EPA Document# EPA-740-D-20-019
April 2020
United States Office of Chemical Safety and
Environmental Protection Agency Pollution Prevention
Draft Scope of the Risk Evaluation for
Dicyclohexyl Phthalate
(1,2- Benzenedicarboxylic acid, 1,2-dicyclohexyl ester)
CASRN 84-61-7
April 2020
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TABLE OF CONTENTS
ACKNOWLEDGEMENTS 4
ABBREVIATIONS AND ACRONYMS 5
EXECUTIVE SUMMARY 8
1 INTRODUCTION 11
2 SCOPE OF THE EVALUATION 11
2.1 Reasonably Available Information 11
2.1.1 Search of Gray Literature 12
2.1.2 Search of Literature from Publicly Available Databases (Peer-reviewed Literature) 13
2.1.3 Search of TSCA Submissions 17
2.2 Conditions of Use 18
2.2.1 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation 18
2.2.2 Activities Excluded from the Scope of the Risk Evaluation 21
2.2.3 Production Volume 22
2.2.4 Overview of Conditions of Use and Lifecycle Diagram 22
2.3 Exposures 24
2.3.1 Physical and Chemical Properties 24
2.3.2 Environmental Fate and Transport 24
2.3.3 Releases to the Environment 24
2.3.4 Environmental Exposures 24
2.3.5 Occupational Exposures 25
2.3.6 Consumer Exposures 26
2.3.7 General Population Exposures 26
2.4 Hazards (Effects) 27
2.4.1 Environmental Hazards 27
2.4.2 Human Health Hazards 27
2.5 Potentially Exposed or Susceptible Subpopulations 27
2.6 Conceptual Models 28
2.6.1 Conceptual Model for Industrial and Commercial Activities and Uses 28
2.6.2 Conceptual Model for Consumer Activities and Uses 30
2.6.3 Conceptual Model for Environmental Releases and Wastes: Potential Exposures and
Hazards 32
2.7 Analysis Plan 34
2.7.1 Physical and Chemical Properties and Environmental Fate 34
2.7.2 Exposure 34
2.7.2.1 Environmental Releases 35
2.7.2.2 Environmental Exposures 37
2.7.2.3 Occupational Exposures 38
2.7.2.4 Consumer Exposures 39
2.7.2.5 General Population 41
2.7.3 Hazards (Effects) 43
2.7.3.1 Environmental Hazards 43
2.7.3.2 Human Health Hazards 44
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2.7.4 Summary of Risk Approaches for Characterization 46
2.8 Peer Review 47
REFERENCES 48
APPENDICES 53
Appendix A LIST OF GRAY LITERATURE SOURCES 53
Appendix B PHYSICAL AND CHEMICAL PROPERTIES OF DICYCLOHEXYL
PHTHALATE 56
Appendix C ENVIRONMENTAL FATE AND TRANSPORT PROPERTIES OF
DICYCLOHEXYL PHTHALATE 58
Appendix I) REGULATORY HISTORY 59
D. 1 Federal Laws and Regulations 59
D.2 State Laws and Regulations ....60
D.3 International Laws and Regulations......... .........61
Appendix E PROCESS, RELEASE AND OCCUPATIONAL EXPOSURE INFORMATION.. 62
E.l Process Information 62
E. 1.1 Manufacture (Including Import) 62
E. 1.1.1 Domestic Manufacturing 62
E.L 1.2 Import 62
E. 1.2 Processing and Distribution 62
E. 1.2.1 Reactant or Intermediate 62
E. 1.2,2 Incorporated into a Formulation, Mixture or Reaction Product 62
E. 1.2.3 Incorporated into an Article 63
E. 1.2.4 Repackaging 63
E. 1.2.5 Recycling 63
E.1.3 Uses 63
E. 1.3.1 Adhesives, Sealants, Paints, and Coatings 63
E. 1.3.2 Building/Construction Materials Not Covered Elsewhere 63
E. 1.3.3 Ink, Toner, and Colorant Products 63
E. 1.3.4 Plastic and Rubber Products 64
E.1.3.5 Other Uses 64
E.1.4 Disposal 64
E.2 Preliminary Occupational Exposure Data....... 65
Appendix F SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR INDUSTRIAL
AND COMMERCIAL ACTIVITIES AND USES 66
Appendix G SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR CONSUMER
ACTIVITIES AND USES 74
Appendix H SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR
ENVIRONMENTAL RELEASES AND WASTES 78
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LIST OF TABLES
Table 2-1. Results of Title Screening of Submissions to EPA under Various Sections of TSCA 18
Table 2-2. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation 18
Table 2-3. Categories and Sources of Environmental Release Data 35
Table 2-4. Potential Sources of Occupational Exposure Data 38
LIST OF FIGURES
Figure 2-1. Gray Literature Tags by Discipline for Dicyclohexyl Phthalate 12
Figure 2-2. Peer-reviewed Literature - Physical-Chemical Properties Search Results for Dicyclohexyl
Phthalate 13
Figure 2-3. Peer-reviewed Literature - Fate and Transport Search Results for Dicyclohexyl Phthalate. 14
Figure 2-4. Peer-reviewed Literature - Engineering Search Results for Dicyclohexyl Phthalate 15
Figure 2-5. Peer-reviewed Literature - Exposure Search Results for Dicyclohexyl Phthalate 16
Figure 2-6. Peer-reviewed Literature - Hazard Search Results for Dicyclohexyl Phthalate 17
Figure 2-7. Dicyclohexyl Phthalate Life Cycle Diagram 23
Figure 2-8. Dicyclohexyl Phthalate Conceptual Model for Industrial and Commercial Activities and
Uses: Worker and Occupational Non-User Exposures and Hazards 29
Figure 2-9. Dicyclohexyl Phthalate Conceptual Model for Consumer Activities and Uses: Consumer
Exposures and Hazards 31
Figure 2-10. Dicyclohexyl Phthalate Conceptual Model for Environmental Releases and Wastes:
Environmental and General Population Exposures and Hazards 33
LIST OF APPENDIX TABLES
Table_Apx A-l. Gray Literature Sources for Dicyclohexyl Phthalate 53
TableApx B-l. Physical and Chemical Properties of Dicyclohexyl Phthalate 56
TableApx C-l. Environmental Fate and Transport Properties of Dicyclohexyl Phthalate 58
Table_Apx D-l. Federal Laws and Regulations 59
Table_Apx D-2. State Laws and Regulations 60
Table Apx D-3. Regulatory Actions by other Governments, Tribes, and International Agreements 61
Table Apx E-l. Summary of NIOSH HHEs with Monitoring for Dicyclohexyl Phthalate 65
Table Apx F-l. Worker and Occupational Non-User Exposure Conceptual Model Supporting Table.. 66
Table Apx G-l. Consumer Exposure Conceptual Model Supporting Table 74
Table Apx H-l. General Population and Environmental Exposure Conceptual Model Supporting Table
78
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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-QPPT-2018-0504.
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
BAF
Bioaccumulation Factor
BBP
Butylbenzyl Phthalate
BCF
Bioconcentration Factor
BMF
Biomagnification factor
BOD
Biochemical oxygen demand
BW34
Body weight scaling to the 3/4 power
CAA
Clean Air Act
CASRN
Chemical Abstracts Service Registry Number
CBI
Confidential Business Information
CDR
Chemical Data Reporting
CEHD
Chemical Exposure Health Data
CFR
Code of Federal Regulations
ChemSTEER Chemical Screening Tool for Exposure and Environmental Releases
CHRIP
Chemical Risk Information Platform
COC
Concentration of Concern
CoRAP
Community Rolling Action Plan
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
DBP
Dibutyl Phthalate
DCHP
Dicyclohexyl Phthalate
DEHP
Di-ethylhexyl Phthalate
DHEXP
Di-n-hexyl Phthalate
DIBP
Di-isobutyl Phthalate
DINP
Di-isononyl Phthalate
DPENP
Di-n-pentyl Phthalate
ECHA
European Chemicals Agency
EC
Engineering Controls
ECx
Effective Concentration that causes a response that is x% of the maximum
ECHA
European Chemicals Agency
EPA
Environmental Protection Agency
ERG
Eastern Research Group
ESD
Emission Scenario Document
EU
European Union
FDA
Food and Drug Administration
FFDCA
Federal Food, Drug and Cosmetic Act
FR
Federal Register
FYI
For your information
GC
Gas Chromatography
GDIT
General Dynamics Information Technology
GESTIS
International Occupational Exposure Limit Database
GS
Generic Scenario
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HAWC
Hg
HHE
HQ
HSDB
ICF
IECCU
IMAP
IMIS
Koc
Kow
LCso
LOAEL
LOEC
MITI
MOA
MP
MRSA
NHANES
NICNAS
NIOSH
NITE
NLM
NOAEL
NOEC
NPDES
OCSPP
OECD
OEL
ONU
OPPT
OSHA
PBPK
PBT
PECO
PESS
POD
POTW
PPE
PVC
RCRA
REACH
RQ
SACC
SDS
SDWA
Health Assessment Workplace Collaborative
Mercury
Health Hazard Evaluation
Headquarters
Hazardous Substances Data Bank
ICF is a global consulting company
Indoor Environmental Concentrations in Buildings with Conditioned and Unconditioned
Zones
Inventory Multi-Tiered Assessment and Prioritisation (Australia)
Integrated Management Information System
Organic Carbon: Water Partition Coefficient
Octanol: Water Partition Coefficient
Lethal Concentration of 50% test organisms
Lowest Observed Adverse Effect Level
Lowest Observed Effect Concentration
Ministry of International Trade and Industry
Mode of Action
Melting Point
Maine Revised Statutes Annotated
National Health and Nutrition Examination Survey
National Industrial Chemicals Notification and Assessment Scheme (Australia)
National Institute for Occupational Safety and Health
National Institute of Technology and Evaluation
National Library of Medicine
No Observed Adverse Effect Level
No Observed Effect Concentration
National Pollutant Discharge Elimination System
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
Potentially Exposed or Susceptible Subpopulation
Point of Departure
Publicly Owned Treatment Works
Personal Protective Equipment
Polyvinyl chloride
Resource Conservation and Recovery Act
Registration, Evaluation, Authorisation and Restriction of Chemicals (European Union)
Risk Quotient
Science Advisory Committee on Chemicals
Safety Data Sheet
Safe Drinking Water Act
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SMILES
Simplified molecular-input line-entry system
SRC
SRC, Inc., formerly Syracuse Research Corporation
SVHC
Substance of Very High Concern (European Union)
SYKE
Finnish Environment Institute
T1/2
Half-Life
TCCR
Transparent, Clear, Consistent and Reasonable
TIAB
Title and Abstract
TSCA
Toxic Substances Control Act
TMF
Trophic Magnification Factors
TRI
Toxics Release Inventory
TSCA
Toxic Substances Control Act
U.S.C.
United States Code
VP
Vapor Pressure
WS
Water solubility
WWT
Wastewater Treatment
WWTP
Wastewater Treatment Plant
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EXECUTIVE SUMMARY
In December 2019, EPA designated dicyclohexyl phthalate (CASRN 84-61-7) as a high-priority
substance for risk evaluation following the prioritization process required by Section 6(b) of the Toxic
Substances Control Act (TSCA) and implementing regulations (40 CFR Part 702) (Docket ID: EPA-
EPA-HQ-Q] 0504). The first step of the risk evaluation process is the development of the
scope document, and this document fulfills the TSCA regulatory requirement to issue a draft scope
document as described in 40 CFR 702.41(c)(7). The draft scope for dicyclohexyl phthalate includes the
following information: the conditions of use, potentially exposed or susceptible subpopulations (PESS),
hazards, and exposures that EPA plans to consider in this 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. EPA is providing a 45-day comment period on the draft scope.
Comments received on this draft scope document will help inform development of the final scope
document and the risk evaluation.
General Information. Dicyclohexyl phthalate is a granular solid with a total production volume in the
United States between 500 thousand and 1 million pounds (U.S. EPA, 2017).
Reasonably Available Information. EPA leveraged the data and information sources already described
in the document supporting the High-Priority Substance designation for dicyclohexyl phthalate to inform
the development of this draft scope document. To further develop this draft scope document, 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 to date are provided in
Section 2.1. EPA is seeking public comment on this draft scope document and will consider additional
information identified following publication of this draft scope document, as appropriate, in developing
the final scope document. EPA is using the systematic review process described in the Application of
Systematic Review in TSCA Risk Evaluations document (U.S. EPA, 2018) to guide the process of
searching for and screening reasonably available information, including information already in EPA's
possession, for use and inclusion in the risk evaluation. EPA is applying these systematic review
methods to collect reasonably available information regarding hazards, exposures, PESS, and conditions
of use that will help inform the risk evaluation for dicyclohexyl phthalate.
Conditions of Use. EPA plans to evaluate manufacturing, including importing; processing; distribution
in commerce; industrial, commercial and consumer uses; and disposal of dicyclohexyl phthalate in the
risk evaluation. Dicyclohexyl phthalate is imported to the United States and domestically manufactured.
The chemical is processed as a reactant, incorporated into a formulation, mixture, or reaction products,
and incorporated into articles. The identified processing activities also include the repackaging of
dicyclohexyl phthalate and the recycling of articles containing dicyclohexyl phthalate. Several industrial
and commercial uses were identified that ranged from use as plastic and rubber products to adhesives
and sealants in transportation equipment manufacturing. Six consumer use categories were identified
including adhesives and sealants, arts, crafts and hobby materials, fabric, textile and leather products,
paper products and toys, playground and sporting equipment. EPA is aware of the Consumer Product
Safety Commission's final rule in 2018 that prohibits children's toys and childcare articles containing
more than 0.1% of dicyclohexyl phthalate. However, children's toys and childcare articles are still
included as a consumer use to capture the products that are potentially still available and in use.
