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SEPA
PUBLIC RELEASE DRAFT
August 2024
EPA Document# EPA-740-D-24-015
August 2024
United States Office of Chemical Safety and
Environmental Protection Agency Pollution Prevention
Draft Risk Evaluation for Diisononyl Phthalate
(DINP)
CASRNs: 28553-12-0 and 68515-48-0
(Representative Structure)
August 2024
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TABLE OF CONTENTS
ACKNOWLEDGEMENTS 9
EXECUTIVE SUMMARY 10
1 INTRODUCTION 16
1.1 Scope of the Risk Evaluation 16
1.1.1 Life Cycle and Production Volume 17
1.1.2 Conditions of Use Included in the Risk Evaluation 21
1.1.2.1 Conceptual Models 28
1.1.3 Populations and Durations of Exposure Assessed 33
1.1.3.1 Potentially Exposed and Susceptible Subpopulations 33
1.2 Organization of the Risk Evaluation 33
2 CHEMISTRY AND FATE AND TRANSPORT OF DINP 35
2.1 Summary of Physical and Chemical Properties 35
2.2 Summary of Environmental Fate and Transport 35
3 RELEASES AND CONCENTRATIONS OF DINP IN THE ENVIRONMENT 37
3.1 Approach and Methodol ogy 37
3.1.1 Manufacturing, Processing, Industrial and Commercial 37
3.1.1.1 Crosswalk of Conditions of Use to Occupational Exposure Scenarios 37
3.1.1.2 Description of DINP Use for Each OES 41
3.1.2 Estimating the Number of Release Days per Year for Facilities in Each OES 41
3.1.3 Daily Release Estimation 44
3.1.4 Consumer (Down-the-Drain) 44
3.2 Summary of Environmental Releases 45
3.2.1 Manufacturing, Processing, Industrial and Commercial 45
3.2.2 Weight of Scientific Evidence Conclusions for Environmental Releases from Industrial and
Commercial Sources 51
3.2.3 Strengths, Limitations, Assumptions, and Key Sources of Uncertainty for the Environmental
Release Assessment 60
3.3 Summary of Concentrations of DINP in the Environment 60
3.3.1 Weight of Scientific Evidence Conclusions 62
3.3.1.1 Surface Water 62
3.3.1.2 Ambient Air - Air to Soil Deposition 63
4 HUMAN HEALTH RISK ASSESSMENT 64
4.1 Summary of Human Exposures 65
4.1.1 Occupational Exposures 65
4.1.1.1 Approach and Methodol ogy 65
4.1.1.2 Summary of Number of Workers and ONUs 69
4.1.1.3 Summary of Inhalation Exposure Assessment 70
4.1.1.4 Summary of Dermal Exposure Assessment 73
4.1.1.5 Weight of Scientific Evidence Conclusions for Occupational Exposure 75
4.1.1.5.1 Strengths, Limitations, Assumptions, and Key Sources of Uncertainty for the
Occupational Exposure Assessment 85
4.1.2 Consumer Exposures 86
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4.1.2.1 Summary of Consumer and Indoor Dust Exposure Scenarios and Modeling
Approach and Methodology 86
4.1.2.2 Modeling Dose Results by COU for Consumer and Indoor Dust 94
4.1.2.3 Monitoring Concentrations of DINP in the Indoor Environment 108
4.1.2.4 Indoor Aggregate Dust Monitoring and Modeling Comparison Ill
4.1.2.5 Weight of Scientific Evidence Conclusions for Consumer Exposure 113
4.1.2.5.1 Strength, Limitations, Assumptions, and Key Sources of Uncertainty for the
Consumer Exposure Assessment 114
4.1.3 General Population Exposures 124
4.1.3.1 General Population Screening-Level Exposure Assessment Results 127
4.1.3.2 Daily Intake Estimates for the U.S. Population Using NHANES Urinary
Biomonitoring Data 131
4.1.3.1 Overall Confidence in General Population Screening-Level Exposure Assessment... 133
4.1.4 Human Milk Exposures 133
4.1.5 Aggregate and Sentinel Exposure 134
4.2 Summary of Human Health Hazard 134
4.3 Human Health Risk Characterization 137
4.3.1 Risk Assessment Approach 137
4.3.1.1 Estimation of Non-cancer Risks 139
4.3.1.2 Estimation of Non-cancer Aggregate Risks 139
4.3.2 Risk Estimates for Workers 140
4.3.2.1 Overall Confidence in Worker Risks 147
4.3.3 Risk Estimates for Consumers 160
4.3.3.1 Overall Confidence in Consumer Risks 162
4.3.4 Risk Estimates for General Population 175
4.3.5 Risk Estimates for Potentially Exposed or Susceptible Subpopulations 175
4.3.6 Cumulative Risk Considerations 176
5 ENVIRONMENTAL RISK ASSESSMENT 177
5.1 Summary of Environmental Exposures 177
5.2 Summary of Environmental Hazards 178
5.3 Environmental Risk Characterization 179
5.3.1 Risk Assessment Approach 179
5.3.2 Risk Estimates for Aquatic and Terrestrial Species 180
5.3.3 Overall Confidence and Remaining Uncertainties Confidence in Environmental Risk
Characterization 185
6 UNREASONABLE RISK DETERMINATION 188
6.1 Human Health 192
6.1.1 Populations and Exposures EPA Assessed for Human Health 193
6.1.2 Summary of Human Health Effects 193
6.1.3 Basis for Unreasonable Risk to Human Health 194
6.1.4 Workers 196
6.1.5 Consumers 198
6.1.6 General Population 200
6.2 Environment 202
6.2.1 Populations and Exposures EPA Assessed for the Environment 202
6.2.2 Summary of Environmental Effects 203
6.2.3 Basis for Risk of Injury to the Environment 204
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6.3 Additional Information Regarding the Basis for the Unreasonable Risk Determination 204
REFERENCES 216
APPENDICES 229
Appendix A KEY ABBREVIATIONS AND ACRONYMS 229
Appendix B REGULATORY AND ASSESSMENT HISTORY 231
B. 1 Federal Laws and Regulations 231
B.2 State Laws and Regulations 233
B.3 International Laws and Regulations 233
B.4 Assessment History 234
Appendix C LIST OF TECHNICAL SUPPORT DOCUMENTS 237
Appendix D UPDATES TO THE DINP CONDITIONS OF USE TABLE 240
Appendix E CONDITIONS OF USE DESCRIPTIONS 250
E. 1 Manufacturing - Domestic Manufacturing 250
E.2 Manufacturing - Importing 250
E.3 Processing - Incorporation into Formulation, Mixture, or Reaction Product - Heat Stabilizer
and Processing Aid in Basic Organic Chemical Manufacturing 251
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]) 251
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]) 252
E.6 Processing - Other Uses - Miscellaneous Processing (Petroleum Refineries; Wholesale and
Retail Trade) 254
E.7 Processing - Repackaging - Plasticizer (All Other Chemical Product and Preparation
Manufacturing; Wholesale and Retail Trade, Laboratory Chemicals Manufacturing) 254
E.8 Processing - Recycling 254
E.9 Distribution in Commerce 255
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) 255
E. 11 Industrial Uses - Automotive, Fuel, Agricultural, Outdoor Use Products - Automotive
Products, Other than Fluids 256
E.12 Industrial Uses - Construction, Paint, Electrical, and Metal Products -
Building/Construction Materials (Roofing, Pool Liners, Window Shades, Flooring) 256
E.13 Industrial Uses - Construction, Paint, Electrical, and Metal Products - Paints and Coatings. 256
E. 14 Industrial Use - Other Uses - Hydraulic Fluids 257
E. 15 Industrial Use - Other Uses - Pigment (Leak Detection) 257
E. 16 Commercial Use - Other Use - Automotive Products Other than Fluids 257
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E.17 Commercial Use - Construction, Paint, Electrical, and Metal Products - Adhesives and
Sealants 258
E.18 Commercial Use - Construction, Paint, Electrical, and Metal Products - Plasticizer in
Building/Construction Materials (Roofing, Pool Liners, Window Shades); Construction and
Building Materials Covering Large Surface Areas; Including Paper Articles; MetalArticles;
Stone, Plaster, Cement, Glass, and Ceramic Articles 259
E.19 Commercial Use - Construction, Paint, Electrical, and Metal Products - Electrical and
Electronic Products 259
E.20 Commercial Use - Construction, Paint, Electrical, and Metal Products - Paints and Coatings260
E.21 Commercial Use - Furnishing, Cleaning, Treatment/Care Products - Foam Seating and
Bedding Products; Furniture and Furnishings Including Plastic Articles (Soft); Leather
Articles 260
E.22 Commercial Use - Furnishing, Cleaning, Treatment/Care Products - Air Care Products 261
E.23 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) 261
E.24 Commercial Use - Furnishing, Cleaning, Treatment/Care Products - Fabric, Textile, and
Leather Products (Apparel and Footwear Care Products) 261
E.25 Commercial Use - Packaging, Paper, Plastic, and Hobby Products - Arts, Crafts, and Hobby
Materials 262
E.26 Commercial Use - Packaging, Paper, Plastic, and Hobby Products - Ink, Toner, and
Colorant Products 262
E.27 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) 263
E.28 Commercial Use - Packaging, Paper, Plastic, and Hobby Products - Plasticizer (Plastic and
Rubber Products; Tool Handles, Flexible Tubes, Profiles and Hoses) 263
E.29 Commercial Use - Packaging, Paper, Plastic, and Hobby Products - Toys, Playground, and
Sporting Equipment 264
E.30 Commercial Use - Solvents (for Cleaning or Degreasing) 264
E.31 Commercial Use - Other Uses - Laboratory Chemicals 264
E.32 Consumer Use - Other Use - Automotive Care Products, Other Than Fluids 264
E.33 Consumer Use - Construction, Paint, Electrical, and Metal Products - Adhesives and
Sealants 265
E.34 Consumer Use - Construction, Paint, Electrical, and Metal Products - Building Construction
Materials (Wire and Cable Jacketing, Wall Coverings, Roofing, Pool Applications, etc.) 265
E.35 Consumer Use - Construction, Paint, Electrical, and Metal Products - Electrical and
Electronic Products 266
E.36 Consumer Use - Construction, Paint, Electrical, and Metal Products - Paints and Coatings . 266
E.37 Consumer Use - Furnishing, Cleaning, Treatment/Care Products - Foam Seating and
Bedding Products; Furniture and Furnishings Including Plastic Articles (Soft); Leather
Articles 267
E.38 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) 267
E.39 Consumer Use - Furnishing, Cleaning, Treatment/Care Products - Air Care Products 267
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E.40 Consumer Use - Furnishing, Cleaning, Treatment/Care Products - Fabric, Textile, and
Leather Products (Apparel and Footwear Care Products) 268
E.41 Consumer Use - Packaging, Paper, Plastic, Hobby Products - Arts, Crafts, and Hobby
Materials 268
E.42 Consumer Use - Packaging, Paper, Plastic, Hobby Products - Ink, Toner, and Colorant
Products 269
E.43 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 269
E.44 Consumer Use - Packaging, Paper, Plastic, Hobby Products - Packaging (Excluding Food
Packaging), Including Rubber Articles; Plastic Articles (Hard); Plastic Articles (Soft) 269
E.45 Consumer Use - Packaging, Paper, Plastic, Hobby Products - Toys, Playground, and
Sporting Equipment 270
E.46 Consumer Use - Other - Novelty Products 270
E.47 Disposal 270
Appendix F DRAFT OCCUPATIONAL EXPOSURE VALUE DERIVATION 272
F. 1 Draft Occupational Exposure Value Calculations 272
LIST OF TABLES
Table 1-1. Categories and Subcategories of Use and Corresponding Exposure Scenario in the Risk
Evaluation for DINP 22
Table 2-1. Physical and Chemical Properties of DINP 35
Table 3-1. Crosswalk of Conditions of Use to Assessed Occupational Exposure Scenarios 38
Table 3-2. Description of the Function of DINP for Each OES 41
Table 3-3. Generic Estimates of Number of Operating Days per Year for Each OES 42
Table 3-4. Summary of EPA's Daily Release Estimates for Each OES and EPA's Overall Confidence in
these Estimates 46
Table 3-5. Summary of Overall Confidence in Environmental Release Estimates by OES 52
Table 3-6. Summary of High-End DINP Concentrations in Various Environmental Media from
Environmental Releases 62
Table 4-1. Summary of Exposure Monitoring and Modeling Data for Occupational Exposure Scenarios
67
Table 4-2. Summary of Total Number of Workers and ONUs Potentially Exposed to DINP for Each
OES 69
Table 4-3. Summary of Average Adult Worker Inhalation Exposure Results for Each OES 72
Table 4-4. Summary of Average Adult Worker Dermal Exposure Results for Each OES 74
Table 4-5. Summary of Assumptions, Uncertainty, and Overall Confidence in Exposure Estimates by
OES 76
Table 4-6. Summary of Consumer COUs, Exposure Scenarios, and Exposure Routes 88
Table 4-7. Weight of Scientific Evidence Conclusions for Indoor Dust Ingestion Exposure 110
Table 4-8. Comparison between Modeled and Monitored Daily Dust Intake Estimates for DINP 112
Table 4-9. Weight of Scientific Evidence Summary Per Consumer COU 118
Table 4-10. Exposure Scenarios Assessed in General Population Screening-Level Analysis 126
Table 4-11. General Population Surface Water and Drinking Water Exposure Summary 129
Table 4-12. Fish Ingestion for Adults in Tribal Populations Summary 130
Table 4-13. General Population Ambient Air to Soil Deposition Exposure Summary 131
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Table 4-14. Daily Intake Values and MOEs for DINP Based on Urinary Biomonitoring from the 2017 to
2018 NHANES Cycle 132
Table 4-15. Non-cancer HECs and HEDs Used to Estimate Risks 136
Table 4-16. Exposure Scenarios, Populations of Interest, and Hazard Values 138
Table 4-17. Occupational Aggregate Risk Summary Table 148
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 181
Table 5-2. DINP Evidence Table Summarizing Overall Confidence Derived for Environmental Risk
Characterization 186
Table 6-1. Supporting Basis for the Draft Risk Determination for Human Health (Occupational
Conditions of Use) 205
Table 6-2. Supporting Basis for the Draft Risk Determination for Human Health (Consumer Conditions
of Use) 213
LIST OF FIGURES
Figure 1-1. TSCA Existing Chemical Risk Evaluation Process 16
Figure 1-2. Draft Risk Evaluation Document Summary Map 17
Figure 1-3. DINP Life Cycle Diagram 19
Figure 1-4. Percentage of DINP Production Volume by Use 20
Figure 1-5. DINP Conceptual Model for Industrial and Commercial Activities and Uses: Potential
Exposure and Hazards 29
Figure 1-6. DINP Conceptual Model for Consumer Activities and Uses: Potential Exposures and
Hazards 30
Figure 1-7. DINP Conceptual Model for Environmental Releases and Wastes: General Population
Hazards 31
Figure 1-8. DINP Conceptual Model for Environmental Releases and Wastes: Ecological Exposures and
Hazards 32
Figure 3-1. An Overview of How EPA Estimated Daily Releases for Each OES 44
Figure 4-1. Acute Dose Rate for DINP from Ingestion, Inhalation, Dermal Exposure Routes in Infants
<1 Year Old and Toddlers 1 to 2 Years Old 97
Figure 4-2. Acute Dose Rate of DINP from Ingestion, Inhalation, and Dermal Exposure Routes for
Preschoolers 3 to 5 Years Old and Middle Childhood 6 to 10 Years Old 98
Figure 4-3. Acute Dose Rate of DINP from Ingestion, Inhalation, and Dermal Exposure Routes for
Young Teens 11 to 15 Years Old and for Teenagers and Young Adults 16 to 20 Years
Old 100
Figure 4-4. Acute Dose Rate of DINP from Ingestion, Inhalation, and Dermal Exposure Routes in
Adults 21+ Years Old 101
Figure 4-5. Intermediate Dose Rate for DINP from Inhalation Exposure Route in Bystander Infants <1
Year Old and Toddlers 1 to 2 Years Old 102
Figure 4-6. Intermediate Dose Rate for DINP from Inhalation Exposure Route in Bystander Preschoolers
3 to 5 Years Old and Middle Childhood 6 to 10 Years Old 102
Figure 4-7. Intermediate Dose Rate of DINP from Inhalation, and Dermal Exposure Routes for Young
Teen 11 to 15 Years Old and for Teenagers and Young Adults 16 to 20 Years Old 102
Figure 4-8. Intermediate Dose Rate of DINP from Inhalation, and Dermal Exposure Routes for Adults
21+Years Old 103
Figure 4-9. Chronic Dose Rate for DINP from Ingestion, Inhalation, and Dermal Exposure Routes in
Infants <1 Year Old and Toddlers 1 to 2 Years Old 104
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Figure 4-10. Chronic Dose Rate of DINP from Ingestion, Inhalation, and Dermal Exposure Routes for
Preschoolers 3 to 5 Years Old and Middle Childhood 6 to 10 Years Old 105
Figure 4-11. Chronic Dose Rate of DINP from Ingestion, Inhalation, and Dermal Exposure Routes for
Young Teen 11 to 15 Years Old and for Teenagers and Young Adults 16 to 20 Years Old
106
Figure 4-12. Chronic Dose Rate of DINP from Ingestion, Inhalation, and Dermal Exposure Routes in
Adults 21+ Years Old 107
Figure 4-13. Potential Human Exposure Pathways to DINP for the General Population 125
Figure 5-1. Trophic Transfer of DINP in Aquatic and Terrestrial Ecosystems 178
LIST OF APPENDIX TABLES
Table_Apx B-l. Federal Laws and Regulations 231
Table_Apx B-2. State Laws and Regulations 233
Table_Apx B-3. International Laws and Regulations 233
Table_Apx B-4. Assessment History of DINP 234
TableApx D-l. Additions and Name Changes to Categories and Subcategories of Conditions of Use
Based on CDR Reporting and Stakeholder Engagement 240
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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.
Docket
Supporting information can be found in the public docket, Docket ID (EPA-HQ-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), 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, Christopher Green,
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, Brandall Ingle-Carlson, 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, Jason Wight, and Susanna Wegner.
Technical Support: Mark Gibson, Hillary Hollinger, and S. Xiah Kragie
This draft risk evaluation was 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 its draft risk evaluation, EPA's protective, screening-level
approaches demonstrated that uses of DINP under TSCA do not pose risk to the environment or the
general population. Of the 47 conditions of use (COUs) that EPA evaluated, 2 COUs have risk estimates
that raise concerns for workers' exposure: Industrial use of adhesives and sealants, and Industrial use of
paints and coatings. In addition, one COU has risk estimates that raise concerns for consumers: Use of
DINP in construction and building materials that cover large surface areas. These materials include
stone, plaster, cement, glass, and ceramic articles, as well as vinyl, carpeting, and other flooring
materials. Based on this finding, EPA preliminarily finds that DINP presents an unreasonable risk of
injury to human health. Notably, 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 for DINP during its July 2024 meeting. EPA has not yet incorporated
recommendations from SACC or public comments into this draft risk evaluation because the final peer-
review report from SACC is not yet available. After this draft risk evaluation is informed by public
comment and independent, expert peer review advice from the previous SACC, EPA will issue a final
risk evaluation that includes its final determination as to whether DINP presents unreasonable risk of
injury to health or the environment under the COUs.
DINP is used primarily as a plasticizer to manufacture flexible polyvinyl chloride (PVC). It is also used
to make building and construction materials; automotive care and fuel products; and other commercial
and consumer products including adhesives and sealants, paints and coatings, electrical and electronic
products—all of which are considered TSC A uses. 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 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.
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 in 2019 granted the request. 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 based on the latest 2020 CDR data. (EPA describes
production volumes as a range to protect confidential business information.)
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 U.S. Consumer Product Safety
Commission'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. Any food, food additive, drug, cosmetic, or device (as defined in section 201 of the Federal
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Food, Drug, and Cosmetic Act [FFDCA]) when manufactured, processed, or distributed in commerce as
such, do not meet the definition of chemical substance under TSCA.
In this draft 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., food, use in food packaging) were not
evaluated or taken into account by EPA in reaching its preliminary determination of unreasonable risk to
injury of human health. Thus, although EPA is preliminarily determining in this draft risk evaluation
that three specific TSCA COUs significantly contribute to its draft 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. The Agency is including DINP in its forthcoming cumulative risk
assessment along with five other phthalate chemicals. EPA may consider how uses that are not subject
to TSCA or not directly attributable to uses subject to TSCA impact the cumulative risk assessment.
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, EPA, in making the finding of presents unreasonable risk, also considers risk-related factors as
described in its 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, or 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
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.
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. The most sensitive developmental effects include adverse effects on the developing male
reproductive system, sometimes referred to as "phthalate syndrome." EPA is including DINP in its
cumulative risk assessment along with five other phthalate chemicals that also cause effects on
laboratory animals consistent with phthalate syndrome. Notably, assessments by Health Canada, 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. 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 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 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
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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 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
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. This
included exposure from incidental dermal contact or ingestion of surface waters receiving TSCA
releases, ingestion of fish from surface waters receiving TSCA releases, and soil ingestion and dermal
soil contact resulting from air to soil deposition of DINP from TSCA releases. 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 preliminarily finds that exposure of the general population to DINP does not
significantly contribute to unreasonable risk of injury to human health.
However, EPA identified two COUs for workers and one COU for consumers as preliminarily
contributing to unreasonable risk of injury to human health.
The COUs that EPA identified as preliminarily significantly contributing to unreasonable risk from
DINP to workers include those that led to exposures to average adults and women of reproductive age in
scenarios in which unprotected workers used spray adhesives and sealants or paints and coatings that
contain DINP with high-pressure sprayers. This is because doing so could create high concentrations of
DINP in mist that an unprotected worker could inhale.
For consumers, EPA identified one COU as preliminarily significantly contributing to unreasonable risk
because it can lead to exposures to infants, toddlers, and preschool children under the age of 5 years who
may inhale dust containing DINP as a result from settling onto vinyl flooring, in-place wallpaper, and
carpet backing and being resuspended into the indoor environment.
Considerations and Next Steps
EPA evaluated a total of 47 COUs for DINP. The Agency is preliminarily determining that only the
following COUs, considered singularly or in combination with other exposures, 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) due
to high-pressure spray application, and
• Industrial use - construction, paint, and metal products - paints and coatings due to high-
pressure spray application.
In addition to the COUs significantly contributing to unreasonable risk to workers, the Agency is
preliminarily determining the following COU, considered singularly or in combination with other
exposures, significantly contributes to the unreasonable risk of DINP via exposures to consumers:
• Consumer use - furnishing, cleaning, treatment/care products - floor coverings/plasticizer in
construction and building materials covering large surface areas including stone, plaster, cement,
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glass, and ceramic articles; fabrics, textiles and apparel (vinyl tiles, resilient flooring, PVC-
backed carpeting).
For the remaining COUs, EPA has preliminarily determined that they 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 - automotive, fuel, agriculture, outdoor use products - automotive products, other
than fluids;
• Industrial use - construction, paint, electrical, and metal products - building/construction
materials (roofing, pool liners, window shades, flooring);
• Industrial use - other uses - hydraulic fluids;
• Industrial use - other uses - pigment (leak detection);
• Commercial use - automotive, fuel, agriculture, outdoor use products - automotive products
other than fluid;
• Commercial use - construction, paint, electrical, and metal products - adhesives and sealants;
• Commercial use - construction, paint, electrical, and metal products - plasticizer in
building/construction materials (roofing, pool liners, window shades); 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 - construction, paint, electrical, and metal products - paints and coatings;
• 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);
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• 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;
• Consumer use - automotive, fuel, agriculture, outdoor use products - automotive products other
than fluid;
• Consumer use - construction, paint, electrical, and metal products - plasticizer in
building/construction materials (roofing, pool liners, window shades);
• Consumer use - construction, paint, electrical, and metal products - electrical and electronic
products;
• Consumer use - construction, paint, electrical, and metal products - adhesives and sealants;
• Consumer use - construction, paint, electrical, and metal products - paints and coatings;
• 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 products; and
• Disposal.
This draft risk evaluation has been released for public comment. Notably, the draft DIDP risk evaluation
and draft DINP environmental and human health hazard assessments for DINP 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 draft DIDP and DINP risk evaluations, while the human health hazard approaches differed
across the two risk evaluations. The Agency has not yet incorporated recommendations from the SACC
or public comments into this draft risk evaluation because the final peer-review report from the SACC
has not yet been released. EPA will issue a final DINP risk evaluation after considering input from the
public and recommendations received from SACC. If in the final risk evaluation, the Agency determines
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600 that DINP presents unreasonable risk to human health or the environment, EPA will initiate regulatory
601 action to mitigate those risks.
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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 draft 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 draft 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 workers and occupational non-users (ONUs) via inhalation
routes; risk to workers via dermal routes; risk to ONUs via dermal routes for occupational exposure
scenarios (OESs) in mists and dusts; risk to consumers via inhalation, dermal, and oral routes; and risks
to 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 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.
