specific examples of products containing DINP that would fit under this category; however, a 2015 U.S.
CPSC report did identify various commercial/consumer products that contained DINP, which would fit
under this COU—including PVC tablecloths and shower curtains (\] S CPSC. 2015). Information for
products that have DINP incorporated into an adhesive and sealant chemical or paint and coating that is
used in the manufacture of furniture has not been identified at this time.
Examples of CDR Submissions
In the 2016 CDR cycle, one company reported the use of DINP (CASRN 28553-12-0) in furniture and
furnishings not covered elsewhere.
In the 2020 CDR cycle, one company reported the use of DINP (CASRN 68515-48-0) in furniture and
furnishings including plastic articles (soft); leather articles. As well, in the 2020 CDR, one company
reported the use of DINP (CASRN 68515-48-0) in furniture and furnishings including plastic articles
(soft); leather articles.
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E.21 Commercial Use - Furnishing, Cleaning, Treatment/Care Products -
Air Care Products
This COU is referring to the commercial use of DINP in air care products.
DINP is found in certain air care products that are likely to be used in commercial applications. EPA
identified one commercially available scent that is available for candle manufacturers containing DINP
( 2021c). Although the Agency expects that this scent would predominately be used in
commercial candle making activities; it is possible that some consumer DIY candle makers could source
this product from online vendors. EPA did not identify DINP in any additional commercially available
air care products at this time. The expected users of products under this category would be expected to
apply these products through mixing DINP containing liquid substances with various waxes and other
liquid to semi-solid materials in either cold-press or heated environments to create candles for later sale
to consumers.
EPA also notes that this COU was not reported to the CDR in 2016 or 2020 cycles.
E.22 Commercial Use - Furnishing, Cleaning, Treatment/Care Products -
Floor Coverings/Plasticizer in Construction and Building Materials
Covering Large Surface Areas Including Stone, Plaster, Cement,
Glass, and Ceramic Articles; Fabrics, Textiles, and Apparel (Vinyl
Tiles, Resilient Flooring, PVC-Backed Carpeting)
This COU is referring to the commercial use of DINP in various floor coverings and construction and
building materials. DINP is a known constituent of various building/construction materials because of its
use as a general-purpose plasticizer in PVC applications. Although similar to other COUs, EPA expects
that certain commercial uses of building/construction materials covered by this COU use would include
items such as vinyl tiles, resilient flooring, PVC-backed carpeting, and other construction/building
materials that are covering large areas (ACC HPP. 2019). EPA also identified the use of DINP in a
product associated with floor matting ( )21d). The Agency anticipates that these products
would be used in commercial applications. The COU describes the workers handling and installing the
construction materials, tiles, carpeting, etc. that have DINP incorporated into the products and may
involve cutting and shaping the products for installation.
Examples of CDR Submissions
In the 2016 CDR cycle, one company reported the use of DINP (CASRN 28553-12-0) in floor
coverings.
In the 2020 CDR cycle, three companies reported the use of DINP (CASRN 28553-12-0) in construction
and building materials covering large surface areas including stone, plaster, cement, glass, and ceramic
articles.
E.23 Commercial Use - Furnishing, Cleaning, Treatment/Care Products -
Fabric, Textile, and Leather Products (Apparel and Footwear Care
Products)
This COU is referring to the commercial use of DINP already incorporated as a plasticizer in fabric,
textile, and leather products including apparel and footwear products. This COU includes workers
cutting and shaping textiles and workers who wear DINP-containing textiles.
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EPA understands that DINP has been used in fabric, textile, and leather products including apparel and
footwear products (A.CC HPP. 2019). EPA also notes that this COU was included in the Manufacturer
Request for Risk Evaluation Diisononyl Phthalate (DINP) due to DINP's use as a plasticizer to impart
flexibility to PVC applications such as vinyl clothing which are likely to be used in commercial and
consumer applications (i.e., rain boots, gloves, raincoats, etc.) (ACC HPP. 2019). EPA identified DINP
in commercial and consumer fabric, textile, and leather products at concentrations of at least 1 percent
but less than 60 percent ( 02 Id). The National Library of Medicine 2019 database identified
DINP use in injection molding for footwear ( 2Id).
Examples of CDR Submissions
In the 2016 CDR cycle, two companies reported the use of DINP (CASRN 28553-12-0) in fabric,
textile, and leather products not covered elsewhere, and one company reported the use of DINP
(CASRN 68515-48-0) in fabric, textile, and leather products not covered elsewhere.
In the 2020 CDR cycle, one company reported the use of DINP (CASRN 28553-12-0) in apparel and
footwear care products and one company reported the use of DINP (CASRN 68515-48-0) in fabric,
textile, and leather products not covered elsewhere.
