EPA Document# EPA-740-R-20-017
August 2020
FPA United Statcs Office of Chemical Safety and
!¦¦¦ Environmental Protection Agency Pollution Prevention
Final Scope of the Risk Evaluation for
Di-ethylhexyl Phthalate
(1,2-Benzenedicarboxylic acid, l,2-bis(2-ethylhexyl) ester)
CASRN 117-81-7
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August 2020
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TABLE OF CONTENTS
ACKNOWLEDGEMENTS 7
ABBREVIATIONS AND ACRONYMS 8
EXECUTIVE SUMMARY 11
1 INTRODUCTION 14
2 SCOPE OF THE EVALUATION 14
2.1 Reasonably Available Information 14
2.1.1 Search of Gray Literature 15
2.1.2 Search of Literature from Publicly Available Databases (Peer-reviewed Literature) 16
2.1.3 Search of TSCA Submissions 25
2.2 Conditions of Use 26
2.2.1 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation 27
2.2.2 Activities Excluded from the Scope of the Risk Evaluation 31
2.2.3 Production Volume 33
2.2.4 Overview of Conditions of Use and Lifecyle Diagram 33
2.3 Exposures 35
2.3.1 Physical and Chemical Properties 35
2.3.2 Environmental Fate and Transport 37
2.3.3 Releases to the Environment 37
2.3.4 Environmental Exposures 39
2.3.5 Occupational Exposures 40
2.3.6 Consumer Exposures 41
2.3.7 General Population Exposures 41
2.4 Hazards (Effects) 42
2.4.1 Environmental Hazards 42
2.4.2 Human Health Hazards 42
2.5 Potentially Exposed or Susceptible Subpopulations 43
2.6 Conceptual Models 43
2.6.1 Conceptual Model for Industrial and Commercial Activities and Uses: Potential Exposures
and Hazards 43
2.6.2 Conceptual Model for Consumer Activities and Uses 46
2.6.3 Conceptual Model for Environmental Releases and Wastes: Potential Exposures and
Hazards (Regulatory Overlay) 48
2.6.3.1 Exposure Pathways and Risks Addressed by Other EPA Administered Statutes 50
2.6.3.2 Conceptual Model for Environmental Releases and Wastes: Potential Exposures and
Hazards 58
2.7 Analysis Plan 60
2.7.1 Physical and Chemical Properties and Environmental Fate 60
2.7.2 Exposure 61
2.7.2.1 Environmental Releases 61
2.7.2.2 Environmental Exposures 63
2.7.2.3 Occupational Exposures 64
2.7.2.4 Consumer Exposures 66
2.7.2.5 General Population 67
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2.7.3 Hazards (Effects) 68
2.7.3.1 Environmental Hazards 68
2.7.3.2 Human Health Hazards 69
2.7.4 Summary of Risk Approaches for Characterization 71
2.8 Peer Review 72
REFERENCES 73
APPENDICES 82
Appendix A ABBREVIATED METHODS FOR SEARCHING AND SCREENING 82
A. 1 Literature Search of Publicly Available Databases....... 82
A. 1.1 Search Term Genesis and Chemical Verification 82
A. 1.2 Publicly Available Database Searches 83
A. 1.2.1 Query Strings for the Publicly Available Database Searches on Di-ethylhexyl Phthalate
83
A. 1.2.2 Data Prioritization for Environmental Hazard, Human Health Hazard, Fate and Physical
Chemistry 97
A. 1.2.3 Data Prioritization for Occupational Exposures and Environmental Releases and
General Population, Consumer and Environmental Exposures 97
A.2 Peer-Reviewed Screening Process ......97
A.2.1 Inclusion/Exclusion Criteria 98
A.2.1.1 PECO for Environmental and Human Health Hazards 98
A.2.1.2 PECO for Consumer, Environmental, and General Population Exposures 101
A.2.1.3 RESO for Occupational Exposure and Environmental Releases 102
A.2.1.4 PESO for Fate and Transport 104
A.2.1.5 Generation of Hazard Heat Maps 106
A.3 Gray Literature Search and Screening Strategies.... .....107
A.3.1 Screening of Gray Literature 107
A.3.2 Initial Screening of Sources using Decision Logic Tree 108
A.3.3 TSCA Submission Searching and Title Screening 109
A.3.4 Gray Literature Search Results for Di-ethylhexyl phthalate 110
Appendix B PHYSICAL AND CHEMICAL INFORMATION OF DI-ETHYLHEXYL
PHTHALATE 114
Appendix C ENVIRONMENTAL FATE AND TRANSPORT PROPERTIES 115
Appendix D REGULATORY HISTORY 117
D.l Federal Laws and Regulations ........117
D.2 State Laws and Regulations 123
D.3 International Laws and Regulations............................... ...................125
Appendix E PROCESS, RELEASE AND OCCUPATIONAL EXPOSURE INFORMATION 128
E.l Process Information 128
E. 1.1 Manufacture (Including Import) 128
E.l. 1.1 Domestic Manufacturing 128
E.l. 1.2 Import 128
E. 1.2 Processing and Distribution 128
E. 1.2.1 Processing as a Reactant 128
E. 1.2.2 Incorporated into a Formulation, Mixture or Reaction Product 129
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E. 1.2.3 Incorporated into an Article 129
E. 1.2.4 Repackaging 129
E.l.2.5 Recycling 129
E.1.3 Uses 129
E. 1.3.1 Adhesives, Sealants, Paints, and Coatings 129
E.1.3.2 Automotive Products 130
E.1.3.3 Building/Construction Materials Not Covered Elsewhere 130
E.1.3.4 Plastic and Rubber Products 130
E.1.3.5 Other Uses 130
E.1.4 Disposal 131
E.2 Preliminary Occupational Exposure Data 131
Appendix F SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR INDUSTRIAL
AND COMMERCIAL ACTIVITIES AND USES 133
Appendix G SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR CONSUMER
ACTIVITIES AND USES 141
Appendix H In SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR
ENVIRONMENTAL RELEASES AND WASTES 147
LIST OF TABLES
Table 2-1. Results of Title Screening of Submissions to EPA under Various Sections of TSCAa 26
Table 2-2. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation 27
Table 2-3. Physical and Chemical Properties of Di-ethylhexyl Phthalate 35
Table 2-4. Summary of Di-ethylhexyl Phthalate Production-Related Waste Managed in 2018 38
Table 2-5. Summary of Releases of Di-ethylhexyl Phthalate to the Environment During 2018 39
Table 2-6. Categories and Sources of Environmental Release Data 61
Table 2-7. Potential Sources of Occupational Exposure Data 64
LIST OF FIGURES
Figure 2-1. Gray Literature Tags by Discipline for Di-ethylhexyl Phthalate 16
Figure 2-2. Peer-reviewed Literature Inventory Tree - Physical and chemical Properties Search Results
for Di-ethylhexyl Phthalate 17
Figure 2-3. Peer-reviewed Literature Inventory Tree - Fate and Transport Search Results for Di-
ethylhexyl Phthalate 18
Figure 2-4. Peer-reviewed Literature Inventory Heat Map - Fate and Transport Search Results for Di-
ethylhexyl Phthalate 19
Figure 2-5. Peer-reviewed Literature Inventory Tree - Engineering Search Results for Di-ethylhexyl
Phthalate 20
Figure 2-6. Peer-reviewed Literature Inventory Heat Map - Engineering Search Results for Di-
ethylhexyl Phthalate 21
Figure 2-7. Peer-reviewed Literature Inventory Tree - Exposure Search Results for Di-ethylhexyl
Phthalate 22
Figure 2-8. Peer-reviewed and Gray Literature Inventory Heat Map - Exposure Search Results for Di-
ethylhexyl Phthalate 23
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Figure 2-9. Peer-reviewed Literature Inventory Tree - Human Health and Environmental Hazard Search
Results for Di-ethylhexyl Phthalate 24
Figure 2-10. Peer-reviewed Literature Inventory Map - Human Health and Environmental Hazards
Search Results for Di-ethylhexyl phthalate 25
Figure 2-11. Di-ethylhexyl Phthalate Life Cycle Diagram 34
Figure 2-12. Box and Whisker Plots of Reported Physical and Chemical Property Values 37
Figure 2-13. Di-ethylhexyl Phthalate Conceptual Model for Industrial and Commercial Activities and
Uses: Worker and Occupational Non-User Exposures and Hazards 45
Figure 2-14. Di-ethylhexyl Phthalate Conceptual Model for Consumer Activities and Uses: Consumer
Exposures and Hazards 47
Figure 2-15. Di-ethylhexyl Phthalate Conceptual Model for Environmental Releases and Wastes:
Environmental and General Population Exposures and Hazards (Regulatory Overlay).. 49
Figure 2-16. Di-ethylhexyl Phthalate Conceptual Model for Environmental Releases and Wastes:
Environmental Exposures and Hazards 59
LIST OF APPENDIX TABLES
Table_Apx A-l. Sources of Verification for Chemical Names and Structures 82
TableApx A-2. Summary of Data Sources, Search Dates and Number of Peer-Reviewed Literature
Search Results for Di-ethylhexyl Phthalate (DEHP) 84
Table Apx A-3. Hazards Title and Abstract and Full-text PECO Criteria for Di-ethylhexyl Phthalate.. 99
TableApx A-4. Major Categories of Potentially Relevant Supplemental Materials for Di-ethylhexyl
Phthalate 100
Table Apx A-5. Generic Inclusion Criteria for the Data Sources Reporting Exposure Data on General
Population, Consumers and Environmental Receptors 101
Table Apx A-6. Pathways Identified as Supplemental for Di-ethylhexyl Phthalatea 102
Table Apx A-7. Inclusion Criteria for Data Sources Reporting Engineering and Occupational Exposure
Data 102
Table Apx A-8. Engineering, Environmental Release and Occupational Data Necessary to Develop the
Environmental Release and Occupational Exposure Assessments 103
Table Apx A-9. Inclusion Criteria for Data or Information Sources Reporting Environmental Fate and
Transport Data 104
Table Apx A-10. Fate Endpoints and Associated Processes, Media and Exposure Pathways Considered
in the Development of the Environmental Fate Assessment 106
Table_Apx A-l 1. Decision Logic Tree Overview 108
Table Apx A-12. Gray Literature Sources that Yielded Results for Di-ethylhexyl Phthalate 110
Table Apx B-l. Summary Statistics for Reviewed Physical Properties 114
TableApx C-l. Environmental Fate and Transport Properties of Di-ethylhexyl Phthalate 115
Table_Apx D-l. Federal Laws and Regulations 117
Table_Apx D-2. State Laws and Regulations 123
Table Apx D-3. Regulatory Actions by other Governments, Tribes, and International Agreements.... 125
Table Apx E-l. Summary of NIOSH HHEs with Monitoring for Di-ethylhexyl Phthalatea 131
Table Apx E-2. Summary of Industry Sectors with Di-ethylhexyl Phthalate Monitoring Samples
Available from OSHA Inspections Conducted Between 2010 and 2019 132
Table Apx F-l. Worker and Occupational Non-User Exposure Conceptual Model Supporting Table 133
Table Apx G-l. Consumer Exposure Conceptual Model Supporting Table 141
Table Apx H-l. General Population and Environmental Exposure Conceptual Model Supporting Table
147
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LIST OF APPENDIX FIGURES
Figure Apx A-l. Decision Logic Tree Used to Screen Gray Literature Results 108
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ACKNOWLEDGEMENTS
This report was developed by the United States Environmental Protection Agency (U.S. EPA), Office of
Chemical Safety and Pollution Prevention (OCSPP), Office of Pollution Prevention and Toxics (OPPT).
Acknowledgements
The OPPT Assessment Team gratefully acknowledges participation or input from intra-agency
reviewers that included multiple offices within EPA, inter-agency reviewers that included multiple
federal agencies, and assistance from EPA contractors GDIT (Contract No. HHSN316201200013W),
ERG (Contract No. EP-W-12-006), Versar (Contract No. EP-W-17-006), ICF (Contract No.
68HERC19D0003), Abt Associates (Contract No. EP-W-16-009) and SRC (Contract No.
68HERH19F0213). EPA also acknowledges the contributions of technical experts from EPA's Office of
Research and Development.
Docket
Supporting information can be found in public docket: [Docket ID: EPA-HQ-OPPT-2018-04331.
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.
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ABBREVIATIONS AND ACRONYMS
ACGIH
American Conference of Governmental Industrial Hygienists
ADME
Absorption, Distribution, Metabolism, and Excretion
AT SDR
Agency for Toxic Substances and Disease Registry
AWQC
Ambient Water Quality Criteria
BAF
Bioaccumulation Factor
BBP
Butylbenzyl Phthalate
BCF
Bioconcentration Factor
BMF
Biomagnification Factor
BP
Boiling point
BW
Body weight
CAA
Clean Air Act
CASRN
Chemical Abstracts Service Registry Number
CBI
Confidential Business Information
CDR
Chemical Data Reporting
CEHD
Chemical Exposure Health Data
CERCLA
Comprehensive Environmental Response, Compensation and Liability Act
CFR
Code of Federal Regulations
COC
Concentration of Concern
CPCat
Chemical and Product Categories
CPSC
Consumer Product Safety Commission
CPSIA
Consumer Product Safety Improvement Act
CSCL
Chemical Substances Control Law
CWA
Clean Water Act
DC HP
Dicyclohexyl Phthalate
DEHP
Di-ethylhexyl Phthalate
DIBP
Di-isobutyl Phthalate
DINP
Di-isononyl Phthalate
DHEXP
Di-n-hexyl Phthalate
DPENP
Di-n-pentyl Phthalate
DMR
Discharge Monitoring Report
EC
Engineering Controls
ECx
Effective Concentration
ECHA
European Chemicals Agency
EPA
Environmental Protection Agency
EPCRA
Emergency Planning and Community Right-to-Know Act
ERG
Eastern Research Group
ESD
Emission Scenario Document
EU
European Union
FDA
Food and Drug Administration
FFDCA
Federal Food, Drug and Cosmetic Act
FIFRA
Federal Insecticide, Fungicide, and Rodenticide Act
FR
Federal Register
GACT
Generally Available Control Technology
GDIT
General Dynamics Information Technology
GESTIS
International Occupational Exposure Limit Database
GS
Generic Scenario
HAP
Hazardous Air Pollutant
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Hg
HHE
HMTA
HSDB
ICF
IDLH
IECCU
ILO
IMAP
ISHA
JECFA
KOECT
Koc
Kow
LCx
LOAEL
LOEC
MACT
MCL
MCLG
MOA
MP
MSW
NAICS
NEI
NESHAP
NICNAS
NIOSH
NLM
NOAEL
NOEC
NPDES
NPDWR
NPL
NPRI
NTP
OCSPP
OECD
OEL
ONU
OPPT
OSHA
PBPK
PBT
PECO
PEL
PESO
Mercury
Health Hazard Evaluation
Hazardous Materials Transportation Act
Hazardous Substances Data Bank
ICF is a global consulting services company
Immediately Dangerous to Life and Health
Indoor Environmental Concentrations in Buildings with Conditioned and Unconditioned
Zones
International Labour Organization
Inventory Multi-Tiered Assessment and Prioritisation (Australia)
Industrial Safety and Health Act
Joint Expert Committee on Food Additives
Kirk-Othmer Encyclopedia of Chemical Technology
Organic Carbon: Water Partition Coefficient
Octanol: Water Partition Coefficient
Lethal Concentration
Lowest Observed Adverse Effect Level
Lowest Observed Effect Concentration
Maximum Achievable Control Technology
Maximum Contaminant Level
Maximum Contaminant Level Goal
Mode of Action
Melting point
Municipal Solid Waste
North American Industry Classification System
National Emissions Inventory
National Emission Standards for Hazardous Air Pollutants
National Industrial Chemicals Notification and Assessment Scheme (Australia)
National Institute for Occupational Safety and Health
National Library of Medicine
No Observed Adverse Effect Level
No Observed Effect Concentration
National Pollutant Discharge Elimination System
National Primary Drinking Water Regulations
National Priorities List
National Pollutant Release Inventory
National Toxicology Program
Office of Chemical Safety and Pollution Prevention
Organisation for Economic Co-operation and Development
Occupational Exposure Limit
Occupational Non-User
Office of Pollution Prevention and Toxics
Occupational Safety and Health Administration
Physiologically Based Pharmacokinetic
Persistent, Bioaccumulative, Toxic
Population, Exposure, Comparator and Outcome
Permissible Exposure Limit
Pathways and Processes, Exposure, Setting or Scenario, and Outcomes
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PESS
Potentially Exposed or Susceptible Populations
POD
Point of Departure
POTW
Publicly Owned Treatment Works
PPE
Personal Protective Equipment
PVC
Polyvinyl chloride
RCRA
Resource Conservation and Recovery Act
REACH
Registration, Evaluation, Authorisation and Restriction of Chemicals (European Union)
REL
Recommended Exposure Limit
RESO
Receptors, Exposure, Setting or Scenario, and Outcomes
RIVM
Dutch Risk Assessment Agency
RQ
Risk Quotient
SARA
Superfund Amendments and Reauthorization Act
SDS
Safety Data Sheet
SDWA
Safe Drinking Water Act
SOC
Synthetic Organic Chemical
SRC
SRC Inc., formerly Syracuse Research Corporation
STEL
Short-term Exposure Limit
STORET
STORage and RETrieval (water quality data warehouse)
SVHC
Substance of Very High Concern
TIAB
Title and Abstract
TBD
To be determined
TLV
Threshold Limit Value
TMF
Trophic Magnification Factors
TRI
Toxic Release Inventory
TSCA
Toxic Substances Control Act
TTO
Total Toxic Organics
TURA
Toxics Use Reduction Act (Massachusetts)
TWA
Time-weighted average
VOC
Volatile Organic Compound
VP
Vapor Pressure
WHO
World Health Organization
WQX
Water Quality Exchange
WS
Water solubility
WWT
Wastewater Treatment
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EXECUTIVE SUMMARY
In December 2019, EPA designated di-ethylhexyl phthalate (CASRN 117-81-7) as a high-priority
substance for risk evaluation following the prioritization process as required by Section 6(b) of the
Toxic Substances Control Act (TSCA) and implementing regulations (40 CFR part 702) (Docket ID:
EP A-HQ-OPPT~2C ). The first step of the risk evaluation process is the development of the draft
scope document. EPA published the Draft Scope of the Risk Evaluation for Di-ethylhexyl Phthalate
CASRN 117-81-7 (EPA Document No. EPA-740-D-20-017) (U.S. EPA 2020c) and provided a 45-day
comment period on the draft scope per 40 CFR 702.41(c)(7). EPA has considered comments received
(Docket ID: EP A-HQ-OPPT-2018-043 3) during the public comment period to inform the development
of this final scope document, and public comments received will continue to inform the development of
the risk evaluation for di-ethylhexyl phthalate. This document fulfills the TSCA requirement to issue a
final scope document per TSCA Section 6(b)(4)(D) and as described in 40 CFR 702.41(c)(8). The scope
for di-ethylhexyl phthalate includes the following information: the conditions of use, potentially exposed
or susceptible subpopulations (PESS), hazards, and exposures that EPA plans to consider in the risk
evaluation, along with a description of the reasonably available information, conceptual model, analysis
plan and science approaches, and plan for peer review for this chemical substance.
General Information. Di-ethylhexyl phthalate is a colorless liquid with almost no odor. It does not
dissolve in water or evaporate easily and attaches strongly to soil particles.
Reasonably Available Information. EPA leveraged the data and information sources already described
in the Proposed Designation of Di-ethylhexyl phthalate (CASRN 117-81-7) as a High-Priority Substance
for Risk Evaluation ( e) to inform the development of this scope document. Furthermore,
EPA conducted a comprehensive search to identify and screen multiple evidence streams {i.e.,
chemistry, fate, release and engineering, exposure, hazard), and the search and screening results are
provided in Section 2.1. EPA used the systematic review process described in Appendix A to search for
and screen reasonably available information, including information already in EPA's possession, for
inclusion in the risk evaluation. This information includes the hazards, exposures, PESS, and conditions
of use that may help inform the risk evaluation di-ethylhexyl phthalate. EPA has focused on the data
collection phase (consisting of data search, data screening, and data extraction) during the preparation of
the scope document, whereas the data evaluation and integration stages will occur during the
development of the risk evaluation and thus are not part of the scoping activities described in this
document. EPA will consider additional information identified following publication of this scope
document, as appropriate, in developing the risk evaluation, including the Chemical Data Reporting
(CDR) information that the Agency will receive by the end of November 2020.
Conditions of Use. EPA plans to evaluate manufacturing (including importing); processing; distribution
in commerce; industrial, commercial and consumer uses; and disposal of di-ethylhexyl phthalate in the
risk evaluation. Di-ethylhexyl phthalate is manufactured (including imported) within the United States
as well as imported into the United States. The chemical is processed as a reactant, incorporated into
formulation, mixture, or reaction products, and incorporated into articles. The identified processing
activities also include the repackaging and recycling of di-ethylhexyl phthalate. EPA revised the
conditions of use in the final scope of the risk evaluation based on additional information and public
comments (Docket ID: EP A-HQ-OPPT-2018-043 3) on the draft scope document for di-ethylhexyl
phthalate. Section 2.2 provides details about the conditions of use within the scope of the risk
evaluation.
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Conceptual Model The conceptual models for di-ethylhexyl phthalate are presented in Section 2.6.
Conceptual models are graphical depictions of the actual or predicted relationships of conditions of use,
exposure pathways (e.g., media), exposure routes (e.g., inhalation, dermal, oral), hazards and receptors
throughout the life cycle of the chemical substance. EPA considered reasonably available information as
well as public comments received on the draft scope document for di-ethylhexyl phthalate in finalizing
the exposure pathways, exposure routes, and hazards EPA plans to evaluate in the risk evaluation. As a
result, EPA plans to focus the risk evaluation for di-ethylhexyl phthalate on the following exposures,
hazards and receptors:
• Exposures (Pathways and Routes), Receptors and PESS. EPA plans to evaluate releases to the
environment as well as human and environmental exposures resulting from the conditions of use
of di-ethylhexyl phthalate that EPA plans to consider in the risk evaluation. Exposures for di-
ethylhexyl phthalate are discussed in Section 2.3. Additional information gathered through the
results of systematic review searches will also inform expected exposures.
EPA's plan for evaluating environmental exposure pathways in the scope of the risk evaluation
considers whether and how other EPA administered statutes and regulatory cover di-ethylhexyl
phthalate in media pathways falling under the jurisdiction of those authorities. Section 2.6.3.1
discusses those pathways under the jurisdiction of other EPA-administered laws. In Section
2.6.3.2, EPA presents the conceptual model describing the identified exposures (pathways and
routes), receptors and hazards associated with the conditions of use of di-ethylhexyl phthalate
within the scope of the risk evaluation. Based on pathways under the jurisdiction of other EPA-
administered laws, EPA does not plan to evaluate the general population as a receptor in the
scope of the risk evaluation (see Figure 2-16).
EPA considered reasonably available information and comments received on the draft scope for
ethylhexyl phthalate in determining the human and environmental exposure pathways, routes,
receptors and PESS for inclusion in the final scope. EPA plans to evaluate the following human
and environmental exposure pathways, routes, receptors and PESS in the scope of the risk
evaluation:
- Occupational exposure: EPA plans to evaluate exposures to workers and occupational
non-users (ONUs) via the inhalation route and exposures to workers via the dermal route
associated with manufacturing, processing, use, and disposal of di-ethylhexyl phthalate.
EPA plans to analyze dermal exposure for workers and ONUs to mists and dust that
deposit on surfaces.
- Consumer and bystander exposure: EPA plans to evaluate oral, inhalation and dermal
exposure routes to di-ethylhexyl phthalate for consumers and bystanders from the use
and/or handling of consumer adhesives and sealants, arts, crafts and hobby materials;
automotive care products; building/construction materials; electrical and electronic
products; fabric, textile and leather products, furniture and furnishings; ink, toner and
colorant products; lawn and garden care products; paints and coatings; plastic and rubber
products and toys, playground and sporting equipment; and mouthing of products/articles
containing ethylhexyl phthalate for consumers.
- PESS: EPA plans to evaluate children, women of reproductive age (e.g., pregnant
women), workers, and consumers as receptors and PESS in the risk evaluation.
- Environmental exposure: EPA plans to evaluate exposure to di-ethylhexyl phthalate for
aquatic receptors.
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• Hazards. Hazards for di-ethylhexyl phthalate are discussed in Section 2.4. EPA completed
preliminary reviews of information (e.g., federal and international government chemical
assessments) to identify potential environmental and human health hazards for di-ethylhexyl
phthalate as part of the prioritization (U.S. EPA. 2019e) and scoping process ( )2Qc).
EPA also considered reasonably available information collected through systematic review
methods as outlined in Appendix A and public comments received on the draft scope for di-
ethylhexyl phthalate in determining the broad categories of environmental and human health
hazard effects to be evaluated in the risk evaluation. EPA plans to use systematic review methods
to evaluate the epidemiological and toxicological literature for di-ethylhexyl phthalate.
EPA plans to evaluate all potential environmental and human health hazard effects identified for
di-ethylhexyl phthalate in Sections 2.4.1 and 2.4.2, respectively. Identified through the data
screening phase of systematic review, potential environmental hazard effects and related
information that EPA plans to consider for the risk evaluation include: ADME, PBPK, cancer,
cardiovascular, developmental, endocrine, gastrointestinal, hematological and immune, hepatic,
mortality, musculoskeletal, neurological, nutritional and metabolic, ocular and sensory, renal,
reproductive, respiratory and skin and connective tissue for di-ethylhexyl phthalate. Similarly,
the potential human health hazard effects and related information identified through
prioritization and the data screening phase of systematic review for di-ethylhexyl phthalate that
EPA plans to consider for the risk evaluation include: ADME, PBPK, cancer, cardiovascular,
developmental, endocrine, gastrointestinal, hematological and immune, hepatic, mortality,
musculoskeletal, neurological, nutritional and metabolic, ocular and sensory, renal, reproductive,
respiratory and skin and connective tissue.
Analysis Plan. The analysis plan for di-ethylhexyl phthalate is presented in Section 2.7. The analysis
plan outlines the general science approaches that EPA plans to use for the various evidence streams (i.e.,
chemistry, fate, release and engineering, exposure, hazard) supporting the risk evaluation. The analysis
plan is based on EPA's knowledge of di-ethylhexyl phthalate to date which includes a, review of
identified information as described in Section 2.1. Should additional data or approaches become
reasonably available, EPA may consider them for the risk evaluation.
Peer Review. The draft risk evaluation for di-ethylhexyl phthalate will be peer reviewed. Peer review
will be conducted in accordance with relevant and applicable methods for chemical risk evaluations,
including using EPA's Peer Review Handbook (U.S. EPA. 2015b) and other methods consistent with
Section 26 of TSCA (see 40 CFR 702.45).
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1 INTRODUCTION
This document presents the scope of the risk evaluation to be conducted for di-ethylhexyl phthalate
under the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The Frank R. Lautenberg
Chemical Safety for the 21st Century Act amended TSCA on June 22, 2016. The new law includes
statutory requirements and deadlines for actions related to conducting risk evaluations of existing
chemicals.
Under TSCA § 6(b), the Environmental Protection Agency (EPA) must designate chemical substances
as high-priority substances for risk evaluation or low-priority substances for which risk evaluations are
not warranted at the time, and upon designating a chemical substance as a high-priority substance,
initiate a risk evaluation on the substance. TSCA § 6(b)(4) directs EPA to conduct risk evaluations for
existing chemicals, to "determine whether a chemical substance presents an unreasonable risk of injury
to health or the environment, without consideration of costs or other nonrisk 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 § 6(b)(4)(D) and implementing regulations require that EPA publish the scope of the risk
evaluation to be conducted, including the hazards, exposures, conditions of use and PESS that the
Administrator expects to consider, within 6 months after the initiation of a risk evaluation. In addition, a
draft scope is to be published pursuant to 40 CFR 702.41. In December 2019, EPA published a list of 20
chemical substances that have been designated high priority substances for risk evaluations (Docket ID:
EPA-HO-OPPT-2019-013 n (84 FR 71924, December 30, 2019), as required by TSCA § 6(b)(2)(B),
which initiated the risk evaluation process for those chemical substances. Di-ethylhexyl phthalate is one
of the chemicals designated as a high priority substance for risk evaluation. On April 9, 2020, EPA
published the Draft Scope of the Risk Evaluation for Di-ethylhexyl Phthalate (EPA Document No. 740-
D-20-017) (85 FR 22733, April 23, 2020) ( 02.0c) for a 45-day public comment period. After
reviewing and considering the public comments (Docket ID: EPA-HQ-OPPT-2018-0433) received on
the draft scope document, EPA is now publishing this final scope document pursuant to 40 CFR
702.41(c)(8).
2 SCOPE OF THE EVALUATION
2.1 Reasonably Available Information
EPA conducted a comprehensive search for reasonably available information1 to support the
development of this final scope document for di-ethylhexyl phthalate. EPA leveraged the data and
information sources already identified in the documents supporting the chemical substance's high-
priority substance designation. In addition, EPA searched for additional data and information on
physical and chemical properties, environmental fate, engineering, exposure, environmental and human
health hazards that could be obtained from the following general categories of sources:
1. Databases containing publicly available, peer-reviewed literature;
1 Reasonably available information means information that EPA possesses or can reasonably generate, obtain, and synthesize
for use in risk evaluations, considering the deadlines specified in TSCA Section 6(b)(4)(G) for completing such evaluation.
Information that meets the terms of the preceding sentence is reasonably available information whether or not the information
is confidential business information, that is protected from public disclosure under TSCA Section 14 (40 CFR 702.33).
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2. Gray literature, which is defined as the broad category of data/information sources not found in
standard, peer-reviewed literature databases;
3. Data and information submitted under TSCA Sections 4, 5, 8(e), and 8(d), as well as "for your
information" (FYI) submissions.
Following the comprehensive search, EPA performed a title and abstract screening to identify
information potentially relevant for the risk evaluation process. This step also classified the references
into useful categories or tags to facilitate the sorting of information through the systematic review
process.
Search terms were used to search each of the literature streams for gathering di-ethylhexyl phthalate
studies. These terms and the methods used to develop them are listed in Appendix A. The studies
resulting from the search process were loaded into the EPA Health and Environmental Research Online
(HERO) database and then prioritized to screen first the literature likely relevant for each of the
disciplines: fate, physical and chemical properties, engineering, exposure and hazard. The tools and
methods used to manage the screening process are also outlined in Appendix A. The studies resulting
from the search underwent a title/abstract screening process, which tagged them by topic or category.
Following this, a determination was made to move studies forward into full-text screening. The criteria
used in the screening process for each discipline are found in the population, exposure, comparator,
outcome (PECO) statements listed in Appendix A. The screening process results are presented in the
form of literature inventory trees and evidence tables in Section 2.1.2. The screening process was
conducted based on EPA's planning, execution and assessment activities outlined in Appendix A.
EPA has focused on the data collection phase (consisting of data search, data screening, and data
extraction) during the preparation of the scope document, whereas the data evaluation and integration
stages will occur during the development of the risk evaluation and thus are not part of the scoping
activities described in this document.
The subsequent sections summarize the data collection activities completed to date for the general
categories of sources and topic areas (or disciplines) using systematic review methods.
2.1.1 Search of Gray Literature
EPA surveyed the gray literature2 and identified 94 search results relevant to EPA's risk evaluation
needs for di-ethylhexyl phthalate. Appendix A.3.4 lists the gray literature sources that yielded 94
discrete data or information sources relevant to di-ethylhexyl phthalate. EPA further categorized the data
and information into the various topic areas (or disciplines) supporting the risk evaluation (e.g., physical
and chemical properties, environmental fate, environmental hazard, human health hazard, exposure,
engineering) and the breakdown is shown in Figure 2-1. EPA plans to consider additional reasonably
available information from gray literature if it becomes available during the risk evaluation phase.
2 Gray literature is defined as the broad category of data/information sources not found in standard, peer-reviewed literature
databases (e.g., PubMed and Web of Science). Gray literature includes data/information sources such as white papers,
conference proceedings, technical reports, reference books, dissertations, information on various stakeholder websites and
other databases.
15
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Gray Literature Tags by Discipline
Physical.Chemical
Human.Health.Hazard
Environmental.Hazard
Engineering
0 25 50 75 100
Percent Tagged (%)
Figure 2-1. Gray Literature Tags by Discipline for Di-ethylhexyl Phthalate
The percentages across disciplines do not add up to 100%, as each source may provide data or
information for various topic areas (or disciplines).
2.1.2 Search of Literature from Publicly Available Databases (Peer-reviewed Literature)
EPA has begun the systematic review process and has conducted searching and screening of the
reasonably available literature using the process outlined in Appendix A. This includes performing a
comprehensive search of the reasonably available peer review literature on physical and chemical
properties, environmental fate and transport, engineering (environmental release and occupational
exposure), exposure (environmental, general population and consumer) and environmental and human
health hazards of di-ethylhexyl phthalate. Eligibility criteria were applied in the form of PECO
statements (see Appendix A). Included references met the PECO criteria, whereas excluded references
did not meet the criteria (i.e., not relevant), and supplemental material was considered as potentially
relevant (see Appendix A.2). EPA plans to evaluate the reasonably available information identified for
each discipline during the development of the risk evaluation.
EPA created literature inventory trees to graphically illustrate the flow of data and information sources
following full-text screening (see Figure 2-2, Figure 2-3, Figure 2-5, Figure 2-7, and Figure 2-9). EPA
used the Health Assessment Workplace Collaborative (HAWC) tool to develop web-based literature
inventory trees illustrating, through interactive links, studies that were included or excluded. These
literature inventory trees enhance the transparency of the decisions resulting from the screening process
described in Appendix A. For each of the corresponding disciplines, the literature was tagged to be
included for evaluation during the risk evaluation. Literature inventory trees for physical and chemical
properties are provided as static diagrams (Figure 2-2). For all other disciplines, static screen captures
are provided in addition to links within each figure's caption to the interactive trees. The links show
individual studies that were tagged as included, excluded, or supplemental. Supplemental studies did not
meet all inclusion criteria but may be considered during the risk evaluation as supporting information
(see Appendix A). These studies can be accessed through the hyperlink provided in the associated
caption below each figure. In some figures, the sum of the numbers for the various sub-categories may
be larger than the broader category because some studies may be included under multiple sub-
categories. In other cases, the sum of the various sub-categories may be smaller than the main category
because some studies may not be depicted in the sub-categories if their relevance to the risk evaluation
was unclear.
16
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In addition, EPA tabulated the number and characteristics of the data and information sources included
in the full-text screening process in the form of literature inventory heat maps for the fate, engineering,
exposure and hazard disciplines (see Figure 2-4; Figure 2-6; Figure 2-8; and Figure 2-10). For each of
these four disciplines, a static image of the literature inventory heat map is provided, and a link to the
interactive version presented in FIAWC is included in the caption below each diagram.
Water Solublity
log KOW
Henry's Law Constant
Vapor Pressure
Vapor Density
Density
Viscosity
Retrieved for Full-text
Review
Included for Data
Extraction and Data
Evaluation
Dielectric Constant
476
Refractive Index
Total for TIAB:
P-Chem
459
Supplemental Information
Exclusion
Exclusion
Figure 2-2. Peer-reviewed Literature Inventory Tree - Physical and chemical Properties Search
Results for Di-ethylhexyl Phthalate
Data in this static figure represent references obtained from the publicly available databases search (see
Appendix A. 1.2) that were included during full-text screening as of June 2, 2020. TIAB refers to "title
and abstract" screening.
17
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©
Bioconcentration
Q
Biodegradation
O
Hydrolysis
TSCA Fate DEHP (2020)
Retrieved for Full-text
Review
Excluded
304
Supplemental
Included for Data Extraction
and Evaluation
Excluded at Full-text
Supplemental Material -
Full-text
0
Photolysis
©
Sorption
O
Volatilization
4°
Wastewater Treatment
(10)
Other
Figure 2-3. Peer-reviewed Literature Inventory Tree - Fate and Transport Search Results for l)i-
ethylhexyl Phthalate
Click here to view the interactive literature inventory tree. Data in this figure represent references
obtained from the publicly available databases search (See Appendix A. 1.2) that were included during
full-text screening as of June 2, 2020. Additi onal information may be added to the interactive version as
they become available.
18
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Media
Endpoint
Air
Soil,
Sediment
Wastewater,
Biosolids
Water
Other
Grand Total
Bioconcentration
8
41
8
40
59
Biodegradation
2
45
38
27
71
Hydrolysis
1
1
Photolysis
2
1
2
5
7
Sorption
5
49
14
42
57
Volatilization
6
5
1
5
9
Wastewater Treatment
6
38
21
40
Other
2
5
5
5
1
10
Grand Total
16
110
80
113
1
193
Figure 2-4. Peer-reviewed Literature Inventory Heat Map - Fate and Transport Search Results
for Di-ethylhexyl Phthalate
Click here to view the interactive version for additional study details. The column totals, row totals, and
grand totals indicate total numbers of unique references, as some references may be included in multiple
cells. The various shades of color visually represent the number of relevant references identified by
exposure media or endpoint. The various shades of color visually represent the number of relevant
references identified by media or endpoint. The darker the color, the more references are available for a
given exposure media or endpoint. The darker the color, the more references are available for a given
media or endpoint. Data in this figure represents references obtained from the publicly available
databases search (see Appendix A. 1.2) that were included during full-text screening as of June 2, 2020.
Additional data may be added to the interactive version as they become available.
19
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/ ©
General Engineering
Assessment
(3TO) ^
Retrieved for Full-text
Review
2920
W
TSCA Engineering DEHP
(2020)
2444
Excluded
&
Included during Full-text
Review
©
Environmental Release
Excluded during Full-text
Review
Occupational Exposure
©
Supplemental
Figure 2-5. Peer-reviewed Literature Inventory Tree - Engineering Search Results for Di-
ethylhexyl Phthalate
Click here to view the interactive literature inventory tree. Data in this figure represent references
obtained from the publicly available databases search (see Appendix A. 1.2) that were included during
full-text screening as of August 5, 2020. Additional data may be added to the interactive version as they
become available.
20
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Data Type I Evidence Tags
Description of release source 25
Release frequency 6
Environmental Release or emission factors 25
Releases Release quantity 24
Waste treatment methods and pollution control I
Total 51
Chemical concentration
Life cycle description 16
Genera] Number of sites 12
Engineering Process description
Assessment Production, import, or use volume 26
Throughput 9
Total \ 72
Area sampling data
Dermal exposure data 16
Engineering control 7
Exposure duration 15
Exposure frequency 9
Exposure route
Occupational No evidence tag 2
Exposures Number of workers 20
Particle size characterization 1
Personal protective equipment 11
Personal sampling data 24
Physical form 21
Worker activity description I
Total 68
Grand Total 127
Figure 2-6. Peer-reviewed Literature Inventory Heat Map - Engineering Search Results for Di-
ethylhexyl Phthalate.
Click here to view the interactive version for additional study details. Data in this figure represents
references obtained from the publicly available databases search (see Appendix A. 1.2) that were
included during full-text screening as of August 5, 2020. Additional data may be added to the interactive
version as they become available.