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The draft 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 draft 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), CASRNs 28553-12-0 and 68515-
48-0 (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 Draft Systematic
Review Protocol for Diisononyl Phthalate (DINP) (U.S. EPA. 2024ac). or as otherwise noted in the
relevant technical support documents.
Non-cancer Human Health
Hazard Assessmenta
Cancer Human Health
Hazard Assessmenta
Includes biological PESS
Physical Chemistry
Assessmenta
Fate Assessmenta
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
Draft Risk Evaluation
Conditions of Use
Human Health
Risk Characterization
Includes PESS
Environmental Risk
Characterization
Unreasonable
Risk Determination
Environmental
Hazard Assessmenta
Chemical-specific systematic review protocol and data extraction files
Figure 1-2. Draft Risk Evaluation Document Summary Map
"Technical support documents were peer reviewed during the July 2024 meeting of the SACC.
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 to this draft risk
evaluation is provided in Appendix D. The information in the LCD is 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
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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 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) (U.S. EPA. 2020b). The descriptions provide a brief overview of
the use category; the Draft Environmental Release and Occupational Exposure Assessment for
DiisononylPhthalate ( 2024s) 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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MF G/IMPORT
Manufacture
(Including Import)
673
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>
RELEASES AND
WASTE DISPOSAL
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
See Conceptual Model
for Environmental
Releases and Wastes
~»
~
Manufacture
(including import)
Processing
Uses
674 Figure 1-3. DINP Life Cycle Diagram
675 See Table 1-1 for categories and subcategories of conditions of use. Activities related to distribution (e.g., loading, unloading) will be considered
676 throughout the DINP life cycle, as well as qualitatively through a single distribution scenario.
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The production volume for CASRN 28553-12-0 in 2015 was between 100 to 250 million lb and
decreased to 50 to 100 million lb in 2019 based on the latest 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 100,000,000 to 1,000,000,000 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 of the Risk Evaluation for Diisononyl Phthalate (DINP) (U.S. EPA. 202 ic) 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 draft disk 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 this draft risk evaluation, EPA made updates to the COUs listed in the final scope document (U.S.
21c). 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 to this draft risk evaluation is provided in Appendix D. EPA may
further refine the COU descriptions for DINP included in the draft risk evaluation when the final risk
evaluation for DINP is published, based upon further outreach, peer-review comments, and public
comments. Table 1-1 presents the revised COUs that were included and evaluated in this Draft Risk
Evaluation for DINP. Appendix E contains descriptions of each COU.
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730 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
(CASRN 28553-12-0)
Reference
(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-OPPI-2018-0436-0019;
EPA-HO-OPPT-2018-04 ^
(U.S. EPA. 2020a. 2019a;
Polvone. 2018; Silver Fern
Chemical Inc.. 2015) EPA-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-2018-0436-0018;
OPPT-2018-043 6-0019
EPA-HO-OPPT-2018-04
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; U.S. EPA. 2019a)
(U.S. EPA. 2019a)
Recycling
Recycling
(U.S. EPA. 2019a)
Distribution in
Distribution in
Distribution in commerce
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Life Cycle Stage"
Category''
Subcategory of Use"'
Reference
(CASRN 28553-12-0)
Reference
(CASRN 68515-48-0)
Commerce
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)d
(U.S. EPA. 2020a: Tremco. 2019:
U.S. EPA. 2019a. c)
(U.S. EPA. 2019c)
Industrial Use
Automotive, fuel,
agriculture,
outdoor use
products
Automotive products, other than fluids^
(U.S. EPA. 2019c)
(U.S. EPA. 2019c)
Construction,
paint, electrical,
and metal
products
Building/construction materials (roofing,
pool liners, window shades, flooring)''
(U.S. EPA. 2019c)
(U.S. EPA. 2019c)
Paints and coatings^
(Freeman Manufacturing and
SuddIv Company, 2018) EPA-
HO-QPPI-2018-0436-0032
EPA-HO-OPPT-2018-0436-
0032
Hydraulic fluids
EPA-HO-OPPT-2018-04
EPA-HO-OPPT-2018-0436-
0019
Other Uses
Pigment (leak detection)
(U.S. EPA. 2019c)
EPA-HO-OPPT-2018-04
(U.S. EPA. 2019c)
EPA-HO-OPPT-2018-0436-
0019
Other uses
Automotive products, other than fluids^
(U.S. EPA. 2019c)
(U.S. EPA. 2019c)
Adhesives and sealants^
(U.S. EPA. 2020a. 2019c: 3M.
2017)
(U.S. EPA. 2019c)
Commercial Use
Construction,
paint, electrical,
and metal
products
Plasticizer in building/construction materials
(roofing, pool liners, window shades);
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)
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Life Cycle Stage"
Category''
Subcategory of Use"'
Reference
(CASRN 28553-12-0)
Reference
(CASRN 68515-48-0)
Commercial Use
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
(ACC HPP. 2023; U.S. EPA.
2019a; U.S. CPSC. 2015) EPA-
HO-OPPT-2018-0436-0046:
EPA -HO -OPPT-2018-0436-0047;
( JP. 2023; U.S. EPA.
2020a. 2019a; U.S. CPSC.
2015)
EPA-HO-OPPT-2018-0436-
EPA -HO -OPPT-2018-0436-0048;
0046; EPA-HO-OPPT-2018-
EPA -HO -OPPT-2018-0436-0049;
0436-0047; EPA-HO-OPPT-
EPA -HO -OPPT-2018-0436-0050
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)''
( \C€ HPP. 2023; U.S. EPA.
2020a. 2019c)
(m> «'PP. 2023; U.S. EPA.
2019a. c)
Fabric, textile, and leather products (apparel
and footwear care products))
( \C€ HPP. 2023; U.S. EPA.
2019a)
(mi «'PP. 2023; U.S. EPA.
2020a. 2019a)
Packaging, paper,
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,
2019c; Porelon. 2007) EPA-HO-
( >P. 2023; U.S. EPA.
2019c; Polvone. 2018) EPA-
HO-OPPT-2018-0436-0055
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
(U.S. EPA. 2020a. 2019a. c)
(U.S. EPA. 2019a. c)
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Life Cycle Stage"
Category''
Subcategory of Use"'
Reference
(CASRN 28553-12-0)
Reference
(CASRN 68515-48-0)
Commercial Use
plastic, hobby
products
handles, flexible tubes, profiles, and hoses)''
Toys, playground, and sporting equipment^
( \lC HPP. 2023: U.S. EPA.
2019a. c)
(m> «'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
(Siama Aldrich. 2024; Soex
Certioreo LLC. 2019; TCI
America. 2019; Solvents and
Petroleum Service. 2009)
EPA -HO -OPPT-2018-0504-1
EPA-HO-OPPT-2018-0504-
0019
Consumer Use
Automotive, fuel,
agriculture,
outdoor use
products
Automotive products, other than fluids^
("U.S. EPA. 2019a. c)
(U.S. EPA. 2019a. c)
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, etc.)''
( U'C HPP. 2023; U.S. EPA.
2020a. 2019a. c)
( JP. 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
(ACC HPP. 2023; U.S. EPA.
2019a; U.S. CPSC, 2015)
EPA-HO-OPPT-2018-0436-0046;
( JP. 2023; U.S. EPA.
2019a; U.S. CPSC. 2015)
EPA-HO-OPPT-2018-0436-
EPA -HO -OPPT-2018-0436-0047;
0046; EPA-HO-OPPT-2018-
EPA -HO -OPPT-2018-0436-0048;
0436-0047; EPA-HO-OPPT-
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Life Cycle Stage"
Category''
Subcategory of Use"'
Reference
(CASRN 28553-12-0)
Reference
(CASRN 68515-48-0)
EPA -HO -OPPT-2018-0436-0049;
2018-0436-0048; EPA-HO-
EPA -HO -OPPT-2018-0436-0050
OPPI-2018-0436-0049; EPA-
HO-OPPI-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)''
CACC HPP. 2023: U.S. EPA.
2019a, c)
(v»» «'PP. 2023; U.S. EPA.
2019a. c)
Air care products
(Rustic Escentuals, 2015)
Fabric, textile, and leather products (apparel
and footwear care products)''
( U'C HPP. 2023; U.S. EPA.
2020a. 2019a)
(mi «'PP. 2023; U.S. EPA.
2019a)
Arts, crafts, and hobby materials
(U.S. EPA. 202Id)
(U.S. EPA. 202Id)
Consumer Use
Packaging, paper,
plastic, hobby
products
Ink, toner, and colorant products^
( : HPP. 2023; Evonik
Industries. 2019; U.S. EPA.
2019c; Porelon. 2007)
EPA-HO-OPPT-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; hosesd
(U.S. EPA. 2019a. c)
(U.S. EPA. 2020a. 2019a. c)
Packaging, paper,
plastic, hobby
products
Packaging (excluding food packaging),
including rubber articles; plastic articles
(hard); plastic articles (soft)
(U.S. EPA. 2020a)
Toys, playground, and sporting equipment^
( U'C HPP. 2023; U.S. EPA.
2019a. c)
(v»» «'PP. 2023; U.S. EPA.
2019a. c)
Other
Novelty products
(Stabile, 2013)
(Stabile, 2013)
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Life Cycle Stage"
Category''
Subcategory of Use"'
Reference
(CASRN 28553-12-0)
Reference
(CASRN 68515-48-0)
Disposal
Disposal
Disposal
a 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.
h These categories of conditions of use appear in the life cycle diagram, reflect CDR codes, and broadly represent conditions of use of DINP in industrial and/or
commercial settings.
c These subcategories reflect more specific conditions of use of DINP.
d Circumstances on which ACC HPP is requesting that EPA conduct a risk evaluation. DINP is no longer processed into toys (processing into articles); however,
EPA will evaluate risk from toys already in commerce that contain DINP. In addition, DINP processing into playground and sporting equipment is ongoing.
'' 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-HQ-QPPT-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.
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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 ami Commercial
Activities / Uses"
Exposure Pathway
Exposure Route
Populations
Hazards
746
747
748
749
750
751
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 conditions of use.
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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USES
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EXPOSURE EXPOSURE
PATHWAYS ROUTES
POPULATIONS
EXPOSED
HAZARDS
Automotive, fuel, agriculture, outdoor
use products
Construction, paint, electrical, and
metal products
Furnishing, cleaning, treatment/care
products
Packaging, paper, plastic, hobby
products
Other: novelty products
Solid Article /
Product
Inhalation.
Hazards potentially
associated with acute,
Intermediate, and
chronic exposures
i
Bystanders
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
752
753
754
Consumer Handling of Disposal and
Waste
Wastewater, Liquid Wastes and Solid
->¦ H astes (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.
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RELEASES AND WASTES FROM INDUSTRIAL
COMMERCIAL CONSUMER USES
EXPOSURE PATHWAYS
EXPOSURE ROUTES
POPULATIONS
HAZARDS
756 Figure 1-7. DINP Conceptual Model for Environmental Releases and Wastes: General Population Hazards
757 The conceptual model presents the exposure pathways, exposure routes, and hazards to human populations from releases and wastes from industrial,
758 commercial, and/or consumer uses of DINP.
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RELEASES AND WASTES FROM INDUSTRIAL f EXPOSURE PATHWAY'S POPULATIONS HAZARDS
COMMERCIAL ICONSUMER USES FVPOSFT)
759
760 Figure 1-8. DINP Conceptual Model for Environmental Releases and Wastes: Ecological Exposures and Hazards
761 The conceptual model presents the exposure pathways, exposure routes, and hazards to human populations from releases and wastes from industrial,
762 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 6-10 years),
young teens (11-15 years), teenagers (16-20 years), and adults (21 years and above);
• Bystanders, including infants (<1 year), toddlers (1-2 years), and children (3-5 and 6-10 years);
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
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, assessed in the consumer exposure
scenarios), while some experience aggregate or sentinel exposures.
Section 4.3.5 summarizes how PESS were incorporated into the risk evaluation through consideration of
potentially increased exposures and/or potentially increased biological susceptibility and summarizes
additional sources of uncertainty related to consideration of PESS.
1.2 Organization of the Risk Evaluation
This draft 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.
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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 draft 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 draft risk evaluation.
• Section 6 presents EPA's proposed 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 draft 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 technical support documents (TSDs) and
supplemental files included in the draft risk evaluation for DINP.
• Appendix D provides a summary of updates made to COUs for DINP from the final scope
document to this draft risk evaluation.
• Appendix E provides descriptions of the DINP COUs evaluated by EPA.
• Appendix F provides the draft 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, and potential human and
environmental exposed populations that EPA considered in this draft risk evaluation.
Sections 2.1 and 2.2 summarize the physical and chemical properties, and environmental fate and
transport of DINP, respectively. See the Draft Physical Chemistry Assessment for Diisononyl Phthalate
(U.S. EPA. 2024x) and Draft Fate Assessment for Diisononyl Phthalate (U.S. EPA. 2024f) 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 Draft Systematic Review Protocol for Diisononyl Phthalate (DINP) (
2024ac). 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) ( 2024f).
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
CNLM. 2015)
High
Melting point
1
00
O
O
(O'Neil. 2013)
High
Boiling point
>400 °C
(ECHA.: )
High
Density
0.97578 g/cm3
(De Lorenzi et al.. 1998)
High
Vapor pressure
5.40E-07 mmHg
CNLM. 2015)
High
Water solubility
0.00061 mg/L
(Letinski et al., 2002)
High
Molecular formula
C26H42O4
Octanol: water partition
coefficient (log Kow)
8.8
(ECHA. 2016)
High
Octanol:air partition
coefficient (log Koa)
11.9 (EPI Suite™)
(U.S. EPA. 2017)
High
Henry's Law constant
9.14E-05 atm m3/mol at 25 °C
( sins and Mackav.
2000)
High
Flash point
213 °C
(O'Neil. 2013)
High
Autoflammability
400 °C
(ECHA.: )
High
Viscosity
77.6 cP
(ECHA.: )
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 current draft risk evaluation. In assessing
the environmental fate and transport of DINP, EPA considered the full range of results from the
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available 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) (U.S. EPA. 2024d). Other fate
estimates were based on modeling results from EPI Suite™ ( ), 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
Draft Fate Assessment for Diisononyl Phthalate (DINP) ( 024f) 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.
• Is not bioaccumulative in fish in the water column.
• May be bioaccumulative 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 (88 PR 45089). 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 3.1.1.2 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 Draft Environmental Release and
Occupational Exposure Assessment for Diisononyl Phthalate (DINP) ( 24s) provides
further information on specific OESs.
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926 Table 3-1. Crosswalk of Conditions of Use to Assessed Occupational Exposure Scenarios
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
Heat stabilizer and processing aid in basic
organic chemical manufacturing
Incorporation into other
formulations, mixtures, or reaction
products
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))
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
PVC plastics converting;
Non-PVC material converting
manufacturing; electrical equipment,
appliance, and component manufacturing;
ink, toner, and colorant manufacturing
(including pigment))
Recycling
Recycling
Recycling
Disposal
Disposal
Disposal
Disposal
Distribution in
Distribution in
Distribution in commerce
Distribution in commerce
Commerce
commerce
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Life Cycle
Stage
Category
Subcategory
OES
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
Automotive,
fuel,
agriculture,
outdoor use
products
Automotive products, other than fluids
Fabrication or use of final product
or articles
Construction,
paint, electrical,
Building/construction materials (roofing,
pool liners, window shades, flooring)
Fabrication or use of final product
or articles
and metal
products
Paints and coatings
Application of paints and coatings
Other Uses
Hydraulic fluids
Use of lubricants and functional
fluids
Pigment (leak detection)
Application of paints and coatings
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Life Cycle
Stage
Category
Subcategory
OES
Commercial
Use
Automotive,
fuel,
agriculture,
outdoor use
products
Automotive products, other than fluids
Fabrication or use of final product
or articles
Construction,
paint, electrical,
and metal
products
Adhesives and sealants
Application of adhesives and
sealants
Plasticizer in building/construction
materials (roofing, pool liners, window
shades); 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
Furnishing,
cleaning,
treatment/care
products
Foam seating and bedding products;
furniture and furnishings including plastic
articles (soft); leather articles
Fabrication or use of final product
or articles
Air care products
Incorporation into other
formulations, mixtures, or reaction
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)
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
Packaging,
paper, plastic,
hobby products
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 (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
Solvents (for
cleaning or
degreasing)
Solvents (for cleaning or degreasing)
Use of lubricants and functional
fluids
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928
929
930
931
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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 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 operating days for facilities;
however, EPA used generic scenarios (GSs) or emission scenario documents (ESDs) to assess the
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938 number of operating days for a given OES. EPA estimated average daily releases for facilities by
939 assuming that the number of release days is equal to the number of operating days.
940
941 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 Draft Environmental Release and Occupational
Exposure Assessment for Diisononvl Phthalate (DINP) (U.S. EPA.
2024s)) used a 50th to 95th percentile ranse of 208-260 davs/vear
0 5- I l* \ 2022).
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 Draft Environmental Release and Occupational
Exposure Assessment for Diisononvl Phthalate (DINP) (U.S. EPA.
2024s)) used a 50th to 95th percentile ranee of 223-254 davs/vear
0 5- ns\ 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 Draft Environmental Release and
Occupational Exposure Assessment for Diisononyl Phthalate (DINP)
(U.S. EPA. 2024s)) 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 Draft
Environmental Release and Occupational Exposure Assessment for
Diisononvl Phthalate (DINP) (U.S. EPA, 2024s)) used a 50th to 95th
percentile range of 234-280 days/year (U.S. EPA. 202If; ESIG.
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OES
Operating Days
(days/year)
Basis
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 Draft Environmental Release and
Occupational Exposure Assessment for Diisononyl Phthalate (DINP)
(U.S. EPA, 2024s)) used a 50th to 95th percentile ranee of 219-251
davs/vear (U.S. EPA, 202 le).
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 (Draft Environmental Release and Occupational Exposure
Assessment for Diisononyl Phthalate (DINP) (U.S. EPA, 2024s)) used
a 50th to 95th percentile ranee 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 {Draft Environmental
Release and Occupational Exposure Assessment for Diisononyl
Phthalate (DINP) (U.S. EPA. 2024s)) used a 50th to 95th percentile
ranee 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 (Draft Environmental Release and
Occupational Exposure Assessment for Diisononyl Phthalate (DINP)
(U.S. EPA. 2024s)) used a 50th to 95th percentile ranee of 235-258
davs/vear (U.S. EPA. 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 Draft Environmental Release and Occupational
Exposure Assessment for Diisononyl Phthalate (DINP) (U.S. EPA,
2024s)) used a 50th to 95th percentile ranee of 223-254 davs/vear
0 ^ \ 202If. 2014c). EPA evaluated disposal releases within the
assessments for each OES. EPA provided operating days for
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942
943
944
945
946
947
948
949
950
951
952
953
954
955
956
957
958
959
960
961
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963
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OES
Operating Days
(days/year)
Basis
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. Th e Draft Environmental Release and Occupational
Exposure Assessment for Diisononyl Phthalate (DINP) (U.S. EPA. 2024s) 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
section. See EPA's Draft Consumer and Indoor Dust Exposure Assessment for Diisononyl Phthalate
(DINP) (U.S. EPA. 20241) for further details. Adhesives, sealants, paints, lacquers, and coatings can be
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969
970
971
972
973
974
975
976
977
978
979
980
981
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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 Draft Exposure Media Concentration and General Population
Technical Support Document, ( 24r). 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 Draft Environmental Release and Occupational Exposure
Assessment for Diisononyl Phthalate (DINP) (U. 2024s) 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 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 (U.S. EPA. 2024s) for further description).
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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/' or Transfer for
Disposal'
Estimated Release
Frequency across Sites
(days/
Number of
Facilities'
Weight of
Scientific
Evidence
Rating'
Sources
Central
Tendencv
High-End
Central „ .
_ . High-End
Tendency
Manufacturing
1.66E-06
3.78E-06
Fugitive Air
180
1 - Gehring
Montgomery,
Warminster, PA
Moderate
CDR, Peer-
reviewed
literature
(GS/ESD)
2.23E-01
Stack Air
2.05E-01
3.70E-01
Wastewater to Onsite treatment or
Discharge to POTW
5.13
5.34
Onsite Wastewater Treatment,
Incineration, or Landfill
2.16
3.75
Landfill
1.80E-06
3.95E-06
Fugitive Air
180
3 generic sites
Moderate
CDR, Peer-
reviewed
literature
(GS/ESD)
1.16E01
1.73E01
Stack Air
1.01E01
2.26E01
Wastewater to Onsite Treatment
or Discharge to POTW
2.35E02
3.50E02
Onsite Wastewater Treatment,
Incineration, or Landfill
1.00E02
2.38E02
Landfill
4.44E-06
7.92E-06
Fugitive Air
180
2 generic sites
Moderate
CDR, Peer-
reviewed
literature
(GS/ESD)
2.76E02
4.80E02
Stack Air
2.31E02
6.08E02
Wastewater to Onsite Treatment
or Discharge to POTW
5.61E03
9.75E03
Onsite Wastewater Treatment,
Incineration, or Landfill
8.69E02
Landfill
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OES
Estimated Daily Release
across Sites
(kg/site-day)
Type of Discharge," Air
Emission/' or Transfer for
Disposal1
Estimated Release
Frequency across Sites
(days)''
Number of
Facilities''
Weight of
Scientific
Evidence
Sou rces
1.57E-08
2.90E-08
Fugitive Air
208
260
1 - Henkel
Louisville,
Louisville, KY
Moderate
1.47
1.70
Wastewater to Onsite Treatment,
Discharge to POTW, or Landfill
9.70E-08
1.02E-07
Fugitive Air
1 - Formosa
2.03
2.52
Wastewater to Onsite Treatment,
208
260
Global
Moderate
Discharge to POTW, or Landfill
Solutions,
Livingston, NJ
1.00E-07
1.06E-07
Fugitive Air
1 - Chemspec,
Uniontown, OH
5.80
7.17
Wastewater to Onsite Treatment,
208
260
Moderate
Discharge to POTW, or Landfill
1.01E-07
1.07E-07
Fugitive Air
1 - Harwick
6.89
8.52
Wastewater to Onsite Treatment,
Standard
discharge to POTW, or Landfill
208
260
Distribution
Corp. Akron,
OH
Moderate
7.75E-08
1.07E-07
Fugitive Air
1 - Silver Fern
CDR, Peer-
Import and
1.12E01
1.38E01
Wastewater to Onsite Treatment,
208
260
Chemical,
Moderate
reviewed
repackaging
Discharge to POTW, or Landfill
Seattle, WA
literature
1.04E-07
1.12E-07
Fugitive Air
1 -MAK
(GS/ESD)
1.12E01
1.39E01
Wastewater to Onsite Treatment,
Discharge to POTW, or Landfill
208
260
Chemicals Inc.
Clifton, NJ
Moderate
5.13E-08
6.71E-08
Fugitive Air
1 - Mercedes
Benz, Vance AL
1.62E01
2.00E01
Wastewater to Onsite Treatment,
Discharge to POTW, or Landfill
208
260
Moderate
5.55E-08
7.38E-08
Fugitive Air
1 - Univar
2.75E01
3.40E01
Wastewater to Onsite Treatment,
Discharge to POTW, or Landfill
208
260
Solutions,
Redmond, WA
Moderate
1.22E-07
1.41E-07
Fugitive Air
1 - Belt
3.45E01
4.26E01
Wastewater to Onsite Treatment,
208
260
Concepts of
Moderate
Discharge to POTW, or Landfill
America, Spring
Hope, NC
1.29E-07
1.53E-07
Fugitive Air
4.37E01
5.40E01
Wastewater to Onsite Treatment,
Discharge to POTW, or Landfill
208
260
1 - Tribute
Energy Inc.,
Houston, TX
Moderate
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OES
Estimated Daily Release
across Sites
(kg/site-dav)
Type of Discharge," Air
Emission/' or Transfer for
Disposal'
Estimated Release
Frequency across Sites
(days)''
Number of
Facilities''
Weight of
Scientific
Evidence
Sou rces
6.15E-08
8.39E-06
Fugitive Air
1 - Geon
4.38E01
5.41E01
Wastewater to Onsite Treatment,
Discharge to POTW, or Landfill
208
260
Performance
Solutions LLC,
Louisville, KY
Moderate
1.54E-07
1.97E-07
Fugitive Air
1 - Cascade
CDR, Peer-
Import and
7.75E01
9.59E01
Wastewater to Onsite Treatment,
Discharge to POTW, or Landfill
208
260
Columbia
Distribution
Moderate
reviewed
literature
repackaging
5.10E-07
9.15E-07
Fugitive Air
1 - Alac
(GS/ESD)
1.16E03
1.42E03
Wastewater to Onsite Treatment,
Discharge to POTW, or Landfill
208
260
International Inc.
