EPA Document# 740-R1-7021
May 2018
United States Office of Chemical Safety and
Environmental Protection Agency Pollution Prevention
Problem Formulation of the Risk Evaluation for
C.I. Pigment Violet 29
(Anthra[2,l,9-def:6,5,10-d'eT]diisoquinoline-
1,3,8,10(2H,9H)-tetr one)
CASRN: 81-33-4
©-"
May 2018
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TABLE OF CONTENTS
ACKNOWLEDGEMENTS 5
ABBREVIATIONS 6
EXECUTIVE SUMMARY 7
1 INTRODUCTION 9
1.1 Regul atory Hi story 10
1.2 Data and Information Collection 11
1.3 Data Screening During Problem Formulation 12
2 PROBLEM FORMULATION 13
2.1 Physical and Chemical Properties 13
2.2 Conditions of Use 15
2.2.1 Data and Information Sources 15
2.2.2 Identification of Conditions of Use 15
2.2.2.1 Categories and Subcategories Determined Not to be Conditions of Use or Otherwise
Excluded During Problem Formulation 15
2.2.2.2 Categories and Subcategories of Conditions of Use in Scope of the Risk Evaluation... 16
2.2.2.3 Overview of Conditions of Use and Lifecycle Diagram 17
2.3 Exposures 21
2.3.1 Fate and Transport 21
2.3.2 Releases to the Environment 22
2.3.3 Presence in the Environment and Biota 23
2.3.4 Environmental Exposures 24
2.3.5 Human Exposures 24
2.3.5.1 Occupational Exposures 24
2.3.5.2 Consumer Exposures 25
2.3.5.3 General Population Exposures 25
2.3.5.4 Potentially Exposed or Susceptible Subpopulations 26
2.4 Hazards (Effects) 26
2.4.1 Environmental Hazards 26
2.4.2 Human Health Hazards 27
2.4.2.1 Non-Cancer Hazards 27
2.4.2.2 Genotoxicity and Cancer Hazards 28
2.4.2.3 Potentially Exposed or Susceptible Subpopulations 29
2.5 Conceptual Models 29
2.5.1 Conceptual Model for Industrial and Commercial Activities and Uses: Potential Exposures
and Hazards 30
2.5.2 Conceptual Model for Environmental Releases and Wastes: Potential Exposures and
Hazards 31
2.5.2.1 Pathways That EPA Plans to Include and Further Analyze in the Risk Evaluation 32
2.5.2.2 Pathways that EPA Plans to Include in the Risk Evaluation but Not Further Analyze.. 32
2.6 Analysis Plan 37
REFERENCES 38
APPENDICES 40
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Appendix A. REGULATORY HISTORY 40
A-l Background Information on the Inclusion of C.I. Pigment Violet 29 in TSCA 2012 and 2014
Work Plans 40
A-2 Federal Laws and Regulations 41
A-3 International Laws and Regulations 42
Appendix B. LIST OF ON-TOPIC REFERENCES EXCLUDED FROM FURTHER
CONSIDERATION 45
Appendix C. PHYSICAL AND CHEMICAL PROPERTIES 48
Appendix D. ENVIRONMENTAL FATE STUDY SUMMARIES 49
Appendix E. ENVIRONMENTAL HAZARD STUDY SUMMARIES 50
E-l Toxicity to Aquatic Organisms 50
E-1 -1 Aquati c PI ant T oxi city 50
E-1 -2 Aquati c Invertebrate Toxi city 52
E-l-3 Fish Toxicity 53
Appendix F. HUMAN HEALTH HAZARD STUDY SUMMARIES 54
F -1 Acute Toxi city Studi e s 54
F-2 Repeated-Dose Toxicity Studies 55
F-3 Reproductive and Developmental Toxicity Studies 55
F-4 Skin Irritation and Sensitization Studies 56
F-5 Genotoxicity and Cancer Studies 57
Appendix G. INCLUSION AND EXCLUSION CRITERIA FOR FULL TEXT SCREENING. 58
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LIST OF TABLES
Table 2-1. Physical and Chemical Properties of C.I. Pigment Violet 29 14
Table 2-2. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation 16
Table 2-3. Production Volume of C.I. Pigment Violet 29 in Chemical Data Reporting (CDR) Reporting
Period (2012 to 2015) 18
Table 2-4. Environmental Fate Characteristics of C.I. Pigment Violet 29 22
LIST OF FIGURES
Figure 2-1. C.I. Pigment Violet 29 Life Cycle Diagram 20
Figure 2-2. C.I. Pigment Violet 29 Conceptual Model for Industrial and Commercial Activities and
Uses: Potential Exposures and Hazards 34
Figure 2-3. C.I. Pigment Violet 29 Conceptual Model for Consumer Activities and Uses: Potential
Exposures and Hazards 35
Figure 2-4. C.I. Pigment Violet 29 Conceptual Model for Environmental Releases and Wastes: Potential
Exposures and Hazards 36
LIST OF APPENDIX TABLES
TableApx A-l: 2014'TSCAWorkPlan.'...'..!..'...'........ 40
TableApx C-l: Physical and Chemical Properties for C.I. Pigment Violet 29 48
Table Apx D-l: Environmental Fate Studies for C.I. Pigment Violet 29 49
Table_Apx E-l: Aquatic Plant Toxicity Study for C.I. Pigment Violet 29 50
Table_Apx E-2: Aquatic Invertebrate Toxicity Study for C.I. Pigment Violet 29 52
Table_Apx E-3: Fish Toxicity Study for C.I. Pigment Violet 29 53
Table_Apx F-l: Acute Toxicity Studies for C.I. Pigment Violet 29 54
Table Apx F-2: Reproductive and Developmental Study for C.I. Pigment Violet 29 55
Table Apx F-3: Skin Irritation and Sensitization Studies for C.I. Pigment Violet 29 56
Table_Apx F-4: Genotoxicity Studies for C.I. Pigment Violet 29 57
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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 and/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. CIO-SP3,
HHSN316201200013W), ERG (Contract No. EP-W-12-006), Versar (Contract No. EP-W-17-006), ICF
(Contract No. EPC14001) and SRC (Contract No. EP-W-12-003).
Docket
Supporting information can be found in public docket: ] Q-OPPT-2016-072.5.
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
°C Degrees Celsius
AICS Australian Inventory for Chemical Substances
atm atmosphere(s)
BAF Bioaccumulation factor
BCF Bioconcentration factor
CASRN Chemical Abstracts Service Registry Number
CBI Confidential Business Information
CDR Chemical Data Reporting
C.I. Colour Index
CCL Contaminant Candidate List
cm3 Cubic centimeters
CPMA Color Pigments Manufacturing Association
CWA Clean Water Act
DSL Domestic Substances List (Canada)
ECHA European Chemicals Agency
EINECS European Inventory of Existing Commercial Chemical Substances
EPA Environmental Protection Agency
ETAD Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturers
EU European Union
FDA Food and Drug Administration
g Grams
g/mole Grams per Unit-Molar Mass
hPa Hectopascal
IECSC Inventory of Existing Chemical Substances Produced or Imported in China
IRIS Integrated Risk Information System
L Liter(s)
K Thousand
lb Pound
Log Koc Logarithmic Soil Organic Carbon:Water Partition Coefficient
Log Kow Logarithmic Octanol:Water Partition Coefficient
m3 Cubic Meter(s)
mg Milligram(s)
NOAEL No Observed Adverse Effect Level
NPDES National Pollutant Discharge Elimination System
NZloC New Zealand Inventory
OECD Organisation for Economic Co-operation and Development
OPPT Office of Pollution Prevention and Toxics
PICCS Philippines Inventory of Chemicals and Chemical Substances
POTW Publicly owned treatment works
PS Polystyrene
PUR Polyurethane
PVC Polyvinyl chloride
RegDet Regulatory Determination
SAN Styrene Acrylonitrile
SAR Structure-activity relationship
SB Styrene Butadiene
SDS Safety Data Sheet
SDWA Safe Drinking Water Act
TSCA Toxic Substances Control Act
U.S. United States
(.im Micrometer
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EXECUTIVE SUMMARY
TSCA § 6(b)(4) requires the U.S. Environmental Protection Agency (EPA) to establish a risk evaluation
process. In performing risk evaluations for existing chemicals, EPA is directed 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." In December of 2016, EPA published a list of 10 chemical substances that are the
subject of the Agency's initial chemical risk evaluations ( 7), as required by TSCA §
6(b)(2)(A). C.I. Pigment Violet 29 was one of these chemicals.
TSCA § 6(b)(4)(D) requires 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. In June 2017, EPA published the Scope of the Risk Evaluation for
C.I. Pigment Violet 29 ( ) As explained in the scope document, because there was
insufficient time for EPA to provide an opportunity for comment on a draft of the scope, as EPA intends
to do for future scope documents, EPA is publishing and taking public comment on a problem
formulation document to refine the current scope, as an additional interim step prior to publication of the
draft risk evaluation for C.I. Pigment Violet 29. Comments received on this problem formulation
document will inform development of the draft risk evaluation.
This problem formulation document refines the conditions of use, exposures and hazards presented in
the scope of the risk evaluation for C.I. Pigment Violet 29 and presents refined conceptual models and
analysis plans that describe how EPA expects to evaluate the risk for C.I. Pigment Violet 29. EPA also
identifies any conditions of use, hazards, or exposure pathways which were included in the scope
document but which EPA does not plan to further analyze in the risk evaluation. EPA expects to be able
to reach conclusions about particular conditions of use, hazards, or exposure pathways without further
analysis and therefore plans to conduct no further analysis on those conditions of use, hazards or
exposure pathways in order to focus the Agency's resources on more extensive or quantitative analyses.
EPA may, on a case-by case basis, exclude certain activities that EPA has determined to be conditions of
use in order to focus its analytical efforts on those exposures that are likely to present the greatest
concern, and consequently merit a risk evaluation. EPA's overall objectives in the risk evaluation
process are to conduct timely, relevant, high-quality, and scientifically credible risk evaluations within
the statutory deadlines, and to evaluate the conditions of use that raise greatest potential for risk. 82 FR
33726, 33728 (July 20, 2017).
C.I. Pigment Violet 29 is an organic pigment found in the following uses: (1) colorant primarily in
paints and coatings, plastics and rubber products, merchant ink for commercial printing; (2) intermediate
to create or adjust the color of other perylene pigments; (3) formulation, mixture, or reaction product;
and (4) consumer watercolor and artistic color. EPA has received public comments specific to the C.I.
Pigment Violet 29 Scope Document (U.S. EPA. ^available in the public docket: EPA-HQ-OPPT-
2016-0725). which have been reviewed and addressed within the relevant text of this document.
Environmental and human health hazard studies characterizing the physical/chemical properties,
environmental fate, human health, and environmental hazards of C.I. Pigment Violet 29 were identified
in the European Chemicals Agency (ECHA) Database (EC. ) and FDA's Food Additive
Petition (FAP) 8B4626 for C.I. Pigment Violet 29 ( 8a). the results of which were consistent
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with the ECHA studies. EPA has reviewed the robust study summaries of physical/chemical properties,
environmental fate, human health hazard and environmental hazard studies in these databases,
(summarized in Appendix C- Appendix F) and obtained the full study reports from the data owners for
in-depth review. In addition, EPA has reviewed the on-topic literature from the Pigment Violet 29 (81-
bliography: Supplemental File for the TSCA. Scope Document (U.S. EPA. 2017a). No on-topic
references were identified in the literature search for environmental fate, exposure (i.e., general
population and consumers), environmental and human health hazards of C.I. Pigment Violet 29 (U.S.
EPA. 2017a). A review of the three engineering/occupational exposure citations identified as on-topic
revealed that these references are not relevant to the risk evaluation of C.I. Pigment Violet 29. Twenty
other on-topic references previously identified were examined and found to be about pigments other
than C.I. Pigment Violet 29 and will be excluded from further consideration. A preliminary review of
these study summaries indicates that C.I. Pigment Violet 29 presents a low hazard to human health and
environmental receptors.
Analysis of manufacturing conditions, uses and engineering controls of C.I. Pigment Violet 29 indicates
that releases from manufacturing, processing, distribution, use and disposal are expected to be limited.
Physical-chemical characteristics (i.e., low vapor pressure, low water solubility, high sorption to organic
matter, high molecular weight, high Log Kow) indicate exposures would be limited if C.I. Pigment Violet
29 is released to the environment.
All potential exposure pathways to workers, consumers, general population and the environmental
receptors resulting from the manufacturing and use of C.I. Pigment violet 29 are included in the risk
evaluation. However, based on limited releases, low potential for environmental and human exposures,
and low toxicity profile for mammals and aquatic species, EPA concludes that further analysis of these
exposure pathways to workers, consumers, general population and environmental receptors is not
warranted for C.I. Pigment Violet 29.
The analysis plan for C.I. Pigment Violet 29 therefore consists of evaluating the study reports received
by the Agency to ensure that the studies are scientifically sound and the results are consistent with
EPA's preliminary review of the robust summaries in the ECHA database and the FDA Food Additive
Petition (FAP) 8B4626 for C.I. Pigment Violet 29 (BASF. 1998a). If the review of these study reports
indicates that the results are not scientifically sound or consistent with the robust summary reports, EPA
may conduct additional analysis in developing the Draft Risk Evaluation for C.I. Pigment Violet 29,
which may include changes to the pathways analyzed.
EPA is soliciting public comment on this problem formulation document for C.I. Pigment Violet 29, as
an additional interim step, prior to publication of the Draft Risk Evaluation. EPA will carefully consider
comments and additional data/information received as it develops the Draft Risk Evaluation. As per
EPA's final rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances
Control Act, EPA will also take comment and peer review the Draft Risk Evaluation for C.I. Pigment
Violet 29.
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1 INTRODUCTION
This document presents for comment the problem formulation of the risk evaluation for C.I. Pigment
Violet 29 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, the
Nation's primary chemicals management law, on June 22, 2016. The new law includes statutory
requirements and deadlines for actions related to conducting risk evaluations of existing chemicals.
In December of 2016, EPA published a list of 10 chemical substances that are the subject of the
Agency's initial chemical risk evaluations ( ), as required by TSCA § 6(b)(2)(A). These 10
chemical substances were drawn from the 2014 update of EPA's TSCA Work Plan for Chemical
Assessments, a list of chemicals that EPA identified in 2012 and updated in 2014 (currently totaling 90
chemicals) for further assessment under TSCA. EPA's designation of the first 10 chemical substances
constituted the initiation of the risk evaluation process for each of these chemical substances, pursuant to
the requirements of TSCA § 6(b)(4). Additional background information and rationale for C.I. Pigment
Violet 29's inclusion list of the first 10 chemicals is provided in Appendix A-l.
TSCA § 6(b)(4)(D) requires 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. The Scope
Documents for all first 10 chemical substances were issued on June 22, 2017. The first 10 problem
formulation documents are a refinement of what was presented in the first 10 scope documents. TSCA §
6(b)(4)(D) does not distinguish between scoping and problem formulation, and requires EPA to issue
scope documents that include information about the chemical substance, including hazards, exposures,
conditions of use, and the potentially exposed or susceptible subpopulations that the Administrator
expects to consider in the risk evaluation. In the future, EPA expects scoping and problem formulation
to be completed prior to the issuance of scope documents and intends to issue scope documents that
include problem formulation.
As explained in the scope document, because there was insufficient time for EPA to provide an
opportunity for comment on a draft of the scope, as EPA intends to do for future scope documents, EPA
is publishing and taking public comment on a problem formulation document to refine the current scope,
as an additional interim step prior to publication of the draft risk evaluation for C.I. Pigment Violet 29.
Comments received on this problem formulation document will inform development of the draft risk
evaluation.
The Agency defines problem formulation as the analytical phase of the risk assessment in which "the
purpose for the assessment is articulated, the problem is defined, and a plan for analyzing and
characterizing risk is determined" (see Section 2.2 of the Framework for Human Health Risk
Assessment to Inform Decision Making) (U.S. EPA. 2014). The outcome of problem formulation is a
conceptual model(s) and an analysis plan. The conceptual model describes the linkages between
stressors and adverse human health effects, including the stressor(s), exposure pathway(s), exposed life
stage(s) and population(s), and endpoint(s) that will be addressed in the risk evaluation (U.S. EPA.
2014). The analysis plan follows the development of the conceptual model(s) and is intended to describe
the approach for conducting the risk evaluation, including its design, methods and key inputs and
intended outputs as described in the EPA Human Health Risk Assessment Framework (U.S. EPA.
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2014). The problem formulation documents refine the initial conceptual models and analysis plans that
were provided in the scope documents.
During problem formulation, EPA identified any conditions of use, hazards, or exposure pathways
which were included in the scope document and that EPA expects to include in the risk evaluation but
which EPA does not expect to further analyze in the risk evaluation. EPA expects to be able to reach
conclusions about particular conditions of use, hazards or exposure pathways without further analysis
and therefore plans to conduct no further analysis on those conditions of use, hazards or exposure
pathways in order to focus the Agency's resources on more extensive or quantitative analyses. Each risk
evaluation will be "fit-for-purpose," meaning not all conditions of use will warrant the same level of
evaluation and the Agency may be able to reach some conclusions without comprehensive or
quantitative risk evaluations. 82 FR 33726, 33734, 33739 (July 20, 2017).
