DRAFT-EPA Document # 740R18015
November, 2018
Office of Chemical Safety and
Pollution Prevention
Draft Risk Evaluation for
C.I. Pigment Violet 29
(Anthra[2,l,9-def:6,5,10-dfeT]diisoquinoline-
1,3,8,10(2H,9H)-tetrone)
CASRN: 81-33-4
H
November 2018
ACDA United States
LhI	Environmental Protection Agency
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TABLE OF CONTENTS
ACKNOWLEDGEMENTS	3
ABBREVIATIONS	4
1	EXECUTIVE SUMMARY	5
2	INTRODUCTION	6
2.1	Physical and Chemical Properties	8
2.2	Uses and Production Volume	9
2.3	Regulatory and Assessment History	10
2.4	Scope of the Evaluation	11
2.4.1	Conditions of Use Included in the Risk Evaluation	11
2.4.2	Conceptual Models	14
2.5	Systematic Review	18
2.5.1	Data Evaluation	18
2.5.2	Data Integration	19
3	EXPOSURES	19
3.1	Fate and Transport	19
3.2	Environmental Releases and Exposure	20
3.3	Human Exposures	21
3.3.1	Occupational Exposures	21
3.3.1.1 Occupational Exposures Approach and Modeli		22
3.3.2	Consumer Exposures	23
3.3.3	General Population Exposures	23
3.4	Other Exposure Consideralions			23
3.4.1	Potentially 1 \posed or Susceptible Subpopukilions 	23
3.4.2	Aggregate and Senlinel I\posuivs			24
4	HAZARDS (EFFECTS)	24
4.1	I ji\ironnienlal I la/aids			24
4.2	I lunian I leallh I la/aids		25
5	RISK ( IIARU TKRIZATION	26
5.1	Environmental Risk....		26
5.1.1 Assumptions and Kc\ Sources of I ncertainty	27
5.2	Human Health Risk	28
5.2.1	Risk Estimation for Acule. Non-Cancer Inhalation and Dermal	28
5.2.2	Assumptions and l\e\ Sources of Uncertainty	30
6	RISK DETERMINATION	32
7	REFERENCES	33
APPENDICES	36
Appendix A REGULATORY HISTORY	36
A-l Federal Laws and Regulations					36
A-2 International Laws and Regulations	..............37
Appendix B ENVIRONMENTAL FATE STUDY RESULTS	39
Appendix C ENVIRONMENTAL EFFECTS ENDPOINTS	40
Appendix D HUMAN HEALTH EFFECTS ENDPOINTS	41
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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:;	-2016-0725.
Disclaimer
Reference herein to any specific commercial products, process or sei \ ice In Hade 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
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
cm3
Cubic centimeters
CPMA
Color Pigments Manufacturing Association
DSL
Domestic Substances List (Canada)
ECHA
European Chemicals Agency
EPA
Environmental Protection Agency
EU
European Union
FDA
Food and Drug Administration
g
Grams
g/mole
Grams per Unit-Molar Mass
hPa
Hectopascal
L
Liter(s)
K
Thousand
lb
Pound
Log Koc
Logarithmic Soil Organic ( arhon. Wulcr Partilion ( oel'licient
Log K0„
Logarithmic Octanol: Water Partition ( oelTicienl
m3
Cubic Meter(s)
mg
Milligram(s)
NOAEL
No Observed Adverse U'l'ecl Level
NPDES
National Pollulanl Discharge Lliminalion Svslem
OECD
Organisation lor Lconomic ( o-o|vialion and Development
OPPT
Office of Pollution Prevention and To\ies
SACC
Science Advisory (\>mmillee on Chemicals
SAR
Sliucluie-acliv ilv relationship
SDS
Sal'elv Dala Sheet
TSCA
To\ie Suhslanees Control Acl
U.S.
I in led Stales
(im
Micrometer
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1 EXECUTIVE SUMMARY
This document presents the draft 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. All conclusions, findings, and determinations in this document are
draft and subject to comment.
The EPA considered all reasonably available data for C.I. Pigment Violet 29 to make a determination of
whether risk posed by a chemical substance is unreasonable. The EPA concludes that C.I. Pigment
Violet 29 does not present an unreasonable risk of injury to human health or the environment, without
considering costs or other non-risk factors, including no unreasonable risk to potentially exposed and
susceptible subpopulations identified as relevant, under the conditions of use.
As part of this risk evaluation for C.I. Pigment Violet 2l). the l-IW conducted a qualitative assessment of
potential environmental, consumer and general population exposures This assessment is based on a
consideration of the physical-chemical properties of (' I Pigment Violet 2l). w hich includes low
solubility, low vapor pressure, low bioaccumulalion potential, and poor absorption across all routes of
exposure; as well as manufacturing information, u hich indicates that environmental releases from the
conditions of use are limited. The EPA also conducted a quantiiali\ e screening-lc\ el assessment of
occupational exposure using a high end estimate of inhalation and dermal exposure. Qualitative and
quantitative considerations of physical chemical data, en\ ironmental fate data, manufacturing, and use
information indicates that exposures of (' I Pigment Violet 2l) are expected to be limited for the
conditions of use of C.I. Pigment Violet 29
Reasonably available data indicates that no effects were obser\ed in environmental hazard testing with
aquatic species up to the limit of solubility of the chemical and low hazard was reported for all routes of
exposure in human health testing The human health testing reported that no adverse effects were
observed for all routes of exposure (oral, dermal, inhalation) and that C.I. Pigment Violet 29 is negative
for genotoxicity. Structural acli\ily relationships (SAR) considerations support the EPA's conclusion
that C.I. Pigment Violet 2l) is unlikely to be a carcinogen. Environmental hazard data available for fish,
aquatic invertebrates and aquatic plants reported that no effects were observed up to the limit of
solubility of the chemical. Based on the human health and environmental toxicity testing, the EPA
concludes that C.l. Pigment Violet 2l) presents a low hazard to human health and the environment.
The EPA uses reasonably available information, in a fit for purpose approach, to develop risk
evaluations that rely on the best a\ ailable science. The EPA obtained full study reports associated with
the European Chemicals Agency (IXI (A) robust summaries (some of which are also presented in
summary format in an FDA I 'ood Additive Petition (FAP) 8B4626 (BASF. 2.013) and used them to
make a preliminary determination of hazard during problem formulation (U.S. EPA. 2018b). There are
supporting materials (24 individual scientific studies) that contain information protected as Confidential
Business Information (CBI). Twenty of these studies have been submitted to and summarized by the
European Chemicals Agency (ECHA) as part of their information on registered substances and these
ECHA robust summaries are publicly available.1 The EPA has reviewed these full study reports and
confirmed that the results are consistent with the physical and chemical characteristics, environmental
fate characteristics, and the determination of low environmental and human health hazards as presented
in the ECHA robust summaries (presented in Appendices B-D). The EPA reviewed these full study
1 https://echa.enropa.en/information-on-cheniicals/registered-snbstances provides general information. Links to individual
study summaries are provided in the attached table.
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reports and assessed the quality of the methods and reporting of results of the individual studies using
the evaluation strategies described in Application of Systematic Review in TSCA Risk Evaluations (
EPA. 2018a) and concluded that they are of high or medium quality. In addition, the EPA determined
that the information presented in these full study reports is consistent with the robust summaries in the
publicly available ECHA Database (ECHA. 2017V
In summary, based on reviewing the reasonably available information indicating a low hazard to human
health and environmental receptors, low solubility, low vapor pressure, low bioaccumulation potential,
low absorption, limited environmental releases and low potential for resulting exposures, the EPA
concludes that C.I. Pigment Violet 29 does not present an unreasonable risk of injury to human health or
the environment under the conditions of use. As per the EPA's final rule, Procedures for Chemical Risk
Evaluation Under the Amended Toxic Substances Control < (	>3726), the EPA is taking
comment on, and will also obtain peer review on, the dnifl risk e\ alualion for C.I. Pigment Violet 29.
2 INTRODUCTION
This document presents the draft risk evaluation for (' I Pigment Violet 2^ under the Frank R.
Lautenberg Chemical Safety for the 21st Century \ct The Frank R. Lautenhcru Chemical Safety for the
21st Century Act amended the Toxic Substances Control Act. the Nation's primary chemicals
management law, in June 2016.
The Agency published the Scope of the Risk I'valuation for C.I Pigment Violet 29 (U.S. EPA. 2017b)
in June 2017, and the problem formulation on June 1, 2018 (	b), which represented the
analytical phase of risk evaluation in which "the purpose lor the assessment is articulated, the problem is
defined, and a plan for anal\/inu and characterizing risk is determined" as described in Section 2.2 of
the Framework for Hw	sessment • ¦ ¦ Decision Making. The problem
formulation presented 1 hive conceptual models and an anal} bis plan. The preliminary conclusions of the
problem formulation were that no further analysis of tiny exposure pathway, i.e., to workers, consumers
and the general population, was necessary This was hascd on the EPA's analysis of the physical-
chemical and fate properties, limited use \ olumes outside the manufacturing site, limited environmental
releases, and low absorption by all routes of exposure.
The EPA indicated in the analysis plan of the problem formulation that it would review the 24 individual
scientific study reports obtained from the data owners. These study reports characterized the physical
and chemical properties, environmental fate properties, environmental hazard and human health hazards
of C.I. Pigment Violet 29 These study reports contain information protected under statute as
Confidential Business Information (CBI) by the Toxic Substances Control Act (TSCA). Twenty of these
studies have been submitted to and summarized by the European Chemicals Agency (ECHA) as part of
their information on registered substances and these ECHA robust summaries are publicly available. In
certain cases, the same information is also presented in summary format in the Food Additive Petition
(FAP) 8B4626 (ECHA. 2017) (BASF. 2013). The EPA indicated that if, upon review of the full study
reports, the results were not scientifically sound or consistent with the robust summary reports, the EPA
may conduct additional analysis to characterize the potential risks associated with this chemical, which
could include changes to the exposure pathways analyzed. Following review of these studies, the EPA
concluded that the results of these full study reports are consistent with the results presented in the
ECHA robust summaries and the Food Additive Petition (FAP) 8B4626.
In this draft risk evaluation, the EPA presents the risk determination for C.I. Pigment Violet 29 based on
the reasonably available information. The document is structured such that Section 2 presents the basic
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physical-chemical characteristics of the chemical, as well as a background on uses, regulatory history,
conditions of use, conceptual models, with particular emphasis on any changes since the publication of
the problem formulation. This section also includes a discussion of the systematic review process
utilized in this risk evaluation. Section 3 provides a discussion and analysis of the exposures, both
human and environmental that can be expected based on the conditions of use for C.I. Pigment Violet
29. Section 4 discusses environmental and human health hazards of C.I. Pigment Violet 29 based on the
full study reports received from the data owners. Risk characterization is presented in Section 5, which
integrates and assesses reasonably available information on human health and environmental hazards
and exposures, as required by TSCA 15 U.S.C 2605(b)(4)(F). This section also includes a discussion of
any uncertainties and how they impact the risk evaluation. In Section 6, the agency presents the final
determination of whether risk posed by a chemical substance is "unreasonable" as required under
TSCA 15 U.S.C. 2605(b)(4). The EPA received comments on the published problem formulation for
C.I. Pigment Violet 29. This document has considered the comments specific to C.I. Pigment Violet 29
as well as more general comments regarding the EPA's chemical risk evaluation approach for
developing the draft risk evaluations for the first 10 chemicals the I-P \ is evaluating.
As per the EPA's final rule, Procedures for Che.	Evalua	he Amended Toxic
Substances Control Act (82 FR 33726), this draft risk e\ aluation will be subject to both public comment
and peer review, which are distinct but related processes The EPA is providing Ml days for public
comment on this draft risk evaluation prior to the beginning of the meeting to in form the EPA Science
Advisory Committee on Chemicals (SACC) peer review process The purpose of this is to seek public
comment on any and all aspects of this draft risk evaluation, including any conclusions, findings, and
determinations, and the submission of any additional information that might be relevant to the science
underlying the risk evaluation and the outcome of the systematic re\ iew associated with C.I. Pigment
Violet 29. This satisfies TSCA section 6(b)(4)(H) w liich requires the I-PA to provide public notice and
an opportunity for comment on a draft risk evaluation prior to publishing a final risk evaluation.
Peer review will be conducted in accordance with the l-P.Vs regulatory procedures for chemical risk
evaluations, including using the	'	;ok and other methods consistent with section
26 of TSCA (See 40 CFR 702.45). As explained in the Risk Evaluation Rule, the purpose of peer review
is for the independent review of the science underlying the risk assessment. Peer review will therefore
address aspects of the underlying science as outlined in the charge to the peer review panel such as
hazard assessment, assessment of dose-response, exposure assessment, and risk characterization. Peer-
review ensures scientific rigor and enhances transparency to the risk evaluation process.
As the EPA explained in the Risk Evaluation Rule (82 Fed. Reg. 33726; July 20, 2017), it is important
for peer reviewers to consider how the underlying risk evaluation analyses fit together to produce an
integrated risk characterization, which will form the basis of an unreasonable risk determination. The
EPA believes peer reviewers will be most effective in this role if they receive the benefit of public
comments on draft risk evaluations prior to peer review. For this reason, EPA is providing the
opportunity for public comment before peer review on this draft risk evaluation. The final risk
evaluation may change in response to public comments received on the draft risk evaluation and/or in
response to peer review, which itself may be informed by public comments. The EPA will respond to
public and peer review comments received on the draft risk evaluation and will explain changes made to
the draft risk evaluation for C.I. Pigment Violet 29 in response to those comments in the final risk
evaluation.
The EPA has asked for input at several stages of the process: on the use dossiers, the scopes, and the
problem formulations. The EPA has received information and comments at each step specific to
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individual risk evaluations, and information and comments of a more general nature relating to various
aspects of the risk evaluation process, technical issues, and the regulatory and statutory
requirements. The EPA has considered comments and information received at each step in the process
and factored in the information and comments as the Agency deemed appropriate and relevant including
comments on the published problem formulation of C.I. Pigment Violet 29. Thus, in addition to any
new comments on the draft risk evaluation, the public should re-submit or clearly identify at this point
any previously filed comments, modified as appropriate, that are relevant to this risk evaluation and that
the submitter feels have not been responded to. The EPA does not intend to further respond to comments
submitted prior to the publication of this draft risk evaluation unless they are clearly identified in
comments on this draft risk evaluation.
2.1 Physical and Chemical Properties		
C.I. Pigment Violet 29 is a Colour Index (C.I.) name used in sales of products containing anthra[2,l,9-
def:6,5,10-d'e'f ]diisoquinoline-l,3,8,10(2H,9H)-tetrone. C.\SR\ XI-33-4. The name "C.I. Pigment
Violet 29" is assigned, copyrighted and maintained In llie Society of Dyers and Colourists and the
American Association of Textile Colorists and Chemists (EPA-HQ-U 2016-0725-0039).
The EPA has received a full study report which contains two studies that characterize the physical and
chemical properties of C.I. Pigment Violet 29 (BAS	)
•	OECD Guideline 102: Melting point
•	OECD Guideline 105: Partition coefficient n-()ctanol W ater (I'ow)
As indicated in previous sections, a claim of business conlidentiality by the data owners means that the
EPA will not reproduce these lull study reports in this risk e\ aluation However, the EPA has confirmed
that the results of these lull study reports are consistent with the corresponding robust summaries
available inECHA, the results of which are presented in abbreviated format in Table2-1. TheEPAhas
reviewed these according to the data quality e\ aluation criteria found in The Application of Systematic
Review in TS(1 Risk Evaluations (I.	) The results of this data quality evaluation can be
found in CJ neni Viol «i	• new: Supplemental File for the TSCA Risk
EvaJuatuAs a result of this data quality evaluation, the EPA has verified the accuracy of
the melting point data presented in the ECI l.\ database and in the C.I. Pigment Violet 29 problem
formulation.
The partition coefficient (I ,ou k..i.) could not be determined from the study submitted to the EPA due to
unacceptable methods \\ liich did not take into account the poor solubility in octanol and in water of C.I.
Pigment Violet 29. The poor solubility in octanol and water means that the partitioning between the
media cannot be determined. The solubility of C.I. Pigment Violet 29 was done in 8 percent ethanol and
is reported as 0.0046 mg/L and 0.015 mg/L in 95 percent ethanol (BASF. 2013). The solubility of C.I.
Pigment Violet 29 in octanol is reported in ECHA as <0.07 mg/L (H U \ «I ). The EPA has utilized
the data as presented in the ECHA database, which are summarized in Table 2-1. The water solubility of
C.I. Pigment Violet 29 is 0.01 mg/L, as reported in the ECHA Database (ECHA, 2017), indicating that
C.I. Pigment Violet 29 has low water solubility. As a result of these unacceptable methods, the measured
Log Kow was not used in this assessment and the EPI-estimated value of 3.76 for octanol/water partition
coefficient was utilized, as described in the Table 2-1 below (	1018b).
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Table 2-1. Physical and Chemical Properties of C.I. Pigment Violet 29
Property
Value
Reference
Molecular Formula
C24H10N2O4
( )
Molecular Weight
390.35 g/mol
(U.S. EPA. 2012b)
Physical Form
Solid
(ECH.A. 2.017)
Melting Point
No melting point found <400°C
(ECH.A. 2.017)
(BASF. 2013)
Density
1.584 g/cm3 at 20 °C
0 i H \ :ot")
Vapor Pressure
<0 hPa at 20°C
0 i H \ AM")
Solubility in n-
octanol
<0.07 mg/L
(ECH.A. 2017)
Water Solubility
0.01 mg/L at 20°C
(ECH.A. 2017)
Log Kow1
3.76 (estimated)
(U.S. EPA. 2012b)
Henry's Law
Constant
1.84E-021 atm-mVmol (estimated)
(U.S. EPA. 2012b)
1 The measured partition coefficient could not he dclcmniied due to poor soluhilns in octanol and water
so the methods utilized inLogKow tests were uiiaccepiable for charactcri/nm ilns \ alue; thus, the
estimated Log Kow of 3.76 is applicable for ilns e\ alualion.
2.2 Uses and Production Volume		 	
Sun Chemical Corporation (Goose Creek. SO is the only I S manufacturer of C.l. Pigment Violet 29
that reported to the Chemical DataRep< ; (CDR) database in 2"12 and 2016 (	12a; U.S.
EPA. (2016)). Approximately 90 percent of the domestic production \ olume of C.I. Pigment Violet 29 in
2015(~530,000 lbs) was processed as a site-limited intermediate lor the manufacture of other perylene
pigments, while 10 percent of ilie production volume ( (•>().odd Ihs) was processed and used in either
commercial paints and coalings ( 3<).nno lbs) or commercial pUislic and rubber products (-30,000 lbs).
An unknown volume of C.l. Pigment Violet 29 is used in consumer watercolor and acrylic paints. This
use of C.I. Pigment Violet 29 in artistic paint products, while unknown, is reported to comprise less than
1 percent of total sales ( I-!10	•)• For C.I. Pigment Violet 29, CDR reporting is
required for imports above 25,000 pounds per >ear per company per manufacturing site. C.I. Pigment
Violet 29 has not been reported to be imported in the CDR 2012 and 2016 database, nor has evidence of
current importation of C.l. Pigment Violet 29 been identified (U.S. EPA. 2012a; U.S. EPA. (2016)). Due
to no reported importation volumes in CDR, imported volumes of C.I. Pigment Violet 29 are expected to
be lower than the reported production volume. Furthermore, according to a search of data from the U.S.
Customs and Border Patrol Automated Manifest System (AMS), imports of C.I. Pigment Violet 29 have
not been reported since 2<)| I As there are no data indicating current importation, import of C.I. Pigment
Violet 29 is not included as a condition of use. In addition, even if it were imported, any potentially
imported volumes of C.l. Pigment Violet 29 would be expected to be utilized for the same conditions of
use as the domestically manufactured volumes.
The EPA concludes that use of paints containing C.I. Pigment Violet 29 is a condition of use for this risk
evaluation; however, the 2012 and 2016 CDR did not indicate use of C.I. Pigment Violet 29 in products
intended for children ('	\ 2012a. U.S. EPA. (-'<' 1 • )) Comments on C.I. Pigment Violet 29 Use
Document 0 L V Ut^ATJ -.vM.- 0 25-(\XV). (I PMA 20.LL', b) in 2017 indicated that commenters
are not aware of C.I. Pigment Violet 29 being used in 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.
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The following are the four primary industrial and commercial uses and one consumer use identified for
C.I. Pigment Violet 29:
•	An intermediate to create or adjust color of other perylene pigments (-90 percent)
•	Incorporation into paints and coatings used primarily in the automobile industry (~5 percent)
•	Incorporation into plastic and rubber products used primarily in automobiles and industrial
carpeting (~5 percent)
•	Merchant ink for commercial printing (<1 percent)
•	Consumer watercolors and artistic color (<1 percent)
2.3 Regulatory and Assessment History
The EPA conducted a search of existing domestic and international laws, regulations and assessments
pertaining to C.I. Pigment Violet 29. The EPA compiled this summary from data available from federal,
state, international and other government sources, as cited in Appendix A.
Federal Laws and Regulations
C.I. Pigment Violet 29 is regulated under several TSCA sections. Under TSCA Section 6(b) C.I.
Pigment Violet 29 is on the initial list of chemicals lo he evaluated for unreasonable risk (81 FR 91927,
December 19, 2016). Under TSCA Section 8(a), manufacturing (including importing), processing and
use information is reported under the CDR Rule (76 I R 5<)X I (\ August 16, 2011). Under TSCA 8(b),
C.I. Pigment Violet 29 is on the initial TSCA ln\ entory and therefore was not subject to the EPA's new
chemicals review process under TSCA Section 5
C.I. Pigment Violet 29 is subject to one additional federal statute or regulation, other than TSCA, that is
implemented by the U.S. Food and Drug Administration (I DA) Chemicals that come in contact with
food must first be reviewed In the I DA for safety In llWK, 15 ASI¦' (Ludwigshafen, Germany) submitted
a petition for C.I. Pigment Violet 2^ to be a colorant in Ibod-contact polymers. C.I. Pigment Violet 29 is
approved by the FDA to be in finished articles that come in contact with food. It should not exceed 1
percent by weight of polymers and should follow sped lie conditions of use as described in the FDA
regulations (21 CIR I 7S 32l)7) C I Pigment Violet 2^ is not listed as an approved food additive.
The Safety Data Sheet (SI)S) for C I Pigment Violet 29 lists recommended engineering controls to
minimize workplace exposure to C I Pigment Violet 29. Engineering controls for C.I. Pigment Violet
29, as staled directly in the SI)S. include adequate ventilation, processing enclosure, and local exhaust
ventilation or other engineering controls. Personal protective equipment (PPE) includes safety glasses
with side-shields, dust goggle under certain circumstances, chemical resistant impervious gloves, and
particulate respirators i I" needed (	2017; CPMA. »I ,,, Sun Chemical. 2017).
State Laws and Regulations
The EPA did not identify information indicating that C.I. Pigment Violet 29 is subject to state statutes or
regulations implemented by state agencies or departments.
Laws and Regulations in Other Countries and International Treaties or Agreements
Multiple countries have C.I. Pigment Violet 29 on their chemical inventory list. (See Appendix A-3).
C.I. Pigment Violet 29 is one of 23,000 chemicals on the Canadian Inventory's Domestic Substances
List (DSL). However, the Canadian Ecological Risk Classification for C.I. Pigment Violet 29 did not
meet the criteria for categorization as a prioritized substance for further evaluation. This determination
for C.I. Pigment Violet 29 and seven other similar pigments were made using a combination of QSAR
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modeling and hazard data for analogous pigments with low solubility (Pigment Red 149; CAS RN 4948-
15-6). The conclusion of Canada's screening indicated that because of low toxicity and low solubility,
C.I. Pigment Violet 29's hazard potential is low (Environment Canada. 2006).
2.4 Scope of the Evaluation
2.4.1 Conditions of Use Included in the Risk Evaluation
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." The conditions of use are described below in
Table 2-2. There have been two modifications since the problem formulation (U.S. EPA. 2018b): the
categories "other uses" and "import" have been removed due lo the agency's inability to prove that they
are actually conditions of use.2 Besides these two modifications, no additional information was received
by the EPA following the publication of the problem form illation that would update or otherwise require
changes to the use document 0 T \ 4Q-QPPT-20 i - • a °5^ . conditions of use (Table 2-2) or the
life cycle diagram as presented in the problem formulation (	8b). The updated life cycle
diagram is presented below in Figure 2-1.
2 A list of "other uses" was compiled during EPA's initial searches. However, no further evidence was found during the
problem formulation and risk evaluation to support the actual use of C.I. Pigment Violet 29 for these uses. This list of other
uses included the following: 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 (EPA-HO-QPPT-2016-0725-0004). As a result, these uses are
not included in Table 2-2 and Figure 2-2.
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MFG/IMPORT
PROCESSING
INDUSTRIAL, COMMERCIAL, CONSUMER USES
RELEASES and WASTE DISPOSAL
See Figure 2-4 for Environmental Releases
and Wastes
1-2%; 6,000 lbs to 12,000 lbs
Paints and Coatings
(~5%; 30,000 lbs)
Plastic and Rubber Products
(~5%; 30,000 lbs)
Other Uses
(Unknown minor volume;
(«1% of volume)
Consumer Watercolor and
Artistic Color
(Unknown minor volume)
Merchant Ink for Commercial
Printing
(<1% of volume; < 6,000 lbs)
Manufacture a
(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%; 530,000 lbs)
Emissions to Air
Liquid Wastes'5
Wastewater
Solid Wastes
~ Manufacture	~ Processing	~ Industrial/Commercial Use
~
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 only includes volumes reported to CDR which does not include volumes below the reporting threshold (U.S. EPA. 2012a: U.S. EPA (2016)).
b Wastewater: combination of water and organic liquid, where the organic content is < 50 percent. Liquid Wastes: combination of water and organic liquid, where the
organic content is > 50 percent.
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Table 2-2. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation
Life Cycle Stage
Category a
Subcategory b
References
Manufacture
Domestic manufacture
Domestic manufacture
U.S. EPA (2016)
Processing
Processing -
Incorporating into
formulation, mixture, or
Paints and Coatings
U.S. EPA (2016); Public
Comment. EPA-HO-OPPT-
2016-0725-0006

