January 2021
| ' United States Office of Chemical Safety and
¦¦¦¦ » * Environmental Protection Agency Pollution Prevention
Non-Technical Summary 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
January 2021
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ACTION
• EPA is releasing the final risk evaluation on C.I. Pigment Violet 29 (PV29). After evaluating
14 conditions of use of PV29, EPA has determined that PV29 presents an unreasonable risk
under 10 conditions of use. This includes an unreasonable risk to workers and occupational
non-users when domestically manufacturing or importing the chemical, processing the
chemical for a variety of uses, and when used in a variety of industrial and commercial
conditions of use. PV29 does not pose an unreasonable risk under distribution in commerce
or in a variety of industrial and commercial and consumer applications. EPA also determined
that PV29 does not present an unreasonable risk to the environment and general population.
• This final risk evaluation is conducted pursuant to the Toxic Substances Control Act (TSCA),
as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which
requires EPA to prioritize and evaluate the safety of existing chemicals to determine whether
a chemical presents an unreasonable risk of injury to health or the environment under the
conditions of use. Under TSCA, if a chemical is determined to present an unreasonable risk,
then EPA must regulate the substance to address the unreasonable risk.
• The final risk evaluation and supplemental materials can be found in docket EPA-HQ-OPPT-
2018-0604 on www.regulations.gov.
• PV29 was selected in 2016 as one of the first 10 chemicals for risk evaluation under section 6
of TSCA.
• Public comments and external scientific peer review informed the development of the PV29
final risk evaluation. EPA published the PV29 revised draft risk evaluation in October 2020,
the PV29 draft risk evaluation in November 2018, the PV29 problem formulation document
in June 2018, and the scope document in June 2017.
KEY POINTS
• After evaluating 14 conditions of use, EPA determined that PV29 presents an unreasonable
risk under 10 conditions of use. This includes an unreasonable risk of injury to health of
workers and occupational non-users (ONUs).
• Between the revised draft and the final risk evaluation, industrial/commercial use in
automobile paint changed from no unreasonable risk to unreasonable risk and risk to all
ONUs changed from no unreasonable risk to unreasonable risk. This change is due to a
different model being used and the margin of exposure (MOE) changing from 30 to 100 with
the new model. The APF assumed for industrial/commercial use in automobile paint of 25,
was no longer protective. Also, two conditions of use were changed from unreasonable risk
to no unreasonable risk because PV29 in plastic and rubber products is encapsulated in the
plastic matrix and not expected to leach out. These conditions of use were not quantitatively
evaluated in the final risk evaluation because exposure PV29 from these conditions of use is
negligible.
• These unreasonable risks of injury to health include alveolar hyperplasia, inflammatory and
morphological changes in the lower respiratory tract for chronic inhalation exposures.
• The conditions of use with unreasonable risks include domestic manufacturing and import;
processing: incorporation into formulation, mixture, or reaction products in paints, coatings,
plastic and rubber products; processing: use as an intermediate in the creation or adjustment
of color of other perylene pigments; recycling; several industrial and commercial uses
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including in paints for automobiles (e.g., original equipment manufacturing and refinishing),
coatings and basecoats; use in merchant ink for commercial printing; and disposal.
• The conditions of use that EPA determined do not present an unreasonable
risk include distribution in commerce; industrial and commercial uses including in finished
plastic and rubber products for automobile plastics and industrial carpeting; and consumer
use in professional quality watercolor and acrylic artist paint.
• EPA released the draft risk evaluation for PV29 in November 2018 for a 60-day public
comment period. Additionally, EPA held a peer review meeting of the Science Advisory
Committee on Chemicals (SACC) on the draft risk evaluation of PV29 on June 18-21, 2019.
• EPA released the revised draft risk evaluation for PV29 in October 2020 for a 30-day public
comment period, which was extended for an additional 20 days. Additionally, a letter peer
review was conducted for members on the SACC during the 30-day public comment period.
Both reports are in the TSCA SACC docket (EPA-HQ-OPPT-2018-0604) on
www.regulations.gov. Along with the final risk evaluation, EPA is releasing a document that
provides a response to public and peer review comments.
BACKGROUND
• Leading applications for PV29 include use as an intermediate to create or adjust color of
other perylene pigments, incorporation into paints and coatings used primarily in the
automobile industry, incorporation into plastic and rubber products used primarily in
automobiles and industrial carpeting, use in merchant ink for commercial printing, and use in
consumer watercolors and artistic color. The total aggregate production volume reported
under the Chemical Data Reporting rule for the 2016 period indicates over 600,000 pounds
of PV29 were manufactured (including imports) in the United States.
• Evaluation and risk management steps for the PV29 final risk evaluation:
o EPA has issued the final risk evaluation for PV29, meeting the requirements set forth
in TSCA section 6. EPA is now initiating the process to address the unreasonable
risks identified in the final risk evaluation. EPA has two years following the issuance
of the final risk evaluation to address, by rule, the unreasonable risks identified.
NEXT STEPS
• EPA has issued the final risk evaluation for PV29, meeting the requirements set forth in
TSCA section 6(b). EPA is now initiating the process to address the unreasonable risks
identified. EPA has two years following the issuance of the final risk evaluation to address,
by rule, the unreasonable risks identified.
SUMMARY OF UNREASONABLE RISK DETERMINATIONS
EPA has determined that the following conditions of use of C.I. Pigment Violet 29 do not present
an unreasonable risk of injury to health or the environment. These determinations are considered
final agency action and are being issued by order pursuant to TSCA Section 6(i)(l).
Conditions of Use that Do Not Present an Unreasonable Risk
• Distribution in Commerce
• Plastic and rubber products - Automobile plastics
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• Plastic and rubber products - Industrial carpeting
• Consumer Use - Consumer watercolor and acrylic paints - Professional quality
watercolor and acrylic artist paint
EPA has determined that the following conditions of use of C.I. Pigment Violet 29 present an
unreasonable risk of injury. EPA will initiate TSCA Section 6(a) risk management actions on
these conditions of use as required under TSCA Section 6(c)(1). Pursuant to TSCA Section
6(i)(2), the unreasonable risk determinations for these conditions of use are not considered final
agency action. The details of these determinations are in Section Error! Reference source not
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• Domestic Manufacture
• Import
Processing
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