New York, NY
Moderate
1.93E-07
3.79E-07
Fugitive Air
2.07E02
3.51E02
Wastewater to Onsite Treatment,
Discharge to POTW, or Landfill
208
260
10 generic sites
Moderate
2.77E-06
7.88E-06
Fugitive Air
4.94E03
9.58E03
Wastewater to Onsite Treatment,
Discharge to POTW, or Landfill
208
260
5 generic sites
Moderate
3.30E01
1.46E02
Fugitive or Stack Air
PVC plastics
compounding
8.23E01
2.74E02
Fugitive Air, Wastewater,
Incineration, or Landfill
110-215 generic
sites
CDR, Peer-
reviewed
literature
(GS/ESD)
4.28E2
6.81E02
Wastewater, Incineration, or
Landfill
223
254
Moderate
1.09E02
1.64E02
Wastewater
2.23E01
1.11E02
Incineration or Landfill
1.58
6.94
Fugitive or Stack Air
PVC plastics
converting
3.92
1.30E01
Fugitive Air, Wastewater,
Incineration, or Landfill
2,386-4,662
generic sites
CDR, Peer-
reviewed
literature
(GS/ESD)
1.54E01
2.35E01
Wastewater, Incineration, or
Landfill
219
251
Moderate
5.14
7.85
Wastewater
1.43E01
2.27E01
Incineration or Landfill
5.47E01
2.15E02
Fugitive or Stack Air
Non-PVC material
compounding
4.77
1.86E01
Fugitive Air, Wastewater,
Incineration, or Landfill
CDR, Peer-
reviewed
literature
(GS/ESD)
1.20E03
2.60E03
Wastewater, Incineration, or
Landfill
234
280
5-9 generic sites
Moderate
1.11E02
1.86E02
Wastewater
7.96E01
2.81E02
Incineration or Landfill
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OES
Estimated Daily Release
across Sites
(kg/site-day)
Type of Discharge," Air
Emission/' or Transfer for
Disposal'
Estimated Release
Frequency across Sites
(days/
Number of
Facilities''
Weight of
Scientific
Evidence
Sou rces
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
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
[2.65E011
7.84E01
[8.22E011
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—121
3.35E-09
[3.82E—121
Fugitive or Stack Air
235
[260]
258
[260]
586-4,912
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
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OES
Estimated Daily Release
across Sites
(kg/site-dav)
Type of Discharge," Air
Emission/' or Transfer for
Disposal'
Estimated Release
Frequency across Sites
(days)''
Number of
Facilities''
Weight of
Scientific
Evidence
Sou rces
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)
Recycling
4.33E-02
8.67E-01
Stack Air
223
254
58 generic sites
Moderate
CDR, Peer-
reviewed
literature
(GS/ESD)
3.46
6.30
Fugitive Air, Wastewater,
Incineration, or Landfill
223
254
58 generic sites
CDR, Peer-
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
b 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 condition of use.
' Where available. EPA used 2020 CDR (U.S. EPA. 20203). 2020 U.S. Countv Business Practices (U.S. Census Bureau. 2022). and Monte Carlo models to estimate the
number of sites that use DINP for each condition of use.
' See Section 3.2.2 for details on EPA's determination of the weight of scientific evidence rating.
992
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993
994
995
996
997
998
999
1000
1001
1002
1003
1004
1005
1006
1007
1008
1009
1010
1011
1012
1013
1014
1015
1016
1017
1018
1019
1020
1021
1022
1023
1024
1025
PUBLIC RELEASE DRAFT
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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. EPA made a judgment on the weight of scientific
evidence supporting 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 ( )21a) (also
called the "2021 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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1026 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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OES
Weight of Scientific Evidence Conclusion in Release Estimates
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 svstematic review process (OECD. 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 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 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 Waterbome Coatings, which has a medium data aualitv rating based on svstematic review (U.S. EPA.
2014a). 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 bv 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 waterbome 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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Weight of Scientific Evidence Conclusion in Release Estimates
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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OES
Weight of Scientific Evidence Conclusion in Release Estimates
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 (U.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 (U.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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Weight of Scientific Evidence Conclusion in Release Estimates
2003 EU Risk Assessment Revort (ECJRC. 2003b) for expected U.S. DINP use rates ocr 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. 2021 a: 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 Revort (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 (U.S. EPA. 2014b; OECD. 2011b; U.S. EPA. 2004c). 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 (U.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
Draft Environmental Release and Occupational Exposure Assessment for Diisononyl Phthalate (DINP)
( |s), 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
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drinking water was conducted for the Human Health Risk Assessment (Section 4). Given the physical
chemical 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 Draft Fate Assessment for Diisononyl Phthalate (DINP) (U.S. EPA. 2024f) and its use for
determining pathways to assess are detailed in Draft Environmental Exposure Assessment for Diisononyl
Phthalate (DINP) (I v < PA. 2024o). Briefly, based on DINP's fate parameters, EPA anticipated DINP
to be expected predominantly in water, soil, and sediment, with DINP in soils attributable to air to soil
deposition and land application of biosolids. Therefore, EPA 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 to 8.5 hours
( £017; Lertsirisopon et al. 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
Draft Environmental Media and General Population Screening for Diisononyl Phthalate (DINP) (U.S.
E Mr). Screening level assessments are useful when there is little location- or scenario-specific
information available. Because of limited environmental monitoring data and lack of 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
(U.S. EPA. 2019b).
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 concentration 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 Draft Environmental
Exposure Assessment for Diisononyl Phthalate (DINP) (U, 2024o) and for general population
exposure described in EPA's Draft Environmental Media and General Population Screening for
Diisononyl Phthalate (DINP) ( Mr). 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 a major 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
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functional 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 OES 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 Draft
Environmental Media and General Population Screening for Diisononyl Phthalate (DINP) (U.S. EPA.
2024r). 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 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 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 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 here 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 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 Draft Environmental Release and Occupational
Exposure Assessment for Diisononyl Phthalate (DINP) ( 24s) 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 purposed of a risk screening-level assessment, EPA has robust confidence that its
modeled releases used for estimating air to soil deposition is appropriately conservative for a screening-
level analysis.
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1168 4 HUMAN HEALTH RISK ASSESSMENT
DIM'- 11 ii iii;iii Health Risk Assessment (Section 4):
key Points
lil'A e\ ill lulled al I reasonably a\ ailahle information to support human health risk characterization of
l)l\P for workers. ()\l s. consumers. In slanders, and the general population, Exposures to workers.
()\l s. consumers, bystanders, and the general population are described in Section 4 I. Human health
hazards are described in Section 4 2 I luman health risk characterization is described in Section 4 3
ICxposnre hey Points
• lil'A assessed inhalation and dermal exposures for workers and OM s. as appropriate, for each
CGI'(Section 4 I I). llowe\er. the primary route of exposure was inhalation.
• lil'A assessed inhalation, dermal, and oral exposures for consumers and bystanders, as appropriate,
for each COl (Section 4 I 2) in scenarios that represent a range of use patterns and beha\ iors The
primary route of exposure was inhalation
• lil'A assessed oral and dermal exposures for the general population, as appropriate. \ la 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 I ,i() and 4 .V4) I !PA
did not assess inhalation exposure to DIM' from ambient air for the general population because
ambient air is not expected to be a pathway of concern for DIM' This is because l.)l\P is not
persistent in the air and rapidly partitions to sediment, soil, and surface water
11nZtirtl hey Points
• lil'A identified h\er and de\ elopmental toxicity as the most sensili\e and robust non-cancer
hazards associated with oral exposure to l.)l\P 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.}() was selected for use as the
benchmark margin of exposure
• A non-cancer I'OI.) of 3 5 mg kg-day was selected to characterize non-cancer risks for chronic
durations of exposure A total uncertainty factor of.}() was selected for use as the benchmark
margin of exposure
• l)l\P has been shown to cause 11\ er cancer in experimental studies of rats and mice. howe\er. 11\ er
cancer in rodents occurred at higher doses than obser\ed for other non-cancer effects on the 11\ er
and the de\eloping male reproducli\e system Therefore. e\alualing and protecting human health
from non-cancer risks associated with exposure to DINP will also be protectee of cancer effects
Risk . 1 ssessinent hey Points
• Dermal and ingestion exposures were not a risk dri\er for any duration of exposure or population
• Inhalation exposures dri\e acute, intermediate, and chronic non-cancer risks to workers in
occupational sellings (Section 4 3 2).
• Inhalation exposures dri\e chronic non-cancer risks to consumers (Section 4 3 3)
• \o potential non-cancer risk was identified for the general population
• I-PA considered combined exposure across all routes of exposure for each indi\ idual occupational
and consumer COl to calculate aggregate risks (Sections 4 3.2 and 4 3 3)
1169
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August 2024
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 Draft
Environmental Release and Occupational Exposure Assessment for Diisononyl Phthalate (DINP) (U.S.
24s) 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 condition of use, 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 was reasonably available, EPA used this data to characterize central tendency
and high-end inhalation exposures (see also Figure 4-1). Where no inhalation monitoring data was
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) ( )21e). 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 Draft Environmental Release and Occupational
Exposure Assessment for Diisononyl Phthalate (DINP) ( >24s).
Page 65 of 274
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1221
1222
1223
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PUBLIC RELEASE DRAFT
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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. EPA preferred to provide the 50th percentile of the
distribution. However, 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, EPA 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 OESs, 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
EPA 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 Occupational Exposure Scenarios
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
l/
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
l/
X.
Moderate
N/A
Page 67 of 274
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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
i/
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 OES where inhalation exposure
to vapor may occur during the heating and cooling plastic and non-plastic polymer materials.
Page 68 of 274
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1235
1236
1237
1238
1239
1240
1241
1242
1243
1244
1245
1246
1247
1248
1249
1250
1251
1252
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August 2024
4.1.1.2 Summary of Number of Workers and ONUs
The Draft Environmental Release and Occupational Exposure Assessment for Diisononyl Phthalate
(DINP) (U .S. EPA. 2024s) 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. EPA 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 Draft
Environmental Release and Occupational Exposure Assessment for Diisononyl Phthalate (DINP) (U.S.
24s) 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 OES. 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 ("U.S. 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 69 of 274
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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 Draft Environmental Release and Occupational Exposure
Assessment for Diisononyl Phthalate (DINP) (U.S. EPA, 20248)
1256
1257 4.1.1.3 Summary of Inhalation Exposure Assessment
1258 Table 4-3 presents a summary of inhalation exposure results based on monitoring data and exposure
1259 modeling for each OES. This tables provides a summary of the 8 and 10-hour time weighted average (8
1260 or 10-hour TWA) inhalation exposure estimates, as well as the acute dose (AD), the intermediate
1261 average daily dose (IADD), and the chronic average daily dose (ADD). The Draft Environmental
1262 Release and Occupational Exposure Assessment for Diisononyl Phthalate (DINP) ( 24s)
1263 provides exposure results for females of reproductive age and ONUs. The Draft Environmental Release
1264 and Occupational Exposure Assessment for Diisononyl Phthalate (DINP) ( 2024s) also
Page 70 of 274
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PUBLIC RELEASE DRAFT
August 2024
1265 provides additional details regarding AD, IADD, and ADD calculations along with EPA's approach and
1266 methodology for estimating inhalation exposures.
Page 71 of 274
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August 2024
Table 4-3. Summary of Average Adult Worker Inhalation Exposure Results for Each PES
OES
Inhalation Estimates (Average Adult Worker)
Vapor/Mist 8-hr or
[ 10-hr] TWA
(mg/m3)
PNOR 8-hr TWA
(mg/mJ)
AD
(mg/kg/dav)
IADD
(mg/kg/dav)
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
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August 2024
1268 4.1.1.4 Summary of Dermal Exposure Assessment
1269 Table 4-4 presents a summary of dermal exposure results, which are based on both empirical dermal
1270 absorption data and dermal absorption modeling estimation efforts. This table provides a summary of
1271 the Acute Potential Dose Rate (APDR) for occupational dermal exposure estimates, as well as the AD,
1272 IADD, and Chronic ADD. The Draft Environmental Release and Occupational Exposure Assessment
1273 for DiisononylPhthalate (DINP) (U.S. EPA. 2024s) provides exposure results for females of
1274 reproductive age and ONUs. The Draft Environmental Release and Occupational Exposure Assessment
1275 for Diisononyl Phthalate (DINP) also provides additional details regarding AD, IADD, and ADD
1276 calculations along with EPA's approach and methodology for estimating dermal exposures.
Page 73 of 274
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1277 Table 4-4. Summary of Average Adult Wor
PUBLIC RELEASE DRAFT
August 2024
ter 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 74 of 274
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1278
1279
1280
1281
1282
1283
1284
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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 2021 Draft Systematic Review Protocol ( 1021a). 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 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 2021 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.
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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 OELs. EPA used PBZ air concentration data to assess inhalation exposures, with the data source having a high data quality
ratine 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 LOD. EPA also assumed 8 exposure hours per day and 180 exposure days per year
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 duality 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
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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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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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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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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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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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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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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. However, the modeling approach for determining the aqueous permeability coefficient was used outside the range
of applicability given the p-chem parameters of DINP. Also, it is acknowledged that variations in chemical concentration and co-formulant
components affect the rate of dermal absorption. To provide the most human health protective assessment, EPA utilized the maximum
aaueous solubility value identified through systematic review (NLM, 2 : iward et al., 1985). These sources of aaueous solubility
received high ratings through EPA's systematic review process. Therefore, it is assumed that absorption of aqueous DINP serves as a
reasonable upper bound for the dermal absorption of DINP from solid matrices, and the modeling approach 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 eaual 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.
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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 plausible but protective 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, EPA'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, EPA'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, 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 EPA'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 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 EPA'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. EPA defined statistical
distributions for parameters using documented statistical variations where available. Where the
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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' 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 Draft Consumer and Indoor Dust Exposure
Assessment for Diisononyl Phthalate (DINP) ( 3241) provides additional details on the
development of approaches and the exposure assessment results. The consumer exposure assessment
evaluated exposures from individual COUs while the indoor dust assessment uses 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
and others) where possible to characterize low, medium, and high exposure for a given condition of use.
Should only a range be reported as the minimum, average, and maximum EPA used these for the low,
medium, and high, respectively. See Draft Consumer and Indoor Dust Exposure Assessment for
Diisononyl Phthalate (DINP) ( 241) 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 the Center for Disease Control
and Prevention (CDC) guidelines (CDC. 2021) and EPA's A Framework for Assessing Health Risks of
Exposures to Children (U.S. EPA. 2006). 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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1416 Table 4-6. Summary of Consumer CPUs, Exposure Scenarios, and Exposure Routes
Consumer Condition
of Use Category
Consumer Condition of
Use Subcategory
Product/Article
Exposure Scenario and
Route
Evaluated Routes
Inhalation
Dermal
Ingestion
Qualitative /
Quantitative /
None
Suspended
Dust
Settled
Dust
ex
a
2
s
1
Automotive, fuel,
agriculture, outdoor use
products
Automotive products,
other than fluids
Car mats
Direct contact during use.
See routine contact
scenario inhalation of
emissions / ingestion of
dust adsorbed chemical
%/ a
%/
%/ a
%/ a
X
Quantitative
Construction, paint,
electrical, and metal
products
Adhesives and sealants
Adhesive foam
Use of product in DIYc
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 DIYc
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 DIYc
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 DIYc
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 DIYc
home repair activities.
Direct contact during use;
inhalation of emissions
during use
%/
%/
X
X
X
Quantitative
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Consumer Condition
of Use Category
Consumer Condition of
Use Subcategory
Product/Article
Exposure Scenario and
Route
Evaluated Routes
Construction, paint,
electrical, and metal
products
Adhesives and sealants
Roofing adhesives
Use of product in DIYc
home repair. Direct contact
during use; inhalation of
emissions during use
%¦>'*
X
X
X
Quantitative
Construction, paint,
electrical, and metal
products
Building construction
materials (wire and cable
jacketing, wall coverings,
roofing, pool applications,
etc.)
Roofing membranes (also
fabrics and film)
Direct contact while
repairing or maintenance
Xc
%¦>'*
X
X
X
Quantitative
Construction, paint,
electrical, and metal
products
Building construction
materials (wire and cable
jacketing, wall coverings,
roofing, pool applications,
etc.)
Electrical tape, spline
Direct contact during
application.
X
%¦>'*
X
X
X
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
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
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Consumer Condition
of Use Category
Consumer Condition of
Use Subcategory
Product/Article
Exposure Scenario and
Route
Evaluated Routes
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
%/
V a
V a
%/
Quantitative
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
Xc
%/
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
Xc
%/
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
•%/ 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
Solid (resilient) vinyl
flooring tiles
Direct contact, inhalation
of emissions / ingestion of
dust adsorbed chemical
V a
%/
V a
V a
X
Quantitative
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Consumer Condition
of Use Category
Consumer Condition of
Use Subcategory
Product/Article
Exposure Scenario and
Route
Evaluated Routes
tiles, resilient flooring,
PVC-backed carpeting)
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, cement, glass, and
ceramic articles; fabrics,
textiles, and apparel (vinyl
tiles, resilient flooring,
PVC-backed carpeting)
Wallpaper
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
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
%b
%¦>'*
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
%b
%¦>'*
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
%b
%¦>'*
X
X
Quantitative
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Consumer Condition
of Use Category
Consumer Condition of
Use Subcategory
Product/Article
Exposure Scenario and
Route
Evaluated Routes
mouthed by children
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
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
%/ a
%¦>'*
%/ a
%/ a
Quantitative
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Consumer Condition
of Use Category
Consumer Condition of
Use Subcategory
Product/Article
Exposure Scenario and
Route
Evaluated Routes
particulate; ingestion by
mouthing
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
Novelty products
Adult toys
Direct contact during use,
ingestion by mouthing
%b
%¦>'*
X
X
Quantitative
Disposal
Disposal
Down the drain products and
articles
Down the drain and
releases to environmental
media
X
X
X
X
X
Qualitative
Disposal
Disposal
Residential end-of-life
disposal, product demolition
for disposal
Product and article end-of-
life disposal and product
demolition for disposal
X
X
X
X
X
Qualitative
%# Scenario is considered either qualitatively or quantitatively in this assessment.
v* " Scenario used in Indoor Dust Exposure Assessment in Section 4.1.2.3. 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 in which dust can deposit and contribute to significantly
larger concentration of dust than single small articles and products.
* Scenario was deemed unlikely based 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 low possibility of dust on surface due to barriers or low surface area for dust ingestion.
*''' Scenario was deemed unlikely based low volatility and small surface area and likely negligible gas and suspended particle phase concentration.
* Outdoor use with significantly higher ventilation minimizes inhalation.
DIY° - Do-it-yourself
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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 Draft
Consumer and Indoor Dust Exposure Assessment for Diisononyl Phthalate (DINP) (U.S. EPA. 20241).
Calculations, sources, input parameters and results are also available in Draft Consumer Exposure
Analysis for Diisononyl Phthalate (DINP) ( ,024m). 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).
Low, medium, and high scenarios correspond to the use of reported statistics, or single values usually an
average, or range of maximum and minimum or when different values are reported for low, medium,
and high, the corresponding statistics are maximum, calculated average from maximum and minimum,
and minimum. 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 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 EPA. 2016). For all scenarios, the near-
field modeling option was selected to account for a small personal breathing zone 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 ( 3241) and (U.S. EPA.
2024m) 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 Draft Consumer Exposure Analysis for
Diisononyl Phthalate (DINP) ( 24m). 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 (U.S.
I Ml).
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 Draft Consumer and Indoor Dust Exposure Assessment for
Diisononyl Phthalate (DINP) ( 241) and DINP Draft Consumer Risk Calculator (
2024n).
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Acute, Intermediate, and Chronic Dose Rate Results, Conclusions, and Data Patterns
Figure 4-1 to Figure 4-12 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 ( 241) narrative 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 (U.S. EPA. 20241). 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 that are not in direct use or application of
the product but 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, like
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 4-1 show all exposure routes for infants less than a year old and toddlers 1 to 2 years old and
Figure 4-2 show all exposure routes for preschoolers ages 3 to 5 and middle childhood children ages 6 to
10 years. Exposure patterns were very similar for products or articles and routes of exposure across
these four lifestages. Ingestion route acute dose results in the figure show the sum of all ingestion
scenarios, mouthing, suspended dust and surface dust. Inhalation exposure from toys, flooring, carpet
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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 old. 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 (US
241) 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.
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Carpet Backing
Children's toys (legacy)
Children's toys (new)
Foam Cushions^?
Indoor Furniture
Rubber Eraser
Shower Curtain
Specialty Wall Coverings (In-Place)
Sports Mats
Vinyl Flooring
Wallpaper (In Place)
Wire Insulation
Adhesive Foam
Automotive Adhesives
Caulking Compounds
Crafting Resin
Paint/Lacquer (Large Project)
Paint/Lacquer (Small Project)
Polyurethane Injection Resin
Roofing Adhesives
Scented Oil
Clothing
Outdoor Furniture
Small Articles with Potential for semi-routine contact
0 A
-ow Exposure Scenario
Medium Exposure Scenario
ligh Exposure Scenario
^Oa
M
0
\*> A
V o A
V o A
0 A
V o A
v 0
10**6 10A-5 10A-4 0.001 0.01 0.1 1
ADR (jjg/kg/day) in Infant Users and Bystanders
Figure 4-1. Acute Dose Rate for DINP from Ingestion, Inhalation, Dermal Exposure Routes
Infants <1 Year Old and Toddlers 1 to 2 Years Old
in
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Carpet Backing
-ow Exposure Scenario
Medium Exposure Scenario
High Exposure Scenario
Children's toys (legacy)
Children's toys (new)
Foam Cushions^
Indoor Furniture
Shower Curtain
0 A
V 0 A
v o
A
Specialty Wall Coverings (In-Place)
V 0 A
Sports Mats
V o A
Vinyl Flooring
0 A
Wallpaper (In Place)
V 0 A
Wire Insulation
V o
Adhesive Foam
Automotive Adhesives
Caulking Compounds
Crafting Resin
Paint/Lacquer (Large Project)
Paini/Lacquer (Small Project)
Polyurethane Injection Resin
Roofing Adhesives
Scented Oil
Clothing
Outdoor Furniture
Small Articles with Potential for semi-routine contact
10**6
10A-4 0.001 0.01 0.1
ADR (fjg/kg/day) in Child Users and Bystanders
Figure 4-2. Acute Dose Rate of DINP from Ingestion, Inhalation, and Dermal Exposure Routes for
Preschoolers 3 to 5 Years Old and Middle Childhood 6 to 10 Years Old
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Young Teens, Teenagers, Young Adults, and Adults (11 to 21 Years and >21 Years)
Figure 4-3 show all exposure routes for young teens (11 to 15 years) and teenagers and young adults (16
to 20 years) combined. Figure 4-4 show all exposure routes for adults above 21 years old. Exposure
patterns were very similar for all products and articles and routes of exposure in these four lifestages,
except teenagers and young adults, 16 to 20, 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 (16- to 20-year-old) can use these
products in similar capacity as adults during 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.
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Adult Toys
__lsr
Inhalation
v Low Exposure Scenario
A Medium Exposuie Scenaii
£ High Exposure Scenario
V
o
>
Carpel Backing
—3-*
'vOA
Car mats
a
$
Children's loys (legacy)
V
0 A
Children's toys (new)
1
>
Foam Cushions^ Q ^
Indoor Furniture
V o A
Rubber Eraser
—
Shower Curtain
VO £
Specialty Wall Coverings (lit-Place)
V o
A
Sports Mats
V ^
A
ammr
Vinyl Flooring
V
0 A
Wallpaper (In Place)
V 0 A
Wire Insulation
v 0
A
Adhesive Foam
-
Automotive Adhesives
Caulking Compounds
Crafting Resin
Paini/Lacquer (Large Project)
Paint/Lacquer (Small Project)
Polyurelhane Injection Resin
1 —¦—
Roofing Adhesives
Scented Oil
Clothing
Outdoor Furniture
Roofing Membrane
Small Articles with Potential for semi-routine contact
Specialty Wall Coverings (Installation)
Track Awning
Wallpaper (Installation)
Adhesives for Small Repairs
IO*-6 IO*-5 I0M 0.001 0.01 0.1
ADR ((ig/kg/day) in Teenager Users and Bystanders
ms.
10
1576 Figure 4-3. Acute Dose Rate of DINP from Ingestion, Inhalation, and Dermal Exposure Routes for
1577 Young Teens 11 to 15 Years Old and for Teenagers and Young Adults 16 to 20 Years Old
1578
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Adult Toys
Carpet Backing
Car mats
Children's toys (legacy)
Children's toys (new)
Foam Cushion sy
Indoor Furniture
Rubber Eraser
Shower Curtain
Specialty Wall Coverings (In-Place)
Wallpaper (In Place)
Wire Insulation
Adhesive Foam
Automotive Adhesives
Caulking Compounds
Crafting Resin
Paint/Lacquer (Large Project)
Painty Lacquer (Small Project)
Polyureihane Injection Resin
Roofing Adhesives
Scented Oil
Clothing
Outdoor Furniture
Roofing Membrane
Small Articles with Potential for semi-routine contact
Specialty Wall Coverings (Installation)
Track Awning
Wallpaper (Installation)
Adhesives for Small Repairs
Inhalation
y Low Exposure Scenario
A Medium Exposure Scenario
A High Exposure Scenario
0 A
0 A
0 A
V 0 A
A
V OA
V o A
0 A
V 0 A
V 0 A
&
¦*
10**6 10**5 IOA-4 0.001 0.0 ! 0.1
ADR (pg/kg/day) in Adult Users and Bystanders
Figure 4-4. Acute Dose Rate of DINP from Ingestion, Inhalation, and Dermal Exposure Routes in
Adults 21+ Years Old
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Intermediate Dose Results for All Lifestages
Only automotive adhesives and construction adhesives qualified to be used in intermediate scenarios.