EPA received comments on the published scope document for C.I. Pigment Violet 29 and has
considered the comments specific to C.I. Pigment Violet 29 in this problem formulation document. EPA
is soliciting public comment on this problem formulation document and when the draft risk evaluation is
issued the Agency intends to respond to comments that are submitted. In its draft risk evaluation, EPA
may revise the conclusions and approaches contained in this problem formulations, including the
conditions of use and pathways covered and the conceptual models and analysis plans, based on
comments received.
1.1 Regulatory History
EPA conducted a search of existing domestic and international laws, regulations and assessments
pertaining to C.I. Pigment Violet 29. EPA compiled this summary from data available from federal,
state, international and other government sources, as cited in Appendix A. EPA evaluated and
considered the impact of existing laws and regulations (e.g., regulations on landfill disposal, design, and
operations) in the problem formulation step to determine what, if any further analysis might be
necessary as part of the risk evaluation. Consideration of the nexus between these existing regulations
and TSCA uses may additionally be made as detailed/specific conditions of use and exposure scenarios
are developed in conducting the analysis phase of the risk evaluation. This is discussed in detail in
Section 2.5.2. As part of the problem formulation, background information on the inclusion of C.I.
Pigment Violet 29 in 2012 and 2014 TSCA Work Plans was added to Appendix A-l.
Federal Laws and Regulations
C.I. Pigment Violet 29 is subject to one federal statute or regulation, other than TSCA, that is
implemented by the U.S. Food and Drug Administration. A summary of federal laws, regulations and
implementing authorities, including the U.S. Food and Drug Administration, is provided in Appendix A-
2. In response to comments from the Color Pigments Manufactures Association (CPMA) (EPA.-H.Q-
QPPT-2016-0725-00391 (CP? ), EPA has clarified that C.I. Pigment Violet 29 does not have
any regulatory restrictions under Federal Hazardous Substance Act (FHSA) and Consumer Product
Safety Commission (CPSC) as had been indicated in the scope. Therefore, these regulations were
removed from Appendix A-2.
State Laws and Regulations
C.I. Pigment Violet 29 is not subject to state statutes or regulations implemented by state agencies or
departments.
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Laws and Regulations in Other Countries and International Treaties or Agreements
In response to a comment (EPA-HQ-OPPT-0039) indicating that additional countries have
C.I. Pigment Violet 29 on their chemical inventory list, EPA has added chemical inventories for China,
Korea, New Zealand, the Philippines, Taiwan and Vietnam to Appendix A-3 . C.I. Pigment Violet 29 is
listed on the Canadian Inventory of the 23,000 substances on the Domestic Substances List (DSL) but
the Ecological Risk Classification for C.I. Pigment Violet 29 did not meet the criteria for categorisation
as a prioritized substance for further evaluation. These determinations for C.I. Pigment Violet 29 and
seven other similar pigments were made using a combination of QSAR modeling and hazard data for
analogous pigments with low solubility (Pigment Red 149; CAS RN 4948-15-6). The conclusion of this
screening was consistent with EPA's findings and indicated that because of low toxicity and low
solubility, C.I. Pigment Violet 29 did not meet the criteria for further evaluation and the potential hazard
is low (Environment Canada. 2006).
1.2 Data and Information Collection
EPA/Office of Pollution Prevention and Toxics (OPPT) generally applies a systematic review process
and workflow that includes: (1) data collection; (2) data evaluation; and (3) data integration of the
scientific data used in risk evaluations developed under TSCA. Scientific analysis is often iterative in
nature as new knowledge is obtained. Hence, EPA/OPPT expects that multiple refinements regarding
data collection will occur during the process of risk evaluation. Additional information that may be
considered and was not part of the initial comprehensive bibliographies will be documented in the Draft
Risk Evaluation for C.I. Pigment Violet 29.
Data Collection: Data Search
EPA/OPPT conducted chemical-specific searches for data and information on: physical and chemical
properties; environmental fate and transport; conditions of use information; environmental exposures,
human exposures, including potentially exposed or susceptible subpopulations; environmental hazard,
human health hazard, including potentially exposed or susceptible subpopulations.
EPA/OPPT designed its initial data search to be broad enough to capture a comprehensive set of sources
containing information potentially relevant to the risk evaluation. For most disciplines, the search was
not limited by date and was conducted on a wide range of data sources, including but not limited to:
peer-reviewed literature and gray literature (e.g., publicly-available industry reports, trade association
resources, government reports). When available, EPA/OPPT relied on the search strategies from recent
assessments, such as EPA Integrated Risk Information System (IRIS) assessments and the National
Toxicology Program's (NTP) Report on Carcinogens, to identify relevant references and supplemented
these searches to identify relevant information published after the end date of the previous search to
capture more recent literature. EPA/OPPT also searched for relevant information published after the end
date of the previous search to capture more recent literature. Strategy for Conducting Literature
Searches for Pigment Violet 29: Supplemental File for the TSCA Scope Document provides details about
the data sources and search terms that were used in the initial search 0 \ 1 X Jxi u).
Data Collection: Data Screening
Following the data search, references were screened and categorized using selection criteria outlined in
Strategy for Conducting literature Searches for Pigment Violet 29: Supplemental File for the TSCA
Scope Document 0 S J [\ ; M • )• Titles and abstracts were screened against the criteria as a first step
with the goal of identifying a smaller subset of the relevant data to move into the subsequent data
extraction and data evaluation steps. Prior to full-text review, EPA/OPPT anticipates refinements to the
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search and screening strategies, as informed by an evaluation of the performance of the initial
title/abstract screening and categorization process.
The categorization scheme (or tagging structure) used for data screening varies by scientific discipline
(i.e., physical and chemical properties; environmental fate and transport; chemical use/conditions of use
information; human and environmental exposures, including potentially exposed or susceptible
subpopulations identified by virtue of greater exposure; human health hazard, including potentially
exposed or susceptible subpopulations identified by virtue of greater susceptibility; and environmental
hazard). Within each data set, there are two broad categories or data tags: (1) on-topic references or (2)
off-topic references. On-topic references are those that may contain data and/or information relevant to
the risk evaluation. Off-topic references are those that do not appear to contain data or information
relevant to the risk evaluation. Strategy for Conducting Literature Searches for Pigment Violet 29:
Supplemental File for the TSCA Scope' Document discusses the inclusion and exclusion criteria that
EPA/OPPT used to categorize references as on-topic or off-topic (U.S. EPA. ).
Additional data screening using sub-categories (or sub-tags) was also performed to facilitate further
sorting of data/information - for example, identifying references by source type (e.g., published peer-
reviewed journal article, government report); data type (e.g., primary data, review article); human health
hazard (e.g., liver toxicity, cancer, reproductive toxicity); or chemical-specific and use-specific data or
information. These sub-categories are described in Strategy for Conducting .Literature Searches for
Pigment Violet 29: Supplemental File for the TSCA Scope Document and were used to organize the
different streams of data during the stages of data evaluation and data integration steps of systematic
review.
Results of the initial search and categorization results can be found in the Pigment Violet 29 fCASRN:
81-3. bliographv: Supplemental File for the TSCA. Scope Document (U.S. EPA. 2017a). This
document provides a comprehensive list (bibliography) of the sources of data identified by the initial
search and the initial categorization for on-topic and off-topic references. Because systematic review is
an iterative process, EPA/OPPT expects that some references may move from the on-topic to the off-
topic categories, and vice versa. Moreover, targeted supplemental searches may also be conducted to
address specific needs for the analysis phase (e.g., to locate specific data needed for modeling); hence,
additional on-topic references not initially identified in the initial search may be identified as the
systematic review process proceeds.
1.3 Data Screening During Problem Formulation
The Pigment Violet ography: Supplemented "File for the TSCA Scope
Document did not identify any on-topic literature search results for environmental fate, exposure
(general population and consumers), environmental and human health hazards of C.I. Pigment Violet 29
(U.S. EPA.: ) with the exception of the study summaries in the ECHA Database, three
engineering/occupational exposure literature search results and the two studies from Food Additive
Petition (FAP) 8B4626 (BASF. 1998a): (1) Solubility of C.I. Pigment Violet 29 in ethanol and; (2)
Reverse mutation assay AMES test using Salmonella typhimurium and Escherichia coli. Further review
of the three engineering/occupational exposure citations identified as on-topic revealed that these
references are not relevant to the C.I. Pigment Violet 29 risk evaluation. The full study report for the
solubility of C.I. Pigment Violet 29 in ethanol has been reviewed by EPA and summarized in Section
2.1. The full study report for the Reverse mutation assay AMES test using Salmonella typhimurium and
Escherichia coli has been received by the agency and will be reviewed according to the evaluation
strategy discussed below.
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The Pigment Violet 29 (CASK 'ibliography: Supplemental File for the TSCA Scope
Document also identified twenty other references previously cited in OPPT's documents. Based on a
comment received IYEPA.~H.O~2016-0725-0039) ("CPMA. 2017b)l. EPA conducted a second
title/abstract screening and determined that some of these references were not relevant to C.I. Pigment
Violet 29. As such, these references were excluded from further consideration for C.I. Pigment Violet
29. EPA also identified a number of EPA guidance documents and previous OPPT documents and plans
to consider them during the development of the draft risk evaluation for C.I. Pigment Violet 29.
Appendix B contains a list of the on-topic references that were excluded from further consideration for
C.I. Pigment Violet 29.
EPA plans to review the full study reports related to physical/chemical characteristics, environmental
fate, human health and environmental hazard of C.I. Pigment Violet 29 using the evaluation strategies as
described in Application of Systematic Review in TSCA Risk Evaluations (U.S. EPA. 2018a). These
studies correspond to robust summaries in the ECHA Database as well as a full study report for the
Ames assay from the Food Additive Petition (FAP) 8B4626. The study quality evaluation of the study
reports is intended to confirm or update the conclusions of the robust summaries available from the
ECHA Database that were used to support the preliminary findings discussed in this problem
formulation document.
2 PROBLEM FORMULATION
As required by TSCA, the scope of the risk evaluation identifies the conditions of use, hazards,
exposures and potentially exposed or susceptible subpopulations that the Administrator expects to
consider. To communicate and visually convey the relationships between these components, EPA
included in the scope document a life cycle diagram and conceptual models that describe the actual or
potential relationships between C.I. Pigment Violet 29 and human and environmental receptors. For this
problem formulation, EPA conducted a preliminary data review of reasonably available fate, exposure
and hazard data and determined its suitability for analysis and to identify exposure pathways, receptors
and health endpoints for analysis. EPA summarized the outcome of this evaluation in conceptual models
that illustrate the exposure pathways, receptor populations and effects that will be subject to further
analysis in the risk evaluation (Section 2.5). EPA also prepared an analysis plan to convey the proposed
approach to conducting the risk evaluation (Section 2.6).
2.1 Physical and Chemical Properties
Physical-chemical properties influence the environmental behavior and the toxic properties of a
chemical, thereby informing the potential conditions of use, exposure pathways and routes and hazards
that EPA intends to consider. The C.I. Pigment Violet 29 scope document had physical and chemical
properties based on estimated values (U.S. EPA. 2017c). During problem formulation, the physical and
chemical properties have been updated, where possible, to reflect measured values from the ECHA
Database and are provided in Table 2-1. An estimated value for the octanol/water partition coefficient
(Log Kow) is presented in Table 2-1. The measured partition coefficient could not be determined due to
poor solubility in octanol and water; thus, the estimated Log Kow of 3.76 is applicable for this
evaluation. EPA plans to review the full study reports identified in Table Apx C-l, which the Agency
has received from the data owner(s), using the evaluation strategies as described in the Application of
Systematic Review in TSCA Risk Evaluations (U.S. EPA. 2018a).
Page 13 of 58
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Table 2-1. Physical and Chemical Properties of C.I. Pigment Violet 29
Property
Value
Reference
Molecular Formula
C24H10N2O4
(ECHA. 201 /Is)
Molecular Weight
390.35 g/mole
0 v i i \ JiLb)
Physical Form
Solid
( )
Melting Point
No melting point found < 400°C
( )
Boiling Point
Not available
Density
1.584 g/cm3 at 20 °C
(EC 17b)
Vapor Pressure
< 0 hPa at 20°C
( )
Vapor Density
Not available
Water Solubility
0.01 mg/L at 20°C
( HA. 2017b)
Log Kow
3.76 (estimated)
(U.S. EPA. 2.012b)
Henry's Law
Constant
1.84E-021 atm-m3/mole (estimated)
(U.S. EPA. 2.012b)
Flash Point
Not available
Auto Flammability
Not available
Viscosity
Not available
Refractive Index
Not available
Dielectric Constant
Not available
C.I. Pigment Violet 29 is a Colour Index name used in sales of products containing anthra[2,l,9-
def:6,5,10-d'e'f ]diisoquinoline-l,2,8,10(2H,9H)-tetrone, CASRN 81-33-4. The name "C.I. Pigment
Violet 29" is assigned, copyrighted and maintained by the Society of Dyers and Colourists and the
American Association of Textile Colorists and Chemists (EP A-HQ-OPPT-2016-0725-0039). The
Colour Index is an international standard and classification system describing essential colorants which
comprise commercial dyes and pigments.
Anthra[2,l,9-def:6,5,10-d'e'f ]diisoquinoline-l,2,8,10(2H,9H)-tetrone identified by CASRN 81-33-4, is
a violet or red-brown pigment and called by the following Colour Index names: C.I. Pigment Violet 29
and C.I. Pigment Brown 26. The difference in color between C.I. Pigment Brown 26 and C.I. Pigment
Violet 29 is related to particle size and not crystal form (Sun Chemical. 2017a).
EPA preliminarily reviewed a full study report of the solubility of C.I. Pigment Violet 29 in ethanol
from the Food and Drug Administration's Food Additive Petition (FAP) 8B4626 ( a).
According to FAP 8B4626, solubility of various pigments including C.I. Pigment Violet 29 was done in
8% and 95% ethanol. In the study, the solubility in 8% ethanol is reported as 0.0046 mg/L and 0.015
mg/L in 95% ethanol. Based on these results, C.I. Pigment Violet 29 has very low solubility in ethanol.
Solubility of C.I. Pigment Violet 29 was also assessed in octanol. The solubility in octanol is reported as
0.07 mg/L. The water solubility of C.I. Pigment Violet 29 is 0.01 mg/L per ECHA Database. Based on
all solubility test results, C.I. Pigment Violet 29 has low solubility.
There are no known by-products or degradation products resulting from the manufacture of C.I. Pigment
Violet 29. There is a residual amount of naphthalimide, the starting material used in the fusion, at
approximately 1% (Sun Chemical. 2017a). Per robust study summary reports from the ECHA Database,
the hazard profile of naphthalimide is low for human health and environmental receptors (ECHA.
2017a). Based on the minimal amount of naphthalimide released from manufacturing and low hazard,
Page 14 of 58
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EPA will not conduct any further analysis of the naphthalimide residual associated with C.I. Pigment
Violet 29 production.
2.2 Conditions of Use
TSCA § 3(4) defines the conditions of use as "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."
Pigments are widely used and found in a wide range of products that are colored. Below is specific use
information for C.I. Pigment Violet 29.
2.2.1 Data and Information Sources
Since conditions of use has not changed since the issuance of the C.I. Pigment Violet 29 scope
document ( ) on June 22, 2017, the conditions of use remain the same for problem
formulation.
2.2.2 Identification of Conditions of Use
To determine the current conditions of use of C.I. Pigment Violet 29 and inversely, activities that do not
qualify as conditions of use, EPA conducted extensive research and outreach. This included EPA's
review of published literature and online databases including the most recent data available from EPA's
Chemical Data Reporting program (CDR) and Safety Data Sheets (SDSs). EPA also conducted online
research by reviewing company websites of potential manufacturers, importers, distributors, retailers, or
other users of C.I. Pigment Violet 29 and queried government and commercial trade databases. EPA also
received comments on the Scope of the Risk Evaluation for Pigment Violet 29 (I ); »j \ _01 />:) that
were used to determine the current conditions of use. In addition, EPA convened meetings with
companies, industry groups, chemical users, states, environmental groups, and other stakeholders to aid
in identifying conditions of use and verifying conditions of use identified by EPA. Those meetings
included a February 14, 2017 public meeting with such entities and a September 15, 2017 meeting with
several representatives from trade associations.
As explained in the final rule for 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 potentially exposed or susceptible subpopulations the Administrator expects to
consider" in a risk evaluation, suggesting that EPA may exclude certain activities that EPA has
determined to be conditions of use on a case-by-case basis. (82 FR 33736, 33729; July 20, 2017). For
example, EPA may exclude conditions of use that the Agency has sufficient basis to conclude would
present only de minimis exposures or otherwise insignificant risks (such as use in a closed system that
effectively precludes exposure or use as an intermediate) or that have been adequately assessed by
another regulatory agency.
The activities that EPA no longer believes are conditions of use or that were otherwise excluded during
problem formulation are described in Section 2.2.2.1. The conditions of use included in the scope of the
risk evaluation are summarized in Section 2.2.2.2.
2.2.2.1 Categories and Subcategories Determined Not to be Conditions of Use or
Otherwise Excluded During Problem Formulation
No conditions of use were excluded during problem formulation; thus, Table 2-3 from the C.I. Pigment
Violet 29 Scope Document ( ) remains the same and is presented in Table 2-2 below.