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EPA identified these conditions of use from information reported to EPA through Chemical Data
Reporting (CDR), published literature, and consultation with stakeholders for both uses currently in
production and uses whose production may have ceased. Section 2.2 provides additional details about
the conditions of use within - and outside - the scope of the risk evaluation. In addition, EPA plans to
analyze distribution in commerce and disposal as part of the risk evaluation.
Conceptual Model. The conceptual models for dicyclohexyl 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 plans to focus the risk evaluation for
dicyclohexyl phthalate on the following exposures, hazards and receptors with the understanding that
updates may be made in the final scope document after consideration of public comments and
completion of the systematic review data collection phase.
• Exposures (Pathways and Routes), Receptors and PESS. EPA plans to analyze both human and
environmental exposures resulting from the conditions of use of dicyclohexyl phthalate that EPA
plans to consider in the risk evaluation. Exposures for dicyclohexyl phthalate are discussed in
Section 2.3. Additional information gathered through systematic review searches will also
inform expected exposures.
In Section 2.6.3, EPA presents the conceptual models describing the identified exposures
(pathways and routes), receptors and hazards associated with the conditions of use of
dicyclohexyl phthalate within the scope of the risk evaluation.
Preliminarily, EPA plans to evaluate the following human and environmental exposure
pathways, routes, receptors and PESS in the scope of the risk evaluation. However, EPA plans to
consider comments received on this draft scope and other reasonably available information when
finalizing this scope document, and to adjust the exposure pathways, exposure routes and
hazards included in the scope document as needed.
- Occupational exposures associated with industrial and commercial conditions of use:
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 the
manufacturing, processing, use or disposal of dicyclohexyl phthalate (Section 2.2).
- Consumer and bystander exposures associated with consumer conditions of use: EPA
plans to evaluate inhalation, dermal, and oral exposure to dicyclohexyl phthalate for
consumers and bystanders from the use of fabric, textile, and leather products not covered
elsewhere; paper products; plastic and rubber products not covered elsewhere; toys,
playground, and sporting equipment; adhesives and sealants; and arts, crafts and hobby
materials.
- General population exposures: EPA plans to evaluate exposure to dicyclohexyl phthalate
via drinking water, surface water, groundwater, ambient air, soil, and fish ingestion for
the general population.
- Receptors and PESS: EPA plans to include children, women of reproductive age (e.g.,
pregnant women), workers and consumers as receptors and PESS in the risk evaluation
(Section 2.5).
- Environmental exposures: EPA plans to evaluate exposure to dicyclohexyl phthalate for
aquatic and terrestrial receptors.
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• Hazards. Hazards for dicyclohexyl phthalate are discussed in Section 2.4. EPA completed
preliminary reviews of information from peer-reviewed assessments and databases to identify
potential environmental and human health hazards for dicyclohexyl phthalate as part of the
prioritization process. Although EPA did not identify environmental hazard information during
the prioritization process, EPA is in the process of identifying additional reasonably available
information through systematic review methods and public comments that may inform potential
environmental hazards associated with dicyclohexyl phthalate exposure.
EPA plans to use systematic review methods to evaluate the epidemiological and toxicological
literature for dicyclohexyl phthalate. Relevant mechanistic evidence will also be considered, if
reasonably available, to inform the interpretation of findings related to potential human health
effects and the dose-repose assessment. EPA plants to evaluate all of the potential human health
hazards for dicyclohexyl phthalate identified in Section 2.4.2. The broad health effect categories
include reproductive and developmental, immunological, nervous system, genotoxicity,
carcinogenicity, absorption, distribution, metabolism, and excretion (ADME), and irritation
effects.
Analysis Plan. The analysis plan for dicyclohexyl 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 dicyclohexyl phthalate to date, which includes a partial, but
ongoing, review of identified information as described in Section 2.1. EPA plans to consider new
information submitted by the public. Should additional data or approaches become reasonably available,
EPA may update its analysis plan in the final scope document.
EPA plans to seek public comments on the systematic review methods supporting the risk evaluation for
dicyclohexyl phthalate, including the methods for assessing the quality of data and information and the
approach for evidence synthesis and evidence integration supporting the exposure and hazard
assessments. The details will be provided in a supplemental document that EPA anticipates releasing
prior to the finalization of the scope document.
Peer Review. The draft risk evaluation for dicyclohexyl 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 and other methods consistent with Section 26 of TSCA
(40 CFR 702.45V
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1 INTRODUCTION
This document presents for comment the draft scope of the risk evaluation to be conducted for
dicyclohexyl 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 the Toxic Substances Control
Act (TSCA) on June 22, 2016. The new law includes statutory requirements and deadlines for actions
related to conducting risk evaluations of existing chemicals.
TSCA § 6(b) and 40 CFR Part 702, Subpart A require the Environmental Protection Agency (EPA) to
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, in
conducting 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 non-
risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation
identified as relevant to the risk evaluation by the Administrator, under the conditions of use."
TSCA § 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 potentially exposed
or susceptible subpopulations 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 (84 FR 71924). as required by TSCA § 6(b)(2)(B), which initiated the
risk evaluation process for those chemical substances. Dicyclohexyl phthalate is one of the chemicals
designated as a high-priority substance for risk evaluation.
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 draft scope document for dicyclohexyl 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;
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.
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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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. EPA conducted the search and screening process based on general expectations for the
planning, execution and assessment activities outlined in the Application of Systematic Review in TSCA
Risk Evaluations document (U.S. EPA, 2018). EPA plans to publish supplemental documentation on the
systematic review methods supporting the dicyclohexyl phthalate risk evaluation to explain the literature
and screening process presented in this document in the form of literature inventory trees. Please note
that EPA focuses on the data collection phase (consisting of data search, data screening, and data
extraction) during the preparation of the TSCA scope document, whereas the data evaluation and
integration stages will occur during the development of the draft risk evaluation and thus are not part of
the scoping activities described in this document.
The subsequent sections summarize the data collection activities completed up to date for the general
categories of sources and topic areas (or disciplines) using systematic review methods. EPA plans to
seek public comments on the systematic review methods supporting the risk evaluation for dicyclohexyl
phthalate upon publication of the supplemental documentation of those methods.
2.1A_ Search of Gray Literature
EPA surveyed the gray literature2 and identified 95 search results relevant to EPA's risk assessment
needs for dicyclohexyl phthalate. Appendix A lists the gray literature sources that yielded 95 discrete
data or information sources relevant to dicyclohexyl phthalate. EPA further categorized the data and
information into the various topic areas (or disciplines) supporting the risk evaluation (e.g., physical-
chemical (p-chem) properties, environmental fate, environmental hazard, human health hazard,
exposure, engineering) and the breakdown is shown in Figure 2-1. EPA is currently identifying
additional reasonably available information (e.g., public comments), and the reported numbers in Figure
2-1 may change.
Gray Literature Tags by Discipline
Physical.Chemical
Hum an .Health. Hazard
50/95
Exposure
Environmental. Hazard
68/95
Engineering
0 25 50 75 100
Percent Tagged (%)
Figure 2-1. Gray Literature Tags by Discipline for Dicyclohexyl 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).
2Gray 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.
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2.1.2 Search of Literature from Publicly Available Databases (Peer-reviewed
Literature)
EPA is currently conducting a systematic review of the reasonably available literature. This includes
performing a comprehensive search of the reasonably available peer review literature on p-chem
properties, environmental fate and transport, engineering (environmental release and occupational
exposure), exposure (environmental, general population and consumer) and environmental and human
health hazards of dicyclohexyl phthalate. Eligibility criteria were applied in the form of PECO
(population, exposure, comparator, outcome) statements. 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. EPA plans to analyze the reasonably available information identified
for each discipline during the development of the risk evaluation. The literature inventory trees depicting
the number of references that were captured and those that were included, excluded, or tagged as
supplemental material during the screening process for each discipline area are shown in Figure 2-2
through Figure 2-6. "TIAB" in these figures refers to title and abstract screening. Note that 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.
Water Soiubiity
r~\ I—"(°)
Retrieved for FefS-teif ftckKted for Data 0 I
Kmms Extraction art Data . %-T
Rev**
tost mm
Toiat tor TIAB:
P-Chem
Escltisw
Exclusion
Figure 2-2. Peer-reviewed Literature - Physical-Chemical Properties Search Results for
Dicyclohexyl Phthalate
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Included
TSCA Fate DCHP (2020)
52
Excluded
©
Supplemental
Figure 2-3. Peer-reviewed Literature - Fate and Transport Search Results for Dicyclohexyl
Phthalate
Click here for interactive Health Assessment Workplace Collaborative (HAWC) Diagram.
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©
General Facility Estimate
I
Included
©
Environmental Release
TSCA Engineering DCHP
(2020)
25
Excluded
©
Occupational Exposure
©
Supplemental
Figure 2-4. Peer-reviewed Literature - Engineering Search Results for Dicyclohexyl Phthalate
Click here for interactive HAWC Diagram.
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24
TSCA Exposure DCHP
(2020)
Include
Supplemental
Exclude
o
indoor air
o
ambient air
o
soil
biosolids'sludge
o
sediment
0
olids/slt
surface water
©
ground water
—©
drinking water
aquatic species
terrestrial species
o
epidemiological/human
biomonjtoriqg study
sruttriixj!
0"
consumer uses and/or
products
\ Ci)
dietary
®
unclear
Figure 2-5. Peer-reviewed Literature - Exposure Search Results for Dicyclohexyl Phthalate
Click here for interactive HAWC Diagram.
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@
Human
©
Human Health Model
Retrieved for Full-text
Review
(is;
Animal
0
Ecotoxicological Model
3982
3940
0
Plant
TSCA Hazard DCHP (2020)
Exclusion
Supplemental Material
Figure 2-6. Peer-reviewed Literature - Hazard Search Results for Dicyclohexyl Phthalate
Click here for interactive HAWC Diagram.
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 the TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st
Century Act. EPA screened a total of 13 submissions using inclusion/ exclusion criteria specific to
individual disciplines (see Table 2-1 for the list of disciplines). The details about the criteria are not part
of this document but will be provided in a supplemental document that EPA anticipates releasing prior
to the finalization of the scope document. EPA identified three submissions that met the inclusion
criteria in these statements and identified 10 submissions with supplemental data. EPA excluded zero
submissions. EPA plans to conduct additional deduplication at later stages of the systematic review
process (e.g., full text screening), when more information regarding the reports is reasonably available.
17
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Table 2-1. Results of Title Screening of Submissions to EPA under Various Sections of TSCA
Discipline
Included
Supplemental
P-Chem Properties
0
0
Environmental Fate and Transport
1
0
Environmental and General Population Exposure
1
0
Occupational Exposure/Release Information
0
0
Environmental Hazard
0
0
Human Health Hazard
2
10
2.2 Conditions of Use
As described in the Promised Designation ofdicyclohexyl ph.thala.te (CASRN 84-61-7) as a High-
Priority Substance for Risk Evaluation (U.S. EPA 2019a), EPA assembled information from the CDR to
determine conditions of use3 or significant changes in conditions of use of the chemical substance. EPA
also consulted a variety of other sources to identify uses of dicyclohexyl phthalate, including: published
literature, company websites, and government and commercial trade databases and publications. To
identify formulated products containing dicyclohexyl phthalate, EPA searched for safety data sheets
(SDS) using internet searches, EPA Chemical and Product Categories (CPCat) 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 will be included
in the scope of the risk evaluation (Section 2.2.1). The conditions of use included in the scope are those
reflected in the life cycle diagrams and conceptual models.
After gathering reasonably available information related to the manufacture, processing, distribution in
commerce, use, and disposal of dicyclohexyl phthalate, EPA identified those categories or subcategories
of use activities for dicyclohexyl phthalate the Agency determined not to be conditions of use or will
otherwise be excluded during scoping. These categories and subcategories 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
l.ifc Cycle Slsi«e
CiiU'Korv
SiihcsHcsorv
References
Manufacturing
Domestic
Manufacturing/Import
Domestic
Manufacturing/Import
U.S. EPA. (2019b)
3 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 (15
U.S.C. § 2602(4)).