21
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629
Data Sources Obtained from
Peer-Reviewed Literature
Search
3
Excluded • TIAB
Retrieyfed - Fyll-text
602
Supplemental • TIAB
( 64S )
Included--^ ull-text
fe)
Excluded • Full-text
®
Supplemental - Full-text
Data Sources Obtained from
Grey Literature Search
0
Monitoring Study
Modeling Study
Completed Assessment
©
Experimental Study
©
Epidemiological Study
©
Database
Survey
®
Monitoring Study
®
Modeling Study
@
Completed Assessment
®
Experimental Study
"THE) ,
Epidemiological Study
®
Database
®
Survey
Figure 2-7. Peer-reviewed Literature Inventory Tree - Exposure Search Results for Di-ethylhexyl
Phthalate
Click here to view the interactive literature inventory tree. Data in this figure represent all references
obtained from the publicly available databases search (Appendix A. 1.2), and gray literature references
search (see Appendix A.3) that were included during full-text screening as of July 31, 2020. Additional
data may be added to the interactive version as they become available.
22
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Data Type
Media (group)
Monitoring
Study
Modeling Study
Completed
Assessment
Experimental
Study
Epidemiological
Study
Database
Survey
Grand Total
Ambient Air
Biosolids/Sludge
10
2
4
2
2
10
Drinking Water
Groundwater
Land Disposal/ Landfill
Sediment
9
5
4
2
2
11
Soil
23
9
16
1
6
1
31
Surface Water
12
4
7
4
1
16
Wastewater
Aquatic Species
6
3
4
1
3
1
6
Terrestrial Species
7
1
4
3
2
9
Consumer
69
35
38
45
17
1
16
107
Dietary
70
36
39
19
9
2
10
93
Dust
102
47
46
7
23
20
127
Exposure Factors
31
24
16
4
14
2
6
44
Exposure Pathway
28
16
15
8
9
1
5
41
Human Biomonitoring |
385
68
50
6
175
24
51
398
Indoor Air
88
48
38
25
14
1
9
124
Isomers
8
1
1
3
8
Use Information
16
8
13
4
8
1
5
23
No Evidence Type
3
1
1
1
3
Grand Total
565
149
117
62
199
26
70
645
Figure 2-8. Peer-reviewed and Gray Literature Inventory Heat Map - Exposure Search Results
for Di-ethylhexyl Phthalate
Click here to view the interactive version for additional study details. The column totals, row totals, and
grand totals indicate total numbers of unique references, as some references may be included in multiple
cells. The various shades of color visually represent the number of relevant references identified by
exposure media or data type. The darker the color, the more references are available for a given
exposure media or data type. Data in this figure represent all references obtained from the publicly
available databases search (see Appendix A. 1.2), and gray literature references search (see Appendix
A.3) that were included during full-text screening as of July 31, 2020. Additional data may be added to
the interactive version as they become available.
23
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Included during Full-text
Review
Human
®
Animal
©
Plant
(441J
Human Health Model
Environmental Model
Retrieved for Full-text
Review
8061
0
Exclusion
1593
Supplemental Materia)
Excluded during Full-text
Review
Supplemental Material •
FulMext
Mecj>aqrttic
AOME/T K/PBPK
<§)
Mixture
©
Case Study or Case Scries
®
No Original Data
©
Conference Abstract
©
Susceptible Population
©
Field Study
Mechanistic
/ ^ ©
ADME/TK/P8PK
@
Mixture
0
Case Study or Case Series
®
No Original Data
©
Conference Abstract
©
Susceptible Population
©
Non-English Record
©
PECO-Relevant Isomer
Study
Figure 2-9. Peer-reviewed Literature Inventory Tree - Human Health and Environmental Hazard
Search Results for Di-ethylhexyl Phthalate
Click here for interactive literature inventory tree. Data in this figure represent references obtained from
the publicly available databases search (see Appendix A. 1.2) that were included during full-text
screening as of June 16, 2020. Additional data may be added to the interactive version as they become
available.
24
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Evidence Type
Animal -
Animal -
Health Outcomes
Human
Human Health Environmental
Plant
Grand Total
Model
Model
ADME
273
129
35
9
436
Cancer
18
81
8
102
Cardiovascular
24
34
5
63
Developmental
204
249
60
6
504
Endocrine
116
252
57
4
416
Gastrointestinal
4
20
3
25
Hematological and Immune
145
170
24
328
Hepatic
10
177
26
205
Mortality
10
25
25
2
60
Musculoskeletal
16
25
16
55
Neurological
51
58
20
124
Nutritional and Metabolic
95
117
30
6
239
Ocular and Sensory
28
20
4
52
PBPK
7
3
1
10
Renal
160
52
4
215
Reproductive
178
265
58
2
489
Respiratory
36
30
5
71
Skin and Connective Tissue
24
18
5
46
No Tag
2
18
24
6
48
Grand Total
312
441
123
21
871
Figure 2-10. Peer-reviewed Literature Inventory Map - Human Health and Environmental
Hazards Search Results for Di-ethylhexyl phthalate
Click here to view the interactive version for additional study details. The numbers indicate the number
of studies with TIAB keywords related to a particular health outcome, not the number of studies that
observed an association with di-ethylhexyl phthalate. Evidence types were manually extracted, and
Health Systems were determined via machine learning. Therefore, the studies examining multiple Health
Outcomes and Evidence types, connections between health outcome, and evidence type may not be
accurately represented. If a study evaluated multiple health outcomes or included multiple populations
or study designs, it is shown here multiple times. Data in this figure represents references obtained from
the publicly available databases search (see Appendix A. 1.2) that were included during full-text
screening as of June 16, 2020. Additional data may be added to the interactive version as they become
available.
2.1.3 Search of TSCA Submissions
Table 2-1 presents the results of screening the titles of data sources and reports submitted to EPA under
various sections of TSCA. EPA screened a total of 279 submissions using PECO or similar statements
that identify inclusion/exclusion criteria specific to individual disciplines (see Table 2-1 for the list of
disciplines). The details about the criteria are presented in Appendix A.2.1. EPA identified 182
submissions that met the inclusion criteria in these statements and identified 76 submissions with
25
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supplemental data.3 EPA excluded 21 submissions because the reports were identified as one of the
following:
• Submission on a different chemical
• Study summaries with limited information
• Commentary on a published study
• Meeting notes
• Ranking of chemicals for proposed evaluation
• Letter of notification with no data
• NTP annual plan
• Cover sheet of a study
• Preliminary results of a final available submitted study
Table 2-1. Results of Title Screening of Submissions to EPA under Various Sections of TSCAa
Discipline
Included
Supplemental1'
Physical and Chemical Properties
13
0
Environmental Fate and Transport
23
3
Environmental and General Population Exposure
54
0
Occupational Exposure/Release Information
22
0
Environmental Hazard
42
10
Human Health Hazard
54
66
a Individual submissions may be relevant to multiple disciplines.
b Included submissions may contain supplemental data for other disciplines, which will be identified at full-text review.
2.2 Conditions of Use
As described in the Proposed Designation of Di-ethylhexyl Phthalate (CASRN117-81-7) as aHigh-
Priority Substance for Risk Evaluation) (U.S. EPA. 2019e) EPA assembled information from the CDR
and TRI programs to determine conditions of use4 or significant changes in conditions of use of the
chemical substance. Once the 2020 CDR reporting period ends in November 2020, EPA plans to utilize
the most recent CDR information. EPA also consulted a variety of other sources to identify uses of di-
ethylhexyl phthalate, including published literature, company websites, and government and commercial
trade databases and publications. To identify formulated products containing di-ethylhexyl phthalate,
EPA searched for safety data sheets (SDS) using internet searches, EPA Chemical and Product
Categories (CPCat) ( i) data, and other resources in which SDSs could be found. SDSs
were cross-checked with company websites to make sure that each product SDS was current. In
addition, EPA incorporated communications with companies, industry groups, environmental
organizations, and public comments to supplement the use information.
EPA identified and described the categories and subcategories of conditions of use that EPA plans to
consider in the risk evaluation (Section 2.2.1; Table 2-2). The conditions of use included in the scope of
the risk evaluation are those reflected in the life cycle diagrams and conceptual models.
3 EPA may further consider some supplemental or excluded references depending on the reasons for tagging as supplemental
or excluded.
4 Conditions of use means the circumstances, as determined by the Administrator, under which a chemical substance is
intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of
(TSCA § 3(4)).
26
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After gathering reasonably available information related to the manufacture, processing, distribution in
commerce, use and disposal of di-ethylhexyl phthalate, EPA identified those activities for di-ethylhexyl
phthalate the Agency determined not to be conditions of use or are otherwise excluded from the scope of
the risk evaluation. These excluded activities are described in Section 2.2.2.
2.2.1 Categories and Subcategories of Conditions of Use Included in the Scope of the
Risk Evaluation
Table 2-2 lists the conditions of use that are included in the scope of the risk evaluation.
Table 2-2. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation
Life Cycle
Stage"
Category1'
Subcategory'
References
Manufacture
Domestic
Manufacture
Domestic
Manufacture
>019c); ACROS
Organics (2002); Eastman.
Chemical Company (2020);
Harwick Stan da w!
Spectrum (2.008); Tenoit Co. Ltd
(202.0)
Import
Import
Ml9c); Comet
Chemical Company Ltd (2
Processing
As a reactant
Plasticizer in plastic
material and resin
manufacturing, rubber
product
manufacturing, and
synthetic rubber
manufacturing
1019c); Natrochem
Adhesive and sealant
chemical in adhesive
manufacturing
>019c); Morgan
Advanced Materials (2016a, 2016b)
Incorporation into article
Plasticizer in all other
basic organic
chemical
manufacturing,
plastics product
manufacturing
>019c); Victor
HP 1 1 " f f\ '% t**%\
iechnologies u
Plastic material and
resin manufacturing
>019c); 3M Comoanv
(2.018)
Plasticizer in custom
compounding of
purchased resin
lIS-EPA(-0'J':)
27
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Incorporation into
formulation, mixture, or
reaction product
Plasticizer in all other
basic organic
chemical
manufacturing;
custom compounding
of purchased resins;
miscellaneous
manufacturing; paint
and coating
manufacturing;
plastics material and
resin manufacturing;
plastics product
manufacturing;
Ml 9c)
Plasticizer in adhesive
manufacturing; all
other basic inorganic
chemical
manufacturing; rubber
product
manufacturing; and
services
>019c)
Plasticizer in all other
chemical product and
preparation
manufacturing
>019c)
Solid rocket motor
EP A-HO-OPPT-2019-0501 -0043
insulation
Intermediate
Intermediate in
plastics product
manufacturing
>019c)
Recycling
Recycling
Repackaging
Other functional use
in wholesale and retail
trade
>019c)
Distribution
Distribution
Industrial Use
Processing aid, specific to
Hydraulic fracturing
use of Representatives
petroleum production
^_vi n; iw cmu ^.vi n
Paints and Coatings
Paints and Coatings
(e.g., Industrial
Polish)
3 ioanv (2019b)
28
-------
Reference material
and/or laboratory reagent
Laboratory chemicals
'RA Scientific Inc (2014);
Restek ( O-OPPT-
2019-0501-0043
Transportation Equipment
Manufacturing
(e.g., formulations for
diffusion bonding and
manufacture of aero
engine fan blades)
Morgan Advanced Materials
{'2016a. 2016b)
Commercial
Use
Adhesives and sealants
Adhesives and
sealants
>019c): NLM (2019);
Airserco Manufacturing Company
(09); 3M Company (2011);
Imperial Tools (2012); Valspar
irAU „V, Valspar (2017); Tremco
(2.015); StatSpin Inc (2004)
Arts, crafts, and hobby
materials
Arts, crafts, and
hobby materials
U.S. EPA (2.019c)
Automotive care products
Automotive and
interior car care
products
' ^ 2019c); ACCOn I
Dani ); 3M Company
(2017)
Batteries
Batteries (e.g., Digital
camera)
Amazon (2020)
Building/construction
materials not covered
elsewhered
Building/construction
materials not covered
elsewhere,
Ml 9c)
Dyes and pigments
Dyes, pigments, and
fixing agents
>019b): U.S. EPA
• 1f ' ). Identity Group (2.016);
sshn L:oro
Electrical and electronic
products
Electrical and
electronic products
>019c); 3M Company
Rakuten (2019)
Fabric, textile, and leather
products not covered
elsewhere
Fabric, textile, and
leather products not
covered elsewhere
>.019c); Office Stock
USA (2019)
Furniture and furnishings
not covered elsewhere
Furniture and
furnishings not
covered elsewhere
>019c)
Lawn and garden care
products
Lawn and garden care
products
>019c)
Paints and coatings
Paints and coatings
(e.g., sealer for
decorative concrete as
>019c): CETCO (2014);
Chemsol (2020); Dupli-Color
nets Company (2.017); Glidden
29
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waterproof
polyurethane)
umI' 9); LOK< * Corporation
COfO. LOkm ^oration
Pacific Coast Lacquer (2016);
Ramuc Specialty Pools (2010);
Republic Powdered Metals Inc.
(2002); The Sherwin-Williams
l ciivpanv (20 TO
Plastic and rubber
products not covered
elsewhere
Plastic and rubber
products not covered
elsewhere
JO 19c); Lighthouse
Office Supplv (2018); Ouad Citv
Safetv Inc (2.019a. 201
Toys, playground, and
sporting equipment
Toys, playground, and
sporting equipment
>019c)
Consumer Use
Adhesives and sealants
Adhesives and
sealants
I -v < * \ i 2019c); NLM (-V ),
Airserco Manufacturing Company
109); 3M Company (2011);
Valspar (2017); Valspar (2019);
ico (2015); StatSpin Inc (2004)
Arts, crafts, and hobby
materials
Arts, crafts, and
hobby materials
l'SEPAf20W
Automotive care products
Automotive and
interior car care
products
JO 19b); ACC (2.019);
Dani );
>V t * ipanv )
Batteries
Batteries (e.g., digital
camera)
Amazon (2020)
Building/ construction
materials not covered
elsewhere
Building/construction
materials not covered
elsewhere
JO 19c)
Dyes and pigments
Dyes, pigments, and
fixing agents
JO 19b); U.S. EPA.
(1999); Identity Group (2016);
Electrical and electronic
products
Electrical and
electronic products
JO 19c); 3M Company
(2019a); 3M Company (2.011);
Rakuten
Fabric, textile, and leather
products not covered
elsewhere
Fabric, textile, and
leather products not
covered elsewhere
JO 19c); Office Stock
iau;ojio
Furniture and furnishings
not covered elsewhere
Furniture and
furnishings not
covered elsewhere
JO 19c);
Reference material
and/or laboratory reagent
Laboratory chemicals
hPA-HQ-OPPT-2019-0501.0043
30
-------
Lawn and garden care
products
Lawn and garden care
products
Ml 9c)
Paints and coatings
Paints and coatings
(e.g., sealer for
decorative concrete as
waterproof
polyurethane)
Ml9c); CETCO (2.014);
Chemsol (202.0); Dupli-Color
nets Company (2017); Glidden
t
-------
of use on a case-by-case basis (82 FR 33736, 33729; July 20, 2017). TSCA Section 3(4) also grants EPA
discretion to determine the circumstances that are appropriately considered to be conditions of use for a
particular chemical substance.5 As a result, EPA does not plan to include in this scope or in the risk
evaluation activities described below that the Agency does not consider to be conditions of use or for
which EPA is exercising discretionary authority provided by TSCA Section 6(b)(4)(D).
TSCA Section 3(2) also excludes from the definition of "chemical substance" "any food, food additive,
drug, cosmetic, or device (as such terms are defined in Section 201 of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 321]) when manufactured, processed, or distributed in commerce for use as a
food, food additive, drug, cosmetic, or device" as well as "any pesticide (as defined in the Federal
Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.]) when manufactured, processed, or
distributed in commerce for use as a pesticide." EPA has determined that the following uses of di-
ethylhexyl phthalate are non-TSCA uses:
• EPA determined that di-ethylhexyl phthalate is used in fragrances which meets the definition of
cosmetics under Section 201 of the Federal Food, Drug and Cosmetics Act, 21 U.S.C. § 321, M,
and are therefore excluded from the definition of "chemical substance" in TSCA § 3(2)(B)(vi).
Activities and releases associated with such cosmetics are therefore not "conditions of use"
(defined as circumstances associated with "a chemical substance," TSCA § 3(4)) and will not be
evaluated during risk evaluation.
• EPA recognizes that the Food and Drug Administration lists di-ethylhexyl phthalate as an
optional substance to be used in food packaging materials. Food packaging materials meet the
definition for a "food additive" described in Section 201 of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. § 321. Therefore, these uses are excluded from the definition
of "chemical substance" in TSCA § 3(2)(B)(vi) and are not included in Table 2-2. Activities and
releases associated with the use of such food packaging materials are therefore not "conditions of
use" (defined as circumstances associated with "a chemical substance," TSCA § 3(4)) and will
not be evaluated during risk evaluation.
• Medical Devices. Di-ethylhexyl phthalate has been listed as being used in medical devices and
the flexible tubing and containers in the medical industry. These uses meet the definition of a
"medical device" in Section 201 of the FFDCA, 21 U.S.C. § 321. Therefore, the uses are
excluded from the definition of "chemical substance" in TSCA § 3(2)(B)(vi) and are not
included in Table 2-2. Activities and releases associated with the use of medical devices are not
"conditions of use" (defined as circumstances associated with "a chemical substance," TSCA §
3(4)) and will not be evaluated during risk evaluation.
5Chemical substance means any organic or inorganic substance of a particular molecular identity, including any combination
of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, and any element or
uncombined radical. Chemical substance does not include (1) any mixture; (2) any pesticide (as defined in the Federal
Insecticide, Fungicide, and Rodenticide Act) when manufactured, processed, or distributed in commerce for use as a
pesticide; (3) tobacco or any tobacco product; (4) any source material, special nuclear material, or byproduct material (as
such terms are defined in the Atomic Energy Act of 1954 and regulations issued under such Act); (5) any article the sale of
which is subject to the tax imposed by Section 4181 of the Internal Revenue Code of 1954 (determined without regard to any
exemptions from such tax provided by Section 4182 or 4221 or any other provision of such Code), and; (6) any food, food
additive, drug, cosmetic, or device (as such terms are defined in Section 201 of the Federal Food, Drug, and Cosmetic Act)
when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device (TSCA
§ 3(2)).
32
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• Pharmaceuticals also fall under 21 U.S.C. § 321 of the FFDCA and are non-TSCA uses beyond
the scope of the risk evaluation for di-ethylhexyl phthalate.
• EPA determined that di-ethylhexyl phthalate is used as a propellant in cartridge munitions and
rocket motors. TSCA section 3(2)(B)(v) excludes from the definition of "chemical substance,"
any "article the sale of which is subject to the tax imposed by section 4181 of the Internal
Revenue Code of 1986 [26 U.S.C. 4181] (determined without regard to any exemptions from
such tax provided by section 4182 or 4221 or any other provision of such Code) and any
component of such an article (limited to shot shells, cartridges, and components of shot shells
and cartridges)". Section 4181 of the Internal Revenue Code imposes a tax on the following
articles: "pistols", "revolvers", "firearms (other than pistols and revolvers)" and "Shells, and
cartridges." Propellants used in cartridge munitions and rocket motors, when present as a
component of a cartridge, meet this definition and, therefore, are excluded from the definition of
"chemical substance" in TSCA § 3(2)(B)(vi) and are not included in Table 2-2. Activities and
releases associated with these uses are not "conditions of use" (defined as circumstances
associated with "a chemical substance," TSCA § 3(4)) and will not be evaluated during risk
evaluation.
2.2.3 Production Volume
As reported to EPA during the 2016 CDR reporting period and described here as a range to protect
production volumes that were claimed as confidential business information (CBI), total production
volume of di-ethylhexyl phthalate in 2015 was between 100 million and 250 million pounds (
2020a). EPA also uses pre-2015 CDR production volume information, as detailed in the Proposed
Designation of Di-ethylhexyl Phthalate (CASRN117-81-7) as a High-Priority Substance for Risk
Evaluation) (U.S. EPA. 2019e) and will include more recent production volume information from the
2020 CDR reporting period in the risk evaluation to support the exposure assessment.
2.2.4 Overview of Conditions of Use and Lifecyle Diagram
Figure 2-11 provides the life cycle diagram for di-ethylhexyl phthalate. The life cycle diagram is a
graphical representation of the various life stages of the industrial, commercial and consumer use
categories included within the scope of the risk evaluation. The information in the life cycle diagram is
grouped according to the CDR processing codes and use categories (including functional use codes for
industrial uses and product categories for industrial, commercial and consumer uses). Appendix E
contains additional descriptions (e.g., process descriptions, worker activities, process flow diagrams) for
each manufacturing, processing, distribution in commerce, use, and disposal category.
33
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MFG/IMPORT
Manufacture (Including
Imported)
PROCESSING
-K>
INDUSTRIAL. COMMERCIAL, CONSUMER USES
Processing as Reactant
(Plasticizer in: Plastic material and resin manufacturing;
Rubber product manufacturing; Synthetic rubber
manufacturing; Adhesives ancfsealant chemical in:
Adhesive manufacturing; Intermediate in: Plastic product
manufacturing)
Incorporation into Article
(Plasticizer in: All other basic organic chemical
manufacturing; Plastic products manufacturing; Plastics
material and resm manufacturing; Custom compounding
of purchased resins)
Repackaging
Incorporation into Formulation, Mixture, or Reaction
Product
(Plasticizer in: Ail other basic organic chemical
manufacturing; Custom compounding of purchased
resins: Miscellaneous manufacturing; faint and coating
manufacturing: Plastics material and resin manufacturing;
Plastics product manufactunng; Adhesive manufacturing;
All other basic inorganic chemical manufacturing; P.ubber
product manufacturing; Sendees; All other chemical
product and preparation manufacturing; Solid rocket
motor insulation)
3:
Adhesives and sealants 1.2
Arts, crafts, and hobby materials 2
Automotive care products 1,2
Building/construction materials not covered elsewhere 1J
Electrical and electronic products 1,2
Fabric,textile.and leather products not covered elsewhere 1,2
Paints and coatings U
Recycling
Furniture and furnishings not covered elsewhere 1,2
Plastic and rubber products not covered elsewhere 1,2
Miscellaneous uses 1,2
e.g., Hydraulic fracturing; Laboratory chemicals; Transportation
equipment manufacturing"Batteries; Dyes and Pigments; Lawn and
garden care products; Toys, playground, and sporting equipment...
RELEASES AND WASTE DISPOSAL
Disposal
See Conceptual Model for
Environmental Releases and
Wastes
Manufacture
(including import)
Processing
Uses
1. Industrial and or Commercial
2. Consumer
Figure 2-11. Di-ethylhexyl Phthalate Life Cycle Diagram
34
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2.3 Exposures
For TSCA exposure assessments, EPA plans to analyze human and environmental exposures and
releases to the environment resulting from the conditions of use within the scope of the risk evaluation
for di-ethylhexyl phthalate. In this section, the physical and chemical properties, environmental fate and
transport properties and releases to the environment are described in addition to potential human and
environmental exposures from TSCA conditions of use and from other possible or known sources.
Release pathways and routes will be described in Section 2.6 to characterize the relationship or
connection between the conditions of use of the chemical and the exposure to human receptors,
including PESS, and environmental receptors. EPA plans to consider, where relevant, the duration,
intensity (concentration), frequency and number of exposures in characterizing exposures to di-
ethylhexyl phthalate.
2.3.1 Physical and Chemical Properties
Consideration of physical and chemical properties is essential for a thorough understanding or prediction
of environmental fate {i.e., transport and transformation) and the eventual environmental concentrations.
It can also inform the hazard assessment. Table 2-3 summarizes the physical and chemical property
values preliminarily selected for use in the risk evaluation from among the range of reported values
collected as of June 2020. This table differs from that presented in the Proposed Designation of Di-
Ethylhexyl Phthalate fCASRN 117-81-7) as a Hish-Priority Substance for Risk Evaluation (U.S. EPA.
2.019e) and may be updated as EPA continues to evaluate and integrate additional information through
systematic review methods. Figure 2-12. summarizes the distribution of reported values for eight
physical and chemical properties routinely used in existing chemical risk evaluations. Appendix B
presents summary statistics for reported physical and chemistry property values. All physical and
chemistry property values that were extracted and evaluated as of June 2020 are presented in the
supplemental file Data Extraction and Data Evaluation Tables for Physical and Chemical Property
Studies (EPA-HO-QPPT-2018-0433Y
Table 2-3. Physical and Chemical Properties of Di-ethylhexyl Phthalate
Properly or Kndpoinl
Value"
Reference
Data Quality
Ualing
Molecular formula
C24H38O4
NA
NA
Molecular weight
390.57 g/mol
NA
NA
Physical state
Liquid
Rumble (2018)
High
Physical properties
Colorless, oily liquid;
slight odor
NLM (2015a)
High
Melting point
-55°C
NLM (2015a)
High
Boiling point
384°C
NLM (2015a)
High
Density
0.981 g/cm3 at 25°C
NLM (2015a)
High
Vapor pressure
1.42xl0"7 mm Hg at 25°C
NLM (2015a)
High
Vapor density
16.0 (air = 1)
NLM (2015a)
High
Water solubility
0.27 mg/L at 25°C
NLMOOiia}
High
35
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Octanol/water partition coefficient
(log Kow)
7.6
NLM (2015a)
High
Henry's Law constant
1.71 xlO"5 atmm3/mol
Elsevier (2019)
High
Flash point
206°C
O'Neil C
High
Auto flammability
Not available
Viscosity
57.94 cP at 25°C
Myloma et al.
(2.013)
High
Refractive index
1.4853
Rumble (2018)
High
Dielectric constant
5.06 at 25°C
Elsevier (2019)
High
a Measured unless otherwise noted.
NA = Not applicable
Figure 2-12 displays a summary of the data collected as of June 2020 for eight physical and chemical
values routinely used in TSCA existing chemical risk evaluations. The box and whisker plots for each
endpoint illustrate the mean (average, indicated by the blue diamond) and the 10th, 25th, 50th (median),
75th, and 90th percentiles. All individual data points are indicated by black squares, and value
preliminarily selected for use in the risk evaluation is overlaid (indicated by the orange circle) to provide
context for where it lies within the distribution of the dataset. The number of unique primary data
sources is indicated below each box and whisker plot. If multiple sources presented equivalent values
and cited the same primary source, only one of those was included in the statistical calculations. As a
result, the number of sources listed in Figure 2-12 may differ from the total number of data sources
presented in Figure 2-2.
36
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0.050-
10-
Leqend
216
214-
0.025-
400-
90th Percentile
^212-
e o.ooo-
E 210-
75th Percentile
300-
-0.025-
Proposed
Value
206-
Flash Point
-------
Under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA), di-
ethylhexyl phthalate is a TRI-reportable substance effective January 1, 1987 (40 CFR 372.65). For TRI
reporting6, facilities in covered sectors in the United States are required to disclose release and other
waste management activity quantities of di-ethylhexyl phthalate under the CASRN 106-99-0 if they
manufacture (including import) or process more than 25,000 pounds or otherwise use more than 10,000
pounds of the chemical in a given year by July 1 of the following year.
Table 2-4 provides production-related waste management data for di-ethylhexyl phthalate reported by
facilities to the TRI program for reporting year 2018.7 As shown in the table, 118 facilities managed, in
total, nearly 8 million pounds of di-ethylhexyl phthalate as waste. Of this total: more than 6.5 million
pounds were recycled; over 600,000 pounds were treated; nearly 80,000 pounds were burned for energy
recovery, and just over 710,000 pounds were released to the environment. Most (82%) of the total
quantity of production-related waste was managed by recycling. Roughly 60% of all the production-
related waste was managed on site. For recycling and energy recovery, the portions managed on site
were higher at 67% and 82%, respectively. The inverse was true for treatment-related quantities;
approximately 3/4 of the total quantity was treated off-site. A relatively small portion (-710,000 pounds,
9%) of the total quantity of production-related waste was released to the environment, and most (90%)
of this amount was disposed of or otherwise released off-site.
Table 2-4. Summary of Di-ethylhexyl Phthalate Production-Related Waste Managed in 2018
Year
N il m her of
l-'acilities
Recycled
(I'hs)
Recovered
lor
r.iier«v
(lbs)"
Treated
(lbs)
Released111"
(lbs)
Total Production Related
Waste
(lbs)
2018
118
6,541,493
79,746
607,502
710,514
7,939,256
Data source: U.S. EPA (2019:0
3 Terminology used in these columns may not match the more detailed data element names used in the TRI public data and analysis access points.
b Does not include releases due to one-time event not associated with production such as remedial actions or earthquakes.
c Counts all releases including release quantities transferred and release quantities disposed of by a receiving facility reporting to TRI.
Table 2-5 provides a summary of the di-ethylhexyl phthalate disposed of or otherwise released to the
environment during 2018.7 Less than 31 pounds of di-ethylhexyl phthalate were released to water.
Disposal to land, however, accounted for approximately 90% of the total quantity of di-ethylhexyl
phthalate released to the environment. Of the total quantity of di-ethylhexyl phthalate released (disposed
of) to land, 96% was reported as "all other land disposal". This includes di-ethylhexyl phthalate sent off-
site to Class II-V underground injection wells (62% of total land disposal), as well as di-ethylhexyl
phthalate sent off-site for disposal in non-RCRA (Resource Conservation and Recovery Act) Subtitle C
landfills (34%) of total land disposal). Quantities of di-ethylhexyl phthalate released on site to air totaled
nearly 47,000 pounds, which accounted for 6.6% of the total quantity of di-ethylhexyl phthalate released
6 For TRI reporting criteria see https://www.epa.gov/toxics-release-itiventorv-t.ri-program/basics-tri-reporting
7 Reporting year 2018 is the most recent TRI data available. Data presented in Table 2-4 were queried using TRI Explorer
and uses the 2018 National Analysis data set (released to the public in November 2019). This dataset includes revisions for
the years 1988 to 2018 processed by EPA.
38
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to the environment during 2018. Nearly 3/4 of these air releases were in the form of stack emissions, with
fugitive air releases accounting for the remaining Vi. The majority of "other releases" occurred off-site.
Table 2-5. Summary of Releases of Di-ethylhexyl Phthalate to the Environment During 2018
Air Releases
Land Disposal
Year
Nil m her
of
l-'acilities
Stack
Air
Releases
(Ihs)
Kughive
Air
Releases
(Ihs)
Water
Releases
(Ihs)
Class 1
I nder-
ron iid
Injection
(Ihs)
RCRA
Subtitle
(
Landfills
(Ihs)
All other
Land
Disposal11
Oilier
Releases
;i
(Ihs)
Totsil
Releases
r
(lbs)
2018
118
33,879
12,795
30.57
5
22,909
619,423
21,651.8
Q
710,694
46,674
642,337
O
Data source: U.S. EPA (2019ft
3 Terminology used in these columns may not match the more detailed data element names used in the TRI public data and analysis access points.
b These release quantities include releases due to one-time events not associated with manufacture, processing, distribution in commerce, disposal or use such as
remedial actions or earthquakes.
c Counts release quantities once at final disposition, accounting for transfers to other TRI reporting facilities that ultimately dispose of the chemical waste.
The total production-related waste managed quantity shown in Table 2-4 does not include any quantities
reported as catastrophic or one-time releases or otherwise not associated with production. Release
quantities shown in Table 2-5 include both production-related and non-production-related quantities.
Total release quantities differ by 180 pounds between Table 2-4 and Table 2-5 due to differences in TRI
calculation methods for reported release range estimates (U.S. EPA. 2019a). Table 2-4 includes
quantities transferred off-site to receiving facilities for release or disposal and, if the receiving facilities
are subject to the TRI reporting requirements, they would report these quantities as on-site releases, and
these same quantities would be included in the total release aggregate. This is referred to as "double
counting", because the quantities are counted twice. This is done because total production-related waste
values in the TRI database considers all instances of where and how the waste is managed (first as a
quantity sent off-site for disposal and next as a quantity disposed of on-site), and reflects both the off-
site transfer and the on-site disposal quantities, In processing the data, the TRI program recognizes that
this is the same quantity of the chemical and includes it only once in the total releases value, such as in
Table 2-5. The production-related waste value in the TRI database, however, considers all instances
where the waste is managed (first as a quantity sent off-site for disposal and next as a quantity disposed
of on-site), and reflects both the off-site transfer and the on-site disposal. In the case of di-ethylhexyl
phthalate, the similarity in the total release quantities shown in Table 2-4 and Table 2-5 indicates that di-
ethylhexyl phthalate waste quantities transferred off-site for disposal to land are received by facilities
not required to report to TRI.
EPA plans to review these data in conducting the exposure assessment component of the risk evaluation
for di-ethylhexyl phthalate.
2.3.4 Environmental Exposures
The manufacturing, processing, distribution, use and disposal of di-ethylhexyl phthalate can result in
releases to the environment and exposure to aquatic receptors (biota). Environmental exposures to biota
are informed by releases into the environment, overall persistence, degradation, and bioaccumulation
within the environment, and partitioning across different media. Concentrations of chemical substances
39
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in biota provide evidence of exposure. EPA plans to review reasonably available environmental
monitoring data for di-ethylhexyl phthalate.
Monitoring data were identified in EPA's data search for di-ethylhexyl phthalate and can be used in the
exposure assessment. Relevant and reliable monitoring studies provide(s) information that can be used
in an exposure assessment. Monitoring studies that measure environmental concentrations or
concentrations of chemical substances in biota provide evidence of exposure. Environmental monitoring
data shows that di-ethylhexyl phthalate has been identified in various environmental compartments
including air, water, soil/sediment and other environmental media (NICNAS. 2.019; NTP. 2016; IARC.
2013 a; ECB. 2008; NTP-CERHR. 2006; AT SDR. 2002; OEH1 _ ) EPA anticipates possible
presence of di-ethylhexyl phthalate in soil, sediment, and water (NICNAS. 2019; NTP. 20 i:>). Di-
ethylhexyl phthalate has been found in in aquatic invertebrates, fish, and monkeys (IARC. 2013a; ECB.
2.008; ATSDR. 2002). EPA plans to review reasonably available environmental monitoring data for di-
ethylhexyl phthalate.
2.3.5 Occupational Exposures
EPA plans to evaluate worker activities where there is a potential for exposure under the various
conditions of use (manufacturing, processing, industrial/commercial uses, and disposal) described in
Section 2.2. In addition, EPA plans to evaluate exposure to occupational non-users (ONUs), i.e.,
workers who do not directly handle the chemical but perform work in an area where the chemical is
present. EPA also plans to consider the effect(s) that engineering controls (EC) and/or personal
protective equipment (PPE) have on occupational exposure levels as part of the risk evaluation.
Examples of worker activities associated with the conditions of use within the scope of the risk
evaluation for di-ethylhexyl phthalate that EPA may analyze, include, but are not limited to:
Unloading and transferring di-ethylhexyl phthalate to and from storage containers to process
vessels;
Handling and disposing of waste containing di-ethylhexyl phthalate;
Cleaning and maintaining equipment;
Sampling chemicals, formulations, or products containing di-ethylhexyl phthalate for quality
control;
Repackaging chemicals, formulations, or products containing di-ethylhexyl phthalate;
Performing other work activities in or near areas where di-ethylhexyl phthalate is used.
Di-ethylhexyl phthalate is a liquid at room temperature and has a vapor pressure of 1.42x 10"7 mm Hg at
25 °C (NLM. 2015b) and inhalation exposure to vapor is expected to be low when working with the
material at room temperature. However, EPA plans to analyze inhalation exposure for workers and
ONUs in occupational scenarios where di-ethylhexyl phthalate is applied via spray or roll application
methods or is handled as a dry powder or at elevated temperatures. In addition, for certain COUs, di-
ethylhexyl phthalate may be present as a component of solid products. For these COUs, EPA plans to
consider inhalation exposure to dust/particulates (e.g., particulate generated during handling of plastic
resins, finishing operations associated with the manufacture and finishing of plastics and plastic articles
and incorporation of plastics and other article components into finished products) for workers and
ONUs.
Di-ethylhexyl phthalate has an Occupational Safety and Health Administration (OSHA) permissible
exposure limit (PEL) (OSHA. 2009). The PEL is 5 mg/m3 over an 8-hour workday, time weighted
average (TWA). The American Conference of Governmental Industrial Hygienists (ACGIH) set the
threshold limit value (TLV) at 5 mg/m3 TWA. The National Institute for Occupational Safety and Health
40
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(NIOSH) has set the Recommended Exposure Limit (REL) of 5 mg/m3 TWA and set the short-term
exposure limit (STEL) of 10 mg/m3 (NIOSH. 2019). NIOSH considers di-ethylhexyl phthalate to be a
potential occupational carcinogen with an Immediately Dangerous to Life or Health (IDLH) value of
5000 mg/m3 ffilQSH. 2020. 2016V
Based on the conditions of use, EPA plans to analyze worker exposure to liquids and/or solids via the
dermal route. EPA plans to analyze dermal exposure for workers and ONUs to mists and dust that
deposit on surfaces.
EPA generally does not evaluate occupational exposures through the oral route. Workers and ONUs
may inadvertently ingest inhaled particles that deposit in the upper respiratory tract. In addition, workers
may transfer chemicals from their hands to their mouths. The frequency and significance of this
exposure route are dependent on several factors including the physical and chemical properties of the
substance during worker activities, the visibility of the chemicals on the hands while working,
workplace training and practices, and personal hygiene that is difficult to predict (Cherrie et at.. 2006).
EPA plans to consider the relevance of this exposure route on a case-by-case basis, taking into
consideration the aforementioned factors and any reasonably available information, and may assess oral
exposure for workers for certain COUs and worker activities where warranted. For certain conditions of
use of di-ethylhexyl phthalate, EPA plans to consider inhalation exposure to dust/particulates for
workers and ONUs. As inhalation exposure to dust/particulates may occur, EPA plans to consider
potential exposure for particulates that deposit in the upper respiratory tract from inhalation exposure
and may be ingested via the oral route.
2.3.6 Consumer Exposures
CDR reporting and conversations with industry indicate the presence of di-ethylhexyl phthalate in a
number of consumer products and articles including: Adhesives and Sealants; Arts, Crafts and Hobby
Materials; Automotive Care Products; Building/Construction Materials not Covered Elsewhere;
Electrical and Electronic Products; Fabric, Textile and Leather Products not Covered Elsewhere;
Furniture and Furnishings not Covered Elsewhere; Ink, Toner and Colorant Products; Lawn and Garden
Care Products; Paints and Coatings; Plastic and Rubber Products not Covered Elsewhere; and Toys,
Playground and Sporting Equipment. (See Section 2.6.2 and Figure 2-14.). These uses can result in
exposures to consumers and bystanders (non-product users that are incidentally exposed to the product).
Based on reasonably available information on consumer conditions of use, inhalation of di-ethylhexyl
phthalate is possible through either inhalation of vapor/mist during product usage or indoor air/dust.
Oral exposure of di-ethylhexyl phthalate is possible through either ingestion through product use via
transfer from hand to mouth, through mouthing of articles containing di-ethylhexyl phthalate, or via
dust. Dermal exposure may occur via contact with vapor, mist, or dust deposition onto the skin; via
direct liquid contact during use; or direct dermal contact of articles containing di-ethylhexyl phthalate.