reaction product
Plastic and Rubber Products
U.S. EPA (2016); 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-HO-
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-HO-
OPPT-2016-0725-0006


Industrial carpeting
Public Comment. EPA-HO-
OPPT-2016-0725-0006

Paints and coatings
Automobile (OEM and refinishing)
Public Comment. EPA-HO-
OPPT-2016-0725-0006;
Public Comment. EPA-HO-
OPPT-2016-0725-0013;
Public Comment. EPA-HO-
OPPT-2016-0725-0009


Coatings and basecoats
Public Comment. EPA-HO-
OPPT-2016-0725-0008;
Public Comment. EPA-HO-
OPPT-2016-0725-0007

Merchant ink for
commercial printing
Merchant ink
Use Document. EPA-HO-
OPPT-2016-0725-0004;
Public Comment. EPA-HO-
OPPT-2016-0725-0006

Consumer watercolor
and acrylic paints
Professional quality watercolor and
acrylic artist paint
Use Document. EPA-HO-
OPPT-2016-0725-0004
Disposal
Emissions to Air
Air

Page 13 of 43

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Life Cycle Stage
Category a
Subcategory b
References

Wastewater
Industrial pre-treatment
Mott, 2017b; This
reference applied only to
manufacturing no other
Industrial wastewater treatment
Publicly owned treatment works
(POTW)
sources specific to C.I.
Pigment Violet 29 found.
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 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.
2.4.2 Conceptual Models
The conceptual models for this risk evaluation are shown below in Figure 2-2, Figure 2-3, and Figure 2-
4. The EPA considered the potential for hazards to human health and the environment resulting from
exposure pathways outlined in the preliminary conceptual models of the C.I. Pigment Violet 29 scope
document (U.S. EPA, 2017b). These conceptual models considered potential exposures resulting from
consumer activities and uses, industrial and commercial activities, and environmental releases and
wastes. The problem formulation documents refined the initial conceptual models and analysis plans that
were provided in the scope documents (U.S. EPA 2018b). Based on review and evaluation of
reasonably available data for C.I. Pigment Violet 29, which indicated low hazard and limited exposures,
the EPA determined in the problem formulation that no further analysis of any of the pathways outlined
in the conceptual models was necessary due to low hazards and limited exposure for human health and
the environment.
The EPA made two modifications to the conceptual models since the problem formulation. The first was
the removal of the term "other uses" and "import" as no further evidence was found to support the actual
use of C.I. Pigment Violet 29 in this category. The second change involved carrying out a quantitative
screening-level analysis of risks to the population with the highest potential exposure. This was carried
out by developing a screening-level analysis of sentinel exposure (dermal and inhalation) to workers (the
population with the theoretical highest anticipated exposure) as described in Section 5.2.
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INDUSTRIAL AND COMMERCIAL
ACTIVITIES /USES a
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
Distribution
Wastewater, Liquid
Wastes, Solid Wastes
(See Figure 2-4)
EXPOSURE PATHWAY
EXPOSURE ROUTE
RECEPTORS c
HAZARDS
~ Liquid Contact
Fugitive
Emissions b
Mist/Dust
Dermal
Workers
Occupational
Non-Users
nha ation
Low Hazard Associated with Acute
and/or Chronic Exposures
Outdoor Air (See Figure
2-4 for Emissions to Air)
Stack
Emissions b
Air Pollution Control
Liquid Contact, Dust
~ Dermal, Inhalation
Workers d
KEY:
	~ Pathways that were analyzed further
	^ Pathways that were not further
analyzed
Gray Text: In scope, but were not further analyzed
Black Text In scope, but were further analyzed
Figure 2-2. C.I. Pigment Violet 29 Final 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 Some products are used in both commercial and consumer applications.
b 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.
0 Receptors include potentially exposed and susceptible subpopulations.
d When data and information are available to support the analysis, the EPA also considers the effect that engineering controls and/or personal protective equipment (PPE)
have on occupational exposure levels.
f The EPA has reviewed the full study reports to confirm low hazard conclusions.
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CONSUMER ACTIVITIES / USES!
EXPOSURE PATHWAY
EXPOSURE ROUTE
RECEPTORS b
HAZARDS c
Consumer Watercolor and Artistic
Color
	1	
l
Liquid Contact
(Indoor Use)
Dermal
Consumers,
Bystanders
Low Hazard Associated with Acute
and/or Chronic Exposures
Consumer Handling, Recycling and
Disposal of Waste
Liquid Contact
Dermal
Consumers,
Bystanders
KEY:
Wastewater, Liquid Wastes, Solid Wastes
(See Figure 2-4)
	~ Pathways that were not further
analyzed
Gray Text: In scope, but were not further analyzed
Figure 2-3. C.I. Pigment Violet 29 Final 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 from 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 subpopulations.
0 The EPA has reviewed the full study reports to confirm low hazard conclusions.
Page 16 of 43

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RELEASES AND WASTES FROM
EXPOSURE PATHWAY
EXPOSURE ROUTE
RECEPTORS c
HAZARDS d
INDUSTRIAL / COMMERCIAL / CONSUMER USES




Direct
discharge
Water,
Sediment
Aquatic
Species
r -
Indirect discharge
Biosolids
-j
General
Population
Ground
water
>-~
	I
Soil

	~
_Waste Transport_
Air
Terrestrial
Species
Emissions to Air

POTW
Wastewater or
Liquid Wastes a
Inhalation b
Recycling, Other
Treatment
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 were not further
analyzed
Gray Text: In scope, but were not further analyzed
KEY:
Figure 2-4. C.I. Pigment Violet 29 Final 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 subpopulations.
d The EPA lias reviewed the full study reports to confirm preliminary low hazard conclusions.
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2.5 Systematic Review
TSCA requires the EPA to use scientific information, technical procedures, measures, methods,
protocols, methodologies and models consistent with the best available science and base decisions under
section 6 on the weight of scientific evidence. Within the TSCA risk evaluation context, the weight of
the scientific evidence is defined as "a systematic review method, applied in a manner suited to the
nature of the evidence or decision, that uses a pre-established protocol to comprehensively, objectively,
transparently, and consistently identify and evaluate each stream of evidence, including strengths,
limitations, and relevance of each study and to integrate evidence as necessary and appropriate based
upon strengths, limitations, and relevance". (40 C.F.R. 702.33). The EPA indicated in the analysis plan
that it would review the full study reports obtained for all physical and chemical properties,
environmental fate properties, environmental hazard and human health hazard data. The results of these
studies were compared with the corresponding robust summaries, which presented in the ECHA
Database (with the exception of four full studies; discussed below in Section 3.1 and Section 4.2), while
some are also available in summary form in the Food Additive Petition (FAP) 8B4626 (EC]	)
(BASF. 2013). The EPA received a total of 24 studies which were conducted to determine the physical -
chemical properties (n=2), environmental fate properties (n=2), human health hazards (n=17) and
environmental hazards (n=3). Of these 24 studies, 20 study reports are described in robust summary
format in ECHA. Summaries of these studies as presented in the ECHA database are exhibited in
Appendices B-D. Due to a claim of business confidentiality, the full study reports are not publicly
available.3 Three human health studies and one environmental fate study received from the data owners
were not explicitly summarized in the ECHA Database, or the Food Additive Petition (FAP) 8B4626. A
review of these four studies led the EPA to conclude that the conclusions are consistent with other
robust summaries presented in ECHA that were conducted under the same guideline.
Several references initially identified as on-topic during a preliminary title and abstract screen were
excluded after further screening based primarily on lack of information specific to C.I. Pigment Violet
29, due to the limited nature of these references, but were utilized in the assessment. This included
exposure and engineering citations, i.e., correspondences with industry, considered to be on-topic and
used to inform the likelihood of exposure. The nature of these documents is such that the current
framework as outlined in the Application of Systematic Review in TSCA Risk Evaluations (
2018a) is not well suited for the review of these types of references. And as such, these references were
individually addressed, and as with all references utilized in the document are cited in the references
section, and are publicly available in the	database. As a result, formal data quality
evaluation of these references according to the Application of Systematic Review in TSCA Risk
Evaluations (U.S. EPA, 2018a) was not conducted.
2.5.1 Data Evaluation
During the data evaluation stage, the EPA typically assesses the quality of the methods and reporting of
results of the individual studies identified during problem formulation using the evaluation strategies
described in Application of Systematic Review in TSCA Risk Evaluations (	). The EPA
evaluated the quality of the C.I. Pigment Violet 29 study reports to confirm the conclusions of the robust
summaries available from the ECHA database. All studies were given either an overall high or medium
confidence rating during data evaluation. The results of these data quality evaluations are summarized in
Sections 2.1 (Physical and Chemical Properties), 3.1 (Fate and Transport) and 4 (Hazards (Effects)).
Appendices B-D also present the overall confidence ratings for each study, and the Pigment Violet
3 Due to a claim of confidentiality, the full reports are not publicly available. However, it is important to note that peer
reviewers will have access to all information claimed business confidential to help inform their review.
Page 18 of 43

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29 (81-33-4) Systematic Review: Supplemental File for the TSCA Risk Evaluation Document presents
details of the data evaluations for each study, including scores for each metric and the overall study
score.
2.5.2 Data Integration
During data integration and analysis, the EPA considers quality, consistency, relevancy, coherence and
biological plausibility to make final conclusions regarding the weight of the scientific evidence. As
stated in Application of Systematic Review in TSCA Risk Evaluations (U.S. EPA, 2018a), data
integration involves transparently discussing the significant issues, strengths, and limitations as well as
the uncertainties of the reasonably available information and the major points of interpretation (U.S.
EPA. 2018c).
EPA analyzed and synthesized available lines of evidence regarding C.I. Pigment Violet 29's chemical
properties, environmental fate and transport properties, potential for exposure and hazard. The EPA also
analyzed and synthesized available evidence on potentially exposed or susceptible subpopulations. The
sections below describe the EPA's analysis of the relevant lines of evidence that were found acceptable
for the risk evaluation based on the data quality reviews.
3 EXPOSURES
3.1 Fate and Transport
Table 3-1 summarizes the environmental fate characteristics of C.I. Pigment Violet 29. The EPA used
EPI Suite™ estimations and reasonably available fate data for C.I. Pigment Violet 29 to characterize the
environmental fate and transport of the chemical.
Table 3-1. Environmental Fate Characteristics of C.I. Pigment Violet 29
Property or Endpoint
Value a
References
Indirect photodegradation
7.0 hours (estimated)
(U.S. EPA 2012b)
Hydrolysis half-life
Stable (estimated)
(U.S. EPA 2012b)
Biodegradation
Lowbiodegradability: 0-10 percent degradation in
28 days (OECD 30IF)
(ECHA 2017; BASF,
1999)
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 which is an uncertainty regarding the fate characterization.
Despite the limitation in the dataset, similarities with other organic classes indicates that these predicted fate properties can
be estimated by substructure fragments.
C.I. Pigment Violet 29 is highly persistent and has low bioaccumulation potential. 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 water.
If released to air, it is unlikely to undergo direct photolysis and is expected to be in the solid phase (i.e.
Page 19 of 43