18
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I.ifo Cycle Slsi«e
CiiU'Korv
SiihcsHcsorv
Uel'eronccs
Processing
Processing as a reactant
Processing aids not otherwise
listed in: miscellaneous
manufacturing
U.S. EPA. (2019b)
Process regulator in: paint and
coating manufacturing; plastic
material and resin
manufacturing; plastic product
manufacturing; rubber product
manufacturing
:019b")
Processing -
incorporation into
formulation, mixture, or
reaction product
Laboratory chemicals
SPEX CertiPreo (2019)
Process regulators in: adhesive
manufacturing
U.S. EPA (2019b)
Adhesive and sealant
chemicals in: adhesive
manufacturing
V ">¦ VP\ 12019b)
Filler in: rubber product
manufacturing
U.S. EPA (2019b)
Plasticizer in: adhesive
manufacturing; paints and
coating manufacturing;
plastics product
manufacturing; printing ink
manufacturing; rubber product
manufacturing
*019b);
Meeting ffiPA-HO-OPPT-
2018-0504-00! 8); EPA-
H'Mtpj t ^
-------
I.ifo Cycle Slsi«e
CiiU'Korv
SiihcsHcsorv
Uel'eronccs
Distribution in
Distribution in
Distribution in commerce
commerce
commerce
Industrial Use
Adhesives and sealants
Adhesives and sealants in:
EP A-HO-OPPT-2018-
transportation equipment
0x1 { 00 i>-; Hcnkel (2019);
manufacturing; computer and
Henkel (2014)
electronic product
manufacturing
Food packaging
Food packaging (e.g.,
cellophane)
CPSC (2010); PR
Newswire C
Inks, toner and colorant
Inks, toner and colorant
CPS!
products
products
Plastic and rubber
Plastic and rubber products not
EP A-HO-OPPT-2018-
products not covered
covered elsewhere in:
0504-0016; CP5
elsewhere
transportation equipment
manufacturing; computer and
electronic product
manufacturing
Commercial Use
Adhesives and sealants
Adhesives and sealants
1019b)
Building/construction
Building/construction
U.S. EPA (2019b)
materials not covered
materials not covered
elsewhere
elsewhere
Fabric, textile, and
Fabric, textile, and leather
Descartes Datamyne
leather products not
products not covered
(2018)
covered elsewhere
elsewhere
Inks, toner and colorant
Inks, toner and colorant
CPSC (2
products
products
Laboratory chemicals
Laboratory chemicals
SPEX CertiPreo (2019)
Paints and coatings
Paints and coatings
Carbolin
Paper products
Paper products
CPS!
Plastic and rubber
Plastic and rubber products not
>b)
products not covered
covered elsewhere
elsewhere
Consumer Use
Adhesives and sealants
Adhesives and sealants
ITW Permatex (2018)
Arts, crafts, and hobby
Arts, crafts, and hobby
CPSC (2.015)
materials
materials (e.g., modeling clay)
Fabric, textile, and
Fabric, textile, and leather
Descartes Datamyne
leather products not
products not covered
(2018)
covered elsewhere
elsewhere
Paper products
Paper products
CPSC (2
Plastic and rubber
Plastic and rubber products not
>b)
products not covered
covered elsewhere
elsewhere
20
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I.il'c Cvcli' Sliiyi'
C':ili'«iorv
SuhcsHi'«orv
Ui'fi'ri'iiei's
Toys, playground, and
sporting equipment
Toys, playground, and
sporting equipment
CPSC (2
Disposal
Disposal
Disposal
Life Cycle Stage Use Definitions
- "Industrial use" means use at a site at which one or more chemicals or mixtures are manufactured (including
imported) or processed.
- "Commercial use" means the use of a chemical or a mixture containing a chemical (including as part of an article)
in a commercial enterprise providing saleable goods or services.
- "Consumer use" means the use of a chemical or a mixture containing a chemical (including as part of an article,
such as furniture or clothing) when sold to or made available to consumers for their use.
The Agency has included information in this draft scope document sourced from the 2012 and 2016 Chemical Data
Reporting (CDR) Rule collections. In instances where representations of fact derived from CDR data included in this
document were claimed as confidential business information (CBI) in the CDR datasets, the Agency reviewed the claims
and secured the necessary declassifications.
2.2.2 Activities Excluded from the Scope of the Risk Evaluation
As explained in the final rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic
Substances Control Act, TSCA Section 6(b)(4)(D) requires EPA to identify the hazards, exposures,
conditions of use, and the PESS the Administrator expects to consider in a risk evaluation, suggesting
that EPA may exclude certain activities that it determines to be conditions of use on a case-by-case
basis (82 FR 33726, 33729; July 20, 2017). As a result, EPA does not plan to include in this scope or in
the risk evaluation the activities described below that the Agency has concluded do not constitute
conditions of use.
EPA recognizes that the Food and Drug Administration lists dicyclohexyl phthalate as an optional
substance to be used in food packaging materials such as: adhesives as components of articles intended
for use, in accordance with prescribed conditions, in packaging, transporting, or holding food (21 CFR §
175.105); the base sheet and coating of cellophane (21 CFR § 177.1200); plasticizers in polymeric
substances (21 CFR § 178.3740); paper and paperboard components intended to contact dry food (21
CFR § 176.180) or aqueous and fatty foods (21 CFR § 176.170). 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, the consumer uses are excluded from the definition of "chemical
substance" in TSCA § 3(2)(B)(vi) and are not included in Table 2-2. However, manufacturing,
processing, and industrial uses of these products are covered by TSCA and will be considered a
condition of use.
Additionally, according to the U.S. Consumer Product Safety Commission dicyclohexyl phthalate could
be used in hearing protection aids, but this activity and releases are not considered a TSCA condition of
use and will not be evaluated during the risk evaluation (CPSC 2015). Medical devices are covered by
the FFDCA, 21 U.S.C. § 321 and are therefore outside the scope of the definition of chemical substance4
as regulated by TSCA.
4 Chemical 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
21
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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 dicyclohexyl phthalate in 2015 was between 500 thousand and 1 million pounds (U.S. EPA
2017). EPA also uses pre-2015 CDR production volume information, as detailed in the Proposed
Desisnation of Dicyclohexyl Phthalate fCASRN 's a Hish-Priority Substance for Risk
Evaluation (U.S. EPA 2019a) and will include future production volume information as it becomes
reasonably available to support the exposure assessment.
2.2.4 Overview of Conditions of Use and Lifecycle Diagram
The life cycle diagram provided in Figure 2-7 depicts the conditions of use that are considered within
the scope of the risk evaluation for the various life cycle stages as presented in Section 2.2.1. The
activities that EPA determined are out of scope are not included in the life cycle diagram. Appendix E
contains more detailed descriptions (e.g., process descriptions, worker activities, process flow diagrams)
for each manufacture, processing, distribution in commerce, use and disposal category.
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). The production volume of dicyclohexyl phthalate in 2015 is included in
the lifecycle diagram, as reported to EPA during the 2016 CDR reporting period and described here as a
range between 500 thousand and 1 million pounds (U.S. EPA 2017) to protect production volume claims
that were claimed as CBI.
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.
22
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MFG/IMPORT
Manufacture
(Including Imported)
(500K-1M lbs)
PROCESSING
Processing as Reactant
(Processing aids, not otherwise listed in:
Miscellaneous manufacturing;
Process regulators in: Plastic material and resin
manufacturing; Plastics product manufacturing; Paint
and coating manufacturing; Rubber product
manufacturing: )
Incorporation into Formulation, Mixture, or
Reaction Product
(Additive in: Laboratory chemicals
Process regulator in: Adhesive manufacturing
Adhesive and sealant chemical in adhesive
manufacturing
Fillers for: Rubber product manufacturing;
Plasticizer in: Plastics product manufacturing;
Printing ink manufacturing; Paints and coatings
manufacturing: Rubber product manufacturing;
Adhesive manufacturing
Paint additives and coating additives not described by
other codes: Printing ink manufacturing
Processing aids not otherwise listed in: Services; Paint
and coating manufacturing; Asphalt paving, roofing,
and coating materials manufacturing; Adhesive
manufacturing)
Incorporation into Article
(Plasticizers for: Plastics product manufacturing;
Paper product manufacturing)
Repackaging
J
-K>
INDUSTRIAL, COMMERCIAL, CONSUMER USES RELEASES AND WASTE DISPOSAL
't
Adhcsivcs and sealants 1.2
Arts, crafts, and hobby materials 2
Building/construction materials not covered elsewhere 1
Fabric,textile,and leather products not covered elsewhere 2
Inks, toner, and colorant products t
Paints and coatings 1
Plastic and rubber products not covered elsewhere 1.2
Miscellaneous uses
e.g.. Laboratory chemicals; Paper products; Toys, playground, and
sporting equipment;...
v—~
Recycling
Disposal
See Conceptual Model for
Environmental Releases and
Wastes
Manufacture
(including import)
Uses
1. Industrial and/or Commercial
2. Consumer
Figure 2-7. Dicyclohexyl Phthalate Life Cycle Diagram
Volume is not depicted in the life cycle diagram for processing and industrial, commercial, and consumer uses as specific production volume is claimed as CBI and
withheld pursuant to TSCA Section § 14.
23
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2.3 Exposures
For TSCA exposure assessments, EPA plans to analyze exposures and releases to the environment
resulting from the conditions of use within the scope of the risk evaluation for dicyclohexyl phthalate.
Release pathways and routes will be described 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 dicyclohexyl phthalate.
2.3.1 Physical and Chemical Properties
Consideration of p-chem 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. EPA plans to use the physical and chemical properties described
in the Promised Designation of Dicyclohexyl Phthalate (CASRN 84-61-7) as a High-Priority Substance
for Risk Evaluation (U.S. EPA 2019a) to support the development of the risk evaluation for
dicyclohexyl phthalate. The values for the physical and chemical properties (Appendix B) may be
updated as EPA collects additional information through systematic review methods.
2.3.2 Environmental Fate and Transport
Understanding of environmental fate and transport processes assists in the determination of the specific
exposure pathways and potential human and environmental receptors that need to be assessed in the risk
evaluation for dicyclohexyl phthalate. EPA plans to use the environmental fate characteristics described
in the Proposed Designation of Dicyclohexyl Phthalate (CASRN 84-61-7) as a High-Priority Substance
for Risk Evaluation (U.S. EPA 2019a) to support the development of the risk evaluation for
dicyclohexyl phthalate. The values for the environmental fate properties (Appendix C) may be updated
as EPA collects additional information through systematic review methods.
2.3.3 Releases to the Environment
Releases to the environment from conditions of use (e.g., manufacturing, industrial and commercial
processes, commercial or consumer uses) are a component of potential exposure and may be derived
from reported data that are obtained through direct measurement, calculations based on empirical data or
assumptions and models.
Dicyclohexyl phthalate is not reported to the Toxics Release Inventory (TRI). There may be releases of
dicyclohexyl phthalate from industrial sites to wastewater treatment plants (WWTP), surface water, air
and landfill. Articles that contain dicyclohexyl phthalate may release dicyclohexyl phthalate to the
environment during use or through recycling and disposal. EPA plans to review these data in conducting
the exposure assessment component of the risk evaluation for dicyclohexyl phthalate.
2.3.4 Environmental Exposures
The manufacturing, processing, distribution, use and disposal of dicyclohexyl phthalate can result in
releases to the environment and exposure to aquatic and terrestrial receptors (biota). Environmental
exposures are informed by releases into the environment, overall persistence, degradation, and
bioaccumulation within the environment, and partitioning across different media. Concentrations of
chemical substances in biota provide evidence of exposure. EPA plans to review reasonably available
information on environmental exposures in biota to inform the development of the environmental
exposure assessment for dicyclohexyl phthalate.
Relevant and reliable monitoring studies provide information that can be used in an exposure
assessment. Monitoring studies that measure environmental concentrations or concentrations of
24
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chemical substances in biota provide evidence of exposure. Based on fate properties, such as vapor
pressure and water solubility, EPA anticipates possible presence of dicyclohexyl phthalate in water and
soil. EPA plans to review reasonably available environmental monitoring data found in the literature for
dicyclohexyl phthalate found in surface water, sediment and soil. EPA also plans to review reasonably
available monitoring data found in the literature on the presence of dicyclohexyl phthalate in biota.
2.3.5 Occupational Exposures
EPA plans to analyze worker activities where there is a potential for exposure under the various
conditions of use described in Section 2.2.2 In addition, EPA plans to analyze exposure to 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 draft risk evaluation.
Worker activities associated with the conditions of use within the scope of the risk evaluation for
dicyclohexyl phthalate that will be analyzed include, but are not limited to:
• Unloading and transferring dicyclohexyl phthalate to and from storage containers to process
vessels;
• Handling, transporting and disposing of waste containing dicyclohexyl phthalate;
• Cleaning and maintaining equipment;
• Sampling chemicals, formulations or products containing dicyclohexyl phthalate for quality
control;
• Repackaging chemicals, formulations or products containing dicyclohexyl phthalate;
Dicyclohexyl phthalate is a solid at room temperature and has a vapor pressure of 8.69x 10"7 mm Hg at
25 °C (NLM. 2015) 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 in occupational
scenarios where dicyclohexyl phthalate is applied via spray or roll application methods or is handled as a
dry powder or at elevated temperatures. Dicyclohexyl phthalate does not have occupational exposure
limits established by the Occupational Health and Safety Administration (OSHA), the National Institute
for Occupational Safety and Health (NIOSH), or the American Conference of Governmental Industrial
Hygienists (ACGIH).
Based on the conditions of use, EPA plans to analyze worker exposure to liquids and/or solids via the
dermal route. EPA does not plan to analyze dermal exposure for ONUs because they do not directly
handle dicyclohexyl phthalate.
EPA generally does not evaluate occupational exposures through the oral route. Workers may
inadvertently transfer chemicals from their hands to their mouths or ingest inhaled particles that deposit
in the upper respiratory tract. The frequency and significance of this exposure route are dependent on
several factors including the p-chem properties of the substance during expected worker activities,
workers' awareness of the chemical hazards, the visibility of the chemicals on the hands while working,
workplace practices, and personal hygiene that is difficult to predict (Cherrie et al., 2006). However,
EPA will consider oral exposure on a case-by-case basis for certain COUs and worker activities where
there is information and data on incidental ingestion of inhaled dust. EPA will consider ingestion of
inhaled dust as an inhalation exposure for dicyclohexyl phthalate.