The consumer exposure pathways in the scope of this evaluation are described in Sections 2.6.2 and
2.7.2.4.
2.3.7 General Population Exposures
Releases of di-ethylhexyl phthalate from certain conditions of use, such as manufacturing, processing, or
disposal activities, may result in general population exposures. General population exposures are
primarily via drinking water ingestion and inhalation from air releases. Exposure can also occur orally
through consumption of food containing di-ethylhexyl phthalate, either through contamination from
environmental sources or as a result of leaching from food packaging materials (CPSC. -01 \ \ 1 SDR.
41
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2002; OEHHA. 1997). Environmental monitoring data indicates that di-ethylhexyl phthalate has been
identified in various environmental compartments including air, water, soil/sediment and other
environmental media CNICNAS. 2019; NTP. 2016; I ARC. 2013b; ECB. 2008; NTP-CERHR. 2006;
ATSDR. 2002; OEHHA.. 1997V
In human matrices, di-ethylhexyl phthalate has been detected in serum, breast milk, adipose tissue, cord
blood and stored blood (NTP. < t \ "«t** 2013b; ECB. 2008; NTP-CERHR. 2006; OEHHA. 2005;
¦\ 1" DR.. 2002; OEHHA. 1997; Nj r'S2), whereas metabolites of di-ethylhexyl phthalate have been
detected in urine, saliva, breast milk, cord blood, and serum (NTP. 2016; CPSC. 2014; IARC. 201
ECHA. 2010; NICNAS. 2010; ECB. 2008; NTP-CERHR. 200c. i'SPR. 20021
The presence in environmental media and biomonitoring data suggest that general population exposures
are occurring. The general population pathways in the scope of this evaluation are described in Sections
2.6.3 and 2.7.2.5.
2.4 Hazards (Effects)
2.4.1 Environmental Hazards
EPA considered reasonably available information (e.g., federal and international government chemical
assignments) on di-ethylhexyl phthalate as well as public comments received on the Proposed
Designation of Di-Ethylhexyl Phthalate (CASRN117-81-7) as a High-Priority Substance for Risk
Evaluation (U.S. EPA. 2019e) and draft scope for di-ethylhexyl phthalate ( BP A. 2020c) to identify
potential environmental hazards. During prioritization, EPA identified environmental hazard effects for
aquatic and terrestrial organisms.
Since prioritization, EPA applied automated techniques during the data screening phase of systematic
review to identify the following potential environmental hazards and related information that may be
considered for the risk evaluation (as explained in Appendix A): ADME, PBPK, cancer, cardiovascular,
developmental, endocrine, gastrointestinal, hematological and immune, hepatic, mortality, musculo-
skeletal, neurological, nutritional and metabolic, ocular and sensory, renal, reproductive, respiratory, and
skin and connective tissue (Figure 2-10). A summary of references identified during the screening step
of systematic review is included in the interactive literature inventory trees (Figure 2-9). As EPA
continues to evaluate reasonably available and relevant hazard information identified through systematic
review, EPA may update the list of potential hazard effects to be analyzed in the risk evaluation.
2.4.2 Human Health Hazards
EPA considered reasonably available information (e.g., federal and international government chemical
assessments) on di-ethylhexyl phthalate as well as public comments received on the Proposed
Designation of Di-ethylhexyl Phthalate (CASRN 117-81-7) as a High-Priority Substance for Risk
Evaluation ( ) and draft scope for di-ethylhexyl phthalate ( 320c) to identify
potential human health hazards. During prioritization, EPA identified the following potential human
health hazards and related information: reproductive, developmental and systemic effects.
Since prioritization, EPA applied automated techniques during the data screening phase of systematic
review to identify the following additional potential human health hazards and related information that
may be considered for the risk evaluation (as explained in Appendix A): ADME, PBPK, cancer,
cardiovascular, endocrine, gastrointestinal, hematological and immune, hepatic, mortality, musculo-
skeletal, neurological, nutritional and metabolic, ocular and sensory, renal, respiratory, and skin and
42
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connective tissue (Figure 2-10). A summary of references identified during the screening step of
systematic review is included in the interactive literature inventory trees (Figure 2-9). As EPA continues
to evaluate reasonably available and relevant hazard information identified through systematic review,
EPA may update the potential human health hazards considered in the risk evaluation.
2.5 Potentially Exposed or Susceptible Subpopulations
TSCA§ 6(b)(4) requires EPA to determine whether a chemical substance presents an unreasonable risk
to "a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation."
TSCA §3(12) states that "the term 'potentially exposed or susceptible subpopulation' 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, or the elderly." General population is "the total of individuals inhabiting an area or making up a
whole group" and refers here to the U.S. general population (U.S. EPA. 201 la).
EPA identified the following PESS based on CDR information and studies reporting developmental and
reproductive effects: children, women of reproductive age (e.g., pregnant women), workers, including
ON Us and users, and consumers, including users and bystanders (U.S. EPA. 2.019c). EPA plans to
evaluate these PESS in the risk evaluation. Following further evaluation of the reasonably available
information, EPA may evaluate PESS in the general population as they relate to fence line communities.
Following further evaluation of the reasonably available information, EPA may evaluate PESS in the
general population as they relate to fence line communities.
In developing exposure scenarios, EPA plans to analyze reasonably available data to ascertain whether
some human receptor groups may be exposed via exposure pathways that may be distinct to a particular
subpopulation or life stage (e.g., children's crawling, mouthing or hand-to-mouth behaviors, ingestion of
breast milk) and whether some human receptor groups may have higher exposure via identified
pathways of exposure due to unique characteristics (e.g., activities, duration or location of exposure)
when compared with the general population (U.S. EPA. 2006b). Likewise, EPA plans to evaluate
reasonably available human health hazard information to ascertain whether some human receptor groups
may have greater susceptibility than the general population to the chemical's hazard(s). Based on these
analyses, EPA may update the list of PESS in the risk evaluation.
2.6 Conceptual Models
In this section, EPA presents the conceptual models describing the identified exposures (pathways and
routes), receptors and hazards associated with the conditions of use of di-ethylhexyl phthalate. Pathways
and routes of exposure associated with workers and ONU's are described in Section 2.6.1, and pathways
and routes of exposure associated with consumers are described in Section 2.6.2. Pathways and routes of
exposure associated with environmental releases and wastes, including those pathways that are under the
jurisdiction of other EPA-administered laws, are discussed and depicted in the conceptual model shown
in Section 2.6.3.1. Pathways and routes of exposure associated with environmental releases and wastes,
excluding those pathways that are under the jurisdiction of other EPA-administered laws, are presented
in the conceptual model shown in Section 2.6.3.2.
2.6.1 Conceptual Model for Industrial and Commercial Activities and Uses: Potential
Exposures and Hazards
Figure 2-13 illustrates the conceptual model for the pathways of exposure from industrial and
commercial activities and uses of di-ethylhexyl phthalate that EPA plans to include in the risk
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evaluation. There is potential for exposures to workers and occupational non-users via inhalation routes
and exposures to workers via dermal routes. The conceptual model also includes potential worker and
ONU via dermal exposure to di-ethylhexyl phthalate in mists and dusts. EPA plans to evaluate activities
resulting in exposures associated with distribution in commerce (e.g., loading, unloading) throughout the
various lifecycle stages and conditions of use (e.g., manufacturing, processing, industrial use,
commercial use, and disposal) rather than a single distribution scenario.
For each condition of use identified in Table 2-2, a determination was made as to whether or not EPA
plans to evaluate each combination of exposure pathways, routes, and receptors in the risk evaluation.
The results of that analysis along with the supporting rationale are presented in Appendix F.
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I>WSTmLA>TO COMMERCIAL EXPOSURE PATHWAY EXPOSURE ROUTE RECEPTORS HAZARDS
Manufacturing
Liquid Solid Contact
Dermal
Workers
Hazards potentially
associated with acute
and or chronic
exposures
Processing
-As a reactant
-Incorporation into formulation,
mixture, or reaction product
-Incorporation mto article
-Repackaging
Indoor
Vapor Mist Dust
Adliesives and sealants
Automotive care products
Fugitive Emissions
Building/construction materials not
covered elsewhere
Electrical and electronic products
Fabric, textile, and leather products
not covered elsewhere
Furniture and furnishings not
covered elsewhere
Paints and coatings
Plastic and rubber products not covered
elsewhere
Miscellaneous uses
Waste Handling,
Treatment, ana
Disposal
'• ujilc i'Vttlcf.. LtfU* -JlsiliA >ruj»w
(See Environmental Release Conceptual Model
Figure 2-13. Di-ethvlhexyl Phthalate Conceptual Model for Industrial and Commercial Activities and Uses: Worker and
Occupational Non-User Exposures and Hazards
The conceptual model presents the exposure pathways, exposure routes, and hazards to human receptors from industrial and commercial
activities and uses of di-ethylhexyl phthalate.
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2.6.2 Conceptual Model for Consumer Activities and Uses
The conceptual model in Figure 2-14 presents the exposure pathways, exposure routes and hazards to
human receptors from consumer activities and uses of di-ethylhexyl phthalate. EPA expects that
consumers and bystanders may be exposed through use of products or articles or via dust containing di-
ethylhexyl phthalate through oral, dermal, and inhalation routes. During use of articles, EPA expects that
consumers may also be exposed via direct dermal contact or mouthing. EPA plans to analyze pathways
and routes of exposure that may occur during the varied identified consumer activities and uses. The
supporting rationale for consumer pathways considered for di-ethylhexyl phthalate are included in
Appendix G.
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CONSUMl K V< IIMII1 s&
1 SFS
F.XPOSI'RK
PATHWAY
KXPOSURK
ROUTE
RECEPTORS
\KIK 1 IS
Bmkin £ (, mWH UlOll MtCo\eiv.d F1
Eicctrica' md! ioo'.Miic Products
^ Direct
Coalacl Motiihii
F.vhuv T.xhk, .udU'.H
ProducN iici Ct^ciod f Kevshei
T U rtttUK ilftd ro.iissbliigs
1101 i. t ed Ll"s
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2.6.3 Conceptual Model for Environmental Releases and Wastes: Potential Exposures
and Hazards (Regulatory Overlay)
In this section, EPA presents the conceptual models describing the identified exposures (pathways and
routes from environmental releases and wastes) and hazards to general population and environmental
receptors associated with the conditions of use of di-ethylhexyl phthalate within the scope of the risk
evaluation. This section also discusses those pathways that may be addressed pursuant to other EPA-
administered laws.
The conceptual model in Figure 2-15 presents the potential exposure pathways, exposure routes and
hazards to general population and environmental receptors from releases and waste streams associated
with industrial, commercial and consumer uses of di-ethylhexyl phthalate. The conceptual model shows
the overlays, labeled and shaded to depict the regulatory under EPA-administered statutes and associated
pathways that EPA considered for the scope of the risk evaluation. The regulatory programs that cover
these environmental release and waste pathways are further described in Section 2.6.3.1.
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RELEASES AND WASTES FROM
INDUSTRIAL / COMMERCIAL /
CONSUMER USES
EXPOSURE PATHWAYS
EXPOSURE
ROUTES
RECEPTORS
CWA-AWQC
SDWA
Water. Sediment
Indirect discharge
Aquatic
Species
Oral
RCRA-IIazList
Biosolids
Land
Disposal
General
Population
Dermal
Ground
Water
CAA-HAP
Inhalation
Fugitive Emissions
Air
Terrestrial
Species
^ Underground
Injection
Emissions to Air
L>
Off-site Waste
Transfer
Recycling, Other
Treatment
Hazardous and
Municipal Waste
Landfill
Industrial Pre-
Treatment or
Industrial WWT
Wastewater or
Liquid Wastes
Liquid Wastes
Solid Wastes
Hazardous and
Municipal Waste
Incinerators
Hazards Potentially
Associated with
Acute and/or Chronic
Exposures
Figure 2-15. Di-ethylhexyl Phthalate Conceptual Model for Environmental Releases and Wastes: Environmental and General
Population Exposures and Hazards (Regulatory Overlay)
The conceptual model presents the exposure pathways, exposure routes and hazards to human and environmental receptors from releases and wastes from
industrial, commercial, and consumer uses of Di-ethylhexyl phthalate including the environmental statutes covering those pathways.
a) Industrial wastewater or liquid wastes may be treated on-site and then released to surface water (direct discharge), or pre-treated and released to
Publicly Owned Treatment Works (POTW) (indirect discharge). For consumer uses, such wastes may be released directly to POTW. Drinking water
will undergo further treatment in drinking water treatment plant. Ground water may also be a source of drinking water. Inhalation from drinking water
may occur via showering
b) Receptors include PESS (see Section 2.5).
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2.6.3.1 Exposure Pathways and Risks Addressed by Other EPA Administered
Statutes
In its TSCA Section 6(b) risk evaluations, EPA is coordinating action on certain exposure pathways and
risks falling under the jurisdiction of other EPA-administered statutes or regulatory programs. More
specifically, EPA is exercising its TSCA authorities to tailor the scope of its risk evaluations, rather than
focusing on environmental exposure pathways addressed under other EPA-administered statutes or
regulatory programs or risks that could be eliminated or reduced to a sufficient extent by actions taken
under other EPA-administered laws. EPA considers this approach to be a reasonable exercise of the
Agency's TSCA authorities, which include:
o TSCA Section 6(b)(4)(D): "The Administrator shall, not later than 6 months after the initiation
of a risk evaluation, publish the scope of the risk evaluation to be conducted, including the
hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations
the Administrator expects to consider.
o TSCA Section 9(b)(1): "The Administrator shall coordinate actions taken under this chapter with
actions taken under other Federal laws administered in whole or in part by the Administrator. If
the Administrator determines that a risk to health or the environment associated with a chemical
substance or mixture could be eliminated or reduced to a sufficient extent by actions taken under
the authorities contained in such other Federal laws, the Administrator shall use such authorities
to protect against such risk unless the Administrator determines, in the Administrator's
discretion, that it is in the public interest to protect against such risk by actions taken under this
chapter."
o TSCA Section 9(e): "...[I]f the Administrator obtains information related to exposures or
releases of a chemical substance or mixture that may be prevented or reduced under another
Federal law, including a law not administered by the Administrator, the Administrator shall
make such information available to the relevant Federal agency or office of the Environmental
Protection Agency."
o TSCA Section 2(c): "It is the intent of Congress that the Administrator shall carry out this
chapter in a reasonable and prudent manner, and that the Administrator shall consider the
environmental, economic, and social impact of any action the Administrator takes or proposes as
provided under this chapter."
o TSCA Section 18(d)(1): "Nothing in this chapter, nor any amendment made by the Frank R.
Lautenberg Chemical Safety for the 21st Century Act, nor any rule, standard of performance,
risk evaluation, or scientific assessment implemented pursuant to this chapter, shall affect the
right of a State or a political subdivision of a State to adopt or enforce any rule, standard of
performance, risk evaluation, scientific assessment, or any other protection for public health or
the environment that— (i) is adopted or authorized under the authority of any other Federal law
or adopted to satisfy or obtain authorization or approval under any other Federal law.
These TSCA authorities supporting tailored risk evaluations and intra-agency referrals are described in
more detail below:
TSCA Section 6(b)(4)(D)
TSCA Section 6(b)(4)(D) requires EPA, in developing the scope of a risk evaluation, to identify the
hazards, exposures, conditions of use, and PESS the Agency "expects to consider" in a risk evaluation.
This language suggests that EPA is not required to consider all conditions of use, hazards, or exposure
pathways in risk evaluations. As EPA explained in the Procedures for Chemical Risk Evaluation Under
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the Amended Toxic Substances Control Act (82 FR 33726, July 20, 2017) ("Risk Evaluation Rule"),
"EPA may, on a case-by-case basis, tailor the scope of the risk evaluation . .in order to focus its
analytical efforts on those exposures that are likely to present the greatest concern, and consequently
merit an unreasonable risk determination." 82 FR 33726, 33729 (July 20, 2017).
In the problem formulation documents for many of the first 10 chemicals undergoing risk evaluation,
EPA applied the same authority and rationale to certain exposure pathways, explaining that "EPA is
planning to exercise its discretion under TSCA 6(b)(4)(D) to focus its analytical efforts on exposures
that are likely to present the greatest concern and consequently merit a risk evaluation under TSCA, by
excluding, on a case-by-case basis, certain exposure pathways that fall under the jurisdiction of other
EPA-administered statutes." This is informed by the legislative history of the amended TSCA, which
supports the Agency's exercise of discretion to focus the risk evaluation on areas that raise the greatest
potential for risk. See June 7, 2016 Cong. Rec., S3519-S3520. Consistent with the approach articulated
in the problem formulation documents, and as described in more detail below, EPA is exercising its
authority under TSCA to tailor the scope of exposures evaluated in TSCA risk evaluations, rather than
focusing on environmental exposure pathways addressed under other EPA-administered, media-specific
statutes and regulatory programs.
TSCA Section 9(b)(1)
In addition to TSCA Section 6(b)(4)(D), the Agency also has discretionary authority under the first
sentence of TSCA Section 9(b)(1) to "coordinate actions taken under [TSCA] with actions taken under
other Federal laws administered in whole or in part by the Administrator." This broad, freestanding
authority provides for intra-agency coordination and cooperation on a range of "actions." In EPA's
view, the phrase "actions taken under [TSCA]" in the first sentence of Section 9(b)(1) is reasonably read
to encompass more than just risk management actions, and to include actions taken during risk
evaluation as well. More specifically, the authority to coordinate intra-agency actions exists regardless
of whether the Administrator has first made a definitive finding of risk, formally determined that such
risk could be eliminated or reduced to a sufficient extent by actions taken under authorities in other
EPA-administered Federal laws, and/or made any associated finding as to whether it is in the public
interest to protect against such risk by actions taken under TSCA. TSCA Section 9(b)(1) therefore
provides EPA authority to coordinate actions with other EPA offices without ever making a risk finding
or following an identification of risk. This includes coordination on tailoring the scope of TSCA risk
evaluations to focus on areas of greatest concern rather than exposure pathways addressed by other
EPA-administered statutes and regulatory programs, which does not involve a risk determination or
public interest finding under TSCA Section 9(b)(2).
In a narrower application of the broad authority provided by the first sentence of TSCA Section 9(b)(1),
the remaining provisions of Section 9(b)(1) provide EPA authority to identify risks and refer certain of
those risks for action by other EPA offices. Under the second sentence of Section 9(b)(1), "[i]f the
Administrator determines that a risk to health or the environment associated with a chemical substance
or mixture could be eliminated or reduced to a sufficient extent by actions taken under the authorities
contained in such other Federal laws, the Administrator shall use such authorities to protect against such
risk unless the Administrator determines, in the Administrator's discretion, that it is in the public interest
to protect against such risk by actions taken under [TSCA]." Coordination of intra-agency action on
risks under TSCA Section 9(b)(1) therefore entails both an identification of risk, and a referral of any
risk that could be eliminated or reduced to a sufficient extent under other EPA-administered laws to the
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EPA office(s) responsible for implementing those laws (absent a finding that it is in the public interest to
protect against the risk by actions taken under TSCA).
Risk may be identified by OPPT or another EPA office, and the form of the identification may vary. For
instance, OPPT may find that one or more conditions of use for a chemical substance present(s) a risk to
human or ecological receptors through specific exposure routes and/or pathways. This could involve a
quantitative or qualitative assessment of risk based on reasonably available information (which might
include, e.g., findings or statements by other EPA offices or other federal agencies). Alternatively, risk
could be identified by another EPA office. For example, another EPA office administering non-TSCA
authorities may have sufficient monitoring or modeling data to indicate that a particular condition of use
presents risk to certain human or ecological receptors, based on expected hazards and exposures. This
risk finding could be informed by information made available to the relevant office under TSCA Section
9(e), which supports cooperative actions through coordinated information-sharing.
Following an identification of risk, EPA would determine if that risk could be eliminated or reduced to a
sufficient extent by actions taken under authorities in other EPA-administered laws. If so, TSCA
requires EPA to "use such authorities to protect against such risk," unless EPA determines that it is in
the public interest to protect against that risk by actions taken under TSCA. In some instances, EPA may
find that a risk could be sufficiently reduced or eliminated by future action taken under non-TSCA
authority. This might include, e.g., action taken under the authority of the Safe Drinking Water Act
(SDWA) to address risk to the general population from a chemical substance in drinking water,
particularly if the Office of Water has taken preliminary steps such as listing the subject chemical
substance on the Contaminant Candidate List (CCL). This sort of risk finding and referral could occur
during the risk evaluation process, thereby enabling EPA to use more a relevant and appropriate
authority administered by another EPA office to protect against hazards or exposures to affected
receptors.
Legislative history on TSCA Section 9(b)(1) supports both broad coordination on current intra-agency
actions, and narrower coordination when risk is identified and referred to another EPA office for action.
A Conference Report from the time of TSCA's passage explained that Section 9 is intended "to assure
that overlapping or duplicative regulation is avoided while attempting to provide for the greatest
possible measure of protection to health and the environment." S. Rep. No. 94-1302 at 84. See also H.
Rep. No. 114-176 at 28 (stating that the 2016 TSCA amendments "reinforce TSCA's original purpose of
filling gaps in Federal law," and citing new language in Section 9(b)(2) intended "to focus the
Administrator's exercise of discretion regarding which statute to apply and to encourage decisions that
avoid confusion, complication, and duplication"). Exercising TSCA Section 9(b)(1) authority to
coordinate on tailoring TSCA risk evaluations is consistent with this expression of Congressional intent.
Legislative history also supports a reading of Section 9(b)(1) under which EPA coordinates intra-agency
action, including information-sharing under TSCA Section 9(e), and the appropriately positioned EPA
office is responsible for the identification of risk and actions to protect against such risks. See, e.g.,
Senate Report 114-67, 2016 Cong. Rec. S3522 (under TSCA Section 9, "if the Administrator finds that
disposal of a chemical substance may pose risks that could be prevented or reduced under the Solid
Waste Disposal Act, the Administrator should ensure that the relevant office of EPA receives that
information"); H. Rep. No. 114-176 at 28, 2016 Cong. Rec. S3522 (under Section 9, "if the
Administrator determines that a risk to health or the environment associated with disposal of a chemical
substance could be eliminated or reduced to a sufficient extent under the Solid Waste Disposal Act, the
Administrator should use those authorities to protect against the risk"). Legislative history on Section
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9(b)(1) therefore supports coordination with and referral of action to other EPA offices, especially when
statutes and associated regulatory programs administered by those offices could address exposure
pathways or risks associated with conditions of use, hazards, and/or exposure pathways that may
otherwise be within the scope of TSCA risk evaluations.
TSCA Sections 2(c) and 18(d)
Finally, TSCA Section 2(c) supports coordinated action on exposure pathways and risks addressed by
other EPA-administered statutes and regulatory programs. Section 2(c) directs EPA to carry out TSCA
in a "reasonable and prudent manner" and to consider "the environmental, economic, and social impact"
of its actions under TSCA. Legislative history from around the time of TSCA's passage indicates that
Congress intended EPA to consider the context and take into account the impacts of each action under
TSCA. S. Rep. No. 94-698 at 14 ("the intent of Congress as stated in this subsection should guide each
action the Administrator takes under other sections of the bill").
Section 18(d)(1) specifies that state actions adopted or authorized under any Federal law are not
preempted by an order of no unreasonable risk issued pursuant to TSCA Section 6(i)(l) or a rule to
address unreasonable risk issued under TSCA Section 6(a). Thus, even if a risk evaluation were to
address exposures or risks that are otherwise addressed by other federal laws and, for example,
implemented by states, the state laws implementing those federal requirements would not be preempted.
In such a case, both the other federal and state laws, as well as any TSCA Section 6(i)(l) order or TSCA
Section 6(a) rule, would apply to the same issue area. See also TSCA Section 18(d)(l)(A)(iii). In
legislative history on amended TSCA pertaining to Section 18(d), Congress opined that "[t]his approach
is appropriate for the considerable body of law regulating chemical releases to the environment, such as
air and water quality, where the states have traditionally had a significant regulatory role and often have
a uniquely local concern." Sen. Rep. 114-67 at 26.
EPA's careful consideration of whether other EPA-administered authorities are available, and more
appropriate, for addressing certain exposures and risks is consistent with Congress' intent to maintain
existing federal requirements and the state actions adopted to locally and more specifically implement
those federal requirements, and to carry out TSCA in a reasonable and prudent manner. EPA believes it
is both reasonable and prudent to tailor TSCA risk evaluations, rather than attempt to evaluate and
regulate potential exposures and risks from those media under TSCA. This approach furthers
Congressional direction and EPA aims to efficiently use Agency resources, avoid duplicating efforts
taken pursuant to other Agency programs, and meet the statutory deadline for completing risk
evaluations.
EPA-administered statutes and regulatory programs that address specific exposure pathways and/or risks
are listed as follows:
Ambient Air Pathway
The Clean Air Act (CAA) contains a list of hazardous air pollutants (HAP) and provides EPA with the
authority to add to that list pollutants that present, or may present, a threat of adverse human health
effects or adverse environmental effects. For stationary source categories emitting HAP, the CAA
requires issuance of technology-based standards and, if necessary, additions or revisions to address
developments in practices, processes, and control technologies, and to ensure the standards adequately
protect public health and the environment. The CAA thereby provides EPA with comprehensive
authority to regulate emissions to ambient air of any hazardous air pollutant, di-ethylhexyl phthalate is a
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HAP. See 42 U.S.C. 7412. EPA has issued a number of technology-based standards for source
categories that emit di-ethylhexyl phthalate to ambient air and, as appropriate, has reviewed, or is in the
process of reviewing remaining risks. See 40 CFR part 63.
Emission pathways to ambient air from commercial and industrial stationary sources and associated
inhalation exposure of the general population or terrestrial species in this TSCA evaluation from
stationary source releases of di-ethylhexyl phthalate to ambient air are covered under the jurisdiction of
the CAA. EPA's Office of Air and Radiation and Office of Pollution Prevention and Toxics will
continue to work together to provide an understanding and analysis of the CAA regulatory analytical
processes and to exchange information related to toxicity and occurrence data on chemicals undergoing
risk evaluation under TSCA. As such, EPA does not plan to evaluate exposures to the general population
from ambient air in the risk evaluation under TSCA. This regulatory coverage is represented by the red
shading in Figure 2-15
Drinking Water Pathway
EPA has regular analytical processes to identify and evaluate unregulated drinking water contaminants
of potential regulatory concern for public water systems under the SDWA. In addition, the SDWA
requires EPA to review and revise "as appropriate" existing drinking water regulations every 6 years.
EPA has promulgated National Primary Drinking Water Regulations (NPDWRs) under the SDWA for
di-ethylhexyl phthalate. See 40 CFR part 151. EPA has set an enforceable Maximum Contaminant Level
(MCL) as close as feasible to a health based, non-enforceable Maximum Contaminant Level Goal
(MCLG). Public water systems are required to monitor for the regulated chemical based on a
standardized monitoring schedule to ensure compliance with the MCL. The MCL for di-ethylhexyl
phthalate in water is 0.006 mg/L and the MCLG is 0 mg/L.
Hence, because the drinking water exposure pathway for di-ethylhexyl phthalate is currently addressed
in the SDWA regulatory analytical process for public water systems, EPA does not plan to evaluate
exposures to the general population from the drinking water exposure pathway in the risk evaluation for
di-ethylhexyl phthalate under TSCA. This regulatory coverage is represented by the dark blue shading in
Figure 2-15. EPA's Office of Water and Office of Pollution Prevention and Toxics will continue to work
together providing understanding and analysis of the SDWA regulatory analytical processes and to
exchange information related to toxicity and occurrence data on chemicals undergoing risk evaluation
under TSCA.
Ambient Water Pathway
EPA has developed Clean Water Act (CWA) Section 304(a) recommended human health criteria for 122
chemicals and aquatic life criteria for 47 chemicals. A subset of these chemicals is identified as "priority
pollutants" (103 human health and 27 aquatic life), including di-ethylhexyl phthalate. The CWA
requires that states adopt numeric criteria for priority pollutants for which EPA has published
recommended criteria under Section 304(a), the discharge or presence of which in the affected waters
could reasonably be expected to interfere with designated uses adopted the state. For pollutants with
recommended human health criteria, EPA regulations require that state criteria contain sufficient
parameters and constituents to protect designated uses. Once states adopt criteria as water quality
standards, the CWA requires that National Pollutant Discharge Elimination System (NPDES) discharge
permits include effluent limits as stringent as necessary to meet standards CWA Section 301(b)(1)(C).
This permit issuance process accounts for risk in accordance with the applicable ambient water exposure
pathway (human health or aquatic life as applicable) for the designated water use.
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EPA develops recommended water quality criteria under Section 304(a) of the Clean Water Act (CWA)
for pollutants in surface water that are protective of aquatic life or human health designated uses. EPA
has developed recommended water quality criteria for protection of human health for di-ethylhexyl
phthalate which are available for possible adoption into state water quality standards and are available
for possible use by National Pollution Discharge Elimination System (NPDES) permitting authorities in
deriving effluent limits to meet state narrative and/or numeric criteria. See, e.g., 40 CFR part 423,
Appendix A; 40 CFR 131.11(b)(1); 40 CFR 122.44(d)(l)(vi). As such, EPA does not plan to evaluate
exposures to the general population from surface water in the risk evaluation under TSCA. This
regulatory coverage is represented by the light blue shading in Figure 2-15. EPA's OW and OPPT will
continue to work together providing understanding and analysis of the CWA water quality criteria
development process and to exchange information related to toxicity of chemicals undergoing risk
evaluation under TSCA. EPA may update its CWA Section 304(a) water quality criteria for di-
ethylhexyl phthalate in the future under the CWA.
For pollutants with recommended human health criteria, EPA regulations require that state criteria
contain sufficient parameters and constituents to protect designated uses. Once states adopt criteria as
water quality standards, the CWA requires that NPDES discharge permits include effluent limits as
stringent as necessary to meet standards CWA Section 301(b)(1)(C). This permit issuance process
accounts for risk in accordance with the applicable ambient water exposure pathway (human health or
aquatic life as applicable) for the designated water. As such, EPA is not evaluating exposures to the
general population from surface water in the risk evaluation under TSCA. This regulatory coverage is
represented by the light blue shading in Figure 2-15.
EPA has not developed CWA Section 304(a) recommended water quality criteria for the protection of
aquatic life for di-ethylhexyl phthalate, so there are no national recommended criteria for this use
available for adoption into state water quality standards and available for use in NPDES permits. As
such, EPA is evaluating exposures to aquatic species from surface water in the risk evaluation under
TSCA. The Office of Water may issue CWA Section 304(a) aquatic life criteria for dz-ethylhexyl
phthalate in the future.
Onsite Releases to Land Pathway
The Comprehensive Environmental Response, Compensation, and Liability Act, otherwise known as
CERCLA, provides broad authority under the statute (generally referred to as Superfund) to clean up
uncontrolled or abandoned hazardous-waste sites as well as accidents, spills, and other releases of
hazardous substances, pollutants and contaminants into the environment. Through CERCLA, EPA was
given authority to seek out those parties potentially responsible for the release of hazardous substances
and either have them clean up the release or compensate the Federal government for undertaking the
response action.
CERCLA Section 101(14) defines "hazardous substance" by referencing other environmental statutes,
including toxic pollutants listed under CWA Section 307(a); hazardous substances designated pursuant
to CWA Section 311(b)(2)(A); hazardous air pollutants listed under CAA Section 112; imminently
hazardous substances with respect to which EPA has taken action pursuant to TSCA Section 7; and
hazardous wastes having characteristics identified under or listed pursuant to RCRA Section 3001. See
40 CFR 302.4. CERCLA Section 102(a) also 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. EPA must also promulgate
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regulations establishing the quantity of any hazardous substance the release of which must be reported
under Section 103. Section 103 requires persons in charge of vessels or facilities to report to the
National Response Center if they have knowledge of a release of a hazardous substance above the
reportable quantity threshold.
Jz-Ethylhexyl phthalate is a hazardous substance under CERCLA. Releases of Jz-ethylhexyl phthalate in
excess of 100 pounds within a 24-hour period must be reported (40 CFR 302.4, 302.6). The scope of this
EPA TSCA risk evaluation does not include on-site releases of di-ethylhexyl phthalate to the
environment at Superfund sites and subsequent exposure of the general population or non-human
species.
Disposal and Soil Pathways
J/'-Ethylhexyl phthalate is included on the list of hazardous wastes pursuant to the Resource
Conservation and Recovery Act (RCRA) Section 3001 (40 CFR § 261.33) as a listed waste on the U list
(U070). The general standard in Section RCRA 3004(a) for the technical criteria that govern the
management (treatment, storage, and disposal) of hazardous waste are those "necessary to protect human
health and the environment," RCRA 3004(a). The regulatory criteria for identifying "characteristic"
hazardous wastes and for "listing" a waste as hazardous also relate solely to the potential risks to human
health or the environment (40 CFR §§ 261.11, 261.21-261.24). RCRA statutory criteria for identifying
hazardous wastes require EPA to "tak[eJ into account toxicity, persistence, and degradability in nature,
potential for accumulation in tissue, and other relatedfactors such as flammability, corrosiveness, and
other hazardous characteristicsSubtitle C controls cover not only hazardous wastes that are landfilled,
but also hazardous wastes that are incinerated (subject to joint control under RCRA Subtitle C and the
CAA hazardous waste combustion Maximum Achievable Control Technology (MACT)) or injected into
Underground Injection Control (UIC) Class I hazardous waste wells (subject to joint control under
Subtitle C and the SDWA).8
The disposal of di-ethylhexyl phthalate as a constituent of produced water primarily falls under the
jurisdiction of the Safe Drinking Water Act. Most of the produced water (about 93% in 2012) is injected
in Class II wells, which are regulated under the Underground Injection Control Program of the Safe
Drinking Water Act (42 U.S.C. § 300f; 40 CFR pt. 146, Subpart C). As a result, EPA is not evaluating
exposures of the general population or the environment from the disposal of di-ethylhexyl phthalate as a
constituent of produced water in Class II wells.
EPA does not plan to evaluate emissions to ambient air from municipal and industrial waste incineration
and energy recovery units that form combustion by-products from incineration treatment of di-
ethylhexyl phthalate wastes or associated exposures to the general population in the risk evaluation, as
those emissions are subject to CAA regulations, as would di-ethylhexyl phthalate burned for energy
recovery. See 40 CFR part 60.
EPA does not plan to evaluate on-site releases to land that go to underground injection or associated
exposures to the general population or terrestrial species in its risk evaluation. TRI reporting in 2018
indicated 5 pounds released to underground injection to a Class I well (Table 2-5). Environmental
disposal of di-ethylhexyl phthalate injected into Class I hazardous well types fall under the jurisdiction
of RCRA and SDWA; and the disposal of di-ethylhexyl phthalate via underground injection to Class I
8 This is not an exclusive list of Subtitle C authority, as it also covers, for example, disposal to surface impoundments, waste
piles, and land treatment.
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hazardous waste wells is not likely to result in environmental and general population exposures. See 40
CFR parts 144.
EPA has identified releases to land that go to RCRA Subtitle C hazardous waste landfills in the risk
evaluation. Based on 2018 reporting, TRI land disposal includes Subtitle C landfills (22,909 lbs) with
another 619,423 lbs transferred to "all other land disposal" both on-site and off-site (Table 2-5). Di-
ethylhexyl phthalate is present in commercial and consumer products that may be disposed of in
landfills, such as Municipal Solid Waste landfills. Design standards for Subtitle C landfills require
double liner, double leachate collection and removal systems, leak detection system, run on, runoff, and
wind dispersal controls, and a construction quality assurance program. They are also subject to closure
and post-closure care requirements including installing and maintaining a final cover, continuing
operation of the leachate collection and removal system until leachate is no longer detected, maintaining
and monitoring the leak detection and groundwater monitoring system. Bulk liquids may not be
disposed in Subtitle C landfills. Subtitle C landfill operators are required to implement an analysis and
testing program to ensure adequate knowledge of waste being managed, and to train personnel on
routine and emergency operations at the facility. Hazardous waste being disposed in Subtitle C landfills
must also meet RCRA waste treatment standards before disposal. See 40 CFR part 264. As a result, EPA
does not plan to evaluate on-site releases to land from RCRA Subtitle C hazardous waste landfills or
exposures of the general population or terrestrial species from such releases in the TSCA evaluation.
This regulatory coverage is represented by the pink shading in Figure 2-15.
Evaporation ponds, percolation pits and tanks can also be used for the disposal of di-ethylhexyl
phthalate when it is disposed of as a constituent in produced water. On-site releases of di-ethylhexyl
phthalate in such a manner fall under the jurisdiction of RCRA subtitle D (see 40 CFR pt. 257). As such,
EPA is not evaluating exposures of the general population or terrestrial species from such on-site
releases to evaporation ponds, percolation pits, or tanks.
EPA does not plan to evaluate on-site releases to land from RCRA Subtitle D municipal solid waste
(MSW) landfills or exposures of the general population or terrestrial species from such releases in the
TSCA evaluation. Di-ethylhexyl phthalate is present in commercial and consumer products that may be
disposed of in landfills, such as Municipal Solid Waste (MSW) landfills. On-site releases to land from
RCRA Subtitle D municipal solid waste landfills leading to exposures of the general population
(including susceptible populations) or terrestrial species from such releases in this TSCA evaluation may
occur. While permitted and managed by the individual states, municipal solid waste (MSW) landfills are
required by federal regulations to implement some of the same requirements as Subtitle C landfills.
MSW landfills generally must have a liner system with leachate collection and conduct groundwater
monitoring and corrective action when releases are detected. MSW landfills are also subject to closure
and post-closure care requirements and must have financial assurance for funding of any needed
corrective actions. MSW landfills have also been designed to allow for the small amounts of hazardous
waste generated by households and very small quantity waste generators (less than 220 lbs per month).
Bulk liquids, such as free solvent, may not be disposed of at MSW landfills. See 40 CFR part 258. As a
result, EPA does not plan to evaluate on-site releases to land from RCRA Subtitle D municipal solid
waste (MSW) landfills or exposures of the general population or terrestrial species from such releases in
the TSCA evaluation. This regulatory coverage is represented by the pink shading in Figure 2-15.
EPA does not plan to evaluate on-site releases to land from industrial non-hazardous waste and
construction/demolition waste landfills or associated exposures to the general population in the
methylene chloride risk evaluation. On-site releases to land may occur from industrial non-hazardous
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and construction/demolition waste landfills. Industrial non-hazardous and construction/demolition waste
landfills are primarily regulated under authorized state regulatory programs. States must also implement
limited federal regulatory requirements for siting, groundwater monitoring, and corrective action, and a
prohibition on open dumping and disposal of bulk liquids. States may also establish additional
requirements such as for liners, post-closure and financial assurance, but are not required to do so. As a
result, EPA is not evaluating on-site releases to land from industrial non-hazardous waste and
construction/demolition waste landfills or associated exposures to the general population. See e.g.,
RCRA Section 3004(c), 4007; 40 CFR part 257. As a result, EPA does not plan to evaluate on-site
releases to land from industrial non-hazardous waste and construction/demolition waste landfills or
associated exposures to the general population. This regulatory coverage is represented by the pink
shading in Figure 2-15.