E.24 Commercial Use - Packaging, Paper, Plastic, and Hobby Products -
Arts, Crafts, and Hobby Materials
This COU is referring to the commercial use of DINP in arts, crafts, and hobby materials.
EPA identified use of DINP in various arts, crafts, and hobby materials including glitter board products
and in polymer clay bricks, canes, and eraser products ( ). The Agency expects that
these products are likely to be used in both commercial and consumer applications. EPA identified two
erasers which contained DINP ( 32 Id). The users of products under this category would be
expected to make the aforementioned products using DINP containing substances through cutting and
shaping (or otherwise adjusting shape for use) for the clay and eraser products and possibly through
liquid applications for glitter products. EPA expects that these products would be used by commercial
hobbyists who are using these products to create saleable goods. The Agency notes that weight fractions
were reported in (ECHA. 2012) for erasing rubber made of PVC. In one sample from a 2006 Danish
investigation, the combination of DINP and DIDP was reported as 32 percent.
This COU was not reported in the 2016 or 2020 CDR cycles.
E.25 Commercial Use - Packaging, Paper, Plastic, and Hobby Products -
Ink, Toner, and Colorant Products
This COU is referring to the commercial use of DINP in ink, toner, and colorant products.
DINP is used in printing ink, at least one stamp product, and pigments (\ c. < ^ \ JO J I. ). The
Manufacturer Request for Risk Evaluation Diisononyl Phthalate (DINP) lists the use of pigments in its
non-PVC applications (<5% of DINP use). EPA identified a polyurethane pigment containing more than
60 percent DINP by weight ( ,02 Id). The Agency expects that the majority of ink, toner, and
colorant products containing DINP would be commercial in nature; however, it is possible that these
products are used by DIY consumers as many of the commercial products are available for consumer
purchasers through various online vendors. EPA would expect the commercial users of these products to
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apply them through the typical applications in commercial printing and drafting shops albeit at a larger
quantity as those consumer DIYers who may also be using these products.
This use was not reported to EPA in the 2016 or 2020 CDR cycles.
E.26 Commercial Use - Packaging, Paper, Plastic, and Hobby Products -
Packaging, Paper, Plastic, Hobby Products (Packaging (Excluding
Food Packaging), Including Rubber Articles; Plastic Articles (Hard);
Plastic Articles (Soft)
This COU is referring to the commercial use of DINP in various packaging, paper, plastic, and hobby
products. EPA notes that this reporting code in the 2020 CDR is intended to describe products such as
phone covers, personal tablets covers, styrofoam packaging, and bubble wrap. Given the use of DINP as
a general-purpose plasticizer for PVC and non-PVC applications, EPA expects that this use of DINP has
been identified in previous CDR reports as "plastic and rubber products not covered elsewhere."
The type of products being reported under this code are likely to be both commercial and consumer in
nature. The expected users of products under this category would be anticipated to use liquid or solid
mixtures containing DINP and mold or otherwise form the various products for commercial and
consumer applications.
Examples of CDR Submissions
In the 2020 CDR cycle, two companies reported the use of DINP (CASRN 28553-12-0) in packaging
(excluding food packaging); including rubber articles; plastic articles (hard); plastic articles (soft) and
one company reported the use of DINP (68515-48-0) in packaging (excluding food packaging);
including rubber articles; plastic articles (hard); plastic articles (soft).
E.27 Commercial Use - Packaging, Paper, Plastic, and Hobby Products -
Plasticizer (Plastic and Rubber Products; Tool Handles, Flexible
Tubes, Profiles and Hoses)
This COU is referring to the commercial use of DINP incorporated as a plasticizer in several durable
commercial goods such as plastic and rubber products, tool handles, flexible tubes, profiles, and hoses.
These products when used by workers in commercial settings may also contain DINP and exposure to
commercial end users could occur during the regular use of the product during its life cycle.
Examples of CDR Submissions
In the 2016 CDR cycle, although not specifically identified as being used as a plasticizer, six companies
reported the use of DINP in plastic and rubber products not covered elsewhere (CASRN 28553-12-0)
while three companies reported the use of DINP (CASRN 68515-48-0) in plastic and rubber products
not covered elsewhere.
Examples of CDR Submissions
In the 2020 CDR cycle, two companies reported the use of DINP (CASRN 28553-12-0) in plastic and
rubber products not covered elsewhere and two companies reported the use of DINP (CASRN 68515-
48-0) in plastic and rubber products not covered elsewhere. For one of these companies reporting on
DINP (CASRN 68515-48-0) in the 2020 CDR cycle they did not explicitly note that it was being used as
a plasticizer.