25
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2.3.6 Consumer Exposures
CDR reporting, conversations with industry and other sources indicate the presence of dicyclohexyl
phthalate in a number of consumer products and articles including: Adhesives and Sealants; Arts, Crafts,
and Hobby Materials; Fabric, Textile, and Leather Products not Covered Elsewhere; Paper Products;
Plastic and Rubber Products not Covered Elsewhere; and Toys, Playground, and Sporting Equipment
(See Section 2.6.2 and Figure 2-9)(CPSC 2010, CPSC 2015, U.S. EPA 2019b). 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 dicyclohexyl
phthalate is possible through either inhalation of vapor/mist during product usage or indoor air/dust.
Oral exposure of dicyclohexyl phthalate is possible through either ingestion through product use via
transfer from hand to mouth or via through mouthing of articles containing dicyclohexyl phthalate.
Dermal exposure may occur via contact with vapor or mist deposition onto the skin, via direct liquid
contact during use, or direct dermal contact of articles containing dicyclohexyl phthalate. Based on these
potential sources and pathways of exposure, EPA plans to analyze oral, dermal and inhalation exposures
to consumers and inhalation exposures to bystanders that may result from the conditions of use of
dicyclohexyl phthalate.
2.3.7 General Population Exposures
Releases of dicyclohexyl phthalate from certain conditions of use, such as manufacturing, processing, or
disposal activities, may result in general population exposures. General population may be exposed
mainly via dermal contact and inhalation from air releases (CPSC. 2010). EPA plans to review the
reasonably available information for the presence of dicyclohexyl phthalate in environmental media
relevant to general population exposure
A review of the reasonably available literature and databases suggests that human biomonitoring data
exist, including a CPSC (2010) study which showed that in the United States, the 2001-2002 National
Health and Nutrition Examination Survey (NHANES) measured metabolites of dicyclohexyl phthalate
in urine at concentrations ranging from below the level of detection (50th percentile) up to 0.400 [j,g/L
creatinine (90th percentile).
The presence in environmental media and biomonitoring data suggest that general population exposures
are occuring. EPA plans to review reasonably available data related to general population exposures in
the risk evaluation.
26
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2.4 Hazards (Effects)
2.4.1 Environmental Hazards
As described in the Promised Designation of Dicyclohexyl Phthalate (CASRN 84-61-7) as a High-
Priority Substance for Risk Evaluation (U.S. EPA 2019a), EPA considered reasonably available
information from peer-reviewed assessments and databases to identify potential environmental hazards
for dicyclohexyl phthalate. EPA did not identify environmental hazard information for dicyclohexyl
phthalate during the prioritization process (U.S. EPA 2019a). However, EPA is in the process of
identifying additional reasonably available information through systematic review methods and public
comments that may inform potential environmental hazards associated with dicyclohexyl phthalate
exposure.
2.4.2 Human Health Hazards
As described in the Proposed Designation of dicyclohexyl phthalate (CASRN 84-61-7) as a High-
Priority Substance for Risk Evaluation (U.S. EPA 2019a), EPA considered reasonably available
information from peer-reviewed assessments and databases to identify potential human health hazards
for dicyclohexyl phthalate. EPA plans to evaluate all of the potential human health hazards for
dicyclohexyl phthalate identified during prioritization. The health effect categories identified during
prioritization included acute toxicity, repeated dose toxicity, irritation/corrosion, dermal sensitization,
respiratory sensitization, genetic toxicity, reproductive toxicity, developmental toxicity, immunotoxicity,
neurotoxicity, carcinogenicity, epidemiological or biomonitoring studies and ADME.
EPA is in the process of identifying additional reasonably available information through systematic
review methods and public input, which may update the list of potential human health hazards under the
scope of the risk evaluation. If necessary, EPA plans to update the list of potential hazards in the final
scope document of the dicyclohexyl phthalate 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 for 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 ( 01 la).
During the Prioritization process, 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 and consumers (U.S. EPA 2019a). EPA plans to evaluate these PESS in the
risk evaluation.
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) 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. 2006). Likewise, EPA plans to evaluate reasonably available human
27
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health hazard information to ascertain whether some human receptor groups may have greater
susceptibility than the general population to the chemical's hazard(s).
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 dicyclohexyl phthalate. Pathways
and routes of exposure associated with workers and ONUs 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 are discussed and depicted the conceptual
model shown in Section 2.6.3.
2.6.1 Conceptual Model for Industrial and Commercial Activities and Uses
Figure 2-8 illustrates the conceptual model for the pathways of exposure from industrial and commercial
activities and uses of dicyclohexyl phthalate that EPA plans to include in the risk evaluation. There is
potential for exposures to workers and/or ONUs via inhalation routes and exposures to workers via
dermal routes. 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 2.2.1, an initial determination was made as to whether
or not each combination of exposure pathway, route, and receptor will be analyzed in the risk
evaluation. The results of that analysis along with the supporting rationale are presented in Appendix F.
28
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INDUSTRIAL AND COMMERCIAL EXPOSURE PATHWAY EXPOSURE ROUTE RECEPTORS HAZARDS
ACTIVITIES / USES
Dermal
Liquid/Solid Contact
Workers
Processing
uitl. rks'te
and ot chiomc exposures
-As a reactaot
-Inc u u i "»tmi 'ato foraiulafioii. mixture* or
reaction product
-In, oi,kh into article
Rep) ku.iu
Adhesive* and sealants
Building/construction materials Hal
covered elsewhere
Fugitive Emissions
Fabric, textile, and leather products
Dot covered elsewhere
PsinK and coatings
Plastic and rubber products not
covered elsewhere
Miseelhuieous uses
Recycling
Figure 2-8. Dicyclohexyl 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
dicyclohexyl phthalate.
29
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2.6.2 Conceptual Model for Consumer Activities and Uses
The conceptual model in Figure 2-9 presents the exposure pathways, exposure routes and hazards to
human receptors from consumer activities and uses of dicyclohexyl phthalate. EPA expects that
consumers may be exposed through use of products or articles containing dicyclohexyl phthalate via
oral, dermal, and inhalation routes. During use of articles, EPA expects that consumers may also be
exposed via direct dermal contact or mouthing. Bystanders would be exposed via inhalation during
product use. While inhalation exposures are possible, dicyclohexyl phthalate has a low vapor pressure
of 8.69 x 10"7mm Hg at 25 °C (77 °F) and inhalation exposure would be expected to be negligible
when vapors are generated from liquids with vapor pressures below 0.001 mm Hg at ambient room
temperature conditions. However, identified conditions of use for dicyclohexyl phthalate including
adhesives and sealants, paint additives and coating additives may generate mists depending on their
application method. 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 dicyclohexyl phthalate are included in Appendix G.
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CONSUMER ACTIVITIES &
USES
EXPOSURE
PATHWAY
EX POM R!
ROi U
RECEPTORS
HAZARDS
ARTICLES
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Figure 2-9. Dicyclohexyl Phthalate Conceptual Model for Consumer Activities and Uses: Consumer Exposures and Hazards
The conceptual model presents the exposure pathways, exposure routes, and hazards to human receptors from consumer activities and uses of dicylcohexyl phthalate.
31
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2.6.3 Conceptual Model for Environmental Releases and Wastes: Potential Exposures
and Hazards
Figure 2-10 presents the potential exposure pathways, exposure routes and hazards to human and
environmental receptors from releases and waste streams associated with industrial, commercial and
consumer uses of dicyclohexyl phthalate. EPA plans to evaluate exposures to receptors (e.g., general
population, aquatic, terrestrial species) that may occur from industrial and/or commercial and consumer
releases to air, water or land, including biosolids and soil, and other conditions of use. EPA expects
humans to be exposed to dicyclohexyl phthalate from air emissions via inhalation as well as from water,
liquid, and solid waste releases; orally via drinking water, fish and soil ingestion; and dermally from
contact with groundwater and soil. The supporting rationale for general population and environmental
pathways considered for dicyclohexyl phthalate are included in Appendix H.
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RELEASES AND WASTES FROM INDUSTRIAL /
COMMERCWl. / CONSISMF.il I tfRS
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Figure 2-10. Dicyclohexyl Phthalate Conceptual Model for Environmental Releases and Wastes: Environmental and General
Population 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 dicyclohexyl phthalate that EPA plans to consider in the risk evaluation. Notes:
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
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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2.7 Analysis Plan
The analysis plan is based on EPA's knowledge of dicyclohexyl phthalate to date which includes a
partial, but not complete, review of reasonably available information as described in Section 2.1. EPA
encourages submission of additional data, such as full study reports or workplace monitoring from
industry sources, that may be relevant for EPA's evaluation of conditions of use, exposures, hazards,
and PESS during risk evaluation. Further, EPA may consider any relevant CBI in a manner that protects
the confidentiality of the information from public disclosure. EPA plans to continue to consider new
information submitted by the public. Should additional data or approaches become reasonably available,
EPA may update its analysis plan in the final scope document.
2.7.1 Physical and Chemical Properties and Environmental Fate
EPA plans to analyze the physical and chemical (p-chem) properties and environmental fate and
transport of dicyclohexyl phthalate as follows:
1) Review reasonably available measured or estimated p-chem and environmental fate
endpoint data collected using systematic review procedures and, where reasonably
available, environmental assessments conducted by other regulatory agencies.
EPA plans to review data and information collected through the systematic review process and
public comments about the p-chem properties (Appendix B) and fate endpoints (Appendix C),
some of which appeared in the Proposed Designation of Dicyclohexyl Phthalate (CASRN 84-61-
7) as a High-Priority Substance for Risk Evaluation (U.S. EPA 2019a). All sources cited in
EPA's analysis will be evaluated according to the procedures described in the systematic review
documentation that EPA plans to publish prior to finalizing the scope document. Where the
systematic review process fails to identify experimentally measured chemical property values of
sufficiently high quality, these 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 p-chem 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 p-chem properties and environmental
fate endpoints will be used to characterize the persistence and movement of dicyclohexyl
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.
3) Conduct a weight of the scientific evidence evaluation of p-chem and environmental fate
data, including qualitative and quantitative sources of information.
During risk evaluation, EPA plans to evaluate and integrate the p-chem and environmental fate
evidence identified in the literature inventory using the methods described in the systematic
review documentation that EPA plans to publish prior to finalizing the scope document.
2.7.2 Exposure
EPA plans to analyze indoor dust, indoor air, ambient air, surface water, sediment, soil, fish ingestion,
aquatic biota, and terrestrial biota associated with exposure to dicyclohexyl phthalate. EPA has not yet
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determined the exposure levels in these media or how they may be used in the risk evaluation. Exposure
scenarios are combinations of sources (uses), exposure pathways, and exposed receptors. Draft
release/exposure scenarios corresponding to various conditions of use for dicyclohexyl phthalate are
presented in Appendix F, Appendix G, and Appendix H. EPA plans to analyze scenario-specific
exposures.
Based on their p-chem properties, expected sources, and transport and transformation within the outdoor
and indoor environment, chemical substances are more likely to be present in some media and less likely
to be present in others. Exposure level(s) can be characterized through a combination of reasonably
available monitoring data and modeling approaches.
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
continue to review data sources during risk evaluation using the evaluation strategy in the
systematic review documentation that EPA plans to publish prior to finalizing the scope
document. Potential sources of environmental release data are summarized in Table 2-3 below:
Table 2-3. Categories and Sources of Environmental Release Data
U.S. EPA Generic Scenarios
OECD Emission Scenario Documents
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 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 address data gaps identified as
described in steps 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
the Chemical Screening Tool for Occupational Exposures and Releases Ch em STEER (U.S. EPA.
2013).
3) Review reasonably available measured or estimated release data for surrogate chemicals
that have similar uses and physical properties.
If surrogate data are identified, these data will be matched with applicable conditions of use for
potentially filling data gaps. Measured or estimated release data for other phthalate esters may be
considered as surrogates for dicyclohexyl phthalate.
4) Review reasonably available data that may be used in developing, adapting or applying
exposure 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
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conditions of use (and corresponding release scenarios). EPA has identified information from
various EPA statutes (including, for example, regulatory limits, reporting thresholds or disposal
requirements) that may be relevant to release estimation. EPA plans to further 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 2009 ESP
on Adhesive Formulation, the _ ;SD on Coating Application via Spray-Painting in the
Automotive Refinishing Industry, the 2011 ESP on Radiation Curable Coating. Inks and
Adhesives. the \ SP on. the Use of Adhesives. and the 2009 ESP on. Plastic Additives may
be useful to assess potential releases. EPA plans to critically review these generic scenarios and
ESDs 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/chemsteer-chemical-screening-tool-exposures-and-environmental-
releases#genericscenarios
OECD Emission Scenario Documents are available at the following:
http://www.oecd.org/chemicalsafetv/risk-assessment/emissionscenariodocuments.htm
EPA may also need to perform targeted research for applicable models and associated
parameters that EPA may use to estimate releases for certain conditions of use. If ESDs and GSs
are not reasonably available, other methods may be considered. Additionally, for conditions of
use where no measured data on releases are reasonably 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 may further refine the mapping of release scenarios based on
factors (e.g., process equipment and handling, magnitude of production volume used, and release
sources and usage rates of dicyclohexyl phthalate and polymer products and formulations
containing dicyclohexyl phthalate, or professional judgment) corresponding to conditions of use
as additional information is identified during risk evaluation.
7) Evaluate the weight of the scientific evidence of environmental release data.
During risk evaluation, EPA plans to evaluate and integrate the exposure evidence identified in
the literature inventory using the methods described in the systematic review documentation that
EPA plans to publish prior to finalizing the scope document. The data integration strategy will be
designed to be fit-for-purpose in which EPA plans to use 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.