2.6.3.2 Conceptual Model for Environmental Releases and Wastes: Potential
Exposures and Hazards
As described in Section 2.6.3.1, some pathways in the conceptual models are covered under the
jurisdiction of other environmental statutes administered by EPA. The conceptual model depicted in
Figure 2-16 presents the exposure pathways, exposure routes and hazards to general population and
environmental receptors from releases and wastes from industrial, commercial, and consumer uses of di-
ethylhexyl phthalate that EPA plans to evaluate.
The diagram shown in Figure 2-16 includes releases from industrial, commercial and/or consumer uses
to water/sediment, biosolids and soil, via direct and indirect discharges to water, that may lead to
exposure to aquatic receptors. The supporting basis for environmental pathways considered for di-
ethylhexyl phthalate are included in Appendix H.
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RELEASES AND WASTES FROM EXPOSURE
INDUSTRIAL COMMERCIAL / EXPOSURE PATHW AYS ROUTES RECEPTORS HAZARDS
CONSUMER USES
Industrial Pre-
Treatment or
Industrial WWT
Indirect discharge
Wastewater or
Liquid Wastes
POTW
1 Water. Sediment
Biosolids
Land
Disposal
i
Soil
Aquatic
Species
Hazards Potentially
Associated with
Acute and or Chronic
Exposures
Ground
Water
Figure 2-16. Di-ethylhexyl Phthalate Conceptual Model for Environmental Releases and Wastes: Environmental Exposures and Hazards
The conceptual model presents the exposure pathways, exposure routes and hazards to human and environmental receptors from releases and wastes from industrial, commercial, and
consumer uses of di-ethylhexyl phthalate that EPA plans to consider in risk evaluation.
a) Industrial wastewater or liquid wastes may be treated on-site and then released to surface water (direct discharge), or pre-treated and released to POTW (indirect discharge). For consumer
uses, such wastes may be released directly to POTW.
b) Receptors include PESS (see Section 2.5).
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2.7 Analysis Plan
The analysis plan is based on EPA's knowledge di-ethylhexyl phthalate resulting from the full-text
screening of reasonably available information as described in Section 2.1. EPA encourages submission
of additional existing data, such as full study reports or workplace monitoring from industry sources,
that may be relevant to EPA's evaluation of conditions of use, exposures, hazards and PESS during risk
evaluation. As discussed in the Application of Systematic Review in TSCA Risk Evaluations document
(U.S. EPA. 2018). targeted supplemental searches during the analysis phase may be necessary to
identify additional information (e.g., commercial mixtures) for the risk evaluation of di-ethylhexyl
phthalate. For any additional data needs identified during the risk evaluation, EPA may use the
Agency's TSCA authorities under Sections 4, 8 or 11, as appropriate.
2.7.1 Physical and Chemical Properties and Environmental Fate
EPA plans to analyze the physical and chemical properties and environmental fate and transport of di-
ethylhexyl phthalate as follows:
1) Review reasonably available measured or estimated physical and chemical properties and
environmental fate endpoint data collected using systematic review procedures and, where
reasonably available, environmental assessments conducted by other regulatory agencies.
EPA plans to evaluate data and information collected through the systematic review methods and
public comments about the physical and chemical properties (Appendix B) and fate endpoints
(Appendix C), some of which appeared in the Proposed Designation of Di-Ethylhexyl Phthalate
(CASRN117-81-7) as a High-Priority Substance for Risk Evaluation (U.S. EPA. 2Q19e). All
sources cited in EPA's analysis will be evaluated according to the procedures and metrics
described in the Application of Systematic Review in TSCA Risk Evaluations ( 518).
Where the systematic review process does not identify experimentally measured chemical
property values of sufficiently high quality, testing will be requested under the TSCA Section 4
authority, or values will be estimated using chemical parameter estimation models as
appropriate. Model-estimated fate properties will be reviewed for applicability and quality.
2) Using measured data and/or modeling, determine the influence of physical and chemical
properties and environmental fate endpoints (e.g., persistence, bioaccumulation,
partitioning, transport) on exposure pathways and routes of exposure to human and
environmental receptors.
Measured data and, where necessary, model predictions of physical and chemical properties and
environmental fate endpoints will be used to characterize the persistence and movement of di-
ethylhexyl phthalate within and across environmental media. The fate endpoints of interest
include volatilization, sorption to organic matter in soil and sediments, water solubility, aqueous
and atmospheric photolysis rates, aerobic and anaerobic biodegradation rates, and potential
bioconcentration and bioaccumulation. These endpoints will be used in exposure calculations.
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3) Conduct a weight of the scientific evidence evaluation of physical and chemical properties
and environmental fate data, including qualitative and quantitative sources of information.
During risk evaluation, EPA plans to evaluate and integrate the physical and chemical properties
and environmental fate evidence identified in the literature inventory using the methods
described in the Application of Systematic Review in TSCA Risk Evaluations (U.S. EPA. 2018).
2.7.2 Exposure
EPA plans to analyze exposure levels for indoor air, ambient air, surface water, groundwater, sediment,
and aquatic biota associated to exposure to di-ethylhexyl phthalate. Based on the physical and chemical
properties, expected sources, and transport and transformation within the outdoor and indoor
environment, di-ethylhexyl phthalate is more likely to be present in some of these media and less likely
to be present in others. EPA has not yet determined the exposure levels in these media. Exposure
level(s) can be characterized through a combination of reasonably available monitoring data and
estimated exposure levels from modeling approaches. Exposure scenarios are combinations of sources
(uses), exposure pathways, and exposed receptors. Draft exposure scenarios corresponding to various
conditions of use for di-ethylhexyl phthalate are presented in Appendix F, Appendix G and Appendix H.
EPA plans to analyze scenario-specific exposures.
2.7.2.1 Environmental Releases
EPA plans to analyze releases to environmental media as follows:
1) Review reasonably available published literature and other reasonably available
information on processes and activities associated with the conditions of use to analyze the
types of releases and wastes generated.
EPA has reviewed some key data sources containing information on processes and activities
resulting in releases, and the information found is described in Appendix E. EPA plans to review
additional data sources identified. Potential sources of environmental release data are
summarized in Table 2-6 below:
Table 2-6. Categories and Sources of Environmental Release Data
U.S. EPA TRI Data
U.S. EPA Generic Scenarios
OECD Emission Scenario Documents
Discharge Monitoring Report (DMR) surface water discharge data from NPDES-permitted facilities
National Emissions Inventory (NEI) data
2) Review reasonably available chemical-specific release data, including measured or
estimated release data (e.g., data from risk assessments by other environmental agencies).
EPA has reviewed key release data sources including the Toxics Release Inventory (TRI), and
the data from this source is summarized in Section 2.3.3. EPA plans to consider additional
reasonably available information and will evaluate it during development of the risk evaluation.
EPA plans to match identified data to applicable conditions of use and identify data gaps where
no data are found for particular conditions of use. EPA plans to attempt to address data gaps
identified as described in #3 and #4 below by considering potential surrogate data and models.
Additionally, for conditions of use where no measured data on releases are reasonably available,
EPA may use a variety of methods including release estimation approaches and assumptions in
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the Chemical Screening Tool for Exposures and Environmental Releases (ChemSTEER) (U.S.
).
3) Review reasonably available release data for surrogate chemicals that have similar uses
and physical properties.
EPA plans to review literature sources identified and if surrogate data are found, these data will
be matched to applicable conditions of use for potentially filling data gaps. Measured or
estimated release data for other phthalate esters may be considered as surrogates for di-
ethylhexyl phthalate.
4) Review reasonably available data that may be used in developing, adapting or applying
release models to the particular risk evaluation.
This item will be performed after completion of #2 and #3 above. EPA plans to evaluate relevant
data to determine whether the data can be used to develop, adapt or apply models for specific
conditions of use (and corresponding release scenarios). EPA has identified information from
various EPA statutes and sources (including, for example, regulatory limits, reporting thresholds
or disposal requirements) that may be relevant to consider for release estimation and
environmental exposures. EPA plans to consider relevant regulatory requirements in estimating
releases during risk evaluation.
5) Review and determine applicability of OECD Emission Scenario Documents (ESDs) and
EPA Generic Scenarios to estimation of environmental releases.
EPA has identified potentially relevant OECD Emission Scenario Documents (ESDs) and EPA
Generic Scenarios (GS) that correspond to some conditions of use; for example, the 2.009 ESP
on Adhesive Formulation (OEi M '09a). the 2}«n i 1 D on. Coating Application via Spray-
Painting in the Automotive Refinishing Industry (OF.( l'» hi), the 2011 ESP on Chemical
Indus ( ), the 2011 ESP on Radiation Curable Coating. Inks and Adhesives
0 ^ I' ' l> j, the 2015 ESP on the Use of Adhesives (OECP. 2.0151 and the 2009 Er U «>»
Plastic Additives (OECP. 2.009b) may be useful to assess potential releases. EPA plans to
critically review these generic scenarios and ESPs to determine their applicability to the
conditions of use assessed.
EPA Generic Scenarios are available at the following: https://www.epa.gov/tsca-screening-
tools/using-predictive-methods-assess-exposure-and-fate-under-tsca#fate.
OECP Emission Scenario Pocuments are available at the following:
http://www.oecd.org/chemicalsafetv/risk-assessment/emissionscenariodocuments.htm
If ESPs and GSs are not available, other methods may be considered. EPA may also perform
supplemental targeted searches of peer-reviewed or gray literature for applicable models and
associated parameters that EPA may use to estimate releases for certain conditions of use.
Additionally, for conditions of use where no measured data on releases are available, EPA may
use a variety of methods including the application of default assumptions such as standard loss
fractions associated with drum cleaning (3%) or single process vessel cleanout (1%).
6) Map or group each condition of use to a release assessment scenario(s).
EPA has identified release scenarios and mapped {i.e. grouped) them to relevant conditions of
use as shown in Appendix F. EPA plans to refine the mapping/grouping of release scenarios
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based on factors (e.g., process equipment and handling, magnitude of production volume used,
and exposure/release sources) corresponding to conditions of use using reasonably available
information. EPA may perform supplemental targeted searches of peer-reviewed or gray
literature to better understand certain conditions of use to further develop release scenarios.
7) Evaluate the weight of the scientific evidence of environmental release data.
During risk evaluation, EPA plans to evaluate and integrate the environmental release evidence
identified in the literature inventory using the methods described in the Application of Systematic
Review in TSCA Risk Evaluation (U.S. EPA. 2018). EPA plans to integrate the data using
systematic review methods to assemble the relevant data, evaluate the data for quality and
relevance, including strengths and limitations, followed by synthesis and integration of the
evidence.
2.7.2.2 Environmental Exposures
EPA plans to analyze the following in developing its environmental exposure assessment of di-
ethylhexyl phthalate:
1) Review reasonably available environmental and biological monitoring data for all media
relevant to environmental exposure.
For di-ethylhexyl phthalate, environmental media which EPA plans to analyze are sediment, air,
groundwater and surface water.
2) Review reasonably available information on releases to determine how modeled estimates
of concentrations near industrial point sources compare with reasonably available
monitoring data.
EPA plans to analyze and consider reasonably available environmental exposure models that
meet the scientific standards under TSCA Section 26(h) that estimate surface water, and
sediment concentrations will be analyzed and considered alongside reasonably available surface
water, sediment, and monitoring data to characterize environmental exposures. Modeling
approaches to estimate surface water concentrations, sediment concentrations may generally
include the following inputs: direct release into surface water, or sediment, and indirect release
into surface water, sediment, fate and transport (partitioning within media) and characteristics of
the environment (e.g., river flow, volume of lake, meteorological data).
3) Determine applicability of existing additional contextualizing information for any
monitored data or modeled estimates during risk evaluation.
Any studies which relate levels of di-ethylhexyl phthalate in the environment or biota with
specific sources or groups of sources will be evaluated. Review and characterize monitoring
data or modeled estimates to determine how representative they are of applicable use patterns.
4) Group each condition(s) of use to environmental assessment scenario(s).
Refine and finalize exposure scenarios for environmental receptors by considering combinations
of sources (use descriptors), exposure pathways including routes, and populations exposed. For
di-ethylhexyl phthalate, the following are noteworthy considerations in constructing exposure
scenarios for environmental receptors:
Estimates of surface water concentrations, and sediment concentrations near
industrial point sources based on reasonably available monitoring data.
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Consider the following modeling inputs: release into the media of interest, fate and
transport and characteristics of the environment.
Reasonably available biomonitoring data. Monitoring data could be used to compare
with species or taxa-specific toxicological benchmarks.
Applicability of existing additional contextualizing information for any monitored
data or modeled estimates during risk evaluation. Review and characterize the spatial
and temporal variability, to the extent that data are reasonably available, and
characterize exposed aquatic populations.
Weight of the scientific evidence of environmental occurrence data and modeled
estimates.
5) Evaluate the weight of the scientific evidence of environmental occurrence data and
modeled estimates.
During risk evaluation, EPA plans to evaluate and integrate the exposure evidence identified in
the literature inventory using the methods described in the Application of Systematic Review in
TSCA Risk Evaluations ( 018).
2.7.2.3 Occupational Exposures
EPA plans to analyze both worker and occupational non-user exposures as follows:
1) Review reasonably available exposure monitoring data for specific condition(s) of use.
EPA plans to review exposure data including workplace monitoring data collected by
government agencies such as the OSHA and the NIOSH, and monitoring data found in published
literature. These workplace monitoring data include personal exposure monitoring data (direct
exposures) and area monitoring data (indirect exposures).
EPA has identified additional data sources that may contain relevant monitoring data for the
various conditions of use. EPA plans to review these sources (identified in Table 2-7) and extract
relevant data for consideration and analysis during risk evaluation.
EPA plans to consider the influence of regulatory limits and recommended exposure guidelines
on occupational exposures set by OSHA, NIOSH, and ACGIH in the occupational exposure
assessment.
Table 2-7. Potential Sources of Occupational Exposure Data
2019 Draft ATSDR Toxicological Profile for DEHP
U.S. OSHA Chemical Exposure Health Data (CEHD) program data
U.S. NIOSH Health Hazard Evaluation (HHE) Program reports
2) Review reasonably available exposure data for surrogate chemicals that have uses,
volatility and physical and chemical properties similar to di-ethylhexyl phthalate.
EPA plans to review literature sources identified and if surrogate data are found, these data will
be matched to applicable conditions of use for potentially filling data gaps. EPA believes other
phthalate esters utilized in similar ways to di-ethylhexyl phthalate may serve as surrogates for di-
ethylhexyl phthalate.
3) For conditions of use where data are limited or not reasonably available, review existing
exposure models that may be applicable in estimating exposure levels.
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EPA has identified potentially relevant OECD ESDs and EPA GS corresponding to some
conditions of use. For example, the 2015 ESP on the Use of Adhesives (OEC ) and the
2009 ESP on Plastic Additives (OECD. 2009b) are some of the ESDs and GS's that EPA may
use to estimate occupational exposures. EPA plans to critically review these generic scenarios
and ESDs to determine their applicability to the conditions of use assessed. EPA may conduct
industry outreach or perform additional supplemental targeted searches of peer-reviewed or gray
literature to understand those conditions of use where ESDs or GS's were not identified, which
may inform the exposure scenarios. EPA may also need to perform such targeted supplemental
searches to identify applicable models that EPA may use to estimate exposures for certain
conditions of use.
4) Review reasonably available data that may be used in developing, adapting or applying
exposure models to a particular risk evaluation scenario.
This step will be performed after #2 and #3 are completed, and based on information developed
from #2 and #3, EPA plans to evaluate relevant data to determine whether the data can be used to
develop, adapt, or apply models for specific conditions of use (and corresponding exposure
scenarios). EPA may utilize existing, peer-reviewed exposure models developed by EPA, other
government agencies, or reasonably available in the scientific literature, or EPA may elect to
develop additional models to assess specific condition(s) of use. Inhalation exposure models may
be simple box models or two-zone (near-field/far-field) models. In two-zone models, the near-
field exposure represents potential inhalation exposures to workers, and the far-field exposure
represents potential inhalation exposures to occupational non-users.
5) Consider and incorporate applicable EC and/or PPE into exposure scenarios.
EPA plans to review potentially relevant data sources on EC and PPE to determine their
applicability and incorporation into exposure scenarios during risk evaluation. OSHA
recommends employers utilize the hierarchy of controls to address hazardous exposures in the
workplace. The hierarchy of controls strategy outlines, in descending order of priority, the use of
elimination, substitution, engineering controls, administrative controls, and lastly personal
protective equipment (PPE). EPA plans to assess worker exposure pre- and post-implementation
of EC, using reasonably available information on available control technologies and control
effectiveness. For example, EPA may assess worker exposure in industrial use scenarios before
and after implementation of local exhaust ventilation.
6) Map or group each condition of use to occupational exposure assessment scenario(s).
EPA has identified occupational exposure scenarios and mapped them to relevant conditions of
use (see Appendix F). As presented in Table Apx F-l, EPA has completed an initial mapping of
exposure scenarios to conditions of use. EPA plans to refine mapping or grouping of
occupational exposure scenarios based on factors (e.g., process equipment and handling,
magnitude of production volume used, and exposure/release sources) corresponding to
conditions of use as additional information is identified. EPA may perform supplemental
targeted searches of peer-reviewed or gray literature to better understand certain conditions of
use to further develop exposure scenarios.
7) Evaluate the weight of the scientific evidence of occupational exposure data, which may
include qualitative and quantitative sources of information.
During risk evaluation, EPA plans to evaluate and integrate the exposure evidence identified in
the literature inventory using the methods described in the Application of Systematic Review in
TSCA Risk Evaluations ( ). EPA plans to rely on the weight of the scientific
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evidence when evaluating and integrating occupational data. EPA plans to integrate the data
using systematic review methods to assemble the relevant data, evaluate the data for quality and
relevance, including strengths and limitations, followed by synthesis and integration of the
evidence.
2.7.2.4 Consumer Exposures
EPA plans to analyze both consumers using a consumer product and bystanders associated with the
consumer using the product as follows:
1) Group each condition of use to consumer exposure assessment scenario(s).
Refine and finalize exposure scenarios for consumers by considering combinations of sources
(ongoing consumer uses), exposure pathways including routes, and exposed populations.
For di-ethylhexyl phthalate, the following are noteworthy considerations in constructing
consumer exposure scenarios:
Conditions of use
Duration, frequency and magnitude of exposure
Weight fraction of chemical in products
Amount of chemical used
2) Evaluate the relative potential of indoor exposure pathways based on reasonably available
data.
Based on physical and chemical properties of di-ethylhexyl phthalate and the consumer uses
identified, inhalation of particles is expected to be an important indoor exposure pathway for
consumers. Other pathways include dust ingestion, mouthing of articles and dermal contact to
liquids or articles as a result of indoor use of di-ethylhexyl phthalate consumer products.
Inhalation of vapor and mist and oral ingestion of liquid and mist are also possible.
The data sources associated with the inhalation, oral, and dermal pathways have not been
comprehensively evaluated, so quantitative comparisons across exposure pathways have not yet
been made. EPA plans to review all reasonably available information in developing the
consumer exposure scenarios and evaluating the exposure pathways in indoor environments.
3) Review existing indoor exposure models that may be applicable in estimating indoor air
exposures.
Indoor exposure models that estimate emissions from use of consumer products are available.
These models generally consider physical and chemical properties (e.g., vapor pressure,
molecular weight), product specific properties (e.g., weight fraction of the chemical in the
product), use patterns (e.g., duration and frequency of use), user environment (e.g., room of use,
ventilation rates), and receptor characteristics (e.g., exposure factors, activity patterns). The
OPPT's Consumer Exposure Model (CEM) and other similar models can be used to estimate
indoor air exposures from consumer products.
There are models that also estimate emission and migration of semi-volatile organic compounds
(SVOCs) into the indoor environment models. These models generally consider indoor fate and
transport properties such as mass transfer as informed by the gas-phase mass transfer coefficient,
the solid-phase diffusion coefficient and the material-air partition coefficient. These properties
vary based on physical and chemical properties and properties of the material. The OPPT's
Indoor Environmental Concentrations in Buildings with Conditioned and Unconditioned Zones
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(IECCU) model and other similar models can be used to estimate indoor air and dust exposures
from indoor sources.
4) Review reasonably available empirical data that may be used in developing, adapting or
applying exposure models to a particular risk evaluation scenario. For example, existing
models developed for a chemical assessment may be applicable to another chemical
assessment if model parameter data are reasonably available.
To the extent other organizations have already modeled a di-ethylhexyl phthalate consumer
exposure scenario that is relevant to the OPPT's assessment, EPA plans to evaluate those
modeled estimates. In addition, if other chemicals similar to di-ethylhexyl phthalate have been
modeled for similar uses, those modeled estimates will also be evaluated. The underlying
parameters and assumptions of the models will also be evaluated.
5) Review reasonably available consumer product-specific sources to determine how those
exposure estimates compare with each other and with indoor monitoring data reporting di-
ethylhexyl phthalate in specific media (e.g., dust or indoor air).
The availability of di-ethylhexyl phthalate concentration for various conditions of use will be
evaluated. This data provides the source term for any subsequent indoor modeling. EPA plans to
analyze source attribution between overall indoor air and dust levels and various indoor sources
will be analyzed.
6) Review reasonably available population- or subpopulation-specific exposure factors and
activity patterns to determine if PESS need to be refined.
For di-ethylhexyl phthalate, EPA plans to evaluate exposure scenarios that involve PESS and
plans to consider age-specific behaviors, activity patterns and exposure factors unique to those
subpopulations. For some exposure scenarios related to consumer uses, EPA plans to consider
whether exposures for adults may different from those of children due to different activities (e.g.,
children may mouth certain products) or exposure factors (e.g., inhalation rates).
7) Evaluate the weight of the scientific evidence of consumer exposure estimates based on
different approaches.
EPA plans to rely on the weight of the scientific evidence when evaluating and integrating data
related to consumer exposure. The weight of the scientific evidence may include qualitative and
quantitative sources of information. EPA plans to integrate the data using systematic review
methods to assemble the relevant data, evaluate the data for quality and relevance, including
strengths and limitations, followed by synthesis and integration of the evidence.
2.7.2.5 General Population
EPA does not plan to analyze general population exposures, based on a review of exposure pathways as
described in Section 2.6.3.1. EPA does not plan to include in the risk evaluation pathways under
programs of other environmental statutes administered by EPA.
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2.7.3 Hazards (Effects)
2.7.3.1 Environmental Hazards
EPA plans to conduct an environmental hazard assessment of di-ethylhexyl phthalate as follows:
1) Review reasonably available environmental hazard data, including data from alternative
test methods (e.g., computational toxicology and bioinformatics; high-throughput screening
methods; data on categories and read-across; in vitro studies).
EPA plans to analyze the hazards of di-ethylhexyl phthalate to aquatic organisms, including
plants, invertebrates (e.g., insects, arachnids, mollusks, crustaceans), and vertebrates (e.g.,
mammals, birds, amphibians, fish, reptiles) across exposure durations and conditions if potential
environmental hazards are identified through systematic review results and public comments.
Additional types of environmental hazard information will also be considered (e.g., analogue and
read-across data) when characterizing the potential hazards of di-ethylhexyl phthalate to aquatic
organisms.
EPA plans to evaluate environmental hazard data using the evaluation strategies laid out in the
Application of Systematic Review in TSCA Risk Evaluations (l__S 1S). The study
evaluation results will be documented in the risk evaluation phase and data from acceptable
studies will be extracted and integrated in the risk evaluation process.
Mechanistic data may include analyses of alternative test data such as novel in vitro test methods
and high throughput screening. The association between acute and chronic exposure scenarios to
the agent and each health outcome will also be integrated. Study results will be extracted and
presented in evidence tables or another appropriate format by organ/system.
2) Derive hazard thresholds for aquatic organisms.
Depending on the robustness of the evaluated data for a particular organism or taxa (e.g., aquatic
invertebrates), environmental hazard values (e.g., ECx, LCx, NOEC, LOEC) may be derived and
used to further understand the hazard characteristics of di-ethylhexyl phthalate to aquatic species.
Identified environmental hazard thresholds may be used to derive concentrations of concern
(COC), based on endpoints that may affect populations of organisms or taxa analyzed.
3) Evaluate the weight of the scientific evidence of environmental hazard data.
During risk evaluation, EPA plans to evaluate and integrate the environmental hazard evidence
identified in the literature inventory using the methods described in the Application of Systematic
Review in TSCA Risk Evaluation ( ).
4) Consider the route(s) of exposure, based on reasonably available monitoring and modeling
data, and other available approaches to integrate exposure and hazard assessments.
EPA plans to consider aquatic (e.g., water and sediment exposures) pathways in the di-
ethylhexyl phthalate conceptual model. These organisms may be exposed to di-ethylhexyl
phthalate via a number of environmental pathways (e.g., surface water, sediment, diet).
5) Consider a persistent, bioaccumulative, and toxic (PBT) assessment of di-ethylhexyl
phthalate.
EPA plans to consider the persistence, bioaccumulation, and toxic (PBT) potential of di-
ethylhexyl phthalate after reviewing relevant physical and chemical properties and exposure
pathways. EPA plans to assess the reasonably available studies collected from the systematic
68
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review process relating to bioaccumulation and bioconcentration (e.g., BAF, BCF) of di-
ethylhexyl phthalate. In addition, EPA plans to integrate traditional environmental hazard
endpoint values (e.g., LC50, LOEC) and exposure concentrations (e.g., surface water
concentrations, tissue concentrations) for di-ethylhexyl phthalate with the fate parameters (e.g.,
BAF, BCF, BMF, TMF).
6) Conduct an environmental risk estimation and characterization of di-ethylhexyl phthalate.
EPA plans to conduct a risk estimation and characterization of di-ethylhexyl phthalate to identify
if there are risks to the aquatic environments from the measured and/or predicted concentrations
of di-ethylhexyl phthalate in environmental media (e.g., water, sediment). Risk quotients (RQs)
may be derived by the application of hazard and exposure benchmarks to characterize
environmental risk (U.S. EPA. 1998; Barnthouse et at.. 1982). Analysis of risk for
characterization includes a confidence statement in risk estimation which qualitative judgment
describing the certainty of the risk estimate considering the strength the evidence scores for
hazard and exposure and the limitations, and relevance.
2.7.3.2 Human Health Hazards
EPA plans to analyze human health hazards as follows:
1) Review reasonably available human health hazard data, including data from alternative
test methods (e.g., computational toxicology and bioinformatics; high-throughput screening
methods; data on categories and read-across; in vitro studies; systems biology).
EPA plans to evaluate human health studies using the evaluation strategies laid out in the
Application of Systematic Review in TSCA Risk Evaluations ( 1018) and updates to the
epidemiological data quality criteria released with the first ten risk evaluations. The study
evaluation results will be documented in the risk evaluation phase and data from acceptable
studies will be extracted and integrated in the risk evaluation process.
Mechanistic data may include analyses of alternative test data such as novel in vitro test methods
and high throughput screening. The association between acute and chronic exposure scenarios to
the agent and each health outcome will also be integrated. Study results will be extracted and
presented in evidence tables or another appropriate format by organ/system.
2) In evaluating reasonably available data, determine whether particular human receptor
groups may have greater susceptibility to the chemical's hazard(s) than the general
population.
Reasonably available human health hazard data will be evaluated to ascertain whether some
human receptor groups may have greater susceptibility than the general population to di-
ethylhexyl phthalate hazard(s). Susceptibility of particular human receptor groups to di-
ethylhexyl phthalate will be determined by evaluating information on factors that influence
susceptibility.
EPA has reviewed some sources containing hazard information associated with susceptible
populations and lifestages such as pregnant women and infants. Pregnancy (i.e., gestation) and
childhood are potential susceptible lifestages for di-ethylhexyl phthalate exposure. EPA may
quantify these differences in the risk evaluation following further evaluation of the reasonably
available data and information.
69
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3) Conduct hazard identification (the qualitative process of identifying non-cancer and cancer
endpoints) and dose-response assessment (the quantitative relationship between hazard
and exposure) for identified human health hazard endpoints.
Human health hazards from acute and chronic exposures will be identified by evaluating the
human and animal data that meet the systematic review data quality criteria described in the
Application of Systematic Review in TSCA Risk Evaluation ( ). Hazards identified
by studies meeting data quality criteria will be grouped by routes of exposure relevant to humans
(e.g., oral, dermal, inhalation) and by the cancer and noncancer endpoints identified in Section
2.4.2.
Dose-response assessment will be performed in accordance with EPA guidance (U.S. EPA.
2.012a. 2*.' l l b, l 0 developing points of departure (POD) for either margins of exposure
(MOEs), cancer slope factors (CSFs), oral slope factors (OSFs), and/or inhalation unit risks
(IURs). Dose-response analyses may be used if the data meet data quality criteria and if
additional information on the identified hazard endpoints are not reasonably available or would
not alter the analysis.
The cancer mode of action (MOA) analyses determine the relevancy of animal data to human
risk and how data can be quantitatively evaluated. If cancer hazard is determined to be applicable
to di-ethylhexyl phthalate, EPA plans to evaluate information on genotoxicity and the MOA for
all cancer endpoints to determine the appropriate approach for quantitative cancer assessment in
accordance with the U.S. EPA Guidelines for Carcinogen Risk Assessment (U.S. EPA. 2005a). In
accordance with EPA's Supplemental Guidance for Assessing Susceptibility from Early-life
Exposures to Carcinogens (U.S. EPA. 2.005b). EPA plans to determine whether age-dependent
adjustment factors (ADAFs) are appropriate for di-ethylhexyl phthalate for specific conditions of
use based upon potential exposures to children.
4) Derive points of departure (PODs) where appropriate; conduct benchmark dose modeling
depending on the reasonably available data. Adjust the PODs as appropriate to conform
(e.gadjust for duration of exposure) to the specific exposure scenarios evaluated.
Hazard data will be evaluated to determine the type of dose-response modeling that is applicable.
Where modeling is feasible, a set of dose-response models that are consistent with a variety of
potentially underlying biological processes will be applied to empirically model the dose-
response relationships in the range of the observed data consistent with the EPA's Benchmark
Dose Technical Guidance Document (U. S. EPA... 2012a). Where dose-response modeling is not
feasible, NOAELs or LOAELs will be identified. Non-quantitative data will also be evaluated
for contribution to weight of the scientific evidence or for evaluation of qualitative endpoints that
are not appropriate for dose-response assessment.
EPA plans to evaluate whether the reasonably available PBPK and empirical kinetic models are
adequate for route-to-route and interspecies extrapolation of the POD, or for extrapolation of the
POD to standard exposure durations (e.g., lifetime continuous exposure). If application of the
PBPK model is not possible, oral PODs may be adjusted by BW3 4 scaling in accordance with
U.S. EPA (2 ), and inhalation PODs may be adjusted by exposure duration and chemical
properties in accordance with U.S. EPA (1994).
5) Evaluate the weight of the scientific evidence of human health hazard data.
70
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During risk evaluation, EPA plans to evaluate and integrate the human health hazard evidence
identified in the literature inventory under acute and chronic exposure conditions using the
methods described in the Application of Systematic Review in TSCA Risk Evaluation (U.S. EPA.
2018V
6) Consider the route(s) of exposure (e.goral, inhalation, dermal), reasonably available
route-to-route extrapolation approaches; biomonitoring data; and approaches to correlate
internal and external exposures to integrate exposure and hazard assessment.
At this stage of review, EPA believes there will be sufficient reasonably available data to
conduct a dose-response analysis and/or benchmark dose modeling for the oral route of
exposure. EPA plans to also evaluate any potential human health hazards following dermal and
inhalation exposure to di-ethylhexyl phthalate, which could be important for worker, consumer
and general population risk analysis. Reasonably available data will be assessed to determine
whether or not a point of departure can be identified for the dermal and inhalation routes.
If sufficient reasonably available toxicity studies are not identified through the systematic review
process to assess risks from inhalation or dermal exposure, then a route-to-route extrapolation
may be needed. The preferred approach is to use a PBPK model (U.S. EPA. 2006a). Without an
adequate PBPK model, considerations regarding the adequacy of data for route-to-route
extrapolation are described in Methods for Derivation of Inhalation Reference Concentrations
and Application of Inhalation Dosimetry (U, 4). EPA may use these considerations
when determining whether to extrapolate from the oral to the inhalation route of exposure.
Similar approaches for oral-to-dermal route extrapolation are described in EPA guidance
document Risk Assessment Guidance for Superfund Volume I: Human Health Evaluation
Manual (Part Supplemental Guidance for Dermal Risk Assessment) ( 1004).
If there are acceptable inhalation data after completion of systematic review, EPA may also
consider extrapolating from the inhalation to the dermal route if first-pass metabolism through
the liver via the oral route is expected because in that case, use of data from the oral route is not
recommended (U.S. EPA. 1994). EPA may also consider inhalation-to-dermal route
extrapolation if an inhalation toxicity study with a sensitive hazard endpoint is used to evaluate
risks. Based on these considerations, EPA extrapolated from the inhalation to the dermal route
for several of the first ten risk evaluations under amended TSCA, including methylene chloride
(\ s.i l\ 2020dN) and carbon tetrachloride (\ s_ 1 ]:^20bY
7) Conduct a human health risk estimation and characterization of di-ethylhexyl phthalate.
Analysis of risk for characterization includes a confidence statement in risk estimation. This
confidence statement is based on qualitative judgment describing the certainty of the risk
estimate considering the strength of the evidence scores for hazard and exposure along with their
limitations and relevance. The lowest confidence evaluation for either hazard or exposure will
drive the overall confidence estimate.
2.7.4 Summary of Risk Approaches for Characterization
Risk characterization is an integral component of the risk assessment process for both environmental and
human health risks. EPA plans to derive the risk characterization in accordance with the EPA's Risk
Characterization Handbook (U, S. EPA. 2000). As defined in the EPA's Risk Characterization Policy,
"the risk characterization integrates information from the preceding components of the risk evaluation
and synthesizes an overall conclusion about risk that is complete, informative and useful for decision
71
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makers." ( 300). Risk characterization is considered to be a conscious and deliberate process
to bring all important considerations about risk, not only the likelihood of the risk but also the strengths
and limitations of the assessment, and a description of how others have assessed the risk into an
integrated picture.
The level of information contained in each risk characterization varies according to the type of
assessment for which the characterization is written. Regardless of the level of complexity or
information, the risk characterization for TSCA risk evaluations will be prepared in a manner that is
transparent, clear, consistent, and reasonable (U.S. EPA. 2.000). and consistent with the requirements of
the Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (82 FR
33726, July 20, 2017). As discussed in 40 CFR 702.43, risk characterization has a number of
considerations. This is the step where EPA integrates the hazard and exposure assessments into risk
estimates for the identified populations (including any PESS) and ecological characteristics and weighs
the scientific evidence for the identified hazards and exposures. The risk characterization does not
consider costs or other nonrisk factors, and takes into account, "where relevant, the likely duration,
intensity, frequency, and number of exposures under the condition(s) of use...." The risk
characterization also summarizes the following considerations: (1) uncertainty and variability in each
step of the risk evaluation; (2) data quality, and any applicable assumptions used; (3) alternative
interpretations of data and analyses, where appropriate; and (4) any considerations for environmental
risk evaluations, if necessary (e.g., related to nature and magnitude of effects).
EPA plans to also be guided by EPA's Information Quality Guidelines ( 002) as it provides
guidance for presenting risk information. Consistent with those guidelines, in the risk characterization,
EPA plans to also identify: (1) Each population addressed by an estimate of applicable risk effects; (2)
the expected risk or central estimate of risk for the PESS affected; (3) each appropriate upper-bound or
lower bound estimate of risk; (4) each significant uncertainty identified in the process of the assessment
of risk effects and the studies that would assist in resolving the uncertainty; and (5) peer reviewed
studies known to the Agency that support, are directly relevant to, or fail to support any estimate of risk
effects and the methodology used to reconcile inconsistencies in the scientific information.
2.8 Peer Review
Peer review will be conducted in accordance with EPA's regulatory procedures for chemical risk
evaluations, including using EPA's Peer Review Handbook (U.S. EPA. 2015b) and other methods
consistent with Section 26 of TSCA (see 40 CFR 702.45). As explained in the Risk Evaluation Rule, the
purpose of peer review is for the independent review of the science underlying the risk assessment. Peer
review will therefore address aspects of the underlying science as outlined in the charge to the peer
review panel such as hazard assessment, assessment of dose-response, exposure assessment, and risk
characterization. The draft risk evaluation for di-ethylhexyl phthalate will be peer reviewed.
72
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APPENDICES
Appendix A ABBREVIATED METHODS FOR SEARCHING AND
SCREENING
A.l Literature Search of Publicly Available Databases
A.l.l Search Term Genesis and Chemical Verification
To develop the chemical terms for the subsequent literature search for di-ethylhexyl phthalate, several
online sources were queried.
• California Department of Pesticide Regulation:
https://www.cdpr.ca.gov/docs/chemical/monster2.htm
• USEPA Chemistry Dashboard: https://comptox.epa.gov/dashboard
• University of Hertfordshire PPDB: Pesticide Properties DataBase:
https://sitem.herts.ac.uk/aeru/ppdb/en/search.htm
• USEPA Reregi strati on Eligibility Decision (RED) documents:
https://archive.epa.gov/pesticides/reregistration/web/html/status.html
• Office of Pesticide Programs Pesticide Chemical Search:
https://ofmpub.epa.gov/apex/pesticides/f?p=CHEMICALSEARCH:l
• Food and Agriculture Organization of the United Nations: http://www.fao.org/home/en/
• PAN Pesticides Database: http://www.pesticideinfo.org/Search Chemicals.i sp
Prior to inclusion in the search term string, all forms of chemical names were subjected to verification
from several potential sources (e.g., US EPA Chemistry Dashboard, STN International-CAS; see
complete list of sources for chemical verification in Table Apx A-l). From these sources, all chemical
names, synonyms, CAS number(s), trade names, etc. were documented and used to generate terms for
database searches.
Table Apx A-l. Sources of Verification for Chemical Names and Structures
CHEMICAL SOURCE
CONTENTS
DOCUMENT
LOCATION
Chemistry Dashboard
dittos ://coniDtox,CDa. uo\/dashboard)
CAS Numbers, Synonyms, Structures,
Properties, Environmental Fate and Transport.
Online
Dictionary of Chemical Names and Synonyms
Wide assortment of chemical compounds by
chemical name and synonym, has CAS index
and some structure data
ECOTOX
Farm Chemicals Handbook-1992
Pesticide information, CAS numbers and
synonyms, some structure data
***Sometimes CAS number presented for a
compound is for the main constituent only
ECOTOX
OPPT SMILES Verification Source
Structure Data
Electronic verification
RTECS (Registry of Toxic Effects of
chemical substance, 1983-84 ed., 2 vols)
Chemical names, synonyms and CAS numbers
ECOTOX
Sigma - Aldrich website58784
htte>://www. sisma-aldrich.com
Organic and inorganic Compounds by chemical
name, has CAS index and some structure and
Physical Property data
Online
82
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CHEMICAL SOURCE
CONTENTS
DOCUMENT
LOCATION
STN International (CAS) 1994
***Most complete source of chemical name,
synonym and structure information, no physical
properties
Online
The Pesticide Manual 10th edition, 1994
Pesticide Compounds by chemical name,
synonym, product code, has CAS index and
some structure and Physical Property data
ECOTOX
TSCA (Toxic Substances Control Act
Chemical Substance Inventory, 1985 ed., 5
vols)
Chemical names, synonyms and CAS numbers
ECOTOX
World Wide Web (misc. web sources) A copy
of the verification page is saved to the
Attachments tab of the chemical entry. This
includes company MSDS sheets or Chemical
Labels.