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 4-5 to Figure 4-8 for
intermediate dose visual representation.
Inhalation
y Low Exposure Scenario
a Medium Exposure Scenario
A High Exposure Scenario
Adhesive Foam
Automotive Adhesives
10^-6 10A-5 10A-4 0.001 0.01
Intermediate Exposure Dose (|ig/kg/day) in Infant Users and Bystanders
Figure 4-5. Intermediate Dose Rate for DINP from Inhalation Exposure Route in Bystander
Infants <1 Year Old and Toddlers 1 to 2 Years Old
Adhesive Foam
V
0
A
Inhalation
Low Exposure Scenario
Medium Exposure Scenario
High Exposure Scenario
Automotive Adhesives
10A-6
10M 10A-4 0.001
Intermediate Exposure Dose (pg/kg/day) in Child Users and Bystanders
0.01
Figure 4-6. Intermediate Dose Rate for DINP from Inhalation Exposure Route in Bystander
Preschoolers 3 to 5 Years Old and Middle Childhood 6 to 10 Years Old
Adhesives for Small Repairs
Adhesive Foam
Automotive Adhesives
10A-6
Dermal
Inhalation
y Low Exposure Scenario
a Medium Exposure Scenario
High Exposure Scenario
10A-5 10A-4 0.001 0.01 0.1
Intermediate Exposure Dose (pg/kg/day) in Teenager Users and Bystanders
Figure 4-7. Intermediate Dose Rate of DINP from Inhalation, and Dermal Exposure Routes for
Young Teen 11 to 15 Years Old and for Teenagers and Young Adults 16 to 20 Years Old
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Adhesives for Small Repairs
Adhesive Foam
Dermal
Inhalation
v Low Exposure Scenario
a Medium Exposure Scenario
A High Exposure Scenario
Automotive Adhesives
10^-6 10A-5 10A-4 0.001 0.01 0.1
Intermediate Exposure Dose (jig/kg/day) in Adult Users and Bystanders
Figure 4-8. Intermediate Dose Rate of DINP from Inhalation, and Dermal Exposure Routes for
Adults 21+ Years Old
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 4-9 to Figure 4-12)
show chronic average daily dose data for all products and articles modeled in all lifestages. For each
lifestage, figures are provided which 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.
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Carpet Backing
Car mats
Children's toys (legacy)
Children's toys (new)
Foam Cushions^
Indoor Furniture
Rubber Eraser
Shower Curtain
Specialty Wall Coverings (ln-Place)
Sports Mats
Vinyl Flooring
Wallpaper (In Place)
Wire Insulation
Caulking Compounds
Crafting Resin
Paint/Lacquer (Large Project)
Paint/Lacquer (Small Project)
Polyurethane Injection Resin
Roofing Adhesives
Scented Oil
Clothing
Outdoor Furniture
Small Articles with Potential for semi-routine contact
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0 A
Inhalation
Ingestion
3bb Dermal
v Low Exposure Scenario
a Medium Exposure Scenario
X High Exposure Scenario
V)A
0 A
0 A
w
V o A
v0 A
V 0 A
V 0 A
V
0 A
V 0 a
V o A
I0*-6 10A-5 10A-4 0.001 0.01 0.1 1
CADD (|jg/kg/day) in Infant Users and Bystanders
Figure 4-9. Chronic Dose Rate for DINP from Ingestion, Inhalation, and Dermal Exposure Routes
in Infants <1 Year Old and Toddlers 1 to 2 Years Old
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Carpet Backing
Children's toys (legacy)
Children's toys (new)
Foam Cushions^
Indoor Furniture
Shower Curtain
Specialty Wall Coverings (In-Place)
Sports Mats
Vinyl Flooring
Wallpaper (In Place)
Wire Insulation
Caulking Compounds
Crafting Resin
Paint/Lacquer (Large Project)
Paint/Lacquer (Small Project)
Polyurethane Injection Resin
Roofing Adhesives
Scented Oil
Clothing
Outdoor Furniture
Small Articles with Potential for semi-routine contact
10A-6
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0 A
Inhalation
ingestion
Dermal
y Low Exposure Scenario
a Medium Exposure Scenario
A High Exposure Scenario
V>A
0 A
V 0 A
v 0
v0 A
0 A
V o A
V
0 A
V o A
V o
a
0.001
10^-4 0.001 0.01 0.1 1
CADD (jig/kg/day) in Child Users and Bystanders
Figure 4-10. Chronic Dose Rate of DINP from Ingestion, Inhalation, and Dermal Exposure Routes
for Preschoolers 3 to 5 Years Old and Middle Childhood 6 to 10 Years Old
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Adult Toys
Carpet Backing
Children's toys (legacy)
Children's toys (new)
Indoor Furniture
Rubber Eraser
Shower Curtain
Specialty Wall Coverings (In-Place)
Sports Mats
Vinyl Flooring
Wallpaper (In Place)
Wire Insulation
Caulking Compounds
Crafting Resin
Faint/Lacquer (Large Project)
Paint/Lacquer (Small Project)
Polyurethane Injection Resin
Roofing Adhesives
Clothing
Outdoor Furniture
Small Articles with Potential for semi-routine contact
Track Awning
10**6
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Foam Cushions^ Q ^
iihalation
.Exposure Scenario
v 0
site
0 a
0 a
V o A
<50 A
v o A
V o A
0 A
¦w
V 0 A
V o A
10**4 0.001 0.01 0.1
CADD (fig/kg/day) in Teenager Users and Bystanders
Figure 4-11. Chronic Dose Rate of DINP from Ingestion, Inhalation, and Dermal Exposure Routes
for Young Teen 11 to 15 Years Old and for Teenagers and Young Adults 16 to 20 Years Old
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Adult Toys
Carpet Backing
Children's toys (legacy)
Children's toys (new)
Foam Cushions^
Indoor Furniture
Rubber Eraser
Shower Curtain
Specialty Wall Coverings (In-Place)
Vinyl Flooring
Wallpaper (In Place)
Wire Insulation
Caulking Compounds
Paint/Lacquer (Large Project)
Paint/Lacquer (Small Project)
Polyurethane Injection Resin
Roofing Adhesives
Clothing
Outdoor Furniture
Small Articles with Potential for semi-routine contact
Track Awning
10A-6
0 A
Ingestion
Dermal
mbh Inhalation
v I-ow Exposure Scenario
a Medium Exposure Scenario
A High Exposure Scenario
v 0
¦V0A
0 A
0 A
V o A
V0 A
V 0 A
V o A
0 A
V <> A
V 0 A
10*-4 0.001 0.01 0.1
CADD (jig/kg/day) in Adult Users and Bystanders
Figure 4-12. Chronic Dose Rate of DINP from Ingestion, Inhalation, and Dermal Exposure Routes
in Adults 21+ Years Old
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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. While
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 Draft Consumer and Indoor Dust Exposure Assessment for
DiisononylPhthalate (DINP) ( 241).
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 United States data on residential
measured DINP concentrations in dust (Hammet et ai. 2019; Dodson et al.. 2017; Shin et ai. 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. (2 was the only U.S. study identifying
DINP concentrations in residential dust that was not focused on a particular subpopulation. This study
collected paired house dust, hand wipe, and urine samples from 203 children aged 3 to 6 from 190
households in Durham, North Carolina between 2014 and 2016. and additionally analyzed product use
and presence of materials in the house. The households were participants in the Newborn Epigenetics
Study (NEST), a prospective pregnancy cohort study that was conducted between 2005 and 2011.
Participants were re-contacted 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 ( 20241).
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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. The
challenges are listed below:
1. 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.
2. Samples may have been collected at a time or location when there were multiple sources of
DINP that included non-TSCA COUs.
3. 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.
4. 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 Ham met 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 ( 301). 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 ( ), in which they 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. 2013).
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
includes 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 (Hammet et ai. 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 US 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 ( 241) and in this
document in Section 4.1.2.3, 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 Draft Consumer and Indoor
Dust Exposure Assessment for Diisononyl Phthalate (DINP) ( II).
For the modeling indoor dust assessment EPA identified article specific information by COU to
construct relevant and representative exposure scenarios from the consumer assessment, Section 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 is the information reported in 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 (> ~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 this articles list, specialty coverings, car mats, sporting mats are not expected to be commonly found
in homes. Furthermore, because the monitoring data is 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. These
discrepancies partially stem from differences in the exposure assumptions of the CEM model versus 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
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.
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Indoor Dust Exposure Assessment Conclusions
For the indoor exposure assessment, EPA considered modeling and monitoring data. Monitoring data is
expected to represent aggregate exposure to DINP in dust resulting from all sources present in a home.
While it is not a good indicator of individual contributions of specific COUs, it provides 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 environment
using consumer products and articles commonly present in indoor spaces inhalation exposure from toys,
flooring, synthetic leather furniture, wallpaper, and wire insulation include a consideration of dust
collected on the surface of a relatively large area, like flooring, furniture, and wallpaper, but also
multiple toys and wires collecting dust with DINP and subsequent inhalation and ingestion. Other non-
residential environments can have these articles, such as 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
(see 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.
Hence, the COU scenarios of the articles used in the indoor assessment were utilized in risk estimates
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 Draft Consumer and Indoor Dust Exposure
Assessment for DiisononylPhthalate (DINP) ( 3241). 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, and when the assessor is making
the best scientific assessment possible in the absence of complete information and 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, see 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 sheets, data bases, 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 and 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 ( 241). 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 Institute. 1983). 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 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, and 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 versus human skin for DINP, EPA is confident that the in vivo dermal
absorption data using male F344 rats (Midwest Research Institute. 1983) provides an upper bound of
dermal absorption of DINP based on the findings of Scott ( 7).
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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 draft 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.
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, EPA 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 ( 023a) 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
and the Environment (RIVM) (ECJRC. 2003b; RIVM. 1998). 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
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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; Meutime 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 to 60%) and measurements
for weight fractions less than 15 percent are very rarely represented in the data set. Thus, it is unclear
whether these migration rate values are applicable to consumer goods with low (<15 percent) weight
fractions of DINP, where rates might be lower than represented by "typical" or worst-case values
determined by existing data sets. 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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2045 Table 4-9. Weight of Scientific Evidence Summary Per Consumer CPU
Consumer COU
Category and
Subcategory
Weight of Scientific Evidence
Overall Confidence
Automotive, fuel,
agriculture, outdoor use
products; Automotive
care products
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
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 and are represented 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
Construction, paint,
electrical, and metal
products; Building
construction materials
(wire and cable jacketing,
wall coverings, roofing,
pool applications, 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 are
represented 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
Inhalation, Dust Ingestion,
and Dermal - Moderate
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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.
Construction, paint,
electrical, and metal
products; Electrical and
electronic products
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
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 and represent a wide range of possible scenarios. 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.
Inhalation, Dust Ingestion,
Mouthing, and Dermal -
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 and are represented 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 are represented in the high,
medium, and low intensity use estimates. The overall confidence in this COU inhalation and dust
Inhalation and Dust
Ingestion - Robust
Dermal - Moderate
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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.
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 are represented 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 and are represented 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.
Inhalation - Robust
Dermal - Moderate
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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;
Fabric, textile, and
leather products (apparel
and footwear care
products)
Two 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): 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.
Dermal - 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 and are represented 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
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
Inhalation and Ingestion -
Robust
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direct contact during
normal use including
rubber articles; plastic
articles (hard); vinyl tape;
flexible tubes; profiles;
hoses
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.
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.
Dermal - Moderate
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
Inhalation, Dust Ingestion,
and Mouthing - Robust
Dermal - Moderate
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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.
Other; Novelty products
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
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
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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 Draft Environmental Release and
Occupational Exposure Assessment for Diisononyl Phthalate (DINP) ( 24s), releases of
DINP are expected in air, water, and disposal to landfills. Figure 4-13 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).
EPA 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 Draft Environmental Release and Occupational Exposure Assessment for Diisononyl
Phthalate (DINP) ( 2024s). 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
Draft Environmental Media and General Population Screening for Diisononyl Phthalate (DINP) (U.S.
I Mr).
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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 4-13. 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 Draft. Environmental Media and General Population Screening for Diisononyl Phthalate (DINP)
(U.S. EPA, 2024r) 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 taie 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
OES/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 EPA 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 OES 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 was 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 and
there is 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 Draft Environmental Media and General Population Screening for
Diisononyl Phthalate (DINP) ( 24r). 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 for
qualitative assessments
Qualitative
All
Landfills
No specific exposure scenarios were assessed for
qualitative assessments
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
Youth
(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
Adult
(>21 years)
Quantitative
Ingestion of fish for
subsistence fishers
Adult
(>21 years)
Quantitative
Ingestion of fish for tribal
populations
Adult
(>21 years)
Quantitative
Non-PVC
plastic
compounding
Ambient Air
Oral
Ingestion of DINP in soil
resulting from air to soil
deposition
Infant and
Children
(6 months to
12 years)
Quantitative
Dermal
Dermal exposure to DINP in
soil resulting from air to soil
deposition
Infant and
Children
(6 months
to 12 years)
Quantitative
"Table 3-1 provides the crosswalk of OES to COUs
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EPA also considered biomonitoring data, specifically urinary biomonitoring data from the Centers for
Disease Control and Prevention's (CDC) National Health and Nutrition Examination Survey
(NHANES), to estimate exposure using reverse dosimetry (see Section 10.2 of EPA's Draft
Environmental Media and General Population Screening for Diisononyl Phthalate (DINP) (U.S. EPA.
2024rV). Reverse dosimetry is a powerful tool for estimating exposure, but reverse dosimetry modeling
does not distinguish between routes or pathways of exposure and does not allow for source
apportionment (i.e., exposure from TSCA COUs cannot be isolated from uses that are not subject to
TSCA). 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 is
not directly comparable the exposure estimates from the various environmental media presented in this
document. 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 10~4 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 (U.S. EPA.
2024f) 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 (PSC), to estimate concentrations of DINP within
surface water and to estimate 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 and older) and youth
(11 to 15 years). Exposure scenarios leading to the highest modeled ADR are shown in Table 4-11.
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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
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 are not expected for 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 a wastewater treatment removal efficiency of 98 percent and no further drinking
water treatment, as well as a scenario that assumed a wastewater treatment removal efficiency of 98
percent and 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 are 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.
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Table 4-11. General Population Surface Water and Drinking Water Exposure Summary
Occupational
Exposure Scenario"
Water Column
Concentrations
Incidental Dermal
Surface Water*
Incidental Ingestion
Surface Waterc
Drinking Water d
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
a Table 3-1 provides a crosswalk of industrial and commercial COUs to OES.
h Most exposed age group: Adults (21+ years)
c Most exposed age group: Youth (11-15 years)
J Most exposed age group: Infant (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
concentrations exceeded the estimates of the water solubility limit for DINP (approximately 6.1 x 10~4
mg/L) by five-to-eight orders of magnitude based on 7Q10 flow conditions (see Draft Physical
Chemistry Assessment for Diisononyl Phthalate (DINP) (U.S. EPA. 2024x)Y Additionally, as described
in the Draft Environmental Exposure Assessment for Diisononyl Phthalate (U.S. EPA. 2024o). 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 Draft Environmental Exposure
Assessment for Diisononyl Phthalate (DINP) (U.S. EPA. 2024o) 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, EPA 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 Draft Environmental Media and General Population Screening for Diisononyl
Phthalate (DINP) (U.S. EPA. 2024r).
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 Draft
Environmental Media and General Population Screening for Diisononyl Phthalate (DINP) (U.S. EPA.
2024r). Exposure estimates were the highest for tribal populations because of their elevated fish
ingestion rates compared to the general population and subsistence fisher populations (U.S. EPA.
2024q). 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
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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 are above 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 SWC 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
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 (ages 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 Draft Environmental Media and General Population Screening for Diisononyl Phthalate (DINP)
( 2024r) for more details).
Using the highest modelled 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 expected for the ambient air pathway; therefore, the ambient air pathway is
not considered to be a pathway of concern to DINP for the general population.
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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 inc
h Air and soil concentrations are 95th p
c MOE for soil ingestion and dermal cc
ustrial and commercial COUs to OES.
ercentile at 100 m from the emitting facility
ntact represent aggregated exposure
4.1.3.2 Daily Intake Estimates for the U.S. Population Using NHANES Urinary
Biomonitoring Data
Herein, EPA used a screening4evel 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
to 2018 NHANES cycles), mono-oxoisononyl phthalate (MONP) (measured in the 2017 to 2018
NHANES cycle), and mono-(carboxyoctyl) phthalate (MCOP) (measured in the 2005 to 2018 NHANES
cycles). Urinary MiNP, MONP, and MCOP levels reported in the most recent NHANES survey {i.e.,
2017 to 2018) were used to calculate daily intake 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 to 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 Draft Environmental Media and General Population Screening for Diisononyl Phthalate (DINP)
(U.S. EPA. 2024rV
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 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 to 11 years old), 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.
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. While NHANES may be used to provide context for aggregate
exposures in the U.S. population, NHANES 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
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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. Further, 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 ( SC.
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 need for 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
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 old
1.5 (1.4-1.6)
5.7(0.2-11.2)
2,300
610
6-11 years old
1 (0.9-1.2)
6.2 (3.3-9.1)
3,500
560
12-15 years old
0.7 (0.5-0.8)
5.2 (-1.1 to 11.5)
5,000
670
16-49 years old
0.7 (0.6-0.7)
4 (1.9-6.2)
5,000
875
16+ years old
0.6 (0.6-0.6)
3.5 (2.7-4.4)
5,800
1,000
Males 3-5 years old
1.4 (1.3-1.6)
4.8 (-4.7 to 14.4)
2,500
730
Males 6-11 years old
1 (0.8-1.2)
3.4(1.1-5.7)
3,500
1,030
Males 12-15 years old
0.6 (0.5-0.8)
AT
5,800
740
Males 16-49 years old
0.6 (0.6-0.7)
3.4 (2-4.9)
5,800
1,030
Males 16+ years old
0.6 (0.5-0.6)
3.4 (2.4-4.4)
5,800
1,030
Females 3-5 years old
1.5 (1.3-1.7)
7.4 (-0.7 to 15.5)
2,300
470
Females 6-11 years old
1 (0.9-1.2)
8.1fl
3,500
430
Females 12-15 years old
0.7 (0.4-0.9)
5.2"
5,000
670
Females 16-49 years old
0.7 (0.6-0.8)
5.6(2-9.3)
5,000
630
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Females 16+ years old
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 Draft
Environmental Media and General Population Screening for Diisononyl Phthalate (DINP) (U.S. EPA.
2024r). EPA summarized its weight of scientific evidence using confidence descriptors: robust,
moderate, slight, or indeterminate. EPA used general considerations (i.e., relevance, data quality,
representativeness, consistency, variability, 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, 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, EPA 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
processes, among other reasons. Reasonably available information from studies of experimental animal
models also indicates that DINP is a developmental toxicant ( '024wY 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. 2024rY
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 though 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. EPA 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 Draft Environmental Media and
General Population Exposure for Diisononyl Phthalate (DINP) ( 024r).
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4.1.5 Aggregate and Sentinel Exposure
TSCA section 6(b)(4)(!•")(ii) (15 USC 2605(bX4)(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 draft DINP risk
evaluation, EPA considered aggregate risk across all routes of exposure for each individual consumer
and occupational COU evaluated for acute, intermediate, and chronic exposure durations. EPA did not
consider aggregate exposure for the general population. As described in Section 4.1.3, EPA 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 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).
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 draft 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 condition of use. 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
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 Draft Non-cancer Human Health
Hazard Assessment for Diisononyl Phthalate (DINP) (]j_S IT \ 2024w) and Draft Cancer Human
Health Hazard Assessment for Diisononyl Phthalate (DINP) ( E024k). which were subject to
peer-review during the July 2024 SACC meeting.
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 (U.S. CPSC. 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).
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To calculate non-cancer risks from oral to DINP for acute and intermediate durations of exposure in the
draft risk evaluation of DINP, EPA selected 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
BMDLs 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 (NASEM. 2017). The BMDL5 of 49 mg/kg-day was converted to a human
equivalent dose (HED) of 12 mg/kg-day based on allometric body weight scaling to the three-quarter
power ( ). As discussed in the Draft Non-cancer Human Health Hazard Assessment for
Diisononyl Phthalate (DINP) ( 24w) 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 an
within 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 Draft Non-cancer Human Health Hazard Assessment for
Diisononyl Phthalate (DINP) ( 24w), EPA has robust overall confidence in the proposed
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, and infants. Use of this
POD to assess risk for other age groups {e.g., older children and adult males) is conservative.
To calculate non-cancer risks from oral to DINP for chronic durations of exposure in the draft risk
evaluation of DINP, EPA preliminarily selected a no-observed-adverse-effect level (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 at s , < '< .mics. 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 ( Ea). The Agency has performed % 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 Draft Non-cancer Human Health Hazard Assessment for
Diisononyl Phthalate (DINP) ( 24w), EPA has robust overall confidence in the proposed
POD based on hepatic outcomes for use in characterizing risk from exposure to DINP for chronic
exposure scenarios.
No data were 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
draft 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 ( ). 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 draft risk evaluation.
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Table 4-15. Non-cancer HECs and HEDs Used to Estimate Risks
Exposure
Scenario
Target
Organ
System
Species
(Sex)
Duration
POD
(mg/kg-
day)
Effect
HEC
(mg/m3)
[ppm]
HED
(mg/
kg-day)
Benchmark
MOE
Reference
Acute and
Intermediate
Develop-
mental
Rat
5 to 14 days
throughout
gestation
BMDL5
= 49°
| fetal
testicular
testosterone
63
[3.7]
12
UFA= 3
UFH=10
Total UF=30
(NASEM.
2017)
Chronic
Liver
Rat
2 years
NOAEL
= 15
t liver weight,
t serum
chemistry,
histopathology''
19
[1.1]
3.5
UFA= 3
UFH=10
Total UF=30
(Lineton et
al.. 1997;
Bio/dvnamic
s. 1986)
HEC = human equivalent concentration; HED = human equivalent dose; POD = point of departure; MOE = margin of
exposure; BMDL = benchmark dose lower limit; UF = uncertainty factor; NOAEL = no-observed-adverse-effect-level
" The BMDLs was derived bv NASEM (2017) throueh meta-reeression and BMD modeline of fetal testicular testosterone
data from two studies of DINP with rats (Bobere et al.. 2011; Hannas et al.. 2011). R code suDDortine NASEM's meta-
reeression and BMD analysis of DINP is Diibliclv available throueh GitHub.
b 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 (Linetonet al.. 1997; Bio/dvnamics. 1986).
Cancer Human Health Hazards
DINP has been evaluated for carcinogenicity in two 2-year dietary studies of F344 rats (Covance Labs.
1998b; Lington et al.. 19971 one 1-year dietary study of SD rats (Bio/dynamics. 1987). and one 2-year
dietary study of B6C3F1 mice (Covance 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 (2024k)).
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.
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 al.. 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
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(Covance Labs. 1998a). As discussed further in EPA's Draft Cancer Human Health Hazard Assessment
for Diisononyl Phthalate (DINP) ( 24k). 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 (Thomas et al. 2007). 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 MOA 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 ECHA (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, considerable scientific uncertainty remains. Therefore, EPA did not consider it appropriate to
derive quantitative estimates of cancer hazard for data on MNCL from these two studies in F344 rats.
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 (:01 I, iOlO). Health Canada (ECCC/HC. 2020; EC/HC. 2015a: Health Canada. 2015).
ECHA (: ), and NICNAS ( ) have postulated that DINP causes liver tumors in rats and mice
through a peroxisome proliferator-activated receptor alpha (PPARa) MOA. Consistent with HP A
Guidelines for Carcinogen Risk Assessment ( 05a) and the IPCS 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 ( )05a). 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 Draft Non-cancer
Human Health Hazard Assessment for Diisononyl Phthalate (DINP) (U.S. EPA. 2024w)) 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.
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2526 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
• 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 33 years
Exposure Routes - Inhalation, dermal, and oral (depending on exposure scenario)
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)
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)
Population of Interest
and Exposure Scenario
Health Effects,
Concentration and
Time Duration
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4.3.1.1 Estimation of Non-cancer Risks
EPA used a margin of exposure (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)
Human Exposure
Margin of exposure for acute, short-term, or chronic
risk comparison (unitless)
HEC (mg/m3) or HED (mg/kg-day)
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 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 ( Dl). 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
MOlUjrat
M
M()IUnha!allon
Margin of exposure for aggregate scenario (unitless)
Margin of exposure for oral route (unitless)
Margin of exposure for dermal route (unitless)
Margin of exposure for inhalation route (unitless)
Total MOE risk estimates may be interpreted in relation to benchmark MOEs, similarly as to described
in the preceding Section 4.3.1.1.