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E.28 Commercial Use - Packaging, Paper, Plastic, and Hobby Products -
Toys, Playground, and Sporting Equipment
This COU is referring to the commercial use of DINP in toys, playground, and sporting equipment. The
COU includes the commercial installation, use, and maintenance of toys (such as in daycare or school
environments by workers [e.g., teachers or providers]), playgrounds, and sporting equipment that
contain DINP.
EPA notes in the final scope that the Consumer Product Safety Innovation Act of 2008 and the U.S.
CPSC banned the use of DINP at concentrations greater than 0.1 percent in children's toys and childcare
articles in 2008 and 2018, respectively. EPA expects that the use of DINP in toys manufactured or
processed prior to the ban may still be occurring.
Examples of CDR Submissions
In the 2016 CDR cycle, one company reported the use of DINP (CASRN 28553-12-0) in toys,
playground, and sporting equipment. This use was not reported in the 2020 CDR cycle.
E.29 Commercial Use - Solvents (for Cleaning or Degreasing)
This COU is referring to the use of DINP in solvents intended for cleaning or degreasing.
DINP was identified in at least one commercial solvent associated with cleaning or degreasing (Ij
21c). Although EPA expects that most of the use will be industrial, there are some products,
such as a lithographic press cleaning solvent are likely to be used commercially ( 2Id). The
use of this type of product would be specific to the printing community and would be expected to be
applied through mechanical methods but not through aerosolized methods.
This use was not reported to EPA in the 2016 or 2020 CDR cycles.
E.30 Commercial Use - Other Uses - Laboratory Chemicals
This COU is referring to the commercial use of DINP in laboratory chemicals.
DINP can be used as a laboratory chemical, such as a chemical standard or reference material during
analyses. Some laboratory chemical manufacturers identify use of DINP as a certified reference material
and research chemical. The users of products under this category would be expected to apply these
products through general laboratory use applications. Commercial use of laboratory chemicals may
involve handling DINP by hand-pouring or pipette and either adding to the appropriate labware in its
pure form to be diluted later or added to dilute other chemicals already in the labware. EPA expects that
laboratory DINP products are pure DINP in neat liquid form. The Agency notes that the same
applications and methods used for quality control can be applied in industrial and commercial settings.
This use was not reported to EPA in the 2016 or 2020 CDR cycles.
E.31 Commercial Use - Other Use - Automotive Articles
This COU is referring to the commercial use of DINP in automotive articles, which already have DINP
incorporated into them. This is a use of DINP-containing automotive articles in a commercial setting,
such as an automotive parts business or a worker driving a vehicle, as opposed to upstream use of DINP
(e.g., when DINP containing products are used in the manufacturing of the automotive) or use in an
industrial setting.
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The Manufacturer Request for Risk Evaluation Diisononyl Phthalate (DINP) notes the use of DINP as a
general-purpose plasticizer in automotive applications such as doors, wire and cable jacketing, and use
in automotive paints. ACC's website details the use of high-molecular weight phthalates, such as DINP,
in automobile interiors, vinyl seat covers, and interior trim because it can prevent degradation of these
components (ACC. 2024).
This COU was not reported in the 2016 or 2020 CDR cycles.
E.32 Consumer Use - Construction, Paint, Electrical, and Metal Products -
Adhesives and Sealants
This COU is referring to the consumer use of DINP in adhesives and sealants.
EPA notes in the final scope that DINP is used as an adhesive sealant for automotive care products (U.S.
21c). EPA expects that the use of these types of products would occur in commercial
applications; however, the Agency notes that this product are likely to be sourced by DIY consumers
through various online vendors. The Manufacturer Request for Risk Evaluation Diisononyl Phthalate
(DINP) also notes the use of DINP as a general-purpose plasticizer in automotive applications such as
window glazing, doors, wire and cable jacketing, underbody coatings, and acrylic plastisol sealants in
wheel wells, and paints (ACC HPP. 2019). The 2016 CDR reporting identified automotive care products
as containing concentrations of DINP of at least 1 percent but less than 30 percent by weight (
202Id). EPA identified several automotive adhesives that are likely to be used in
industrial/commercial/consumer applications ( 02Id). The Agency does expect the primary
use of these automotive adhesives and sealants to be industrial and commercial in nature but the
possibility for consumer use is still possible.
EPA understands this COU to include more than one type of consumer use {i.e., driving with or without
other vehicle passengers vs. consumer DIYers who may perform exterior or interior car maintenance
involving adhesives and sealants). Any product containing DINP that is applied as an undercover
coating would most likely be applied by spraying the coating on the underside of the vehicle.
According to the Manufacturer Request for Risk Evaluation Diisononyl Phthalate (DINP), less than five
percent of DINP is used in non-PVC applications such as those associated with adhesives and sealants.