Chemical names, synonyms and CAS numbers
Online
California Department of Pesticide Regulation
(htte>://www.cdt>r.ca.eov/dt>rdatabase.htm)
Multiple databases containing chemicals,
pesticides, companies, products, etc.
Online
PAN Pesticide Database
(htte>://www.t>esticideinfo.ore/Search Chemic
als.iso)
Pesticides searchable by name or CAS #.
Includes CAS #, Name, synonyms, targets,
toxicity data, related chemicals and regulatory
information.
Online
US EPA Office of Pesticide Programs
Pesticide Fate Database - No web access
available. An electronic copy of the data file is
located at the Contractor site:
PFATE 37 Tables.mdb.
Multiple databases containing chemicals,
pesticides, companies, products, etc.
Online
A.1.2 Publicly Available Database Searches
The databases listed below were searched for literature containing the chemical search terms. Database
searching occurred during April and May of 2019 by an information specialist and the results were
stored in the Health and Environmental Research Online (HERO) database and assigned a HERO
reference identification number.9 The present literature search focused only on the chemical name
(including synonyms and trade names) with no additional limits. Full details of the search strategy for
each database are presented in Appendix A. 1.2.1.
After initial deduplication in HERO10, these studies were imported into SWIFT Review software
(Howard et at.. 2016) to identify those references most likely to be applicable to each discipline area (i.e.
consumer, environmental, and general population exposure, occupational exposure and environmental
releases, environmental hazards, human health hazards, and fate and physical chemistry).
A.l.2.1 Query Strings for the Publicly Available Database Searches on Di-ethylhexyl
Phthalate
Table Apx A-2 presents a list of the data sources, the search dates and number of peer-reviewed
references resulting from the searches for di-ethylhexyl phthalate. The sources are found as online
databases and the resulting references were gathered and uploaded into the EPA Health and
9EPA's HERO database provides access to the scientific literature behind EPA science assessments. The database includes
more than 600,000 scientific references and data from the peer-reviewed literature used by EPA to develop its regulations.
10 Deduplication in HERO involves first determining whether a matching unique ID exists (e.g., PMID, WOSid, or DOI). If
one matches one that already exists in HERO, HERO will tag the existing reference instead of adding the reference again.
Second, HERO checks if the same journal, volume, issue and page number are already in HERO. Third, HERO matches on
the title, year, and first author. Title comparisons ignore punctuation and case.
-------
Environmental Research Online (HERO) database for literature screening.
TableApx A-2. Summary of Data Sources, Search Dates and Number of Peer-Reviewed
Literature Search Results for Di-et
lylhexyl Phthalate (DEHP)
Source
Date of Search
N ilm her of References
Current Contents
07. U5.2019
9488
WOS Core Collection
09/11/2019
14,279
ProQuest CSA
07/05/2019
13,506
Dissertation Abstracts
07/11/2019
85
Science Direct
07/05/2019
3332
Agricola
07/10/2019
3391
TOXNET
07/08/2019
3376
PubMed
07/08/2019
8331
UNIFY
07/23/2019
523
Totals:
56,311
GENERAL:
General search terms were compiled and used in the search strategies for each of the databases/sources
listed below. Based upon the online search manuals for the respective databases/sources, it was
necessary to construct searches as noted for each of the sources. The search terms are listed below in full
for each source and noted if the general search terms or other search terms were used.
"1,2-Benzenedicarboxylic acid, 1,2-diisooctyl ester" OR "1,2-Benzedicarboxylic acid, bis(2-ethyl-hexyl)
ester" OR "1,2-Benzenedicarboxylic acid bis(2-ethylhexyl) ester" OR "1,2-Benzenedicarboxylic acid,
l,2-bis(2-ethylhexyl) ester" OR "1,2-Benzenedicarboxylic acid, 1,2-diisooctyl ester" OR "1,2-
Benzenedicarboxylic acid, bis(2-ethylhexyl) ester" OR "1,2-Benzenedicarboxylic acid, bis(2-
ethylhexyl)ester" OR "1,2-Benzenedicarboxylic acid, Butyl phenylmethyl ester" OR "1,2-
Benzenedicarboxylic acid, diisooctyl ester" OR "1,2-Benzenedicarboxylic acid,bis(2-ethylhexylester)"
OR "2-Ethylhexyl phthalate" OR "AI3-27697-X" OR "Bis(2-ethylhexyl) 1,2-benzenedicarboxylate" OR
"Bis(2-ethylhexyl) benzene-1,2-dicarboxylate" OR "Bis(2-ethylhexyl) o-phthalate" OR "Bis(2-
ethylhexyl) phthalate" OR "Bis(2-ethylhexyl)ester, Phthalic acid" OR "Bis(2-ethylhexyl)phthalat" OR
"Bis(2-ethylhexyl)phthalate" OR "Bis-(2-ethylhexyl)-phthalate" OR "Bis(ethylhexyl) phthalate" OR
"Bisoflex 81" OR "Bisoflex DOP" OR "BRN 1890696" OR "Butylbenzyl Phthalate" OR
"Butylbenzylphthalate" OR "Caswell No. 392K" OR "Codan Set L 86P" OR "Compound 889" OR
"Corflex 400" OR "Corflex 880" OR "DEHP" OR "Di(2-ethylhexyl) o-phthalate" OR "Di(2-ethylhexyl)
orthophthalate" OR "Di(2-ethylhexyl) phthalate" OR "Di-(2-ethylhexyl) phthalate" OR "Di(2-
ethylhexyl)orthophthalate" OR "Di(2-ethylhexyl)phthalate" OR "di(alpha-Ethylhexyl) phthalate" OR
"Di(ethylhexyl) phthalate" OR "Di-(Ethylhexyl)phthalate" OR "Di(isooctyl) phthalate" OR "Di-2-
ethylhexlphthalate" OR "Di-2-ethylhexyl phthalate" OR "DI-2-ETHYLHEXYL-PHTHALATE" OR
"Diacizer DOP" OR "Diethylhexyl phthalate" OR "Di-ethylhexyl phthalate" OR
"Diethylhexylphthalate" OR "Diisooctyl 1,2-benzenedicarboxylate"
"Diisooctyl ester 1,2-Benzenedicarboxylic acid" OR "Diisooctyl o-phthalate" OR "Diisooctyl phthalate"
OR "di-iso-Octyl phthalate" OR "Diisooctylphthalat" OR "Diisooctylphthalate" OR "Dioctyl phthalate"
OR "Diplast O" OR "Di-sec-octyl phthalate" OR "Ergoplast FDO" OR "Ergoplast FDO-S" OR "ESBO-
D 82" OR "Etalon" OR "Ethylhexyl phthalate" OR "Ethylhexyl phthlate" OR "Eviplast 80" OR
"Eviplast 81" OR "Fleximel" OR "Flexol DOD" OR "Flexol DOP" OR "Flexol Plasticizer DIOP" OR
84
-------
"Flexol Plasticizer DOP" OR "Garbeflex DOP-D 40" OR "Good-rite GP 264" OR "Hatco DOP" OR
"Hatcol DOP" OR "Hercoflex 260" OR "Hexaplas DIOP" OR "Hexaplas M/O" OR "Isooctyl phthalate"
OR "Isooctylphthalate" OR "Jayflex DIOP" OR "Jayflex DOP" OR "JSSD-DOP" OR "Kodaflex DEHP"
OR "Kodaflex DOP" OR "Mollan O" OR "Monocizer DOP" OR "NCI-C52733" OR "NSC 17069" OR
"NSC 6381" OR "Nuoplaz DOP" OR "Octoil" OR "Octyl phthalate" OR "Palatinol AH" OR "Palatinol
AH-L" OR "Palatinol DOP" OR "PHTHALATE, BIS(2-ETHYLHEXYL)" OR "Phthalic acid bis(2-
ethylhexyl) ester" OR "Phthalic acid di(2-ethylhexyl) ester"
"Phthalic acid dioctyl ester" OR "Phthalic acid, bis(2-ethylhexyl) ester" OR "PHTHALIC ACID, BIS(2-
ETHYLHEXYL)ESTER" OR "Phthalic acid, bis(6-methylheptyl)ester" OR "Phthalic acid, diisooctyl
ester" OR "Pittsburgh PX 138" OR "Pittsburgh PX-138" OR "Plasthall DOP" OR "Platinol AH" OR
"Platinol DOP" OR "RC Plasticizer DOP" OR "RCRA waste number U028" OR "Reomol D 79P" OR
"Reomol DOP" OR "Sansocizer DOP" OR "SansocizerR 8000" OR "Scandinol SC 1000" OR
"Sconamoll DOP" OR "Sicol 150" OR "Staflex DOP" OR "Truflex DOP" OR "Unem 5005" OR "UNII-
6A121LGB40" OR "UNII-C42K0PH13C" OR "Vestinol AH" OR "Vinicizer 80" OR "Vinycizer 80"
OR "Vinycizer 80K" OR "Witcizer 312"
CURRENT CONTENTS CONNECT: (access.webofknowledge.com)
General search terms applied to the search strategy for Current Contents.
Date Searched: 07/05/2019
Date Range of Search: 1998 to Present
N = 9488
Current Contents 01:
TS=("l,2-Benzenedicarboxylic acid, 1,2-diisooctyl ester" OR "1,2-Benzedicarboxylic acid, bis(2-ethyl-
hexyl) ester" OR "1,2-Benzenedicarboxylic acid bis(2-ethylhexyl) ester" OR "1,2-Benzenedicarboxylic
acid, l,2-bis(2-ethylhexyl) ester" OR "1,2-Benzenedicarboxylic acid, 1,2-diisooctyl ester" OR "1,2-
Benzenedicarboxylic acid, bis(2-ethylhexyl) ester" OR "1,2-Benzenedicarboxylic acid, bis(2-
ethylhexyl)ester" OR "1,2-Benzenedicarboxylic acid, Butyl phenylmethyl ester" OR "1,2-
Benzenedicarboxylic acid, diisooctyl ester" OR "1,2-Benzenedicarboxylic acid,bis(2-ethylhexylester)"
OR "2-Ethylhexyl phthalate" OR "AI3-27697-X" OR "Bis(2-ethylhexyl) 1,2-benzenedicarboxylate" OR
"Bis(2-ethylhexyl) benzene-1,2-dicarboxylate" OR "Bis(2-ethylhexyl) o-phthalate" OR "Bis(2-
ethylhexyl) phthalate" OR "Bis(2-ethylhexyl)ester, Phthalic acid" OR "Bis(2-ethylhexyl)phthalat" OR
"Bis(2-ethylhexyl)phthalate" OR "Bis-(2-ethylhexyl)-phthalate" OR "Bis(ethylhexyl) phthalate" OR
"Bisoflex 81" OR "Bisoflex DOP" OR "BRN 1890696" OR "Butylbenzyl Phthalate" OR
"Butylbenzylphthalate" OR "Caswell No. 392K" OR "Codan Set L 86P" OR "Compound 889" OR
"Corflex 400" OR "Corflex 880" OR "DEHP" OR "Di(2-ethylhexyl) o-phthalate" OR "Di(2-ethylhexyl)
orthophthalate" OR "Di(2-ethylhexyl) phthalate" OR "Di-(2-ethylhexyl) phthalate" OR "Di(2-
ethylhexyl)orthophthalate" OR "Di(2-ethylhexyl)phthalate" OR "di(alpha-Ethylhexyl) phthalate" OR
"Di(ethylhexyl) phthalate" OR "Di-(Ethylhexyl)phthalate" OR "Di(isooctyl) phthalate" OR "Di-2-
ethylhexlphthalate" OR "Di-2-ethylhexyl phthalate" OR "DI-2-ETHYLHEXYL-PHTHALATE" OR
"Diacizer DOP" OR "Diethylhexyl phthalate" OR "Di-ethylhexyl phthalate" OR
"Diethylhexylphthalate" OR "Diisooctyl 1,2-benzenedicarboxylate")
N = 4128
Current Contents 02:
TS=("Diisooctyl ester 1,2-Benzenedicarboxylic acid" OR "Diisooctyl o-phthalate" OR "Diisooctyl
phthalate" OR "di-iso-Octyl phthalate" OR "Diisooctylphthalat" OR "Diisooctylphthalate" OR "Dioctyl
85
-------
phthalate" OR "Diplast O" OR "Di-sec-octyl phthalate" OR "Ergoplast FDO" OR "ErgoplastFDO-S"
OR "ESBO-D 82" OR "Etalon" OR "Ethylhexyl phthalate" OR "Ethylhexyl phthlate" OR "Eviplast 80"
OR "Eviplast 81" OR "Fleximel" OR "Flexol DOD" OR "Flexol DOP" OR "Flexol Plasticizer DIOP"
OR "Flexol Plasticizer DOP" OR "Garbeflex DOP-D 40" OR "Good-rite GP 264" OR "Hatco DOP" OR
"Hatcol DOP" OR "Hercoflex 260" OR "Hexaplas DIOP" OR "Hexaplas M/O" OR "Isooctyl phthalate"
OR "Isooctylphthalate" OR "Jayflex DIOP" OR "Jayflex DOP" OR "JSSD-DOP" OR "Kodaflex DEHP"
OR "Kodaflex DOP" OR "Mollan O" OR "Monocizer DOP" OR "NCI-C52733" OR "NSC 17069" OR
"NSC 6381" OR "Nuoplaz DOP" OR "Octoil" OR "Octyl phthalate" OR "Palatinol AH" OR "Palatinol
AH-L" OR "Palatinol DOP" OR "PHTHALATE, BIS(2-ETHYLHEXYL)" OR "Phthalic acid bis(2-
ethylhexyl) ester" OR "Phthalic acid di(2-ethylhexyl) ester")
N = 5359
Current Contents 03:
TS=("Phthalic acid dioctyl ester" OR "Phthalic acid, bis(2-ethylhexyl) ester" OR "PHTHALIC ACID,
BIS(2-ETHYLHEXYL)ESTER" OR "Phthalic acid, bis(6-methylheptyl)ester" OR "Phthalic acid,
diisooctyl ester" OR "Pittsburgh PX 138" OR "Pittsburgh PX-138" OR "Plasthall DOP" OR "Platinol
AH" OR "Platinol DOP" OR "RC Plasticizer DOP" OR "RCRA waste number U028" OR "Reomol D
79P" OR "Reomol DOP" OR "Sansocizer DOP" OR "Sansocizer R 8000" OR "Scandinol SC 1000" OR
"Sconamoll DOP" OR "Sicol 150" OR "Staflex DOP" OR "Truflex DOP" OR "Unem 5005" OR "UNII-
6A121LGB40" OR "UNII-C42K0PH13C" OR "Vestinol AH" OR "Vinicizer 80" OR "Vinycizer 80"
OR "Vinycizer 80K" OR "Witcizer 312")
N = 1
WOS Core Collection: (https://intranet.epa.eov/desktop/databases.htm
General Search Terms applied to the search strategy for WOS Core Collection
Date Searched: 09/11/2019
Date Range of Search: 1998 to Present
N= 14,279
WOS Core Collection 01:
TS=("l,2-Benzenedicarboxylic acid, 1,2-diisooctyl ester" OR "1,2-Benzedicarboxylic acid, bis(2-ethyl-
hexyl) ester" OR "1,2-Benzenedicarboxylic acid bis(2-ethylhexyl) ester" OR "1,2-Benzenedicarboxylic
acid, l,2-bis(2-ethylhexyl) ester" OR "1,2-Benzenedicarboxylic acid, 1,2-diisooctyl ester" OR "1,2-
Benzenedicarboxylic acid, bis(2-ethylhexyl) ester" OR "1,2-Benzenedicarboxylic acid, bis(2-
ethylhexyl)ester" OR "1,2-Benzenedicarboxylic acid, Butyl phenylmethyl ester" OR "1,2-
Benzenedicarboxylic acid, diisooctyl ester" OR "1,2-Benzenedicarboxylic acid,bis(2-ethylhexylester)"
OR "2-Ethylhexyl phthalate" OR "AI3-27697-X" OR "Bis(2-ethylhexyl) 1,2-benzenedicarboxylate" OR
"Bis(2-ethylhexyl) benzene-1,2-dicarboxylate" OR "Bis(2-ethylhexyl) o-phthalate" OR "Bis(2-
ethylhexyl) phthalate" OR "Bis(2-ethylhexyl)ester, Phthalic acid" OR "Bis(2-ethylhexyl)phthalat" OR
"Bis(2-ethylhexyl)phthalate" OR "Bis-(2-ethylhexyl)-phthalate" OR "Bis(ethylhexyl) phthalate" OR
"Bisoflex 81" OR "Bisoflex DOP" OR "BRN 1890696" OR "Butylbenzyl Phthalate" OR
"Butylbenzylphthalate" OR "Caswell No. 392K" OR "Codan Set L 86P" OR "Compound 889" OR
"Corflex 400" OR "Corflex 880" OR "DEHP" OR "Di(2-ethylhexyl) o-phthalate" OR "Di(2-ethylhexyl)
orthophthalate" OR "Di(2-ethylhexyl) phthalate" OR "Di-(2-ethylhexyl) phthalate" OR "Di(2-
ethylhexyl)orthophthalate" OR "Di(2-ethylhexyl)phthalate" OR "di(alpha-Ethylhexyl) phthalate" OR
"Di(ethylhexyl) phthalate" OR "Di-(Ethylhexyl)phthalate" OR "Di(isooctyl) phthalate" OR "Di-2-
ethylhexlphthalate" OR "Di-2-ethylhexyl phthalate" OR "DI-2-ETHYLHEXYL-PHTHALATE" OR
"Diacizer DOP" OR "Diethylhexyl phthalate" OR "Di-ethylhexyl phthalate" OR
86
-------
"Diethylhexylphthalate" OR "Diisooctyl 1,2-benzenedicarboxylate")
N = 5864
WOS Core Collection 02:
TS=("Diisooctyl ester 1,2-Benzenedicarboxylic acid" OR "Diisooctyl o-phthalate" OR "Diisooctyl
phthalate" OR "di-iso-Octyl phthalate" OR "Diisooctylphthalat" OR "Diisooctylphthalate" OR "Dioctyl
phthalate" OR "Diplast O" OR "Di-sec-octyl phthalate" OR "Ergoplast FDO" OR "Ergoplast FDO-S"
OR "ESBO-D 82" OR "Etalon" OR "Ethylhexyl phthalate" OR "Ethylhexyl phthlate" OR "Eviplast 80"
OR "Eviplast 81" OR "Fleximel" OR "Flexol DOD" OR "Flexol DOP" OR "Flexol Plasticizer DIOP"
OR "Flexol Plasticizer DOP" OR "Garbeflex DOP-D 40" OR "Good-rite GP 264" OR "Hatco DOP" OR
"Hatcol DOP" OR "Hercoflex 260" OR "Hexaplas DIOP" OR "Hexaplas M/O" OR "Isooctyl phthalate"
OR "Isooctylphthalate" OR "Jayflex DIOP" OR "Jayflex DOP" OR "JSSD-DOP" OR "Kodaflex DEHP"
OR "Kodaflex DOP" OR "Mollan O" OR "Monocizer DOP" OR "NCI-C52733" OR "NSC 17069" OR
"NSC 6381" OR "Nuoplaz DOP" OR "Octoil" OR "Octyl phthalate" OR "Palatinol AH" OR "Palatinol
AH-L" OR "Palatinol DOP" OR "PHTHALATE, BIS(2-ETHYLHEXYL)" OR "Phthalic acid bis(2-
ethylhexyl) ester" OR "Phthalic acid di(2-ethylhexyl) ester")
N = 8413
WOS Core Collection 03:
TS=("Phthalic acid dioctyl ester" OR "Phthalic acid, bis(2-ethylhexyl) ester" OR "PHTHALIC ACID,
BIS(2-ETHYLHEXYL)ESTER" OR "Phthalic acid, bis(6-methylheptyl)ester" OR "Phthalic acid,
diisooctyl ester" OR "Pittsburgh PX 138" OR "Pittsburgh PX-138" OR "Plasthall DOP" OR "Platinol
AH" OR "Platinol DOP" OR "RC Plasticizer DOP" OR "RCRA waste number U028" OR "Reomol D
79P" OR "Reomol DOP" OR "Sansocizer DOP" OR "Sansocizer R 8000" OR "Scandinol SC 1000" OR
"Sconamoll DOP" OR "Sicol 150" OR "Staflex DOP" OR "Truflex DOP" OR "Unem 5005" OR "UNII-
6A121LGB40" OR "UNII-C42K0PH13C" OR "Vestinol AH" OR "Vinicizer 80" OR "Vinycizer 80"
OR "Vinycizer 80K" OR "Witcizer 312")
N = 2
PROOUEST Agricultural and Scientific Database: (www.csa.com)
General Search Terms applied to the search strategy for ProQuest Agricultural and Scientific Database.
Date Searched: 07/05/2019
Date Range of Search: 1900 to Present
N= 13,506
PROQUEST 01:
ALL(" 1,2-Benzenedicarboxylic acid, 1,2-diisooctyl ester" OR "1,2-Benzedicarboxylic acid, bis(2-ethyl-
hexyl) ester" OR "1,2-Benzenedicarboxylic acid bis(2-ethylhexyl) ester" OR "1,2-Benzenedicarboxylic
acid, l,2-bis(2-ethylhexyl) ester" OR "1,2-Benzenedicarboxylic acid, 1,2-diisooctyl ester" OR "1,2-
Benzenedicarboxylic acid, bis(2-ethylhexyl) ester" OR "1,2-Benzenedicarboxylic acid, bis(2-
ethylhexyl)ester" OR "1,2-Benzenedicarboxylic acid, Butyl phenylmethyl ester" OR "1,2-
Benzenedicarboxylic acid, diisooctyl ester" OR "1,2-Benzenedicarboxylic acid,bis(2-ethylhexylester)"
OR "2-Ethylhexyl phthalate" OR "AI3-27697-X" OR "Bis(2-ethylhexyl) 1,2-benzenedicarboxylate" OR
"Bis(2-ethylhexyl) benzene-1,2-dicarboxylate" OR "Bis(2-ethylhexyl) o-phthalate" OR "Bis(2-
ethylhexyl) phthalate" OR "Bis(2-ethylhexyl)ester, Phthalic acid" OR "Bis(2-ethylhexyl)phthalat" OR
"Bis(2-ethylhexyl)phthalate" OR "Bis-(2-ethylhexyl)-phthalate" OR "Bis(ethylhexyl) phthalate" OR
"Bisoflex 81" OR "Bisoflex DOP" OR "BRN 1890696" OR "Butylbenzyl Phthalate" OR
"Butylbenzylphthalate" OR "Caswell No. 392K" OR "Codan Set L 86P" OR "Compound 889" OR
87
-------
"Corflex 400" OR "Corflex 880" OR "DEHP" OR "Di(2-ethylhexyl) o-phthalate" OR "Di(2-ethylhexyl)
orthophthalate" OR "Di(2-ethylhexyl) phthalate" OR "Di-(2-ethylhexyl) phthalate" OR "Di(2-
ethylhexyl)orthophthalate" OR "Di(2-ethylhexyl)phthalate" OR "di(alpha-Ethylhexyl) phthalate" OR
"Di(ethylhexyl) phthalate" OR "Di-(Ethylhexyl)phthalate" OR "Di(isooctyl) phthalate" OR "Di-2-
ethylhexlphthalate" OR "Di-2-ethylhexyl phthalate" OR "DI-2-ETHYLHEXYL-PHTHALATE" OR
"Diacizer DOP" OR "Diethylhexyl phthalate" OR "Di-ethylhexyl phthalate" OR
"Diethylhexylphthalate" OR "Diisooctyl 1,2-benzenedicarboxylate") AND STYPE("Scholarly Journals"
OR Reports OR Thesis OR "Government Documents") AND LA(ENG)
N = 7289
PROQUEST 02:
ALL("Diisooctyl ester 1,2-Benzenedicarboxylic acid" OR "Diisooctyl o-phthalate" OR "Diisooctyl
phthalate" OR "di-iso-Octyl phthalate" OR "Diisooctylphthalat" OR "Diisooctylphthalate" OR "Dioctyl
phthalate" OR "Diplast O" OR "Di-sec-octyl phthalate" OR "Ergoplast FDO" OR "ErgoplastFDO-S"
OR "ESBO-D 82" OR "Etalon" OR "Ethylhexyl phthalate" OR "Ethylhexyl phthlate" OR "Eviplast 80"
OR "Eviplast 81" OR "Fleximel" OR "Flexol DOD" OR "Flexol DOP" OR "Flexol Plasticizer DIOP"
OR "Flexol Plasticizer DOP" OR "Garbeflex DOP-D 40" OR "Good-rite GP 264" OR "Hatco DOP" OR
"Hatcol DOP" OR "Hercoflex 260" OR "Hexaplas DIOP" OR "Hexaplas M/O" OR "Isooctyl phthalate"
OR "Isooctylphthalate" OR "Jayflex DIOP" OR "Jayflex DOP" OR "JSSD-DOP" OR "Kodaflex DEHP"
OR "Kodaflex DOP" OR "Mollan O" OR "Monocizer DOP" OR "NCI-C52733" OR "NSC 17069" OR
"NSC 6381" OR "Nuoplaz DOP" OR "Octoil" OR "Octyl phthalate" OR "Palatinol AH" OR "Palatinol
AH-L" OR "Palatinol DOP" OR "PHTHALATE, BIS(2-ETHYLHEXYL)" OR "Phthalic acid bis(2-
ethylhexyl) ester" OR "Phthalic acid di(2-ethylhexyl) ester") AND STYPE("Scholarly Journals" OR
Reports OR Thesis OR "Government Documents") AND LA(ENG)
N = 6216
PROQUEST 03:
ALL("Phthalic acid dioctyl ester" OR "Phthalic acid, bis(2-ethylhexyl) ester" OR "PHTHALIC ACID,
BIS(2-ETHYLHEXYL)ESTER" OR "Phthalic acid, bis(6-methylheptyl)ester" OR "Phthalic acid,
diisooctyl ester" OR "Pittsburgh PX 138" OR "Pittsburgh PX-138" OR "Plasthall DOP" OR "Platinol
AH" OR "Platinol DOP" OR "RC Plasticizer DOP" OR "RCRA waste number U028" OR "Reomol D
79P" OR "Reomol DOP" OR "Sansocizer DOP" OR "Sansocizer R 8000" OR "Scandinol SC 1000" OR
"Sconamoll DOP" OR "Sicol 150" OR "Staflex DOP" OR "Truflex DOP" OR "Unem 5005" OR "UNII-
6A121LGB40" OR "UNII-C42K0PH13C" OR "Vestinol AH" OR "Vinicizer 80" OR "Vinycizer 80"
OR "Vinycizer 80K" OR "Witcizer 312") AND STYPE("Scholarly Journals" OR Reports OR Thesis
OR "Government Documents") AND LA(ENG)
N = 1
PROQUEST Dissertations and Theses: (search.proquest.com)
General Search Terms applied to the search strategy for ProQuest Dissertations and Theses.Date
Searched: 07/11/2019
Date Range of Search: 1900 to Present
N = 85
Dissertations and Theses 01:
ALL(" 1,2-Benzenedicarboxylic acid, 1,2-diisooctyl ester" OR "1,2-Benzedicarboxylic acid, bis(2-ethyl-
hexyl) ester" OR "1,2-Benzenedicarboxylic acid bis(2-ethylhexyl) ester" OR "1,2-Benzenedicarboxylic
acid, l,2-bis(2-ethylhexyl) ester" OR "1,2-Benzenedicarboxylic acid, 1,2-diisooctyl ester" OR "1,2-
88
-------
Benzenedicarboxylic acid, bis(2-ethylhexyl) ester" OR "1,2-Benzenedicarboxylic acid, bis(2-
ethylhexyl)ester" OR "1,2-Benzenedicarboxylic acid, Butyl phenylmethyl ester" OR "1,2-
Benzenedicarboxylic acid, diisooctyl ester" OR "1,2-Benzenedicarboxylic acid,bis(2-ethylhexylester)"
OR "2-Ethylhexyl phthalate" OR "AI3-27697-X" OR "Bis(2-ethylhexyl) 1,2-benzenedicarboxylate" OR
"Bis(2-ethylhexyl) benzene-1,2-dicarboxylate" OR "Bis(2-ethylhexyl) o-phthalate" OR "Bis(2-
ethylhexyl) phthalate" OR "Bis(2-ethylhexyl)ester, Phthalic acid" OR "Bis(2-ethylhexyl)phthalat" OR
"Bis(2-ethylhexyl)phthalate" OR "Bis-(2-ethylhexyl)-phthalate" OR "Bis(ethylhexyl) phthalate" OR
"Bisoflex 81" OR "Bisoflex DOP" OR "BRN 1890696" OR "Butylbenzyl Phthalate" OR
"Butylbenzylphthalate" OR "Caswell No. 392K" OR "Codan Set L 86P" OR "Compound 889" OR
"Corflex 400" OR "Corflex 880" OR "DEHP" OR "Di(2-ethylhexyl) o-phthalate" OR "Di(2-ethylhexyl)
orthophthalate" OR "Di(2-ethylhexyl) phthalate" OR "Di-(2-ethylhexyl) phthalate" OR "Di(2-
ethylhexyl)orthophthalate" OR "Di(2-ethylhexyl)phthalate" OR "di(alpha-Ethylhexyl) phthalate" OR
"Di(ethylhexyl) phthalate" OR "Di-(Ethylhexyl)phthalate" OR "Di(isooctyl) phthalate" OR "Di-2-
ethylhexlphthalate" OR "Di-2-ethylhexyl phthalate" OR "DI-2-ETHYLHEXYL-PHTHALATE" OR
"Diacizer DOP" OR "Diethylhexyl phthalate" OR "Di-ethylhexyl phthalate" OR
"Diethylhexylphthalate" OR "Diisooctyl 1,2-benzenedicarboxylate") AND LA(ENG)
N = 22
Dissertations and Theses 02:
ALL("Diisooctyl ester 1,2-Benzenedicarboxylic acid" OR "Diisooctyl o-phthalate" OR "Diisooctyl
phthalate" OR "di-iso-Octyl phthalate" OR "Diisooctylphthalat" OR "Diisooctylphthalate" OR "Dioctyl
phthalate" OR "Diplast O" OR "Di-sec-octyl phthalate" OR "Ergoplast FDO" OR "ErgoplastFDO-S"
OR "ESBO-D 82" OR "Etalon" OR "Ethylhexyl phthalate" OR "Ethylhexyl phthlate" OR "Eviplast 80"
OR "Eviplast 81" OR "Fleximel" OR "Flexol DOD" OR "Flexol DOP" OR "Flexol Plasticizer DIOP"
OR "Flexol Plasticizer DOP" OR "Garbeflex DOP-D 40" OR "Good-rite GP 264" OR "Hatco DOP" OR
"Hatcol DOP" OR "Hercoflex 260" OR "Hexaplas DIOP" OR "Hexaplas M/O" OR "Isooctyl phthalate"
OR "Isooctylphthalate" OR "Jayflex DIOP" OR "Jayflex DOP" OR "JSSD-DOP" OR "Kodaflex DEHP"
OR "Kodaflex DOP" OR "Mollan O" OR "Monocizer DOP" OR "NCI-C52733" OR "NSC 17069" OR
"NSC 6381" OR "Nuoplaz DOP" OR "Octoil" OR "Octyl phthalate" OR "Palatinol AH" OR "Palatinol
AH-L" OR "Palatinol DOP" OR "PHTHALATE, BIS(2-ETHYLHEXYL)" OR "Phthalic acid bis(2-
ethylhexyl) ester" OR "Phthalic acid di(2-ethylhexyl) ester") AND LA(ENG)
N = 63
Dissertations and Theses 03:
ALL("Phthalic acid dioctyl ester" OR "Phthalic acid, bis(2-ethylhexyl) ester" OR "PHTHALIC ACID,
BIS(2-ETHYLHEXYL)ESTER" OR "Phthalic acid, bis(6-methylheptyl)ester" OR "Phthalic acid,
diisooctyl ester" OR "Pittsburgh PX 138" OR "Pittsburgh PX-138" OR "Plasthall DOP" OR "Platinol
AH" OR "Platinol DOP" OR "RC Plasticizer DOP" OR "RCRA waste number U028" OR "Reomol D
79P" OR "Reomol DOP" OR "Sansocizer DOP" OR "Sansocizer R 8000" OR "Scandinol SC 1000" OR
"Sconamoll DOP" OR "Sicol 150" OR "Staflex DOP" OR "Truflex DOP" OR "Unem 5005" OR "UNII-
6A121LGB40" OR "UNII-C42K0PH13C" OR "Vestinol AH" OR "Vinicizer 80" OR "Vinycizer 80"
OR "Vinycizer 80K" OR "Witcizer 312") AND LA(ENG)
SCIENCE DIRECT: (www.sciencedirect.com)
General Search Terms applied to the search strategy for Science Direct
Date Searched: 07/05/2019
89
-------
Date Range of Search: 1823 to Present
N = 3332
Science Direct 01:
"1,2-Benzenedicarboxylic acid, 1,2-diisooctyl ester" OR "1,2-Benzedicarboxylic acid, bis(2-ethyl-hexyl)
ester" OR "1,2-Benzenedicarboxylic acid bis(2-ethylhexyl) ester" OR "1,2-Benzenedicarboxylic acid,
l,2-bis(2-ethylhexyl) ester" OR "1,2-Benzenedicarboxylic acid, 1,2-diisooctyl ester" OR "1,2-
Benzenedicarboxylic acid, bis(2-ethylhexyl) ester" OR "1,2-Benzenedicarboxylic acid, bis(2-
ethylhexyl)ester" OR "1,2-Benzenedicarboxylic acid, Butyl phenylmethyl ester" OR "1,2-
Benzenedicarboxylic acid, diisooctyl ester"
N = 0
Science Direct 02:
"1,2-Benzenedicarboxylic acid,bis(2-ethylhexylester)" OR "2-Ethylhexyl phthalate" OR "AI3-27697-X"
OR "Bis(2-ethylhexyl) 1,2-benzenedicarboxylate" OR "Bis(2-ethylhexyl) benzene-1,2-dicarboxylate"
OR "Bis(2-ethylhexyl) o-phthalate" OR "Bis(2-ethylhexyl) phthalate" OR "Bis(2-ethylhexyl)ester,
Phthalic acid" OR "Bis(2-ethylhexyl)phthalat"
N = 0
Science Direct 03:
"Bis(2-ethylhexyl)phthalate" OR "Bis-(2-ethylhexyl)-phthalate" OR "Bis(ethylhexyl) phthalate" OR
"Bisoflex 81" OR "Bisoflex DOP" OR "BRN 1890696" OR "Butylbenzyl Phthalate" OR
"Butylbenzylphthalate" OR "Caswell No. 392K"
N = 0
Science Direct 04:
"Codan Set L 86P" OR "Compound 889" OR "Corflex 400" OR "Corflex 880" OR "DEHP" OR "Di(2-
ethylhexyl) o-phthalate" OR "Di(2-ethylhexyl) orthophthalate" OR "Di(2-ethylhexyl) phthalate" OR
"Di-(2-ethylhexyl) phthalate"
N = 0
Science Direct 05:
"Di(2-ethylhexyl)orthophthalate" OR "Di(2-ethylhexyl)phthalate" OR "di(alpha-Ethylhexyl) phthalate"
OR "Di(ethylhexyl) phthalate" OR "Di-(Ethylhexyl)phthalate" OR "Di(isooctyl) phthalate" OR "Di-2-
ethylhexlphthalate" OR "Di-2-ethylhexyl phthalate" OR "DI-2-ETHYLHEXYL-PHTHALATE"
N = 0
Science Direct 06:
"Diacizer DOP" OR "Diethylhexyl phthalate" OR "Di-ethylhexyl phthalate" OR
"Diethylhexylphthalate" OR "Diisooctyl 1,2-benzenedicarboxylate"
N= 197
Science Direct 07:
"Diisooctyl ester 1,2-Benzenedicarboxylic acid" OR "Diisooctyl o-phthalate" OR "Diisooctyl phthalate"
OR "di-iso-Octyl phthalate" OR "Diisooctylphthalat" OR "Diisooctylphthalate" OR "Dioctyl phthalate"
OR "Diplast O" OR "Di-sec-octyl phthalate"
N = 283
90
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Science Direct 08:
"Ergoplast FDO" OR "Ergoplast FDO-S" OR "ESBO-D 82" OR "Etalon" OR "Ethylhexyl phthalate"
OR "Ethylhexyl phthlate" OR "Eviplast 80" OR "Eviplast 81" OR "Fleximel"
N = 2684
Science Direct 09:
"Flexol DOD" OR "Flexol DOP" OR "Flexol Plasticizer DIOP" OR "Flexol Plasticizer DOP" OR
"Garbeflex DOP-D 40" OR "Good-rite GP 264" OR "Hatco DOP" OR "Hatcol DOP" OR "Hercoflex
260"
N = 0
Science Direct 10:
"Hexaplas DIOP" OR "Hexaplas M/O" OR "Isooctyl phthalate" OR "Isooctylphthalate" OR " Jayflex
DIOP" OR "Jayflex DOP" OR "JSSD-DOP" OR "Kodaflex DEHP" OR "Kodaflex DOP"
N = 7
Science Direct 11:
"Mollan O" OR "Monocizer DOP" OR "NCI-C52733" OR "NSC 17069" OR "NSC 6381" OR "Nuoplaz
DOP" OR "Octoil" OR "Octyl phthalate" OR "Palatinol AH"
N= 161
Science Direct 12:
"Palatinol AH-L" OR "Palatinol DOP" OR "PHTHALATE, BIS(2-ETHYLHEXYL)" OR "Phthalic acid
bis(2-ethylhexyl) ester" OR "Phthalic acid di(2-ethylhexyl) ester"
N = 0
Science Direct 13:
"Phthalic acid dioctyl ester" OR "Phthalic acid, bis(2-ethylhexyl) ester" OR "PHTHALIC ACID, BIS(2-
ETHYLHEXYL)ESTER" OR "Phthalic acid, bis(6-methylheptyl)ester" OR "Phthalic acid, diisooctyl
ester" OR "Pittsburgh PX 138" OR "Pittsburgh PX-138" OR "Plasthall DOP" OR "Platinol AH"
N = 0
Science Direct 14:
"Platinol DOP" OR "RC Plasticizer DOP" OR "RCRA waste number U028" OR "Reomol D 79P" OR
"Reomol DOP" OR "Sansocizer DOP" OR "SansocizerR 8000" OR "Scandinol SC 1000" OR
"Sconamoll DOP"
N = 0
Science Direct 15:
"Sicol 150" OR "Staflex DOP" OR "Truflex DOP" OR "Unem 5005" OR "UNII-6A121LGB40" OR
"UNII-C42K0PH13C" OR "Vestinol AH" OR "Vinicizer 80" OR "Vinycizer 80"
N = 0
Science Direct 16:
"Vinycizer 80K" OR "Witcizer 312"
N = 0
AGRICOLA: (www.nal .usda. gov)
91
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General Search Terms applied to the search strategy for Agricola. The Agricola database contains a
significant amount of gray literature including proceedings, symposia, and progress reports from
government and educational institutions. Agricola is not used when conducting a search for the Office
of Water.