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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. In summary, it was
determined that the central tendency estimates of worker exposure and risk are most representative for
all manufacturing, processing, industrial and commercial COUs—with exception of some industrial
COUs for Adhesive and sealant chemicals and Paints and coatings due to the potentially elevated
inhalation exposures from pressurized spray operations.
Application of Adhesives and Sealants
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
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 (benchmark = 30). 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 estimates from inhalation exposure
alone.
EPA used mist monitoring data from the ESD on Coating Application via Spray-Painting in the
Automotive Refinishing Industry (OE ) to evaluate inhalation exposure for the Application of
Adhesives and Sealants - Spray Application exposure scenario. The ESD indicated a central tendency
(i.e., 50th percentile) of 8-hour TWA mist concentrations from automotive refinishing of 3.38 mg/m3
and a high-end concentration (i.e., 95th percentile) of 22.1 mg/m3. The underlying mist concentration
data considered in the ESD reflected a variety of industrial and commercial automotive refinishing
scenarios (e.g., different gun types and booth configurations), but all scenarios used the spray
application of auto refinishing coatings. The more highly pressurized spray guns led to higher exposure
levels, and less pressurized spray guns led to lower exposure levels. Therefore, the high-end inhalation
exposure estimates are more representative of high-pressure spray applications (e.g., conventional spray
guns), whereas the central tendency estimates are more representative of low-pressure applications (e.g.,
HVLP spray guns).
For inhalation exposure from the Application of Adhesives and Sealants - Non-spray Application ESD,
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 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.
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Regarding product concentrations, the various commercial adhesive and sealant products considered are
summarized in Appendix F of the Draft Environmental Release and Occupational Exposure Assessment
for DiisononylPhthalate (DINP) ( 24s). There are also two industrial adhesive and sealant
products (i.e., Tremco JS443 A & B) listed in Appendix F of the Draft 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, there was a larger range of potential inhalation exposures for the spray application of
adhesives and sealants.
Because the mist monitoring data from the ESD on Coating Application via Spray-Painting in the
Automotive Refinishing Industry (OECD. 201 la) is directly applicable to the spray application of
adhesives and sealants, the inhalation exposure estimates from Table 4-17 for Application of Adhesives
and Sealants - Spray Application are expected to be representative of industrial operations where
adhesives and sealants are applied using spray methods (i.e., Industrial COU: Adhesive and sealant
chemicals). Exposures from high-pressure spray applications (e.g., conventional spray guns) are best
represented by the high-end exposure estimates, whereas as exposures from low-pressure spray
applications (e.g., HVLP spray guns) are best represented by central tendency estimates. However, any
occupational use of adhesives and sealants that does not generate mist would be best characterized by
exposure estimates under the Application of adhesives and sealants - non-spray application exposure
scenario. For example, the Tremco JS443 products are intended for industrial use in the insulated glass
(IG) unit manufacturing industry, and the products are precision applied such that mist generation is not
expected. Therefore, worker exposures from the industrial use of Tremco JS443 A & B are best
characterized under the Application of adhesives and sealants - non-spray application exposure
scenario.
Lastly, the commercial adhesive and sealant products that were identified through the risk evaluation
process and summarized in Appendix F of Draft Environmental Release and Occupational Exposure
Assessment for Diisononyl Phthalate (DINP) ( 024s) are not generally applied through spray
methods, but rather bead, brush, or roll applications where mist generation is not expected. Therefore,
occupational exposures to DINP from the commercial use of adhesives and sealants (i.e., Commercial
COU: adhesives and sealants) is represented by the Application of adhesives and sealants - non-spray
application exposure scenario in Table 4-17.
Application of Paints and Coatings
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
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dermal MOEs ranged from 33 to 114 (benchmark = 30). 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
small differences in MOEs when compared to MOE estimates from dominant exposure route alone.
EPA used mist monitoring data from the ESD on Coating Application via Spray-Painting in the
Automotive Refinishing Industry (OECD. 201 la) to evaluate inhalation exposure for the Application of
paints and coatings - spray application exposure scenario. The ESD indicated a central tendency {i.e.,
50th percentile) of 8-hour TWA mist concentrations from automotive refinishing of 3.38 mg/m3 and a
high-end concentration {i.e., 95th percentile) of 22.1 mg/m3. The underlying mist concentration data
considered in the ESD reflected a variety of industrial and commercial automotive refinishing scenarios
{e.g., different gun types and booth configurations), but all scenarios used the spray application of auto
refinishing coatings. The more highly pressurized spray guns led to higher exposure levels, and less
pressurized spray guns led to lower exposure levels. Therefore, the high-end inhalation exposure
estimates are more representative of high-pressure spray applications {e.g., conventional spray guns)
whereas the central tendency estimates are more representative of low-pressure applications {e.g., HVLP
spray guns).
For inhalation exposure from the Application of paints and coatings - non-spray application exposure
scenario, 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 Draft Environmental Release and Occupational Exposure Assessment
for DiisononylPhthalate (DINP) ( 24s). 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 percent) to represent the central tendency product
concentration and the upper bound product concentration {i.e., 20 percent) 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, there was a larger range of potential inhalation exposures for the application of paints and
coatings.
Since the mist monitoring data from the ESD on Coating Application via Spray-Painting in the
Automotive Refinishing Industry (OECD. 201 la) is directly applicable to the spray application of paints
and coatings, the exposure estimates from Table 4-17 for the Application of paints and coatings - spray
application are expected to be representative of industrial operations where paints and coatings are
applied using spray methods {i.e., Industrial COU: Paints and coatings). Exposures from high-pressure
spray applications {e.g., conventional spray guns) are best represented by the high-end exposure
estimates, whereas as exposures from low-pressure spray applications {e.g., HVLP spray guns) are best
represented by central tendency estimates. There was one paint and coating product identified for
potential industrial use {i.e., Freeman 90 - Burnt Orange Pattern Coating), with a DINP concentration
ranging from 1 to 5 percent, and is intended to be brush-applied or spray-applied at low-pressure if
thinned. Because the product is intended to be spray-applied at low-pressure when thinned, and the
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product concentration is near the mode product concentration {i.e., 5 percent), the industrial use of
Freeman 90 - Burnt Orange Pattern Coating is best characterized by the central tendency exposure
estimates of the Application of paints and coatings - spray application exposure scenario. However, any
occupational use of paints and coatings that does not generate mist would be best characterized by
exposure estimates under the Application of paints and coatings - non-spray application exposure
scenario.
The conditions of use 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 Draft Environmental Release and Occupational
Exposure Assessment for Diisononyl Phthalate (DINP) (U, 2024s) are not generally applied
through highly pressurized spray methods, but rather low-pressure hand pump sprayers, small volume
spray cans, and buff coating applications are used for the available commercial paint and coating
products containing DINP. Therefore, occupational exposures to DINP from the commercial use of paint
and coating products {i.e., Commercial COU: Paints and coatings) are represented by the central
tendency levels of exposure of the Application of Paints and Coatings - Spray Application exposure
scenario in Table 4-17. However, any products that are not expected to generate mist during use would
be best characterized by exposure estimates under the Application of paints and coatings - non-spray
application exposure scenario. For instance, the industrial uses of pigments for leak detection and
commercial uses of ink, toner, and colorant products {i.e., Industrial COUs: Pigment [leak detection];
Commercial COUs: Ink, toner, and colorant products) are not expected to generate mist and are best
characterized by the Application of paints and coatings - non-spray application exposure scenario.
PVC Plastics Compounding and Non-PVC Material Compounding
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 below.
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
( ). 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
industry provided DINP concentration range in PVC {i.e., 10 to 45 percent) and non-PVC {i.e., 1 to 40
percent) products, respectively, to estimate DINP particulate concentrations in the air. The differences in
the central tendency and high-end dust concentrations and DINP concentrations in PVC and non-PVC
products, led to significant differences between the central tendency and high-end risk estimates.
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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 assume that the concentration of DINP in workplace dust is the same as
the concentration of DINP in PVC plastics and non-PVC materials. 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. Due to the uncertainty of DINP concentrations
in workplace dust, central tendency values of exposure are expected to be most 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]).
PVC Plastics Converting and Non-PVC Material Converting
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.
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
(I ). EPA did not have a robust dataset for vapor exposures with all monitoring data
existing below the LOD, therefore EPA 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
facilities with NAICS codes starting with 326 (Plastics and Rubber Manufacturing). EPA multiplied
these dust concentrations by the industry provided DINP concentration range in PVC {i.e., 10 to 45
percent) and non-PVC {i.e., 1 to 40 percent) products, respectively, to estimate DINP particulate
concentrations in the air. The differences in the central tendency and high-end dust concentrations, as
well as DINP concentrations in the dust, led to significant differences between the central tendency and
high-end risk estimates.
Though the PNOR {i.e., dust) concentration data provides a reliable range of dust concentrations that a
worker may experience in the converting 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. Due to the
uncertainty of DINP concentration in workplace dust, central tendency values of exposure are expected
to be most reflective of worker exposures within the COUs covered under the PVC plastics converting
and the Non-PVC material converting OESs {i.e., Processing COUs: Plasticizers [playground and
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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)]).
Fabrication and Final Use of Products or Articles
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
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 below.
EPA estimated worker inhalation exposures using the PNOR model for dust exposures (U.S. EPA.
7X ). For inhalation exposure to PNOR, EPA 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 percent) 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.
Though the PNOR {i.e., dust) concentration data provides a reliable range of dust concentrations that a
worker may experience in the end use and 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. Due to uncertainty in
DINP concentration in workplace dust, central tendency values of exposure are expected to be most
reflective of worker exposures within the COUs covered under the "Fabrication and final use of
products and articles" OES {i.e., Industrial COUs: Automotive products, other than fluids;
Building/construction materials (roofing, pool liners, window shades, flooring). Commercial COUs:
Automotive products, other than fluids; Plasticizer in building/construction materials (roofing, pool
liners, window shades); 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 (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]).
Recycling and Disposal
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
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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
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 below.
EPA estimated worker inhalation exposures using the PNOR model for dust exposures (U.S. EPA.
2i ). For inhalation exposure to PNOR, EPA 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 percent) 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.
Though 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.
Therefore, central tendency values of exposure are expected to be more reflective of worker exposures
within the COUs covered under the "Recycling" and the "Disposal" OESs (i.e., Industrial COUs:
"Recycling" and "Disposal").
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.
Though 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.
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 greater than or equal to 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
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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:
• 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 percent), 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:
• 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).
4.3.2.1 Overall Confidence in Worker Risks
As described in Section 4.1.1.5 and the Draft Environmental Release and Occupational Exposure
Assessment for DiisononylPhthalate (DINP) ( 324s). 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 ( !24v)). 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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2952 Table 4-17. Occupational Aggregate Risk Summary Table
Life Cycle
Stage/
Category
Subcategory
OES
Population
Exposu re
Level
Inhalation Risk Estimates
(Benchmark MOE = 30)
Dermal Risk Estimates
(Benchmark MOE = 30)
Aggregate Risk Estimates
(Benchmark MOE = 30)
Acute
Intcrmcd.
Chronic
Acute
Intcrmcd.
Chronic
Acute
Intcrmcd.
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
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Life Cycle
Stage/
Catcnorv
Subcategory
OES
Population
Exposure
Level
Inhalation Risk Estimates
(Benchmark MOE = 30)
Dermal Risk Estimates
(Benchmark MOE = 30)
Aggregate Risk Estimates
(Benchmark MOE = 30)
Plasticizers
(paint and
coating
manufacturing;
ink, toner, and
colorant
manufacturing
(including
pigment))
Worker:
High-End
153,600
209,455
65,408
77
105
33
77
105
33
Processing -
Incorporation
Average Adult
Worker
Central
Tendency
307,200
418,909
130,816
154
210
66
154
210
65
into
Incorporation
into paints and
coatings
Worker:
High-End
139,056
189,622
59,215
84
114
36
84
114
36
Formulation,
Mixture, or
Reaction
Female of
Reproductive
Age
Central
Tendency
278,112
379,244
118,429
167
228
71
167
228
71
Product
High-End
153,600
209,455
65,408
N/A
N/A
N/A
153,600
209,455
65,408
ONU
Central
Tendency
307,200
418,909
130,816
N/A
N/A
N/A
307,200
418,909
130,816
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
Central
307,200
418,909
130,816
154
210
66
154
210
65
and processing
Tendency
Processing -
Incorporation
into
aid in basic
organic
chemical
manufacturing
Incorporation
into other
formulations,
mixtures, and
reaction
products not
covered
elsewhere
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
High-End
153,600
209,455
65,408
N/A
N/A
N/A
153,600
209,455
65,408
Product
other 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
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Life Cycle
Stage/
Catcnorv
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
Formulation,
Mixture, or
Reaction
Product
Plasticizers
(custom
compounding of
purchased resin;
plastic material
and resin
manufacturing)
PVC plastics
compounding
Worker:
Average Adult
Worker
High-End
45
62
19
77
105
33
29
39
12
Central
Tendency
925
1,261
441
154
210
73
132
180
63
Worker:
Female of
Reproductive
Age
High-End
41
56
17
84
114
36
28
38
12
Central
Tendency
837
1,142
400
167
228
80
140
190
67
ONU
High-End
922
1,257
393
39,024
53,215
16,618
901
1,228
385
Central
Tendency
925
1,261
441
39,024
53,215
18,630
903
1,232
431
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
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Life Cycle
Stage/
Catcnorv
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
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
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
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Life Cycle
Stage/
Catcnorv
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 -
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
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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PUBLIC RELEASE DRAFT
August 2024
Life Cycle
Stage/
Catcnorv
Subcategory
OES
Population
Exposure
Level
Inhalation Risk Estimates
(Benchmark MOE = 30)
Dermal Risk Estimates
(Benchmark MOE = 30)
Aggregate Risk Estimates
(Benchmark MOE = 30)
Industrial
Worker:
High-End
11
15
4.6
77
105
33
9.5
13
4.1
Uses -
Average Adult
Central
142
194
61
154
210
66
74
101
31
Construction,
Worker
Tendency
Paint,
High-End
9.8
13
4.2
84
114
36
8.8
12
3.7
Electrical, and
Metal
Products
Paints and
Application of
paints and
coatings -
spray
application
Worker:
Female of
Reproductive
Commercial
uses -
coatings
Age
Central
Tendency
129
176
55
167
228
71
73
99
31
Construction,
High-End
142
194
61
154
210
66
74
101
31
Paint,
Central
142
194
61
154
210
66
74
101
31
Electrical, and
Metal
ONU
Tendency
Products
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PUBLIC RELEASE DRAFT
August 2024
Life Cycle
Stage/
Catcnorv
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
Construction,
Paint,
Electrical, and
Metal
Products
Paints and
coatings
Application of
paints and
coatings -
non-spray
application
Worker:
Average Adult
Worker
High-End
153,600
209,455
65,408
77
105
33
77
105
33
Commercial
Uses -
Construction,
Paint,
Electrical, and
Metal
Products
Industrial uses
- Other Uses
Pigment (leak
detection)
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
Commercial
Uses -
Packaging,
Paper, Plastic,
Hobby
Products
Ink, toner, and
colorant
products
Central
Tendency
307,200
418,909
130,816
N/A
N/A
N/A
307,200
418,909
130,816
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PUBLIC RELEASE DRAFT
August 2024
Life Cycle
Stage/
Catcnorv
Subcategory
OES
Population
Exposure
Level
Inhalation Risk Estimates
(Benchmark MOE = 30)
Dermal Risk Estimates
(Benchmark MOE = 30)
Aggregate Risk Estimates
(Benchmark MOE = 30)
Commercial
Uses - Other
Uses
Laboratory
chemicals
Use of
laboratory
chemicals -
liquid
Worker:
Average Adult
Worker
High-End
1,391
1,897
592
77
105
33
73
99
31
Central
Tendency
2,783
3,794
1,261
154
210
70
146
199
66
Worker:
Female of
Reproductive
Age
High-End
1,260
1,718
536
84
114
36
79
107
33
Central
Tendency
2,519
3,435
1,141
167
228
76
157
214
71
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
1,261
N/A
N/A
N/A
2,783
3,794
1,261
Commercial
Uses - Other
Uses
Laboratory
chemicals
Use of
laboratory
chemicals -
solid
Worker:
Average Adult
Worker
High-End
1,185
1,616
505
19,512
26,608
8,309
1,117
1,524
476
Central
Tendency
16,842
22,967
7,172
39,024
53,215
16,618
11,765
16,043
5,010
Worker:
Female of
Reproductive
Age
High-End
1,073
1,463
457
21,237
28,960
9,044
1,021
1,393
435
Central
Tendency
15,247
20,792
6,493
42,475
57,920
18,087
11,220
15,300
4,778
ONU
High-End
16,842
22,967
7,172
39,024
53,215
16,618
11,765
16,043
5,010
Central
Tendency
16,842
22,967
7,172
39,024
53,215
16,618
11,765
16,043
5,010
Commercial
Uses -
Solvents (for
Cleaning or
Decreasing)
Solvents (for
cleaning or
degreasing)
Use of
lubricants and
functional
fluids
Worker:
Average Adult
Worker
High-End
1,391
10,435
37,029
77
577
2,047
73
547
1,940
Central
Tendency
2,783
41,739
148,116
154
2,308
8,189
146
2,187
7,760
Worker:
Female of
Reproductive
Age
High-End
1,260
9,447
33,523
84
628
2,228
79
589
2,089
Industrial uses
- Other Uses
Hydraulic fluids
Central
Tendency
2,519
37,787
134,091
167
2,512
8,913
157
2,355
8,358
ONU
High-End
2,783
20,870
74,058
N/A
N/A
N/A
2,783
20,870
74,058
Central
Tendency
2,783
41,739
148,116
N/A
N/A
N/A
2,783
41,739
148,116
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PUBLIC RELEASE DRAFT
August 2024
Life Cycle
Stage/
Catcnorv
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 -
Automotive,
Fuel,
Agriculture,
Outdoor Use
Products
Automotive
products, other
than fluids
Fabrication
and Final Use
of Products or
Articles
Worker:
Average Adult
Worker
High-End
119
162
50
19,512
26,608
8,309
118
161
50
Industrial
Uses -
Automotive,
Fuel,
Agriculture,
Outdoor Use
Products
Building
/construction
materials
(roofing, pool
liners, window
shades,
flooring)
Central
Tendency
1,067
1,455
454
39,024
53,215
16,618
1,038
1,416
442
Industrial
Uses -
Automotive,
Fuel,
Agriculture,
Outdoor Use
Products
Automotive
products, other
than fluids
Commercial
uses -
Construction,
paint,
electrical, and
metal
products
Plasticizer in
building/
construction
materials
(roofing, pool
liners, window
shades);
construction and
building
materials
covering large
surface areas,
including paper
articles; metal
articles; stone,
plaster, cement,
glass, and
ceramic articles
Worker:
Female of
Reproductive
Age
High-End
107
146
46
21,237
28,960
9,044
107
146
45
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PUBLIC RELEASE DRAFT
August 2024
Life Cycle
Stage/
Category
Subcategory
OES
Fabrication
and Final Use
of Products or
Articles
Population
Worker:
Female of
Reproductive
Age
Exposure
Level
Inhalation Risk Estimates
(Benchmark MOE = 30)
Dermal Risk Estimates
(Benchmark MOE = 30)
Aggregate Risk Estimates
(Benchmark MOE = 30)
Electrical and
electronic
products
Commercial
Uses -
Furnishing,
Cleaning,
Treatment/
Care Products
Commercial
Uses -
Furnishing,
Cleaning,
Treatment/
Care Products
Foam seating
and bedding
products;
furniture and
furnishings
including plastic
articles (soft);
leather articles
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)
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)
Arts, crafts, and
hobby materials
ONU
High-End
1,067
1,455
454
39,024
53,215
16,618
1,038
1,416
442
Page 157 of 274
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PUBLIC RELEASE DRAFT
August 2024
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)
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))
Fabrication
Commercial
Use:
Packaging,
Paper, Plastic,
Hobby
Plasticizer
(plastic and
rubber products;
tool handles,
flexible tubes,
profiles, and
hoses)
and Final Use
of Products or
Articles
ONU
Products
Central
Tendency
1,067
1,455
454
39,024
53,215
16,618
1,038
1,416
442
Toys,
playground, and
sporting
equipment
Fabrication
and Final Use
of Products or
Articles
Processing -
Recycling
Recycling and
Worker:
High-End
61
83
26
19,512
26,608
8,309
61
83
26
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PUBLIC RELEASE DRAFT
August 2024
Life Cycle
Stage/
Category
Recycling
Subcategory
OES
Disposal
Population
Average Adult
Worker
Exposure
Level
Inhalation Risk Estimates
(Benchmark MOE = 30)
Dermal Risk Estimates
(Benchmark MOE = 30)
Aggregate Risk Estimates
(Benchmark MOE = 30)
Central
Tendency
889
1,212
424
39,024
53,215
18,630
869
1,185
415
Worker:
Female of
Reproductive
Age
High-End
55
75
23
21,237
28,960
9,044
55
75
23
Disposal -
Disposal
Disposal
Central
Tendency
805
1,097
384
42,475
57,920
20,277
790
1,077
377
ONU
High-End
889
1,212
379
39,024
53,215
16,618
869
1,185
371
Central
Tendency
889
1,212
424
39,024
53,215
18,630
869
1,185
415
2953
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2955
2956
2957
2958
2959
2960
2961
2962
2963
2964
2965
2966
2967
2968
2969
2970
2971
2972
2973
2974
2975
2976
2977
2978
2979
2980
2981
2982
2983
2984
2985
2986
2987
2988
2989
2990
2991
2992
2993
2994
2995
2996
2997
2998
2999
3000
3001
PUBLIC RELEASE DRAFT
August 2024
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)). Further, Table
4-18 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 (> ~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 Draft Consumer Risk Calculator for Diisononyl Phthalate (DINP) (
202411).
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 Draft Consumer and Indoor Exposure
Assessment for Diisononyl Phthalate (DINP) ( 3241) and Draft Non-cancer Human Health
Hazard Assessment for Diisononyl Phthalate (DINP) ( '024w\ 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.
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3002
3003
3004
3005
3006
3007
3008
3009
3010
3011
3012
3013
3014
3015
3016
3017
3018
3019
3020
3021
3022
3023
3024
3025
3026
3027
3028
3029
3030
3031
3032
3033
3034
3035
3036
3037
3038
3039
3040
3041
3042
3043
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August 2024
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 11 years old to adults (21+ years), while high-
intensity chronic aggregate MOEs ranged from 22 to 27 for users 11 years old 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 11 years old to adults (21+ years), while
aggregate MOEs ranged from 51 to 66 for users 11 years old to adults (21+ years).
For the high-intensity scenario, inhalation and dermal exposure routes contribute equally to aggregate
risk indicating that for certain higher weight fraction 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. 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 because the CEM default parameters are
representative of 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. Additionally, EPA
has robust overall confidence in the underlying chronic POD based on liver toxicity (Section 4.2).
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.
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3060
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3067
3068
3069
3070
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PUBLIC RELEASE DRAFT
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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 to 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. Additionally, EPA has robust overall confidence in the underlying chronic POD
based on liver toxicity used to estimate MOEs (Section 4.2).
4.3.3.1 Overall Confidence in Consumer Risks
As described in Section 4.1.2 and in more technical details in the Draft Consumer and Indoor Exposure
Assessment for Diisononyl Phthalate (DINP) ( 3241). EPA has moderate and robust
confidence in the assessed inhalation, ingestion, and dermal consumer exposure scenarios, and robust
confidence in the acute/intermediate and chronic non-cancer PODs selected to characterize risk from
acute, intermediate, and chronic duration exposures to DINP (see Section 4.2 and ( 024w)).
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.
Page 162 of 274
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PUBLIC RELEASE DRAFT
August 2024
3090 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:
Automotive, fuel,
agriculture, outdoor
use products:
Automotive
products, other than
fluids
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 274
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PUBLIC RELEASE DRAFT
August 2024
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 274
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PUBLIC RELEASE DRAFT
August 2024
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,
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: 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
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
Page 165 of 274
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PUBLIC RELEASE DRAFT
August 2024
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: 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
-
-
-
-
-
-
-
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
29
35
50
72
84
100
M
39
42
51
73
100
120
150
Aggregate
H
25
26
30
46
68
80
97
M
36
38
44
68
94
110
150
Page 166 of 274
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PUBLIC RELEASE DRAFT
August 2024
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 (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
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
-
-
-
-
-
-
-
-
-
Page 167 of 274
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PUBLIC RELEASE DRAFT
August 2024
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)
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
18
22
32
46
53
67
M
31
33
40
58
82
95
120
Aggregate
H
16
16
19
30
43
50
65
M
29
30
35
54
77
90
120
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
18
22
31
44
52
65
M
35
38
46
67
94
110
140
Aggregate
H
16
16
19
29
41
49
63
M
32
34
40
62
88
100
140
Page 168 of 274
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PUBLIC RELEASE DRAFT
August 2024
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
(Installation)
Acute
Dermal
H
-
-
-
-
40,000
44,000
41,000
Ingestion
H
-
-
-
-
-
-
-
Inhalation
H
-
-
-
-
-
-
-
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
-
-
-
-
-
-
-
-
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
Page 169 of 274
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PUBLIC RELEASE DRAFT
August 2024
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)
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
36
44
72
102
116
142
M
83
94
112
179
256
304
382
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
Page 170 of 274
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PUBLIC RELEASE DRAFT
August 2024
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)
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
Consumer Uses:
Packaging, paper,
plastic, hobby
products: Arts,
crafts, and hobby
materials
Rubber Eraser
Acute
Dermal
H
430,000
500,000
580,000
720,000
910,000
990,000
930,000
Ingestion
H
-
-
1,400
2,300
-
-
-
Inhalation
H
-
-
-
-
-
-
-
Aggregate
H
-
-
1,400
2,300
-
-
-
Intermed.