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2.7.2.2 Environmental Exposures
EPA plans to analyze the following in developing its environmental exposure assessment of
dicyclohexyl phthalate:
1) Review reasonably available environmental and biological monitoring data for all media
relevant to environmental exposure.
For dicyclohexyl phthalate, environmental media which will be analyzed are sediment, soil, air,
drinking water, 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.
Reasonably available environmental exposure models that meet the TSCA Science Standards
and that estimate surface water, sediment, and soil concentrations will be analyzed and
considered alongside reasonably available surface water, groundwater, sediment, and soil
monitoring data to characterize environmental exposures. Modeling approaches to estimate air
concentrations, groundwater concentrations, surface water concentrations, sediment
concentrations and soil concentrations generally will include the following inputs: direct release
into air, groundwater, surface water, sediment, or soil, indirect release into air, groundwater,
surface water, sediment, or soil (i.e., air deposition or volatilization), 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 dicyclohexyl phthalate in the environment or biota with
specific sources or groups of sources will be evaluated.
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
dicyclohexyl phthalate, the following are noteworthy considerations in constructing exposure
scenarios for environmental receptors:
Estimates of air concentrations, groundwater concentrations, surface water concentrations,
sediment concentrations and soil concentrations near industrial point sources based on
reasonably available monitoring data.
Modeling inputs for 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 and terrestrial populations.
Weight of the scientific evidence of environmental occurrence data and modeled
estimates.
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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 systematic review methods.
2,7.2,3 Occupational Exposures
EPA plans to analyze both worker and ONU exposures as follows:
1) Review reasonably available exposure monitoring data for specific condition(s) of use.
EPA plans to review reasonably available dicyclohexyl phthalate exposure monitoring data for
specific conditions of use. Example exposure data include workplace monitoring data collected
by government agencies such as OSHA and NIOSH, and monitoring data found in published
literature. The data may include personal exposure monitoring measurements and area
monitoring measurements.
EPA has preliminarily reviewed reasonably available monitoring data collected by NIOSH
(identified in Table 2-4) and will match these data to applicable conditions of use.
Table 2-4. Potential Sources of Occupational Exposure Data
U.S. NIOSH Health Hazard Evaluation (HHE) Program reports
2) Review reasonably available exposure data for surrogate chemicals that have uses,
volatility and chemical and physical properties similar to dicyclohexyl 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 dicyclohexyl phthalate may serve as surrogates for
dicyclohexyl 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.
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 and the 2009 ESP on
Plastic Additives are some of the ESDs and GSs that EPA may use to estimate occupational
exposures. EPA plans to critically review these ESDs and GSs to determine their applicability to
the conditions of use assessed. EPA plans to perform additional targeted research to understand
those conditions of use where ESDs or GSs were not identified, which may inform the exposure
scenarios. EPA may also need to perform targeted research 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 Steps #2 and #3 are completed. Based on information
developed from Steps #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/OPPT, 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.
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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 ONUs.
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. EPA plans to
assess worker exposure pre- and post-implementation of EC, using reasonably available
information on 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 the fourth column in Table Apx F-l, EPA has grouped
the scenarios into representative release/exposure scenarios. EPA was not able to identify
occupational scenarios corresponding to some conditions of use. EPA plans to perform targeted
research to understand those uses which may inform identification of occupational exposure
scenarios. EPA may further refine the mapping/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 during risk evaluation.
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 systematic review documentation that
EPA plans to publish prior to finalizing the scope document. EPA plans to rely on the weight of
the scientific evidence when evaluating and integrating occupational data. The data integration
strategy will be designed to be fit-for-purpose in which EPA plans to use 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 dicyclohexyl phthalate, the following are noteworthy considerations in constructing
consumer exposure scenarios:
Conditions of use and type of consumer product
Duration, frequency and magnitude of exposure
Weight fraction of chemical in products
Amount of chemical used
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2) Evaluate the relative potential of indoor exposure pathways based on reasonably available
data.
Indoor exposures may include dust ingestion, mouthing of products, inhalation of indoor air, and
dermal contact with dust and articles. The data sources associated with these respective pathways
have not been comprehensively evaluated, so quantitative comparisons across exposure
pathways or in relation to toxicity thresholds are not yet reasonably available.
3) Review existing indoor exposure models that may be applicable in estimating indoor air
concentrations.
Indoor exposure models that estimate emissions from consumer products are available. These
models generally consider p-chem 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.
Indoor exposure models that estimate emission and migration of SVOCs into the indoor
environment are available. These models generally consider 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 p-chem properties and properties of the
material. The OPPT's Indoor Environmental Concentrations in Buildings with Conditioned and
Unconditioned Zones (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 dicyclohexyl 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 dicyclohexyl 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
dicyclohexyl phthalate in specific media (e.g., indoor air).
The availability of dicyclohexyl phthalate concentration for various ongoing uses will be
evaluated. This data provides the source term for any subsequent indoor modeling. Source
attribution between overall indoor air 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 further refined.
During risk evaluation, EPA plans to evaluate and integrate the exposure evidence identified in
the literature inventory using the methods described in the systematic review documentation that
EPA plans to publish prior to finalizing the scope document.
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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. The data integration strategy will be designed to be fit-for-
purpose in which EPA plans to use 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 plans to analyze general population exposures as follows:
1) Refine and finalize exposure scenarios for general population by considering combinations
of sources and uses, exposure pathways including routes, and exposed populations.
For dicyclohexyl phthalate, the following are noteworthy considerations in constructing exposure
scenarios for the general population:
Review reasonably available environmental and biological monitoring data for media to
which general population exposures are expected.
For exposure pathways where data are not reasonably available, review existing exposure
models that may be applicable in estimating exposure levels.
Consider and incorporate applicable media-specific regulations into exposure scenarios
or modeling
Review reasonably available data that may be used in developing, adapting, or applying
exposure models to the particular risk evaluation. For example, existing models
developed for a chemical assessment may be applicable to another chemical assessment if
model parameter data are reasonably available.
Review reasonably available information on releases to determine how modeled
estimates of concentrations near industrial point sources compare with reasonably
available monitoring data.
Review reasonably available population- or subpopulation-specific exposure factors and
activity patterns to determine if PES S need to be further defined.
Evaluate the weight of the scientific evidence of general population exposure data.
Map or group each condition of use to general population exposure assessment
scenario(s).
Environmental exposure pathways regulated by non-TSCA EPA laws and regulations
will be excluded from analysis.
EPA intends to evaluate a variety of data types to determine which types are most appropriate
when quantifying exposure scenarios. Environmental monitoring data, biomonitoring data,
modeled estimates, experimental data, epidemiological data, and survey-based data can all be
used to quantify exposure scenarios. In an effort to associate exposure estimates with sources of
exposure and/or conditions of use, EPA plans to consider source apportionment across exposure
scenarios during risk evaluation. EPA anticipates that there will be a wide range in the relative
exposure potential of the exposure scenarios identified in Appendix G. Source apportionment
characterizes the relative contribution of any of the following: a use/source toward a total media
concentration, a media concentration toward a total exposure route, or an exposure route toward
41
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a total external or internal dose. This consideration may be qualitative, semi-quantitative, or
quantitative, and is dependent upon reasonably available data and approaches. For example, EPA
may consider the co-location of TSCA industrial facilities with reasonably available monitoring
data or modeled estimates. EPA may compare modeled estimates for discrete outdoor and indoor
sources/uses that apply to unique receptor groups.
After refining and finalizing exposure scenarios, EPA plans to quantify concentrations and/or
doses for these scenarios. The number of scenarios will depend on how combinations of uses,
exposure pathways, and receptors are characterized. The number of scenarios is also dependent
upon the reasonably available data and approaches to quantify scenarios. When quantifying
exposure scenarios, EPA plans to use a tiered approach. First-tier analysis is based on data that is
reasonably available without a significant number of additional inputs or assumptions, and may
be qualitative, semi-quantitative, or quantitative. The results of first tier analyses inform whether
scenarios require more refined analysis. Refined analyses will be iterative and require careful
consideration of variability and uncertainty. Should data become reasonably available that
summarily alters the overall conclusion of a scenario through iterative tiering, EPA can refine its
analysis during risk evaluation.
2) For exposure pathways where empirical data are not reasonably available, review existing
exposure models that may be applicable in estimating exposure levels.
For dicyclohexyl phthalate, media where exposure models will be considered for general
population exposure include models that estimate ambient air concentrations, surface water
concentrations, groundwater concentrations, sediment concentrations, soil concentrations, and
uptake from aquatic and terrestrial environments into edible aquatic and terrestrial organisms.
3) Review reasonably available exposure modeled estimates. For example, existing models
developed for a previous dicyclohexyl phthalate chemical assessment may be applicable to
EPA's assessment. In addition, another chemical's assessment may also be applicable if
model parameter data are reasonably available.
To the extent other organizations have already modeled dicyclohexyl phthalate general
population exposure scenario that is relevant to this assessment, EPA plans to evaluate those
modeled estimates. In addition, if modeled estimates for other chemicals with similar p-chem
properties and similar uses are reasonably available, those modeled estimates will also be
evaluated. The underlying parameters and assumptions of the models will also be evaluated.
4) Review reasonably available information on releases to determine how modeled estimates
of concentrations near industrial point sources compare with reasonably available
monitoring data.
The expected releases from industrial facilities are changing over time. Any modeled
concentrations based on recent release estimates will be carefully compared with reasonably
available monitoring data to determine representativeness.
5) Review reasonably available information about population- or subpopulation-specific
exposure factors and activity patterns to determine if PESS need to be further defined (e.g.,
early life and/or puberty as a potential critical window of exposure).
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For dicyclohexyl phthalate, exposure scenarios that involve PESS will consider age-specific
behaviors, activity patterns, and exposure factors unique to those subpopulations. For example,
children will have different intake rates for soil than adults.
6) Evaluate the weight of the scientific evidence of general population exposure estimates
based on different approaches.
During risk evaluation, EPA plans to evaluate and integrate the exposure evidence identified in
the literature inventory using the methods described in the systematic review documentation that
EPA plans to publish prior to finalizing the scope document.
2.7.3 Hazards (Effects)
2.7.3,1 Environmental Hazards
If EPA identifies hazards through the current systematic review methods and public input, EPA plans to
conduct an environmental hazard assessment of dicyclohexyl 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 dicyclohexyl phthalate to aquatic and/or terrestrial
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
dicyclohexyl phthalate to aquatic and/or terrestrial organisms.
Environmental hazard data will be evaluated using the environmental toxicity data quality
criteria outlined in the systematic review documentation that EPA plans to publish prior to
finalizing the scope document. The study evaluation results will be documented in the risk
evaluation phase and data from suitable studies will be extracted and integrated in the risk
evaluation process.
Hazard endpoints (e.g., mortality, growth, immobility, reproduction) will be evaluated, while
considering data availability, relevance, and quality.
2) Derive hazard thresholds for aquatic and/or terrestrial 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 dicyclohexyl phthalate to aquatic and/or
terrestrial 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.
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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 systematic review
documentation that EPA plans to publish prior to finalizing the scope document.
4) Consider the route(s) of exposure, based on reasonably available monitoring and modeling
data and other reasonably available approaches to integrate exposure and hazard
assessments.
EPA plans to consider aquatic (e.g., water and sediment exposures) and terrestrial pathways in
the dicyclohexyl phthalate conceptual model. These organisms may be exposed to dicyclohexyl
phthalate via a number of environmental pathways (e.g., surface water, sediment, soil, diet).
5) Conduct an environmental risk characterization of dicyclohexyl phthalate.
EPA plans to conduct a risk characterization of dicyclohexyl phthalate to identify if there are
risks to the aquatic and/or terrestrial environments from the measured and/or predicted
concentrations of dicyclohexyl phthalate in environmental media (i.e., water, sediment, soil).
Risk quotients (RQs) may be derived by the application of hazard and exposure benchmarks to
characterize environmental risk (U.S. EPA. 1998; Bamthouse et at... 1982).
6) Consider a Persistent, Bioaccumulative, and Toxic (PBT) Assessment of dicyclohexyl
phthalate.
EPA plans to consider the persistence, bioaccumulation, and toxic (PBT) potential of
dicyclohexyl phthalate after reviewing relevant p-chem properties and exposure pathways. EPA
plans to assess the reasonably available studies collected from the systematic review process
relating to bioaccumulation and bioconcentration (e.g., BAF, BCF) of dicyclohexyl phthalate. In
addition, EPA plans to integrate traditional environmental hazard endpoint values (e.g., LCso,
LOEC) and exposure concentrations (e.g., surface water concentrations, tissue concentrations)
for dicyclohexyl phthalate with the fate parameters (e.g., BAF, BCF, BMF, TMF).
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 use systematic review methods to evaluate the epidemiological and toxicological
literature for dicyclohexyl phthalate. EPA plans to publish the systematic review documentation
prior to finalizing the scope document.
Relevant mechanistic evidence will also be considered, if reasonably available, to inform the
interpretation of findings related to potential human health effects and the dose-repose
assessment. 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.
44
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2) 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
systematic review documentation that EPA plans to publish prior to finalizing the scope
document. Hazards identified by studies meeting data quality criteria will be grouped by routes
of exposure relevant to humans (oral, dermal, inhalation) and by cancer and noncancer
endpoints.
Dose-response assessment will be performed in accordance with EPA guidance (U.S. EPA.
2012a. 2}n\{<, i '0. 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) determines how cancer risks can be quantitatively evaluated.