Page 15 of 58
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2.2.2.2 Categories and Subcategories of Conditions of Use in Scope of the Risk
Evaluation
Because no conditions of use were excluded during problem formulation, Table 2-2 below remains the
same as presented in the C.I. Pigment Violet 29 Scope Document [Table 2-3 in (U.S. EPA. )] and
in Section 2.2.2.1.
Table 2-2. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation
l.il'e Cycle Stage
Category "
Subcategory h
References
\ 1;i i in l;icl m re
1 )omes|ic Mi;iiliil;iclmiv
1 )oines|ic 11i;iiliil;icl11iv
Import
Import
Processing
Processing -
Incorporating into
formulation, mixture, or
reaction product
Paints and Coatings
U.S. EPA (2016b): Public
Comment. EPA-HO-OPPT-
2016-0725-0006
Plastic and Rubber Products
U.S. EPA (2016b): Public
Comment. EPA-HO-OPPT-
2016-0725-0006
Processing - Use as an
Intermediate
Creation or adjustment to other
perylene pigments
U.S. EPA (2016b): Public
Comment. EPA-HO-OPPT-
2016-0725-0006; Public
Comment, EPA-HO-OPPT-
2016-0725-0008
Recycling
Recycling
U.S. EPA (2016b): Use
Document, EPA-HO-
OPPT-2016-0725-0004
Distribution in commerce
Distribution
Distribution
Use Document, EPA-HO-
OPPT-2016-0725-0004:
Public Comment, EPA-HQ-
OPPT-2016-0725-0006
Industrial/commercial/
consumer use
Plastic and rubber
products
Automobile plastics
Use Document, EPA-HO-
OPPT-2016-0725-0004:
Public Comment, EPA-HQ-
OPPT-2016-0725-0006
Industrial carpeting
Public Comment, EPA-HQ-
OPPT-2016-0725-0006
Paints and coatings
Automobile (OEM and refinishing)
Public Comment, EPA-HQ-
OPPT-2016-0725-0006:
Public Comment, EPA-HQ
OPPT-2016-0725-0013;
Public Comment, EPA-HQ
OPPT-2016-0725-0009
Coatings and basecoats
Public Comment, EPA-HQ-
OPPT-2016-0725-0008:
Public Comment, EPA-HQ-
OPPT-2016-0725-0007
Merchant ink for
commercial printing
Merchant ink
Use Document, EPA-HQ-
OPPT-2016-0725-0004:
Page 16 of 58
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l.il'e Cycle Stage
Category 11
Subcategory h
References
Public Comment, EPA-HC
OPPT-2016-0725-0006
Other uses
Applications in odor agents,
cleaning/washing agents, surface
treatment, absorbents and
adsorbents, laboratory chemicals,
light-harvesting materials,
transistors, molecular switches,
solar cells, optoelectronic devices,
paper, architectural uses, polyester
fibers, adhesion, motors,
generators, vehicle components,
sporting goods, appliances,
agricultural equipment and oil and
gas pipelines
Use Document. EPA-HO-
OPPT-2016-0725-0004
Consumer watercolor
and acrylic paints
Professional quality watercolor and
acrylic artist paint
Use Document, EPA-HQ-
OPPT-2016-0725-0004
Disposal
Emissions to Air
Air
Standard EPA approach, no
sources specific to C.I.
Pigment Violet 29 found
Wastewater
Industrial pre-treatment
Industrial wastewater treatment
Publicly owned treatment works
(POTW)
Underground injection
Solid wastes and liquid
wastes
Municipal landfill
Hazardous landfill
Other land disposal
Municipal waste incinerator
Hazardous waste incinerator
Off-site waste transfer
a These categories appear in the life cycle diagram (Figure 2-1), reflect CDR codes and broadly represent conditions of use
of C.I. Pigment Violet 29 in industrial and/or commercial settings.
b These subcategories reflect more specific uses of C.I. Pigment Violet 29.
2.2.2.3 Overview of Conditions of Use and Lifecycle Diagram
The life cycle diagram provided in Figure 2-1 depicts the conditions of use that are considered within
the scope of the risk evaluation during various life cycle stages including manufacturing, processing,
distribution, use (industrial, commercial, consumer; when distinguishable) and disposal. Additions or
changes to conditions of use based on additional information gathered or analyzed during problem
formulation are described further in Sections 2.2.2.1 and 2.2.2.2. The activities that EPA determined are
out of scope during problem formulation are not included in the life cycle diagram. The information is
grouped according to Chemical Data Reporting (CDR) processing codes and use categories (including
functional use codes for industrial uses and product categories for industrial, commercial and consumer
uses), in combination with other data sources (e.g., published, peer reviewed literature and consultation
with stakeholders), to provide an overview of conditions of use. EPA notes that some subcategories of
Page 17 of 58
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use may be grouped under multiple CDR categories (Appendix D in Instructions for Reporting
TSCA. Chemical Data Reporting). ( a).
Use categories include the following: "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 ( ))•
To understand conditions of use relative to one another and associated potential exposures under those
conditions of use, the life cycle diagram includes the volume information associated with each stage of
the life cycle, as reported in the 2016 CDR reporting ( 016b).
The 2016 CDR reporting data for C.I. Pigment Violet 29 are provided in Table 2-3 (U.S. EPA. 2016b).
The 2016 CDR reporting period encompasses production and import volumes for 2012 to 2015. The C.I.
Pigment Violet 29 scope document 2012 production volume data was the aggregate production volume
for the 2012 CDR reporting cycle and the 2016 CDR data was not presented due to CBI claims. During
problem formulation, EPA worked with the CDR reporter to remove CBI claims, such that Table 2-3
now shows 2016 CDR data including the final production volume for 2012; therefore, the production
volumes for 2012 differed slightly between the C.I. Pigment Violet 29 scope document and this problem
formulation document.
Table 2-3. Production Volume of C.I. Pigment Violet 29 in Chemical Data Reporting (CDR)
Reporting Period (2012 to 2015) a'b
Reporting Year
2012
2013
2014
2015
Total Aggregate Production
Volume (lbs)
517,980 c
474,890
535,139
603,420
a Sun Chemical has waived all claims of CBI for C.I. Pigment Violet 29 in the 2016 CDR f Sun Chemical, 2017b).
b The CDR data for the 2016 reoortine period is available via ChemView (1ittDs://iava.eDa.gov/chemview) (U.S. EPA.
2016b). Because of an ongoing CBI substantiation process required by amended TSCA, the CDR data available in the
problem formulation document is more specific and up-to-date than currently in ChemView.
0 Final production volume for 2012 reported in 2016 CDR reporting cycle.
Descriptions of the industrial, commercial and consumer use categories identified from the
and included in the life cycle diagram are summarized below ( 2016b).
Sun Chemical Corporation is the only U.S. manufacturer of C.I. Pigment Violet 29 that reported to CDR
in 2012 and 2016 ( 2012a). EPA is also aware of C.I. Pigment Violet 29 being imported into
the United States below the reporting threshold of 25,000 lbs per year from a confidential source per
comments from CPMA [EPA-HQ-QPPT-2016-072.5-0006. (CPMA. 2017a).
Figure 2-1 shows the production volume of C.I. Pigment Violet 29 that is associated with each life cycle
stage. The imported material is used for merchant ink for commercial printing, other uses, and consumer
watercolor and artistic color (Figure 2-1, (CPMA. 2017a)). This information also indicates that import
volume is considerably less than the manufacturing volume.
Page 18 of 58
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Four primary industrial and commercial uses and one consumer use have been identified for C.I.
Pigment Violet 29:
• Use as an intermediate to create or adjust color of other perylene pigments (-90%)
• Incorporation into paints and coatings used primarily in the automobile industry (-5%)
• Incorporation into plastic and rubber products used primarily in automobiles and industrial
carpeting (-5%)
• Use in merchant ink for commercial printing (< 1%)
• Consumer watercolors and artistic color (unknown minor volume)
Public comments on the C.I. Pigment Violet 29 Use Document [EPA-H.O-OPPT-2016-072? (
EPA. 2017b VI and 2016 CDR (U.S. EPA. 2.016b). indicate 90% of the 2015 domestic production volume
(540,000 lbs) is processed as a site-limited intermediate in the manufacture of other perylene pigments.
This use is corroborated by the American Coatings Association statement that C.I. Pigment Violet 29 is
used to adjust the color of other perylene pigments r(EPA-HQ-OPV [ 11 * J *725-0008). ( U \ ,^17)1.
Approximately 10% of the production volume (-60,000 lbs) is processed and used in either commercial
paints and coatings (-30,000 lbs) or commercial plastic and rubber products (-30,000 lbs). The 2012
CDR did not indicate these products were intended for or specifically marketed to children (U.S. EPA.
2012a). Automotive and industrial coatings that include metallic finishes and textile printing are types of
commercial paints and coatings [Q \ \ K tQ-QPPT-201».«-0725-0006). (CPMA. 2017a)l. C.I. Pigment
Violet 29 can be a component in a variety of plastics applications such as polyolefins, polyvinyl chloride
(PVC), polyurethane (PUR), polystyrene (PS), styrene butadiene (SB), styrene acrylonitrile (SAN) and
other polymers (BASF. 1998b). (COLORS.! ). Less than 1% of the production volume (-6,000 lbs)
is processed into ink and then used in merchant ink for commercial printing.
An unknown minor volume of C.I. Pigment Violet 29 is used in consumer watercolor and acrylic paints.
Furthermore, C.I. Pigment Violet 29 used in professional artistic paint products is less than 1% of total
sales r(EPA-HO-OPPT-2016-0725-0039). (CPMA. 2017bVI. The 2012 CDR did not indicate use of C.I.
Pigment Violet 29 in products intended for children ( i). In the 2017 comments on C.I.
Pigment Violet 29 Use Document IYEPA-H.O-OPPT-2016-0725-0006). (CPMA. )], commenters
indicated they are not aware of C.I. Pigment Violet 29 being used for paints that are marketed to
children, although there are no explicit age-related restrictions on the purchase of professional artistic
paints such as watercolors and acrylics. However, consumer products that are widely available, like
watercolor and acrylic paints, could be reasonably foreseen to be used by children.
The changes in life cycle diagram since June 22, 2017 include showing the estimated releases from
manufacturing and updated production volume values where applicable, as a result of CBI claims being
removed.
Page 19 of 58
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MFG/IMPORT
PROCESSING
INDUSTRIAL, COMMERCIAL, CONSUMER USES
RELEASES and WASTE DISPOSAL
~ 1-2%; 6,000 lbs to 12,000 lbs
See Figure 2-4 for Environmental Releases
and Wastes
Plastic and Rubber Products
(~5%; 30,000 lbs)
Paints and Coatings
(~5%; 30,000 lbs)
Other Uses
(Unknown minor volume;
(«1% of volume)
Merchant Ink for Commercial
Printing
(<1% of volume; < 6,000 lbs)
Consumer Watercolor and
Artistic Color
(Unknown minor volume)
Manufacture'
(603,420 lbs, of which
17,266 lbs are
exported)
Incorporated into
Formulation, Mixture,
or Reaction Product
(~10%; 60,000 lbs)
Use as an Intermediate
to Create or Adjust
Color of Other
Perylene Pigments
(~90%; 540,000 lbs)
Emissions to Air
Liquid Wastes
Wastewater
Solid Wastes
~ Manufacture ~ Processing ~ Industrial/Commercial I
~
Consumer Use
Figure 2-1. C.I. Pigment Violet 29 Life Cycle Diagram
The life cycle diagram depicts the conditions of use during various life cycle stages including manufacturing, processing, use (industrial,
commercial, consumer), distribution and disposal. The production volumes shown are for reporting year 2015 from the 2016 CDR reporting
period. Activities related to distribution (e.g., loading, unloading) will be considered throughout the C.I. Pigment Violet 29 life cycle, rather
than using a single distribution scenario.
a 603,420 lbs does not include import volumes since it is below the CDR reporting threshold of 25,000 lbs (CPMA. 2017a): however, uses of imported C.I. Pigment Violet
29 are represented in the LCD.
b Wastewater: combination of water and organic liquid, where the organic content than < 50%. Liquid Wastes: combination of water and organic liquid, where the organic
content is > 50%.
Page 20 of 58
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2.3 Exposures
For TSCA exposure assessments, EPA expects to evaluate exposures and releases to the environment
resulting from the conditions of use applicable to C.I. Pigment Violet 29. Post-release pathways and
routes will be described to characterize the relationship or connection between the conditions of use for
C.I. Pigment Violet 29 and the exposure to human receptors, including potentially exposed or
susceptible subpopulations and environmental receptors. EPA will consider, where relevant, the
duration, intensity (concentration), frequency and number of exposures in characterizing exposures to
C.I. Pigment Violet 29.
2.3.1 Fate and Transport
Environmental fate includes both transport and transformation processes. Environmental transport is the
movement of the chemical within and between environmental media. Transformation occurs through the
degradation or reaction of the chemical with other species in the environment. Hence, knowledge of the
environmental fate of the chemical informs the determination of the specific exposure pathways and
potential human and environmental receptors EPA expects to consider in the risk evaluation.
During problem formulation, EPA considered volatilization during wastewater treatment, volatilization
from lakes and rivers, biodegradation rates, and organic carbon:water partition coefficient (log Koc) and
bioaccumulation potential when making changes, as described in Section 2.5, to the conceptual models.
Systematic literature review is currently underway, so model results, robust study summaries from
ECHA, and basic principles were used to support the fate data used in problem formulation.
The C.I. Pigment Violet 29 ( 017c) fate properties described here are based on review of
ECHA robust study summaries (ECHA. 2.017b) and EPA EPI Suite estimated values ( )
as summarized in Table 2-4. As indicated previously, EPA's literature search ( 317a) did not
identify any other on-topic references pertinent to fate and transport of C.I. Pigment Violet 29.
C.I. Pigment Violet 29 is expected to be highly persistent and has low bioaccumulation potential.
Preliminary review of robust summaries for studies related to biodegradation indicates that it is not
readily biodegradable. Due to its physical properties, it is expected to bind strongly to soil organic
matter and migration through soil to groundwater is likely to be minimal. If released to water, hydrolysis
is expected to be negligible. Based on its estimated Henry's Law Constant, C.I. Pigment Violet 29 is not
expected to volatilize from environmental waters. If released to air, it is unlikely to undergo direct
photolysis and expected to be in the particulate phase. Based on its estimated indirect photodegradation
half-life of 7 hours, it is considered to degrade moderately to slowly by reaction with atmospheric
hydroxyl radicals.
Page 21 of 58
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Table 2-4. Environmental Fate Characteristics of C.I. Pigment Violet 29
Properly or Kmlpoinl
Value 11
References
hull reel plkilndeuradalkiii
" (i hours (esiimaledi
Hydrolysis half-life
Stable
Biodegradation
Low biodegradability: 010% degradation in
28 days (OECD 30IF)
ECHA (2017b)
Bioconcentration factor (BCF)
Low bioconcentration: BCF=140 (estimated) b
U.S. EPA (2012b)
Bioaccumulation factor (B AF)
BAF = 50 (estimated)b
U.S. EPA (2012b)
Soil organic carbon:water partition
coefficient (Log K0c)
5.0 (estimated)b
U.S. EPA (2012b)
a Measured unless otherwise noted.
b There are limited pigment data in the EPI Suite training set, therefore values should be used with caution.
Fate test data EPA identified in the ECHA Database for this chemical includes biodegradation and
activated sludge respiration inhibition testing (ECHA.. z ). During problem formulation, EPA
requested and received these studies from the data owner(s):
1. OECD Guideline 301 F: Biodegradability: Manometric Respirometry Test
2. OECD Guideline 209: Activated Sludge, Respiration Inhibition Test
EPA plans to review the full study reports for these tests using the evaluation strategies as described in
Application of Systematic Review in TSCA Risk Evaluations ( 1018a).
However, pigments commonly exist as aggregates in particles sizes of approximately 0.1 |im and exhibit
low affinity for water and octanol. The bioaccumulation of such aggregates is likely limited by their
molecular weight and size.
2.3.2 Releases to the Environment
C.I. Pigment Violet 29 is manufactured and imported as a solid and in solution and has a low vapor
pressure (<0 hPa at 20°C). It is handled and processed as a dry powder and formulation during all
conditions of use. Because the chemical is not volatile at process temperatures during any conditions of
use, evaporative losses (volatile fugitive air emissions) are not expected.
The sole domestic manufacturer of C.I. Pigment Violet 29 has estimated standard yield loss of 1-2% of
the volume during the manufacturing (6,000- 12,000 lbs for 2015) (M ). Most of the lost C.I.
Pigment Violet 29 is captured and disposed such that a very minimal amount is released. Potential
release sources at this site and sites that process and use C.I. Pigment Violet 29 include, but are not
limited to: residual material in storage and transfer containers that are subsequently cleaned or disposed
of, pigment that is spilled during the handling of the dry powder during transfer operations, equipment
cleaning, and overspray of coatings.
Air and water releases directly to the environment from manufacturing are expected to be limited based
on information provided from the domestic manufacturer. Dust handling systems are in place at the
manufacturing facility that capture dust in baghouses. The efficiency rate is greater than 99.5% (Mott.