-
-
-
-
-
-
-
-
-
Chronic
Dermal
H
120,000
150,000
170,000
210,000
260,000
290,000
270,000
Ingestion
H
-
-
400
680
-
-
-
Inhalation
H
-
-
-
-
-
-
-
Aggregate
H
-
-
400
680
-
-
-
Consumer Uses:
Packaging, paper,
plastic, hobby
products: Arts,
crafts, and hobby
materials
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:
Current products were not identified. Foreseeable uses were matched with the lacquers, and paints (small projects) because similar use patterns are expected.
Page 171 of 274
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PUBLIC RELEASE DRAFT
August 2024
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)
Packaging, paper,
plastic, hobby
products: Ink, toner,
and colorant
products
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 172 of 274
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PUBLIC RELEASE DRAFT
August 2024
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: Novelty
products
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
Page 173 of 274
-------
PUBLIC RELEASE DRAFT
August 2024
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).
Page 174 of 274
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PUBLIC RELEASE DRAFT
August 2024
4.3.4 Risk Estimates for General Population
As described in the Draft Environmental Media and General Population Screening for Diisononyl
Phthalate (DINP) ( 2024r) 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. 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 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 draft 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 Draft Non-cancer Human Health Hazard Assessment for
Diisononyl Phthalate (DINP) ( 24w), 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 draft 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) leading to greater exposure. EPA
accounted for these populations with greater exposure in the draft 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 ( 1023b)
and in agreement with SACC peer-review comments ( 023d). 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, EPA considers acute and intermediate
duration exposures during the critical window of development most relevant for a disruption of
androgen action based on reduced fetal testicular testosterone.
In this draft 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 EPA'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 and intermediate risk was identified
for two occupational COUs (i.e., industrial use of adhesives and sealants, and 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.
EPA plans to subsequently issue a draft cumulative risk assessment that will go out for public comment
and peer review, followed by a final cumulative assessment. Consideration of cumulative risk may
impact the final DINP risk evaluation, including which COUs contributed to unreasonable risk.
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3175 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 preliminarily determination that
there is no risk for all pathways assessed for exposure to ecological receptors. The
Agency has robust confidence in the preliminary determination of no risk to aquatic receptors
and moderate confidence in the preliminary 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.
3176 5.1 Summary of Environmental Exposures
3177 EPA evaluated the reasonably available information for environmental exposures of DINP to aquatic
3178 and terrestrial species. EPA expects the main environmental exposure pathway for DINP is to be
3179 released to surface water with subsequent deposition to sediment. The ambient air exposure pathway
3180 was also assessed for its limited contribution via deposition to soil. DINP exposure to aquatic species via
3181 surface water and sediment were modeled to estimate concentrations from the COU/OES that resulted in
3182 the highest environmental media concentrations. EPA calculated concentrations of DINP in
3183 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 6.1x1 o 4 mg/L and the
predicted BCF of 5.2 L/kg, the modelled concentration of DINP in fish was 3.2 10 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, and 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 concentrations 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 concentrations at least three orders
of magnitude greater than calculated concentrations in an aquatic-dependent mammal based on the
maximum measured concentrations from the published literature. 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).
Figure Legend
Partitioning/T ransportatiori
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. EPA reviewed 46
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references and determined that 32 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 Toxicity Reference Value (TRV) 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.
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, EPA 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 ( 2024r). 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 ( )24f). 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 (U.S. EPA. 2024r)>
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 (I S hT X 2024ac). 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
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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 (\ c. < i1 \ 2024o).
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 ( 024r).
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 (\ c. < i1 \ 2024o). Using these maximum modeled deposition rates from
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
1,460 |ig/kg ( s24o).
DINP is expected to have a low potential for bioaccumulation and biomagnification in aquatic
organisms (Blair et at.. 2009; McConnell. 2007; Mackintosh et ai. 2004).
Monitored concentrations of DINP within differing aquatic taxa reflect dilution across trophic levels
fMcConnell. 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 a
major exposure pathway. 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) ( 2024p).
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.
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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 riska
Air deposition to surface water,
sediment
Aquatic species; Aquatic dependent
mammal
No riska
Air deposition to soil
Terrestrial mammal
No riska
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
a 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 (2024o).
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 ( ). 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).
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 ( 324t).
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. 2024t).
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 ( )24p). Thus, with no
observed hazard to aquatic organisms, EPA has preliminarily 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
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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 ( 2024p). The fate and transport of DINP in surface water are governed by water
solubility, organic carbon partitioning coefficients, and volatility, though volatilization is not expected to
be a significant source of loss of DINP from surface water (U.S. EPA. 2024f). 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
(I E024o)) 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
preliminary 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 ( s24t). The OES with the highest environmental
media release to surface water was the manufacturing. Modeled environmental media concentrations
resulting from this OES were assessed as worst-case (conservative) exposures to organisms (U.S. EPA..
20240). 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 ( 2024p). No hazard
effects of sediment DINP to sediment dwelling animals were documented in the literature (
2024p). 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 preliminary 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. 2024t). 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 (•, c. < ^ \ :024o). 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 ( )24q). Based on the conservative VVWM-
PSC outputs for surface water and sediment shown in ( 2024q). the COUs/OESs based water
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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 preliminarily 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 no-observed-effect-concentration (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 2.4xl0~3 mg/kg, respectively. Because DINP has
low bioaccumulation potential ( )24f) and biodilutes (Mackintosh et al. 2004). the transfer
of DINP through a food web is expected to dilute in each trophic level and this is less than the amount
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 a NOEC 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 al..
2019; Trail et al.. 2015; Zhang et al.. 201 \ «,iu et al.. 2010; Zeng et al.. 2009; Zeng et al.. 2008;
Vikels0e et al.. 2002). 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
preliminary 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 (Duvar et al.. 2021; Kalmykova et al..
2013). Furthermore, any DINP that may present in landfill leachates will not be mobile in receiving soils
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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
( strong et at.. 2018; ECJRC. 2003a). The half-life of 28 to 52 days in aerobic soils (SRC. 1983)
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 combination of
factors such as biodegradation (SRC. 1983) and the weight of evidence supporting a lack of
bioaccumulation and biomagnifi cation (Mackintosh et at.. 2004; ECJRC. 2003a; Gob as et at.. 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 conditions of use (e.g., manufacturing,
processing, industrial use, commercial use, disposal) rather than a single distribution scenario. Data were
not reasonably available for EPA 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 since 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 Draft Environmental Release and Occupational Exposure Assessment for Diisononyl Phthalate
(DINP) ( 2024s). 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.
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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 the Technical Support Document (TSD),
Draft Environmental Media and General Population Screening for Diisononyl Phthalate (DINP) (U.S.
EPA. f2024r)l represented by modeled and monitored data. Trophic transfer confidence is represented
by evidence type as reported in I v « « \ * _ 024o), Draft Environmental Exposure Assessment for
Diisononyl Phthalate (DINP). Hazard confidence was represented by evidence type as reported
previously in )24p). Draft Environmental Hazard Assessment for Diisononyl Phthalate
(DINP). The following confidence determinations for risk characterization inputs are robust confidence
for the aquatic evidence and robust confidence for terrestrial evidence (Table 5-2).
Exposure
Conservative approaches within both environmental media modeling (e.g., AERMOD and 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
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.
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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. Robust 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 024tl 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 since, 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 (2024t). 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.
Table 5-2. DINP Evidence Table Summarizing Overall Confidence Derived for Environmental
Risk Characterization
Types of Evidence
Exposure
Hazard
Trophic
Transfer
Risk
Characterization
Confidence
.\t| ual ic
Acute aquatic assessment
++ VVWM-PSC fl
+ AERMOD b
+ + +
N/A
Robust
Chronic aquatic assessment
+ +
N/A
Chronic benthic assessment
+ + +
N/A
Algal assessment
+ + +
N/A
Tcnvsliul
Chronic avian assessment
N/A
N/A
N/A
Indeterminate
Chronic mammalian assessment
++ VVWM-PSC fl
+ AERMOD
+ +
+ +
Moderate
Terrestrial invertebrates
+ AERMOD
+ + +
N/A
Robust
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
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Types of Evidence
Exposure
Hazard
Trophic
Transfer
Risk
Characterization
Confidence
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 potentially exposed or susceptible
subpopulation (PESS) identified by EPA as relevant to the risk evaluation, under the TSCA COUs.
EPA is preliminarily determining that DINP presents an unreasonable risk of injury to human health
under the COUs. Risk of injury to the environment does not contribute significantly to EPA's
preliminary determination of unreasonable risk. This draft unreasonable risk determination is based on
the information in previous sections of this draft risk evaluation, the TSDs that support this draft risk
evaluation, and their appendices in accordance with TSCA section 6(b). It is also based on (1) the best
available science (TSCA section 26(h)), (2) the weight of scientific evidence standards (TSCA section
26(i)), and (3) relevant implementing regulations in 40 CFR part 702, including the amendments to the
procedures for chemical risk evaluations under TSCA finalized in May of 2024.
As noted in the EXECUTIVE SUMMARY, DINP is used primarily as a plasticizer to make flexible
PVC. It is also used to make building and construction materials; automotive care and fuel products; and
other commercial and consumer products including adhesives and sealants, paints and coatings,
electrical and electronic products, which are all considered TSCA 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 properties, most of
it will end up in the sediment at the bottom of lakes and rivers. If it is released into the air, DINP will
attach to dust particles and then be deposited onto 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.
As explained in Sections 4.1.3 and 4.3.4, EPA used a screening-level approach in this draft 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. As explained
in Sections 5.3.1 and 5.3.2, EPA first characterized risk based upon the COU with the highest estimated
concentrations for a given pathway, based on the OES and the associated environmental media used in
the draft risk evaluation. Then, if this exposure concentration did not exceed the hazard thresholds
harmful to organisms, EPA based the draft risk determination on this maximum exposure scenario to be
most inclusive and protective by encompassing the exposures from other COUs within the OES. EPA
determined that the hazard data for fish, aquatic invertebrates, sediment-dwelling organisms, algae,
terrestrial invertebrates, and terrestrial mammals indicated no adverse effects from exposures up to and
exceeding the limit of water solubility.
Following EPA's Guidelines for Carcinogen Risk Assessment ( )5a), EPA determined that
DINP is Not Likely to be Carcinogenic to Humans at doses below levels that do not result in peroxisome
proliferator activated receptor alpha (PPARa) activation. Further, the non-cancer chronic POD based on
non-cancer liver effects will adequately account for all chronic toxicity, including carcinogenicity,
which could potentially result from exposure to DINP. EPA did not further evaluate DINP for
carcinogenic risk to humans, including workers, consumers, and the general population.
Whether EPA makes a determination of unreasonable risk for a particular chemical substance under
amended TSCA depends upon risk-related factors beyond exceedance of benchmarks, such as the
endpoint under consideration, the reversibility of the effect, exposure-related considerations (e.g.,
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duration, magnitude, or frequency of exposure, or population exposed), and the confidence in the
information used to inform the hazard and exposure values.
To determine if an occupational COU contributed significantly to unreasonable risk, EPA compared the
risk estimates of the OES used to evaluate the COUs, and considered whether the risk from the COU
was best represented by the central tendency or high-end risk estimates. For DINP, whether risk was
best characterized by central tendency estimates as opposed to high end estimates for a given COU was
based on examination of the specific parameters used in the OES, including: (1) the method of
application, (2) accuracy of the amount of DINP found in the product(s) or in dust, and (3) accuracy of
the frequency of use for the product(s). The method of application is important for the determination of
the exposure level to DINP and the estimate of exposure for a particular COU. For example, if high-
pressure spray application is used, there is a higher concentration of mist generated. The higher
concentration of mist leads to higher inhalation exposure levels. In comparison, the central tendency
estimates are more representative of low-pressure spray applications and non-spray methods such as
brush, roll, dip, and bead applications. If the low-pressure applications are used for a particular COU,
risk for that COU is best represented by the central tendency estimates. The accuracy of the frequency of
use and/or amount of DINP can also affect the exposure estimates. If the frequency of use and/or the
amount of DINP is overestimated, this leads to a level of uncertainty in the high-end estimates, and
therefore, the central tendency estimates would be more representative of the exposure for some COUs.
EPA did not identify any products containing DINP that are currently used in high-pressure spray
applications. However, based on the presence of DINP in products that could be spray applied in various
different capacities and the available information regarding industrial settings, EPA expects that high-
pressure spray applications could be used in industrial settings for the application of adhesives and
sealants and in industrial settings for the application of paints and coatings. Therefore, EPA is
preliminarily determining that the high-end estimates best represent the Industrial use - adhesives and
sealants COU as well as the Industrial use - construction, paint, electrical, and metal products - paints
and coatings COU (see Table 4-17 or more details). EPA notes that it is preliminarily determining that
the processing into these formulations do not contribute significantly to the unreasonable risk because—
due to the low vapor pressure of DINP—inhalation exposures from vapor-generating activities (without
dust or mist generation) are quite low, and the processing does not involve any high-pressure spray of
DINP. Additionally, for commercial use of adhesives and sealants EPA is basing its preliminary
determination on the non-spray application scenario, which indicated no unreasonable risk, even when
considering high-end estimates. For Commercial use of paints and coatings, EPA is basing its
preliminary determination on central tendency risk estimates because the Agency expects (1) that
commercial users will use low-pressure spray applications in commercial settings, and (2) the central
tendency risk estimates indicate no unreasonable risk.
The consumer and bystander exposure scenarios described in this draft risk evaluation represent a wide
selection of consumer use patterns. High-intensity consumer exposure scenarios may use conservative
inputs representing sentinel exposures (e.g., 24 hours of exposure for consumers who stay at home all
day), but EPA still has moderate or robust confidence in the majority of inputs used for modeling the
high-intensity risk estimates. The high-intensity consumer and bystander risk estimates represent an
upper bound exposure scenario.
EPA is preliminarily determining the following COUs, considered singularly or in combination with
other exposures, 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
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manufacturing, and adhesion/cohesion promoter in transportation equipment manufacturing) due
to high-pressure spray application;
• Industrial use - construction, paint, and metal products - paints and coatings due to high-
pressure spray application;
and
• 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).
EPA is preliminarily determining that the following COUs do not contribute significantly 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 - automotive, fuel, agriculture, outdoor use products - automotive products, other
than fluids;
• Industrial use - construction, paint, electrical, and metal products - building/construction
materials (roofing, pool liners, window shades, flooring);
• Industrial use - other uses - hydraulic fluids;
• Industrial use -other uses - pigment (leak detection);
• Commercial use - automotive, fuel, agriculture, outdoor use products - automotive products
other than fluid;
• Commercial use - construction, paint, electrical, and metal products - adhesives and sealants;
• Commercial use - construction, paint, electrical, and metal products - plasticizer in
building/construction materials (roofing, pool liners, window shades); 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 - construction, paint, electrical, and metal products - paints and coatings;
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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;
• Consumer use - automotive, fuel, agriculture, outdoor use products - automotive products other
than fluid;
• Consumer use - construction, paint, electrical, and metal products - plasticizer in
building/construction materials (roofing, pool liners, window shades);
• Consumer use - construction, paint, electrical, and metal products - electrical and electronic
products;
• Consumer use - construction, paint, electrical, and metal products - adhesives and sealants
• Consumer use - construction, paint, electrical, and metal products - paints and coatings;
• 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 products; and
• Disposal.
In this draft risk evaluation, the Agency describes the strength of the scientific evidence supporting the
human health and environmental assessments as robust, moderate, or slight. Robust confidence suggests
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thorough understanding of the scientific evidence and uncertainties, and 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. 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 exposure estimates. Slight
confidence is assigned when the weight of scientific evidence may not be adequate to characterize the
scenario, and when the Agency is making the best scientific assessment possible in the absence of
complete information. The overall confidence in the human health exposure assessment as well as the
hazard assessment is described for each human population in the respective risk estimates section for
that population in Section 4.
For the environment, Section 5.3.3 describes weighing the scientific evidence for exposures and hazards
to determine overall confidence in the environmental risk assessment. The draft DINP risk evaluation
and the supporting technical supplements as well as scoping, assessments, and other documents and
spreadsheets can be accessed in the dockets EPA-HQ-QPPT-2018-0436 and EPA-HO-QPPT-2024-
0073. In the draft DINP unreasonable risk determination, EPA has considered COUs with limited
reasonably available information. In general, the Agency makes an unreasonable risk determination
based on risk estimates that have an overall confidence rating of moderate or robust, since those
confidence ratings indicate the scientific evidence is adequate to characterize risk estimates despite
uncertainties or is such that it is unlikely the uncertainties could have a significant effect on the risk
estimates.
If, in the final TSCA risk evaluation for DINP, EPA determines that DINP presents an unreasonable risk
of injury to health or the environment under the COUs, the Agency will initiate risk management
rulemaking to mitigate identified unreasonable risk associated with DINP under the COUs by applying
one or more of the requirements under TSCA section 6(a) to the extent necessary so that DINP no longer
presents such risk. Under TSCA section 6(a), EPA is not limited to regulating the specific COUs found
to contribute significantly to the 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" activities (e.g.,
processing, distribution in commerce) to address downstream activities that contribute significantly to
unreasonable risk (e.g., use)—even if the upstream activities are not contributing significantly 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 EPA-administered authority to protect against such risk pursuant to
TSCA section 9(b), as appropriate.
6.1 Human Health
This assessment provides a risk profile of DINP by presenting a range of estimates (MOEs1) for
different health effects for different COUs. When characterizing the risk to human health from
occupational exposures during risk evaluation under TSCA, EPA conducts baseline assessments of risk
and makes its determination of unreasonable risk from a baseline scenario that does not assume use of
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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respiratory protection or other personal protective equipment (PPE). Making unreasonable risk
determinations based on the baseline scenario should not be viewed as an indication that EPA believes
there are no occupational safety protections in place at any location, or that there is widespread
noncompliance with existing regulations that may be applicable to. Rather, it reflects the Agency's
recognition that unreasonable risk may exist for subpopulations of workers that may be highly exposed
because they are (1) not covered by Occupational Safety and Health Administration (OSHA) standards,
such as self-employed individuals and public sector workers who are not covered by a State Plan or
because their employer is out of compliance with OSHA standards; or (2) because EPA finds
unreasonable risk for purposes of TSCA notwithstanding existing OSHA requirements. In addition,
some risk estimates are based on exposure scenarios with monitoring data that likely reflects existing
requirements, such as those established by OSHA, industry, or sector best practices.
A calculated 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 again
that these calculated risk estimates alone are not bright-line indicators of unreasonable risk. For
example, before determining whether a COU contributed significantly to the unreasonable risk of DINP
due to occupational or consumer exposure, EPA also examined the COU and the exposure scenario to
determine the uncertainties and which risk estimates best represented the contribution from that COU to
the unreasonable risk.
6.1.1 Populations and Exposures EPA Assessed for Human Health
EPA evaluated risk to workers—including ONUs; female workers of reproductive age; 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 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 evaluated risk from inhalation, dermal, and oral-exposure to
consumer users and for relevant COUs (including COUs where children could have dermal exposures
from the products or articles, such as wallpaper), and risk from inhalation exposure to bystanders.
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 draft risk evaluation. Uncertainties for overall exposures and
hazards are presented in this draft risk evaluation and TSDs—including the Draft Consumer and Indoor
Exposure Assessment for Diisononyl Phthalate (DINP), the Draft Environmental Media and General
Population Screening for Diisononyl Phthalate (DINP), and the Environmental Release and
Occupational Exposure Assessment for Diisononyl Phthalate (DINP)—and all are considered in this
preliminary unreasonable risk determination.
6.1.2 Summary of Human Health Effects
EPA is preliminarily determining that the unreasonable risk presented by DINP is due to
• non-cancer effects in workers from inhalation exposures, and
• non-cancer effects in consumers from inhalation exposures.
With respect to health endpoints upon which EPA is basing this preliminary unreasonable risk
determination, the Agency has robust overall confidence in the proposed POD based on fetal testicular
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testosterone for use in characterizing risk from exposure to DINP for acute and intermediate exposure
scenarios. Similarly, EPA has robust overall confidence in the proposed POD based on hepatic outcomes
for use in characterizing risk from exposure to DINP for chronic exposure scenarios. The confidence on
the PODs is described in Section 4.2.
Given the reasonably available information discussed in the risk characterization regarding the
confidence in the cancer risk, EPA did not quantify cancer risk and exposures under the COUs do not
contribute significantly to the unreasonable risk presented by DINP due to cancer.
Table 6-1 and Table 6-2 provide further detail regarding which COUs contribute significantly to the
above risks.
EPA's exposure and overall risk characterization confidence levels are summarized in Section 4.3, with
specific confidence levels presented in Sections 4.3.2.1 (occupational exposure) and 4.3.3.1 (consumer
exposure). Additionally, health risk estimates for workers—including ONUs, consumers, bystanders,
and the general population—can be found in Sections 4.3.2 (workers and ONUs), 4.3.3 (consumers and
bystanders), 4.3.4 (general population), and 4.3.5 (PESS).
EPA also reviewed the weight fractions in products associated with COUs contributing significantly to
unreasonable risk and has determined that a weight fraction of 0.1 percent does not contribute
significantly to the unreasonable risk of DINP to human health. This is consistent with regulation by
U.S. CPSC, who banned the sale, distribution in commerce, or importation into the United States of all
children's toys and child care articles that contain concentrations of more than 0.1 percent DINP (16
CFR part 1307). Similarly, the cutoff value under OSHA Hazard Communication Standard is 0.1
percent (29 CFR 1910.1200).
For context, the weight fractions identified for COUs and scenarios that contributed significantly to
unreasonably risk of DINP are all at least 100-fold higher than 0.1 percent. For industrial use of
adhesives and sealants, weight fractions used were 10 and 40 percent for central tendency and high-end
exposure estimates, respectively, while a weight fraction of 20 percent was selected for the high-end
exposure estimate for the Industrial use of paints and coatings COU. For the one consumer COU that
EPA is determining to contribute to the unreasonable risk of DINP in this risk evaluation, 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), three product use
scenarios were found to contribute significantly to the unreasonable risk of DINP, including carpet
backing, vinyl flooring, and in-place wallpaper. Weight fractions were 16, 25, and 26 percent for high-
intensity use scenarios for carpet backing, vinyl flooring, and in-place wallpaper, respectively.
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 draft risk
evaluation, EPA identified as PESS, people who are expected to have greater exposure to DINP, such as
workers or consumers, women of reproductive age, infants and children who frequently have contact
with consumer products containing high concentrations of DINP, and tribes whose diets include large
amounts of fish. Additionally, the Agency identified population group lifestages that may have greater
susceptibility to the health effects of DINP as PESS: women of reproductive age, pregnant women,
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infants, children, and adolescents. A full PESS analysis can be found in Section 4.3.5 of this draft risk
evaluation.
Risk estimates based on high-end exposure levels (e.g., 95th percentile) are generally intended to cover
individuals with sentinel exposure levels whereas risk estimates at the central tendency exposure are
generally estimates of average or typical exposure. However, EPA was able to calculate risk estimates
for PESS groups in this assessment (e.g., female workers of reproductive age, infants and children). The
use of either central tendency or high-end risk estimates for female workers of reproductive age to make
a determination of unreasonable risk was based on assumptions about the COU based on reasonably
available information about a typical scenario and process within the COU (e.g., non-spray application
versus low- or high-pressure spray application). To make an unreasonable risk determination for
consumers, EPA considered risk estimates for consumers (e.g., infants and children) representing 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 hours vs. 2 hours for high versus 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, EPA 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 in risk estimates when compared to risk estimates from
inhalation alone, since the inhalation exposure is the predominant route of exposure. For consumers,
dermal, oral, and inhalation routes were aggregated. For three consumer COUs, chronic, high-intensity
aggregate risk estimates were below the benchmark of 30. For all other consumer COUs, aggregate risk
estimates did not indicate risk. However, as explained in Section 6.1.5, the aggregate risks are based on
conservative, high intensity use scenarios; therefore, EPA is preliminarily determining that most
consumer uses do not contribute significantly to unreasonable risk. Additional detail about this
preliminary determination for consumer uses is provided in Section 6.1.5 of this unreasonable risk
determination. The uncertainty factor of 30 is based on an interspecies extrapolation to account for the
animal to human extrapolation and to account for human variability or intraspecies extrapolation.