EPA believes that although this product is intended for commercial applications it, and products like it,
are likely to be used in various consumer applications as well. The expected users of these products
would be DIY users that spray, caulk bead, and roll apply the various adhesives and sealants based on
application, as well as bystanders. Heat is likely to be used depending on the application as well.
Examples of CDR Submissions
In the 2016 CDR cycle, one company reported the use of DINP (CASRN 28553-12-0) in adhesives and
sealants.
E.33 Consumer Use - Construction, Paint, Electrical, and Metal Products -
Building Construction Materials (Wire and Cable Jacketing, Wall
Coverings, Roofing, Pool Applications, Water Supply Piping, etc.)
This COU is referring to the consumer use of DINP in various building and construction materials such
as wire and cable jacketing, wall coverings, roofing, and pool applications. As reported in the
Manufacturer Request for Risk Evaluation Diisononyl Phthalate (DINP), DINP is used in PVC-backed
carpet, vinyl tiles, wire and cable jacketing, and resilient flooring (ACC HPP. 2019). EPA also notes that
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DINP is used in wall coverings, roofing, and pool applications as a general plasticizer. The expected
consumers and DIY users of products under this category live with or are installing various building
materials such as electrical wires and wall coverings that contain DINP as part of the building material
in an indoor environment. A public commenter for the draft risk evaluation for DINP noted that DINP is
also used in water supply piping which could be used for industrial, commercial, and consumer
applications (EPA-HO-OPPT-2018-0436-0Q95V
The use of DINP in other building materials and joinery installation has been reported in Nordic
countries, but no further information about this COU in the United States was found at this time (
21d).
Examples of CDR Submissions
In the 2016 CDR cycle, three companies reported the use of DINP (CASRN 28553-12-0) in
building/construction materials not covered elsewhere.
In the 2020 CDR cycle, one company reported the use of DINP (CASRN 28553-12-0) in
building/construction materials not covered elsewhere.
E.34 Consumer Use - Construction, Paint, Electrical, and Metal Products -
Electrical and Electronic Products
This COU is referring to the consumer use of DINP in electrical and electronic products, including
consumer DIY handling of electrical products during installation and use that may have DINP
incorporated into the products. The expected users of products under this category would be consumers
who are living in indoor environments with various electrical and electronic products that have wires or
other components that have DINP as part of their construction.
The Manufacturer Request for Risk Evaluation Diisononyl Phthalate (DINP) states that DINP is used as
a general-purpose plasticizer for PVC used in building and construction, particularly wire associated
with electronic products (AilCilf !°)-
Examples of CDR Submissions
In the 2016 CDR cycle, one company reported the use of DINP (CASRN 28553-12-0) in electrical and
electronic products and one company reported the use of DINP (CASRN 68515-48-0) in electrical and
electronic products.
In the 2020 CDR cycle, one company reported the use of DINP (CASRN 68515-48-0) in electrical and
electronic products.
E.35 Consumer Use - Construction, Paint, Electrical, and Metal Products -
Paints and Coatings
This COU is referring to the consumer use of DINP in paints and coatings, meaning consumer DIY use
of DINP-containing paints and coatings in indoor environments applied as part of their construction.
DINP is used in a variety of paint and coating products, often used as a surfactant in paints and coatings.
The Manufacturer Request for Risk Evaluation Diisononyl Phthalate (DINP) reports use of DINP in
consumer paints and coatings (A.CC HPP. 2019). The application procedure depends on the type of paint
or coating formulation and the type of substrate. The formulation is loaded into the application reservoir
or apparatus and applied to the substrate via brush, spray, roll, dip, curtain, or syringe or bead
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application. After application, the paint or coating is allowed to dry or cure. It is possible that some
paints and coatings containing DINP would be pressure-applied by consumer DIYers through gravity
fed and compressed air guns. This COU would include underbody coatings applied in a consumer DIY
scenario.
Examples of CDR Submissions
In the 2016 CDR cycle, one company reported the use of DINP (CASRN 28553-12-0) in paints and
coatings.
E.36 Consumer Use - Furnishing, Cleaning, Treatment/Care Products -
Foam Seating and Bedding Products; Furniture and Furnishings
Including Plastic Articles (Soft); Leather Articles
This COU is referring to the consumer use of foam seating and bedding products that contain DINP and
in the fabrication of various textiles that are likely to be used by consumers in standard household
furniture indoors.
EPA understands that DINP has been used in foam seating and bedding products as well as furniture
(including plasticized vinyl seats) at concentrations by weight of at least 30 percent but less than 60
percent (U.S. EPA. 202Id). The Agency also notes that this COU was included in the Manufacturer
Request for Risk Evaluation Diisononyl Phthalate (DINP) due to DINP's use as a plasticizer to impart
flexibility to PVC applications (A.CC HPP. 2019). EPA was unable to find any specific examples of
products containing DINP that would fit under this category; however, a 2015 U.S. CPSC report did
identify various commercial/consumer level products that contained DINP which would fit under this
COUP S CPSC. ).