If cancer hazard is determined to be applicable to dicyclohexyl phthalate, EPA plans to evaluate
information on genotoxicity and the mode of action 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. 2005).
3) 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
dicyclohexyl phthalate hazard(s). Susceptibility of particular human receptor groups to
dicyclohexyl 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 dicyclohexyl phthalate exposure. EPA plans to
review the current state of the literature in order to potentially quantify these differences for risk
evaluation purposes.
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.g., adjust 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 EPA's Benchmark Dose
Technical Guidance Document. Where dose-response modeling is not feasible, NOAELs or
LOAELs will be identified. Non-quantitative data will also be evaluated for contribution to
45
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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
1011). and inhalation PODs may be adjusted by exposure duration and chemical
properties in accordance with M).
5) Evaluate the weight of the scientific evidence of human health hazard data.
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 systematic review documentation that EPA plans to publish prior to
finalizing the scope document.
6) Consider the route(s) of exposure (oral, inhalation, dermal), reasonably available route-to-
route extrapolation approaches, reasonably available biomonitoring data and reasonably
available approaches to correlate internal and external exposures to integrate exposure and
hazard assessment.
At this stage of review, EPA believes there will be sufficient data to conduct dose-response
analysis and/or benchmark dose modeling for the oral route of exposure. EPA also plans to
evaluate any potential human health hazards following dermal and inhalation exposure to
dicyclohexyl 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. This may include using route-to-
route extrapolation methods where appropriate and depending on the nature of reasonably
available data.
If insufficient toxicity studies are identified in the literature search to assess risks from dermal
and inhalation exposures, then a route-to-route extrapolation from oral toxicity studies would be
needed to assess systemic risks from dermal or inhalation exposures. Without an adequate PBPK
model, the approaches described in EPA guidance document Risk Assessment Guidance for
Superfund Volume I: Human Health Evaluation Manual (Part E, Supplemental Guidance for
Dermal Risk Assessment) (U.S. EPA, 2004) could be applied to extrapolate from oral to dermal
exposure. These approaches may be able to further inform the relative importance of dermal
exposures compared with other routes of exposure. Similar methodology may also be used for
assessing inhalation exposures
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 EPA's Risk
Characterization Handbook (U.S. EPA. 2000). As defined in 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
makers." 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
46
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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 (TCCR) (U.S. EPA. 2000) and consistent with the
requirements of the Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances
Control Act (82 FR 33726). For instance, in the risk characterization summary, EPA plans to further
carry out the obligations under TSCA Section 26; for example, by identifying and assessing uncertainty
and variability in each step of the risk evaluation, discussing considerations of data quality such as the
reliability, relevance and whether the methods utilized were reasonable and consistent, explaining any
assumptions used, and discussing information generated from independent peer review.
EPA will also be guided by EPA's Information Quality Guidelines ( )02) as it provides
guidance for presenting risk information. Consistent with those guidelines, EPA plans to identify in the
risk characterization the following: (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 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 (see 82 Fed. Reg. 33726,
33744 [July 12, 2017]). 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 dicyclohexyl phthalate will be peer
reviewed.
47
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52
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APPENDICES
Appendix A LIST OF GRAY LITERATURE SOURCES
Table Apx A-l. Gray Literature Sources for Dicyclohexyl Phthalate
Source/Agency
Source Name
Source Type
Source Category
Australian
Government,
Department of Health
NICNAS Assessments
(eco)
International
Resources
Assessment or Related
Document
Australian
Government,
Department of Health
NICNAS Assessments
(human health. Tier I,
11 or 111)
International
Resources
Assessment or Related
Document
CPSC
Chronic Hazard
Advisory Panel
Reports
Other US Agency
Resources
Assessment or Related
Document
CPSC
Technical Reports:
Exposure/Risk
Assessment
Other US Agency
Resources
Assessment or Related
Document
CPSC
Technical Reports:
Toxicity Review
Other US Agency
Resources
Assessment or Related
Document
ECHA
ECHA Documents
International
Resources
Assessment or Related
Document
Env Canada
Canada Substance
Grouping Pages
International
Resources
Assessment or Related
Document
Env Canada
Guidelines, Risk
Management,
Regulations
International
Resources
Assessment or Related
Document
EPA
Office of Air:
National Emissions
Inventory (NEl) -
National Emissions
Inventory (NEl) Data
(2014, 2011, 2008)
US EPA Resources
Database
EPA
Other EPA: Misc
sources
US EPA Resources
General Search
EPA
EPA: AP-42
US EPA Resources
Regulatory Document
or List
53
-------
Source/Agency
Source Name
Source Type
Source Category
EPA
TRI: Envirofacts
Toxics Release
Inventory 2017
Updated Dataset
US EPA Resources
Database
EPA
Chemical Data
Reporting (2012 and
2016 non-CBI CDR
database)
US EPA Resources
Database
EPA
Chemical Data
Reporting (2012 and
2016 CBI CDR
database)
US EPA Resources
Database
EPA
EPA: Generic
Scenario
US EPA Resources
Assessment or Related
Document
EPA
EPA Discharge
Monitoring Report
Data
US EPA Resources
Database
EPA
Office of Water: CFRs
US EPA Resources
Regulatory Document
or List
EPA
Office of Air: CFRs
and Dockets
US EPA Resources
Regulatory Document
or List
KOECT
Kirk-Othmer
Encyclopedia of
Chemical Technology
Journal Article
Other Resource
Encyclopedia
NIOSH
CDC NIOSH - Health
Hazard Evaluations
(HHEs)
Other US Agency
Resources
Assessment or Related
Document
NLM
National Library of
Medicine's Hazardous
Substance Databank
Other US Agency
Resources
Database
NLM
National Library of
Medicine's HazMap
Other US Agency
Resources
Database
OECD
OECD Emission
Scenario Documents
International
Resources
Assessment or Related
Document
54
-------
Source/Agency
Source Name
Source Type
Source Category
OECD
OECD: General Site
International
Resources
General Search
OSHA
U.S. OSHA Chemical
Exposure Health Data
(CEHD) program data
[ERG]
Other US Agency
Resources
Database
55
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Appendix B PHYSICAL AND CHEMICAL PROPERTIES OF
DICYCLOHEXYL PHTHALATE
This appendix provides p-chem information and data found in preliminary data gathering for
dicyclohexyl phthalate. Table Apx B-l summarizes the p-chem property values preliminarily selected
for use in the risk evaluation from among the range of reported values collected as of March 2020. This
table differs from that presented in the Proposed Designation of Dicyclohexyl Phthalate (CASRN S
7) as a Hish-Priority Substance for Risk Evaluation (U.S. EPA 2019a) and may be updated as EPA
collects additional information through systematic review methods. All p-chem property values that
were extracted and evaluated as of March 2020 are presented in the supplemental file Data Extraction
and Data Evaluation Tables for Physical Chemical Property Studies (EPA-HQ-OPPT-2018-0504).
Table Apx B-l. Physical and Chemical Properties of Dicyclohexyl Phthalate
Properly or Kmlpoinl
Value51
Reference
Data Qualify
Kill in«
Molecular formula
C20H26O4
NA
NA
Molecular weight
330.43 g/mol
NA
NA
Physical state
Solid
NLM. 2015
High
Physical properties
White, granular solid;
mildly aromatic odor
NLM. 2015
High
Melting point
66°C
NLM. 2015
High
Boiling point
426.7 - 476.9°C
RSC. 2019
Medium
Density
1.383 g/cm3 at 20°C
NLM. 2015
High
Vapor pressure
8.69><10"7 mm Hg at
25°C
NLM. 2015
High
Vapor density
Not available
Water solubility
4.0 mg/L at 24°C
NLM. 2015
High
Log Octanol/water partition
coefficient (Log Kow)
4.602
RSC. 2019
Medium
Henry's Law constant
7.39><10"7 atmm3/mol at
25°C (Bond method)
U.S. EPA, 2012b
Flash point
207°C
RSC. 2019
Medium
56
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Propcrlv or Kmlpoinl
YsiIik"1
Uc IV mice
Qiiiililv
Killing
Auto flammability
Not available
Viscosity
Solid at 20°C
NLM. 2015
High
Refractive index
1.431
NLM. 2015
High
Dielectric constant
Not available
a Measured unless otherwise noted.
NA = Not applicable
57
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Appendix C ENVIRONMENTAL FATE AND TRANSPORT
PROPERTIES OF DICYCLOHEXYL PHTHALATE
Table Apx C-l provides the environmental fate characteristics that EPA identified and considered in
developing the scope for dicyclohexyl phthalate.
Table Apx C-l. Environmental Fate and Transport Properties of Dicyclohexyl Phthalate
Properly or Knilpoint
Value-1
Reference
Direct Photodegradation
Contains chromophores that absorb at wavelengths >290 nm
and, therefore, may be susceptible to direct photolysis by
sunlight
NLM, 2015
citing Lyman,
1990
Indirect Photodegradation
ti/2 = 0.441 day (based on a 12-hour day with 1.5 x 106
•OH/cm3 and -OH rate constant of 2.43 x 10"11 cm3/molecule-
second; estimated)13
U.S. EPA, 2012b
Hydrolysis
Not expected to undergo hydrolysis due to the lack of
functional groups that hydrolyze under environmental
conditions
NLM.
20 lSciting
Lyman, 1990
Biodegradation (Aerobic)
Water: 68.5%/4 weeks based on BOD and 91%/4 weeks
based on GC (Japanese MITI test at an initial test substance
concentration of 100 ppm with sludge at concentrations of 30
ppm)
NITE, 2019
Sediment: tin =11.1 days calculated in 6 river sediment
samples from Taiwan under aerobic conditions
NLM., 2015
citing Yuan,
2002
Biodegradation
(Anaerobic)
Sediment: tin = 26.4 days calculated in 6 river sediment
samples from Taiwan under anaerobic conditions
NLM. 2015
citing Yuan,
2002
Wastewater Treatment
100% total removal (89% by biodegradation, 11% by sludge
adsorption, and 0% by volatilization to air; estimated)b
U.S. EPA, 2012b
Bioconcentration Factor
1.2-3.2 and 0.5-6.9 (Cyprinus caprio); test substance
concentrations of 0.4 and 0.04 mg/L, respectively
SYKE, 2018
Bioaccumulation Factor
137 (log BAF = 2.1; estimated)13
U.S. EPA, 2012b
Soil Organic
Carbon:Water Partition
Coefficient (Log Koc)
4.2 (estimated)13
U.S. EPA, 2012b
aMeasured unless otherwise noted;
bEPI Suite™ physical property inputs: MP = 66°C, VP = 8.69 x 10"7 mm Hg, WS = 4 mg/L, BioP = 4, BioA
= 1 and BioS = 1, SMILES: 0=C(0C(CCCCl)Cl)c(c(ccc2)C(=0)0C(CCCC3)C3)c2
OH = hydroxyl radical; MITI = Ministry of International Trade and Industry; BOD = biochemical oxygen
demand; BAF = bioaccumulation factor; Koc = organic carbon-water partition coefficient
58
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Appendix D REGULATORY HISTORY
The chemical substance, dicyclohexyl 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 dicyclohexyl phthalate are listed in Table Apx D-3.
D.l Federal Laws and Regulations
Table Apx D-l. Federal Laws and Regulations
Mat ulcs/Uegulal ions
Description of Authority/Regulation
Description of Regulation
EPA Regulations
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.
Dicyclohexyl 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 dicyclohexyl
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,
quantities and uses of chemical substances produced
domestically and imported into the United States.
Dicyclohexyl
phthalate manufacturing
(including importing),
processing and use
information is reported under
the CDR rule (16 FR 50816.
August 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.
Dicyclohexyl 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).
Clean Water Act (CWA)
- Sections 301, 304, 306,
307, and 402
Clean Water Act Section 307(a) established a list of
toxic pollutants or combination of pollutants under
the CWA. The statute specifies a list of families of
toxic pollutants also listed in the Code of Federal
Regulations at 40 CFR 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
As a phthalate ester,
dicyclohexyl phthalate is
designated as a toxic
pollutant under Section
307(a)(1) of the CWA, and as
such is subject to effluent
limitations.
59
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
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.
Other Federal Regulations
Federal Food, Drug, and
Cosmetic Act (FFDCA)
Provides the FDA with authority to oversee the safety
of food, drugs and cosmetics.
Dicyclohexyl phthalate is
listed as an optional
substance to be used in:
adhesives to be used as
components of articles
intended for use, in
accordance with prescribed
conditions, in packaging,
transporting, or holding food
(21 CFR § 175.105); the base
sheet and coating of
cellophane. (21 CFR §
177.1200); plasticizers in
polymeric substances (21
CFR § 178.3740V
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 dicyclohexyl
phthalate at concentrations
greater than 0.1 percent is
banned in toys and child care
articles
( IFR oart 1307)
D.2 State Laws and Regulations
Table Apx D-2. State Laws and Regulations
Stale Actions
Description of Action
Chemicals of High Concern
to Children
Several states have adopted reporting laws for chemicals in children's products
containing dicyclohexyl phthalate, including Maine (38 MRSA Chapter 16-D) and
Washington State (Wash. Admin. Code 173-334-130).
Other
Dicyclohexyl phthalate is listed as a Candidate Chemical under California's Safer
Consumer Products Program established under Health and Safety Code § 25252
and 25253 ("California. Candidate Chemicals List. Accessed April 16. 2019).
California lists dicyclohexyl phthalate as a designated priority chemical for
biomonitoring under criteria established by California SB 1379 (Biomonitoring
California, Priority Chemicals, February 2019).