Further information on how EPA characterized sentinel and aggregate risks is provided in Section 4.1.5
while the calculation of the benchmark MOE in described in Section 4.2.
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, EPA
considers acute and intermediate duration exposures during the critical window of development most
relevant for a disruption of androgen action based on reduced fetal testicular testosterone. The Agency
has not yet accounted for its cumulative phthalate risk assessment nor taken into consideration
cumulative phthalate exposure in its risk estimates and in the unreasonable risk determination. More
information on the cumulative risk considerations is provided in Section 4.3.6.
For the following COU, the Agency had limited data available and has assessed the human health risk
contribution from this COU qualitatively. Additional explanation regarding the qualitative assessment is
included in Section 4.3:
• Distribution in commerce.
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6.1.4 Workers
Based on the occupational risk estimates and related risk factors, EPA is preliminarily determining that
the non-cancer risks from worker acute, intermediate, and chronic inhalation exposure to DINP and
worker aggregate exposures to DINP in industrial uses where high-pressure spray applications are used
contribute significantly to the unreasonable risk of DINP.
All occupational COUs were quantitatively assessed, and worker risks were evaluated using the central
tendency, with exception of two industrial COUs (Adhesive and sealant chemicals and Paints and
coatings) for which high-end estimates were used due to the potentially elevated inhalation exposures
from pressurized spray operations. Susceptible populations that may be exposed while working were
accounted for by including risk estimates for female workers of reproductive age (see Table 4-17).
EPA analyzed vapor/mist and/or particulate concentration inhalation exposure in the occupational
scenarios using a time weighted average (TWA) for a typical 8- or 10-hour shift, depending on the OES
(see Table 4-3). Separate estimates of central tendency and high-end exposures were made for male and
female adolescents and adults (>16 years old) workers, female workers of reproductive age, and ONUs.
Dermal exposure in the occupational exposure scenarios was analyzed using the acute potential dose
rate. Dermal exposure for ONUs was assessed for COUs where exposure to DINP is likely to occur via
mist or dust deposited on surfaces. For the COUs assessed, dermal exposure for ONUs was evaluated
using the central tendency estimates for workers as the risk to ONUs are assumed to be equal to or less
than risk to workers who handle materials containing DINP as a part of their job.
Non-cancer risk estimates were calculated from acute, intermediate, and chronic exposures. For most
OESs, acute refers to an exposure time frame of an 8-hour single workday; intermediate refers to an
exposure time frame of 22 workdays, 8 hours per day; and chronic refers to an exposure time frame of
250 days per year for 31 to 40 years, 8 hours per day.
To make a preliminary risk determination, EPA analyzed the individual COUs to determine if the COU
was best represented by central tendency or high-end estimates for workers and ONUs based on the
description of the COU and the parameters and assumptions used in the occupational exposure
scenarios. Risk was not indicated to workers including ONUs for any COU at the high-end or central
tendency for dermal exposure estimates.
There were COUs with MOEs below the benchmark of 30 at the high-end estimates of inhalation
exposure for worker populations. However, the high-end MOEs for some of these COUs represent high-
pressure spray-application, and for other COUs, the high-end MOEs represent total PNOR {i.e., dust)
concentrations that contain a variety of constituents besides DINP. For some COUs, EPA is
preliminarily determining the high-end MOEs represent a high-pressure spray application. The COUs
best represented by high-end MOEs indicating high-pressure spray applications were: Industrial use -
adhesives and sealants, and Industrial use - construction, paint, electrical, and metal products - paints
and coatings (Table 4-17). Therefore, due to the possible use of high-pressure spray application, EPA is
preliminarily concluding that these two COUs contribute significantly to the unreasonable risk to human
health based on the high-end acute, intermediate, and chronic inhalation risk estimates for average male
workers and females of reproductive age. For COUs that had high-end MOEs representing total PNOR
concentrations (45% DINP), EPA is preliminarily determining that these COUs do not contribute
significantly to the unreasonable risk DINP presents to workers due to the uncertainty of the
composition of workplace dust {i.e., the dust may not be comprised solely of PNOR) and is instead
relying on central tendency estimates of the PNOR (10% DINP) to estimate risks to workers.
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As discussed in Section 4.3.2 of this draft risk evaluation, the high-end inhalation exposures for the
COUs associated with spray application are more representative of high-pressure spray applications.
EPA reviewed the percent of DINP in products that were associated with each of these COUs,
uncertainties, and their method of application in processing, industrial, and commercial uses. The
primary limitation of the inhalation risk estimates for these COUs is the lack of DINP-specific
monitoring data. EPA used surrogate monitoring data from the emission scenario document (ESD) on
Coating Application via Spray-Painting in the Automotive Refinishing Industry to estimate inhalation
exposures ("OECD. i ). The ESD served as a source of monitoring data representing the level of
exposure that could be expected at a typical work site for a given spray application method. EPA expects
that the percent of DINP will not vary considerably between products used for processing, industrial,
and commercial uses; only uses that have known pressurized spray applications associated with their use
were represented by the high-end inhalation exposure estimates. EPA is preliminarily concluding that
Industrial uses adhesives - adhesives and sealants and Industrial use - construction paint, electrical, and
metal products - paints and coatings contribute significantly to the unreasonable risk to human health
based on the high-end acute, intermediate, and chronic inhalation exposure estimates for average
workers and females of reproductive age—even though the inhalation and dermal central tendency risk
estimates do not indicate that the COUs contribute significantly to the unreasonable risk. An additional
uncertainty regarding the high-end inhalation risk estimates for these two COUs is whether the
automotive refinishing products in the surrogate data used for estimating inhalation exposure are similar
to DINP-containing adhesives and sealants. Lastly, the inhalation dose-response value used for the
assessment is based on route-to-route extrapolation from oral data, which is an additional source of
uncertainty.
Furthermore, EPA is not determining that other COUs with low-pressure spray applications or non-spray
applications contribute significantly to unreasonable risk at this time. The other COUs assessed are not
generally applied using high-pressure spray applications and high-end inhalation exposures would not
occur. These COUs are in commercial settings and/or where the most likely methods of applications
would be low-pressure spray applications or non-spray applications (e.g., brush, roll, dip, or bead
application). Therefore, the best representation of inhalation exposure for the Commercial use -
construction, paint, electrical, and metal products - paints and coatings as well as Commercial use -
construction, paint, electrical, and metal products - adhesives and sealants COUs are the central
tendency estimates for the spray application scenario (i.e., low-pressure spray application) and both the
high-end and central tendency estimates from the non-spray application scenario, respectively.
For all processing COUs represented by plastics compounding and converting scenarios, inhalation
exposure estimates were based on inhaling dust containing other constituents besides DINP for both
workers and ONUs, and dermal exposures were based on exposure to liquid DINP or DINP mist and
dust on surfaces for workers or ONUs, respectively. As there was uncertainty in the amount of DINP in
dust, EPA concluded that the central tendency estimates are the best representation of inhalation
exposure for these COUs.
For the purposes of the unreasonable risk determination, distribution in commerce of DINP 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. EPA did not calculate risk estimates for the
distribution in commerce COU. Data was not reasonably available for the Agency to determine
environmental releases and exposures (and subsequent general population and environmental receptor
exposures) related to distribution of DINP in commerce as a single OES. Instead, EPA evaluated
distribution in commerce qualitatively. The Agency does not expect distribution in commerce to
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contribute significantly to DINP's unreasonable risk to human health because distribution in commerce
does not generate dust or mist, and DINP's low vapor pressure results in inhalation exposures that are
quite low for workers. EPA expects 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 (see Section 4.3.2). Therefore, EPA is preliminary determining that distribution in commerce
does not contribute significantly to the unreasonable risk presented by DINP.
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, EPA 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 4.3.2.1.
6.1.5 Consumers
Based on the consumer risk estimates and related risk factors, EPA is preliminarily determining that one
consumer use significantly contributes to the unreasonable risk of DINP: 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) due to high-intensity modeling of
inhalation risks to infants, toddlers, and preschoolers. Although EPA considered MOEs that were below
the benchmark for one other consumer COU: Consumer use - construction, paint, electrical, and metal
products - adhesives and sealants, the Agency is preliminary finding that this COU does not contribute
significantly to the unreasonable risk, and more information is provided below.
Consumer and bystander risks representing specific age groups were evaluated for consumer COUs.
Typically, consumers are adults since most products purchased are for adult use or application.
Bystanders would include other adults in the home, as well as children. However, 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;
therefore, all age groups assessed under the indoor dust exposure scenarios are considered users
(consumers) of the articles being assessed. Consumer and bystander populations assessed were infants
(<1 year), toddlers (1-2 years), preschoolers (3-5 years), middle childhood (6-10 years), young teens
(11-15 years), teenagers (16-20 years), and adults (21+ years).
Dermal exposure was evaluated through direct contact with the product or article. Inhalation exposure
was evaluated assuming exposure occurred through the emission of DINP from the product or article.
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 and the U.S. CPSC finalized a ban in 2018 for all remaining articles. EPA
expects that the use of DINP in toys and childcare articles manufactured or processed prior to the bans in
2008 and 2018, respectively, may still be occurring.
Due to the low volatility of DINP, airborne DINP particles released from household items are more
likely to be found on settled and suspended dust and then inhaled or ingested. EPA included the
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ingestion and inhalation of dust for the assessment of six consumer COUs. One of the consumer COUs
included in the indoor dust assessment was found to contribute significantly to the unreasonable risk of
DINP—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—by
estimating the amount of DINP-containing dust that would be generated from indoor articles such as
carpet backing, vinyl flooring, in-place wallpaper, and indoor furniture.
For the consumer COU, 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),
the risk to infants, toddlers, and preschoolers is primarily driven by conservative estimates of chronic
inhalation of DINP and to a lesser extent ingestion of DINP partitioned to surface dust from in-place
wallpaper and vinyl flooring. The conservative high-intensity exposure scenario represents an upper
bound exposure scenario. Additionally, for carpet backing, the aggregation of exposures routes for the
chronic high-intensity exposure scenario for infants resulted in an MOE value of 25 and the chronic
high-intensity exposure scenario for toddlers resulted in an MOE value of 26. The high-intensity model
conservatively assumes that a relatively large surface area of the house is covered with in-place
wallpaper (200 m2), and for vinyl flooring and carpet, the high-intensity model assumed 100 percent of
the house was covered (482 m2). Model parameters for frequency and duration of use were well
understood and representative because CEM default parameters represent actual use patterns and
location of use; the largest source of modeling uncertainty was DINP weight fraction (16, 25, and 26%
for carpet backing, vinyl flooring, and in-place wallpaper, respectively) and dermal absorption of DINP
from solid objects. As explained in this draft unreasonable risk determination, benchmarks are not
bright-line indicators of risk. While conservative approaches were used for estimating risk to infants,
toddlers, and preschoolers, the low MOEs and EPA's confidence in the chronic POD for liver toxicity
(which is relevant for all age groups) and other modeling parameters support making an unreasonable
risk determination based on in-place wallpaper, vinyl flooring, and carpet backing.
For Construction, paint, electrical, and metal products - adhesives and sealants, chronic, high-intensity
aggregate risk estimates were below the benchmark of 30 for young teens (11 to 15 years), teenagers (16
to 20 years), and adults (21+ years). No acute, intermediate (where assessed), or chronic inhalation risk
estimates for bystanders indicated risk for the COUs assessed. Dermal and oral exposures were assessed
for non-cancer risks for consumers only since 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 time frame of 1 day, intermediate refers to an exposure time frame of 30
days, and chronic refers to a time frame of 365 days. Professional judgment and product use descriptions
were used to estimate the intermediate time frame. EPA identified one age group, young teens (11 to 15
years) with aggregate risk from inhalation and dermal exposures to DINP in roofing adhesive. To
estimate aggregate risk to this age group, EPA assumed a young teen would have dermal contact (inside
of two palms) with the adhesive during one large (8-hour) roofing project in 1 year. EPA also 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 since, 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 EPA did not consider the potential for outdoor exposures to be negligible. The
Agency does not consider it reasonable for roofing adhesives to be used indoors for roofing projects, but
if they were, then the inhalation exposures resulting from high intensity indoor use aggregated with
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dermal exposures indicate risk for young teens. However, there is uncertainty from dermal absorption
due to the extrapolation from animal studies to humans. In addition, EPA was not able to quantify the
uncertainty from applying the CEM to outdoor use; therefore, it is unable to quantify the uncertainty
from aggregating conservative risk estimates of inhalation and dermal routes of exposure, resulting in an
aggregate MOE that overestimates the risk. Therefore, EPA is preliminarily determining that the
consumer COU Construction, paint, electrical, and metal products - adhesives and sealants, in an
outdoors or well-ventilated setting, does not contribute significantly to the unreasonable risk of DINP.
Therefore, EPA is preliminarily determining that only one 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), contributes significantly to the
unreasonable risk of DINP.
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. EPA 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 draft
risk evaluation and the Draft Consumer and Indoor Dust Exposure Assessment for Diisononyl Phthalate
(DINP) ( ).
6.1.6 General Population
EPA employed a screening-level approach for general population exposures for DINP. The Agency
evaluated surface water, drinking water, fish ingestion, and ambient air pathways quantitatively, as well
as land pathways {i.e., landfills and application of biosolids) qualitatively (see Section 4.3.4). EPA is
preliminarily determining that the COUs do not contribute significantly to the unreasonable risk of
DINP to the general population, including people living or working near facilities (fenceline
populations) from the ambient air, due to non-cancer risk.
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 and therefore, does not expect there to be
risk to the general population from the land pathway. For further information, see Section 4.1.3.1.
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. Since 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 and the
surface water pathway is not considered to be a pathway of concern to DINP for the general population.
For further information, see Section 4.1.3.1.
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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. EPA evaluated drinking water scenarios that assumed a wastewater
treatment removal efficiency of 98 percent and no further drinking water treatment, as well as a with a
conservative drinking water treatment removal rate of 79 percent. EPA 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 analysis, risk
for non-cancer health effects is not expected for the drinking water pathway and the drinking water
pathway is not considered to be a pathway of concern to DINP for the general population. For further
information, see Section 4.1.3.1.
Risk estimates for fish ingestion generated at concentrations of DINP at the water solubility limit or at
highest measured concentrations in surface water did not indicate risk to tribal populations. 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.
Tribal populations are considered to represent the sentinel exposure scenario. MOEs based on
conservative values, such as surface water concentration from a stormwater catchment area, still resulted
in risk estimates that are above their benchmarks. Therefore, based on this screening-level analysis, fish
ingestion does not contribute significantly to the unreasonable risk for DINP for tribal members,
subsistence fishers, and the general population. For further information, see Section 4.1.3.1.
EPA also considered concentrations of DINP in ambient air and deposition of DINP from air. Inhalation
exposure was not assessed because it is not expected to be a major pathway of exposure to DINP for the
general population and therefore does not contribute significantly to the unreasonable risk. The Agency
used the occupational exposure scenario 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. Therefore, based
on this screening-level analysis, risk for non-cancer health effects is not expected for the ambient air
pathway and the ambient air pathway is not considered to be a pathway of concern to DINP for the
general population. For further information, see Section 4.1.3.1.
In addition, EPA conducted a screening-level analysis of the NHANES biomonitoring data and
considered the U.S. CPSC evaluation of DINP exposures. EPA concluded that the exposures to the
general population via ambient air, surface water, and drinking water identified in this draft risk
evaluation are likely overestimates, since the estimates from individual pathways exceed the total intake
values measured, even at the 95th percentile of the U.S. population for all ages. For further information,
see Section 4.1.3.1.
EPA expects that general population inhalation exposures from distribution in commerce would be even
lower than those for workers. Therefore, the Agency is preliminarily determining that distribution in
commerce does not contribute significantly to the unreasonable risk of DINP due to the injury to health.
EPA has robust confidence in its qualitative assessment of biosolids and landfills. EPA has moderate
confidence in the surface water exposure scenarios that were used to estimate incidental ingestion and
dermal contact, since the estimated environmental releases were slightly biased toward over-estimation.
EPA has slight confidence in its fish ingestion estimates that used the monitored surface water
concentrations. Additionally, EPA has slight confidence in the modeled exposure doses used for
exposure scenarios for soil ingestion and contact. The moderate or slight confidence is based on the
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scenarios not presenting realistic scenarios of DINP exposure, but the exposure estimate capturing high-
end estimates. It is important to note that these confidence conclusions refer to the confidence in the data
quality and numerical accuracy of the underlying data and the resulting model estimates. Further, EPA's
overall confidence that the exposure estimates capture high-end exposure scenarios is robust, and further
refinement of the models is not warranted because risks were not indicated for the pathways with the
highest potential for exposure. Additional information on EPA's confidence in these risk estimates and
their associated uncertainties can be found in Section 4.1.3.1 and the Draft Environmental Media and
General Population Exposure for Diisononyl Phthalate (DINP) ( 024r).
6.2 Environment
Risk of injury to the environment does not contribute significantly to EPA's preliminary determination
of unreasonable risk from DINP. The environmental risk characterization for DINP involved
determining the COUs associated with the highest release estimates to environmental media for a given
pathway and comparing it to the hazard values for aquatic and terrestrial organisms. If the exposure for
the most conservative estimates did not exceed the hazard threshold, it was determined that exposures
due to releases from other COUs would not lead to environmental risk. Under no circumstances did
exposure exceed the hazard threshold for terrestrial mammals. EPA has robust confidence in the
expected lack of risk to aquatic receptors and moderate confidence in the lack of risk to terrestrial
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. A
qualitative analysis of exposure was used because 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, and then COUs
with lower environmental releases would also have lower risk.
EPA expects the main environmental exposure pathway for aquatic species to be releases to surface
water and subsequent deposition to sediment. The Agency also determined the amount of DINP released
to surface water, ambient air, and subsequent deposition to water and sediment, as well as landfills and
subsequent deposition to water and sediment. DINP is not likely to be persistent in groundwater/
subsurface environments unless anoxic conditions exist. As a result, the evidence presented indicates
that 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. 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.
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 a major exposure pathway. Despite no reasonably available
studies of the DINP hazard effects on terrestrial mammals in the literature, a Toxicity Reference Value
(TRV) was derived from laboratory rodent studies to obtain a threshold dose concentration to represent
hazard effects on generic 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 ( Mo). Empirical toxicity data for rats and mice were used to estimate a TRV for
terrestrial mammals at 139 mg/kg-bw/day. EPA expects that DINP has a low bioconcentration and
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biomagnification potential across trophic levels. Under no circumstances did exposure exceed the hazard
threshold for terrestrial mammals.
Although the conservative nature of model outputs resulted in slight confidence for the air releases and
moderate confidence in the modeled water releases, there is robust to moderate confidence that the
modeled environmental media concentrations do not underestimate exposure to ecological receptors and
the risk characterization is protective of the environment, as noted in Table 5-2. EPA has robust
confidence in the reasonably available information of DINP concentrations within surface waters.
However, due to the lack of reasonably available release data for facilities discharging DINP to surface
waters, all releases were modeled.
In general, EPA has an overall robust confidence in the risk characterization for the aquatic assessment.
Studies used for the aquatic environmental hazard assessment consisted of 19 studies with an overall
quality determination of high or medium from the systematic review process. Consistently, no effects
were observed up to the highest DINP concentration tested within all aquatic hazard studies. And
monitoring data from published literature report DINP concentrations within surface water and sediment
lower than the highest NOEC values for different aquatic species. EPA has an overall moderate
confidence in the inputs for the terrestrial risk characterization. EPA assigned an overall quality of high
or medium to 12 toxicity studies used as surrogates for terrestrial mammals. Robust confidence in
hazard was assigned for terrestrial invertebrates due to an earthworm study. Confidence in the chronic
mammalian risk characterization was moderate. EPA has also determined an indeterminate confidence
in chronic avian and terrestrial plant assessments as there is a lack of reasonably available hazard data.
However, the TRV was used for a screening-level trophic transfer analysis. For more information,
please see Section 5.3.3 of this draft risk evaluation and the Draft Environmental Hazard Assessment for
DiisononylPhthalate (DINP) (U.S. EPA. 2024p).
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 is preliminarily identifying:
• 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.
The TRV was used as the hazard threshold for mammals that permitted 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's 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 since, even with conservative assumptions, dietary
DINP exposure concentrations from this analysis are not equal to or greater than the TRV. These results
indicate that DINP has low bioaccumulation potential and will not biomagnify, which has been seen in
previous studies.
EPA expects that environmental releases from distribution in commerce will be similar or less than the
exposure estimates from the COUs evaluated qualitatively, which did not exceed hazard to ecological
receptors; therefore, the Agency has preliminarily determined that distribution in commerce also would
not result in exposures that significantly contribute to the unreasonable risk of DINP.
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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. However, modeling tools and consideration of the physical and chemical properties of
DINP allows EPA to conduct a qualitative assessment. Drinking water treatment removal rates from 79
percent to over 96 percent removal, and even with the use of 79 percent, all drinking water exposures
resulted in minimal human exposure and subsequent risk. 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 drinking water treatment. Therefore, the consumer COUs do not significantly
contribute to the unreasonable risk of DINP due to down-the-drain releases.
6.2.3 Basis for Risk of Injury to the Environment
Based on the draft 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 did not identify risk of injury to the environment that would contribute significantly to the
unreasonable risk determination for DINP. 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 were
varied and are summarized in the Draft Environmental Exposure Assessment for Diisononyl phthalate
(DINP) (U.S. EPA. 2024oY
6.3 Additional Information Regarding the Basis for the Unreasonable Risk
Determination
Table 6-1 summarizes the basis for this draft unreasonable risk determination of injury to human health
and the environment presented in this draft risk evaluation for those COUs with a qualitative 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 draft
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 and
Table 6-2 represent risk at the high-end and central tendency exposure level as discussed in Section 6.1.
See Section 4.3.2 for a summary of risk estimates.
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Table 6-1. Su
pporting Basis for the Draft Risk Determination
'or Human Healt
i (Occupational Conditions of Use)
Life Cycle
Stage
Category
Subcategory
Population
Exposure
Route
Acute Non-
cancer
Intermediate
Non-cancer
Chronic Non-
cancer
Manufacturing
Domestic
manufacturing
Domestic manufacturing
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Aggregate
Importing
Importing
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Aggregate
Processing
Incorporation
in formulation,
mixture, or
reaction
product
Heat stabilizer and processing aid in
basic organic chemical manufacturing
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Aggregate
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])
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Aggregate
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Life Cycle
Stage
Category
Subcategory
Population
Exposure
Route
Acute Non-
cancer
Intermediate
Non-cancer
Chronic Non-
cancer
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
Inhalation
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Life Cycle
Stage
Category
Subcategory
Population
Exposure
Route
Acute Non-
cancer
Intermediate
Non-cancer
Chronic Non-
cancer
Processing
Recycling
Recycling
Reproductive Age
Dermal
Aggregate
ONU
Inhalation
Dermal
Aggregate
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
~
V
V
Dermal
Aggregate
•/
•/
V
Worker: Female of
Reproductive Age
Inhalation
S
•/
V
Dermal
Aggregate
V
V
V
ONU
Inhalation
Dermal
Aggregate
V
Automotive,
fuel,
agriculture,
outdoor use
products
Automotive products, other than fluid
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)
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
Paints and coatings
Worker: Average
Adult Worker
Inhalation
S
S
V
Dermal
Aggregate
V
V
V
Worker: Female of
Inhalation
V
V
V
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Life Cycle
Stage
Category
Subcategory
Population
Exposure
Route
Acute Non-
cancer
Intermediate
Non-cancer
Chronic Non-
cancer
Industrial Use
Construction,
paint, electrical,
and metal
products
Paints and coatings
Reproductive Age
Dermal
Aggregate
~
V
V
ONU
Inhalation
Dermal
Aggregate
Other uses
Hydraulic fluids
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
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
Commercial
Use
Automotive,
fuel,
agriculture,
outdoor use
products
Automotive products, other than fluids
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
Adhesives and sealants
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Inhalation
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Life Cycle
Stage
Category
Subcategory
Population
Exposure
Route
Acute Non-
cancer
Intermediate
Non-cancer
Chronic Non-
cancer
Commercial
Use
Construction,
paint, electrical,
and metal
products
Adhesives and sealants
Reproductive Age
Dermal
Aggregate
ONU
Inhalation
Aggregate
Plasticizer in building/construction
materials (roofing, pool liners, window
shades); construction and building
materials covering large surface areas,
including paper articles; metal articles;
stone, plaster, cement, glass, and ceramic
articles^
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
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
Foam seating and bedding products;
furniture and furnishings including
plastic articles (soft); leather articles
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
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Life Cycle
Stage
Category
Subcategory
Population
Exposure
Route
Acute Non-
cancer
Intermediate
Non-cancer
Chronic Non-
cancer
Commercial
Use
Furnishing,
cleaning,
treatment/care
products
Foam seating and bedding products;
furniture and furnishings including
plastic articles (soft); leather articles
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
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Aggregate
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
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Dermal
Aggregate
Fabric, textile, and leather products
(apparel and footwear care products))
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Dermal
Aggregate
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Life Cycle
Stage
Category
Subcategory
Population
Exposure
Route
Acute Non-
cancer
Intermediate
Non-cancer
Chronic Non-
cancer
Commercial
Use
Packaging,
paper, plastic,
hobby products
Arts, crafts, and hobby materials
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Dermal
Aggregate
Ink, toner, and colorant products
Worker: Average
Adult Worker
Inhalation
Dermal
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
Page 211 of 274
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Life Cycle
Stage
Category
Subcategory
Population
Exposure
Route
Acute Non-
cancer
Intermediate
Non-cancer
Chronic Non-
cancer
Commercial
Use
Packaging,
paper, plastic,
hobby products
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
degreasing)
Solvents (for cleaning or degreasing)
Worker: Average
Adult Worker
Inhalation
Dermal
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
Disposal
Disposal
Disposal
Worker: Average
Adult Worker
Inhalation
Dermal
Aggregate
Worker: Female of
Reproductive Age
Inhalation
Dermal
Aggregate
ONU
Inhalation
Page 212 of 274
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Life Cycle
Stage
Category
Subcategory
Population
Exposure
Route
Acute Non-
cancer
Intermediate
Non-cancer
Chronic Non-
cancer
Dermal
Aggregate
4334
4335
4336
Table 6-2. Supporting Basis for the Draft Risk Determination for Human Health (Consumer Conditions of Use)
Life Cycle
Stage
Category
Subcategory
Product or Article
Population"
Exposure Route
Human Health Effects''
Acute
Non-
cancer
Intermediate
Non-cancer
Chronic
Non-
cancer
Consumer Use
Automotive,
fuel,
agriculture,
outdoor use
products
Automotive
products, other than
fluids
Car Mats
Construction,
paint,
electrical, and
metal products
Adhesives and
sealants
Roofing Adhesives
Consumer:
Young Teen
Aggregate
V
Building
construction
materials (wire and
cable jacketing, wall
coverings, roofing,
pool applications,
etc.)