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particulates). Based on its estimated indirect photodegradation half-life of 7 hours, it is considered to
degrade slowly to moderately by reacting with atmospheric hydroxyl radicals.
The EPA received and reviewed the full study reports for the following environmental fate studies:
•	OECD Guideline 301 F: Biodegradability: Manometric Respirometry Test
•	OECD Guideline 209: Activated Sludge, Respiration Inhibition Test
These full study reports contain information protected under statute as Confidential Business
Information (CBI) by the Toxic Substances Control Act (TSCA) and therefore are not publicly
available. The results of the OECD Guideline 301 F: Biodegradability: Manometric Respirometry Test
as presented in the ECHA robust summary which are presented in Appendix B. The EPA reviewed these
studies and concluded that C.I. Pigment Violet 29 is poorly biodegradable under normal environmental
conditions. The activated sludge, respiration inhibition test study is not presented as robust summary in
the ECHA database or the Food Additive Petition (FAP)	l-'ol lowi ng review of these full study
reports, the Agency has confirmed that the conclusions of the acth tiled sludge, respiration inhibition test
are consistent with the conclusions of the biodegradahilily test, as summarized in ECHA. Furthermore,
the Agency has reviewed these full study reports according to the data qualil\ e\ aluation criteria found
in The Application of Systematic Review in TSCA Risk I .valuations (	) and determined
that these studies have received high confidence scores based on the evaluation metrics for
environmental fate studies. The resulls of these evaluations can be found in C.I. i mi Violet 29 (SI-
'S, stematic Review: Swplemem	7SCA j	itkm Document.
3.2 Environmental Releases and Exposure
The EPA determined that (}<> percent of the production \ olume is used on site as a chemical
intermediate. As a result, only I n percent of the total production \ olume (-60,000 lbs) is used in a way
that could result in environmental releases and exposures (	8b; Mott. 2017a; Mott. 2017b).
Chemical manufactured and used as a site limited intermediate typically requires minimum handling,
resulting in limited releases and exposure During the use as a chemical intermediate, C.I. Pigment
Violet 29 is consumed during the reaction Releases and exposure as a result of this use is included in
the releases and exposure during manufacturing. The majority of this volume is used in either
commercial and consumer products. Specifically, paint products are for both commercial and consumer
uses, while coatings, plastic and rubber products are for commercial uses only. C.I. Pigment Violet 29 is
manufactured as a solid and in solution and has a low vapor pressure (<0 hPa at 20°C) (
2012a;	) It is handled and processed as a dry powder and formulation during all
conditions of use.
Physical-chemical (see Table 2-1) and fate (see Table 3-1) properties as well as engineering controls
limiting manufacturing releases (as discussed below), are expected to result in limited exposure to air,
water and sediment, groundwater via biosolids, and landfill leaching. The EPA concludes that
approximately 1-2 percent of the volume is potentially released to air, landfill and surface water. Any
potential surface water fraction is sent to an on-site waste water treatment during manufacturing (U.S.
EPA. 2018b; Mott. 2017b). Sources of the loss include liquid solid separation, residues left in
equipment, incidental spills, and dust emission.
Reasonably available information indicates that airborne exposures from both incineration and fugitive
releases from manufacturing and/or processing are expected to be limited due to the low vapor pressure
and volatility of C.I. Pigment Violet 29 (Henry's Law Constant 
-------
during any conditions of use, evaporative losses (volatile fugitive air emissions) are not expected. Air
releases directly to the environment from manufacturing are expected to be limited based on the use of
dust handling systems by the manufacturer. (Mott. / }.
The remainder (1-2 percent of the volume) of C.I. Pigment Violet 29 that may enter the surface water
via either direct discharge to a water of the U.S. or discharge after treatment at POTWs as a component
of total suspended solids (TSS) from the sole U.S. manufacturer and from downstream users of C.I.
Pigment Violet 29. Due to the low water solubility, solid physical state and high sorption of C.I.
Pigment Violet 29, the vast majority of this chemical partitions to particulates and sediment where it is
captured as sludge via an on-site above ground biological wastewater treatment system. This sludge is
subsequently disposed of via incineration or landfill disposal (Mott. 2017b). Although there are no C.I.
Pigment Violet 29-specific discharge limitations in National Pollutant Discharge Elimination System
(NPDES) permits, discharges of C.I. Pigment Violet 29 could be subject to compliance with aNPDES
discharge permit as a component of discharge limitations on TSS. thereby limiting potential discharges
to water. Ultimately, of the NPDES-permitted TSS discharges lor this sole domestic manufacturing
facility, it is estimated that 0.6 lb/day of C.I. Pigment Violet 29 is heinu discharged (<0.1 percent of
produced C.I. Pigment Violet 29) (Mott. }.
As indicated above, the sole U.S. manufacturer of C I Pigment Violet 29 sends its non-hazardous
wastewater treatment residuals (sludge) to the Oak Ridge I .mull! 11 in Dorchester County or the Berkeley
County Landfill. Both landfills are RCR.A Subtitle-D lined landfills permitted under the authority of
South Carolina Regulation Number 61 -107.19. While permitted and managed by the individual states,
sites such as municipal solid waste landfills (MSWLFs) are required by federal regulations to implement
many of the same requirements as Subtitle C landfills. MSWLFs must have a liner system with leachate
collection and conduct groundwater monitoring and corrective action when releases are detected.
MSWLFs are also subject to closure and post-closure care requirements, as well as providing financial
assurance for funding of any needed corrective actions. Industrial wastes are sent to licensed industrial
waste handlers where destruction removal efficiencies for incinerators are expected to be >99 percent
(C'P\	J In addition to design standards for Subtitle-D lined landfills, sorption to particulates
and biosolids for CI. Pigment Violet 2^ are expected to be strong and water solubility is low, so
leaching of C I Pigment Violet 2l) from landfills is expected to be negligible.
Physical-chemical characteristics and manufacturing and use information was sufficient to determine
that environmental exposures are likely to be limited for C.I. Pigment Violet 29. As a result, no further
analysis was necessary for en\ ironmental releases and environmental exposure. Because per site
volumes handled by dou nstrcam users are likely to be much less than the manufacturer (i.e., less than 5
percent each), it is expected that potential C.I. Pigment Violet 29 discharges per site to water and its
related sediment, infiltration to groundwater via land application of biosolids, other landfill leaching,
and air emissions will be proportionally lower.
3.3 Human Exposures
No additional information was received or identified by the EPA following the publication of the
problem formulation that would alter the preliminary conclusions presented in the problem formulation
that occupational, consumer and general population exposures to C.I. Pigment Violet 29 are limited
(	2018b).
3.3.1 Occupational Exposures
Workers may be exposed via inhalation and dermal routes during handling of neat materials. However,
absorption via inhalation pathways is expected to be poor due to low water solubility and dermal
Page 21 of 43