Date Searched: 07/10/2019
Date Range of Search: 15th century to the Present
N = 3391
Agricola 01:
1,2-Benzenedicarboxylic acid, 1,2-diisooctyl ester
1,2-Benzedicarboxylic acid, bis(2-ethyl-hexyl) ester
1,2-Benzenedicarboxylic acid bis(2-ethylhexyl) ester
1,2-Benzenedicarboxylic acid, l,2-bis(2-ethylhexyl) ester
1,2-Benzenedicarboxylic acid, 1,2-diisooctyl ester
1,2-Benzenedicarboxylic acid, bis(2-ethylhexyl) ester
1,2-Benzenedicarboxylic acid, bis(2-ethylhexyl)ester
1,2-Benzenedicarboxylic acid, Butyl phenylmethyl ester
1,2-Benzenedicarboxylic acid, diisooctyl ester
1,2-Benzenedicarboxylic acid,bis(2-ethylhexylester)
N = 0
Agricola 02:
2-Ethylhexyl phthalate
AI3-27697-X
Bis(2-ethylhexyl) 1,2-benzenedicarboxylate
Bis(2-ethylhexyl) benzene-1,2-dicarboxylate
Bis(2-ethylhexyl) o-phthalate
Bis(2-ethylhexyl) phthalate
Bis(2-ethylhexyl)ester, Phthalic acid
Bis(2-ethylhexyl)phthalat
Bis(2-ethylhexyl)phthalate
Bis-(2-ethylhexyl)-phthalate
N = 787
Agricola 03:
Bis(ethylhexyl) phthalate
Bisoflex 81
Bisoflex DOP
BRN 1890696
Butylbenzyl Phthalate
Buty lb enzy lphthal ate
Caswell No. 392K
Codan Set L 86P
Compound 889
Corflex 400
N = 37
92
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Agricola 04:
Corflex 880
DEHP
Di(2-ethylhexyl) o-phthalate
Di(2-ethylhexyl) orthophthalate
Di(2-ethylhexyl) phthalate
Di-(2-ethylhexyl) phthalate
Di(2-ethylhexyl)orthophthalate
Di(2-ethylhexyl)phthalate
di(alpha-Ethylhexyl) phthalate
Di(ethylhexyl) phthalate
N = 885
Agricola 05:
Di-(Ethylhexyl)phthalate
Di(isooctyl) phthalate
Di-2-ethylhexlphthalate
Di-2-ethylhexyl phthalate
DI-2-ETHYLHEXYL-PHTHALATE
Diacizer DOP
Diethylhexyl phthalate
Di-ethylhexyl phthalate
Diethylhexylphthalate
Diisooctyl 1,2-benzenedicarboxylate
N = 681
Agricola 06:
Diisooctyl ester 1,2-Benzenedicarboxylic acid
Diisooctyl o-phthalate
Diisooctyl phthalate
di-iso-Octyl phthalate
Diisooctylphthalat
Diisooctylphthalate
Dioctyl phthalate
Diplast O
Di-sec-octyl phthalate
Ergoplast FDO
N = 73
Agricola 07:
Ergoplast FDO-S
ESBO-D 82
Etalon
Ethylhexyl phthalate
Ethylhexyl phthlate
Eviplast 80
Eviplast 81
Fleximel
93
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Flexol DOD
Flexol DOP
N = 822
Agricola 08:
Flexol Plasticizer DIOP
Flexol Plasticizer DOP
Garbeflex DOP-D 40
Good-rite GP 264
Hatco DOP
Hatcol DOP
Hercoflex 260
Hexaplas DIOP
Hexaplas M/O
Isooctyl phthalate
N = 2
Agricola 09:
Isooctylphthalate
Jay flex DIOP
Jayflex DOP
JSSD-DOP
Kodaflex DEHP
Kodaflex DOP
Mollan O
Monocizer DOP
NCI-C52733
NSC 17069
N = 0
Agricola 10:
NSC 6381
Nuoplaz DOP
Octoil
Octyl phthalate
Palatinol AH
Palatinol AH-L
Palatinol DOP
PHTHALATE, BIS(2-ETHYLHEXYL)
Phthalic acid bis(2-ethylhexyl) ester
Phthalic acid di(2-ethylhexyl) ester
N= 104
Agricola 11:
Phthalic acid dioctyl ester
Phthalic acid, bis(2-ethylhexyl) ester
PHTHALIC ACID, BIS(2-ETHYLHEXYL)ESTER
Phthalic acid, bis(6-methylheptyl)ester
94
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Phthalic acid, diisooctyl ester
Pittsburgh PX 138
Pittsburgh PX-138
Plasthall DOP
Platinol AH
Platinol DOP
N = 0
Agricola 12:
RC Plasticizer DOP
RCRA waste number U028
Reomol D 79P
Reomol DOP
Sansocizer DOP
Sansocizer R 8000
Scandinol SC 1000
Sconamoll DOP
Sicol 150
Staflex DOP
N = 0
Agricola 13:
Truflex DOP
Unem 5005
UNII-6A121LGB40
UNII-C42K0PH13 C
Vestinol AH
Vinicizer 80
Vinycizer 80
Vinycizer 80K
Witcizer 312
N = 0
TOXNET: (toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?TOXLINE)
General Search Terms applied to the search strategy for TOXNET.
Date Searched: 07/08/2019
Date Range of Search: 1900 to Present
N = 3376
TOXNET 01:
117-81-7 OR 27554-26-3 OR 8033-53-2 OR 40120-69-2 OR 50885-87-5
N = 3374
TOXNET 02:
109630-52-6 OR 126639-29-0 OR 137718-37-7 OR 205180-59-2 OR 275818-89-8
N = 1
TOXNET 03:
95
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607374-50-5 OR 1330-91-2 OR 25103-50-8 OR 41375-90-0
N = 1
PubMed:
PubMed may be accessed through the EPA Desktop Library
(hiim://www.ncbi.nlm.nih.2ov/pubmed/)Da.te Searched: 07/08/2019
Date Range of Search: 1900 to present
N = 8331
PubMed 01:
"1,2-Benzenedicarboxylic acid, 1,2-diisooctyl ester" OR "1,2-Benzedicarboxylic acid, bis(2-ethyl-hexyl)
ester" OR "1,2-Benzenedicarboxylic acid bis(2-ethylhexyl) ester" OR "1,2-Benzenedicarboxylic acid,
l,2-bis(2-ethylhexyl) ester" OR "1,2-Benzenedicarboxylic acid, 1,2-diisooctyl ester" OR "1,2-
Benzenedicarboxylic acid, bis(2-ethylhexyl) ester" OR "1,2-Benzenedicarboxylic acid, bis(2-
ethylhexyl)ester" OR "1,2-Benzenedicarboxylic acid, Butyl phenylmethyl ester" OR "1,2-
Benzenedicarboxylic acid, diisooctyl ester" OR "1,2-Benzenedicarboxylic acid,bis(2-ethylhexylester)"
OR "2-Ethylhexyl phthalate" OR "AI3-27697-X" OR "Bis(2-ethylhexyl) 1,2-benzenedicarboxylate" OR
"Bis(2-ethylhexyl) benzene-1,2-dicarboxylate" OR "Bis(2-ethylhexyl) o-phthalate" OR "Bis(2-
ethylhexyl) phthalate" OR "Bis(2-ethylhexyl)ester, Phthalic acid" OR "Bis(2-ethylhexyl)phthalat" OR
"Bis(2-ethylhexyl)phthalate" OR "Bis-(2-ethylhexyl)-phthalate" OR "Bis(ethylhexyl) phthalate" OR
"Bisoflex 81" OR "Bisoflex DOP" OR "BRN 1890696" OR "Butylbenzyl Phthalate" OR
"Butylbenzylphthalate" OR "Caswell No. 392K" OR "Codan Set L 86P" OR "Compound 889" OR
"Corflex 400" OR "Corflex 880" OR "DEHP" OR "Di(2-ethylhexyl) o-phthalate" OR "Di(2-ethylhexyl)
orthophthalate" OR "Di(2-ethylhexyl) phthalate" OR "Di-(2-ethylhexyl) phthalate" OR "Di(2-
ethylhexyl)orthophthalate" OR "Di(2-ethylhexyl)phthalate" OR "di(alpha-Ethylhexyl) phthalate" OR
"Di(ethylhexyl) phthalate" OR "Di-(Ethylhexyl)phthalate" OR "Di(isooctyl) phthalate" OR "Di-2-
ethylhexlphthalate" OR "Di-2-ethylhexyl phthalate" OR "DI-2-ETHYLHEXYL-PHTHALATE" OR
"Diacizer DOP" OR "Diethylhexyl phthalate" OR "Di-ethylhexyl phthalate" OR
"Diethylhexylphthalate" OR "Diisooctyl 1,2-benzenedicarboxylate"
N = 4229
PubMed 02:
"Diisooctyl ester 1,2-Benzenedicarboxylic acid" OR "Diisooctyl o-phthalate" OR "Diisooctyl phthalate"
OR "di-iso-Octyl phthalate" OR "Diisooctylphthalat" OR "Diisooctylphthalate" OR "Dioctyl phthalate"
OR "Diplast O" OR "Di-sec-octyl phthalate" OR "Ergoplast FDO" OR "Ergoplast FDO-S" OR "ESBO-
D 82" OR "Etalon" OR "Ethylhexyl phthalate" OR "Ethylhexyl phthlate" OR "Eviplast 80" OR
"Eviplast 81" OR "Fleximel" OR "Flexol DOD" OR "Flexol DOP" OR "Flexol Plasticizer DIOP" OR
"Flexol Plasticizer DOP" OR "Garbeflex DOP-D 40" OR "Good-rite GP 264" OR "Hatco DOP" OR
"Hatcol DOP" OR "Hercoflex 260" OR "Hexaplas DIOP" OR "Hexaplas M/O" OR "Isooctyl phthalate"
OR "Isooctylphthalate" OR "Jayflex DIOP" OR "Jayflex DOP" OR "JSSD-DOP" OR "Kodaflex DEHP"
OR "Kodaflex DOP" OR "Mollan O" OR "Monocizer DOP" OR "NCI-C52733" OR "NSC 17069" OR
"NSC 6381" OR "Nuoplaz DOP" OR "Octoil" OR "Octyl phthalate" OR "Palatinol AH" OR "Palatinol
AH-L" OR "Palatinol DOP" OR "PHTHALATE, BIS(2-ETHYLHEXYL)" OR "Phthalic acid bis(2-
ethylhexyl) ester" OR "Phthalic acid di(2-ethylhexyl) ester"
N = 4102
PubMed 03:
96
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"Phthalic acid dioctyl ester" OR "Phthalic acid, bis(2-ethylhexyl) ester" OR "PHTHALIC ACID, BIS(2-
ETHYLHEXYL)ESTER" OR "Phthalic acid, bis(6-methylheptyl)ester" OR "Phthalic acid, diisooctyl
ester" OR "Pittsburgh PX 138" OR "Pittsburgh PX-138" OR "Plasthall DOP" OR "Platinol AH" OR
"Platinol DOP" OR "RC Plasticizer DOP" OR "RCRA waste number U028" OR "Reomol D 79P" OR
"Reomol DOP" OR "Sansocizer DOP" OR "SansocizerR 8000" OR "Scandinol SC 1000" OR
"Sconamoll DOP" OR "Sicol 150" OR "Staflex DOP" OR "Truflex DOP" OR "Unem 5005" OR "UNII-
6A121LGB40" OR "UNII-C42K0PH13C" OR "Vestinol AH" OR "Vinicizer 80" OR "Vinycizer 80"
OR "Vinycizer 80K" OR "Witcizer 312"
N = 0
ECOTOX UNIFY:
This is an internal EPA database that is not accessible to the public. Results from the ECOTOX Unify
search strategy.
Date Searched: 07/23/2019
Date Range of Search: all years
N = 523
A.l.2.2 Data Prioritization for Environmental Hazard, Human Health Hazard, Fate
and Physical Chemistry
In brief, SWIFT Review has pre-set literature search strategies ("filters") developed by information
specialists that can be applied to identify studies that are more likely to be useful for identifying human
health and ecotoxicity content from those that likely do not (e.g., analytical methods). The filters
function like a typical search strategy where studies are tagged as belonging to a certain filter if the
terms in the filter literature search strategy appear in title, abstract, keyword or medical subject headings
(MeSH) fields content. The applied SWIFT Review filters focused on lines of evidence: human, animal
models for human health, ecological taxa (which includes ecotoxicological animal models, plants, and
other taxa), and in vitro studies. The details of the search strategies that underlie the filters are available
online. Studies not retrieved using these filters were not considered further. Studies that included one or
more of the search terms in the title, abstract, keyword, or MeSH fields were exported as a RIS file for
screening in Swift-ActiveScreener or DistillerSR.."
A.l.2.3 Data Prioritization for Occupational Exposures and Environmental Releases
and General Population, Consumer and Environmental Exposures
To prioritize references related to occupational exposure, environmental release, general population
exposure, consumer exposure, and environmental exposure, EPA used positive and negative seed studies
to build a classification model in SWIFT Review. The positive seeds were identified using relevant
literature pool for the first ten TSCA risk evaluations, while the negative seeds were identified from a
subset of literature for the current high-priority substances. The model was then applied to the
unclassified literature to generate a classification score for each reference. Scores above a certain
threshold value were then prioritized for further review in SWIFT-ActiveScreener.
A.2 Peer-Reviewed Screening Process
The studies identified from publicly available database searches and SWIFT-Review filtering/
prioritization were housed in HERO system and imported into SWIFT-ActiveScreener or DistillerSR for
title/abstract and full-text screening. Both title/abstract and full-text screening were conducted by two
independent reviewers. Screening is initiated with a pilot phase of screening (between 10 and 50) studies
"DistillerSR is a web-based systematic review software used to screen studies available at
https://www.evidencepartiiers.com/products/distiUersr-SYStematic-review-software.
97
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to identify areas where clarification in screening criteria might be needed or chemical-specific
supplemental material tags might be identified. Records that met PECO (or equivalent criteria
(Appendix A.2.1) during title and abstract screening were considered for full-text screening. At both the
title/abstract and full-text review levels, screening conflicts were resolved by topic-specific experts
and/or discussion among the primary screeners. For citations with no abstract, the articles are initially
screened based on all or some of the following: title relevance (titles that suggest a record is not relevant
can be excluded rather than marked as unclear), and page numbers (articles two pages in length or less
were assumed to be conference reports, editorials, or letters). During title/abstract or full-text level
screening in DistillerSR, studies that did not meet the PECO criteria, but which could provide
supporting information were categorized (or "tagged") as supplemental information.
It is important to emphasize that being tagged as supplemental material does not mean the study would
necessarily be excluded from consideration in an assessment. The initial screening level distinctions
between a study meeting the PECO criteria and a supplemental study are often made for practical
reasons and the tagging structures (as seen in the literature inventory trees and heat maps in Section 2.1
of this document) are designed to ensure the supplemental studies are categorized for easy retrieval if
needed while conducting the assessment. The impact on the assessment conclusions of individual studies
tagged as supporting material is often difficult to assess during the screening phase of the assessment.
These studies may emerge as being critically important to the assessment and need to be evaluated and
summarized at the individual study level (e.g., cancer MOA mechanistic or non-English-language
studies), or be helpful to provide context (e.g., summarize current levels of exposure, provide hazard
evidence from routes or durations of exposure not pertinent to the PECO), or not be cited at all in the
assessment (e.g., individual studies that contribute to a well-established scientific conclusion). Studies
maybe be tagged as supplemental material during either title and abstract or full-text screening. When
tagged as supplemental material during title and abstract screening, it may not be completely clear
whether the chemical of interest is reported in the study (i.e., abstracts may not describe all chemicals
investigated). In these cases, studies are still tagged with the expectation that if full-text retrieval is
pursued, then additional screening would be needed to clarify if the study is pertinent.
A.2.1 Inclusion/Exclusion Criteria
A PECO statement is typically used to focus the research question(s), search terms, and inclusion/
exclusion criteria in a systematic review. PECO criteria were developed a priori to screening and
modified to fit the various discipline areas supporting the TSCA risk evaluations. Variations include the
RESO (receptor, exposure, scenario/setting, and outcome) used for the occupational exposure and
environmental releases discipline, and PESO (pathways/processes, exposures, setting/scenario, and
outcomes) used by the fate and transport discipline. All PECOs and PECO-equivalent criteria can be
found in the following sections.
A.2.1.1 PECO for Environmental and Human Health Hazards
The PECO used in this evidence map to identify literature pertinent to di-ethylhexyl phthalate effects on
human health and environmental hazard is presented in TableApx A-3. In addition to the PECO
criteria, studies containing potentially relevant supplemental material were tracked and categorized
during the literature screening process as outlined in Table Apx A-4.
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TableApx A-3. Hazards Title and Abstract and Full-text PECO Criteria for Di-ethylhexyl
Phthalate
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P
• Human: Any population and life stage (e.g., occupational or general population, including children
and other sensitive populations).
• Animal: Aquatic and terrestrial species (live, whole organism) from any life stage (e.g.,
preconception, inutero, lactation, peripubertal, and adult stages). Animal models will be inventoried
according to the categorization below:
- Human health models: rat. mouse, rabbit, doe. hamster, euinea Die. cat. non-human
primate, pig, hen (neurotoxicity only)
- Environmental models: invertebrates (e.s.. insects, soidcrs. crustaceans, mollusks. and
worms) and vertebrates (e.g., mammals and all amphibians, birds, fish, and reptiles).
All hen studies (including neurotoxicity studies) will be included for ecotoxicological
models.
• Plants: All aquatic and terrestrial species (live), including algal, moss, lichen and fungi species.
Screener note:
• To identify human health and environmental hazards, other organisms not listed above in their
respective categories can also be used. Non-mammalian model systems are increasingly used to
identify potential human health hazards (e.g.,Xenopus, zebrafish), and traditional human health
models (e.g., rodents) can be used to identify potential environmental hazard. Neurotoxicity studies
performed in hens (e.g., OECD 418 and 419) are considered relevant to both human and eco hazard
• PECO considerations should be directed toward effects on target species only and not on the indirect
effects expressed in taxa as a result of chemical treatment (e.g., substance is lethal to a targeted pest
species leading to positive effects on plant growth due to diminished presence of the targeted pest
species).
• Tests of the single toxicants in in vitro and ex vivo systems or on gametes, embryos, or plant or
fungal sections capable of forming whole, new organisms will be tagged as potentially supplemental
(mechanistic studies). Bacteria and yeast studies specific for assessing genotoxicity or mutagenicity
(e.g., Ames assay) will also be tagged as potentially supplemental (mechanistic studies) but are
otherwise excluded. Studies on viruses are excluded.
E
Relevant forms:
• Diethylhexyl phthalate (DEHP) (CASRN 117-81-7)
Isomer: Isooctvl ohthalate - CASRN 27554-26-3
Svnonvms for Diethvlhexvl phthalate (CASRN 27554-26-3) can be found on the EPA Chemistry
Dashboard.
• Human: Any exposure to DEHP singularly or in mixture, including exposure as measured by
internal concentrations of these chemicals or metabolites of these chemicals in a biological matrix
(i.e., urine, blood, semen, etc.). See list of common metabolites for each phthalate below.
• Animal: Any exposure to DEHP including via water (including environmental aquatic exposures),
soil or sediment, diet, gavage, injection, dermal, and inhalation.
• Plants: Any exposure to DEHP including via water or soil, or sediment.
Screener note:
• Field studies with media concentrations (surface water, interstitial water, soil, sediment) and/or
bodv/tissue concentrations of animals or olants are to be identified as Supplemental if anv biolosical
effects are reported.
• Studies involving exposures to mixtures will be Included onlv if thev also include exposure to
DEHP alone. Otherwise, mixture studies will be tagged as supplemental.
• Controlled outdoor experimental studies (e.g., controlled crop/greenhouse studies, mesocosm
studies, artificial stream studies) are considered to be laboratory studies (not field studies) because
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i»i:c o
Klcnicnl
K\ idcnco
there is a known and prescribed exposure dose(s) and an evaluation of hazardous effect(s). Whereas
field studies (e.g., biomonitoring) where there is no prescribed exposure dose(s) will be excluded if
there is no evaluated hazardous effect, and tagged as supplemental field, if there is an evaluated
hazardous effect.
C
• Human: A comparison or referent population exposed to lower levels (or no exposure/exposure
below detection limits) of DEHP, or exposure to DEHP for shorter periods of time.
• Animal and Plants: A concurrent control group exposed to vehicle-only treatment and/or untreated
control (control could be a baseline measurement).
Screener note:
• If no control group is explicitly stated or implied (e.g. by mention of statistical results that could
only be obtained if a control group was present), the study will be marked as Unclear during
Title/Abstract Screening.
• All case series and case studies describing findings in a sample size of less than 20 people in any
setting (e.g., occupation, general population) will be tracked as Supplemental Case-control, case-
crossover, case-referent, case-only, case-specular, case-cohort, case-parent, nested case-control
study designs are all Included.
O
• Human: All health outcomes (cancer and noncancer) at the organ level or higher.
• Animal and Plants: All apical biological effects (effects measured at the organ level or higher) and
bioaccumulation from laboratory studies with concurrently measured media and/or tissue
concentrations). Apical endpoints include but are not limited to reproduction, survival, and growth.
Screener note:
• Measurable biological effects relevant for humans, animals and plants may include but are not
limited to: mortality, behavioral, population, cellular, physiological, growth, reproduction, systemic,
point of contact (irritation and sensitization) effects.
• Effects measured at the cellular level of biological organization and below are to be tagged as
supplemental, mechanistic.
TableApx A-4. Major Categories of Potentially Relevant Supplemental Materials for Di-
ethylhexyl Phthalate
( aleiion
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Mechanistic studies
All studies that report results at the cellular level and lower in both mammalian and non-
mammalian model systems, including in vitro, in vivo, ex vivo, and in silico studies. These
studies include assays for genotoxicity or mutagenicity using bacteria or yeast.
ADME, PBPK, and
toxicokinetic
Studies designed to capture information regarding absorption, distribution, metabolism, and
excretion (ADME), toxicokinetic studies, or physiologically based pharmacokinetic (PBPK)
models.
Case reports or case series
Case reports (n < 3 cases) and case series (non-occupational) will be tracked as potentially
relevant supplemental information.
Susceptible populations
(no health outcome)
Studies that identify potentially susceptible subgroups; for example, studies that focus on a
specific demographic, life stage, or genotype. This tag applies primarily during full-text
screening.
Screener note: If biolosical susceptibility issues are clearlv Dresent or stronelv implied in the
title/abstract, this supplemental tag may be applied at the title abstract level. If uncertain at
title/abstract, do not apply this tag to the reference during title/abstract screening.
Mixture studies
Experimental mixture studies that are not considered PECO-relevant because they do not
contain an exposure or treatment group assessing only the chemical of interest. Human health
100
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(a logon
l.\ idcncc
animal model and environmental animal model/plant will be tagged separately for mixture
studies.
Records with no original
data
Records that do not contain original data, such as other agency assessments, informative
scientific literature reviews, editorials or commentaries.
Conference abstracts
Records that do not contain sufficient documentation to support study evaluation and data
extraction.
Field Studies
Field studies with media concentrations (e.g., surface water, interstitial water, soil, sediment)
and/or body /tissue concentrations of animals or plants if biological effects reported.
Isomer
PECO-relevant studies with an exposure to one of the identified isomers, if any.
A.2.1.2 PECO for Consumer, Environmental, and General Population Exposures
Table Apx A-5. Generic Inclusion Criteria for the Data Sources Reporting Exposure Data on
General Population, Consumers and Environmental Receptors
Pl.( () l lemenl
l'.\ idcncc
Population
Human: General DODulation: consumers: bystanders in the home: near-facilitv DODulations
(includes industrial and commercial facilities manufacturing, processing, or using the chemical
substance); children; susceptible populations (life stages, preexisting conditions, genetic factors),
pregnant women; lactating women, women of childbearing age. Many human population groups
may be exposed. No chemical-specific exclusions are suggested at this time.
Environmental: Aauatic soccics. terrestrial SDecics. terrestrial Dlants. aauatic olants (field
studies only).
Exposure
Expected Primary Exposure Sources, Pathways, Routes:
Pathways: indoor air/vaoor/mist: indoor dust: ^articles: outdoor/ambient air; surface water;
biosolids; sediment; breastmilk; food items containing di-ethylhexyl phthalate including fish;
consumer product uses in the home (including consumer product containing chemical);
Routes of Exposure: Inhalation. Oral. Dermal
Comparator
(Scenario)
Human: Consider mcdia-SDCcific background exposure scenarios and use/source specific
exposure scenarios as well as which receptors are and are not reasonably exposed across the
projected exposure scenarios.
Environmental Consider mcdia-SDCcific background exposure scenarios and use/source
specific exposure scenarios as well as which receptors are and are not reasonably exposed across
the projected exposure scenarios.
Outcomes for
Exposure
Concentration or
Dose
Human: Acute, subchronic. and/or indoor air and water concentration estimates (me/m3 or
mg/L). Both external potential dose and internal dose based on biomonitoring and reverse
dosimetry mg/kg/day will be considered. Characteristics of consumer products or articles (weight
fraction, emission rates, etc) containing di-ethylhexyl phthalate.
Environmental: A wide ranee of ecoloeical rcccotors will be considered (ranee dcDcndine on
available ecotoxicity data) using surface water concentrations, sediment concentrations.
101
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Table Apx A-6. Pathways Identified as Supplemental for Di-ethylhexyl Phthalate"
( hemical
Drinking
Water
Amhienl
Air
Ail-
Disposal
land
Disposal
I nder^round
Disposal
(.round Waler
Di-ethylhexyl
phthalate (DEHP)
X
X
X
X
X
X
a "Supplemental pathways" refer to pathways addressed by other EPA administered statutes (see Section 2.6.3.1).
Studies tagged under these pathways provide media information that is not prioritized in the screening process.
A.2.1.3 RESO for Occupational Exposure and Environmental Releases
EPA developed a generic RESO statement to guide the screening of engineering and occupational
exposure data or information sources for the TSCA risk evaluations. Data or information sources that
comply with the inclusion criteria specified in the RESO statement are eligible for inclusion, considered
for evaluation, and possibly included in the environmental release and occupational exposure
assessments. On the other hand, data or information sources that fail to meet the criteria in the RESO
statement are excluded from further consideration.
Assessors seek information on various chemical-specific engineering and occupational exposure data
needs as part of the process of developing the exposure assessment for each risk evaluation. EPA uses
the RESO statement (TableApx A-7) along with the information in TableApx A-8 when screening the
engineering and occupational exposure data and information.
Table Apx A-7. Inclusion Criteria for Data Sources Reporting Engineering and Occupational
Exposure Data
RI.SO l leinenl
l.\ irience
Receptors
• Humans:
Workers, including occupational non-users
• Environment:
All environmental receptors (relevant release estimates input to Exposure)
Please refer to the conceptual models for more information about the environmental and human
receptors included in the TSCA risk evaluation.
Exposure
• Worker exposure to and relevant environmental releases of the chemical substance from occupational
scenarios:
Dermal and inhalation exposure routes (as indicated in the conceptual model)
Oral route (as indicated in the conceptual model)
Please refer to the conceptual models for more information about the routes and media/pathways
included in the TSCA risk evaluation.
Setting or
Scenario
• Any occupational setting or scenario resulting in worker exposure and relevant environmental
releases (includes all manufacturing, processing, use, disposal.
Outcomes
• Quantitative estimates* of worker exposures and of relevant environmental releases from
occupational settings
• General information and data related and relevant to the occupational estimates*
* Metrics (e.g., mg/kg/day or mg/m3 for worker exposures, kg/site/day for releases) are determined by toxicologists for
worker exposures and by exposure assessors for releases; also, the Engineering, Release and Occupational Exposure Data
Needs (Table Apx A-8) provides a list of related and relevant general information.
TSCA=Toxic Substances Control Act
102
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TableApx A-8. Engineering, Environmental Release and Occupational Data Necessary to
Develop the Environmental Release and Occupational Exposure Assessments
Ol).joc(i\o
Ikkrinincd
(lurinii Scoping
T\|>e of Diilii''
General
Engineering
Assessment (may
apply to
Occupational
Exposures and /
or Environmental
Releases)
Description of the life cycle of the chemical(s) of interest, from manufacture to end-of-life (e.g., each
manufacturing, processing, or use step), and material flow between the industrial and commercial life
cycle stages.
The total annual U.S. volume (lb/yr or kg/yr) of the chemical(s) of interest manufactured, imported,
processed, and used; and the share of total annual manufacturing and import volume that is processed
or used in each life cycle step.
Description of processes, equipment, and unit operations during each industrial/ commercial life cycle
step.
Material flows, use rates, and frequencies (lb/site-day or kg/site-day and days/yr; lb/site-batch and
batches/yr) of the chemical(s) of interest during each industrial/ commercial life cycle step. Note: if
available, include weight fractions of the chemicals (s) of interest and material flows of all associated
primary chemicals (especially water).
Number of sites that manufacture, process, or use the chemical(s) of interest for each industrial/
commercial life cycle step and site locations.
Concentration of the chemical of interest
Occupational
Exposures
Description of worker activities with exposure potential during the manufacture, processing, or use of
the chemical(s) of interest in each industrial/commercial life cycle stage.
Potential routes of exposure (e.g., inhalation, dermal).
Physical form of the chemical(s) of interest for each exposure route (e.g., liquid, vapor, mist) and
activity.
Breathing zone (personal sample) measurements of occupational exposures to the chemical(s) of
interest, measured as time-weighted averages (TWAs), short-term exposures, or peak exposures in
each occupational life cycle stage (or in a workplace scenario similar to an occupational life cycle
stage).
Area or stationary measurements of airborne concentrations of the chemical(s) of interest in each
occupational setting and life cycle stage (or in a workplace scenario similar to the life cycle stage of
interest).
For solids, bulk and dust particle size characterization data.
Dermal exposure data.
Exposure duration (hr/day).
Exposure frequency (days/yr).
Number of workers who potentially handle or have exposure to the chemical(s) of interest in each
occupational life cycle stage.
PPE types employed by the industries within scope.
EC employed to reduce occupational exposures in each occupational life cycle stage (or in a workplace
scenario similar to the life cycle stage of interest), and associated data or estimates of exposure
reductions.
Environmental
Releases (to
relevant
environmental
media)
Description of sources of potential environmental releases, including cleaning of residues from process
equipment and transport containers, involved during the manufacture, processing, or use of the
chemical(s) of interest in each life cycle stage.
Estimated mass (lb or kg) of the chemical(s) of interest released from industrial and commercial sites to
each environmental medium (water) and treatment and disposal methods (POTW), including releases
per site and aggregated over all sites (annual release rates, daily release rates)
Release or emission factors.
Number of release days per year.
Waste treatment methods and pollution control devices employed by the industries within scope and
associated data on release/emission reductions.
a These are the tags included in the full-text screening form. The screener makes a selection from these specific tags, which
describe more specific types of data or information.
103
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Ohjec(i\e
Ikkrinincd
Tjpc of Dalii''
(lurinii Scoping
In addition lo llie dnln l>pes listed nbo\ e, 1 !l* \ mn\ ideiihfs additional ikiui needs lor mathematical modeling These d;il;i
needs will be determined on a case-by-case basis.
Abbreviations:
hr=Hour
kg=Kilogram(s)
lb=Pound(s)
yr=Year
PV=Particle volume
POTW=Publicly owned treatment works
PPE=Personal protection equipment
PSD=Particle size distribution
TWA=Time-weighted average
A.2.1.4 PESO for Fate and Transport
EPA developed a generic PESO statement to guide the screening of environmental fate data or
information sources for the TSCA risk evaluations. Data or information sources that comply with the
inclusion criteria in the PESO statement are eligible for inclusion, considered for evaluation, and
possibly included in the environmental fate assessment. On the other hand, data or information sources
that fail to meet the criteria in the PESO statement are excluded from further consideration.
Assessors seek information on various chemical-specific fate endpoints and associated fate processes,
environmental media and exposure pathways as part of the process of developing the environmental fate
assessment for each risk evaluation. EPA uses the PESO statement (
TableApx A-9) along with the information in TableApx A-10 when screening the fate data or
information sources to ensure complete coverage of the processes, pathways and data or information
relevant to the environmental fate and transport of the chemical substance undergoing risk evaluation.
Table Apx A-9. Inclusion Criteria for Data or Information Sources Reporting Environmental
Fate and Transport Data
PI-ISO 1. lemon (
l.\ iricncc
Pathways and
Processes
Environmental fate, transport, partitioning and degradation behavior across environmental media
to inform exposure pathways of the chemical substance of interest
Exposure pathways included in the conceptual models: air, surface water, groundwater,
wastewater, soil, sediment and biosolids.
Processes associated with the target exposure pathways
Bioconcentration and bioaccumulation
Destruction and removal by incineration
Please refer to the conceptual models for more information about the exposure pathways included in
each TSCA risk evaluation.
104
-------
PI'.SO 1. lemon (
l.\ idcnco
Exposure
Environmental exposure of environmental receptors (i.e., aquatic and terrestrial organisms) to the
chemical substance of interest, mixtures including the chemical substance, and/or its
degradation products and metabolites
Environmental exposure of human receptors, including any PESS, to the chemical substance of
interest, mixtures including the chemical substance, and/or its degradation products and
metabolites
Please refer to the conceptual models for more information about the environmental and human
receptors included in each TSCA risk evaluation.
Setting or
Scenario
Any setting or scenario resulting in releases of the chemical substance of interest into the natural or
built environment (e.g., buildings including homes or workplaces, or wastewater treatment
facilities) that would expose environmental (i.e., aquatic and terrestrial organisms) or human
receptors (i.e., general population, and PESS)
Outcomes
Fate properties which allow assessments of exposure pathways:
Abiotic and biotic degradation rates, mechanisms, pathways, and products
Bioaccumulation magnitude and metabolism rates
Partitioning within and between environmental media (see Pathways and Processes)
105
-------
TableApx A-10. Fate Endpoints and Associated Processes, Media and Exposure Pathways
Considered in the Development of the Environmental Fate Assessment
l-'iilo l);ilii I'.ndpoini
Associated Process!es)
Associalcd Mcdia/l'.\posiirc Pathways
Sii rl'acc
\\ alcr.
\\ aslcwalcr.
Sediment
Soil,
liiosolids
(>roundwalcr
Air
Required Lmirouinciilal l aic
X
Abiotic reduction rates or half-
lives
Abiotic reduction, Abiotic
dehalogenation
Aerobic biodegradation rates or
half-lives
Aerobic biodegradation
X
X
Anaerobic biodegradation rates
or half-lives
Anaerobic biodegradation
X
X
X
Aqueous photolysis (direct and
indirect) rates or half-lives
Aqueous photolysis (direct
and indirect)
X
Atmospheric photolysis (direct
and indirect) rates or half-lives
Atmospheric photolysis
(direct and indirect)
X
Bioconcentration factor (BCF),
Bioaccumulation factor (BAF)
Bioconcentration,
Bioaccumulation
X
X
X
Biomagnification and related
information
Trophic magnification
X
Desorption information
Sorption, Mobility
X
X
X
Destruction and removal by
incineration
Incineration
X
Hydrolysis rates or half-lives
Hydrolysis
X
X
X
Koc and other sorption
information
Sorption, Mobility
X
X
X
Wastewater treatment removal
information
Wastewater treatment
X
X
for Oivtinniih Fn
vironmental Fate Data
Abiotic transformation
products
Hydrolysis, Photolysis,
Incineration
X
X
Aerobic biotransformation
products
Aerobic biodegradation
X
X
Anaerobic biotransformation
products
Anaerobic biodegradation
X
X
X
Atmospheric deposition
information
Atmospheric deposition
X
Coagulation information
Coagulation, Mobility
X
X
Incineration removal
information
Incineration
X
A.2.1.5 Generation of Hazard Heat Maps
As stated in Appendix A. 1.2.2, SWIFT Review has pre-set literature search strategies ("filters")
developed by information specialists that can be applied to identify studies that are more likely to be
useful for identifying human health and ecotoxicity content. The filters function like a typical search
106
-------
strategy where studies are tagged as belonging to a certain filter if the terms in the filter literature search
strategy appear in title, abstract, keyword or MeSH fields content.
After the completion of full-text screening for hazard data, all references tagged as included (or "PECO-
relevant) were uploaded to the SWIFT Review tool for further filtering. The SWIFT Review filters
applied at this phase focused on types of health outcomes included: "ADME", "PBPK", "cancer",
"cardiovascular", "developmental", "endocrine", "gastrointestinal", "hematological and immune",
"hepatic", "mortality", "musculoskeletal", "neurological", "nutritional and metabolic", "ocular and
sensory", "renal", "reproductive", "respiratory", and "skin and connective tissue". The details of these
health outcome search strategies that underlie the filters are available online. Studies that included one
or more of the search terms in the title, abstract, keyword, or MeSH fields were exported and used to
populate the Hazard Heat Map (Figure 2-10). Studies that were not retrieved using these filters were
tagged as "No Tag". The evidence type listed in the heat map (e.g., human, animal-human health model,
animal- environmental model, and plant) was manually assigned to each reference by screeners during
the full-text screening.
The health outcome tags were originally designed for vertebrate systems, and as such, did not conform
well to plant evidence. Therefore, any plant studies tagged for: "cancer", "cardiovascular",
"gastrointestinal", "hematological and immune", "hepatic", "musculoskeletal", "neurological", "ocular
and sensory" and "renal and respiratory" were manually reviewed and re-tagged to more appropriate
health outcomes.
A.3 Gray Literature Search and Screening Strategies
EPA conducted a gray literature search for available information to support the TSCA risk evaluations
for the next twenty TSCA risk evaluations. Gray literature is defined as the broad category of
data/information sources not found in standard, peer-reviewed literature databases (e.g., PubMed and
Web of Science). Gray literature includes data/information sources such as white papers, conference
proceedings, technical reports, reference books, dissertations, information on various stakeholder
websites, and other databases. Given the nature of how gray literature is searched and collected, results
may not come with a bibliographic citation or abstract and were therefore processed using a decision
tree logic described in Appendix A.3.1 for potential relevance prior to entering full text screening where
a discipline-specific PECO is applied.
Search terms were variable dependent on source and based on knowledge of a given source to provide
discipline-specific information. A summary of sources is provided in Appendix A.3.4. The criteria for
determining the potential relevance of documents identified from gray literature sources is described in
the following sections for each discipline.
A.3.1 Screening of Gray Literature
To reduce the overall burden of processing gray literature results, EPA developed a screening process to
determine the potential relevance of gray literature. This step was introduced prior to collecting the
resulting documents. Figure Apx A-l describes the decision logic used to screen gray literature results.