2017b; Sun Chemical. 2017b). Spilled pigment from handling of the dry powder is collected and placed
in contaminated industrial waste bins. The bags and waste bins are subsequently sent to a licensed
industrial waste handler for disposal (CPMA. 2017a). One to two percent of produced C.I. Pigment
Page 22 of 58
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Violet 29 is lost during handling and most are channeled to an on-site aboveground biological
wastewater treatment system that captures C.I. Pigment Violet 29 (Mott.! ). Of this material that is
captured during the wastewater treatment process, greater than 95% of the wastewater treatment residue
is disposed of at either the Oak Ridge Landfill in Dorchester County or the Berkeley County Landfill,
RCRA Subtitle-D lined landfills permitted under the authority of South Carolina Regulation Number 61-
h' ' I' v'Olid Waste Management (Mott. JO 1 ;i), (RCRAInfo Facility Information). Less than 0.1% of
produced C.I. Pigment Violet 29 is released to surface waters (0.6 lb/day, as reported by the
manufacturer).
C.I. Pigment Violet 29 is supplied to formulator as dry powders, press cakes, or slurries. Pigments
grinding or milling is required when the size of the particles in the dispersion needs to be reduced. After
grinding and/or milling, C.I. Pigment Violet 29 is blended with other additives and solvents. Formulated
paint and coatings (5% of total production volume) are filtered prior to packaging. For plastics and
rubber (5% of total production volume), pigments and other additives are mixed with polymer resins and
other raw materials to produce compound resin master batch. It is then transferred into an extruder
where it is converted into pellets, sheets, films, or pipes. The extruded plastics are shipped to
downstream converting sites where they are formed into the desired shape through a variety of
converting methods, including extrusion, injection molding and thermoforming.
No data pertaining to environmental releases from the twenty downstream industrial facilities that
process C.I. Pigment Violet 29 into plastics, paints and coatings were identified. These uses account for
10%) of the total production volume. However, CPMA indicated that all of these facilities are subject to
EPA and state regulations resulting in limiting releases to air, water, and land of materials to the
environment.
Exposure and releases are possible when handling concentrated C.I. Pigment Violet 29 but once it is
encapsulated in plastics or paint resins, it is not expected to leach out l"21 CFR 178.32.97. (BASF.
1998a) "I.
No specific release information for C.I. Pigment Violet 29 was found in the references identified during
the full-text screening of the on-topic references under the Engineering section of Pigment Violet 29
(CAS 'C X _ 3-4) Bibliography: Supplemental File for the TSCA Scope Document (i v M ^ i).
However, releases to the environment from the conditions of use are possible (e.g., from manufacturing
and use as a site-limited intermediate which is —1-2%; incorporation into plastics, paints and coatings;
application of coatings).
Based on information provided by the domestic manufacturer that is summarized above, releases from
the manufacturing site are expected to be limited. Based on the information from industries, use
information, and the physical properties of C.I. Pigment Violet 29, most of the waste from
manufacturing as well as the various processing and uses are expected to be sent to landfills or
incineration for disposal and only limited quantities are expected to be released to surface water.
2.3.3 Presence in the Environment and Biota
Monitoring studies or a collection of relevant and reliable biomonitoring studies provide(s) information
that can be used in an exposure assessment. Monitoring studies that measure environmental
concentrations or concentrations of chemical substances in biota provide evidence of exposure. EPA did
not find environmental monitoring data (e.g., presence in air, soil, sediment, surface water, or biota)
indicating the presence of C.I. Pigment Violet 29 in the U.S. or internationally ( £017a). EPA
also did not find biomonitoring data for C.I. Pigment Violet 29 ( 317a). Although the
Page 23 of 58
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persistence and tendency to sorb to sediment means that there is the potential for entry into the aquatic
food web, available data indicate that the BAF is low so uptake and bioaccumulation is likely to be
limited.
2.3.4 Environmental Exposures
The manufacturing, processing, distribution, use and disposal of C.I. Pigment Violet 29 can result in
releases to the environment. In this section, EPA presents exposures to aquatic and terrestrial organisms.
As outlined above, physical-chemical and fate properties as well as engineering controls limiting
manufacturing (the largest use) releases are expected to result in limited exposure to water and sediment,
groundwater via biosolids, landfill leaching, and air. It is estimated that less than one pound per day of
C.I. Pigment Violet 29 is being released as the overall total of the National Pollutant Discharge
Elimination System (NPDES)-permitted total suspended solids (TSS) discharges from the sole US
manufacturer (Mott 2017b). Because volumes used by downstream users are markedly less than the
manufacturer (less than 5% each), it is expected that there will be minimal releases to water and
sediment, groundwater via biosolids, landfill leaching, and air.
Where releases do occur, they are expected to result in limited environmental exposures. Specifically,
releases of C.I. Pigment Violet 29 to water and sediment could occur during the wastewater treatment
process following manufacturing/processing through possible releases of TSS, but these releases and
corresponding aquatic exposures are expected to be limited since the high sorption of this chemical to
organic matter (Log Koc = 5.0; see Table 2-4) will result in the vast majority of C.I. Pigment Violet 29
being captured as sludge in wastewater treatment facilities which is subsequently disposed of via
incineration or landfill disposal. Similarly, the strong sorption properties would be expected to limit
exposure via migration to groundwater from C.I. Pigment Violet 29 disposed of in landfills or applied
via biosolids.
Air exposures from both incineration and fugitive releases from manufacturing and/or processing are
expected to be low due to described fate properties and waste handling practices. Specifically, due to the
low vapor pressure and volatility of C.I. Pigment Violet 29 (Henry's Law Constant 99% (CPMA.
2017a).
2.3.5 Human Exposures
Human exposure to C.I. Pigment Violet 29 through occupational (Figure 2-2), consumer (Figure 2-3) or
general population (Figure 2-4) activities and uses is possible, but exposures via all routes (oral, dermal,
and inhalation) are expected to be low when physical-chemical properties are considered.
2.3.5.1 Occupational Exposures
Workers may be exposed via inhalation and dermal routes. However, absorption via inhalation pathways
is expected to be low due to low water solubility and dermal absorption is estimated to be negligible for
the neat material (because it is a solid of high molecular weight), and poor absorption in solution (based
on high molecular weight and low solubility). EPA received inhalation exposure monitoring information
from the domestic manufacturer of C.I. Pigment Violet 29. The information indicates a workplace air
concentration of 0.5 mg/m3 over a 12-hour shift (Mott.: ). It is not clear if the monitoring result was
for C.I. Pigment Violet 29 or for total dust. If the level was for total dust, the actual air concentration of
C.I. Pigment Violet 29 is likely to be lower than 0.5 mg/m3 (i.e., lower exposure).
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Oral contact is not a relevant pathway for workers manufacturing C.I. Pigment Violet 29 since eating is
not allowed in the production and laboratory work areas and proper personal protective equipment (PPE)
are expected to be worn at the sole C.I. Pigment Violet 29 US manufacturing facility (Mott. 2017a). In
addition, oral absorption is negligible due to low water solubility.
For downstream processors and users, worker exposure via inhalation through particulates that deposit
in the upper respiratory tract or oral routes such as incidental ingestion of C.I. Pigment Violet 29 residue
on hands is possible. These exposures are possible during handling solids and spray application of
coatings containing C.I. Pigment Violet 29. However, oral and inhalation exposures to downstream
processors and users are likely to be limited due to the use of PPEs and negligible oral absorption due to
low water solubility IYBA.SF. 20171 (Sun Chemical. 2017d). (CPMA. 2017a)"I.
EPA reviewed available Safety Data Sheets (SDSs) for C.I. Pigment Violet 29. The SDSs recommend
the use of personal protective equipment to minimize exposure, including the use of chemical-resistant
protective gloves and safety glasses with side-shields or a face shield if a splashing hazard exists. It also
recommends adequate ventilation when handling C.I. Pigment Violet 29 IYBASF. 2017). (Sun Chemical.
2017d). (Sun Chemical. 2017c)"I.
The domestic manufacturer of C.I. Pigment Violet 29 also indicates that workers in production and
laboratory areas at their facility wear long sleeves and gloves to prevent dermal exposure (Mott. 2017a).
Furthermore, while limited exposures are deemed possible, and as mentioned above, absorption via
dermal and inhalation routes is expected to be low (see Section 2.4.2.1).
2.3.5.2 Consumer Exposures
Possible exposure pathways/routes for C.I Pigment Violet 29 in consumer products are through liquid
contact with paint and subsequent dermal absorption or oral ingestion (Figure 2-3). Inhalation is not
identified as a route of exposure for consumers since C.I. Pigment Violet 29 is not expected to be
released from consumer watercolor and artistic color as a vapor due to its low vapor pressure. Consumer
exposures via oral and dermal routes are expected to be limited based on physical-chemical properties of
C.I. Pigment Violet 29. Oral ingestion is expected to be negligible due to the low water solubility (see
Table 2-1; 0.01 mg/L) and dermal absorption is estimated to be negligible for the neat material (because
it is a solid of high molecular weight) and poor absorption in liquid (based on high molecular weight and
low solubility). Further, C.I. Pigment Violet 29 was approved as a colorant for food packaging and is
expected to remain within plastics (Appendix A-2). Therefore, consumer exposures associated with
identified consumer uses are expected to be limited.
2.3.5.3 General Population Exposures
General population exposures to C.I. Pigment Violet 29 are expected to be limited due to the limited
releases of C.I Pigment Violet 29 outlined above (Section 2.3.4). Possible exposure routes for the
general population include oral ingestion of water or groundwater and inhalation of air associated with
releases of C.I. Pigment Violet 29 (Figure 2-4). Oral ingestion of C.I. Pigment Violet 29 is expected to
be negligible due to low concentrations expected in surface and ground water. This low concentration in
water is due to high capture efficiency of C.I. Pigment Violet 29 during the waste water treatment
process limiting releases to surface water and strong sorption to soil reducing migration to groundwater
(Section 2.3.4). Additionally, physical-chemical properties indicate that even if ingested, absorption
would be expected to be limited due to low water solubility. Inhalation of C.I. Pigment Violet 29 is
expected to be limited due to limited fugitive and incineration air releases (Figure 2-4, Section 2.3.2).
Low volatilization rates will limit fugitive air releases as vapor (Section 2.3.1), while engineering
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controls during manufacturing capture the majority of any C.I. Pigment Violet 29 that would be released
(see Section 2.3.1). Downstream industrial facilities are subject to EPA and state regulations that would
be expected to similarly limit air releases (Section 2.3.2). Furthermore, absorption via inhalation is
expected to be low due to low water solubility. Dermal exposures, should they occur, are expected to be
limited because dermal absorption is estimated to be negligible because it is a solid of high molecular
weight and solubility.
2.3.5.4 Potentially Exposed or Susceptible Subpopulations
TSCA requires the determination of whether a chemical substance presents an unreasonable risk to "a
potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation" by EPA.
TSCA § 3(12) states that "the term 'potentially exposed or susceptible subpopulation' means a group of
individuals within the general population identified by the Administrator who, due to either greater
susceptibility or greater exposure, may be at greater risk than the general population of adverse health
effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women,
workers, or the elderly." General population is "the total of individuals inhabiting an area or making up a
whole group" and refers here to the U.S. general population ( 011).
As part of the Problem Formulation, EPA identified potentially exposed and susceptible subpopulations
for further analysis during the development and refinement of the life cycle, conceptual models,
exposure scenarios, and analysis plan. In this section, EPA addresses the potentially exposed or
susceptible subpopulations identified as relevant based on greater exposure. EPA will address the
subpopulations identified as relevant based on greater susceptibility in the hazard section.
Exposures of C.I. Pigment Violet 29 would be expected to be higher amongst workers and consumers
using C.I. Pigment Violet 29 as compared to the general population. However, these potential exposures
are likely to be limited due to physical-chemical and fate properties resulting in limited absorption and
engineering controls during the manufacturing, processing and use of C.I. Pigment Violet 29 as outlined
above.
2.4 Hazards (Effects)
For scoping, EPA conducted comprehensive searches for data on hazards of C.I. Pigment Violet 29, as
described in Strategy for Conducting Literature Searches for Pigment Violet 29: Supplemental File for
the TSCA Scope Document ( 317d). No specific human health or environmental hazard
information for C.I. Pigment Violet 29 was identified during the full-text screening of the on-topic
references under the human health hazard or environmental hazard sections of Pigment Violet 29
(CASjkC ¦>( • i>* biography: Supplemental File for the TSCA Scope Document 0 v I C \ ,).
Based on initial screening of the robust summaries available in the ECHA and FAP databases the
hazards to human and environmental receptors are expected to be low. EPA plans to confirm the low
hazards of C.I. Pigment Violet 29 by reviewing the study reports that were used to formulate the robust
summaries. When conducting the risk evaluation, the relevance of any hazard within the context of a
specific exposure scenario will be judged for appropriateness. For C.I. Pigment Violet 29, exposures are
expected to be low. This means that it is unlikely that exposure scenarios will be further analyzed in the
risk evaluation.
2.4.1 Environmental Hazards
As indicated previously, the environmental hazard data identified for C.I. Pigment Violet 29 were the
studies described in the robust summaries in ECHA Database (EC i).
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Aquatic toxicity data were available, which measured the acute toxicity of C.I. Pigment Violet to a fish,
aquatic invertebrate, and aquatic plant species. Appendix E presents the robust summaries available
from the ECHA Database that EPA used to preliminarily characterize the environmental hazard of C.I.
Pigment Violet 29.
The Agency is currently in possession of full study reports for the following studies:
• OECD Guideline 203: Fish Acute Toxicity Test
• OECD Guideline 202: Daphnia sp., Acute Immobilization Test
• OECD Guideline 221: Lemna sp., Growth Inhibition test
EPA will review all full study reports during risk evaluation using the data quality review evaluation
metrics and the rating criteria described in Application of Systematic Review in TSCA Risk Evaluations
(U.S. EPA. 2018a).
Review of the robust summaries indicates that no adverse effects were observed in fish (acute), aquatic
invertebrate (acute), and aquatic plants at the limit of solubility for C.I. Pigment Violet 29. Based on the
lack of adverse effects observed, EPA preliminarily concludes that the aquatic hazard is low for C.I.
Pigment Violet 29. This is consistent with the Canadian Ecological Risk Classification for C.I. Pigment
Violet 29, discussed in Appendix A-l, where it was determined that C.I. Pigment Violet 29 did not meet
the criteria for categorisation as a prioritized substance for further evaluation and the potential hazard is
low.
As noted in Section 2.3.1, C.I. Pigment Violet 29 is not expected to degrade in the environment, so EPA
has no concerns for environmental degradation products for C.I. Pigment Violet 29.
No studies were identified that characterized the effects of chronic exposure of C.I. Pigment Violet 29 to
aquatic species, or the effects to terrestrial species. As a result of uncertainties inherent in extrapolating
between acute and chronic exposure regimes and dissimilar environmental receptors, multiple lines of
evidence were considered to evaluate the potential for hazards under chronic aquatic exposure
conditions and to terrestrial organisms. The combination of low hazard of C.I. Pigment Violet 29 to
aquatic species, low hazard in mammalian tests (see Section 2.4.2), the low limit of solubility, low vapor
pressure, low bioaccumulation potential, low environmental releases and resulting exposures from
manufacturing, use, and disposal, as well as low absorption (see Section 2.4.2) indicate that hazard to
terrestrial and aquatic receptors from acute and chronic exposures to C.I. Pigment Violet 29 is expected
to be low.
2.4.2 Human Health Hazards
C.I. Pigment Violet 29 does not have an existing EPA IRIS Assessment; however there is available
toxicity data on C.I. Pigment Violet 29 from ECHA (ECHA.. 2017b) and the Food Additive Petition
(FAP) 8B4626 (BASF. 1998a). EPA plans to review these studies using the approaches and/or methods
described in the Application of Systematic Review in TSCA Risk Evaluations ( ) to
ensure that EPA is considering information that has been made available. Based on the
reasonably available information, the following sections describe the hazards EPA expects to further
analyze.
2.4.2.1 Non-Cancer Hazards
As indicated previously, the human health hazard data identified for C.I. Pigment Violet 29 were those
described in the robust summaries in ECHA Database (EG 17b). Several of the studies were
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referenced in the Food Additive Petition (FAP) 8B4626 ( ?. 1998a). The results of the studies
referenced in the FAP were compared against the results of the summaries in the ECHA database and
were found to be consistent. No additional information was available in the FAP to define the non-
cancer hazards of C.I Pigment Violet 29.
The Agency is currently in possession of the full study reports for the human health studies summarized
in Appendix F:
• OECD Guideline 401: Acute Oral Toxicity with Rats
• OECD Guideline 404: Acute Dermal Irritation/Corrosion
• OECD Guideline 405: Acute Eye Irritation/Corrosion
• OECD Guideline 429: Skin Sensitisation: Local Lymph Node Assay
• OECD Guideline 421: Reproduction / Developmental Toxicity Screening Test
• Non-Guideline Acute Toxicity: Acute Intraperitoneal Toxicity with Rats
• Non-Guideline Acute Toxicity: Acute Inhalation Toxicity with Rats
Together, these full study reports represent all the human health data on C.I. Pigment Violet 29 found in
the ECHA Database. Additional study summaries were identified in the ECHA database, but these were
found to be conducted on analogous chemicals, so these studies were not requested at this time. EPA
will review all full study reports and the expanded summary documents during risk evaluation using the
data quality review evaluation metrics and the rating criteria described in the Application of Systematic
Review in TSCA Risk Evaluations ( l).