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absorption is estimated to be negligible for the neat material because it is a solid of high molecular
weight, use of PPE, and due to poor absorption in solution based on low solubility. When C.I. Pigment
Violet 29 is encapsulated in plastics or paint resins, it is not expected to leach out (	.32.97.
(BASF. 1998)). The sole manufacturer of C.I. Pigment Violet 29 reported an approximate maximum
workplace air concentration of 0.5 mg/m3 would be expected over a 12 hour shift (Mott 2017a). It is not
clear if the monitoring data were for C.I. Pigment Violet 29 or for total dust. If the data were for total
dust, the actual air concentration of C.I. Pigment Violet 29 is likely to be lower than 0.5 mg/m3 (Mott,
2017a).
Oral ingestion is not a relevant pathway for workers manufacturing C.I. Pigment Violet 29 since there is
no forseeable route of exposure. Standard workplace practices prohibit eating and smoking in
manufacturing facilities. In addition, minimal incidential oral exposures are avoided by the use of
personal protective equipment (PPE) that are discussed below (	7a). In addition, oral
absorption is poor due to low water solubility.
Engineering controls for C.I. Pigment Violet 29, as staled directly in the SI)S. include adequate
ventilation, processing enclosure, and local exhaust \ entilation or other engineering controls. Personal
protective equipment (PPE) includes safety glasses with side-shields, dust goggle under certain
circumstances, chemical resistant impervious gloves, and particulate respirators if needed (BASF, 2017;
CPMA. 1^4 \i, Sun Chemical. 2.017). Oral and inhalation exposures from downstream processors and
users are possible; however, occupational exposures from these downstream users are likely to be
limited due to the expected use of PPE (per Safely Data Sheet for C.I. Pigment Violet 29) and poor oral
absorption due to low water solubility (B	.	. 2017a; Sun Chemical. . Although
oral and dermal exposure are expected to he limited due to poor adsorption and PPE utilized by workers,
the EPA conducted a screening-lex el analysis to quantify a theoretical high-end scenario for workers,
which assumes that PPE are not utilized
3.3.1.1 Occupational Kxposuros Approach and Modeling
Inhalation lixposure
Workers at the manufacturing site handle large volumes of C.I. Pigment Violet 29 at nearly 100 percent
concentration As a result, a high-end exposure analysis was performed to represent a theoretical high-
end exposure of (' I Pigment Violet 2') at a manufacturing site. This high-end estimate assumes that no
particulate respirators are used. Using the air monitoring data from the one manufacturing site (0.5
mg/m3 over 12 hours (.lav) and com erting to an inhalation Potential Dose Rate (PDR) for workers is
7.5mg/day using the following equation:
(0.5 mg/m3 x 1.25 in'/hour x 12 hours/day) = 7.5mg/day
Where:
o 0.5 mg/m3= Manufacturer-provided workplace air monitoring results for total workplace dust
(this conservatively assumes that 100 percent of the total dust is C.I. Pigment Violet 29) (Mott.
2017a)
o 1.25 m3/hour= EPA default assumption of respiration rate4
o 12 hours/day= Assumed maximum shift length
4 https://nepis.epa.gov/Exe/ZvPDF.cgi/P10000VS.PDF?Dockev=P10000VS.PDF
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Dermal Exposure:
For the purposes of this screening-level assessment, the dermal potential dose rate for workers is
assumed to be the theoretical maximum exposure of 3100 mg/day, which is the worst-case assumption
used by the EPA for dermal exposure based on 2-hand dermal contact with solids without gloves.5
3.3.2	Consumer Exposures
Consumer exposures via oral and dermal routes are expected to be limited based on the uses and
physical-chemical properties of C.I. Pigment Violet 29. Of the uses for C.I. Pigment Violet 29, the only
consumer use is as a component of watercolor and artistic paint. Based on these uses, inhalation is not
identified as a route of exposure for consumers since C.T. Pigment Violet 29 is not expected to volatilize
from consumer watercolor and artistic color due to its low vapor pressure. Oral ingestion is expected to
be limited due to the low water solubility (0.01 mg/L) and dermal and oral absorption are estimated to
be poor for the neat material (because it is a solid with low solubility) and poor absorption in liquid
(based on low solubility) (EC|	). As a result, the exposure scenarios calculated above for
occupational exposure via inhalation and dermal arc expected to greatly exceed any potential consumer
exposure to paints. The only consumer exposure would be through artistic paints which are not directly
marketed to infants or children. Even if there is incidental exposure as a result of oral consumption of
paint, the exposure is not expected to exceed the high-end exposures of unprotected workers as
calculated above. Based on the low potential for exposure through drinking water as discussed below in
Section 3.3.3, or as a result of the consumer uses, it is not expected that the conditions of use for C.I.
Pigment Violet 29 will exceed the exposure dose calculated lor workers. As a result, no further analysis
was conducted for consumer exposure.
3.3.3	General Population Exposures		
General population exposures to C.l. Pigment Violet 2l) are expected to be limited due to the limited
releases of C.I. Pigment Violet 29. Oral ingestion of (' I Pigment Violet 29 is expected to be limited due
to concentrations expected in surface and ground water This limited concentration in water is due to
high remo\ al efficiency of C.I. Pigment Violet 2^ during the waste water treatment process on site or at
POTWs limiting releases to surface water and strong sorption to soil reducing migration to groundwater.
Additionally, physical-chemical properties indicate that if ingested, absorption would be expected to be
poor due to low water solubility. Inhalation of C.I. Pigment Violet 29 is expected to be low due to
limited fugitive and incineration air releases. Low volatilization rates will limit fugitive air releases as
vapor, while dust handling systems in place at the manufacturing facility are designed to capture dust in
baghouses (Mott 2 ). Any incidental exposures to the general population, in addition to being
unlikely given the understanding of the uses and physical chemical properties of C.I. Pigment Violet 29,
are not expected to be greater than the high-end exposure calculated for workers. As a result, no further
analysis was conducted for exposure to the general population.
3.4 Other Exposure Considerations
3.4.1 Potentially Exposed or Susceptible Subpopulations
TSCA requires that a risk evaluation "determine whether at chemical substance presents an
unreasonable risk of injury to health or the environment, without consideration of cost or other non-risk
factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified
as relevant to the risk evaluation by the Administrator, under the conditions of use." TSCA § 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
5 ChemSTEER user guide (pg. 264) https://www.epa.gov/sites/production/files/2015-05/documents/user guide.pdf
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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 risk evaluation, the EPA analyzed the reasonably available information to ascertain
whether some human receptor groups may have greater exposure or susceptibility than the general
population to the hazard posed by a chemical. The results of the available human health data, which
reported no effects for all routes of exposure (oral, dermal, and inhalation), indicating that there is no
evidence of increased susceptibility for any single group relative to the general population. Exposures of
C.I. Pigment Violet 29 would be expected to be higher amongst workers using C.I. Pigment Violet 29 as
compared to the general population, so the exposure calculation for workers is based on full immersion
and is therefore protective of all other subpopulations, such as children and pregnant women in the
general population, which are not expected be exposed to (' I Pigment Violet 29 at similarly high levels.
Additionally, engineering controls during the manufacturing and processing of C.I. Pigment Violet 29 as
outlined above would likely limit exposure to workers
3.4.2 Aggregate and Sentinel Kxposti res
Section 2605(b)(4)(F)(ii) of TSCA requires the 1- PA. as a part of the risk e\ aluation, to describe whether
aggregate or sentinel exposures under the conditions of use u ere considered and the basis for their
consideration. The EPA has defined aggregate exposure as "the combined exposures to an individual
from a single chemical substance across multiple routes and across multiple pathways." As a result of
the limited nature of all routes of exposure resulting from the conditions of use of C.I. Pigment Violet
29, a consideration of aggregate exposures of C.I. Pigment Violet was deemed not to be appropriate
for this risk evaluation. The EPA defines sentinel exposure as '"the exposure to a single chemical
substance that represents the plausible upper bound of exposure relati\ e to all other exposures within a
broad category of similar or related exposures " In terms of this risk evaluation, the EPA considered
sentinel exposure in the Ibmi of a high-end screening le\ el scenario for occupational exposure resulting
from dermal and inhalation exposures, as these exposure routes are the most likely to result in the
highest exposure gi\ en the details of the manufacturing process and the potential exposure scenarios
discussed aho\ e The calculation for dermal exposure is especially conservative given that it assumes
full contact immersion
4 HAZARDS (EF1 IX I S)
4.1 Environmental Hazards
The only environmental ha/ard data identified for C.I. Pigment Violet 29 were three acute ecotoxicity
studies presented in summit r\ formal in the ECHA Database (	8b; ECHA. 2017). The
EPA has received and reviewed full study reports corresponding to the ECHA robust summaries, which
included the following study types:
•	OECD Guideline 203: Fish Acute Toxicity Test
•	OECD Guideline 202: Daphnia sp., Acute Immobilization Test
•	OECD Guideline 221: Lemna sp., Growth Inhibition test
As indicated in previous sections, a claim of business confidentiality by the data owners means that the
EPA will not reproduce these full study reports in this risk evaluation. However, the EPA has confirmed
that the results of these full study reports are consistent with the corresponding robust summaries
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available in ECHA, which are presented in abbreviated format in Appendix C. The EPA has reviewed
these full study reports according to the data quality evaluation criteria found in The Application of
Systematic Review in TSCA Risk Evaluations (U.S. EPA. 2.018a). The data quality evaluation indicated
these studies are of high confidence and can be used to characterize the environmental hazards of C.I.
Pigment Violet 29. The results of this data quality evaluation can be found in C.L Pigment Violet 29 (81-
3. stemaiic Review: Supplemental File for the TSCA Risk Evaluation Document.
These ECHA robust summaries indicate that toxicity effects were not observed for fish, daphnia and
aquatic plants up to the limit of solubility of the chemical and that C.I. Pigment Violet 29 presents a low
environmental hazard. This is consistent with the Canadian Ecological Risk Classification for C.I.
Pigment Violet 29, which did not present additional information, where it was determined that C.I.
Pigment Violet 29 did not meet the criteria for categorization as a prioritized substance for further
evaluation and the potential hazard is low (Environment Ci	)
4.2 Human Health Hazards
The EPA concludes that C.I. Pigment Violet 29 presents a low hazard lo human health across all routes
of exposure (	18b). This conclusion is hasccl on full stud} reports of the human health
studies identified in the ECHA Database and Food Addilix e Petition (FAP) XB4026 (ECHA. 2.017;
BASF. 1998). The full study reports received by the I-PA included the following study types:
•	OECD Guideline 401: Acute Oral Toxicity with Rats (two studies)
•	OECD Guideline 404: Acute Dermal Irritation/Corrosion (two studies)
•	OECD Guideline 405: Acute Eye Irritation/Corrosion (two studies)
•	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 (two studies)
•	Non-Guideline Acute Toxicity Acute Inhalation Toxicity with Rats (two studies)
•	OECD Guideline 47(-> In vitro Mammalian Cell Gene Mutation Test
•	Re\erse mutation assay AMI-S test: using Salmonella typhimurium and Escherichia coli
These full stuck reports concluded that no adverse effects were observed for all routes of exposure (oral,
dermal, inhalation), nor were dermal or eye irritation effects reported. As a result, the EPA concludes
that C.I. Pigment Violet 29 presents a low hazard to human health. Toxicity effects were observed in the
intraperitoneal studies at high concentrations (LD5o= 7000-9000 mg/kg-bw). However, the nature of this
route of exposure is not relevant for (' I. Pigment Violet 29 because the test material is injected directly
into the intra-peritonium (body ca\ ity) and C.L Pigment Violet 29 is poorly absorbed by all routes due
to its low solubility. The genotoxicity studies reported that C.L Pigment Violet 29 is negative for
genotoxicity. While no suitable analogs were identified for C.L Pigment Violet 29 concerning
genotoxicity, structural activity relationships (SAR) considerations and the expected poor absorption and
uptake of C.L Pigment Violet 29, support the EPA's conclusion that C.L Pigment Violet 29 is unlikely
to be a carcinogen. Hence, C.L Pigment Violet 29 would not cause spatial or temporal perturbations to
the DNA integrity. No data was found on the metabolism of C.L Pigment Violet 29; hence the metabolic
fate is unknown. However, C.L Pigment Violet 29 is unlikely to be metabolized based on poor
absorption.
In a reproduction/developmental toxicity screening test (as described in the ECHA robust summary),
Wistar rats (10/sex/group) were administered C.L Pigment Violet 29 in water via oral gavage at doses of
0, 100, 300, or 1000 mg/kg-bw/day. Males were dosed daily for 2 weeks prior to mating, during mating,
and until the day prior to scheduled necropsy (study day 31). Females were dosed daily for two weeks
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prior to mating, during mating, during gestation, and during lactation until the day prior to scheduled
necropsy (study day 57). Litters were sacrificed on postnatal day 4. Males and females at 300 and 1000
mg/kg-bw/day showed black discoloration of feces throughout the study and of the contents of the
glandular stomach, jejunum, and/or colon. The discoloration was considered to be the result of oral
intake of the test substance, which is a pigment. There were no adverse, test substance-related effects on
parental mortality, body weight, food consumption, macroscopic findings, organ weights (evaluated in
males only), histopathology, spermatogenesis, mating or fertility indices, pre-coital interval, gestation
index or length, number of implantation sites, post-implantation loss, live birth index, numbers of
delivered pups, liveborn pups, and stillborn pups, pup viability index, pup sex ratio, pup clinical signs,
pup body weights, or pup necropsy. Discoloration of the feces and contents of the glandular stomach,
jejunum, and colon was considered non-adverse; therefore, the \TOAF.L for systemic toxicity in parental
animals was 1000 mg/kg-bw/day. The NOAEL for reproducti\ e de\ elopmental toxicity in males and
females was 1000 mg/kg-bw/day.
As indicated in previous sections, the EPA has reviewed these lull study reports and determined that the
results are consistent with the conclusions and information presented in the corresponding robust
summaries in ECHA (Appendix D). Furthermore, the I -PA has reviewed these according to the data
quality evaluation criteria found in The Application of Systematic Review /// IS(1 Risk Evaluations
(	2018a) and concludes that these studies are ofhiuh or medium confidence based on the
evaluation metrics for human health hazard studies. The result of the data quality e\ aluation can be
found in Appendix D, while the data qualitx e\ aluations are located in the C.l Pigment Violet 29 (81-
3 stematic Review: Supplemem	W-Aj	ition Document.
Listed below are three additional studies submitted In one data o\\ ner. these were not available as robust
summaries in the ECHA database or the Food Additi\ e Petition (I AP) KIJ4626:
•	OECD Guideline 4dI Acute Oral Toxicity with Ruts
•	OECD Guideline 4<>4 Acute Dermal Irritation Corrosion
•	OECD Guideline 4<)5 Acute I-ye Irritation, Corrosion
The EPA rc\ iewed these studies and concluded that the results of these three additional studies are
consistent with the results of the full studies recci\ ed that were conducted according to the same
guideline that are publicly available in IX "I IA Furthermore, following data evaluation of these three
studies, the LP A concludes that these three studies are of high confidence based on the evaluation
metrics for human health hazard studies.
5 RISK CHARACTERIZATION
5.1 Environmental Risk
Based on the results of toxicity testing with aquatic species, the EPA concludes that C.I. Pigment Violet
29 demonstrates a low hazard to environmental receptors. A total of three environmental hazard studies
were identified for C.I. Pigment Violet 29 and were given high overall confidence ratings during data
evaluation. The Pigment Violet 29 f'81-35 - /) S\ stematic Review: SupplementalFile for the TSCA. Risk
Evaluation Document presents details of the data evaluations for each study, including scores for each
metric and the overall study score. No effects were observed in acute toxicity testing with fish, aquatic
invertebrates, and aquatic plants up to the limit of solubility of C.I. Pigment Violet 29. As a result, no
concentration of concern can be calculated for this chemical, as it is not possible to dissolve sufficient
quantities of C.I. Pigment Violet in water to elicit a response in aquatic organisms. As discussed above,
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the EPA conducted a qualitative assessment of potential environmental exposures. This analysis
considered reasonably available information including manufacture, use, and release information, and
physical chemical characteristics. The EPA determines that environmental exposures of C.I. Pigment
Violet 29, for the conditions of use of C.I. Pigment Violet 29, are expected to be limited as a result of a
qualitative consideration of reasonably available physical-chemical, environmental fate, manufacturing
and release, and exposure data. Considering the limited nature of the environmental exposures resulting
from the conditions of use of C.I. Pigment Violet 29 and the lack of effects observed in the available
environmental hazard studies, environmental concentrations of C.I. Pigment Violet are not expected to
reach a concentration where adverse effects to environmental receptors could occur.
5.1.1 Assumptions and Key Sources of Uncertainty
All available environmental hazard data indicated that C. I Pigment Violet 29 presents a low hazard, as
no effects were observed to fish, aquatic invertebrates and aquatic plains following acute exposure up to
the highest concentrations tested (limit of solubility). While the I -PA determined that sufficient data are
available to characterize environmental hazards of C.I. Pigment Violet 29. there are uncertainties.
The EPA has determined there is low hazard to environmental receptors hased on a ecotoxicity dataset
that is comprised of acute testing with three aquatic species. As a result, there are no data that
characterize the hazard of C.I. Pigment Violet 29 to aquatic species following chronic exposure, nor are
there toxicity testing with terrestrial species data a\ ailahlc to characterize the hazards of C.I. Pigment
Violet 29, so there is some uncertainty regarding the en\ ironmental risk following acute exposure to
sediment-dwelling invertebrates, chronic exposure to aquatic species, and exposure to terrestrial species.
In addition, the lack of environmental monitoring data means that the limited predicted environmental
concentrations cannot be verified empirically.
In the previous sections, the F.P A determined that expected releases and subsequent environmental
exposures are limited as a result of a qualitative consideration of available physical-chemical,