107
-------
Potentially Relevant
1. Information (quDfittttv
qualitative) related e> the TSCA
risk evaluation? (*)
Grav Literature Sources
Y e -n to a ten ate P rocesses
Complete/Ava abe
.1 Has the source been
provided from a US state
source"
1.1 Is tta secondajy
source (assessment, robust
summary. etc.)?
22 Is there an e
pro:edure for data collection
casnication. peer review, and
reporting"
Has the source been
provided from a
International Gov. source
B. Foilovi
Procedure for
international Gov
source validation
1.2 Is this study in a peer
revieisedpubttshed
journal?
Is the source Publicauv Available.
Accessible
j .1 Is tfce source TSCA
CBI. proprietary. TSCA
orNGO stakeholder
submission?
C.FO
procedure f
incorporating
proprietary TSCA
Dupticat
( Exclude from Gray Lierature
I Check if caught in Pear Review
V Searc h J
duplicative
i'i :r:r.
FigureApx A-1. Decision Logic Tree Used to Screen Gray Literature Results
A.3.2 Initial Screening of Sources using Decision Logic Tree
The purpose of the inclusion/exclusion decision logic tree in Figure_Apx A-l is to provide a broad,
general screening technique to determine whether each gray literature source should be included and
further screened or excluded with no additional screening necessary. The diamonds in the decision tree
require analysis by the screener, whereas the rectangular boxes are used to classify the type of source.
All the questions used in the decision process are provided in Table_Apx A-l 1.
Table Apx A-l
. Decision Logic Tree Overview
Step
Metric
Questions to consider
1
Potential Relevance
Does the result have information (qualitative or
quantitative) related to TSCA risk evaluations?
* Apply Discipline relevancy metric
2.1.1
Complete / Available
Is it a secondary data source (assessment, robust summary,
TSCA submission databases, etc.)?
2.1.2
Is the document from a peer reviewed/published journal?
108
-------
Step
M el ric
Quest ions lo consider
2.2
Is there an established procedure for data collection,
communication, peer review, and/or reporting?
2.2.1
Has the data been provided by a US governmental/state
source?
2.2.2
Has the data been provided by an international
governmental source?
2.3
Are these data publicly available/accessible?
2.3.1
Is the source TSCA CBI, proprietary, TSCA or NGO
stakeholder submission?
3
Duplicate
Does the result contain any duplicative information found
in other sources?
Results of the gray literature search and decision tree process are included in Appendix A.3.4.
A.3.3 TSCA Submission Searching and Title Screening
EPA screens information submitted under TSCA Sections 4, 5, 8(e), and 8(d), as well as for your
information (FYI) submissions. In the gray literature process defined in Appendix A.3.2, EPA considers
the databases that contain TSCA submissions to be secondary sources (Step 1.1) because the metadata in
the databases are secondary. These databases then advance to Step 2.3.1 and then to Process C. The
Process C steps are described here.
EPA first screens the titles using two screeners per title. EPA conducts this step primarily to reduce the
number of full studies to be obtained because some studies are available only on microfiche or in long-
term storage. Screening is done using the inclusion and exclusion criteria within the relevant PECOs,
PESOs or RESOs for each topic area (Appendix A.2.1). EPA excludes interim reports (e.g., interim
sacrifices for toxicity studies) and only final reports are further considered. If the title is not clear
regarding the document's contents, EPA obtains the full text and advances to the next steps.
After full texts were obtained, EPA reviewed some sources (prior to full-text screening) based on
whether they have several factors; primary data, an established procedure for peer review, data
collection, communication and/or reporting and are publicly available. Sources that have these factors
will move on to full text screening. Other sources will go straight to full text screening using PECO-type
criteria without going through this extra step.
EPA may decide to initiate a backwards search on sources that are deemed to have secondary data. In
situations where parameters such as procedures for peer review and data collection are unclear, EPA
may reach out to the authors to retrieve information to gauge whether the source should be included or
excluded. Studies that are not publicly available (such as proprietary or CBI sources) may undergo
additional screening steps.
During the full-text screening step, two individuals screen each source according to the PECOs, PESOs
and RESOs (Appendix A.2.1).
109
-------
Results of the TSCA submission search and decision tree process are included in Appendix A.3.4
A.3.4 Gray Literature Search Results for Di-ethylhexyl phthalate
Table Apx A-12 provides a list of gray literature sources that yielded results for di-ethylhexyl phthalate.
Table Apx A-12. Gray Literature Sources that Yielded Results for Di-ethylhexyl Phthalate
Source .. .. ... Souixo .. .... .
, Source >:tme Source type Source \Nensile
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ATSDR Tn\ Profile I ixb.k's
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ATSDR
ATSDR Toxicological
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Other US
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Australian
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Resources
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httos://wwwindustrialcheniica
ls.eov.au/chemical-
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assessments
CAL EPA
Technical Support
Documents for regulations:
Cancer Potency Information
Other US
Agency
Resources
Assessment
or Related
Document
httDs://oehha.ca.eov/chemicals
CAL EPA
Technical Support
Documents for regulations:
Proposition 65, Reproductive
Toxicity
Other US
Agency
Resources
Assessment
or Related
Document
httDs://oehha.ca.aov/chemicals
CALEPA
Technical Support
Documents for regulations:
Drinking Water Public Health
Goals
Other US
Agency
Resources
Assessment
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Document
httDs://oehha.ca.aov/chemicals
CALEPA
Technical Support
Documents for regulations:
Proposition 65, Cancer
Other US
Agency
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CPSC
Chronic Hazard Advisory
Panel Reports
Other US
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httDs://www.cDsc.aov/chaD
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Technical Reports:
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110
-------
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httDs://www.canada.ca/en .htm 1
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sheets)
International
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httDs://www.canada.ca/en/heal
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Office of Air: CFRs and US EPA
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111
-------
Source Nsinio Source Tvpe Source Wehsile
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or Related
Document
littt)s://www.fda.eov/
I ARC
I ARC Monograph
International
Resources
Assessment
or Related
Document
http://monograDhs.iarc.fr/ENG
/Monosraolis/PDFs/index.DliD
ILO
International Chemical Safety
Cards (ICSCs)
International
Resources
Database
littos://wwwilo.ors/safework/i
nfo/oublications/WCMS 1131
34/lang--en/index.htm
Japan
Japanese Ministry of the
Environment Assessments -
Environmental Risk
Assessments (Class I
Designated Chemical
Substances Summary Table)
International
Resources
Regulatory
Document
or List
littos://www.env.so.iD/en/clie
m i/ortr/siibstances/
KOECT
Kirk-Othmer Encyclopedia of
Chemical Technology Journal
Article
Other
Resource
Encyclopedi
a
httDs://onlinelibrarv .wilev.com
/doi/bool 3.2/0471.23896
NIOSH
CDC NIOSH - Occupational
Health Guideline Documents
Other US
Agency
Resources
Assessment
or Related
Document
www.cdc.eov/niosh/toDics/che
mical.litml/
NIOSH
CDC NIOSH - Pocket Guide
Other US
Agency
Resources
Database
littos://www.cdc.eov/niosli/nD
e/defau It.liti.nl
NIOSH
CDC NIOSH - Health Hazard
Evaluations (HHEs)
Other US
Agency
Resources
Assessment
or Related
Document
littt)s://www2a.cdc.eov/lilie/se
arch.asD
NIOSH
CDC NIOSH - Publications
and Products
Other US
Agency
Resources
Assessment
or Related
Document
httDs://www2a.cdc.sov/nioshti
c-2/
NLM
National Library of
Medicine's PubChem
Other US
Agency
Resources
Database
httDs://Dubchem.ncbi.nlm.nih.a
ov/
NTP
Additional NTP Reports
Other US
Agency
Resources
Assessment
or Related
Document
h tto s: //n to. n ieh s. n ih. go v/du b 1 ic
ations/index.html
NTP
Technical Reports
Other US
Agency
Resources
Assessment
or Related
Document
h tto s: //n to. n ieh s. n ih. go v/du b 1 ic
ations/reports/index.htm 1 ?tvpe
=Technical+ReDort
112
-------
Source Nsinio Source Type Source Wehsile
( silegorv
NTP
OHAT Monographs
Other US
Agency
Resources
Assessment | }1^s://njD_njeils_nji1_eov/Dubjie
or Related 1 a|t|t/|tat/lloms/evals.html
Document |
OECD
OECD: General Site
International
Resources
General
Search
littos://www.oecd.ore/
OECD
OECD Emission Scenario
Documents
International
Resources
Assessment
or Related
Document
httD://www.oecd.ors/document
/46/0.2340.en 2649 20118' <
ll
OSHA
OSHA Chemical Exposure
Health Data
Other US
Agency
Resources
Database
samoleslitml/
RIVM
RIVM Reports: Risk
Assessments
International
Resources
Assessment
or Related
Document
httDs://www. rivm.nl/en
TERA
Toxicology Excellence for
Risk Assessment
Other
Resources
Assessment
or Related
Document
mUmmsmrnl
UNEP
Risk Profile / Stockholm
Convention
y . . Assessment
International „ , ^ ,
„ or Related
Resources „
Document
http://chm .dods. int/TheConven
tion/TliePOPs/AHPOPs/tabii
509/Default.asDx
113
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Appendix B PHYSICAL AND CHEMICAL INFORMATION OF DI-
ETHYLHEXYL PHTHALATE
Table Apx B-lsummarizes statistics for the physical and chemical property values identified through
systematic review as of June 2020. The "N" column indicates the number of unique primary sources of
data for that endpoint. That is, if multiple sources presented equivalent values and cited the same
primary source, only one of those was included in these statistics and included in the statistical
calculations. All physical and chemical property values that were extracted and evaluated as of June
2020 are presented in the supplemental file Data Extraction and Data Evaluation Tables for Physical
and Chemical Property Studies (EP A-HQ-OPPT-2018-0433).
Table Apx B-l. Summary Statistics for Reviewed Physical Properties
Properly or Kndpoinl
N
I nil
Mean
Standard
Deviation
Min
Max
Molecular formula
-
-
NA
NA
NA
NA
Molecular weight
-
g/mol
NA
NA
NA
NA
Physical state
6
-
NA
NA
NA
NA
Physical properties
4
-
NA
NA
NA
NA
Melting point
13
°C
-51.8
3.2
-55
-47
Boiling point
11
°C
349
80
230
460
Density
7
g/cm3
0.9827
0.0028
0.98
0.9861
Vapor pressure
9
mm Hg
10.8
32.0
4.05 x 10"8
96
Vapor density
1
-
16
-
16
16
Water solubility
11
mg/L
0.22
0.15
6.0 x 10"4
0.4
Octanol/water partition
coefficient (log Kow)
11
-
6.66
2.48
1.9
9.64
Henry's Law constant
1
atmm3/mol
1.71 x 10"5
-
1.71 x 10"5
1.71 x
10"5
Flash point
4
°C
209.05
4.66
206
216
Auto flammability
0
°C
-
-
-
-
Viscosity
3
CP
23.89
29.51
5.6
57.94
114
-------
Properly or Kndpoinl
\
I nil
Mean
Standard
Deviation
Mill
Max
RelYactiv e index
7
-
1.49
U.U19U
1.48
1.535
Dielectric constant
2
-
4.68
0.54
4.3
5.06
NA = Not applicable
Appendix C ENVIRONMENTAL FATE AND TRANSPORT
PROPERTIES
Table Apx C-l provides the environmental fate characteristics that EPA identified and considered in
developing the scope for di-ethylhexyl phthalate. This information was presented in the Proposed
Designation of Di-ethylhexyl Phthalate (CASRN117-81-7) as a High-Priority Substance for Risk
Evaluation ( ) and may be updated as EPA collects additional information through
systematic review methods.
Table Apx C-l. Environmental Fate and Transport Properties of Di-ethylhexyl Phthalate
Property or
Kmlpoinl
Value-'
Role rcn cc
Direct
Photodegradation
di-ethylhexyl phthalate contains chromophores that absorb at
wavelengths >290 nm and will undergo photolysis; irradiation
with a 300 W xenon lamp resulted in the decomposition of this
compound with gaseous carbon dioxide being one of the main
products 2-ethyl-l-hexene, 2-ethylhexanol, and phthalic acid
were major byproducts
NLM (2015b) citing
Kawasuchi (1994)
Direct
Photodegradation
Direct photolysis and photooxidation are not likely to be
important removal pathways
DR (2002) citina
Warns (1987)
Direct
Photodegradation
tl/2 = <2 days
NLM (2015 b) citina
Cadogan et al. (1994)
Indirect
Photodegradation
tl/2 = 5.85 hours (based on -OH reaction rate constant of 21.96
x 10"12 cm3/mol-second at 25 °C and 1.5 * 106 -OH
radicals/cm3) (estimated)13
U.S. EPA (2012b)
Hydrolysis
tl/2 = 2,000 years (pH 7; calculated)
Staples et al. (1997)
(calculated from data in
Wolfe etal. (1980))
Biodegradation
(Aerobic)
In a static flask test with domestic wastewater as the inoculum,
degradation increased weekly as adaptation increased. Weekly
degradation from week 0-3 were 0, 43, 80, and 95%.
NLM (2015 b) citina
TabaketJ it°81}
Biodegradation
(Aerobic)
tl/2 = 0.8 days (activated sludge)
NLM (2015 b) citina
Saeeer and Tucker
115
-------
Properly or
Knilpoinl
Value-'
Reference
Biodegradation
(Aerobic)
>64% removal in activated sludge reactor and a biological
aerated filter
NLM (2015 b) citina
ClaDD et, 4)
Biodegradation
(Aerobic)
tl/2 = 4.5 weeks (river water)
tl/2 = 14 days (hydrosoil)
NLM (2015 b) citina
Biodegradation
(Aerobic)
Over 63 days
34-50% in Neuherburg soil at pH 7.2 28-41% in Ebersberger
Forest soil at pH 3.4 24-36% in Baierbrunn soil at pH 4.5
NLM (2015b)
Biodegradation
(Anaerobic)
83.3% (municipal sludge)
NLM (2015b) citina
Parker et 4)
Biodegradation
(Anaerobic)
0%/278 days (municipal solid waste samples)
NLM (2015 b) citina
Eilertsson et 6)
Biodegradation
(Anaerobic)
tl/2 = 198 days, 173 days (anaerobic sludge)
NLM (2015b) citina
Gavalaet al. (2003)
Wastewater
Treatment
tl/2 = 23 days (wastewater treatment plants)
NLM (2015 b) citina
Bvrns (2(
Wastewater
Treatment
94% total removal (0.78% by biodegradation, 93% by sludge
adsorption, and 0% by volatilization to air; estimated)13
U.S. EPA (2012b)
Bioconcentration
Factor
1,380 (Pimephales promelas)
ECHA (2019)
Bioconcentration
Factor
582-614, 737-891 (Pimephales promelas)
EC-HA (20.1.9)
Bioconcentration
Factor
850 (Pimephales promelas)
NLM (20.1.5 b) citina
Veitfa et i »
Bioconcentration
Factor
199 (Lepomis macrochirus)
NLM (20.1.5 b) citina
Barrows et al. (.1.980)
Soil Organic
Carbon:Water
Partition
Coefficient (Log
KOC)
4.9-6
DR. (2002) citina
Staples et al. (.1.997)
Soil Organic
Carbon:Water
Partition
Coefficient (Log
KOC)
4-5 in clays and sediments
NLM (20.1.5b) citina
Sullivan et al. (.1.982)
aMeasured unless otherwise noted
bEPI Suite™ physical property inputs: Log Kow = 7.60, BP = 384 °C, MP = 55 °C, VP = 1.42 x 10~7 mm Hg, WS =
0.27 mg/L
Koc = organic carbon-water partition coefficient; J OH = hydroxyl radical
116
-------
Appendix D REGULATORY HISTORY
The chemical substance, di-ethylhexyl phthalate , is subject to federal and state laws and regulations in
the United States (TableApx D-l and TableApx D-2). Regulatory actions by other governments,
tribes and international agreements applicable to di-ethylhexyl phthalate are listed in Table Apx D-3.
D.l Federal Laws and Regulations
Table Apx D-l. Federal Laws and Regulations
Slatiilcs/Rcgu hit ions
Description of Authority/Regulation
Description ol' Regulation
EPA Statutes/Regulations
Toxic Substances Control
Act (TSCA)
Section 4
Provides EPA with authority to issue
rules, orders, or consent agreements
requiring manufacturers (including
importers) and processors to test
chemical substances and mixtures.
25 chemical data submissions from
test rules received for di-ethylhexyl
phthalate: Ecotoxicity
Acute aquatic plant toxicity (1)
Acute aquatic toxicity (8)
Chronic aquatic toxicity (1)
Environmental fate
Persistence (3)
Biodegradation (3)
Transport Between Environmental
Compartments (Fugacity) (1)
Sorption to Soil and Sediments (1)
Human health
Metabolism and Pharmacokinetics
(3)
Mutagenicity/Genetic toxicity (6)
Physical and chemical properties
Vapor pressure (1)
Water solubility (1) (1982-1985)
(U.S. EPA, ChemView. Accessed
April 9, 2019).
Toxic Substances Control
Act (TSCA) - Section 6(b)
EPA is directed to identify high-priority
chemical substances for risk evaluation;
and conduct risk evaluations on at least
20 high priority substances no later than
three and one-half years after the date of
enactment of the Frank R. Lautenberg
Chemical Safety for the 21st Century
Act.
Di-ethylhexyl phthalate is one of
the 20 chemicals EPA designated
as a High-Priority Substance for
risk evaluation under TSCA (84
FR 71924. December 30. 2019).
Designation of di-ethylhexyl
phthalate as high-priority
substance constitutes the initiation
of the risk evaluation on the
chemical.
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,
Di-ethylhexyl phthalate
manufacturing (including
importing), processing and use
information is reported under the
117
-------
Stiitiiles/Ro«ii hit ions
Description of Aiilhority/Uo^uhKion
Description ol' kc^uhition
quanlilics and uses ol'chcmical
substances produced domestically and
imported into the United States.
( l)R rule ( _ _ . Aiiijusl
16,2011).
Toxic Substances Control
Act (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 in the
United States.
Di-ethylhexyl phthalate was on the
initial TSCA Inventory and
therefore was not subject to EPA's
new chemicals review process
under TSCA Section 5 ("60 FR
16309, March 29, 1995).
Toxic Substances Control
Act (TSCA) - Section 8(d)
Provides EPA with authority to issue
rules requiring producers, importers, and
(if specified) processors of a chemical
substance or mixture to submit lists
and/or copies of ongoing and completed,
unpublished health and safety studies.
No health and safety studies were
received for di-ethylhexyl phthalate
(1982-1992). (U.S. EPA,
ChemView. Accessed April 24,
2019). Di-ethylhexyl phthalate is
listed under the category "Alkyl
phthalates — all alkyl esters of 1,
2-benzenedicarboxylic
acid (ortho -phthalic acid)" (40
( :)).
Toxic Substances Control
Act (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.
14 risk reports received for di-
ethylhexyl phthalate (1992-2009)
(U.S. EPA, ChemView. Accessed
(April 9, 2019)).
Emergency Planning and
Community Right-To-
Know Act (EPCRA) -
Section 313
Requires annual reporting from facilities
in specific industry sectors that employ
10 or more full-time equivalent
employees and that manufacture, process
or otherwise use a TRI-listed chemical in
quantities above threshold levels. A
facility that meets reporting requirements
must submit a reporting form for each
chemical for which it triggered reporting,
providing data across a variety of
categories, including activities and uses
of the chemical, releases and other waste
management (e.g., quantities recycled,
treated, combusted) and pollution
prevention activities (under Section 6607
of the Pollution Prevention Act). These
data include on- and off-site data as well
as multimedia data (i.e., air, land and
water).
Di-ethylhexyl phthalate is a listed
substance subject to reporting
requirements under 40 CFR 372.65
effective as of January 1, 1987.
118
-------
Stiitiiles/Ro«ii hit ions
Description of Aiilhority/Uo^uhKion
Description ol' kc^uhition
Clean Air Act (CAA)
Section 112(b)
Defines llic original lisL of ixy hazardous
air pollutants (HAPs). Under 112(c) of
the CAA, EPA must identify and list
source categories that emit HAP and then
set emission standards for those listed
source categories under CAA Section
112(d). CAA Section 112(b)(3)(A)
specifies that any person may petition the
Administrator to modify the list of HAP
by adding or deleting a substance. Since
1990, EPA has removed two pollutants
from the original list leaving 187 at
present.
Di-clh) IIkvw 1 phlhalalc is listed as
a HAP (42U.S.C. 7412).
Clean Air Act (CAA) -
Section 112(d)
Directs EPA to establish, by rule,
NESHAPs for each category or
subcategory of listed major sources and
area sources of HAPs (listed pursuant to
Section 112(c)). For major sources, the
standards must require the maximum
degree of emission reduction that EPA
determines is achievable by each
particular source category. This is
generally referred to as maximum
achievable control technology (MACT).
For area sources, the standards must
require generally achievable control
technology (GACT) though may require
MACT.
EPA has established NESHAPs
for a number of source categories
that emit di-ethylhexyl phthalate
to air (See
https://www.epa.gov/stationary-
sources-air-pollution/national-
emission-standards-hazardous-
air-pollutants-neshap-9).
Clean Water Act (CWA) -
Section 304(a)(1)
Requires EPA to develop and publish
ambient water quality criteria (AWQC)
reflecting the latest scientific knowledge
on the effects on human health that may
be expected from the presence of
pollutants in any body of water.
In 2015, EPA published updated
AWQC for di-ethylhexyl phthalate,
including recommendations for
"water + organism" and "organism
only" human health criteria for
states and authorized tribes to
consider when adopting criteria
into their water quality standards.
Human Health for the consumption
of Water + Organism(|_ig/L)
0.32
Human Health for the consumption
of Organism Only ((ig/L) 0.37
Human Health WQC is based on
carcinogenicity of 10"6 risk.
119
-------
Stiitiiles/Ro«ii hit ions
Description of Aiilhority/Uo^uhKion
Description ol' kc^uhition
Clean Water Ac I (CAVA)
Section 301, 304, 306,
307, and 402
Clean Water Ac I Section 3 <> 7 (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 Part 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.
Di-eth\ Ihew 1 phllialate is
designated as a toxic pollutant
under Section 307(a)(1) of the
CWA and as such is subject to
effluent limitations (40 CFR
401.15).
Under CWA Section 304, di-
ethylhexyl phthalate is included in
the list of total toxic organics
(TTO) (40 CFR 413.02{i)V
AoDendix A to 40 CFR. Part 423—
.1.26 Priority Pollutants
Aluminum Forming Point Source
Cateeorv 40 CFR 467
The Centralized Waste Treatment
Point Source Cateaorv 40 CFR 437
Coil Coating Point Source
Cateaorv 40 CFR 465
Electrical and Electronic
Components Point Source Category
40 CFR 469
Electroplating Point Source
Cateaorv 40 CFR 4.1.3
Metal Finishing Point Source
Cateaorv 40 CFR 433
Metal Molding and Casting Point
Source Cateaorv 40 CFR 464
Organic Chemicals, Plastics, And
Svnthetic Fibers 40 CFR 414
Plastics Molding And Forming
Point Source Cateaorv 40 CFR 463
Steam Electric Power Generating
Point Source Cateaorv 40 CFR 423
Safe Drinking Water Act
(SDWA) - Section 1412
Requires EPA to publish a non-
enforceable maximum contaminant level
goal (MCLG) for a contaminant for
which EPA makes the determination that
the contaminant: 1. may have an adverse
Di-ethylhexyl phthalate is subject
to NPDWR under the SDWA with
an MCLG of zero and an
enforceable MCL of .006 mg/L ("40
CFR .1.41.24).
120
-------
Stiitiiles/Ro«ii hit ions
Description of Aiilhority/Uo^uhKion
Description ol' kc^uhition
effect on the health of persons; 2. is
known to occur or there is a substantial
likelihood that the contaminant will
occur in public water systems with a
frequency and at levels of public health
concern; and 3. in the sole judgement of
the Administrator, regulation of the
contaminant presents a meaningful
opportunity for health risk reductions for
persons served by public water systems.
When EPA publishes an MCLG, EPA
must also promulgate a National Primary
Drinking Water Regulation (NPDWR)
which includes either an enforceable
maximum contaminant level (MCL), or a
required treatment technique. Public
water systems are required to comply
withNPDWRs.
Resource Conservation and
Recovery Act (RCRA) -
Section 3001
Directs EPA to develop and promulgate
criteria for identifying the
characteristics of hazardous waste, and
for listing hazardous waste, taking into
account toxicity, persistence, and
degradability in nature, potential for
accumulation in tissue and other related
factors such as flammability,
corrosiveness, and other hazardous
characteristics.
Di-ethylhexyl phthalate is included
on the list of hazardous wastes
pursuant to RCRA 3001.
RCRA Hazardous Waste Code:
U028 (40 CFR 261.33).
(Appendix VIII to Part 261—
Hazardous Constituents).
Comprehensive
Environmental
Response, Compensation
and Liability Act
(CERCLA) - Sections
102(a) and 103
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.
EPA must also promulgate regulations
establishing the quantity of any
hazardous substance the release of which
must be reported under Section 103.
Section 103 requires persons in charge of
vessels or facilities to report to the
National Response Center if they have
knowledge of a release of a hazardous
substance above the reportable quantity
threshold.
Di-ethylhexyl phthalate is a
hazardous substance under
CERCLA. Releases of di-
ethylhexyl phthalate in excess of
100 pounds must be reported (40
CFR 302.4V
121
-------
Stiitiiles/Ro«ii hit ions
Description of Authority/Regulation
Description ol' Regulation
Superfund Amendments
and Reauthorization Act
(SARA)
Requires the Agency to revise the
hazardous ranking system and update the
National Priorities List of hazardous
waste sites, increases state and citizen
involvement in the superfund program
and provides new enforcement
authorities and settlement tools.
Di-ethylhexyl phthalate is listed on
SARA, an amendment to CERCLA
and the CERCLA Priority List of
Hazardous Substances. This list
includes substances most
commonly found at facilities on the
CERCLA National Priorities List
(NPL) that have been deemed to
pose the greatest threat to public
health. ATSDR ranked #77.
Other Federal Statutes/Regulations
Consumer Product Safety
Improvement Act of 2008
(CPSIA)
Under Section 108 of the Consumer
Product Safety Improvement Act of 2008
(CPSIA), CPSC prohibits the
manufacture for sale, offer for sale,
distribution in commerce or importation
of eight phthalates in toys and child care
articles at concentrations greater than 0.1
percent: DEHP, DBP, BBP, DINP,
DIBP, DPENP, DHEXP and DCHP.
The use of di-ethylhexyl phthalate
at concentrations greater than 0.1
percent is banned in toys and child
care articles (16 CFR part 1307).
Federal Hazardous
Substance Act (FHSA)
Requires precautionary labeling on the
immediate container of hazardous
household products and allows the
Consumer Product Safety Commission
(CPSC) to ban certain products that are
so dangerous or that the nature of the
hazard is such that labeling is not
adequate to protect consumers.
Use of di-ethylhexyl phthalate was
banned by the CPSC in 2008 in any
children's toy or child care article
that contains concentrations of
more than 0.1 percent of di-
ethylhexyl phthalate ( ft. part
1307)
Federal Food, Drug, and
Cosmetic Act (FFDCA)
Provides the FDA with authority to
oversee the safety of food, drugs and
cosmetics.
Di-ethylhexyl phthalate is an
optional substance that can be used
in: the base sheet and coating of
cellophane, alone or in combination
with other phthalates where total
phthalates do not exceed 5 percent
(21 CFR § 177.1200)
Non-regulatory Warning
FDA Public Health Notification:
PVC Devices Containing the
Plasticizer DEHP (medical).
Occupational Safety and
Health Act (OSHA)
Requires employers to provide their
workers with a place of employment free
from recognized hazards to safety and
health, such as exposure to toxic
chemicals, excessive noise levels,
mechanical dangers, heat or cold stress
OSHA established a PEL for di-
ethylhexyl phthalate of 5 mg/m3 as
an 8-hour. TWA (29 CFR
30).
122
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Sljitiitcs/Rc«>ii hit ions
Description of Aiilhority/Uo^uhKion
Description ol' kc^uhition
or unsunilui) condiLions (29 l.S.C
Section 651 et seq.).
Under the Act, OSHA can issue
occupational safety and health standards
including such provisions as Permissible
Exposure Limits (PELs), exposure
monitoring, engineering and
administrative control measures, and
respiratory protection.
OSllA established a Sampling and
Analytical Method for DEHP.
Federal Hazardous Materials
Transportation Act (HMTA)
Section 5103 of the Act directs the
Secretary of Transportation to:
• Designate material (including an
explosive, radioactive material,
infectious substance, flammable or
combustible liquid, solid or gas,
toxic, oxidizing or corrosive
material, and compressed gas) as
hazardous when the Secretary
determines that transporting the
material in commerce may pose an
unreasonable risk to health and
safety or property.
• Issue regulations for the safe
transportation, including security,
of hazardous material in intrastate,
interstate and foreign commerce.
D-ethylhexyl phthalate is listed as a
hazardous material with regard to
transportation and is subject to
regulations prescribing requirements
applicable to the shipment and
transportation of listed hazardous
materials Reportable Quantity
100 lbs. (45.4 kg)
("49 CFR 172.1. Appendix A. Table
1).
D.2 State Laws and Regulations
Table Apx D-2. State Laws and Regulations
Stale
Actions
Description ol' Action
State Air
Regulations
New Hampshire (I ): Regulated Toxic Air Pollutants)
Toxicity Class I, 24-Hr AAL 18 (|ig/m3 ), Annual AALB 12 (|ig/m3 ), 24-Hr De
Minimis 0.21 (lbs/day), Annual De Minimis 78 (lbs/yr)
Rhode Island (Air Pollution Regulation No. 22)
Acceptable Ambient Levels (AALs) (mg/m3)
24 Hour 70, Annual 0.4
State
Drinking
Water
Arizona (14 Ariz. Admin. Register 2978. August 1. 2008)
MCL .0006 mg/L MCLG 0 mg/L Discharge from rubber and chemical factories
California (Cal Code Regs. Title 26. § 22-64444)
123
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Stsile
Actions
Description of Action
Standards
and
Guidelines
Table 64444-A Maximum Contaminant Levels Organic Chemicals 0.004 mg/L
Connecticut (Conn. Agencies Regs. § 19-13-B102)
Maximum Contaminant Level (mg/1) 0.006
Delaware CDel. Admin. Code Title 16. § 4462)
Synthetic organic contaminants including pesticides and herbicides:
Traditional MCL 0.006 mg/L To convert for CCR, multiply by 1000 MCL in CCR
units 6, MCLG 0
Florida (Fla. Admin. Code R. Chi ), 6 ug/L MCL
Maine (iO t M \!e t ode R. Chat). 231), 0.006 mg/L
Massachusetts (S 10 t <
-------
Stale
Actions
Description of Action
Di-ethylhexyl phthlate is on the MA Toxic Use Reduction Act (TURA) list
MGL. Chapter ction 1 to Section 23
Maine 2019 ME H 1043
Prohibition of sale of food package containing phthalates.
D.3 International Laws and Regulations
Table Apx D-3. Regulatory Actions by other Governments, Tribes, and International Agreements
Country/
()r»;iniz:ition
Requirements iiiul Restrictions
Canada
Di-ethylhexyl phthlate is on the Canadian List of Toxic Substances (Government of
Canada. Managing substances in the environment. Substances search. Database
accessed April 30, 2020).
Other Canadian regulations include:
• Canada's National Pollutant Release Inventory (NPRI).
• For soft vinyl children's toys and child-care articles, compliance and enforcement
of the existing regulation of di-ethylhexyl phthalate (and 5 other phthalates) will
continue as part of the regular enforcement of the Phthalates Regulations under
the Canada Consumer Product Safety Act.
• Compliance and enforcement of the existing requirements for medical devices
containing di-ethylhexyl phthalate will continue as part of the regular
enforcement of the Medical Devices Regulations under the Food and Drugs Act.
• Di-ethylhexyl phthlate, which was previously concluded to be harmful to human
health, was added to the Cosmetic Ingredient Hotlist in 2009. The listing
indicates that the use of di-ethylhexyl phthalate is prohibited and must not be
present in cosmetic products.
• Risk Management Scope for 1,2-Benzenedicarboxylic acid, bis(2-ethylhexyl)
ester [DEHP] Chemical Abstracts Service Registry Number (CAS RN): 117-81-7.
European Union
Di-ethvlhexvl phthlate is registered for use in the EU (European Chemicals Agencv
(ECHA) database. Accessed February 3. 2020).
Restriction
Annex XVII TO REACH - Conditions of restriction
Restrictions on the manufacture, placing on the market and use of certain dangerous
substances, mixtures and articles.
Candidate Substance
In 2008, di-ethylhexyl phthalate was listed on the Candidate list as a Substance of
Very High Concern (SVHC) under Article 59 regulation (EC) No 1907/2006 -
REACH (Registration, Evaluation., Authorization and Restriction of Chemicals due
125
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C'oiinlrv/
Organization
Requirements :tiul Restrictions
Reason lor inclusion To\ic lor
reproduction (Article 57c), Endocrine disrupting properties (Article 57(f) -
environment), Endocrine disrupting properties (Article 57(f) - human health.
Authorisation
In August 2013, di-ethylhexyl phthalate was added to Annex XIV of REACH
(Authorisation List) with a sunset date of February 21, 2015. After the sunset date,
only persons with approved authorization applications may continue to use the
chemical (European Chemicals Agency (ECHA) database. Accessed April 24,
2019).
Commission Delegated Directive ../.../EU of 31.3.2015 amending Annex II to
Directive 2011/65/EU of the European Parliament and of the Council as regards the
list of restricted substances.
Restriction of Hazardous Substances Directive (RoHS), EU/2015/863
Di-ethvlhexvl phthlate is subiectto the Restriction of Hazardous Substances
Directive (RoHS), EU/2015/863. which restricts the use of hazardous substances at
more than 0.1% by weight at the 'homogeneous material' level in electrical and
electronic equipment, beginning July 22, 2019. (European Commission RoHS).
Australia
Di-ethylhexyl phthlate was assessed under Human Health Tier II of the Inventory
Multi-Tiered Assessment and Prioritisation (IMAP).
The chemical is listed on the 2006 High Volume Industrial Chemicals List
(HVICL) with a total reported volume between 10,000 and 99,000 tonnes per
annum.
Di-ethylhexyl phthlate is used in the production of plastic products. Plastic products
that contain more than 1 per cent of di-ethylhexyl phthalate are permanently banned
from sale.
(7,2-Benzenedicarboxylic acid, bis(2-ethylhexyl) ester: Human health tier II
assessment (2013). Accessed April 24, 2019/
Japan
Di-ethylhexyl phthlate is 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)
• Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances
in the Environment and Promotion of Improvements to the Management
Thereof
• Industrial Safety and Health Act (ISHA)
• Air Pollution Control Law
• Water Pollution Control Law
World Health
Organization (WHO)
Evaluations of the Joint FAO/WHO Expert Committee on Food Additives (JECFA)
1989
126
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Country/
Organization
Requirements and Restrictions
The Committee previously concluded that di-ethylhexyl phthalate is a peroxisome-
proliferator and carcinogen in the livers of both rats and mice and induces age-
dependent testicular atrophy in rats. The use of food-contact materials from which
bis(2-ethylhexyl) phthalate may migrate is provisionally accepted on condition that
the amount of the substance migrating into food is reduced to the lowest level
technologically attainable.
Tolerable Intake: NONE ESTABLISHED
1999 Monograph
Australia, Austria,
Belgium, Canada,
Denmark, Finland,
France, Germany,
Hungary, Ireland,
Japan, New Zealand,
Poland, South Korea,
Spain, Sweden
Switzerland, United
Kingdom
Occupational exposure limits for DEHP (GESTIS International limit values for
chemical aeents (Occupational exposure limits., OELs) database. Accessed April
24, 2019).
127
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Appendix E PROCESS, RELEASE AND OCCUPATIONAL
EXPOSURE INFORMATION
This appendix provides information and data found in preliminary data gathering for di-ethylhexyl
phthalate.
E.l Process Information
Process-related information potentially relevant to the risk evaluation may include process diagrams,
descriptions and equipment. Such information may inform potential release sources and worker
exposure activities.
E.l.l Manufacture (Including Import)
The 2016 CDR reports 22 facilities that submitted activity data for 2015. 14 of these facilities stated that
they imported di-ethylhexyl phthalate in 2015, one stated that they manufactured di-ethylhexyl phthalate
in 2015, and the remaining seven facilities' 2015 manufacture or import activity is withheld or claimed
as CBI (U.S. EPA. 2019c). According to 2016 public CDR data, di-ethylhexyl phthalate is imported into
the United States in liquid or pellet form and manufactured in liquid form (U.S. EPA. 2.019c).
E.l.1.1 Domestic Manufacturing
Di-ethylhexyl phthlate is classified as part of the phthalate ester grouping of compounds predominantly
used as plasticizers in the production of flexible plastic products (TURI. 2006). Di-ethylhexyl phthlate is
typically manufactured through catalytic esterification of phthalic anhydride with 2-ethylhexyl alcohol
in the presence of an acid catalyst. Manufacturing operations take place in closed systems either via
batch or more automated continuous operations and will typically involve the purification of di-
ethylhexyl phthalate product streams via either vacuum distillation or by passing over activated charcoal
as a means of recovering unreacted alcohols (CPSC. 2010).
E.l.1.2 Import
In general, chemicals may be imported into the United States in bulk via water, air, land, and intermodal
shipments (Tomer and Kane. 2015). These shipments take the form of oceangoing chemical tankers,
railcars, tank trucks, and intermodal tank containers. Di-ethylhexyl phthlate is shipped in liquid or solid
pellet form according to 2016 CDR (U.S. EPA. 2019cY Of the 14 facilities in 2016 CDR (U.S. EPA.
2019c) that imported di-ethylhexyl phthalate in 2015 (excluding the facilities for which the
importation/manufacturing activity was withheld or claimed CBI), EPA has identified two sites that
imported di-ethylhexyl phthalate directly to their sites for on-site processing or use and 12 sites that
imported di-ethylhexyl phthalate directly to other sites for processing or use (the importing site does not
directly handle or store the imported di-ethylhexyl phthalate) (U.S. EPA. 2020a).
E.1.2 Processing and Distribution
E.l.2.1 Processing as a Reactant
Processing as a reactant is the use of di-ethylhexyl phthalate as a feedstock in the production of another
chemical via a chemical reaction in which di-ethylhexyl phthalate is consumed to form the product. One
company that reported to 2016 CDR indicated that di-ethylhexyl phthalate was processed as a reactant in
the production of plastic material and resin, rubber products, and synthetic rubber ( ,020a)
(U.S. EPA. 2019c; Natrochem. 2016). Di-ethylhexyl phthlate is also processed as a reactant in the
manufacture of the adhesives and sealants (>_ _v < v * 2019c; Morgan Advanced Materials. 201 .'h).