Examples of CDR Submissions
In the 2016 CDR cycle, one company reported the use of DINP (CASRN 28553-12-0) in furniture and
furnishings not covered elsewhere, which EPA understands would be reflected in this COU.
E.37 Consumer Use - Furnishing, Cleaning, Treatment/Care Products -
Floor Coverings/Plasticizer in Construction and Building Materials
Covering Large Surface Areas Including Stone, Plaster, Cement,
Glass, and Ceramic Articles; Fabrics, Textiles, and Apparel (Vinyl
Tiles, Resilient Flooring, PVC-Backed Carpeting)
This COU is referring to the consumer use of DINP in floor coverings and construction and building
materials including various types of flooring. Consumers generally use flooring containing DINP in an
indoor environment and DIYers handle the construction materials (e.g., tiles, carpeting) that have DINP
incorporated into the products, which may involve cutting and shaping the products for installation.
DINP is a known constituent of various building/construction materials because of its use as a general-
purpose plasticizer in PVC applications. Although similar to other COU's that were captured elsewhere
in the final scope, EPA expects that certain building/construction materials that would be covered by this
COU in commercial use would include items such as vinyl tiles, resilient flooring, PVC-backed
carpeting, and other construction/building materials that are covering large areas (A.CC HPP. 2019).
EPA identified the use of DINP in a product associated with floor matting ( 02 Id). EPA
anticipates that given the nature of DIY home improvement that many of these DINP containing
products associated with floor covering could readily be available and used by consumers.
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Examples of CDR Submissions
In the 2016 CDR cycle, one company reported the use of DINP (CASRN 28553-12-0) in floor
coverings.
E.38 Consumer Use - Furnishing, Cleaning, Treatment/Care Products -
Air Care Products
This COU is referring to the consumer use of DINP in air care products.
DINP is found in certain air care products with what EPA believes to be primarily a commercial
application; however, it is possible that consumer use does exist for these products as well. The Agency
identified at least one commercially available scent for candle manufacturers containing DINP (U.S.
21c). Although EPA expects that this scent would predominately be used in commercial candle
making activities, it is possible that some consumer DIY candle makers could source this product from
online vendors. The Agency did not identify DINP in any additional consumer air care products at this
time. Consumer DIY users of these products would apply through mixing DINP containing liquid
substances with various waxes and other liquid to semi-solid materials in either cold-press or heated
environments to create candles for personal use.
This use was not reported to EPA in the 2016 or 2020 CDR cycles.
E.39 Consumer Use - Furnishing, Cleaning, Treatment/Care Products -
Fabric, Textile, and Leather Products (Apparel and Footwear Care
Products)
This COU is referring to the consumer use of DINP in fabric, textile, and leather products including
apparel and footwear products. The consumer users of products under this category would be expected
to purchase and wear various apparel and footwear products that contain DINP.
EPA understands that DINP has been used in fabric, textile, and leather products including apparel and
footwear products (ACC HPP. 2019). The Agency also notes that this COU was included in the
Manufacturer Request for Risk Evaluation Diisononyl Phthalate (DINP) due to DINP's use as a
plasticizer to impart flexibility to PVC applications such as vinyl clothing, which are likely to be used in
commercial and consumer applications (e.g., rain boots, gloves, raincoats) (ACC HPP. ^ ). EPA
identified DINP in commercial and consumer fabric, textile, and leather products at concentrations of at
least 1 percent but less than 60 percent ( ^02 Id). A National Library of Medicine database
identified DINP use in injection molding for footwear ( ). The manufacturer request
also notes that a 2013 EC HA report identified the use of DINP in skinny leather pants, as well (ACC
HPP. 2019).
Examples of CDR Submissions
In the 2016 CDR cycle, two companies reported the use of DINP (CASRN 28553-12-0) in fabric,
textiles, and leather products not covered elsewhere.
In the 2020 CDR cycle, one company reported the use of DINP (CASRN 68515-48-0) in fabric, textiles,
and leather products not covered elsewhere, while one company reported the use of DINP (CASRN
28553-12-0) in apparel and footwear care products.
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E.40 Consumer Use - Packaging, Paper, Plastic, Hobby Products - Arts,
Crafts, and Hobby Materials
This COU is referring to the consumer use of arts, crafts, and hobby materials that contain DINP.
Consumers would be expected to handle products under this COU with their hands.