environmental fate, manufacturing and release, and exposure information. While the agency has
determined that there are sufficient data available to make this determination, environmental monitoring
data were not available to verify the conclusions of limited environmental exposures. This lack of
monitoring data is unlikely to impact the conclusions, as the low solubility of the chemical and lack of
environmental hazard means that it would be unlikely for environmental concentrations to reach a level
where adverse effects could he ohsened in environmental receptors.
Strong sorption to sediment is indicated as a result of the EPI Suite™-estimated Koc value (5.0), which
suggests that potential aquatic releases could result in exposure to sediment-dwelling organisms. Data
are not available to specifically characterize hazard to sediment-dwelling, aquatic invertebrates;
however, based on the weight of e\ idence considering the limited potential for aquatic releases resulting
from the conditions of use of (' I Pigment Violet 29 and the lack of effects observed in all
environmental hazard studies, particularly with Daphnia magna, (a sensitive surrogate species for
aquatic invertebrates for which no adverse effects were observed) the EPA determines that sufficient
data exist to make a determination of risk for these species. Due to a combination of low potential
exposure and low hazard, the EPA concludes that C.I. Pigment Violet 29 is unlikely to present an
unreasonable risk to sediment dwelling, aquatic invertebrates.
With regard to chronic exposure, there is uncertainty because, as mentioned above, chronic exposure
environmental hazard testing with C.I. Pigment Violet 29 is not available. While data characterizing the
potential hazards from chronic exposure are not available and there are uncertainties regarding the
chronic hazard from exposure to C.I. Pigment Violet 29, the limited environmental releases and
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exposure and low hazards reported across all hazard testing indicate that C.I. Pigment Violet 29 is
unlikely to present an unreasonable risk to environmental receptors from chronic exposure.
As discussed above in Section 3.2, engineering controls and high capture efficiency of aquatic C.I.
Pigment Violet 29 is expected to limit the potential for environmental releases and resulting exposures.
These limited exposures across all routes and low hazard across all ecotoxicity and human health testing
indicates that adverse effects are not expected for terrestrial species. Exposures to terrestrial species are
not expected to reach levels where adverse effects could occur.
5.2 Human Health Risk
A total of 17 human health hazard studies were received and e\ aluated for C.I. Pigment Violet 29. All
studies were given a high or medium overall confidence rating during data quality evaluation. Pigment
Violet 29	•tematic Review: Supplemental faut jw me ui sk Evaluation Document
presents details of the data evaluations for each study, including scores lor each metric and the overall
study score. As discussed in Section 4.2, a review of the available human health data identified for C.I.
Pigment Violet 29 indicates low hazard to human health across all routes of exposure (oral, dermal,
inhalation). Available reproductive/developmental information did not report toxicity effects up to the
highest concentration tested. Genotoxicity testing and structural considerations indicate that C.I.
Pigment Violet 29 is unlikely to be a carcinogen. Based on physical chemical properties, C.I. Pigment
Violet 29 is classified as poorly absorbed by all routes of exposure In addition, the EPA conducted a
quantitative assessment of the potential risk concerns resulting from occupational exposure. This
approach involved a screening-level analysis to determine u hot her potential risks to workers exist from
exposure to C.I. Pigment Violet 2^ from the high-end workplace exposure. Using a qualitative analysis
of potential consumer and en\ ironmental exposures, the LP A concludes that C.I. Pigment Violet 29 has
a limited potential for exposure from these routes and is unlikely to exceed the worst-case exposure
scenario calculated below for occupational exposure
5.2.1 Kisk Kslimation lor Acute, Non-Cancer Inhalation and Dermal
The EPA uses a Margin of Lxposure (MOE) approach to assessing non-cancer risk. The MOE is the
ratio of the point of departure (POD) dose divided by the human exposure dose. The MOE is compared
to the benchmark MOE. If the MOL exceeds the benchmark MOE, this indicates that risks to human
health are not expected
The EPA calculated the MOL using the following equation6:
MOE =
( \
(POD * POD%Absorption)
I fPDR\	\
* (.ExposureRoute%Absorptiori)jj
( (DurationAnimal)\
[(DurationHuman) J
Breakdown of the equation:
• POD * POD%Absorption - An estimate of the internal dose in the animal study used for the
NOAEL or LOAEL value.
6 https://www.epa.gov/sites/production/files/2015-05/documents/13.pdf
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•		 - The engineering report exposure is in mg/day, not mg/kg. This term converts the total
B W
exposure to mg/kg. PDR calculated in Section 3.3.1 is 7.5 mg/day for inhalation to workers, and
3100 mg/day for dermal exposure.
(pdr\
) * %ExposureRouteAbsorption - This is a crude estimate of the internal dose in the
human from the scenario exposure route. For C.I. Pigment Violet 29, due to poor absorption
based on the low solubility, ExposureRoute%Absorption is presumed to be 10% from dermal
and 100% from inhalation which are default values for chemical substances with poor
absorption.
•	DurationAnimal/DurationHuman - Adjustment of POD lor differences in days per week
exposure between animal studies and the human exposure scenario. Repeated dose animal
studies are typically conducted for 5 (subchronic, chronic) or 7 (developmental, reproduction)
days. The POD dose used for the human must be adjusted if the animal and human days per
week exposures differ. This is accomplished In utilizing a concentration-duration product
constant (e.g., Haber's rule) to make the adjustment. If durations of exposure per week are
unknown for the POD study or human exposure assume 5 days/week lor each.
Where:
o DurationAnimal = Duration of the animal experiment in days/week (animals in the
reproductive/developmental screening test were dosed for 7 days/week)
o DurationHuman = Duration of human exposure in days week under the scenario being
considered (workers are expected to work 5 days week)
o ExposureRoute"..Absorption = Percent absorption In the scenario exposure route
o MOE = Margin of l-xposure
o PDR = Potential Dose Rate - worker exposure in mg/day. Even the inhalation route is
presented this way
o B\V ~ Bodyw eight of a worker (Si)ku)
o POD = Animal \0.\l-1. or I .OAI -1. POD in ing/kg
o POD"..Absorption Percent of the chemical absorbed in the animal POD study. In this case,
absorption by the oral route
If the POD is based upon a No Obser\ ed Adverse Effect Level (NOAEL) then the acceptable
Benchmark MOE7 is typically I <><) The value of 100 is used to account for variability between species
(Interspecies Uncertainly factor (I T') 10X) times the variability within the human population
(Intraspecies Uncertainty Factor I <))
For both dermal and inhalation exposure, the POD was set at the NOAEL of 1000 mg/kg/day, as no
effects were observed up to the highest tested dose in the reproduction/developmental screening study
available for the C.I. Pigment Violet 29 (Stark et al.. 2013). The MOE of 14,933 was calculated for
inhalation exposure was calculated using the following equation:
/ \
MOE (14,933) =
(1000mg/kg/day * 100%)
^(^80* (1®® % Absorption)^
(7 days/wk)\
(5 days/wk) J
7 https://www.epa.gov/sites/production/files/2015-05/documents/13.pdf
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The MOE of 361 was calculated for dermal exposure was calculated using the following equation:
/
MOE (361) =
\
(1000mg/kg/day * 100%)
V((310080ira3/) * ^/oAbsorption^
(7 days/wk)\
(5 days/wk) J
For C.I. Pigment Violet 29, the benchmark Margins of Exposures (VlOE)8 are set at 100. If the POD is
based upon a No Observed Adverse Effect Level (NOAEL) then the acceptable Benchmark MOE is >
100. The value of 100 is used to account for variability between species (Interspecies Uncertainty factor
(UF) = 10X) times the variability within the human population (Intraspecies Uncertainty Factor = 10).
A comparison of the MOE for inhalation with the benchmark MOE (14,933 100) and the MOE for the
worst-case dermal exposure with the benchmark MOI- (361/100) indicated that risks were not identified
for workers based on inhalation and dermal exposure, as the inhalation and dermal MOEs were greater
than the benchmark MOE. The inhalation benchmark dose is I no\ more than an exposure level that
would trigger a risk concern. There is also no identified risk for the exposure scenario for dermal
exposure (using high-end EPA occupational exposure estimate for two hand dermal contact9), even
though it does not assume the use of glo\es or other protecti\ e equipment described in Section 3.3.1.
Hand to mouth exposure is not likely to result in exposures greater than these high-end screening-level
exposure values, because as discussed above, eating, drinking and smoking are prohibited in
manufacturing facilities Based on the results of this scrcening-lc\ el analysis, risks are not expected for
general population as exposure to the general population would be significantly lower than the
exposures for workers. This suggests that the risk calculation is protective of general population
exposures.
5.2.2 Assumptions sind Kcv Sources of I nccrtainty
All available human health data indicated that, regardless of the exposure route, C.I. Pigment Violet 29
presents a low hazard While the N\\ determines that the data available to characterize human health
hazard of C.I. Pigment Violet 2') are suflicient to make a determination of risk, there are uncertainties
(some may be significant, while others are minor). C.I. Pigment Violet 29 is presented with limited data
sets and one of the factors that is missing is the absorption potential. Despite the lack of an absorption
test, the EPA was able to describe potential absorption of C.I. Pigment Violet 29 based on physical-
chemical properties, which indicate that C.I. Pigment Violet 29 is classified as poorly absorbed by all
routes of exposure (low solubility, low vapor pressure), which led the EPA to consider a default
assumption of 10 percent absorption from dermal exposure and 100 percent absorption from
inhalation.10
The estimation of dermal exposure used in this evaluation was derived from the EPA/OPPT Direct 2-
Hand Dermal Contact with Solids Model. This default value of 3100 mg/day is a high-end estimate of
the total amount of solids remaining on hands as a result of the following worker activities:
8	Margin of Exposure (MOE) = (Non-cancer hazard value, POD) (Human Exposure). The benchmark MOE is used to
interpret the MOEs and consists of the total UF. (UFS=1) x (UFA=10) x (UFH=10) x (UFL=1) = Total UF=Benchmark
MOE=100. UFS=subchronic to chronic UF; UFA=interspecies UF; UFH=intraspecies UF; UFL=LOAEL to NOAEL UF.
9	ChemSTEER user guide (pg. 264) https://www.epa.gov/sites/production/files/2015-05/documents/user guide.pdf
10	ECHA Guidance on Information Requirements and Chemical Safety Assessment. Available online at
http://echa.europa.eu/documents/10162/13632/information requirements r7c en.pdf.
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•	Loading Solids into Transport Containers/Vessels (all activity types)
•	Unloading Solids from Transport Containers/Vessels (all activity types)
•	Cleaning Solid Residuals from Transport Containers/Vessels (all activity types)
•	Sampling Solids (all activity type)
•	Equipment Cleaning Losses of Solids
•	Filter Media Changeout
•	Grinding and Sanding
•	Miscellaneous Activities Related to Solids Processing
Reproductive and health effects are based on one repeated dose study (reproductive/ developmental
screening via gavage). This test does not provide complete information on all aspects of reproduction
and development, but rather provides a limited means of detecting post-natal manifestations of pre-natal
exposure, or effects that may be induced during post-natal exposure A smaller number of animals and
endpoints are utilized in the dose groups, and the duration of ilie study is shorter than a full chronic
toxicity study. Moreover, in the absence of data from other reproduction developmental toxicity tests,
positive results are useful for initial hazard assessment and contribute to decisions with respect to the
necessity and timing of additional testing. This screening test can be used to provide initial screening of
possible effects on reproduction and/or development, either at an early stage (if assessing the
toxicological properties of chemicals, or on chemicals of concern Uncertainties in the way that this
reproductive/developmental screening test was conducted, which was the source of the POD, included
the expression of test concentrations in terms of nominal concentrations, and a lack of reporting of the
stages of spermatogenesis in the testes. In addition, this study was conducted as a screening-level test
per OECD-421. These were minor uncertainties and the results were sufficiently robust to make a
determination of low hazard As no effects were ohser\ ed up to the limit-dose, further chronic toxicity
testing is not needed.
The absence of a chronic exposure carcinogenicity study resulted in some uncertainty regarding the
carcinogenicity of C.I. Pigment Violet 2l-> Based on the available data, C.I. Pigment Violet 29 is not
reported to be a developmental neurotoxin Despite the lack of this study, the carcinogenic potential of
C.I. Pigment Violet 2l-> was sufficiently assessed using available data, which included two short-term
genotoxicity studies and a consideration of the structural activity of the compound, which determined
that C.I. Pigment Violet 29 is not likely to he carcinogenic.
As noted in the pre\ ions sections, the I -PA concludes that occupational, consumer, general population
and environmental exposure is limited as a result of a qualitative and semi-quantitative consideration of
available physical-chemical, en \ iron mental fate, manufacturing and release, and exposure information.
While the EPA determined that there are sufficient data available to make this determination, there is
some uncertainty as monitoring data were not identified to verify the conclusions of low exposure via
water and air. Despite the lack of monitoring data, the low hazard and the low potential for exposure
indicates that exposure concentrations are unlikely to reach a level that will result in adverse effects to
human health. Based on the exposures scenarios for workers, the EPA concludes that C.I. Pigment
Violet 29 presents no unreasonable risk from occupational exposure scenarios. As general population
exposures are expected to be far less than occupational exposures, this determination applies to the
general population as well.
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6 RISK DETERMINATION
The EPA concludes that C.I. Pigment Violet 29 does not present an unreasonable risk of injury to human
health or the environment, without considering costs or other non-risk factors, including no
unreasonable risk to potentially exposed and susceptible subpopulations identified as relevant, under the
conditions of use.
No effects were observed in environmental hazard testing with aquatic species up to the limit of
solubility of the chemical, and it is not expected that aquatic exposures can reach concentrations where
adverse effects can be seen. Low hazard was reported in all human health testing via all routes of
exposure (oral, dermal and inhalation), nor were dermal or eye irritation effects reported. Risks were
not identified based on a screening-level analysis, which calculated an VIOEs based on the worst-case
exposure scenario for routinely exposed population (workers al a manufacturing site operating without
PPE) which were compared to theoretical worst-case MOI-s in Section 5.2. As explained in Section 5.2,
the inhalation MOE and the dermal MOE both exceeded the benchmark MOE indicating that risks were
not identified for workers, or by extension consumers and the general population which are expected to
be exposed at concentrations lower than worker exposures. The EPA expects limited environmental
releases and resulting limited exposures from the conditions of use, based on low solubility, low vapor
pressure, low bioaccumulation potential, poor absorption leased on physical-chemical properties of the
C.I. Pigment Violet 29, so exposures are likely to be less than these worst-case scenarios.
A determination in a risk evaluation that concludes a chemical does not present an unreasonable risk, as
this draft risk evaluation does, must be issued In order See TSCA section 6(i)(l). If finalized as
proposed, the final version of this Risk Determination section would constitute the order required by
TSCA section 6(i)(l).
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7 REFERENCES
BASF. (1975a). Acute inhalation toxicity with rats. BASF report XXV/454. In Product Safety Basel.
(XXV/454). Switzerland: BASF Schweiz AG. (https://echa.europa.eu/registration-dossier/-
/registered-dossier/10330/7/3/3/?document i U» h* • h ».r , i d9-8154-64b027eb3c74).
BASF. (1975b). Acute oral toxicity with rats. BASF report XXV/454. (XXV/454). Switzerland: BASF
Schweiz AG. (https://echa.eiiropa.eu/reeistration-dossier/-/registered-
dossier/10330/7/3/2/?documentUUID=587b216d-aaa5-4f5d-8' :6cd543466).
(1975d). Eye irritation study. BASF report XXV/454. In Product Safety Basel. (XXV/454).
Switzerland: BASF Schweiz AG. (https://echa.europa.eu/registration-dossier/-/registered-
dossier/10330/7/4/3/?documentUUID=0802ac40-5(	f-b449b54abb00).
(1975e). Skin irritation study. BASF report XXV/454. In Pioduct Safety Basel. (XXV/454).
Switzerland: BASF Schweiz AG. (https://echa.europa.f """ ¦' "ation-dossier/-/registered-
dossier/10330/7/4/2/?documenti i ID. 6dd6532-3633	' ¦ - >r '^' -S0J i j.
(1975f). Summary of toxicological investigations with CAS 81 -33-4, Acute intraperitoneal
toxicity with mice. BASF Report XXV/454. In Product Safety Basel (XXV/454). Switzerland:
BASF Schweiz AG. (https://echa.europa.eu/ xatioim-dossk		;ered~
dossier/10330/7/3/5/?documei	jbb . 268e- ^~"-bbbc-e8" ~i65).
BASF. (1978a). Study report for CAS 81-33-4, Acute inhalation toxicity with mis 1} VSF report 77/360.
In Product Safety Basel. (77/360) Suii/erland: BASF Schweiz AG.
(https://echa.europa.eu/registr	:er/-/regi&ic .
dossier/10330/7/3/3/? documei	ia4522-b'/ 14 >bee-af8052ffT73d).
BASF. (1978b). Study report for CAS 81-33-4. Acute intraperitoneal toxicity with mice. BASF report
77/360. In Product Safety Basel. Switzerland: BASF Schweiz AG.
(https://echa.eu	-. rtrati on-dossi er/-/re g:
dossier/10330/'	ientUXJID=d39b ^	-ae32-80485a7703c8).
BASF. (1978c). Study report for CAS SI -33-4, acute oral toxicity with rats. BASF report 77/360. In
Product Safety Basel ("7""36n) Sw itzerland li \SF Schweiz AG.
(https://echa.europr •. ¦ 			-dstered-
dossier/103 3 0/7/3/1	)-a7d0-40cb-8148-bbb0200ab43dy
(1978d). Study report I'or C \S 81-33-4, skin irritation study. BASF report 77/360. In Product
Safety Basel. (77/30") Switzerland BASF Schweiz AG. (https://echa.europa.eu/registration-
dossier/-/registered-ao :h.:¦ ¦ ujji " 2/?document! ! !h _Jd8c3ca-d52c-4608-abfd-
b2Mdb31d34)-
BASF. (1978e). Eye irritation study BASF report 77/360. In Product Safety Basel. (77/360).
Switzerland: BASF Schweiz AG. (https://echa.europa.eu/registration-dossierA/registered-
dossier/10330/7/4/: ' ' ientUUID=lfD8:	b~b085~26bca73fl2feY
BASF. (1988). Testing the acute toxicity in the fish model Zebra danio (brachydanio rerio) over the
course of 96 hours. Germany: Hoechst AG, Pharma Research Toxicology and Pathology.
(https://echa.europa.eu/regi stration-dossier/-/registered-dossier/l 0330/6/2/2.).
(1998).	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.
(1999).	Determination of the biodegradability of perylimid F in the manometric respirometry test
according to GLP, EN 45001 and ISO 9002. Ludwigshafen: BASF Aktiengesellschaft Ecology
and Environmental Analytics Laboratory of Ecology D-67056.
(https://echa.europa.eu/regi stration-dossier/-/registered-dossier/l 0330/5/3/2).
(2012a). H-28548: Paliogen violet 5011, Daphnia magna, acute immobilization test. Pszczyna,
Poland: Institute of Industrial Organic Chemistry, Branch Pszcyna Department of Ecotoxicology.
Page 33 of 43