Roofing Membrane
Electrical and
electronic products
Wire Insulation
Paints and Coatings
Paint/Lacquer
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,
Carpet Backingc
Consumer:
Infant
Inhalation
Aggregate
V
Consumer:
Toddler
Inhalation
Aggregate
V
Vinyl Flooringc
Consumer:
Infant
Inhalation
V
Aggregate
V
Consumer:
Toddler
Inhalation
V
Aggregate
V
Consumer:
Inhalation
V
Page 213 of 274
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Human Health Effects''
Life Cycle
Stage
Category
Subcategory
Product or Article
Population"
Exposure Route
Acute
Non-
cancer
Intermediate
Non-cancer
Chronic
Non-
cancer
textiles and apparel
Preschooler
Aggregate
~
(vinyl tiles, resilient
flooring, PVC-
backed carpeting)
Consumer:
Inhalation
V
Infant
Aggregate
V
Wallpaper (in-place)c
Consumer:
Inhalation
V
Toddler
Aggregate
V
Consumer:
Inhalation
V
Preschooler
Aggregate
V
Furnishing,
cleaning,
treatment/care
products
Foam seating and
bedding products;
furniture and
furnishings
(furniture and
furnishings
including plastic
articles (soft);
leather articles)
Indoor Furniturec
Consumer Use
Air care products
Scented Oil
Fabric, textile, and
leather products
(apparel and
footwear care
products)
Clothing
Arts, crafts, and
hobby materials
Crafting Resin, Rubber
Eraser, Small Articles
with Potential for semi-
routine contact
Packaging,
Ink, toner, and
colorant products
N/A
paper, plastic,
hobby
products
Other articles with
routine direct
contact during
normal use
including rubber
articles; plastic
Shower Curtain; Small
Articles with Potential for
semi-routine contact
Page 214 of 274
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Life Cycle
Stage
Consumer Use
Category
Packaging,
paper, plastic,
hobby
products
Subcategory
Product or Article
Population"
Exposure Route
Human Health Effects''
Acute
Non-
cancer
Intermediate
Non-cancer
Chronic
Non-
cancer
articles (hard): vinyl
tape; flexible tubes;
profiles; hoses
Packaging
(excluding food
packaging),
including rubber
articles plastic
articles (hard);
plastic articles (soft)
Small Articles with
Potential for semi-routine
contact
Toys, playground,
and sporting
equipment
Childrens Toys (legacy
and new) and Sports Mats
Other
Novelty products
Adult Toys
" Only inhalation exposure routes were assessed for bystanders.
h Grayed-out boxes indicate certain exposure routes that were not assessed because it was determined that there was no viable exposure pathway.
c COUs associated with articles included in the indoor environment assessment.
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dicarboxylic acid, 1,2-diisononyl ester, and 1,2-benzenedicarboxylic acid, di-C8-10-branched
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4919 Zeng, F; Cui, K; Xie, Z; Wu, L; Luo, D; Chen, L; Lin, Y; Liu, M; Sun, G. (2009). Distribution of
4920 phthalate esters in urban soils of subtropical city, Guangzhou, China. J Hazard Mater 164: 1171-
4921 1178. http://dx.doi.org/10.1016/i jhazMat.2008.09.029
4922 Zhang, Y; Wang, P; Wang, L; Sun, G; Zhao, J; Zhang, H; Du, N. (2015). The influence of facility
4923 agriculture production on phthalate esters distribution in black soils of northeast China. Sci Total
4924 Environ 506-507: 118-125. http://dx.doi.ore/10.1016/i .scitotenv.201 I 10 0 ^
4925
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4936
4937
4938
4939
4940
4941
4942
4943
4944
4945
4946
4947
4948
4949
4950
4951
4952
4953
4954
4955
4956
4957
4958
4959
4960
4961
4962
4963
4964
4965
4966
4967
4968
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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
CERCLA
Comprehensive Environmental Response, Compensation, and Liability Act
CFR
Code of Federal Regulations
CPSC
Consumer Product Safety Commission
CWA
Clean Water Act
DEHP
Di ethyl hexyl phthalate
DIDP
Diisodecyl phthalate
DINP
Diisononyl phthalate
DIY
Do-it-yourself
DMR
Discharge Monitoring Report
EPA
Environmental Protection Agency (or the Agency)
EPCRA
Emergency Planning and Community Right-to-Know Act
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-observed-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
NEI
National Emissions Inventory
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
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4975
4976
4977
4978
4979
4980
4981
4982
4983
4984
4985
4986
4987
4988
4989
4990
4991
4992
4993
4994
4995
4996
4997
4998
4999
5000
5001
5002
5003
5004
5005
5006
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OCSPP
Office of Chemical Safety and Pollution Prevention
OECD
Organisation for Economic Co-operation and Development
OEL
Occupational exposure limit
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
PECO
Population, exposure, comparator, and outcome
PEL
Permissible exposure limit (OSHA)
PESS
Potentially exposed or susceptible subpopulations
PND
Postnatal day
PNOR
Particulates not otherwise regulated
POD
Point of departure
POTW
Publicly owned treatment works
PPAR.a
Peroxisome proliferator activated receptor alpha
PVC
Polyvinyl chloride
REL
Recommended Exposure Limit
SACC
Science Advisory Committee on Chemicals
SDS
Safety data sheet
SOC
Standard Occupational Classification
SpERC
Specific Emission Release Category
SUSB
Statistics of U.S. Businesses (U.S. Census)
TRI
Toxic Release Inventory
TRV
Toxicity reference value
TSCA
Toxic Substances Control Act
TSD
Technical support document
TWA
Time-weighted average
UF
Uncertainty factor
U.S.
United States
WWTP
Wastewater treatment plant
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
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5007 Appendix B REGULATORY AND ASSESSMENT HISTORY
5008 B.1 Federal Laws and Regulations
5009
5010 Table Apx B-l. Federal Laws and Regulations
Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
1!!' \ 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).
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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
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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).
5011 B.2 State Laws and Regulations
5012
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 § 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 § 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, § 27001).
DINP (CASRN 28553-12-0) is listed as a Candidate Chemical under California's
Safer Consumer Products Program (Health and Safety Code §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)
(European Union Chemical Agency [ECHA] database. Accessed March 1, 2024).
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Country/Organization
Requirements and Restrictions
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).
5017 B.4 Assessment History
5018
5019 Table Apx B-4. Assessment History of DINP
Authoring Organization
Publication
U.S. EPA publications
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
(U.S. EPA. 2005b)
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Authoring Organization
Publication
Other U.S.-based organizations
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)
Ink-rnalional
European Union, European Chemicals Agency (EC] l.\)
( ommittee 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-
branched alkyl esters, C9-rich (Diisononyl Phthalate;
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Authoring Organization
Publication
DINP). Chemical Abstracts Service Registry Numbers:
28553-12-0 and 68515-48-0 (EC/HC. 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 oh thai ate (NICNAS, 2012)
Phthalates hazard compendium: A summary of
physicochemical and human health hazard data for 24
ortho-phthalate chemicals ("NICNAS, 2008)
5020
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5029
5030
5031
5032
5033
5034
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5037
5038
5039
5040
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5042
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5052
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Appendix C LIST OF TECHNICAL SUPPORT DOCUMENTS
Appendix C incudes a list and citations for all supplemental documents included in the Draft 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.
Draft Systematic Review Protocol for Diisononyl Phthalate (DINP) ( ) - 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 Draft 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) (U.S. EPA. 2024f) - 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) (U.S. EPA. 2024d) - 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) (1 c< « i1 \ 2024e) - 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) ( 2024c) - 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. 2024h) - 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.
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5077
5078
5079
5080
5081
5082
5083
5084
5085
5086
5087
5088
5089
5090
5091
5092
5093
5094
5095
5096
5097
5098
5099
5100
5101
5102
5103
5104
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Data Extraction Information for General Population, Consumer, and Environmental Exposure for
Diisononyl Phthalate (DINP) (U.S. EPA. 2024b) - 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) ( 2024i) - 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) ( 20241) - 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)
( 1024&) - 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) ( 024a) - 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.
Draft Physical Chemistry Assessment for Diisononyl Phthalate (DINP) ( I024x).
Draft Fate Assessment for Diisononyl Phthalate (DINP) ( 024t).
Draft Environmental Release and Occupational Exposure Assessment for Diisononyl Phthalate
(DINP) (U.S. EPA. 2024s).
Draft Consumer and Indoor Exposure Assessment for Diisononyl Phthalate (DINP) (U.S. EPA.
2024U.
Draft Environmental Media and General Population Screening for Diisononyl Phthalate (DINP)
( >024r).
Draft Environmental Exposure Assessment for Diisononyl Phthalate (DINP) ( 24o).
Draft Environmental Hazard Assessment for Diisononyl Phthalate (DINP) ( !024p).
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5121
5122
5123
5124
5125
5126
5127
5128
5129
5130
5131
5132
5133
5134
5135
5136
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Draft Non-cancer Human Health Hazard Assessment for Diisononyl Phthalate (DINP) (U.S. EPA.
2024wY
Draft Cancer Human Health Hazard Assessment for Diisononyl Phthalate (DINP) (
2024k).
Draft Consumer Exposure Analysis for Diisononyl Phthalate (DINP) ( 24m).
Draft Consumer Risk Calculator for Diisononyl Phthalate (DINP) ( )24nY
Draft Risk Calculator for Occupational Exposures for Diisononyl Phthalate (DINP) (U.S. EPA.
2024vY
Draft Fish Ingestion Risk Calculator for Diisononyl Phthalate (DINP) ( 024u)
Draft Surface Water Human Exposure Risk Calculator for Diisononyl Phthalate (DINP) for P50
Flow Rates (U.S. EPA. 2024z)
Draft Surface Water Human Exposure Risk Calculator for Diisononyl Phthalate (DINP) for P75
Flow Rates ( Mil)
Draft Surface Water Human Exposure Risk Calculator for Diisononyl Phthalate (DINP) for P90
Flow Rates (U.S. EPA. 2024ab)
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PUBLIC RELEASE DRAFT
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Appendix D UPDATES TO THE DINP CONDITIONS OF USE
TABLE
After the final scope (U.S. EPA.. 2 ), 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, EPA 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.
Table Apx D-l. Additions and Name Changes to Categories and Subcategories of Conditions of
Jse Based on C
)R Reporting and Sta
teholder Engagement
Life Cycle
Stage and
Category
Original Subcategory in
the Final Scope
Document
Occurred Change
Revised Subcategory in the 2024 Draft
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
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Life Cycle
Stage and
Category
Original Subcategory in
the Final Scope
Document
Occurred Change
Revised Subcategory in the 2024 Draft
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])
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Life Cycle
Stage and
Category
Original Subcategory in
the Final Scope
Document
Occurred Change
Revised Subcategory in the 2024 Draft
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])
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Original Subcategory in
Revised Subcategory in the 2024 Draft
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
products, other than fluids
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Stage and
Category
Original Subcategory in
the Final Scope
Document
Occurred Change
Revised Subcategory in the 2024 Draft
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)
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
products, other than fluids
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
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Life Cycle
Stage and
Category
Original Subcategory in
the Final Scope
Document
Occurred Change
Revised Subcategory in the 2024 Draft
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
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Life Cvclc
Original Subcategory in
Revised Subcategory in the 2024 Draft
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); 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.
Consumer use - Other use - Automotive
products, other than fluids
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, etc.)
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Stage and
Category
Original Subcategory in
the Final Scope
Document
Occurred Change
Revised Subcategory in the 2024 Draft
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
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Life Cycle
Stage and
Category
Original Subcategory in
the Final Scope
Document
Occurred Change
Revised Subcategory in the 2024 Draft
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 Products
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 conditions of use, additional comments from stakeholders, and overall systematic review of the
use information.
When developing this draft risk evaluation, EPA concluded that some subcategories of the COUs listed
in the final scope (\ c. < ^ \ AV I h) were redundant and consolidation was needed to avoid evaluation
of the same COU multiple times. EPA 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 draft risk evaluation. Finally, EPA 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 conditions of use, 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 draft RE:
• "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 CEP A-HQ-OPPT-2018-0436-0019). 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 (EPA-HQ-OPPT-2018-0436-0019). 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 products" was added to the draft risk evaluation based on Agency
research into the use of various phthalate in adult sex toys {i.e., novelty products). EPA was
unaware of this use during development of the scope and is therefore adding it during the
development of the draft 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.
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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 EPA identified as the best fit for that submission.
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, 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-C10 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 condition of use 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 condition of use
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, rail cars, tank trucks, and
intermodal tank containers ( >21c). 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).
Examples of CDR Submissions
In the 2016 CDR cycle, 16 CDR companies reported importation of DINP (CASRN 28553-12-0) with
every company importing 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.
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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.
E 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
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
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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).
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
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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-OP
0022. EPA-HQ-QPPT-2018-0436-0032). DINP also is an additive in inks, which are then incorporated
into textiles and articles (EPA-HQ-QPPT-2018-0435-00221
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 ( ? 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).
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
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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.
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 ( aica. 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)
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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.
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 HI ). 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 HPP. ). 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.
E lit1). 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.
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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 - Automotive, Fuel, Agricultural, Outdoor Use
Products - Automotive Products, Other than Fluids
This COU refers to the use of DINP in the automobile manufacturing sector as a component in various
automotive products, other than fluids. 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 products for various industrial uses. The Manufacturer Request for Risk
Evaluation DiisononylPhthalate (DINP) notes that DINP is used in automotive care products; EPA was
unable to identify any specific automotive care products, other than fluids, that contained DINP.
However, the American Chemistry Council'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 COU was not reported in the 2016 or 2020 CDR cycles.
E.12 Industrial Uses - Construction, Paint, Electrical, and Metal Products -
Building/Construction Materials (Roofing, Pool Liners, Window
Shades, Flooring)
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
( \('€ HI i ). 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.
2Id). ACC also notes that DINP can be used in window shades, flooring, roofing, pool liners,
and wall coverings (ACC. 2024).
This COU was not reported in the 2016 or 2020 CDR cycles.
E.13 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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August 2024
According to information provided to EPA, approximately 5 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). 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.14 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 conditions of use.
This use was not reported to EPA in the 2016 or 2020 CDR cycles.
E.15 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
conditions of use.
This use was not reported to EPA in the 2016 or 2020 CDR cycles.
E.16 Commercial Use - Other Use - Automotive Products Other than
Fluids
This COU is referring to the commercial use of DINP in automotive products other than fluids, which
already have DINP incorporated into them. This is a use of DINP-containing automotive products 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.
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
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PUBLIC RELEASE DRAFT
August 2024
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.17 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 5 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 ( 2 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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5614
5615
5616
5617
5618
5619
5620
5621
5622
5623
5624
5625
5626
5627
5628
5629
5630
5631
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PUBLIC RELEASE DRAFT
August 2024
E.18 Commercial Use - Construction, Paint, Electrical, and Metal Products
- Plasticizer in Building/Construction Materials (Roofing, Pool Liners,
Window Shades); 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 (ACC 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).
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.19 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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5659
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5662
5663
5664
5665
5666
5667
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5669
5670
5671
5672
5673
5674
5675
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August 2024
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.20 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 (ACC 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).
EPA also notes that this COU was not reported to the CDR in 2016 or 2020 cycles.
E.21 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 (U.S. EPA. 2 ). 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 (U.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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5708
5709
5710
5711
5712
5713
5714
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5716
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5718
5719
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PUBLIC RELEASE DRAFT
August 2024
E.22 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
(I E021c). 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.23 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 ( >2Id). 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.24 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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5752
5753
5754
5755
5756
5757
5758
5759
5760
5761
5762
5763
5764
5765
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August 2024
EPA understands that DINP has been used in fabric, textile, and leather products including apparel and
footwear products (ACC 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.25 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 (U.S. EPA. 202Id). EPA expects that these
products are likely to be used in both commercial and consumer applications. EPA identified two erasers
which contained DINP ( )21d). 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. EPA notes that weight fractions were
reported in (EC] ) 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.26 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 (\ v < < \ 1 '")• The
Manufacturer Request for Risk Evaluation Diisononyl Phthalate (DINP) lists the use of pigments in its
non-PVC applications (less than 5 percent of DINP use). EPA identified a polyurethane pigment
containing more than 60 percent DINP by weight (\ c. < ^ \ 20 J I
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5798
5799
5800
5801
5802
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5804
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August 2024
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.27 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.28 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 lifecycle.
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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5837
5838
5839
5840
5841
5842
5843
5844
5845
5846
5847
5848
5849
5850
5851
5852
5853
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August 2024
E.29 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.30 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
E 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 ( 202Id). 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.31 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.32 Consumer Use - Other Use - Automotive Care Products, Other Than
Fluids
This COU is referring to the consumer use of DINP in automotive products other than fluids. This COU
includes the use of DINP-containing automotive products in a consumer DIY setting or by consumers
driving a vehicle.
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5886
5887
5888
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5890
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5892
5893
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August 2024
DINP is used in various automotive product 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.33 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 ( 2 Id). The Agency does expect the primary use of these automotive
adhesives and sealants to be industrial/commercial in nature but the possibility for consumer use is still
possible. EPA understands this COU to be consumer use of cars {i.e., driving, and 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 5
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.34 Consumer Use - Construction, Paint, Electrical, and Metal Products -
Building Construction Materials (Wire and Cable Jacketing, Wall
Coverings, Roofing, Pool Applications, 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
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.
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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 (
E 2 Id).
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.35 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 (ACC HPP. ^ ).
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.36 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 (ACC 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
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.
Examples of CDR Submissions
In the 2016 CDR cycle, one company reported the use of DINP (CASRN 28553-12-0) in paints and
coatings.
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August 2024
E.37 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 ( 202Id). The Agency also notes that this COlI 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 level products that contained DINP which would fit under this
COUP S (TSC.l^M ).
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.38 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/bui 1 ding materials that are covering large areas (ACC HPP. 2019).
EPA identified the use of DINP in a product associated with floor matting ( 02Id). 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.
Examples of CDR Submissions
In the 2016 CDR cycle, one company reported the use of DINP (CASRN 28553-12-0) in floor
coverings.
E.39 Consumer Use - Furnishing, Cleaning, Treatment/Care Products -
Air Care Products
This COU is referring to the consumer use of DINP in air care products.
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August 2024
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. EPA
identified at least one commercially available scent for candle manufacturers containing DINP (
21c). 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 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.40 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. 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 (1, c. < ^ \ A National Library of Medicine database
identified DINP use in injection molding for footwear ( 202Id). The manufacturer request
also notes that a 2013 EC HA report identified the use of DINP in skinny leather pants, as well (ACC
19).
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.
E.41 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 ( ). 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 ( ). The Agency anticipates that these erasers would be
used in both commercial and consumer applications.
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PUBLIC RELEASE DRAFT
August 2024
This use was not reported to EPA in the 2016 or 2020 CDR cycles.
E.42 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 (\ v < < \ 1 '")• 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 (ACC H.PP. 2019). 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.43 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 (ACC HPP. ). The National Library of Medicine's database
identified DINP for its use in garden hoses (1 c. 1 i1 \ 202Id).
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.44 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.
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August 2024
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 EPA knows about the use of DINP as a general-purpose plasticizer for PVC and non-PVC
applications, the Agency expects that this use of DINP has been identified under other previously
reported CDR codes. EPA 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.45 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.46 Consumer Use - Other - Novelty Products
This COU is referring to the consumer use of DINP in adult novelty products.
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 DINP in
these products 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 products covered by this COU.
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
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6141 DINP contained in wastewater discharged by consumers or occupational users to a POTW or other, non-
6142 POTW for treatment, as well as other wastes. DINP is expected to be released to other environmental
6143 media, such as introductions of biosolids to soil or migration to water sources, through waste disposal
6144 {e.g., disposal of formulations containing DINP, plastic and rubber products, textiles, and transport
6145 containers). Disposal may also include destruction and removal by incineration (\ v H \ I h).
6146 Additionally, DINP has been identified in EPA's 2016 report, Hydraulic Fracturing for Oil and Gas:
6147 Impacts from the Hydraulic Fracturing Water Cycle on Drinking Water Resources in the United States
6148 ( 36Fb), to be a chemical reported to be detected in produced water, which is
6149 subsequently disposed. Recycling of DINP and DINP containing products is considered a different
6150 COU. Environmental releases from industrial sites are assessed in each COU.
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Appendix F DRAFT OCCUPATIONAL EXPOSURE VALUE
DERIVATION
EPA has calculated a draft 8-hour existing chemical occupational exposure value to summarize the
occupational exposure scenario and sensitive health endpoints into a single value. This calculated draft
value may be used to support risk management efforts for DINP under TSCA section 6(a), 15 U.S.C.
§2605. EPA calculated the draft 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. 1)
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 draft 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 draft 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 draft 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 potentially exposed and susceptible populations (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 draft 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 draft occupational exposure
value. EPA has not separately calculated a draft 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 Draft Occupational Exposure Value Calculations
This appendix presents the calculations used to estimate draft occupational exposure values using inputs
derived in this draft 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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Draft Acute Non-cancer Occupational Exposure Value
The draft 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:
Equation Apx F-l.
HECacute ATHECacute IRresting
gy _ ^^
Benchmark MOEacute ED I ^workers
24/i n£10rm3
3.68 ppm ~T~ 0.6125-i—
* Sir * ¥- = 0-180 ppm
30 8h m3
d i"Zb hr
/mg\ EV ppm * MW 0.180 ppm * 418.6^^ mg
EVacute (m3J Molar Volume 24 45 —^— m3
mol
Draft Intermediate Non-cancer Occupational Exposure Value
The draft 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 HECjntermefljate ^ AThec intermediate^ ^resting
intermediate Benchmark MOfjntermediate ED*EF IRworkers
24/i m3
3.68 ppm — *30d 0.6125-^ mg
= — * -77; * 5— = 0.246 ppm = 4.21 —7
30 22d 1.25^
a hr
Draft Chronic Non-cancer Exposure Value
The draft 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.
gy HECchronjc ^ AT^ec chronic ^ ^resting
chronic Benchmark MOEchronic ED*EF*WY IRworkers
24h 365d n OPm3
1 1 n nm * *40 V*0.6125 , m a
l.lo ppm d v fiy /-> r\ar\a 00
= £2— * —. . 3— = 0.0808 ppm = 1.38 —7
•30 8h 250d „ nrmj "F m3
3U —* *40 v*1.25
d y ' hr
A Thecate = Averaging time for the POD/HEC used for evaluating non-cancer
Where:
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A THECintermediate
A 'I)Ih'J 'chronic
Benchmark M()I\
•acute
Benchmark MOEintermediate =
Benchmark MOEchronic =
EVacute
EVintermediate
E V chronic —
ED
EF
HEC
IR
Molar Volume =
MW
WY
PUBLIC RELEASE DRAFT
August 2024
acute occupational risk based on study conditions and HEC
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/m (see equation associated with the EVacute calculation)
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