Oregon lists dicyclohexyl phthalate as a toxic air contaminate (OAR 340-245-8020
Table 2).
60
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D.3 International Laws and Regulations
Table Apx D-3. Regulatory Actions by other Governments, Tribes, and International Agreements
Country/Tribe/
Organization
Requirements and Restrictions
European Union
On June 27, 2018, dicyclohexyl phthalate was listed on the Candidate list as
a Substance of Very High Concern (SVHC) under regulation (EC) No
1907/2006 - REACH (Registration, Evaluation, Authorization and
Restriction of Chemicals because it is toxic for reproduction (Article 57(c)
and has endocrine disrupting properties (Article 57(f) - human health).
Dicyclohexyl phthalate was evaluated under the 2017 Community rolling action
plan (CoRAP) under regulation (European Commission [EC]) No 1907/2006 -
REACH (Registration, Evaluation, Authorization and Restriction of Chemicals)
(European Chemicals Agency (ECHA) database. Accessed April 16, 2019).
Australia
Dicyclohexyl phthalate was assessed under Human Health Tier II of the
Inventory Multi-Tiered Assessment and Prioritization (IMAP) as part of the
C4-6 side chain transitional phthalates. Uses reported include in adhesives
and printing inks (NICNAS, 2016, Human Health Tier IIassessment for
C4-6 side chain transitional phthalates). In addition, dicyclohexyl phthalate
was assessed under Environment Tier II of IMAP as part of the phthalate
esters. In 2015, dicyclohexyl phthalate was also assessed as a Priority
Existing Chemical (Assessment Report No. 40) (National Industrial
Chemicals Notification and Assessment Scheme (NICNAS). Chemical
inventory. Database accessed April 3, 2019).
Japan
Dicyclohexyl phthalate 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.
(National Institute of Technology and Evaluation [NITE] Chemical Risk
Information Platform [CHRIP], Accessed April 16, 2019).
Austria, Denmark, Ireland,
New Zealand, United
Kingdom
Occupational exposure limits for dicyclohexyl phthalate (GESTIS International
limit values for chemical agents (Occupational exposure limits, OELs) database.
Accessed April 18, 2017). Austria, Ireland, New Zealand and the United Kingdom
have an eight-hours limit of 5 mg/m3. Denmark has an eight-hours limit of 3
mg/m3 and a short-term limit of 6 mg/m3.
61
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Appendix E PROCESS, RELEASE AND OCCUPATIONAL
EXPOSURE INFORMATION
This appendix provides information and data found in preliminary data gathering for dicyclohexyl
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)
I I 1 1 Domestic Manufacturing
Dicyclohexyl phthalate is manufactured through the reaction of phthalic anhydride and cyclohexanol in
solvent at elevated temperatures (130 °C) (CPSC 2010). After the reaction, excess alcohol is recovered
and dicyclohexyl phthalate is purified through distillation or activated charcoal.
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. One company reported importing dicyclohexyl
phthalate in the solid form according to 2016 CDR (U.S. EPA 2019b).
E.1.2 Processing and Distribution
E. 1.2.1 Reactant or Intermediate
Processing as a reactant or intermediate is the use of dicyclohexyl phthalate as a feedstock in the
production of another chemical via a chemical reaction in which dicyclohexyl phthalate is consumed to
form the product. One company that reported to 2016 CDR indicated that dicyclohexyl phthalate was
processed as a reactant in the production of paints and coatings, plastic material and resin, plastic
products, rubber products, and miscellaneous products (U.S. EPA 2019b).
Exact operations for the use of dicyclohexyl 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 dicyclohexyl 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 dicyclohexyl phthalate into a chemical formulation, mixture, or reaction product are
dependent on the specific manufacturing process or processes involved. Companies reported to the 2012
and 2016 CDR that dicyclohexyl phthalate is used as a plasticizer in printing inks and plastic products,
as an additive (likely plasticizer) in adhesives, and as a filler in rubber products (U.S. EPA 2019b).
Dicyclohexyl phthalate is also used in paints and coatings, and ink, toner, and colorant products
(Nouryon Chemicals LLC 2019; Meeting, 2019a; Meeting, 2019b). The exact processes used to
62
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formulate products containing dicyclohexyl 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 further investigate processing uses
of dicyclohexyl 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 dicyclohexyl phthalate-containing formulations or reaction
products are dependent on the article. One company reported that dicyclohexyl phthalate is used as a
plasticizer in plastic products (U.S. EPA 2019b). Dicyclohexyl phthalate is also found as a plasticizer in
paper manufacturing (CPSC, 2015). EPA plans to further investigate processing uses of dicyclohexyl
phthalate during risk evaluation.
E. 1.2.4 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, 1,2.5 Recycling
In 2016 CDR, all three facilities reported that dicyclohexyl phthalate was not recycled (U.S. EPA
2019b). Plastic articles containing dicyclohexyl phthalate may be recycled (CPSC 2015). EPA plans to
further investigate the potential for recycling of dicyclohexyl phthalate during risk evaluation.
E.1.3 Uses
E.l .3.1 Adhesives, Sealants, Paints, and Coatings
Dicyclohexyl phthalate is used in a variety of adhesive, sealant, paint, and coating products.
Specifically, dicyclohexyl phthalate is used as an adhesive sealant for body panel assemblies and parts
by automobile manufacturers applications (EPA-HQ-OPPT-2018-0504-0016) and in paints and coatings
(U.S. EPA 2019b). 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 Building/Construction Materials Not Covered Elsewhere
Dicyclohexyl phthalate is a constituent of building and construction materials (U.S. EPA 2019b). EPA
plans to further investigate processing uses of dicyclohexyl phthalate during risk evaluation.
E.l.3.3 Ink, Toner, and Colorant Products
Dicyclohexyl phthalate is used in printing inks (enhances adhesion and water resistance) (CPSC, 2015).
Printing inks are comprised of colorants (e.g., pigments, dyes and toners) dispersed in a formulation to
form a paste, liquid or solid, which can be applied to a substrate surface and dried (U.S. EPA, 2010).
Industrial printing processes can be categorized as lithographic, flexographic, gravure, letterpress, screen
printing or digital printing. Commercial printing may involve lithographic, flexographic, gravure and
letterpress printing - all of which involve the transfer of images from printing plates to a substrate.
Screen printing requires a mesh screen to transfer the ink to a substrate, whereas digital printing allows
63
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for the transfer of a digital image directly onto a substrate. Inkjet printing is the most common form of
digital printing. It involves the application of small drops of ink onto a substrate, with direct contact
between the ink nozzle and the substrate (U.S. EPA, 2010).
E. 1.3.4 Plastic and Rubber Products
As described in Section E.l.2.3, dicyclohexyl phthalate is used to increase the flexibility of plastic and
rubber products, which may be used industrially, commercially, and by consumers. Dicyclohexyl
phthalate is used in plastics used in the building and construction industry, floor and wall coverings
(such as poly(vinyl chloride) [PVC] materials), and other miscellaneous plastic and rubber products
(EPA-HO-QPPT-2018-0504-0016; CPSC, 2015; CPSC, 2010). Dicyclohexyl phthalate is likely
entrained in the products; however, dicyclohexyl 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 further investigate processing uses of dicyclohexyl phthalate during risk
evaluation.
E.I,3,5 Other Uses
Dicyclohexyl phthalate is used in paper products (CPSC, 2015) and as a laboratory chemical (SPEX
CertiPro, 2019). Laboratory procedures are generally done within a fume hood, on a bench with local
exhaust ventilation or under general ventilation.
EPA plans to further investigate these uses of dicyclohexyl phthalate during risk evaluation.
E.1.4 Disposal
Each of the conditions of use of dicyclohexyl phthalate may generate waste streams of the chemical that
are collected and transported to third-party sites for disposal, treatment, or recycling. 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 dicyclohexyl phthalate to surface water are assessed in
each condition of use assessment (point source discharges are exempt as solid wastes under RCRA).
Wastes of dicyclohexyl phthalate that are generated during a condition of use and sent to a third-party
site for treatment, disposal, or recycling may include the following:
• Wastewater: Dicyclohexyl phthalate may be contained in wastewater discharged to POTW or
other, non-public treatment works for treatment. Industrial wastewater containing dicyclohexyl
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 dicyclohexyl phthalate is included in each of the condition of use assessments.
Solid Wastes: 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). Solid wastes may subsequently meet RCRA's definition
of hazardous waste by either being listed as a waste at 40 CFR §§ 261.30 to 261.35 or by
meeting waste-like characteristics as defined at 40 CFR §§ 261.20 to 261.24. Solid wastes that
are hazardous wastes are regulated under the more stringent requirements of Subtitle C of
RCRA, whereas non-hazardous solid wastes are regulated under the less stringent requirements
of Subtitle D of RCRA.
Dicyclohexyl phthalate is not a listed hazardous waste under RCRA.
64
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• Wastes Exempted as Solid Wastes under RCRA: Certain conditions of use of dicyclohexyl
phthalate may generate wastes of dicyclohexyl phthalate that are exempted as solid wastes under
40 CFR § 261.4(a). For example, the generation and legitimate reclamation of hazardous
secondary materials of dicyclohexyl phthalate may be exempt as a solid waste.
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.
Table Apx E-l summarizes NIOSH Health Hazard Evaluations identified during EPA's preliminary
data gathering. Dicyclohexyl phthalate does not have an OSHAIMIS code. As such, OSHA has not
collected monitoring data for this chemical.
Table Apx E-l. Summary of NIOSH HHEs with Monitoring for Dicyclohexyl Phthalate
Year of
Publication
Report Number
Facility Description
1984
HETA 84-239-1586
Meat Cutting and Wrapping
65
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Appendix F SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR INDUSTRIAL
AND COMMERCIAL ACTIVITIES AND USES
Table Apx F-l. Worker anc
Occupational Non-User Exposure <
Conceptual Model Supporting Table
Life ( \ ik'
Shim-
Ri'k'iisi- / I!\|)iisiiiv
Sii'iiiiriii
l'A|>IIMIIY
I!\|)iisuiv
hi U-
Ki-ii-plor /
I'lipuhiliiin
Philis In
l!\;illl;iU-
K;iliiin;ik-
Manufacture
Domestic
Manufacture
Domestic Manufacture
Manufacture and
Packaging
Liquid
Contact
] )ermal
Workers
No
2016 CDR only references manufacture
in solid form. Thus, the potential for
exposures to workers to liquid
dicyclohexyl phthalate does not exist
during manufacturin".
Solid
Contact
Dermal
Workers
Yes
2016 CDR references manufacture in
pellet form and dry powder form. Thus,
the potential for exposures to workers
exists during manufacturing.
Vapor
Inhalation
Workers,
(ONU)
No
Due to dicyclohexyl phthalate's vapor
pressure (VP) (VP = 8.69 x 10-7 mm
Hg) at room temperature, potential for
vapor generation is low.
Mist
Inhalation/
Dermal
Workers,
ONU
No
In the absence of liquid form, mist
generation is not expected during
manufacturing.
Dust
Inhalation/
Dermal
Workers,
ONU
Yes
2016 CDR references manufacture in
pellet form and dry powder form,
which may form dust. Thus, the
potential for exposures to workers
exists during manufacturing.
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.
66
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Life ( \ ik'
Shim-
(;iU-»iir\
Ri'k'iisi- / I".\|)iisiiiv
Sii-n.iriii
l!\|)iisiiiv
I".\|)IISIIIV
Kiuiu-
Ki-ii-plnr /
I'lipilhlliiili
Pl.lllS III
K;ilimi;ik-
2016 CDR only references import in
Liquid
Contact
solid form. Thus, the potential lor
1 )ermal
Workers
No
exposures to workers to liquid
dicyclohexyl phthalate does not exist
during manufacturing.
2016 CDR references import in pellet
Solid
Contact
Dermal
Workers
Yes
form and dry powder form. Thus, the
potential for exposures to workers
exists during manufacturing.
Due to dicyclohexyl phthalate's vapor
Manufacture
Import
Import
Repackaging of
import containers
Vapor
Inhalation
Workers,
(ONU)
No
pressure (VP) (VP = 8.69 x 10-7 mm
Hg) at room temperature, potential for
vapor generation is low.
Mist
Inhalation/
Dermal
Workers,
ONU
No
In the absence of liquid form, mist
generation is not expected during
import.
2016 CDR references import in pellet
Dust
Inhalation/
Dermal
Workers,
ONU
Yes
form and dry powder 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.
Processing aids not
otherwise listed in:
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during manufacturing of other
chemicals, as dicyclohexyl phthalate
may be in liquid formulations.
Processing as a
Reactant
Miscellaneous
manufacturing
Process regulator in:
Processing as a
reactant
Solid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during manufacturing of other
chemicals, as dicyclohexyl phthalate
may be in solid form.
Processing
Plastic material and
resin manufacturing;
Plastic product
manufacturing; Paint
and coating
manufacturing; Rubber
product manufacturing
Vapor
Inhalation
Workers,
(ONU)
Yes
Due to dicyclohexyl phthalate's vapor
pressure (VP) (VP = 8.69 x 10-7 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/
Workers,
No
Mist generation is not expected during
Dermal
ONU
manufacturing of other chemicals.