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(https://echa.europa.eu/regi stration-dossier/-/registered-dossier/l 0330/6/2/4).
BASF. (2012b). H-28548: Paliogen violet 5011, Lemna gibba L., CPCC 310 growth inhibition test
according to OECD guideline No. 221. Pszczyna, Poland: Institute of Industrial Organic
Chemistry, Branch Pszcyna Department of Ecotoxicology. (https://echa.europa.eu/registration-
dossier/-/registered-dossier/l 0330/6/2/7).
BASF. (2013). Physical-chemical properties of "Paliogen violet 5011". BASF study no. 11 LOO 105.
(11L00105). Ludwigshafen: Competence Center Analytics; BASF SE; D-67056.
(https://echa.europa.eu/regi stration-dossier/-/registered-dossier/l 0330/4/10)
(https://echa.europa.eu/regi stration-dossier/-/registered-dossier/l 0330/4/3).
(2017). Paliogen® Red Violet K 5011: Material Safety Data Sheet.
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/document7iJ-.bPA-HQ-OPPr	£5-0006).
CPMA. (Color Pigment Manufacturers Association). (2017h) I .elter from CPMA to the U.S. EPA.
September 19, 2017. Re: Comments on the Scope of I lie Risk I-valuation, and on EPA's Planned
Problem Formulation, for C.I. Pigment Violet 2l) (Anthra[2, l,9-dcf:6.5,10-d'e'f]diisoquino-line-
1,3,8,10(2H,9H)tetrone), Chemical Abstracts Service No. 81-33-4 (I :PA-HQ-OPPT-2016-0725).
Color Pigments Manufacturers Association. Inc
ECHA. (2017). Perylene-3, 4; 9, 10-tetracarboxydiimide Helsinki, Finland. Retries ed from
https://echa.europa.eu/registration-dossierA/regi	¦ ' '10330.
Environment Canada. (2006). Canadian F.nvironmental Protection \ct Substances List: Categorization
of Existing Substances. (GoCN 2O060905) (Mm	'c.ca/lcpe-cepa/D031CB30-B316-
D54C-01 I * * Ji» 26A.1F/IjoCN 90^ cng.pt J
Johnson. IK. (1999). Local lymph node assay Project no CTL,P,6l94. (CTL/P/6194). Germany: BASF
AktiengesellschalV (	ropa.eu/r ion-dossier/-/registered-
dossier/10330/"	.	ip=3PfT. • .^--u3fe-402e-9a67-0bf9048bb68b).
Jung. R; Weigand. W. (ll'S3) IVi \ limid study of the mutagenic potential in strains of salmonella
typhimurium (Ames l est) and escherichia coli (S3.0695). Germany: Hoechst
Aktiengesellschafl. (	,,.-;ion-dossier/-/registered-
doss:	: 7/2/?d -		 d-0a68-42b7-b 34bbf310a7).
Mott. (2d| 7a) Personal communication between Dr. Robert C. Mott (Sun Chemical Corporation)
and Alio Muneer (EPA) regarding exposure questions [Personal Communication],
Mott. RC. (2<) I 7h) Personal communication between Dr. Robert C. Mott (Sun Chemical Corporation)
and Alie Mi nicer (EPA) regarding release of PV29 to Cooper River [Personal Communication],
Rupprich. N: Wei.	(1984a). Perylimid testing the acute dermal irritant effects/caustic effects on
the rabbit e\ e (84 < >228) Germany: Hoechst AG, Pharma Research Toxicology and Pathology.
Rupprich. N: Weig;v; J (I^S4h) Perylimid testing the acute irritant effects/caustic effects on the
rabbit eye. (84.022l->) Cierniany: Hoechst AG, Pharma Research Toxicology and Pathology.
Rupprich. N: Weigand. W. (1984c). Testing the acute oral toxicity in the male and female Wistar rat.
(84.0225). Germany: Hoechst AG, Pharma Research Toxicology and Pathology.
Stark. D; Treumann. S: van Ravenzwaav. B. (2013). Reproduction/developmental toxicity screening test
in Wistar rats oral administration (gavage). (80R0223/11C162). Germany: BASF SE.
(https://echa.europa.eu/regi stration-dossier/-/registered-
dossier/10330/7/9/2/7documentUUID=7e96ccce-834d-4219-9bab-C?bd8c Q.
Sun Chemical (Sun Chemical Corporation). (2017). Safety Data Sheet: Violet 29.
(U.S. Environmental Protection Agency). (2011). Exposure factors handbook: 2011 edition
(final) [EPA Report], (EPA/600/R-090/052F). Washington, DC: U.S. Environmental Protection
Agency, Office of Research and Development, National Center for Environmental Assessment.
Page 34 of 43