128
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Exact operations for the use of di-ethylhexyl phthalate as a reactant to produce other chemicals are not
known at this time. For using a chemical as a reactant, operations would typically involve unloading the
chemical from transport containers and feeding the chemical into a reaction vessel(s), where the
chemical would react either fully or to a lesser extent. Following completion of the reaction, the
produced substance may be purified further, thus removing unreacted di-ethylhexyl phthalate (if any
exists).
E.l.2.2 Incorporated into a Formulation, Mixture or Reaction Product
Incorporation into a formulation, mixture or reaction product refers to the process of mixing or blending
of several raw materials to obtain a single product or preparation. Exact process operations involved in
the incorporation of di-ethylhexyl phthalate into a chemical formulation, mixture, or reaction product are
dependent on the specific manufacturing process or processes involved. Companies reported to 2016
CDR that di-ethylhexyl phthalate is used as a plasticizer in the formulation of adhesives, all other basic
inorganic and organic chemicals, paints and coatings, printing inks, plastic products, rubber products,
plastic material and resins, compounding of purchased resins, and in other miscellaneous products. Di-
ethylhexyl phthalate is also used in solid rocket motor insulation, which the commenter noted was a
critical use ( IQ-QPPT-2019-0501-0043). The exact processes used to formulate products
containing di-ethylhexyl phthalate are not known at this time; however, several ESDs published by the
OECD and Generic Scenarios published by EPA have been identified that provide general process
descriptions for these types of products. EPA plans to evaluate processing uses of di-ethylhexyl
phthalate during risk evaluation.
E. 1.2.3 Incorporated into an Article
Incorporation into an article typically refers to a process in which a chemical becomes an integral
component of an article (as defined at 40 CFR 704.3) for distribution in commerce. Exact process
operations involved in the incorporation of di-ethylhexyl phthalate-containing formulations or reaction
products are dependent on the article. Di-ethylhexyl phthalate is primarily used as a plasticizer in
compounded resin, rubber products, and plastic products ( 1019c; 3M Company. 2018; Victor
Technologies. 2012). EPA plans to evaluate processing uses of di-ethylhexyl phthalate during risk
evaluation.
E.l.2.4 Repackaging
Repackaging refers to preparation of a chemical substance for distribution into commerce in a different
form, state, or quantity than originally received/stored, where such activities include transferring a
chemical substance form a bulk storage container into smaller containers.
E.l.2.5 Recycling
According to the 2018 TRI, approximately 82% of all di-ethylhexyl phthalate production-related waste,
or more than 6.5 million pounds, was recycled. Approximately 67% of the recycled waste was recycled
on site.
E.1.3 Uses
E.l.3.1 Adhesives, Sealants, Paints, and Coatings
Di-ethylhexyl phthlate is used in a variety of adhesive, sealant, paint, and coating products. Specifically,
di-ethylhexyl phthalate is used in adhesives for electrical tape, industrial adhesives, curing and sealing
compounds, emulsion paints, lacquers, varnishes, paints for traffic markings, and wood coatings (3M
Company. 2019b; LORH ("oiporation. 2019; The Sherwin-Williams Company. 2019; Valspar. jm ,
Dupli-Color Products Company. 2017; Valspar. 2017; Pacific Coast Lacquer. 2016; LORD Corporation.
129
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2015; NLM. 2.015b; Tremco. 2015; CETCO. 2014; 3M Company. 2.011; Raroue Specialty Pools. 2010;
Airserco Manufacturing Company LLC. 2009; StatSpin Inc. 2004; Republic Powdered Metals Inc..
2002; Glidden Co. 1999). A commenter reported di-ethylhexyl phthalate is used as a component of
common off the shelf paints and sealants and specifically in sealant for vacuum system connection
points, which the commenter also noted was a critical use (VP \ KQ-QPPT-2019-0501-0043). The
application procedure depends on the type of adhesive, sealant, 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. Application may be manual
or automated. After application, the adhesive, sealant, paint, or coating is allowed to dry or cure (OECD.
2015). The drying/curing process may be promoted through the use of heat or radiation (radiation can
include ultraviolet (UV) and electron beam radiation (OECD. 2010).
E.l.3.2 Automotive Products
Di-ethylhexyl phthlate is used as an additive in automotive interior and exterior care products, namely
glazing putty and cleaning/washing/stain removing products (ACC. 2019; 3M Company. 2017; Dionisio
et ai. 2015; Danish. EPA. ^ ). EPA plans to evaluate these uses of di-ethylhexyl phthalate during risk
evaluation.
E.l.3.3 Building/Construction Materials Not Covered Elsewhere
Di-ethylhexyl phthlate is a constituent of building and construction materials used for joinery
installation, brick laying, and other, similar end uses. In addition, di-ethylhexyl phthalate is a constituent
of asphalt, concrete coatings, and is an additive found in casting and vinyl tapes (U.S. EPA. 2019c; 3M
Company. 2018; demons Con ere ines. 2018; Valero Marketing & Supply Company. 2014; 3M
Company. 2011). EPA plans to evaluate investigate these uses of di-ethylhexyl phthalate during risk
evaluation.
E.l.3.4 Plastic and Rubber Products
As described in Section E.l.2.3, di-ethylhexyl phthalate is used to increase the flexibility of plastic and
rubber products, which may be used industrially, commercially, and by consumers. Di-ethylhexyl
phthlate is a plasticizer found in plastic and rubber products, such as plastics used in the building and
construction industry and in furniture and furnishings (\ r \ 2019c; 3M Compaq .''18). Di-
ethylhexyl phthlate is likely entrained in the products; however, di-ethylhexyl phthalate may be
available for exposure depending on the application of the end use products, such as if building and
construction materials are cut prior to installation. EPA plans to evaluate these uses of di-ethylhexyl
phthalate during risk evaluation.
E.l.3.5 Other Uses
Di-ethylhexyl phthlate is used as a constituent in batteries (Amazon. 2020). dyes and pigments (SPIN.
2019; U.S. EPA. 2019b. c; Identity Group. 2016). lawn and garden care products (U.S. EPA. 2019c).
and hydraulic fracturing chemicals J5 I h »use of Representatives. 2011). Di-ethylhexyl phthlate was
also identified as a laboratory chemical (Restek. 2019; ULTR \ Scientific Inc. 2014). A commenter also
reported laboratory use including such applications as analytical standards, research, equipment
calibration, sample preparation (EPA-HQ-OPPT-2019-0501 -0043). Laboratory procedures are generally
done within a fume hood, on a bench with local exhaust ventilation or under general ventilation.
EPA plans to evaluate these uses of di-ethylhexyl phthalate during risk evaluation.
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E.1.4 Disposal
Each of the conditions of use of di-ethylhexyl phthalate may generate waste streams of the chemical that
are collected and transported to third-party sites for disposal or treatment. The presence of di-ethylhexyl
phthalate in the reuse of produced waters is included in the disposal condition of use. Industrial sites that
treat or dispose onsite wastes that they themselves generate are assessed in each condition of use
assessment. Similarly, point source discharges of di-ethylhexyl phthalate to surface water are assessed in
each condition of use assessment. Wastes of di-ethylhexyl phthalate that are generated during a
condition of use and sent to a third-party site for treatment, disposal, or recycling may include
wastewater and solid waste. Di-ethylhexyl phthalate may be contained in wastewater discharged to
POTW or other, non-public treatment works for treatment. Industrial wastewater containing di-
ethylhexyl phthalate discharged to a POTW may be subject to EPA or authorized NPDES state
pretreatment programs. The assessment of wastewater discharges to POTWs and non-public treatment
works of di-ethylhexyl phthalate is included in each of the condition of use assessments. Solid wastes
are defined under RCRA as any material that is discarded by being: abandoned; inherently waste-like; a
discarded military munition; or recycled in certain ways (certain instances of the generation and
legitimate reclamation of secondary materials are exempted as solid wastes under RCRA).
According to 2018 TRI (U.S. EPA. 2019f). 118 facilities managed, in total, nearly 8 million pounds of
di-ethylhexyl phthalate as waste. Of this total: more than 6.5 million pounds (82% of all waste) were
recycled; over 600,000 pounds were treated; nearly 80,000 pounds were burned for energy recovery, and
just over 710,000 pounds were released to the environment. Approximately 60% of the production-
related waste was managed on site. For recycling and energy recovery, the portions managed on site
were higher at 67% and 82%, respectively. The inverse was true for treatment-related quantities;
approximately three-quarters of the total quantity was treated off-site. A relatively small portion
(710,000 pounds or 9%) of the total quantity of production-related waste was released to the
environment, and most (90%) of this amount was disposed of or otherwise released off-site.
E.2 Preliminary Occupational Exposure Data
EPA presents below an example of occupational exposure-related information obtained from
preliminary data gathering. EPA plans to consider this information and data in combination with other
data and methods for use in the risk evaluation.
TableApx E-l summarizes NIOSH Health Hazard Evaluations identified during EPA's preliminary
data gathering.
Table Apx E-l. Summary of NIOSH HHEs with Monitoring for Di-ethylhexyl Phthalatea
Year of
Publication
Report Number
Facility Description
1984
HETA 79-034-1440
Plastic/Resin Products Manufacturing - Coating,
Laminating, Printing, and Solvent Use
1983
HETA 82-032-1384
Phthalate Anhydride and DEHP Production
a Table includes HHEs identified to date. HHEs can be found at https://www.cdc.gOv/niosh./hhe/.
Table Apx E-2 summarizes OSHA CEHD identified during EPA's preliminary data gathering.
131
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TableApx E-2. Summary of Industry Sectors with Di-ethylhexyl Phthalate Monitoring Samples
Available from OSHA Inspections Conducted Between 2010 and 2019
NAICS
NAICS Description
Number of Data Pointsa
312113
Ice Manufacturing
2
323111
Commercial Printing (except Screen and Books)
2
326299
All Other Rubber Product Manufacturing
2
333411
Air Purification Equipment Manufacturing
1
334416
Capacitor, Resistor, Coil, Transformer, and Other Inductor
Manufacturing
1
aNumber of data points in Table Apx E-2 was populated from data found at
https://www.osha.gov/opengov/healthsamples.html.
132
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Appendix F SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR INDUSTRIAL
AND COMMERCIAL ACTIVITIES AND USES
Table Apx F-l. Worker and Occupational Non-User Exposure Conceptual Model Supporting Table
l.ik-t \ik-
Shim-
C;ik-»iir\
SiiI)i:iIi-»hi'\
Ri-k-iisi- / I!\|)iisiiiv
Sii-ii;iriii
I!\|)iisiiiv
P;ilh\\;i\
l!\|)osuiv
Rinik-
Ri-ivpliir /
Piipuhiliiin
Plans In
l"\ ;il mill-
R;ilinn;ik-
Manufacture
Domestic
Domestic Manufacture
Manufacture and
2016 CDR references manufacture
Manufacture
Packaging
Liquid
Contact
Dermal
Workers
Yes
in liquid form. Thus, the potential
for exposures to workers exists
during manufacturing.
2016 CDR references manufacture
Solid
Contact
Dermal
Workers
Yes
in pellet form. Thus, the potential
for exposures to workers exists
during manufacturing.
Vapor
Inhalation
Workers,
Occupational
Non-Users
(ONU)
No
Due to di-ethylhexyl phthalate's
vapor pressure (VP) (VP = 1.4 x
10-6 mm Hg) at room
temperature, potential for vapor
generation is low.
Mist
Inhalation/
Workers,
No
Mist generation is not expected
Dermal
ONU
during manufacturing.
2016 CDR references manufacture
Dust
Inhalation/
Dermal
Workers,
ONU
Yes
in pellet form, which may form
dust. Thus, the potential for
exposures to workers exists during
manufacturing.
Dermal exposure by ONU is not
Liquid/Solid
Contact
Dermal
ONU
No
expected for this condition of use
as they are not expected to directly
handle the chemical.
Import
Import
Repackaging of
import containers
2016 CDR references import in
liquid form. The potential for
Liquid
Contact
Dermal
Workers
Yes
exposures to workers exists during
import, but exposure will only
occur in the event the imported
material is repackaged.
2016 CDR references import in
Solid
Contact
Dermal
Workers
Yes
pellet form. The potential for
exposures to workers exists during
import, but exposure will only
133
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l.ik-t \ik-
Shim-
C;ik-»iir\
SiiI)i:iIi-»hi'\
Ri-k-iisi- / I!\|)iisiiiv
Sii-ii;iriii
I!\|)iisiiiv
P;ilh\\;i\
l!\|)osuiv
Rinik-
Ri-ivpliir /
Piipuhiliiin
Plans In
l"\ ;il mill-
R;ilinn;ik-
occur in the event the imported
material is repackaged.
Due to di-ethylhexyl phthalate's
Vapor
Inhalation
Workers,
ONU
No
vapor pressure (VP) (VP = 1.4 x
10-6 mm Hg) at room
temperature, potential for vapor
generation is low.
Mist
Inhalation/
Dermal
Workers,
ONU
No
Mist generation is not expected
during repackaging of import
containers.
2016 CDR references pellet form,
which may create dust. The
Dust
Inhalation/
Dermal
Workers,
ONU
Yes
potential for dust exposures to
workers and ONUs exists during
import, but exposure will only
occur in the event the imported
material is repackaged.
Dermal exposure by ONU is not
Liquid/Solid
Contact
Dermal
ONU
No
expected for this condition of use
as they are not expected to directly
handle the chemical.
Processing
Processing as a
Reactant
Plasticizer in plastic
material and resin
Processing as a
reactant
Liquid
Contact
The potential for exposures to
workers exists during
manufacturing, rubber
product manufacturing,
and synthetic rubber
Dermal
Workers
Yes
manufacturing of other chemicals,
as di-ethylhexyl phthalate may be
in liquid form.
manufacturing
The potential for exposures to
Adhesive and sealant
Solid
Contact
Dermal
Workers
Yes
workers exists during
manufacturing of other chemicals,
chemical in adhesive
manufacturing
as di-ethylhexyl phthalate may be
in solid form.
Intermediate in plastics
product manufacturing
Due to di-ethylhexyl phthalate's
vapor pressure (VP) (VP = 1.4 x
10-6 mm Hg) at room
Vapor
Inhalation
Workers,
ONU
Yes
temperature, potential for vapor
generation is low. However, some
of these operations may occur at
elevated temperatures, which
increase the potential for vapor
generation.
Mist
Inhalation/
Dermal
Workers,
ONU
No
Mist generation is not expected
during processing as a reactant.
134
-------
l.ik t \ik-
C;ik-»iir\
SiiI)i:iIi-»hi'\
Ri-k'iisi- / I!\|)iisiiiv
Sivn;iriu
I!\|)iisiiiv
P;ilh\\;i\
l!\|)osuiv
Rimk-
Ri-u-plur /
Piipuhiliiin
Plans In
l"\ ;il mill-
R;ilinn;ik-
Dust
Inhalation/
Dermal
Workers,
ONU
Yes
The potential for dust exposures to
workers and ONUs exists during
manufacturing of other chemicals,
as di-ethylhexyl phthalate may be
in solid form.
Liquid/Solid
Contact
Dermal
ONU
No
Dermal exposure by ONU is not
expected for this condition of use
as they are not expected to directly
handle the chemical.
Incorporation
into
formulation,
mixture or
reaction product
Plasticizer in all other
basic organic chemical
manufacturing; custom
compounding of
purchased resins;
miscellaneous
manufacturing; paint
and coating
manufacturing; plastics
material and resin
manufacturing; plastics
product manufacturing;
adhesive
manufacturing; all other
basic inorganic
chemical
manufacturing; rubber
product manufacturing;
services; all other
chemical product and
preparation
manufacturing; solid
rocket motor insulation
Processing into
formulations,
mixtures, or reaction
product
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to
workers exists during processing
(incorporation into formulation,
mixture, or reaction product), as
di-ethylhexyl phthalate may be in
liquid form.
Solid
Contact
Dermal
Workers
Yes
The potential for exposures to
workers exists during processing
(incorporation into formulation,
mixture, or reaction product), as
di-ethylhexyl phthalate may be in
solid form.
Vapor
Inhalation
Workers,
ONU
Yes
Due to di-ethylhexyl phthalate's
vapor pressure (VP) (VP = 1.4 x
10-6 mm Hg) at room
temperature, potential for vapor
generation is low. However, some
of these operations may occur at
elevated temperatures, which
increase the potential for vapor
generation.
Mist
Inhalation/
Dermal
Workers,
ONU
No
Mist generation is not expected
during processing (incorporation
into formulation, mixture, or
reaction product).
Dust
Inhalation/
Dermal
Workers,
ONU
Yes
The potential for dust exposures to
workers and ONUs exists during
processing as di-ethylhexyl
phthalate may be in solid form.
Liquid/Solid
Contact
Dermal
ONU
No
Dermal exposure by ONU is not
expected for this condition of use
as they are not expected to directly
handle the chemical.
135
-------
l.ilit \ik-
Sl ;i»i-
C;ili-»iir\
Sul>i:ili-»iir\
Ri-k'iisi- / I!\|)iisuiv
Sii'ii;iriii
I!\|)iisuiv
l';illi\\;i\
l!\|)osuiv
Kiiuli-
Ri-ivpliir /
Piipuhiliiin
Phils In
l"\ ;il mili-
R;ilinn;ili-
Incorporation
Plasticizer in all other
Plastics and Rubber
The potential for exposures to
into articles
basic organic chemical
manufacturing, plastics
product manufacturing;
plastic material and
product manufacturing
(Plastic Converting)
Other article
Liquid
Contact
Dermal
Workers
Yes
workers exists during
incorporation into articles, as di-
ethylhexyl phthalate may be in
liquid form.
resin manufacturing;
custom compounding
of purchased resin
manufacturing
Solid
Contact
Dermal
Workers
Yes
The potential for exposures to
workers exists during processing
(incorporation into articles), as di-
ethylhexyl phthalate may be in
solid form, such as for resins.
Due to di-ethylhexyl phthalate's
vapor pressure (VP) (VP = 1.4 x
10-6 mm Hg) at room
Vapor
Inhalation
Workers,
ONU
Yes
temperature, potential for vapor
generation is low. However, some
of these operations may occur at
elevated temperatures, which
increase the potential for vapor
generation.
Mist
Inhalation/
Dermal
Workers,
ONU
No
Mist generation is not expected
during incorporation into article.
Dust
Inhalation/
Dermal
Workers,
ONU
Yes
The potential for exposures to
workers exists during processing
(incorporation into articles), as di-
ethylhexyl phthalate may be in
solid form, such as for resins.
Dermal exposure by ONU is not
Liquid/Solid
Contact
Dermal
ONU
No
expected for this condition of use
as they are not expected to directly
handle the chemical.
Repackaging
Repackaging
Repackaging into
large and small
containers
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to
workers exists during repackaging,
as di-ethylhexyl phthalate may be
in liquid form.
Solid
Contact
Dermal
Workers
Yes
The potential for exposures to
workers exists during repackaging,
as di-ethylhexyl phthalate may be
incorporated into products in solid
form.
Vapor
Inhalation
Workers,
ONU
No
Due to di-ethylhexyl phthalate's
vapor pressure (VP) (VP = 1.4 x
10-6 mm Hg) at room
136
-------
l.ik t \ik-
Shim-
C;ik-»iir\
SiiI)i:iIi-»hi'\
Ri-k'iisi- / I!\|)iisiiiv
Sivn;iriu
I!\|)iisiiiv
l!\|)osuiv
Kiiuk-
Ri-u-plur /
Piipuhiliiin
Pkilis In
l"\ ;il mill-
R;ilinn;ik-
temperature, potential lor vapor
generation is low.
Mist
Inhalation/
I )emial
Workers.
ONLJ
No
Mist generation is not expected
during repackaging.
Dust
Inhalation/
Dermal
Workers,
ONU
Yes
The potential for dust exposures to
workers and ONUs exists during
processing (repackaging), as di-
ethylhexyl phthalate may be
incorporated into products in solid
form.
Liquid/Solid
Contact
Dermal
ONU
No
Dermal exposure by ONU is not
expected for this condition of use
as they are not expected to directly
handle the chemical.
Recycling
Recycling
Recycling of di-
ethylhexyl phthalate
and products
containing di-
ethylhexyl phthalate
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to
workers exists during this use as
liquid formulations may be
recycled.
Solid
Contact
Dermal
Workers
Yes
The potential for exposures to
workers exists during this use as
solid formulations may be
recycled.
Vapor
Inhalation
Workers,
ONU
No
Due to di-ethylhexyl phthalate's
vapor pressure (VP) (VP = 1.4 x
10-6 mm Hg) at room
temperature, potential for vapor
generation is low.
Mist
Inhalation/
Dermal
Workers,
ONU
No
Mist generation is not expected
during recycling of liquid wastes.
Dust
Inhalation/
Dermal
Workers,
ONU
Yes
Dust generation is possible during
recycling of solid wastes.
Liquid/Solid
Contact
Dermal
ONU
No
Dermal exposure by ONU is not
expected for this condition of use
as they are not expected to directly
handle the chemical.
Industrial/
Commercial
Use
Paints and
coatings;
adhesives and
sealants; lawn
and garden care
products;
Transportation
Paints and coatings;
adhesives and sealants;
lawn and garden care
products;
Transportation
equipment
manufacturing (e.g.,
Spray, brush, roll, dip,
and other forms of
application
Liquid
Contact
Dermal
Workers
Yes
These products are in liquid form;
therefore, exposures to workers
exists for di-ethylhexyl phthalate
used in these products.
Solid
Contact
Dermal
Workers
No
The potential for exposures to
solid di-ethylhexyl phthalate is not
expected during the use of these
137
-------
l.ik t \ik-
C;ik-»iir\
SiiI)i:iIi-»hi'\
Ri-k'iisi- / I!\|)iisiiiv
Sivn;iriu
I!\|)iisiiiv
l!\|)osuiv
Kiiuk-
Ri-u-plur /
Piipuhiliiin
Pkilis In
l"\ ;il mill-
R;ilinn;ik-
equipment
manufacturing
formulations for
diffusion bonding and
products because they are in liquid
form.
(e.g.,
manufacture of aero
Due to di-elhvlhexvl phlhalate's
fonnulations for
diffusion
bonding and
manufacture of
engine fan blades)
Vapor
Inhalation
Workers,
ONIJ
No
vapor pressure (VP) (VP = 1.4 *
1.0-6 mm 1 Ig) at room
temperature, potential for vapor
generation is low.
aero engine fan
blades)
Mist
Inhalation/
Dermal
Workers,
ONU
Yes
Mist generation is possible during
application of these products.
Dust
Inhalation/
Dermal
Workers,
ONU
No
The potential for exposures to
solid di-ethylhexyl phthalate is not
expected during the use of these
products because they are in liquid
form.
Liquid/Solid
Contact
Dermal
ONU
No
Dermal exposure by ONU is not
expected for this condition of use
as they are not expected to directly
handle the chemical.
Hydraulic
fracturing;
Laboratory
Hydraulic fracturing;
Laboratory chemicals;
arts, crafts, and hobby
Use in hydraulic
fracturing
Liquid
Contact
Dermal
Workers
Yes
These products are in liquid form;
therefore, exposures to workers
exists for di-ethylhexyl phthalate
chemicals; arts,
materials; automotive
Use in laboratories
used in these products.
crafts, and
hobby materials;
automotive care
care products; dyes and
pigments
Use of arts, crafts, and
hobby materials
Solid
Contact
Dermal
Workers
No
The potential for exposures to
solid di-ethylhexyl phthalate is not
expected during the use of these
products; dyes
and pigments
Use of automotive
products because they are in liquid
form.
care products
Due to di-ethylhexyl phthalate's
Use of dyes and
Vapor
Inhalation
Workers,
ONU
No
vapor pressure (VP) (VP = 1.4 x
10-6 mm Hg) at room
pigments
temperature, potential for vapor
generation is low.
Mist
Inhalation/
Dermal
Workers,
ONU
No
Mist generation is not expected
during use of these products.
Dust
Inhalation/
Dermal
Workers,
ONU
No
The potential for exposures to
solid di-ethylhexyl phthalate does
not exist during the use of these
products because they are in liquid
form.
Liquid/Solid
Contact
Dermal
ONU
No
Dermal exposure by ONU is not
expected for this condition of use
138
-------
l.ilit \ik-
Sl ;i»i-
C;ili-»iir\
Sul>i:ili-»iir\
Ri-k'iisi- / I!\|)iisuiv
Sii'ii;iriii
I!\|)iisuiv
l!\|)osuiv
Kiiuli-
Ri-ivpliir /
Piipuhiliiin
Phils In
l"\ ;il mili-
R;ilinn;ili-
as they are not expected to directly
handle the chemical.
Batteries;
building and
construction
materials not
covered
elsewhere;
electrical and
electronic
products; fabric,
textile, and
leather products
not covered
elsewhere;
furniture and
furnishings not
covered
elsewhere;
plastic and
rubber products
not covered
elsewhere; toys,
playground, and
sporting
equipment
Batteries; building and
construction materials
not covered elsewhere;
electrical and electronic
products; fabric, textile,
and leather products not
covered elsewhere;
furniture and
furnishings not covered
elsewhere; plastic and
rubber products not
covered elsewhere;
toys, playground, and
sporting equipment
Use of articles made
using di-ethylhexyl
phthalate
Liquid
Contact
1 )ermal
Workers
No
The potential for exposures to
liquid di-ethylhexyl phthalate is
not expected during the use of
these products because they are
solid articles.
Solid
Contact
Dermal
Workers
Yes
These products may include solid
articles in which di-ethylhexyl
phthalate is entrained; therefore,
di-ethylhexyl phthalate exposures
to workers is unlikely but may
occur if cutting /sawing / other
machining operations occur.
Vapor
Inhalation
Workers,
ONU
No
Due to di-ethylhexyl phthalate's
vapor pressure (VP) (VP = 1.4 x
10-6 mm Hg) at room
temperature, potential for vapor
generation is low.
Mist
Inhalation/
Dermal
Workers,
ONU
No
Mist generation is not expected
during use of these products.
Dust
Inhalation/
Dermal
Workers,
ONU
Yes
These products may include solid
articles in which di-ethylhexyl
phthalate is entrained; therefore,
di-ethylhexyl phthalate exposures
to workers and ONUs is unlikely
but may occur if cutting /sawing /
other machining operations occur.
Liquid/Solid
Contact
Dermal
ONU
No
Dermal exposure by ONU is not
expected for this condition of use
as they are not expected to directly
handle the chemical.
Disposal
Disposal
Disposal of di-
ethylhexyl phthalate
wastes
Worker handling of
wastes
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to
workers exists during this use as
liquid formulations may be
disposed.
Solid
Contact
Dermal
Workers
Yes
The potential for exposures to
workers exists during this use as
solid formulations may be
disposed
Vapor
Inhalation
Workers,
ONU
No
Due to di-ethylhexyl phthalate's
vapor pressure (VP) (VP = 1.4 x
139
-------
l.ili t \ik-
C;ik-»iir\
Ri-k-iisi- / I!\|)iisiiiv
Sivn;iriu
I!\|)iisiiiv
l!\|)osuiv
Riiuk-
Ri'ivplur /
Piipuhiliiin
I'hllis In
l"\ ;illl;ili'
R;ilinn;ili'
1.0-6 mm I Ig) at room
temperaliire, potential lor vapor
generation is low.
Mist
Inhalation/
I )ennal
Workers.
ONIJ
No
Mist generation is not expected
during disposal of liquid wastes.
Dust
Inhalation/
Dermal
Workers,
ONU
Yes
Dust generation is possible during
disposal of solid wastes.
Liquid/Solid
Contact
Dermal
ONU
No
Dermal exposure by ONU is not
expected for this condition of use
as they are not expected to directly
handle the chemical.
140
-------
Appendix G SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR CONSUMER
ACTIVITIES AND USES
Table Apx G-l. Consumer Exposure Conceptual Model Supporting Table
l.ilV ( \do
Si;i»e
Siibciiloiion
Kolciiso from
sou rcc
Mxposuiv
Kniilc
Km*|)lor
Pliius In
r.\;ilu;ilc
Kiilioiiiilo
Consumer
Use
Construction,
Paint, Electrical,
and Metal
Products
Building/
Construction
Materials Not
Covered
Elsewhere
(Article)
Direct contact
through handling of
articles containing
chemical
Direct
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this
condition of use and will be analyzed.
Direct contact
through mouthing
of articles
containing
chemical
Mouthing
Oral
Consumers
Yes
Oral exposure may occur for this condition
of use and will be analyzed.
Long-term
emission/mass-
transfer, Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure from
this condition of use may occur and will be
analyzed.
Consumer
Use
Construction,
Paint, Electrical,
and Metal
Products
Electrical and
Electronic
Products
(Article)
Direct contact
through handling of
articles containing
chemical
Direct
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this
condition of use, dermal exposure will be
analyzed.
Direct contact
through mouthing
of articles
containing
chemical
Mouthing
Oral
Consumers
Yes
Oral exposure may occur for this condition
of use and will be analyzed.
Long-term
emission/mass-
transfer, Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure from
this condition of use may occur and will be
analyzed.
Consumer
Use
Furnishing,
Cleaning,
Treatment/Care
Products
Fabric, Textile
and Leather
Products no
Direct contact
through handling of
articles containing
chemical
Direct
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this
condition of use, dermal exposure will be
analyzed.
141
-------
l .ilo ( >cle
SliliiC
Siihciileiion
Kok'iisc I'm in
sou ive
l'l\|)OSIIIV
Kniili'
Km*|)lor
I'lilllS In
i:\iiiuiiic
Kiilimiiik'
Covered
Elsewhere
(Article)
Direct contact
through mouthing
of articles
containing
chemical
Mouthing
Oral
Consumers
Yes
Oral exposure may occur for this condition
of use and will be analyzed.
Long-term
emission/mass-
transfer, Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure from
this condition of use may occur and will be
analyzed.
Consumer
Use
Furnishing,
Cleaning,
Treatment/Care
Products
Furniture and
Furnishings
not Covered
Elsewhere
(Article)
Direct contact
through handling of
articles containing
chemical
Direct
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this
condition of use, dermal exposure will be
analyzed.
Direct contact
through mouthing
of articles
containing
chemical
Mouthing
Oral
Consumers
Yes
Oral exposure may occur for this condition
of use and will be analyzed.
Long-term
emission/mass-
transfer, Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure from
this condition of use may occur and will be
analyzed.
Consumer
Use
Packaging,
Paper, Plastic,
Hobby Products
Plastic and
Rubber
Products not
Covered
Elsewhere
(Article)
Direct contact
through handling of
articles containing
chemical
Direct
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this
condition of use, dermal exposure will be
analyzed.
Direct contact
through mouthing
of articles
containing
chemical
Mouthing
Oral
Consumers
Yes
Oral exposure may occur for this condition
of use and will be analyzed.
Long-term
emission/mass-
transfer, Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure from
this condition of use may occur and will be
analyzed.
142
-------
l .ilo ( >cle
SliliiC
Siihciileiion
Kok'iisc I'm in
sou ive
l'l\|)OSIIIV
Kniili'
Km*|)lor
I'lilllS In
i:\iiiuiiic
Kiilimiiik'
Direct contact
through handling of
articles containing
chemical
Direct
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this
condition of use, dermal exposure will be
analyzed.
Consumer
Use
Packaging,
Paper, Plastic,
Hobby Products
Toys,
Playground,
and Sporting
Equipment
(Article)
Direct contact
through mouthing
of articles
containing
chemical
Mouthing
Oral
Consumers
Yes
Oral exposure may occur for this condition
of use and will be analyzed.
Long-term
emission/mass-
transfer, Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure from
this condition of use may occur and will be
analyzed.
Long-term
emission/mass-
transfer, Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure from
this condition of use may occur and will be
analyzed.
Consumer
Use
Construction,
Paint, Electrical,
and Metal
Products
Adhesives and
Direct contact
through application
or use of products
Liquid
Contact
Dermal
Consumers
Yes
Exposure is expected to be primarily
restricted to consumers who are directly
involved in using the chemical.
Sealants
(Product)
Long-term
emission/mass-
transfer through
application or use
of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible and will be analyzed.
Direct contact
through application
or use of products
Mist
Inhalation
and
Dermal
Consumers
and
Bystanders
Yes
If product is applied as a mist, inhalation
and dermal exposures would be expected
and analyzed.
Packaging,
Paper, Plastic,
Hobby Products
Arts, Crafts,
Long-term
emission/mass-
transfer, Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure from
this condition of use may occur and will be
analyzed.
Consumer
Use
and Hobby
Materials
(Product)
Direct contact
through application
or use of products
Liquid
Contact
Dermal
Consumers
Yes
Exposure is expected to be primarily
restricted to consumers who are directly
involved in using the chemical.
Long-term
emission/mass-
transfer through
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible and will be analyzed.
143
-------
l .ilo ( >cle
SliliiC
Siihciileiion
Kok'iisc I'm in
sou ive
l'l\|)OSIIIV
Kniili'
Km*|)lor
I'lilllS In
i:\iiiuiiic
Kiilimiiik'
application or use
of products
Direct contact
through application
or use of products
Mist
Inhalation
and
Dermal
Consumers
and
Bystanders
Yes
If product is applied as a mist, inhalation
and dermal exposures would be expected
and will be analyzed.
Long-term
emission/mass-
transfer, Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure from
this condition of use may occur and will be
analyzed.
Consumer
Use
Automotive,
Fuel, Agriculture,
Outdoor Use
Products
Automotive
Direct contact
through application
or use of products
Liquid
Contact
Dermal
Consumers
Yes
Exposure is expected to be primarily
restricted to consumers who are directly
involved in using the chemical.
Care Products
(Product)
Long-term
emission/mass-
transfer through
application or use
of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible and will be analyzed.
Direct contact
through application
or use of products
Mist
Inhalation
and
Dermal
Consumers
and
Bystanders
Yes
If product is applied as a mist, inhalation
and dermal exposures would be expected
and evaluated.
Long-term
emission/mass-
transfer, Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure from
this condition of use may occur and will be
analyzed.
Consumer
Use
Packaging,
Ink, Toner and
Colorant
Products
(Product)
Direct contact
through application
or use of products
Liquid
Contact
Dermal
Consumers
Yes
Exposure is expected to be primarily
restricted to consumers who are directly
involved in using the chemical.
Paper, Plastic,
Hobby Products
Long-term
emission/mass-
transfer through
application or use
of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible and will be analyzed.
Direct contact
through application
or use of products
Mist
Inhalation
and
Dermal
Consumers
and
Bystanders
Yes
If product is applied as a mist, inhalation
and dermal exposures would be expected
and analyzed.
Consumer
Use
Automotive,
Fuel, Agriculture,
Lawn and
Garden Care
Long-term
emission/mass-
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure from
this condition of use may occur and will be
analyzed.
144
-------
l .ilo ( >cle
SliliiC
Siihciileiion
Kok'iisc I'm in
sou ive
l'l\|)OSIIIV
Kniili'
Km*|)lor
I'lilllS In
i:\iiiuiiic
Kiilimiiik'
Outdoor Use
Products
Products
(Product)
transfer, Abrasion,
Transfer to Dust
Direct contact
through application
or use of products
Liquid
Contact
Dermal
Consumers
Yes
Exposure is expected to be primarily
restricted to consumers who are directly
involved in using the chemical.
Long-term
emission/mass-
transfer through
application or use
of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible and will be analyzed.
Direct contact
through application
or use of products
Mist
Inhalation
and
Dermal
Consumers
and
Bystanders
Yes
If product is applied as a mist, inhalation
and dermal exposures would be expected
and analyzed.
Consumer
Use
Construction,
Paint, Electrical,
and Metal
Products
Paints and
Coatings
(Product)
Long-term
emission/mass-
transfer, Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure from
this condition of use may occur and will be
analyzed.
Direct contact
through application
or use of products
Liquid
Contact
Dermal
Consumers
Yes
Exposure is expected to be primarily
restricted to consumers who are directly
involved in using the chemical.
Long-term
emission/mass-
transfer through
application or use
of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible and will be analyzed.
Direct contact
through application
or use of products
Mist
Inhalation
and
Dermal
Consumers
and
Bystanders
Yes
If product is applied as a mist, inhalation
and dermal exposures would be expected
and analyzed.
Consumer
Handling of
Disposal and
Waste
Wastewater,
Liquid wastes
and solid wastes
Wastewater,
Liquid wastes
and solid
wastes
Long-term
emission/mass-
transfer, Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dust generation is possible during the
handling of solid waste.
Direct contact
through handling or
disposal of products
Liquid
Contact
Dermal
Consumers
Yes
Exposure is expected to be primarily
restricted to consumers who are directly
involved in handling and disposal of the
chemical.
145
-------
l .ilo ( >cle
SliliiC
Siihciileiion
Kok'iisc I'mm
sou ive
l'l\|)OSIIIV
Rouk'
Km*|)lor
I'lilllS In
Kiilioiiiilc
Long-term
emission/mass-
transfer through
application or use
of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible and will be analyzed.
Direct contact
through application
or use of products
Mist
Inhalation
and
Dermal
Consumers
and
Bystanders
No
Mist generation is not expected during
handling or disposal.
146
-------
Appendix H In SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR
ENVIRONMENTAL RELEASES AND WASTES
Table Apx H-l. Genera
Population and Environmental Exposure Conceptual Model Supporting Table
I.il'c Cycle
S(;i»e
Release
r.\i)(isuiv
PiKhwin /
Medi;i
l'l\|)(ISIIIV
Koii ics
Reeeplor/
Population
I'lilllS lo
l.\;ilu;ik'
R;ilion;ile
Near facililv
amhiciil ;i11
ciiiii_viili;il ions
Inhalation
General
Population
\n
I !llllsslii|ls III
\ll
I !lllisslii|ls III \l
Indirect
depi'sllli'll lii
neailn hudics
i»l" \\ :ilcr ;iiid
soil c;ilchmciils
()ial
DciiikiI
( iCIICI'Ill
l\ llicw I phili;il;ilc is ;i 11 \|» r.cc;iusc
s|;iliiiii;ii> simii'cc releases iil'di-clhs llicw I
phlhnhilc lo ;inihiciil ;iii';iic undci'lhc
IMl isdlCllliM ill" I lie (' \ \
\n
All
Wastewater
or Liquid
Wastes
Direct release
into surface
water and
indirect
partitioning lo
sediment
TBD
Aquatic
Receptors
Yes
Oral
Dermal
General
Population
No
EPA has developed Ambient Water
Quality Criteria for protection of human
health fordi-cthvlhcxyl phthalatc.
Industrial pre-
treatment and
wastewater
treatment, or POTW
Drinking Water
via Surface or
Ground Water
Oral
Dermal and
Inhalation
(e.g.,
showering)
General
Population
No
Drinking water exposure pathway for di-
cthylhcxyl phthalatc is currently addressed
in the NPDWR
Biosolids:
application lo
soil and/or
migration to
groundwater
and/or surface
water
Oral
Inhalation
General
Population
No
TBD
Aquatic
Receptors
Yes
Unlikely to be a route to general
population since di-cthylhcxyl phthalatc is
not expected to migrate to groundwater
from biosolids.
U nderground
injection
Migration to
groundwater.
potential
Oral
Dermal
Inhalation
General
Population
No
Di-cthylhcxyl phthlatc is released lo Class
I Underground Injection Wells which arc
covered bv SDWA and RCRA.
147
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