Preliminary review of the robust summaries indicates lack of effects in any standard toxicity test. These
findings are consistent with the expectation that C.I. Pigment Violet 29 is poorly absorbed by all routes
(oral, dermal, and inhalation) due to its physical-chemical properties.
In March 2013, CPMA submitted study summaries for Perylene Pigments including C.I. Pigment Violet
29 for the High Production Volume (HPV) Test Program (CPIS 17a). The tests specifically for C.I.
Pigment Violet 29 were eye irritation and skin irritation (EPA-HQ-OPPT-2016-0725-0006). These
summaries indicated no skin or eye irritation.
2.4.2.2 Genotoxicity and Cancer Hazards
Genotoxicity data are available for C.I. Pigment Violet 29, including those summarized in the ECHA
Database (ECHA. 2017b) and the Food Additive Petition (FAP) 8B4626 (BASF. 1998a).
The Agency is currently in possession of the following full study reports of genotoxicity tests
summarized in Appendix F:
• OECD Guideline 476: In vitro Mammalian Cell Gene Mutation Test
• Reverse mutation assay AMES test using Salmonella typhimurium and Escherichia coli from
Food Additive Petition (FAP) 8B4626 ( 3a).
EPA will review all full study reports during risk evaluation using the data quality review evaluation
metrics and the rating criteria described in the Application of Systematic Review in TSCA Risk
Evaluations (U. t).
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EPA also considered potential carcinogenicity during problem formulation. Perylene, the 5-ring
polycyclic hydrocarbon moiety in the center of C.I. Pigment Violet 29, has been shown to be a negative
or marginal carcinogen in limited studies (IARC. 2010). This low carcinogenicity potential is supported
by structure-activity relationship (SAR) analysis and EPA's OncoLogic cancer expert system (available
at https://www.epa.gov/tsca-screemng-tools/oncologictrn-cornputer-systern-evaluate-carcinogemc-
potential-chemicals) because the arrangement of the five benzene rings in perylene does not favor
metabolic activation to epoxides. The addition of the imides groups to perylene to form C.I. Pigment
Violet 29 is expected to decrease solubility, increase bulkiness and thereby further reduce the likelihood
of carcinogenic potential. Testing for carcinogenicity of C.I. Pigment Violet 29 has not been conducted.
However, negative genotoxicity results, SAR considerations and the expected negligible absorption and
uptake of C.I. Pigment Violet 29, support EPA's conclusion that C.I. Pigment Violet 29 is unlikely to be
a carcinogen.
2.4.2.3 Potentially Exposed or Susceptible Subpopulations
TSCA requires that the determination of whether a chemical substance presents an unreasonable risk
include consideration of unreasonable risk to "a potentially exposed or susceptible subpopulation
identified as relevant to the risk evaluation" by EPA. TSCA § 3(12) states that "the term 'potentially
exposed or susceptible subpopulation' means a group of individuals within the general population
identified by the Administrator who, due to either greater susceptibility or greater exposure, may be at
greater risk than the general population of adverse health effects from exposure to a chemical substance
or mixture, such as infants, children, pregnant women, workers, or the elderly." In developing the hazard
assessment, EPA will analyze available data to ascertain whether some human receptor groups may have
greater susceptibility than the general population to the chemical's hazard(s).
2.5 Conceptual Models
EPA risk evaluation guidance ( ' ; ), defines Problem Formulation as the
part of the risk evaluation framework that identifies the major factors to be considered in the evaluation.
It draws from the regulatory, decision-making and policy context of the risk evaluation and informs the
evaluation's technical approach.
A conceptual model describes the actual or predicted relationships between the chemical substance and
receptors, either human or environmental. These conceptual models are integrated depictions of the
conditions of use, exposures (pathways and routes), hazards and receptors. The initial conceptual models
describing the scope of the risk evaluation for C.I. Pigment Violet 29, have been refined during problem
formulation. The changes to the conceptual models in this problem formulation are described along with
the rationales.
In this section EPA outlines whether pathways will be included and further analyzed in the risk
evaluation; will be included but will not be further analyzed in risk evaluation; and will not be included
in the TSCA risk evaluation and the underlying rationale for these decisions.
EPA determined as part of problem formulation that it is not necessary to conduct further analysis on the
exposure pathways that were identified in the C.I. Pigment Violet 29 scope document ( )
and that remain in the risk evaluation. Each risk evaluation will be "fit-for-purpose," meaning not all
conditions of use will warrant the same level of evaluation and the Agency may be able to reach some
conclusions without extensive or quantitative risk evaluations. 82 FR 33726, 33734, 33739 (July 20,
2017). EPA expects to be able to reach conclusions about particular hazards or exposure pathways
without extensive evaluation and plans to conduct no further analysis on those hazards or exposure
pathways in order to allow EPA to focus the Agency's resources on more extensive or quantitative
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analyses. As discussed below, EPA preliminarily determined that there are no environmental release and
waste pathways for the environment or general populations that EPA plans to further analyze in the risk
evaluation.
A conceptual model describes the actual or predicted relationships between the chemical substance and
receptors, either human or environmental. These conceptual models are integrated depictions of the
conditions of use, exposures (pathways and routes), hazards and receptors. The initial conceptual models
describing the scope of the risk evaluation for C.I. Pigment Violet 29, have been refined during problem
formulation, where no exposure pathways are expected to be assessed further. The changes to the
conceptual models in this problem formulation are described along with the rationales. Figure 2-2 and
Figure 2-3 illustrate the flow of C.I. Pigment Violet 29 from chemical manufacture and processing
through potential exposure pathways to effects to human receptors (e.g., workers, consumers, general
population). Figure 2-4 illustrates the flow of C.I. Pigment Violet 29 from chemical manufacture and
processing through potential exposure pathways to effects to environmental receptors (e.g., terrestrial
and aquatic wildlife).
2.5.1 Conceptual Model for Industrial and Commercial Activities and Uses: Potential
Exposures and Hazards
The revised conceptual model for Industrial and Commercial Activities and Uses (Figure 2-2) describes
the pathways of exposure from industrial and commercial activities and uses of C.I. Pigment Violet 29
that EPA plans to include in the risk evaluation. The C.I. Pigment Violet 29 Scope Document presented
possible exposure pathways and exposure routes to human and environmental receptors associated with
environmental releases and waste handling, treatment and disposal of C.I. Pigment Violet 29 for
industrial and commercial activities (U.S. EPA. ). During problem formulation, EPA further
analyzed the potential exposures and hazards to workers and has refined the conceptual models
accordingly with releases, pathways and routes of exposure that EPA has concluded do not warrant
further analysis indicated in Figure 2-2.
Inhalation
Mist and dust emissions from fugitive and stack emissions are expected to be limited. Air emissions are
typically relevant for volatile and/or dusty materials and since C.I. Pigment Violet 29 is not volatile, the
vapor pathway is not relevant. Since the vapor pressure of C.I. Pigment Violet 29 is nil, the vapor
release during uses of paint is not a concern. Also, dust handling systems are in place at the
manufacturing facility where the dried powder is added or discharged from the equipment and 99.5% of
dust is captured in baghouses. The resulting dust and bags are handled as contaminated industrial waste
and sent to a licensed waste handler for disposal. Absorption of C.I. Pigment Violet 29 via inhalation is
also expected to be negligible based on low water solubility. Inhalation monitoring has shown that
exposure was about 0.5 nig/m3 over a 12-hr work shift (Mott. 2017a). Due to the low potential for
inhalation exposure and low potential absorption and low inhalation toxicity, this pathway will not be
further analyzed in the risk evaluation.
Oral
Oral contact is not a relevant pathway for workers manufacturing C.I. Pigment Violet 29 since eating is
not allowed in the production and laboratory work areas and proper personal protective equipment are
expected to be worn at the sole C.I. Pigment Violet 29 US manufacturing facility (Mott. 2017a). In
addition, oral absorption is negligible due to low water solubility. EPA plans no further analysis of this
pathway for workers or occupational non-users in the risk evaluation.
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Dermal
Dermal absorption is estimated to be negligible when C.I. Pigment Violet 29 is a solid, and low if it is in
solution based on the low water solubility and high molecular weight. Dermal exposure is possible if
C.I. Pigment Violet 29 is formulated in solvent. However, based on the review of the robust summaries
of human health data in the ECHA Database (ECHA. 2017b). hazards to human health are expected to
be low. Dermal absorption of C.I. Pigment Violet 29 is estimated to be negligible for the neat material
since it is a solid, and poor dermal absorption if it is in solution based on the low water solubility and
high molecular weight. EPA plans no further analysis of this pathway for workers or occupational non-
users in the risk evaluation.
Waste handling, treatment and disposal
Figure 2-2 shows that waste handling, treatment and disposal is expected to lead to the same low hazard
conclusion as other industrial and commercial activities and uses. During problem formulation, EPA
further analyzed the potential exposures and hazards to consumers and bystanders and has refined the
conceptual models accordingly. Releases of C.I. Pigment Violet 29 from recycling of used papers and
plastic articles containing C.I. Pigment Violet 29 is possible. However, due to its low water solubility
and high sorption to particulates and biosolids, most C.I. Pigment Violet 29 in aqueous waste streams is
expected to be captured in the waste water treatment systems. As a result of the lack of exposure
expected to result from this pathway, EPA plans no further analysis of this pathway for workers or
occupational non-users in the risk evaluation. Figure 2-3 in the C.I. Pigment Violet 29 Scope Document
presented the possible exposure pathways, exposure routes and hazards to human receptors from
consumer activities and uses of C.I. Pigment Violet 29 ( 17c). Due to these releases,
pathways and routes of exposure, EPA has concluded no further analysis of these pathways is warranted,
as indicated in Figure 2-3.
Consumer Handling and Recycling and Disposal of Waste
Releases of C.I. Pigment Violet 29 from recycling of used papers and plastic articles containing C.I.
Pigment Violet 29 is possible. However, due to its low water solubility, any C.I. Pigment Violet 29 in
aqueous waste stream is expected to be captured in the waste water treatment systems. As the majority
of C.I. Pigment Violet 29-containing consumer waste consists of consumer products that are expected to
enter the consumer waste streams for landfill disposal or recycling, consumer exposure to these products
is low, as these activities take place in licensed waste management facilities. Similarly, C.I. Pigment
Violet 29 in paints and plastics is expected to remain embedded in these materials, thereby limiting
exposure. Due to the low potential for exposure resulting from consumer activities and low toxicity to
human receptors, EPA plans no further analysis of these pathways for consumer activities in the risk
evaluation.
2.5.2 Conceptual Model for Environmental Releases and Wastes: Potential Exposures
and Hazards
The revised conceptual model (Figure 2-4) in the C.I. Pigment Violet 29 Scope Document presents
possible exposure pathways, exposure routes, and hazards to human and environmental receptors from
environmental releases and wastes of C.I. Pigment Violet 29 (U.S. EPA.! ). During problem
formulation, EPA further analyzed the potential exposures and hazards to the general population and
environmental receptors and has refined the conceptual models accordingly with releases, pathways and
routes of exposure that EPA has concluded do not warrant further analysis indicated in Figure 2-4.
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2.5.2.1 Pathways That EPA Plans to Include and Further Analyze in the Risk
Evaluation
There are no environmental release and waste pathways for the environment or general populations that
EPA plans to further analyze in the risk evaluation.
2.5.2.2 Pathways that EPA Plans to Include in the Risk Evaluation but Not Further
Analyze
Ambient Water and Drinking Water Pathways
Currently, no states or tribes include criteria for C.I. Pigment Violet 29 in water quality standards and
values are not available for use in NPDES permits. Thus, EPA cannot conclude that risk to human health
and aquatic life from exposure to C.I. Pigment Violet 29 in ambient waters has been effectively
managed. As a result, this pathway is included in the Risk Evaluation. EPA may publish CWA section
304(a) human health or aquatic life criteria for Pigment Violet 29 in the future if it is identified as a
priority under the CWA.
As described in Section 2.3.2, releases to water are expected to be limited from the sole U.S.
manufacturer and downstream users. Chemicals may enter surface water via either direct release to
water or release after treatment at POTWs, in compliance with an NPDES discharge permit. Due to low
water solubility and its solid physical state, direct releases of C.I. Pigment Violet 29 to water are
expected to partition into particulates and sediment; but the amounts are expected to be limited due to
minimal releases to surface water. Likewise, C.I. Pigment Violet 29 releases from downstream users to
POTWs would be expected to separate during settling in primary treatment due to low water solubility
and to partition largely to the biosolids and particulates during secondary treatment. Sorption to
particulates and biosolids are expected to be strong and water solubility is low; therefore, biosolids that
contain C.I. Pigment Violet 29 are expected to lead to negligible migration to ground water. Hence, C.I.
Pigment Violet 29 concentrations in surface water and groundwater are expected to be low based on
limited releases and physical-chemical properties (low water solubility).
Based on the environmental fate described, C.I. Pigment Violet 29 is also not expected to be present in
drinking water (surface or ground water) at significant levels and hence, oral ingestion of water is
deemed an insignificant exposure pathway for C.I. Pigment Violet 29. Furthermore, as described
previously, even if oral ingestion occurs, absorption of C.I. Pigment Violet 29 is expected to be limited
due to its very low water solubility. This conclusion is supported by available experimental human
health hazard data showing no adverse effects as a result of exposure to C.I. Pigment Violet 29 in both
acute and repeated-dose studies. Hence, EPA concludes that further analysis for risk to the general
population from oral exposures is not warranted.
Environmental hazard data reported in the ECHA Database indicate no effects were observed at the
solubility limit for C.I. Pigment Violet 29 in toxicity tests with an aquatic plant, an aquatic invertebrate
and a fish. Taken together with the limited releases expected to water (wastewater (direct/indirect) and
groundwater), EPA concludes that further analysis of exposures to aquatic species from exposure to C.I.
Pigment Violet 29 is not warranted. Similarly, as a result of the low potential for exposure to terrestrial
environmental receptors and low acute toxicity to the surrogate species (aquatic and mammalian),
further risk analysis to terrestrial environmental receptors is not warranted. As indicated above, this is
consistent with the Canadian Ecological Risk Classification for C.I. Pigment Violet 29, discussed in
Appendix A-l.
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Air Pathway
As indicated in Sections 2.3.1 and 2.3.2, low volatilization rates will limit fugitive air releases as vapor,
while engineering controls capture the majority of any C.I. Pigment Violet 29 that would be released
during incineration. Dust handling systems are in place at the manufacturing facility that capture C.I.
Pigment Violet 29 lost as dust during manufacturing. The efficiency rate is greater than 99.5% (Mott.
2017b; Sun Chemical. 2.017b). Furthermore, absorption via inhalation is expected to be low due to low
water solubility. Due to the low potential for inhalation exposure and low potential absorption and low
inhalation toxicity, this pathway will not be further evaluated in the risk evaluation.
Disposal Pathways
The sole domestic manufacturer of C.I. Pigment Violet 29 has estimated standard yield loss of 1-2% of
the volume during the manufacturing (6,000- 12,000 pounds for 2015) (Mott 2017b). Greater than 95%
of this loss is estimated to be captured via on-site above ground biological wastewater treatment system
that captures C.I. Pigment Violet 29 as well as dust handling systems in place at the manufacturing
facility, which capture dust in baghouses (Mott. ).
As indicated above, and in Section 2.3.2, the sole U.S. manufacturer of C.I. Pigment Violet 29 sends its
non-hazardous wastewater treatment residuals (sludge) to the Oak Ridge Landfill in Dorchester County
or the Berkeley County Landfill. Both landfills are RCRA Subtitle-D lined landfills permitted under the
authority of South Carolina Regulation Number 61-107.19.
In addition to design standards for Subtitle-D lined landfills which are intended to limit the potential for
leachate, sorption to particulates and biosolids for C.I. Pigment Violet 29 are expected to be strong and
water solubility is low, so leaching of C.I. Pigment Violet 29 from landfills is expected to be negligible.
C.I. Pigment Violet 29 contained in consumer products is expected to be encapsulated in plastics or
paint resins, which further limits the potential for leaching from disposal of these products. Due to the
low potential for exposure, low hazards to human health and low hazard to environmental receptors,
EPA concludes further evaluation of exposures resulting from disposal to landfills is not warranted.
As indicated in Section 2.3.2, the sole U.S. manufacturer of C.I. Pigment Violet 29 sends its non-
hazardous wastewater treatment residuals (sludge) to the Oak Ridge Landfill in Dorchester County or
the Berkeley County Landfill. Both of these landfills are RCRA Subtitle-D lined landfills permitted
under the authority of South Carolina Regulation Number 61-107.19, so land application of biosolids is
not expected to be a release pathway for the manufacturer, so this pathway is outside of scope of this
assessment. Similarly, EPA does not plan to include on-site releases to land that go to underground
injection. There are no current underground injection sites for C.I. Pigment Violet 29 and none are
expected; so this disposal pathway is also outside the scope of this evaluation.