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(U.S. Environmental Protection Agency). (2012a). 2012 Chemical Data Reporting Results.
results (accessed 6/12/2018)
U.S. EPA. (2012b). Estimation Programs Interface (EP1) Suite™ for Microsoft® Windows (Version
4.11). Washington D.C.: Environmental Protection Agency. Retrieved from
U.S. EPA. (2016) 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. 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 o/documents/pv29 comp bib.pdf.
(U.S. Environmental Protection Agency). (2017h) Scope of the risk evaluation for Pigment
Violet 29 (Anthra[2,l,9-def:6,5,10-d'e'f]diisoquinoline-l,3,S. I n(2TI,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/production/files/2 /documents/p\	e 06-., - * pdf.
(U.S. Environmental Protection Agency). (2') I 7c) 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
Pollution Prevention and Toxics. -	ww e- 	it-- ; rorfnetion/fites/
06/documents/pv29 lit search st-
(U.S. Environmental Protection \uenc\) (2<)|Sa) Application of systematic review in TSCA
risk evaluations Version I 0. (74<)|>I K<)<)I) Washington. I) (' U.S. Environmental Protection
Agency, Office ofChemical Safelx and Pollution he\ ention.
(U.S. Environmental Protection Agency) (2d 18b). Problem formulation of the risk evaluation
for C.I. Pigment Violet 29 (Anthra[2.I ,l)-def.(o. IO-d'e'f]diisoquinolinel,3,8,10(2H,9H)-
tetrone). CASRN: 81-33-4 [EPA Report| (l-IW Document# 740-R1-7021). United States
Environmental Protection Agency , OlTice ofChemical Safety and Pollution Prevention, Office
of Pollution Prevention and Toxics. (	.-p.; -;ov/assessing-and-managing-chemicals-
un.de	i. ent-vi olet-29-anthra219-defb :> i u-qefdiisoquinoline-O).
(LSI - n\ i ronmental Protection Agency). (2018c). Strategy for assessing data quality in
TSCA risk e\ filiations. Washington DC: U.S. Environmental Protection Agency, Office of
Pollution lJre\ ention and Toxics.
Wollny. H. (2012). (iene mutation assay in Chinese hamster V79 cells in vitro (V79/HPRT) with
paliogen violet 5<»1 I (1443105). Germany: BASF SE. (https://echa.europa.eu/regi strati on-
dossier/Vregisterea-aossier/10330/7/7/2/? documentUULD=3 be • u >0t<2-4c71-bl74-
)
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APPENDICES
Appendix A REGULATORY HISTORY
A-l Federal Laws and Regulations
TableApx A-4. Federal Laws and Regulations
Statutes/Regulations
Description of
Authority/Regulation
Description of Regulation
EPA Regulations
TSC A - Section 6(b)
The 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).
TSC A - Section 8(a)
The TSCA § 8(a) CDR Rule
requires manufacturers
(including importers) to give the
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).
TSC A - Section 8(b)
The 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 the
EPA's new chemicals review
process under TSCA section 5
(42 FR 64572, December 23,
1977).
Other Federal 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
colorant in food-contact
polymers.
C.I. Pigment Violet 29 is
approved to be in finished
articles that come in contact with
food. It should not to exceed 1
percent by weight of polymers
and should follow specific
conditions of use (21 CFR
Page 36 of 43

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Statutes/Regulations
Description of
Authority/Regulation
Description of Regulation


178.3297). C.I. Pigment Violet
29 is not listed as an approved
food additive.
A-2 International Laws and Regulations
TableApx A-5. International Laws and Regulations
Country/Organization
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 11
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.12
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,
2013.13 There are no restrictions associated with being on the
Chinese inventory.
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, 1981.14 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.
11	Australian Government. National Industrial Chemicals Notification and Assessment Scheme. Accessed March 14, 2017.
littps://www.nicnas.aov.au/searcli/cheniical?id=1189.
12	Government of Canada. Environment and Climate Change Canada. Search Engine for Chemicals and Polymers. Accessed March 14,
2017. http://www.ec.ac.ca/lcpe-cepa/ena/substance/cheniicals polvmers.cfm.
13	Chemical Inspection & Regulation Service. Hie 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-inventorv-of-existing-chemical-substance-in-china-
iecsc-2013-and-updates.html.
14	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.
Page 37 of 43