EPA identified uses of DINP in various arts, crafts, and hobby materials, including glitter board products
and in polymer clay bricks, canes, and eraser products (U.S. EPA. 202Id). The Agency expects that
these products are likely to be used in both commercial and consumer level applications. EPA identified
two erasers that contained DINP (U.S. EPA. 202Id). The Agency anticipates that these erasers would be
used in both commercial and consumer applications.
This use was not reported to EPA in the 2016 or 2020 CDR cycles.
E.41 Consumer Use - Packaging, Paper, Plastic, Hobby Products - Ink,
Toner, and Colorant Products
This COU is referring to the consumer use of DINP in ink, toner, and colorant products.
DINP is used in printing ink, at least one stamp product, and pigments (\ c. < ^ \ JO J I. The
Manufacturer Request for Risk Evaluation Diisononyl Phthalate (DINP) lists the use of pigments in non-
PVC applications (<5% of DINP use) alongside use in paints (AO 19). EPA expects that the
majority of ink, toner, and colorant products containing DINP would be commercial in nature; however,
it is possible that these products are used by DIY consumers as many of the commercial products are
available for consumer purchasers through various online vendors. EPA would expect that if consumer
DIYers were to use these products they would apply them in the same fashion as industrial users, on a
smaller scale at their residences.
This use was not reported to EPA in the 2016 or 2020 CDR cycles.
E.42 Consumer Use - Packaging, Paper, Plastic, Hobby Products - Other
Articles with Routine Direct Contact During Normal Use Including
Rubber Articles; Plastic Articles (Hard); Vinyl Tape; Flexible Tubes;
Profiles; Hoses
This COU is referring to the consumer use of DINP in various consumer products used with routine
direct contact such as vinyl tape, flexible tubes, profiles, and hoses. DINP is used in various rubber and
plastic articles that are intended for consumer use. The CDR reporting category is intended to capture
items such as gloves, boots, clothing, rubber handles, gear levers, steering wheels, handles, pencils, and
handheld device casing. As such, consumers would be expected to handle products covered by this COU
with their hands and wear them on their bodies.
As identified by the Manufacturer Request for Risk Evaluation Diisononyl Phthalate (DINP), tool
handles, flexible tubes, profiles, and hoses are several of the uses for DINP as a general-purpose
plasticizer for PVC applications ( ). The National Library of Medicine's database
identified DINP for its use in garden hoses (1 c. 1 i1 \ 202Id).
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Examples of CDR Submissions
In the 2016 CDR cycle, three companies reported the use of DINP (CASRN 28553-12-0) in plastic and
rubber products not covered elsewhere. Two companies reported the use of DINP (CASRN 68515-48-0)
in plastic and rubber products not covered elsewhere.
In the 2020 CDR cycle, one company reported the use of DINP (CASRN 68515-48-0) in in plastic and
rubber products not covered elsewhere.
E.43 Consumer Use - Packaging, Paper, Plastic, Hobby Products -
Packaging (Excluding Food Packaging), Including Rubber Articles;
Plastic Articles (Hard); Plastic Articles (Soft)
This COU is referring to the consumer use of DINP in various packaging, paper, plastic, and hobby
products.
EPA notes that this use was reported in the 2020 CDR reporting cycle and is intended to describe
products such as phone covers, personal tablets covers, styrofoam packaging, and bubble wrap. Given
what the Agency knows about the use of DINP as a general-purpose plasticizer for PVC and non-PVC
applications, EPA expects that this use of DINP has been identified under other previously reported
CDR codes. The Agency also expects that the type of products being reported under this COU are likely
to be both commercial and consumer in nature. Consumers would be expected to handle products
covered by this COU with their hands.
Examples of CDR Submissions
In the 2020 CDR cycle, one company reported the use of DINP (CASRN 28553-12-0) in packaging
(excluding food packaging), including rubber articles; plastic articles (hard); plastic articles (soft).
E.44 Consumer Use - Packaging, Paper, Plastic, Hobby Products - Toys,
Playground, and Sporting Equipment
This COU is referring to the consumer use of DINP in toys, playground, and sporting equipment. The
COU includes the consumer use or storage of toys, playgrounds, and sporting equipment that contain
DINP in an indoor environment. The use also refers to the DIY building of home sporting equipment.
EPA notes in the final scope that the Consumer Product Safety Innovation Act of 2008 and the U.S.
CPSC banned the use of DINP at concentrations of greater than 0.1 percent in children's toys and
childcare articles in 2008 and 2018, respectively. EPA expects that the use of DINP in toys
manufactured or processed prior to the ban may still be occurring. Consumers would be expected to
handle products made under this COU with their hands or mouth products. For several articles, the
weight fraction of DINP was reported as DINP + DIDP. For example, concentrations of DINP + DIDP
in four teether samples at 32 to 40 percent and in 2 of 3 doll samples at approximately 20 and 26
percent.