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INDUSTRIAL AND COMMERCIAL
ACTIVITIES/USES
Manufacturing
Processing:
• Use as an
Intermediate to
Create or Adjust
Color of Other
Perylene
Pigments
• Incorporated into
Formulation,
Mixture, or
Reaction Product
Paints and Coatings
Plastic and Rubber
Products
Merchant Ink for
Commercial Printing
Wastewater, Liquid
Wastes, Solid Wastes
(See Figure 2-4)
EXPOSURE PATHWAY
EXPOSURE ROUTE
RECEPTORS d
HAZARDSf
Liquid Contact
¦c
Fugitive
Emissions c
Mist/Dust
Workers
Occupational
Non-Users
Low Hazard Associated with Acute
and/or Chronic Exposures
See Section 2.4.2
Outdoor Air (See Figure
2-4 for Emissions to Air)
Stack
Emissions c
Air Pollution Control
¦> Liquid Contact, Dust
Dermal, Inhalation
KEY:
~ Pathways that will not be further
analyzed
Gray Text: In scope; will not be further analyzed
Figure 2-2. C.I. Pigment Violet 29 Conceptual Model for Industrial and Commercial Activities and Uses: Potential 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 C.I. Pigment Violet 29.
a Other uses of C.I. Pigment Violet 29 may include: applications in odor agents, cleaning/washing agents, surface treatment, absorbents and adsorbents, laboratory
chemicals, pharmaceuticals, light-harvesting materials, transistors, molecular switches, solar cells, optoelectronic devices, paper, architectural uses, polyester fibers,
adhesion, motors, generators, vehicle components, sporting goods, appliances, agricultural equipment and oil and gas pipelines
b Some products are used in both commercial and consumer applications.
0 Stack air emissions are emissions that occur through stacks, confined vents, ducts, pipes or other confined air streams. Fugitive air emissions are those that are not stack
emissions, and include fugitive equipment leaks from valves, pump seals, flanges, compressors, sampling connections, open-ended lines; evaporative losses from surface
impoundment and spills; and releases from building ventilation systems.
d Receptors include potentially exposed and susceptible subpopulations.
e When data and information are available to support the analysis, EPA also considers the effect that engineering controls and/or personal protective equipment (PPE)
have on occupational exposure levels.
f EPA will review full study reports to confirm preliminary low hazard conclusions.
Page 34 of 58
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CONSUMER ACTIVITIES / USES a
EXPOSURE PATHWAY
EXPOSURE ROUTE
RECEPTORS b
HAZARDS c
Consumer Watercolor and Artistic
Color
Liquid Contact
(Indoor Use)
Dermal
Consumers,
Bystanders
— +
Low Hazard Associated with Acute
and/or Chronic Exposures
See Section 2.4.2
I
Consumer Handling, Recycling and
Disposal of Waste
Liquid Contact
I
i
Wastewater, Liquid Wastes, Solid Wastes
(See Figure 2-4)
Derma
Consumers,
Bystanders
KEY:
~ Pathways that will not be further
analyzed
Gray Text: In scope; will not be further analyzed
Figure 2-3. C.I. Pigment Violet 29 Conceptual Model for Consumer Activities and Uses: Potential Exposures and Hazards
The conceptual model presents the exposure pathways, exposure routes and hazards to human receptors form consumer activities and uses of
C.I. Pigment Violet 29.
a Some products are used in both commercial and consumer applications.
b Receptors include potentially exposed or susceptible populations.
0 EPA will review Ml study reports to confirm preliminary low hazard conclusions.
Page 35 of 58
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RELEASES AND WASTES FROM EXPOSURE PATHWAY EXPOSURE ROUTE RECEPTORS c HAZARDSd
INDUSTRIAL / COMMERCIAL / CONSUMER USES
Direct
discharge
Water,
Sediment
Aquatic
Species
Indirect discharge
General
Population
Ground
water
>-~
Soil
—~
_Waste Transport_
Air
Terrestrial
Species
Emissions to Air
POTW
Wastewater or
Liquid Wastes a
Recycling, Other
Treatment
Inhalation b
Off-site Waste
Transfer
Oral
Liquid Wastes
Solid Wastes
Industrial Pre-
Treatment or
Industrial WWT
Incinerators
(Municipal &
Hazardous Waste)
Municipal,
Hazardous
Landfill or Other
Land Disposal
Low Hazard Associated with Acute and/or
Chronic Exposures
Low Hazard Associated with Acute and/or
Chronic Exposures
Low Hazard Associated with Acute and/or
Chronic Exposures
~ Pathways that will not be further analyzed.
Gray Text: In scope; will not be further analyzed
KEY:
Figure 2-4. C.I. Pigment Violet 29 Conceptual Model for Environmental Releases and Wastes: Potential Exposures and Hazards
The conceptual model presents the exposure pathways, exposure routes and hazards to human and environmental receptors from environmental releases and
wastes of C.I. Pigment Violet 29.
a Industrial wastewater or liquid wastes may be treated on-site and then released to surface water (direct discharge), or pre-treated and released to POTW (indirect discharge). For
consumer uses, such wastes may be released directly to POTW (i.e., down the drain). Drinking water will undergo further treatment in drinking water treatment plant. Groundwater may
also be a source of drinking water.
b Presence of mist to the enviromnent is not expected.
0 Receptors include potentially exposed or susceptible populations.
d EPA will review full study reports to confirm preliminary low hazard conclusions.
Page 36 of 58
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2.6 Analysis Plan
As described in Section 2.5, due to physical-chemical and fate properties, limited use volumes outside
the manufacturing site, limited environmental releases, and low absorption by all routes of exposure, it is
concluded further analysis of exposure pathways to workers, consumers and the general population is
not warranted. As noted, EPA has obtained full study reports for all physical and chemical properties,
environmental fate, environmental hazard and human health hazard data from the ECHA Database
(ECH.A. 2.017b) and the Food Additive Petition (FAP) 8B4626 ( a). The full study reports
will be reviewed by EPA as it develops the Draft Risk Evaluation. The low environmental and human
health hazards reported in these robust study summaries led the EPA to preliminarily conclude that C.I.
Pigment Violet 29 presents a low hazard to human health and environmental receptors. The aquatic
study summaries indicated that no effects were observed up to the solubility limit of C.I. Pigment Violet
29, while the acute and repeated-dose study summaries for human health reported no adverse effects. If,
upon review of the full study reports, the results are not scientifically sound or consistent with the robust
summary reports, EPA may conduct additional analysis to characterize the potential risks of this
chemical, which could include changes to the pathways analyzed.
Based on all currently available information, including robust study summaries indicating low hazard,
EPA preliminarily proposes no further analysis of environmental releases and exposure pathways. EPA
will review any public comments and additional data/information prior to the publication of the Draft
Risk Evaluation and incorporate these responses in the Draft Risk Evaluation. As per EPA's final rule,
;dures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act EPA will
also take comment and peer review the Draft Risk Evaluation for C.I. Pigment Violet 29.
Page 37 of 58
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REFERENCES
ACA (American Coatings Association). (2017). Letter from ACA to the U.S. EPA. March 15, 2017. RE:
EPA Designation of Ten Chemical Substances for Initial Risk Evaluations Under the Toxic
Substances Control Act; Pigment Violet 29. (EPA-HQ-OPPT-2016-0725).
BASF. (1998a). Food additive petition for safe use of anthra[2,l,9-DEF:6,5,10-D'E'F']diisoquinoline-
1,3,8,10(2H,9H)-tetrone, C.I. Pigment Violet 29, Paliogen® Red Violet K 5011, as a colorant in
all polymers.
BASF. (1998b). Paliogen Redviolet K 5011.
http://www2.basf.iis/additives/pdfs/Paliogen Redviolet K>011 pdf
BASF. (2017). Paliogen® Red Violet K 5011: Material Safety Data Sheet.
COLORS, L. (2011). 1029 Perylene Violet 29. Available online at
http://www.pigm.ents.com/pdf/1029.pdf
CPMA (Color Pigment Manufacturers Association). (2017a). Letter from CPMA to the U.S. EPA.
March 13, 2017 [Comment], (EPA-HQ-OPPT-2016-0725). Color Pigments Manufacturers
Association, Inc. https://www.regulations.gov/document'?D=EPA-HQ-OPPT-2016-0725-0006
CPMA (Color Pigment Manufacturers Association). (2017b). Letter from CPMA to the U.S. EPA.
September 19, 2017. Re: Comments on the Scope of the Risk Evaluation, and on EPA's Planned
Problem Formulation, for C.I. Pigment Violet 29 (Anthra[2,l,9-def;6,5,10-d'e'f]diisoquino-line-
1,3,8,10(2H,9H)tetrone), Chemical Abstracts Service No. 81-33-4. (EPA-HQ-OPPT-2016-0725).
Color Pigments Manufacturers Association, Inc.
ECHA (European Chemicals Agency). (2017a). ECHA registration dossier: Naphthalene-1,8-
dicarboximide. CAS number: 81-83-4. (EC number: 201-379-7). Helsinki, Finland.
https://echa.eiiropa.eu/registration-dossierA/registered-dossier/8318/1
ECHA. (2017b). Perylene-3, 4; 9, 10-tetracarboxydiimide. Helsinki, Finland. Retrieved from
https://eeha.euTOpa.eu/registration-dossierA/registered-dossier/10330
Environment Canada. (2006). Canadian Environmental Protection Act Substances List: Categorization
of Existing Substances. (GoCN_20060905). https://www.ec.gc.ca/lcpe-cepa/D031CB30-B3IB-
D54C~0E46~37E32D526A.lF/GoCN 20060905 eng.pdf
IARC (International Agency for Research on Cancer). (2010). Some non-heterocyclic poly cyclic
aromatic hydrocarbons and some related exposures [IARC Monograph] (pp. 1-853). Lyon,
France. http://monographs.iarc.fr/ENG/Monographs/vol92/mono92.pdf
Mott, RC. (2017a). Personal communication between Dr. Robert C. Mott (Sun Chemical Corporation)
and Alie Muneer (EPA) regarding exposure questions [Personal Communication],
Mott, RC. (2017b). Personal communication between Dr. Robert C. Mott (Sun Chemical Corporation)
and Alie Muneer (EPA) regarding release of PV29 to Cooper River [Personal Communication],
OECD (Organisation for Economic Co-operation and Development). (2017). Categorization results from
the Canadian domestic substance list: Anthra[2,l,9-def:6,5,10-d'e'f]diisoquinoline-
1,3,8,10(2H,9H)-tetrone. CASRN: 81-33-4.
https://canadachemicals.oecd.org/ChemicalDetails.aspx7Chemical 396-fb0b-4c24-
977e-813a67a9d834
Sun Chemical (Sun Chemical Corporation). (2017a). Email from Sun Chemical Corporation to Hannah
Braun at U.S. EPA.
Sun Chemical (Sun Chemical Corporation). (2017b). Response regarding request for substantiation of
Sun Chemical Corporation's confidential business information claims related to Pigment Violet
29 in CDR-2016-01819.
Sun Chemical (Sun Chemical Corporation). (2017c). Safety Data Sheet: PERRINDO® Violet 29.
Page 38 of 58
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Sun Chemical (Sun Chemical Corporation). (2017d). Safety Data Sheet: Violet 29.
U.S. EPA (U.S. Environmental Protection Agency). (1998). Guidelines for ecological risk assessment
[EPA Report], (EPA/630/R-95/002F). Washington, DC: U.S. Environmental Protection Agency,
Risk Assessment Forum, http://www.epa.gov/raf/publications/guidelines-ecological-risk-
assessment.htm
U.S. EPA (U.S. Environmental Protection Agency). (2006). A Framework for Assessing Health Risk of
Environmental Exposures to Children (pp. 1-145). (EPA/600/R-05/093F). Washington, DC: U.S.
Environmental Protection Agency, Office of Research and Development, National Center for
Environmental Assessment, http://cfpub.epa.gov/ncea/cfm/recordisplav.cfm?deid=l58363
U.S. EPA (U.S. Environmental Protection Agency). (2011). TSCA Inventory Update Modifications:
Chemical Data Reporting (pp. 50816-50879). (158). Federal Register.
http://www.regulations.gOv/#! documentDetail:D=EPA-HQ-QPPT-2009-0187-0393
U.S. EPA (U.S. Environmental Protection Agency). (2012a). 2012 Chemical Data Reporting Results.
Available online at https://www.epa.gov/chemical-data-reporting/ fiemical-data-reporting-
results
U.S. EPA (U.S. Environmental Protection Agency). (2012b). Estimation Programs Interface (EPI)
Suite™ for Microsoft® Windows (Version 4.11). Washington D.C.: Environmental Protection
Agency. Retrieved from http://www.epa.gov/opptintr/exposure/pubs/episuite.htm
U.S. EPA (U.S. Environmental Protection Agency). (2012c). TSCA work plan chemicals: Methods
document. 1-28. https://www.epa.gov/sites/production/files/2Q14-
03/documents/work plan methods document web final.pdf
U.S. EPA (U.S. Environmental Protection Agency). (2014). Framework for human health risk
assessment to inform decision making. Final [EPA Report], (EPA/100/R-14/001). Washington,
DC: U.S. Environmental Protection, Risk Assessment Forum.
https://www.epa.gov/risk/framework-hiiman-health-iisk-assessment-inform-decision-making
U.S. EPA (U.S. Environmental Protection Agency). (2016a). Instructions for reporting 2016 TSCA
chemical data reporting, https://www.epa.gov/chemical-data-reporting/instructions-reporting-
2016-tsca-chemical-data-reporting
U.S. EPA (U.S. Environmental Protection Agency). (2016b). Public database 2016 chemical data
reporting (May 2017 release). Washington, DC: US Environmental Protection Agency, Office of
Pollution Prevention and Toxics. Retrieved from https://www.epa.gov/chemical-data-reporting
U.S. EPA (U.S. Environmental Protection Agency). (2017a). Pigment Violet 29 (CASRN: 81-33-4)
bibliography: Supplemental file for the TSCA scope document [EPA Report], U.S. EPA, Office
of Chemical Safety and Pollution Prevention, Office of Pollution Prevention and Toxics.
https://www.epa.gOv/sites/production/files/2 /documents/pv29 comp bib.pdf
U.S. EPA (U.S. Environmental Protection Agency). (2017b). Preliminary information on manufacturing,
processing, distribution, use, and disposal: Anthra[2,l,9-def:6,5,10-d'e'f] diisoquinoline-
1,3,8,10(2h,9h)-tetrone; Pigment violet 29. (EPA-HQ-OPPT-2016-0725-0004).
https://www.regulations.gov/document?D=EPA-HQ-QPPT-2016-0725-0004
U.S. EPA (U.S. Environmental Protection Agency). (2017c). Scope of the risk evaluation for Pigment
Violet 29 (Anthra[2,l,9-def:6,5,10-d'e'f]diisoquinoline-l,3,8,10(2H,9H)-tetrone): CASRN: 81-
33-4 [EPA Report], (740-R1-7011). U.S. EPA, Office of Chemical Safety and Pollution
Prevention, Office of Pollution Prevention and Toxics.
https://www.epa.gov/sites/prodiiction/files/201' -0.'/documents/pv29 scope„CKl_^ pdf
U.S. EPA (U.S. Environmental Protection Agency). (2017d). Strategy for conducting literature searches
for Pigment Violet 29 (PV29): Supplemental document to the TSCA scope document. CASRN:
81-33-4 [EPA Report], U.S. EPA, Office of Chemical Safety and Pollution Prevention, Office of
Page 39 of 58
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Pollution Prevention and Toxics, https://www.epa.gov/sites/production/files/
06/documents/pv29 lit search strategy
U.S. EPA (U.S. Environmental Protection Agency). (2018a). Application of systematic review in TSCA
risk evaluations: Version 1.0. (740P18001). Washington, D.C.: U.S. Environmental Protection
Agency, Office of Chemical Safety and Pollution Prevention.
APPENDICES
Appendix A. REGULATORY HISTORY
A-l Background Information on the Inclusion of C.I. Pigment Violet 29
in TSCA 2012 and 2014 Work Plans
C.I. Pigment Violet 29 was added to the TSCA Work Plan in 2012. As described in detail in the
Methodology (U.S. EPA. 2012c). all chemicals on the Work Plan were scored by 3 criteria: hazard,
exposure and persistence and bioaccumulation. The criteria were scored from 1-3, where 3 is the highest
concern and 1 is the lowest concern. See TableApx A-l for scoring of C.I. Pigment Violet 29. The
purpose of the Work Plan was not to evaluate risk, but used as a tool for screening chemicals.
Table Apx A-l: 2014 TSCA Work Plan
ChfilK.jl MwJim:
Whfin w
PtlSlfttt'ilCC ?r
ItHMa: initiation
C.iiI»mi
-------
criteria for categorisation as a prioritized substance for further assessment. The determination for C.I.
Pigment Violet 29 and seven other similar pigments was made using a combination of QSAR modeling
and hazard data for analogous pigments with low solubility (Pigment Red 149; CAS RNs 4948-15-6).
The conclusion of this screening was consistent with EPA's findings and indicated that because of low
toxicity and low solubility, C.I. Pigment Violet 29 did not meet the criteria for further assessment and
the potential hazard is low (Environment Canada. 2006).
In 2012, C.I. Pigment Violet 29 was given the highest exposure score of 3 based on findings in
consumer products and moderate release to the environment. Data weighed to determine the score were
the production volume in CDR 2012's reporting year (520,916 pounds per year), number of use sites (1),
the Industrial Function Category (pigments) and the reported commercial uses and use in consumer
products. Expert judgment, generic scenarios, experience with new and existing chemical assessments
and exposure scenarios were drawn on to derive the final exposure score of 3. Updated data from the
2016 CDR had no effect on the exposure score. The current Problem Formulation for C.I. Pigment
Violet 29 uses more specific exposure data and should be regarded as more accurate compared to the
scores created in the 2012 and 2014 Work Plan process.