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Country/Organization
Requirements and Restrictions
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.15
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.16 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 29.17
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.18 There are no restrictions
associated with being on the Philippine inventory.
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.19
Vietnam
C.I. Pigment Violet 29 is on the draft (September 2018)
Vietnam National Existing Chemical Inventory. There are no
restrictions associated with being on the Vietnamese
90
inventory.
15	NITE Chemical Risk Information Platform (NITE-CHRIP). Accessed March 14,2017.
http://www.nite.go.ip/en/chem/clirip/clirip search/cmpInfDsp?cid=CO 10-529-
04A&bcPtn=Q&sliMd=0&txNimiSli=ODEtMzMtNA==<NimiTp= 1 &txNmSh=<NmTp=<NmMli= 1 &txNmShl =<NmTp 1 =&txNm
Sli2=<NmTp2=&txNmSh3=<NmTp3=&txMlSli=<MIMli=0<ScDp=0<PgCtSt=100&rbDp=0&txScSML=<ScTp=l&txUpScFl
=null&lidUpScPh=&hdUpHash=&rbScMli=l&txScNvMli=&txMlWtSt=&txMlWtEd=&err
16	Chemical Inspection & Regulation Service. Korea Existing Chemicals Inventory. December 20, 2016. Accessed October 11,2017.
http://www.cirs-reach.com/KoreaTCCA/Korea Existing Chemicals Inventory KECI.html.
17	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.
http://www.epa. govt.nz/search-databases/Pages/nzioc-details.aspx?SubstanceID=35898.
18	Republic of the Philippines Chemical Management Section. Philippine Inventory of Chemicals and Chemical Substances. Accessed
October 11,2017. http://chemical.emb.gov.ph/?page id=138.
19	Occupational Safety and Health Administration, Ministry of Labor. TCSI Search. Accessed October 11, 2017.
https://csnn.osha.gov.tw/content/home/Substance Result.aspx?enc=XpkoFr9qGvTvISX6V8igsO==.
211 ChemSafetyPRO. Vietnam National Existing Chemical Inventory. October 17, 2018. Accessed October 31, 2018.
http://www.chemsafetvpro.com/Topics/Vietnam/Vietnam National Existing Chemical Inventorv.html.
Page 38 of 43

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Appendix B ENVIRONMENTAL FATE STUDY RESULTS21
Apx A-l: Environmental Fate Study Summary for C.I. Pigment Violet 29 (ECHA, 2017)
Target System
Study Type
(year)
Species,
Strain, Sex
(Number/
group)1
Exposure
Route
Doses/
Concentrations
Duration2
Endpoint
Effect3
Affiliated
Reference4
Data
Quality
Evaluation
results of
full study
report5
Biodegradation
OECD 30IF -
Biodegrad-
ability:
Mano metric
Respirometry
Test)
Activated sludge,
domestic, non-
adapted
(Concentration of
sludge: 30 mg/I
Static renewal
100 mg/L
28 Days
Degradation
degree of the
test substance
after 28 days
(percent
BOD/ThOD); 0-
10
Poorly
biodegradable
(BASF. 1999)
High
'Species/strain, sex of animals included in the study.
2Acute exposures defined as those occurring within a single day. Chronic exposures defined as 10 percent or more of a lifetime (U.S. EPA. 20111.
3The effect(s) listed were the most sensitive effects observed for that target organism in that study (i.e., the effect(s) upon which the POD was based).
4This column lists the primary reference of the full study report corresponding to the ECHA summary. 5Information included in this column is the overall quality level resulting from the data quality evaluation - this
also would include unacceptable studies for comparison with acceptable studies. Note that in addition to the final result for the study/endpoint, selected important quality considerations could also be included, such
as low purity etc.
5 One environmental fate study, OECD Guideline 209-Determination of the inhibition of oxygen consumption by activated sludge by Perylimid F in the Activated Sludge Respiration Inhibition Test according to
GLP, EN 45001 and ICO 9002, was received by the data owner but is not reported in the ECHA database
21 The data presented in these tables in Appendix B-D reflects the data summaries as presented in ECHA (ECHA. 2017). A claim of business confidentiality with the data
owners of the full study reports prevents the publication of specific details from the full studies.
Page 39 of 43

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Appendix C ENVIRONMENTAL EFFECTS ENDPOINTS
Table Apx C-l: Aquatic Plant Toxicity Study Summary for C.I. Pigment Violet 29 (ECHA., 2017)
Target System
Study Type
(year)
Species,
Strain, Sex
(Number/
group)1
Exposure Route
Doses/
Concentrations
Duration2
Endpoint
Effect3
Affiliated
Reference4
Data Quality
Evaluation
results of full
study report5
Mortality
OECD-201;
Aquatic
vascular plant: 7
days, static
renewal
Duckweed
(Lemna gibba)
static renewal
Nominal: 0
(control), 1, 3.2,
10, 32, 100 mg/L
based on loading
Measured Test
Concentrations:
0.007 mg/L
(highest)
7 Days
NES
(based on
growth [frond
number and
dry weight])
None reported
(BASF,
2012b)
High

OECD-202;
Acute
freshwater
invertebrate: 48
hours, static,
limit
Daphnia
magna
static
Measured test
concentrations: -
(control), 0.0065
mg/L
48 Hours
NES
None reported
(BASF,
2012a)
High

OECD-203;
Acute
freshwater fish:
96 hours, static
Zebrafish
(Brachydanio
rerio)
static
Nominal test
concentrations: 0
(control), 5000
mg/L
96 Hours
NES
None reported
(BASF,
1988)
High
'Species/strain, sex of animals included in the study.
2Acute exposures defined as those occurring within a single day. Chronic exposures defined as 10 percent or more of a lifetime (U.S. EPA. 2011V
3The effect(s) listed were the most sensitive effects observed for that target organ/system in that study (i.e., the effect(s) upon which the POD was based).
4This column lists the primary reference of the full study report corresponding to the ECHA summary.
5Information included in this column overall quality level resulting from the data quality evaluation - this also would include unacceptable studies for comparison with acceptable studies. Note that in addition to the
final result for the study/endpoint, selected important quality considerations could also be included, such as low purity etc.
Page 40 of 43

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Appendix D HUMAN HEALTH EFFECTS ENDPOINTS
Table Apx C-l: Toxicity Si
udy Summaries for C.I. Pigment Violet 29 as Presented in
the ECHA Database (ECHA, 2017)22
Target Organ/
System
Study Type
(year)
Species,
Strain, Sex
(Number/
group)1
Exposure
Route
Doses/
Concentrations
Duration2
Endpoint
Effect3
Affiliated
Reference4
Data Quality
Evaluation
results of full
study report5
Mortality
OECD-401;
Acute oral
Sprague-
Dawley rat
(5 animals/
sex/dose)
Oral
6810 and 10000
mg/kg bw
14 days
LD50
>10,000
mg/kg bw
None
(BASF. 1975b)
High
(BASF. 1978c)
High
OECD-401;
Acute oral,
single dose
by gavage,
limit
Sprague-
Dawley rat
(5 animals/
sex/dose)
Oral
10000 mg/kg
bw
14 days
LD50
>10,000
mg/kg bw
None
(RuDDrich and
Weisand.
1984c)
High
Acute
Inhalation
Toxicity
WistarRat
(6 per sex)
Inhalation
0.31 mg/1 air
(calculated)
7 Hour
LC5o>0.31
mg/L air
None
(BASF. 1978a)
Medium
Rat (6 per
sex)
Inhalation
14.74 mg/L
8 Hour
l.(\ 14.74
mg/L
None
(BASF. 1975a)
Medium
Acute
Intraperitone-
al Toxicity -
Conducted
according to
internal
protocol
NMRI-
Wiga
Mouse
Intraperitoneal
injection
10,000, 6,810,
4,640 mg/kg
14-day observation
post injection
LD50= 9000
mg/kg-bw
Mortality,
Dyspnea,
apathy,
unsteady
gait and
ruffled fur
(BASF. 1978b)
High
NMRI-
Ivanovas
Mouse (5
animals/
sex/ dose)
Intraperitoneal
injection
2150, 4640 and
10000 mg/kg
14-day observation
post injection
LD50= 7000
mg/kg-bw
Mortality
Dyspnoea,
apathy,
agitation,
bad general
health.
(BASF. 1975f)
High
22
Listed below are three additional studies submitted by one data owner, they were not reported in the ECHA database.
•	OECD Guideline 401: Acute Oral Toxicity with Rats
•	OECD Guideline 404: Acute Dermal Irritation/Corrosion
•	OECD Guideline 405: Acute Eye Irritation/Corrosion
Page 41 of 43

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Target Organ/
System
Study Type
(year)
Species,
Strain, Sex
(Number/
group)1
Exposure
Route
Doses/
Concentrations
Duration2
Endpoint
Effect3
Affiliated
Reference4
Data Quality
Evaluation
results of full
study report5
Reproductive
and
Developmental
OECD-421
Reproduction
and
development
toxicity
Wistar rat
(10 males/
10 females)
Gavage
100, 300, 1000
mg/kg bw/d
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)
NOAEL=
1000 mg/kg
bw/day
None
reported6
(Stark et al..
2013)
High
Skin Irritation
OECD- 404;
Skin
irritation:
occlusive
Weiber
Wiener
rabbit (3
animals)
Occlusive,
applied to
intact and
damaged skin
Not specified,
the test
substance was
given as a 50%
aqueous
preparation.
8 day observation
period
Not
irritating
None
reported
(BASF. 1978d.
1975e)
Medium
Medium
OECD- 404;
Skin
irritation: in
vivo
Weiber
Wiener
rabbit
Occlusive,
applied to
intact skin
Not specified,
the test
substance was
given as a 50%
aqueous
preparation.
20 hour exposure, 8
day observation
period
Not
irritating
None
reported
(RuDDrich and
Weisand.
1984a)
High
Eye irritation
OECD-405;
Eye irritation
/ Corrosion
Weiber
Wiener
Rabbit (3
animals)
Single
application
The substance
was applied
undiluted: 100
111 test material
72 hour observation
period
Not
irritating
None
reported
(BASF. 1975c)
(BASF. 1978e)
High
High
OECD-405;
Eye irritation
/ Corrosion
Weiber
Wiener
Rabbit (2
animals)
The test
substance was
applied to the
conjunctival
sac of one eye
in 2 animals
Single
concentration:
50 nL
8-day observation
period
Not
irritating
None
reported
(RuDDrich and
Weisand.
1984b)
High
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Target Organ/
System
Study Type
(year)
Species,
Strain, Sex
(Number/
group)1
Exposure
Route
Doses/
Concentrations
Duration2
Endpoint
Effect3
Affiliated
Reference4
Data Quality
Evaluation
results of full
study report5
Skin
sensitization
OECD-429;
Skin
sensitization:
mouse local
lymphocyte
assay
(LLNA)
Male
CBA/Ca
mouse (2
animals/
conc.)
The test
substance in
propylene
glycol was
applied, using
a variable
volume micro-
pipette, to the
dorsal surface
of each ear
The test
substance was
applied as 3%,
10% or 30% w/v
preparations in
propylene glycol
3- day repeat
exposure
Not
irritating
None
reported
(Johnson. 1999)
High
Genotoxicity
OECD-471;
Genotoxicity
- gene
mutation {in
vitro)
Salmonella
typhimurium
TA 100, TA
1535, TA
1537, TA
1538, TA 98
and /•'. coli
WP2uvrA
In agar (plate
incorporation)
4, 20, 100, 500,
2500 and 5000
Hg/plate
Exposure duration:
48-72 hours at
37°C in the dark
Negative
The test
compound
proved to be
not toxic.
(June and
Weieand. 1983)
High
OECD-476;
Genotoxicity
- gene
mutation (in
vitro)
Chinese
hamster
lung
fibroblasts
(V79)
Target
gene: HPRT
In-medium
Without
metabolic
activation
system (S9
mix): 10.8; 21.5;
43.0; 86.0;
172.0; 344.0
Hg/ml
With S9 mix:
5.6; 10.8:21.5;
43.0; 86.0;
172.0 ug/ml
7 days after
treatment
Negative
The test
item did not
induce gene
mutations at
the HPRT
locus in
V79 cells.
(Wollnv. 2012)
High
'Species/strain, sex of animals included in the study.
2Acute exposures defined as those occurring within a single day. Chronic exposures defined as 10 percent or more of a lifetime (U.S. EPA. 20111.
3The effect(s) listed were the most sensitive effects observed for that target organ/system in that study (i.e., the effect(s) upon which the POD was based).
4This column lists the primary reference of the full study report corresponding to the ECHA summary.
'Information included in this column is the overall quality level resulting from the data quality evaluation - this also would include unacceptable studies for comparison with acceptable studies. Note that in addition
to the final result for the study/endpoint, selected important quality considerations could also be included, such as low purity etc.
6 Effects observed were parental mortality, body weight, food consumption, macroscopic findings, organ weights (evaluated in males only), histopathology, spermatogenesis, mating or fertility indices, pre-coital
interval, gestation index or length, number of implantation sites, postimplantation loss, live birth index, numbers of delivered pups, livebom pups, and stillborn pups, pup viability index, pup sex ratio, pup clinical
signs, pup body weights, or pup necropsy
Page 43 of 43

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