Examples of CDR Submissions
In the 2016 CDR cycle, one company reported the use of DINP in toys, playground, and sporting
equipment (28553-12-0).
E.45 Consumer Use - Other - Novelty Articles
This COU is referring to the consumer use of DINP in adult novelty articles.
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This COU is describing adult sex toys that are available for consumer use in the United States. Although
the U.S. Food and Drug Administration (FDA) classifies certain sex toys (such as vibrators) as
obstetrical and gynecological therapeutic medical devices many manufacturers label these products "for
novelty use only," they are not subject to the FDA regulations (Stabile. 2013). This same study indicated
tested concentrations of phthalates between 24 and 49 percent of the tested sex toys for creating a softer,
more flexible plastic (Stabile. ). For this reason, EPA assumed that the concentration of D1NP in
these articles to be analogous to the overall content of the mix of phthalates tested and found in that
study. This use was not reported to EPA in the 2016 or 2020 CDR reporting cycles. Consumers could
experience dermal and oral exposure to DINP using the articles covered by this COU.
E.46 Consumer Use - Other Use - Automotive Articles
This COU is referring to the consumer use of DINP in automotive articles. This COU includes the use of
DINP-containing automotive articles in a consumer DIY setting or by consumers driving a vehicle.
DINP is used in various automotive article applications. ACC's website details the use of high
phthalates, such as DINP, in automobile interiors, vinyl seat covers, and interior trim because it can
prevent degradation of these components (ACC. 2024).
This use was not reported to EPA in the 2016 or 2020 CDR cycles.
E.47 Disposal
Each of the COUs of DINP may generate waste streams of the chemical. For purposes of the DINP risk
evaluation, this COU refers to the DINP in a waste stream that is collected from facilities and
households and are unloaded at and treated or disposed at third-party sites. This COU also encompasses
DINP contained in wastewater discharged by consumers or occupational users to a POTW or other, non-
POTW for treatment, as well as other wastes. DINP is expected to be released to other environmental
media, such as introductions of biosolids to soil or migration to water sources, through waste disposal
(e.g., disposal of formulations containing DINP, plastic and rubber products, textiles, and transport
containers). Disposal may also include destruction and removal by incineration ( ).
Additionally, DINP has been identified in EPA's 2016 report, Hydraulic Fracturing for Oil and Gas:
Impacts from the Hydraulic Fracturing Water Cycle on Drinking Water Resources in the United States
(EPA-6C 6Fb), to be a chemical reported to be detected in produced water, which is
subsequently disposed. Recycling of DINP and DINP containing products is considered a different
COU. Environmental releases from industrial sites are assessed in each COU.
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Appendix F OCCUPATIONAL EXPOSURE VALUE DERIVATION
EPA has calculated a 8-hour existing chemical occupational exposure value to summarize the
occupational exposure scenario and sensitive health endpoints into a single value. This calculated value
may be used to support risk management efforts for DINP under TSCA section 6(a), 15 U.S.C. section
2605. EPA calculated the value rounded to 1.40 mg/m3 for inhalation exposures to DINP as an 8-hour
time-weighted average (TWA) and for consideration in workplace settings (see Appendix F.l) based on
the chronic non-cancer human equivalent concentration (HEC) for liver toxicity.
TSCA requires risk evaluations to be conducted without consideration of costs and other non-risk
factors; thus, this occupational exposure value represents a risk-only number. If risk management for
DINP follows the final risk evaluation, EPA may consider costs and other non-risk factors, such as
technological feasibility, the availability of alternatives, and the potential for critical or essential uses.
Any existing chemical exposure limit used for occupational safety risk management purposes could
differ from the occupational exposure value presented in this appendix based on additional consideration
of exposures and non-risk factors consistent with TSCA section 6(c).
This calculated value for DINP represents the exposure concentration below which exposed workers and
ONUs are not expected to exhibit any appreciable risk of adverse toxicological outcomes, accounting for
PESS. It is derived based on the most sensitive human health effect {i.e., liver toxicity) relative to
benchmarks and standard occupational scenario assumptions of 8 hours per day, 5 days per week
exposures for a total of 250 days exposure per year, and a 40-year working life.
EPA expects that at the occupational exposure value of 0.0808 ppm (1.40 mg/m3), a worker or ONU
also would be protected against developmental and liver toxicity from acute and intermediate duration
occupational exposures if ambient exposures are kept below this occupational exposure value. The
Agency has not separately calculated a short-term {i.e., 15-minute) occupational exposure value because
EPA did not identify hazards for DINP associated with this very short duration.
EPA did not identify a government-validated method for analyzing DINP in air.