67
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l.ilV ( >i k-
Shim-
(;iU-»iir\
Ri'k'iisi- / I".\|)iisiiiv
Sii-n.iriii
l!\|)iisiiiv
l>;ilh\\;i\
I".\|)IISIIIV
Kiuiu-
Ki-ii-plnr /
Piipuhiliiin
Plans In
l!\;illl;iU-
K;ilimi;ik-
Dust
Inhalation/
Dermal
Workers,
ONU
Yes
The potential for dust exposures to
workers and ONUs exists during
manufacturing of other chemicals, as
dicyclohexyl 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.
Processing
Incorporated into
formulation, mixture
or reaction product
Laboratory chemicals
Process regulators in:
Adhesive mfg
Adhesive and sealant
chemicals in: Adhesive
mfg
Filler in: Rubber
product mfg
Plasticizer in: Plastics
pdt mfg; Printing ink
mfg; Paints and coating
mfg; Rubber pdt mfg;
Adhesive mfg
Paint additives and
coating additives not
described by other
codes: Print ink mfg
Processing aids not
otherwise listed:
Services; Paint and
coating mfg; Asphalt
paving, roofing, and
coating materials mfg;
Adhesive mfg
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 dicyclohexyl 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 dicyclohexyl phthalate
may be in solid form.
Vapor
Inhalation
Workers,
ONU
Yes
Due to dicyclohexyl phthalate's vapor
pressure (VP) (VP = 8.69 x 10-7 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 dicyclohexyl 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.
Processing
Incorporated into
articles
Plasticizer in: Plastic
product manufacturing
(e.g., cellophane);
Plastics and Rubber
product
manufacturing
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during incorporation into articles,
as dicyclohexyl phthalate may be in
68
-------
l.ilV ( >i k-
(;iU-»iir\
Ri'k'iisi- / I".\|)iisiiiv
Siiiiiiriii
l!\|)iisiiiv
P;i 1 hw :i\
I".\|)IISIIIV
Kiuiu-
Ki-ii-plnr /
Piipuhiliiin
Plans In
l!\;illl;iU-
K;ilimi;ik-
paper manufacturing
(Plastic Converting)
Other article
manufacturing
liquid form.
Solid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during processing (incorporation
into articles), as dicyclohexyl phthalate
may be in solid form, such as for resins.
Vapor
Inhalation
Workers,
ONU
Yes
Due to dicyclohexyl phthalate's vapor
pressure (VP) (VP = 8.69 x 10-7 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
incorporation into article.
Dust
Inhalation/
Dermal
Workers,
ONU
Yes
The potential for exposures to workers
exists during processing (incorporation
into articles), as dicyclohexyl phthalate
may be in solid form, such as for resins.
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.
69
-------
l.ilV- < \ tK-
(;iU-»iir\
Ri'k'iisi- / I".\|)iisiiiv
l!\|)iisiiiv
I".\|)IISIIIV
Ki-ii-plnr /
Plans In
K;ilimi;ik-
Shim-
Siiiiiiriii
l>;ilh\\;i\
Kiuiu-
Piipuhiliiin
l!\;illl;iU-
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during repackaging, as
dicyclohexyl phthalate may be in liquid
form.
Solid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during repackaging, as
dicyclohexyl phthalate may be
incorporated into products in solid
form.
Processing
Repackaging
Repackaging
Repackaging into
large and small
Vapor
Inhalation
Workers,
(ONU)
No
Due to dicyclohexyl phthalate's vapor
pressure (VP) (VP = 8.69 x 10-7 mm
Hg) at room temperature, potential for
vapor generation is low.
containers
Mist
Inhalation/
Workers,
No
Mist generation is not expected during
Dermal
ONU
repackaging.
The potential for dust exposures to
workers and ONUs exists during
Dust
Inhalation/
Dermal
Workers,
ONU
Yes
processing (repackaging), as
dicyclohexyl 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.
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during this use as liquid
formulations may be recycled.
Recycling of
dicyclohexyl
phthalate and
products containing
dicyclohexyl
phthalate
Solid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during this use as solid
formulations may be recycled.
Processing
Recycling
Recycling
Vapor
Inhalation
Workers, o
(ONU)
No
Due to dicyclohexyl phthalate's vapor
pressure (VP) (VP = 8.69 x 10-7 mm
Hg) at room temperature, potential for
vapor generation is low.
Mist
Inhalation/
Dermal
Workers,
ONU
No
Mist generation is not expected as
dicyclohexyl phthalate is not in liquid
form.
Dust
Inhalation/
Dermal
Workers,
ONU
Yes
Dust generation is possible during
recycling of solid wastes.
70
-------
Life ( \ ik'
Shim-
(;iU-»iir\
Ri'k'iisi- / I".\|)iisiiiv
Siiiiiiriii
l!\|)iisiiiv
I".\|)IISIIIV
Kiuiu-
Ki-ii-plnr /
I'lipilhlliiili
Pl.lllS III
K;ilimi;ik-
Liquid/Solid
Contact
I )ermal
ONU
No
Dermal exposure by ONU is not
expected lor this condition of use as
they are not expected to directly handle
the chemical.
Industrial/
Commercial
Use
Adhesives and
sealants; paints and
coatings
Adhesives and
sealants; paints and
coatings
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 dicyclohexyl phthalate used in these
products.
Solid
Contact
Dermal
Workers
No
The potential for exposures to solid
dicyclohexyl phthalate is not expected
during the use of these products
because they are in liquid form.
Vapor
Inhalation
Workers,
(ONU)
No
Due to dicyclohexyl phthalate's vapor
pressure (VP) (VP = 8.69 x 10-7 mm
Hg) at room temperature, potential for
vapor generation is low.
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
dicyclohexyl 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.
71
-------
l.ilV ( >i k-
Shim-
(;iU-»iir\
Ri'k'iisi- / I".\|)iisiiiv
Sii-n.iriii
l'.\|)HSUIV
l>;ilh\\;i\
I".\|)IISIIIV
Kiuiu-
Ki-ii-plnr /
Piipuhiliiin
Plans In
l!\;illl;iU-
K;ilimi;ik-
Industrial/
Commercial
Use
Ink, toner, and
colorant products;
Laboratory
chemicals
Ink, toner, and colorant
products; Laboratory
chemicals
Use of ink, toner,
and colorant
products (e.g.,
printing)
Use in laboratories
Liquid
Contact
Dermal
Workers
Yes
These products are in liquid form;
therefore, exposures to workers exists
for dicyclohexyl phthalate used in these
products.
Solid
Contact
Dermal
Workers
No
The potential for exposures to solid
dicyclohexyl phthalate is not expected
during the use of these products
because they are in liquid form.
Vapor
Inhalation
Workers,
ONU
No
Due to dicyclohexyl phthalate's vapor
pressure (VP) (VP = 8.69 x 10-7 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
No
The potential for exposures to solid
dicyclohexyl 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 as
they are not expected to directly handle
the chemical.
Industrial/
Commercial
Use
Plastic and rubber
products not covered
elsewhere;
building/construction
materials not
covered elsewhere;
fabric, textile, and
leather products;
paper products; food
packaging
Plastic and rubber
products not covered
elsewhere;
building/construction
materials not covered
elsewhere; fabric,
textile, and leather
products; paper
products; food
packaging
Use of articles made
using dicyclohexyl
phthalate
Liquid
Contact
Dermal
Workers
No
The potential for exposures to liquid
dicyclohexyl phthalate is not expected
during the use of these products
because they are solid articles.
Solid
Contact
Dermal
Workers
Yes
These products are solid articles in
which dicyclohexyl phthalate is
entrained; therefore, dicyclohexyl
phthalate exposures to workers is
unlikely but may occur if cutting
/sawing / other machining operations
occur.
Vapor
Inhalation
Workers,
(ONU)
No
Due to dicyclohexyl phthalate's vapor
pressure (VP) (VP = 8.69 x 10-7 mm
Hg) at room temperature, potential for
vapor generation is low.
Mst
Inhalation/
Dermal
Workers,
ONU
No
Mist generation is not expected as
dicyclohexyl phthalate is not in liquid
form.
72
-------
l.ilV ( >i k-
Shim-
(;iU-»iir\
Kck'iisc / l'\|)iisuiv
Sii-n.iriii
l!\|)iisiiiv
P;i 1 hw :i\
I".\|)IISIIIV
Kiuiu-
Ki-ii-plnr /
Piipuhiliiin
Plans In
l!\;illl;iU-
K;ilimi;ik-
Dust
Inhalation/
Dermal
Workers,
ONU
Yes
These products are solid articles in
which dicyclohexyl phthalate is
entrained; therefore, dicyclohexyl
phthalate exposures to workers 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
dicyclohexyl 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 dicyclohexyl phthalate's vapor
pressure (VP) (VP = 8.69 x 10-7 mm
Hg) at room temperature, potential for
vapor generation is low.
Mist
Inhalation/
Dermal
Workers,
ONU
No
Mist generation is not expected as
dicyclohexyl phthalate is not in liquid
fonn.
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.
73
-------
Appendix G SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR CONSUMER
ACTIVITIES AND USES
Table Apx G-l. Consumer Exposure Conceptual Model Supporting Table
l.ilV (\ck'
S(;i»e
("sili'Sion
Siil)c;iU'iion
Kolciisc from
SOIIIW
|-'.\|)OMIIV
Kniili'
Km'plur
I'liins In
K\;ilu;ilc
Kiiliniiiik-
Consumer
Use
Furnishing,
Cleaning,
Treatment/Care
Products
Fabric, Textile,
and Leather
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
74
-------
l.ilV (\ck'
S(;i»o
("sili'Sion
Siil)c;iU'iion
Kolciisc from
SOIIIW
|-'.\|)OMIIV
Kniili'
Km'plor
I'liins In
K\;ilu;ilc
Kiiliniiiik-
Consumer
Use
Packaging,
Paper, Plastic,
Hobby Products
Paper 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
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
75
-------
l.ilV (\ck'
S(;i»o
("sili'Sion
Siil)c;iU'iion
Kolciisc from
SOIIIW
|-'.\|)OMIIV
Kniili'
Km'plor
I'liins In
K\;ilu;ilc
Kiiliniiiik-
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
Construction,
Paint, Electrical,
Adhesives and
Sealants
(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.
Use
and Metal
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
76
-------
l.ilV (\ck'
S(;i»o
("sili'Sion
Siil)c;iU'iion
Kolciisc from
SOIIIW
|-'.\|)OMIIV
Kniili'
Km'plor
I'liins In
K\;ilu;ilc
Kiiliniiiik-
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
Packaging,
Paper, Plastic,
Hobby Products
Arts, Crafts, 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.
Use
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
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
Consumer
Handling of
Wastewater,
Liquid wastes
and solid wastes
Wastewater,
Liquid wastes
and solid wastes
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.
Disposal and
Waste
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
77
-------
Appendix H SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR
ENVIRONMENTAL RELEASES AND WASTES
Table Apx H-l. General Population and Environmental Exposure Conceptual Model Supporting Table
Life
Cjele
S(;i»e
Csilcfion
Release
r.xposiMY Pillliw ;¦>
/ Media
I'lxposiire
Routes
Reeeplor/
Population
I'lilllS lo
llxaluale"
Ralionale
Near facility
ambient air
Inhalation
General Population
Yes
concentrations
Dicyclohexyl phthalate deposition to nearby
bodies of water and soil are expected
exposure pathways, not covered under other
Emissions
to Air
Emissions
to Air
Indirect deposition
to nearby bodies of
water and soil
catchments
Oral
Dermal
General Population
Yes
TBD
Aquatic and
Terrestrial
Receptors
Yes
EPA regulations, and, therefore in scope.
Direct release into
surface water and
TBD
Aquatic and
Terrestrial
Receptors
Yes
Release of dicyclohexyl phthalate into surface
water and indirect partitioning to sediment
exposure pathways to aquatic and terrestrial
receptors will be analyzed
All
Industrial
pre-
treatment
indirect partitioning
to sediment
Oral
Dermal
General Population
Yes
Release of dicyclohexyl phthalate into surface
water and indirect partitioning to sediment
and bioaccumulation exposure pathways to
the general population will be analyzed.
Wastewater
or Liquid
Wastes
and
Oral
wastewater
treatment,
orPOTW
Drinking Water via
Surface or Ground
Water
Dermal and
Inhalation
(e.g.,
showering)
General Population
Yes
Release of dicyclohexyl phthalate into surface
water and indirect partitioning to drinking
water is an expected exposure pathway.
Biosolids:
application to soil
and/or migration to
groundwater and/or
surface water
Oral (e.g.,
ingestion of
soil)
Inhalation
General Population
Yes
EPA plans to analyze the pathway from
biosolids to the general population and
terrestrial species.
TBD
Terrestrial
receptors
Yes
5 The exposure pathways, exposure routes and hazards EPA plans to evaluate are subject to change in the final scope, in light of comments received on this draft scope
and other reasonably available information. EPA continues to consider whether and how other EPA-administered statutes and any associated regulatory programs address
the presence of dicyclohexyl phthalate in exposure pathways falling under the jurisdiction of these EPA statutes.
78
-------
Life
Cjck'
S(;i»e
( ;iU'ii»n
Kck'sisi*
I'lxposuiv PnlliNin
/ Modiii
l'l\|)OMIIV
Routes
Kcccplor /
INipiiliilioii
I'lilllS lo
Kiilioiiiilo
Disposal
Solid and
Liquid
Wastes
Municipal
landfill and
other land
disposal
Leachate to soil,
ground water and/or
mitigation to surface
water
Oral
Dermal
General Population
Yes
EPA plans to analyze the pathway from
municipal landfills and other land disposal to
the general population, aquatic and terrestrial
receptors.
TBD
Aquatic and
Terrestrial
Receptors
79
------- |