A-2 Federal Laws and Regulations
TableApx A-4. Federal Laws and Regulations
Mat ulcs/Uegulal ions
Description of
Authority/Regulation
Description of Regulation
EPA Regulations
TSCA - Section 6(b)
EPA is directed to identify and
begin risk evaluations on
10 chemical substances drawn
from the 2014 update of the
TSCA Work Plan for Chemical
Assessments.
C.I. Pigment Violet 29 is on the
initial list of chemicals to be
evaluated for unreasonable risk
under TSCA (81 FR 91927,
December 19, 2016).
TSCA - Section 8(a)
The TSCA § 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.
C.I. Pigment Violet 29
manufacturing (including
importing), processing and use
information is reported under the
CDR Rule (76 FR 50816, August
16, 2011).
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.
C.I. Pigment Violet 29 was on
the initial TSCA Inventory and
therefore was not subject to
EPA's new chemicals review
process under TSCA section 5
Page 41 of 58
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Statutes/Regulations
Description of
Authority/Regulation
Description of Regulation
(42 FR 64572, December 23,
1977).
Oilier Kederal Regulations
Food and Drug Administration
(FDA)
Chemicals that come in contact
with food must first be reviewed
by the FDA for safety. In 1998
BASF submitted a petition for
C.I. Pigment Violet 29 to be a
food additive.
C.I. Pigment Violet 29 is
approved to be in finished
articles that come in contact with
food. It should not to exceed 1%
by weight of polymers and
should follow specific conditions
of use (21 CFR 178.3297). C.I.
Pigment Violet 29 is not listed as
an approved food additive.
A-3 International Laws and Regulations
TableApx A-5. International Laws and Regulations
Count rv/O rga n i/a 1 io n
Requirements and Restrictions
Australia
C.I. Pigment Violet 29 is on the Australian Inventory for
Chemical Substances (AICS), a database of chemicals
available for industrial use in Australia. There are no
regulatory obligations or conditions cited for C.I. Pigment
Violet 29 1
Canada
C.I. Pigment Violet 29 is on the public portion of the Domestic
Substances List (DSL). The DSL is an inventory of
approximately 23,000 substances manufactured, imported or
used in Canada on a commercial scale. Substances not
appearing on the DSL are considered to be new to Canada and
are subject to notification.2
China
C.I. Pigment Violet 29 is on the non-confidential Inventory of
Existing Chemical Substances Produced or Imported in China
(IECSC). The inventory was last updated on January 31,
2013.3 There are no restrictions associated with being on the
Chinese inventory.
1 Australian Government. National Industrial Chemicals Notification and Assessment Scheme. Accessed March 14,2017.
https://www.nicnas. gov. au/search/chemical?id= 1.1.89.
2 Government of Canada. Environment and Climate Change Canada. Search Engine for Chemicals and Polymers. Accessed March 14,
2017. http://www.ec.gc.ca/lcpe-cepa/eng/substance/chemicals polymers.cfm.
3 Chemical Inspection & Regulation Service. The Inventory of Existing Chemical Substance in China - IECSC (2013 and updates). April
20,2016. Accessed October 11, 2017. http://www.cirs-reach.com/news-and-articles/the-inventory-of-existing-chemical-substance-in-chiiia-
iecsc-201.3-and-updates.html.
Page 42 of 58
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Co ii 111 rv/O r«a n i/a 1io n
Requirements and Restrictions
European Union
C.I. Pigment Violet 29 is on the European Inventory of
Existing Commercial Chemical Substances (EINECS) List,
which includes chemical substances deemed to be on the
European Community market between January 1, 1971 and
September 18, 1981.4 Based on information provided in the
Registration, Evaluation, Authorisation and Restriction of
Chemicals (REACH) dossier, C.I. Pigment Violet 29 is not
classified as a hazard on the Classification and Labelling list.
Japan
In accordance with the provisions of Chemical Substances
Control Law, C.I. Pigment Violet 29 is exempt from the new
chemical notification requirement and listed as Low Molecular
Heterocyclic Organic Compound on the existing chemical
substances list.5
Korea
C.I. Pigment Violet 29 is on the Korea Existing Chemicals
Inventory because it is a chemical that was domestically
commercialized prior to February 2, 1991 and was designated
and published by the Minister of Environment in consultation
with the Minister of Labor.6 There are no restrictions
associated with being on the Korean inventory.
New Zealand
C.I. Pigment Violet 29 was added to the New Zealand
Inventory (NZloC) on January 12, 2006 with the approval
status that it may be used as a component in a product covered
by a group standard, but it is not approved for use as a
chemical in its own right. There are no restrictions or
exclusions associated with C.I. Pigment Violet 29.7
Philippines
C.I. Pigment is on the Philippines Inventory of Chemicals and
Chemical Substances (PICCS). PICCS was developed to
provide government, industry and the public with a core
inventory of all existing chemicals and chemical substances in
the country and is updated annually.8 There are no restrictions
associated with being on the Philipino inventory.
4 ChemSafetyPRO. EU Chemical Inventory: EINECS, ELINCS andNLP. January 18, 2017. Accessed March 14, 2017.
http://www.chemsafetypro.com/Topics/EU/EU Chemical_Inventory EINECS ELINCS NLP.html.
5 NITE Chemical Risk Information Platform (NITE-CHRIP). Accessed March 14,2017.
http://www.nite.go.jp/en/chem/chrip/chrip search/cmpInfDsp?cid=CO 10-529-
04A&bcPtn=0&shMd=0&txNumSh=QDEtMzMtNA:
Sh2=<NmTp2
&1 tNmTp=&l t'.NiiiMh= 1. &txNmSh 1. =&1 t'NiiiTp 1. =&txNm
&txMlSli=<MlMli=0<ScDp=0<PgCtSt=100&rbDp=0&txScSML=<ScTp=l&txIJpScFl
&.txNiiiSh3=<.NiiiTp3
=null&hdUpScPh=&hdUpHash=&rbScMh=l&txScNvMh=&txMlWtSt=&txMlWtEd=&eiT
6 Chemical Inspection & Regulation Service. Korea Existing Chemicals Inventory. December 20, 2016. Accessed October 11, 2017.
http://www.cits-ieach.com/KoreaTCCA/Korea Existing Chemicals Inventory KECI.html.
7 Environmental Protection Authority. Anthra[2,l,9-def:6,5,10-d'e'f]diisoquinoline-l,3,8,10(2H,9H)-tetrone. Accessed October 11,2017
8 Republic of the Philippines Chemical Management Section. Philippine Inventory of Chemicals and Chemical Substances. Accessed
October 11,2017. http://chemicaLemb.gov.pIi/7page id=138.
Page 43 of 58
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Co ii ii 1 rv/O r«a n i/a 1io n
Requirements and Restrictions
Taiwan
C.I. Pigment Violet 29 in on the National Existing Chemical
Inventory in Taiwan. There are no restrictions associated with
being on the Taiwanese inventory.9
Vietnam
C.I. Pigment Violet 29 is on the draft (March 2017) Vietnam
National Existing Chemical Inventory. There are no
restrictions associated with being on the Vietnamese
inventory.10
9 Occupational Safety and Health Administration, Ministry of Labor. TCSI Search. Accessed October 11, 2017.
https://csmi.osha.gov.tw/content/home/Snbstance Result.aspx?enc=XpkoFr9qGvTvISX6V8igsO==.
10 ChemSafetyPRO. Vietnam National Existing Chemical Inventory. October 28, 2016. Accessed October 11, 2017.
http://www.chemsafetvpro.com/Topics/Vietnam/Vietnam National Existing Chemical Inventorv.html.
Page 44 of 58
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Appendix B. LIST OF ON-TOPIC REFERENCES EXCLUDED
FROM FURTHER CONSIDERATION
The following references were listed in their pertinent sections in the C.I. Pigment Violet 29
Bibliography document.
Engineering/Occupational Exposure
The following on-topic references were excluded from further consideration during a second
title/abstract screening:
Guillermet, O; Mossoyan-Deneux, M; Giorgi, M; Glachant, A; Mossoyan, JC. (2006). Structural study
of vapour phase deposited 3,4,9,10-perylene tetracarboxylicacid diimide: Comparison between
single crystal and ultra thin films grown on Pt(100). Thin Solid Films. 514: 25-32.
sciencedirect.
Kozma, E; Catellani, M. (2013). Perylene diimides based materials for organic solar cells. Dyes and
Pigments. 98: 160-179. http://www.sciencedirect.com/science/article/pii/ 31300034X.
Ling, MM; Erk, P; Gomez, M; Koenemann, M; Locklin, J; Bao, Z. (2007). Air-stable n-channel organic
semiconductors based on perylene diimide derivatives without strong electron withdrawing
groups. Adv Mater Deerfield. 19: 1123-1127.
http://onlinelibrary.wiley.com/doi/10.1002/adma.200601705/abstract.
OPPT Risk Assessment, Problem Formulation or Scope Document
The following on-topic references were excluded from further consideration during a second
title/abstract screening because they pertain to pigments other than C.I. Pigment Violet 29:
(1994). Emergency Planning and Community Right to Know Act: Section 313 Release Reporting
Requirements. (700K94001). http://nepis.epa.eov/exe/ZyPIJRL.cgi?Dockev=9100KEB3.txt
(1996). Best Management Practices for Pollution Prevention in the Textile Industry, Manual.
(625R96004). http://nepis.epa.gov/exe/ZyPURL.cgi?Dockey=30004Q2U.txt
(1996). Pollution prevention in the paints and coatings industry. (EPA/625/R-96/003). Cincinnati, OH:
https://nepis.epa.gov/Exe/ZyPDF.cgi/30004PX0.PDF?Dockey=30004PX0.PDF
(2017). Chemical data reporting: Anthra[2,l,9-def:6,5,10-d 'e'f]diisoquinoline-l,3,8,10(2H,9H)-tetrone
[Database], Retrieved from http://java.epa.g+X32:A032ov/chemview
(2017). Echem Portal: Perylene-3,4:9, 10-tetracarboxydiimide [Database]: European Chemicals Agency.
Retrieved from http://www.echemportal.org/echemportal/index7page request locale=en
Ashford, RD. (2001). Perylimide. In Ashford's Dictionary of Industrial Chemicals.
Canada, E; Canada, H. (2014). Screening Assessment. Aromatic Azo and Benzidine-based Substance
Grouping. Certain Diarylide Yellow Pigments. Environment Canada and Health Canada.
Canada, E; Canada, H. (2016). Screening Assessment. Aromatic Azo and Benzidine-based Substance
Grouping. Certain Monoazo Pigments. Environment Canada and Health Canada.
http://www.ec.gc.ca/ese-ees/default. asp?lang=En&n=9C4D A3 06-lhttp://www.ec.gc.ca/ese-
ees/default.asp?lans
.ec.gc.ca/ese-
ees/default.asp?lang=En&n=9C4DA306-lhttp://www.ec.gc.ca/ese-
ees/default.asp?lang=En&n=9C4DA306~l
Charvat, RA. (2004). Colorants for plastics.
Page 45 of 58
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Corporation, AC. (2014). Material Safety Data Sheet AArbor Yellow. Available online at
https://www.kimibiz.com/pdfs/64-1265%20MSDS.pdfhttps://www.kimibiz.com/pdfs/64-
1265%20MSDS.pdfhttps://www.kimibiz.com/pdfs/64-
1265%20MSDS.pdfhttps://www.kimibiz.com/pdfs/64-1265%20MSDS.pdf
CPMA. (2006). High Production Volume (HPV) Challenge Program: Test Plan for Test Plan for C. I.
Pigment Red 48 (Barium), C.I. Pigment Red 48 (Calcium) and C.I. Pigment Red 52 (Calcium).
Monoazo and Related Pigments Committee, Color Pigment Manufacturers Association, Inc.
CPMA. (2006). High Production Volume (HPV) Challenge Program, Test Plan for C.I. Pigment Yellow
14 (CAS NO.: 5468-75-7). Diarylide Pigments Committee, Color Pigment Manufacturers
Association, Inc.
CPMA. (2011). Comments of the Color-Pigments Manufacturers Association, Inc. Regarding Diarylide
Pigments and the CIC Consultation on 3,3'- Dichlorobenzidine-Based Compounds Metabolized
to 3,3'- Dichlorobenzidine. Washington, DC: Color Pigments Manufacturers Association, Inc.
Du, S; Wall, SI; Cacia, D; Rodenburg, LA. (2009). Passive air sampling for polychlorinated biphenyls in
the Philadelphia metropolitan area. Environ Sci Technol 43: 1287-1292.
http://dx.doi.org/10.1021/es802957y
EC (European Commission). (2000). IUCLID Dataset: Yellow 83, CAS No. 5567-15-7. Ispra, Italy:
European Chemicals Bureau, European Commission, http://iuclid.eu
EC (European Commission). (2012). Opinion on Pigment Red 57 ColipaN0 C181. (SCCS/1411/11).
Brussels, Belgium: Scientific Committee on Consumer Safety, Health & Consumers Directorate
D: Health Systems and Products.
http://ec.eiiropa.eii/health/scientific committees/consumer safetv/docs/sccs o 112.pdf
ECCC (Environment and Climate Change Canada). (2013). Search Engine for Chemical and Polymers.
http://www.ec.gc.ca/lcpe-cepa/ene/substance/chem.icals polymers, cfm
Hu, D; Martinez, A; Hornbuckle, K. (2008). Discovery of non-aroclor PCB (3,3'-dichlorobiphenyl) in
Chicago air. Environ Sci Technol 42: 7873-7877. http://dx.doi.ore |0 .K'.'J es801823r
Jaffe, EE. (2004). Pigments, organic. In Kirk-Othmer Encyclopedia of Chemical Technology, [online]:
John Wiley & Sons.
http://onlinelibrary.wilev.eom/doi/10.1002/0 !"/1 J 'S96.I J >j_S0 '01 1001060605.a01 .pub2/abstract
Lai, DY. (1984). Halogenated Benzenes, Naphthalenes, Biphenyls and Terphenyls In The Environment:
Their Carcinogenic, Mutagenic And Teratogenic Potential And Toxic Effects (pp. ENVIRON
CARCINOGREV 2:135-ENVIRON CARCINOG REV 132:184). (ISSN 0736-3001;
EMICBACK/61512). Lai, DY. http://dx.doi.org/10.1080/10590508409373324.
Lai, DY; Woo, Y. (2014). Reducing Carcinogenicity and Mutagenicity Through Mechanism-Based
Molecular Design of Chemicals. In A Voutchkova (Ed.), (pp. 569). Somerset, NJ, USA: Wiley.
Litten, S; Fowler, B; Luszniak, D. (2002). Identification of a novel PCB source through analysis of 209
PCB congeners by US EPA modified method 1668. Chemosphere 46: 1457-1459.
http://dx.doi.ore h< ioto S0045-6535f01)00253-3hm> /S0045~
65 3 5 (01 )0025 3 -3 http: //dx. doi. or e .
3 http://dx.doi.ore/10.1016/50045-6535(01)00253-3 http://dx.doi. ore/1 /S0045-
6535(01)00253-3
NJ DEP (New Jersey Department of Environmental Protection). (1976). Upper limits on atmospheric
ozone reductions following increased application of fixed nitrogen to the soil. Geophys Res Lett
3: 169-172. http://dx.doi.ore/10
NCMCG. (2017). Substances in preparations in Nordic countries: CAS 81-33-4 [Database],
Page 46 of 58
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OECD (Organisation for Economic Co-operation and Development). (1994). SIDS Initial Assessment
Report for SIAM 2: 2-Naphthalenecarboxylic acid, 3-hydroxy-4-[(4- methyl-2-sulfophenyl)azo]-
, calcium salt (D & C Red No. 7), CAS No.: 5281-04-9. Paris, France: Organisation for
Economic Cooperation and Development.
OECD (Organisation for Economic Co-operation and Development). (2003). SIDS Initial Assessment
Report for SIAM 16: C.I. Pigment Yellow 12; Butanamide, 2,2'[(3,3'-dichloro[l,r-biphenyl]-
4,4'diyl)bis(azo)]bis[3-oxy-N-phenyl-; C.I. Pigment Yellow 13; Butanamide, 2,2'[(3,3'-
dichloro[l,r-biphenyl]-4,4'diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxo-; C.I. Pigment
Yellow 83; Butanamide, 2,2'[(3,3'- dichloro[l,r-biphenyl]- 4,4'diyl)bis(azo)]bis[N-(4-chloro-
2,5-dimethoxyphenyl)-3-oxo. Paris, France: Organisation for Economic Cooperation and
Development, http://webnet.oecd.org/hpv/iii/handler.axd7ii '284D-EACC-4DD9-B 1CB-
2 J l 31 I lEEDhttp://webnet.oecd.org/hpv/ui/handler.axd?id=7450284D-EACC-4DD9-B1CB-
2 l-EEDhttp
//webnet.oecd.org/hpv/ui/handler.axd?id=7450284D-EACC-4DDS
2 tj)
//webnet.oecd.org/hpv/ui/handler.axd?id=7450284D-EACC-4DDS
2 EED
OECD (Organisation for Economic Co-operation and Development). (2017). Emission Scenario
Document (ESD) on the use of textile dyes, http ://www. oecd.org/chemicalsafety/risk-
as ses sm ent/em i ssi on seen ari odocum ents. htm
OECD. (2017). Emission Scenario Document (ESD) on the use of textile dyes.
http://www.oecd.org/chemicalsafety/risk-assessment/emissionscenariodocuments.htm
Rodenburg, LA; Guo, J; Du, S; Cavallo, GJ. (2010). Evidence for unique and ubiquitous environmental
sources of 3,3'-dichlorobiphenyl (PCB 11). Environ Sci Technol 44: 2816-2821.
http://dx.doi.org/10 I Oil ^ m >> b
U.S. EPA. (1970). Air pollutant emission factors: Paint and varnish (pp. 6.4.1-6.4.2). (APTD-0923).