The Occupational Safety and Health Administration (OSHA) has not set a permissible exposure limit
(PEL) as an 8-hour TWA, f EPA located several occupational exposure limits for DINP
(CASRN 28553-12-0) in other countries. Identified 8-hour TWA values range from 3 mg/m3 in
Denmark to 5 mg/m3 in Ireland, New Zealand, South Africa, and the United Kingdom (see also
Appendix B.3). Additionally, EPA found that New Zealand and the United Kingdom all have an
established occupational exposure limit of 5 mg/m3 (8-hour TWA) in each country's code of regulation
that is enforced by each country's worker safety and health agency.
F.l Occupational Exposure Value Calculations
This appendix presents the calculations used to estimate occupational exposure values using inputs
derived in this risk evaluation. Multiple values are presented below for hazard endpoints based on
different exposure durations. For DINP, the most sensitive occupational exposure value is based on non-
cancer developmental effects and the resulting 8-hour TWA is rounded to 1.40 mg/m3.
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Acute Non-cancer Occupational Exposure Value
The acute occupational exposure value (EVaCute) was calculated as the concentration at which the acute
MOE would equal the benchmark MOE for acute occupational exposures using EquationApx F-l:
EquationApx F-l.
HECacute ATHECacute IRresting
Benchmark M0Eacui-e ED I Rworkers
24/i
3.68 ppm —
30
Qh
d
m
0.6125-r—
hr
m3
1.25?-
hr
0.180 ppm
/mg\ EV ppm * MW 0.180 ppm * 418.mg
EVacute \m3) MolarVolume 24 45 —^— m3
mol
Intermediate Non-cancer Occupational Exposure Value
The intermediate occupational exposure value (EVintermediate) was calculated as the concentration at
which the intermediate MOE would equal the benchmark MOE for intermediate occupational exposures
using Equation Apx F-2:
Equation Apx F-2.
gy HECjntermediate ^ AThe:c intermediate^ ^resting
intermediate Benchmark MOfj^ej-j^efjiate ED*EF IRworkers
24/i m3
3.68 ppm —*30 d 0.6125-jjt mg
= 30 * 8/1 * ^3 = 0.246 ppm = 4.21 ^
-t-*22 a 1.25 -Tr-
et hr
Chronic Non-cancer Exposure Value
The chronic occupational exposure value (EVchronic) was calculated as the concentration at which the
chronic MOE would equal the benchmark MOE for chronic occupational exposures using
EquationApx F-3:
Equation Apx F-3.
cy HECchronic AThec chronic ^ IRresting
^ V rhrnnir ^
enrome Benchmark MOEchronic ED*EF*WY IRworkers
24h 365d
1 1 o nnm —~z—* *40 y*0.6125—— c
1.13 ppm d y hr _ n aqaq _ 1 QQ^I
* ah ,'cm s- = 0.0808 ppm = 1.38 —
30 40y.l.252i
d y ' hr
Where:
A Thecate = Averaging time for the POD/HEC used for evaluating non-cancer
acute occupational risk based on study conditions and HEC
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A THECintermediate
A 'I)Ih'J 'chronic
Benchmark MOEacute =
Benchmark MOEintermediate =
Benchmark MOEchmnic =
EVacute
EVintermediate
E V chronic —
ED
EF
HEC
IR
Molar Volume =
MW
WY
adjustments (24 h/day).
Averaging time for the POD/HEC used for evaluating non-cancer
intermediate occupational risk based on study conditions and/or
any HEC adjustments (24 h/day for 30 days).
Averaging time for the POD/HEC used for evaluating non-cancer
chronic occupational risk based on study conditions and/or HEC
adjustments (24 h/day for 365 days/yr) and assuming the same
number of years as the high-end working years (WY, 40 years) for
a worker.
Acute non-cancer benchmark margin of exposure, based on the
total uncertainty factor of 30
Intermediate non-cancer benchmark margin of exposure, based on
the total uncertainty factor of 30
Chronic non-cancer benchmark margin of exposure, based on the
total uncertainty factor of 30
Acute occupational exposure value
Intermediate occupational exposure value
Chronic occupational exposure value
Exposure duration (8 h/day)
Exposure frequency (1 day for acute, 22 days for intermediate, and
250 days/yr for chronic and lifetime)
Human equivalent concentration for acute, intermediate, or chronic
non-cancer occupational exposure scenarios
Inhalation rate (default is 1.25 m3/h for workers and 0.6125 m3/h
assumed from "resting" animals from toxicity studies)
24.45 L/mol, the volume of a mole of gas at 1 atm and 25 °C
Molecular weight of DINP (418.62 g/mole)
Working years per lifetime at the 95th percentile (40 years).
Unit conversion:
1 ppm = 18.3 mg/m3 (see equation associated with the EVacute calculation)
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