U.S. EPA (U.S. Environmental Protection Agency). (1970). Air pollutant emission factors: Paint and
varnish (pp. 6.4.1-6.4.2). (APTD-0923). McLean, VA.
U.S. EPA (U.S. Environmental Protection Agency). (1990). Integrated Risk Information System (IRIS)
Chemical Assessment Summary: 3,3'-Dichlorobenzidine; CASRN 91-94-1. Washington, DC: US
Environmental Protection Agency.
https://cfpub.epa.gov/ncea/iris/iris documents/documents/subst/0504 summary.pdfhttps://cfpub.
epa.gov/ncea/iris/iris
/iris/iris docum ents/docum ents/ sub st/0504
?s://cfpub. epa.gov/ncea
summary.pdfhttps://cfpub.epa.gov/ncea/iris/iris doc
um ents/ docum ents/sub st/0504 summary. pdfhttps://cfpub. epa.gov/ncea/iris/iris docum ents/docu
ments/subst/0504 summary.pdfhttps://cfpub.epa.gov/ncea/iris/iris docum ents/ docum ents/sub st/
0504 summarv.pdfhttps://cfpub.epa.gov/ncea/iris/iris docum ents/docum ents/sub st/0504 sum ma
rv.pdfhttps://cfpub.epa.gov/ncea/iris/iris docum ents/ docum ents/sub st/0504 summary.pdf
U.S. EPA. (2010). Generic Scenario on Coating Application Via Spray Painting in the Automotive
Refinishing Industry - Draft Final.
U.S. EPA (U.S. Environmental Protection Agency). (2010). Screening-Level Hazard Characterization.
Sponsored Chemical: C.I. Pigment Yellow 14, CASRN 5468-75-7. Supporting Chemicals: C.I.
Pigment Yellow 13, CASRN 5102-83-0; C.I. Pigment Yellow 83, CASRN 5567-15-7; C.I.
Pigment Yellow 12 CASRN 6358-85-6. Washington, DC: US Environmental Protection Agency.
CI%20Piement%20Yellow%2014 March2010.pdf
U.S. EPA. (2014). Emission scenario document on the use of additives in plastics compounding -
methodology review draft. Washington, DC. oecd.org/chemicalsafety/risk-
assessment/emissionscenariodocuments.htm
Page 47 of 58
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Appendix C. PHYSICAL AND CHEMICAL PROPERTIES
Table Apx C-l: Physical and Chemical Properties for C.I. Pigment Violet 29
l osl miI>M;iikt
I'lnripoinl
Results
Nsinu' of U'sl
niiilci'iiil/Aiiiil.Miciil piii'il>
Tesl (.uidcliiK'/coiiiiiU'iKs
Sou itc
C.I. Pigment Violet
29
Melting point
>400 °C
Paliogen Violet 5011a/ >98-
99%
OECD Guideline 102/No melting
point found below 400 °C
(ECU A. 2017b)
C.I. Pigment Violet
29
Vapor Pressure
<0 hPa at 20 °C
Paliogen Violet 5011/ >98-
99%
OECD Guideline 104
(ECU A. 2017b)
C.I. Pigment Violet
29
Water Solubility
0.01 mg/L at 20 °C
Paliogen Violet 5011/ >98-
99%
OECD Guideline 105
(ECU A. 2017b)
C.I. Pigment Violet
29
Density
1.584 g/cm3 at 20 °C
Paliogen Violet 5011/ >98-
99%
OECD Guideline 109/ relative
density
(ECU A. 2017b)
C.I. Pigment Violet
29
Octanol/water
Partition Coefficient
<0.85 at 23 °C (measured)
3.76 (estimated)
Paliogen Violet 5011/ >98-
99%
Calculated on the basis of the
solubility in water and octanol
determined experimentally
(ECU A. 2017b)
(U.S. EPA,
2012b)
C.I. Pigment Violet
29
Solubility in n-
octanol
<0.07 mg/L at at 20 °C
Paliogen Violet 5011/ >98-
99%
Not stated
(ECU A. 2017b).
a BASF's trade name for C.I. Pigment Violet 29.
Page 48 of 58
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Appendix D. ENVIRONMENTAL FATE STUDY SUMMARIES
Table Apx D-l: Environmental Fate Studies for C.I. Pigment Violet 29
IVsl SIlllMillKT
Siudj (\|>e
I'lnripoinl
Description of icsl
iVMill/aimiiHwils
Sou ivo
C.I. Pigment Violet 29
OECD 30IF -Biodegradability:
Manometric Respirometry
Test)
% Biodegradation
0-10% (%BOD/ThOD)
biodegradation after 28 days.
(ECU A. 2017b)
EPA has received the full study
report from the data owner(s)
and this report is under review
C.I. Pigment Violet 29
OECD 305; Bioaccumulation;
8-weeks bioaccumulation study
Bioaccumulation factor (BCF
and BAF)
No bioaccumulation from the
8-weeks bioaccumulation
study. EPA EPI Suite estimate
has similar result: low
bioaccumulation (BCF=140;
BAF=50)
Private data owner(s)
EPA has received the full study
report from the data owner(s)
and this report is under review
C.I. Pigment Violet 29
OECD 209; Activated Sludge,
Respiration inhibition test
study
EC20 and EC50
Has low toxicity to the
activated sludge process in the
receiving wastewater treatment
plant (EC20 ca.1.8 mg/L, EC50
ca. 6.5 mg/L).
Private data owner(s)
EPA has received the full study
report from the data owner(s)
and this report is under review
Page 49 of 58
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Appendix E. ENVIRONMENTAL HAZARD STUDY SUMMARIES
E-l Toxicity to Aquatic Organisms
E-l-l Aquatic Plant Toxicity
Table Apx E-l: Aquatic Plant Toxicity Study for C.I. Pigment Violet 29
IVsl MlllSlillKT
Slliclj |J|H'
Species
l-lnripoinl
(omiiH'iils
Souivc
C.I. Pigment Violet 29
OECD-201; Aquatic
vascular plant: 7
days, static renewal
Duckweed
(Lemna gibba)
NES
(based on growth [frond
number and dry weight])
Nominal test concentrations: 0
(control), 1, 3.2, 10, 32, 100 mg/L
based on loading
Measured test concentration: 0.007
mg/L (highest)
Test solution preparation: "The control
and each test concentration was
filtrated through a conditioned
cellulose acetate membrane (Filter
Sartorius, 0.20 |im pores). The
concentrations 1.0 and 3.2 mg/L were
prepared by dilution from the
concentration 10.0 mg/L before the
filtration. Before the dilution was
made, the 10 mg/L concentration was
checked carefully for homogeneous
distribution of the test substance and
for presence of precipitated test
material. The test solution was clear
and without precipitates. The test
solution for the control was treated in
the same way as the mixtures for the
test concentrations: it was stirred for
72 hours, conditioned at 20 °C and was
filtrated in the same way as the test
concentrations to exclude any
influences from the preparation of the
test solutions. The preparation of the
test solutions as described resulted in
homogeneous solution, i.e., Water
(ECHA. 2017b)
EPA has received the
full study report from
the data owner(s) and
this report is under
review
Page 50 of 58
-------
IVsl MlllSlillKT
Slliclj |J|K'
Species
l-liidpoini
((miliums
Souivc
Accommodated Fraction (WAF)
which were used for exposure."
CECHA. 2017b)
Analytical measurements: "In fresh
solutions the measured concentrations
of test item were between 0.06 - 0.07
mg/L. The measured values did not
correlate with the loading, which
demonstrates that the measured
concentrations were at the solubility
limit in the test medium under test
conditions. In 48 and 72 hour old
solutions the concentration of test item
was between 0.067 - 0.071 mg/L."
CECHA. 2017b)
Abbreviation: NES = no effects at saturation
Page 51 of 58
-------
E-l-2 Aquatic Invertebrate Toxicity
Table Apx E-2: Aquatic Invertebrate Toxicity Study for C.I. Pigment Violet 29
IVsl SIlllMillKT
Simlj ijpc
Species
l-lnripoinl
('(ininu'iils
Sou ivc
C.I. Pigment Violet 29
OECD-202; Acute freshwater
invertebrate: 48 hours, static,
limit
Daphnia magna
NES
Nominal test concentration: 0
(control), 100 mg/L
Measured test concentration: -
(control), 0.0065 mg/L
Test solution oreoaration: "100.3
mg of test item was weighed into a
glass flask and mixed with Elendt
medium up to 1L. The stock
solution was mixed thoroughly in
an incubator at a temperature of 40
°C for 3 days with stirring resulting
in a homogeneous, intensive grey
mixture with a concentration of 100
mg/L. The stock solution was
conditioned at a temperature of
20°C with continuous stirring. Next
the control and the test
concentration were filtered over a
0.20 |im membrane disc. After the
filtration a clear and transparent
solution was observed in the
concentration of 100.0 mg/L. The
filter was previously saturated with
the test mixture." (ECHA, 2017b)
(ECHA. 20.1.7b)
EPA has received the
full study report from
the data owner(s) and
this report is under
review
Abbreviation: NES = no effects at saturation
Page 52 of 58
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E-l-3 Fish Toxicity
Table Apx E-3: Fish Toxicity Study for C.I. Pigment Violet 29
lost MlhslillKT
Slliclj |J|H'
Species
l-lnripoinl
(nmmcnls
Source
Puritv: >95%
C.I. Pigment Violet 29
OECD-203; Acute
freshwater fish: 96
hours, static
Zebrafish (Brachydanio rerio)
NES
Nominal test concentrations: 0
(control), 5000 mg/L
Test solution preparation: "The test
substance was mixed with the test
medium and homogenized using an
ultra turrax. Evidence of
undissolved material (e.g.
precipitate, surface film, etc):
floating particles of test substance
were visible." (EOHA, 2017b)
(ECU A. 2017b)
EPA has received the
full study report from
the data owner(s) and
this report is under
review
Abbreviation: NES = no effects at saturation
Page 53 of 58
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Appendix F. HUMAN HEALTH HAZARD STUDY SUMMARIES
F-l Acute Toxicity Studies
Table Apx F-l: Acute Toxicity Studies for C.I. Pigment Violet 29
Test subsdincc
Sluclj l\pc
Species
l-'.nripuinl
Description of cffccts/commcnts
Sou rcc
C.I. Pigment Violet 29
OECD-401;
Acute oral,
single dose by
gavage, limit
Sprague-Dawley rat
LD50 > 10,000 mg/kg-
bw
No mortality or macroscopic
abnormalities at necropsy; systemic
dark red coloring of the skin and dark
red coloring of the feces
(ECU A. 2017b)
EPA has received the full study report
from the data owner(s) and this report
is under review
C.I. Pigment Violet 29
OECD 403-
Acule Inhalation
Toxicity
WistarRat
LC5o> 5.2 mg/L air
No mortality observed. Sublethal
effects were irregular, accelerated
and/or intermittent respiration, flight
behaviour and discoloured fur. From
day 7 of the observation period
onward, no abnormalities, except
discoloured fur, were detected in the
animal
(ECU A. 2017b)
EPA has received the full study report
from the data owner(s) and this report
is under review
C.I. Pigment Violet 29
OECD 402-
Acute Dermal
Toxicity
Sprague-Dawley
Rat
LD50 > 2,500 mg/kg-
bw
No mortality, no abnormal findings,
red-brown staining at the application
site observed.
(ECU A, 2017b)
EPA has received the full study report
from the data owner(s) and this report
is under review
Page 54 of 58
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F-2 Repeated-Dose Toxicity Studies
There were no repeated-dose toxicity studies found for C.I. Pigment Violet 29.
F-3 Reproductive and Developmental Toxicity Studies
Table Apx F-2: Reproductive and Developmental Study for C.I. Pigment Violet 29
IVsl miI>M;iikt
Siuclj l\pe
Species
l-'.iulpoinl
Ik-scriplion of cTIVcls/coiiiiiu'iKs
Sou itc
C.I. Pigment Violet 29
OECD-421; Reproductive/
developmental screening via
gavage (exposure: premating
period of 2 weeks and a mating
period [max. of 2 weeks] in both
sexes, approximately 1 week
post-mating in males, and the
entire gestation period as well as
4 days of lactation in females)
Wistar rat
NO A F.I. = 1000
mg/kg-bw/day
(highest dose tested)
No test substance-related, adverse
findings were noted; black discolored
feces from study day 1 until the end of
the study in all male and female animals
at 300 mg/kg-bw/day and 1000 mg/kg-
bw/day; macroscopically black
discoloration of the content of the
digestive tract in numerous animals
(ECHA. 2017b)
EPA has received
the full study report
from the data
owner(s) and this
report is under
review
Page 55 of 58
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F-4 Skin Irritation and Sensitization Studies
Table Apx F-3: Skin Irritation and Sensitization Studies for C.I. Pigment Violet 29
Tcsl SIlllMillHT
Siuclj ijpc
Species
r.nripoini
Description of
cITccls/cnmmcnls
Sou rcc
C.I. Pigment Violet 29
OECD- 404; Skin
irritation: occlusive
Weiber Wiener rabbit
Not irritating
(ECHA. 2017b)
C.I. Pigment Violet 29
OECD-405; Eye
irritation
Rabbit
Not irritating
C.I. Pigment Violet 29
OECD- 404; Skin
irritation: occlusive
Weiber Wiener rabbit
Not irritating
EPA has received the full
study reports from the
data owner(s) and these
reports are under review
C.I. Pigment Violet 29
OECD-405; Eye
irritation
Weiber Wiener rabbit
Not irritating
C.I. Pigment Violet 29
OECD-429; Skin
sensitization: mouse local
lymphocyte assay
Male CBA/Ca mouse
Negative
Page 56 of 58
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F-5 Genotoxicity and Cancer Studies
Table Apx F-4: Genotoxicity Studies for C.I. Pigment Violet 29
Tcsl SllllSlilllCC
Slliclj |J|K'
Species
Knripoinl
Description of cITccls/commcnls
Source
C.I. Pigment Violet
29
OECD-471; Genotoxicity
- gene mutation {in vitro)
Salmonella typhimurium
TA 100, TA 1535, TA
1537, TA 1538, TA 98
and E. coli WP2uvrA
Negative
(ECHA. 2017b).
(BASF. 1998a)
EPA has received
the full study
report from the
data owner(s) and
this report is under
review
C.I. Pigment Violet
29
OECD-476; Genotoxicity
- gene mutation {in vitro)
Chinese hamster lung
fibroblasts (V79)
Target gene: HPRT
Negative
(ECHA. 2017b)
EPA has received
the full study
report from the
data owner(s) and
this report is under
review
Page 57 of 58
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APPENDIX G. INCLUSION AND EXCLUSION CRITERIA FOR FULL
TEXT SCREENING
As indicated in Section 1.2, the Pigment Violet.
the TSCA Scope Document did not identify on-topic literature search results for C.I. Pigment Violet 29
( ). The exceptions are those relevant studies on C.I. Pigment Violet 29 that were identified
in the ECHA Database and the two studies from Food Additive Petition (FAP) 8B4626 (BASF. 1998a). The
Pigment Violet 29 (CASRN: 81-33-4) Bibliography: Supplemental File for the TSCA Scope Document also
identified twenty other references previously cited in OPPT's documents. Based on a comment received
lYEPA-HQ-; 725-0039) (CPMA. 2.017b)1. EPA conducted a second title/abstract screening and
determined that some of these references were not relevant to C.I. Pigment Violet 29. As such, with the
exception of the ECHA and FAP studies, these references were excluded from further consideration for C.I.
Pigment Violet 29.
As no new on topic references were identified during problem formulation, EPA did not develop additional
inclusion/exclusion criteria for C.I. Pigment Violet 29 to guide full text screening activities. EPA/OPPT's
initial methods, approaches and procedures for identifying, compiling, and screening publicly available
information supporting the TSCA risk evaluation for C.I. Pigment Violet 29 can be found in the Strategy
for Conducting Literature Searches for Pigment Violet '29): Supplemental Document to the TSCA
Scope Document. If new information is received by the Agency after the publication of the TSCA Problem
Formulation, EPA plans to use the initial eligibility criteria already published in the Strategy for Conducting
Literature Searches for Pigment Violet 29 (PV29): Supplemental Document to the TSCA Scope Document
to conduct the title and abstract screening. If necessary, EPA will make refinements to the inclusion and
exclusion criteria and include them in the Risk Evaluation.
Page 58 of 58
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