U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
SCREENING-LEVEL HAZARD CHARACTERIZATION
C.I. Pigment Red 48 and 52 Category
SPONSORED CHEMICALS
C.I. Pigment Red 48 Calcium
C.I. Pigment Red 48 Barium
C.I. Pigment Red 52 Calcium
CASRN 7023-61-2
CASRN 7585-41-3
CASRN 17852-99-2
SUPPORTING CHEMICALS
C.I. Pigment Red 57
C.I. Pigment Red 48:4 (Manganese)
CASRN 5281-04-9
CASRN 5280-66-0
The High Production Volume (HPV) Challenge Program1 was conceived as a voluntary initiative
aimed at developing and making publicly available screening-level health and environmental
effects information on chemicals manufactured in or imported into the United States in quantities
greater than one million pounds per year. In the Challenge Program, producers and importers of
HPV chemicals voluntarily sponsored chemicals; sponsorship entailed the identification and
initial assessment of the adequacy of existing toxicity data/information, conducting new testing if
adequate data did not exist, and making both new and existing data and information available to
the public. Each complete data submission contains data on 18 internationally agreed to "SIDS"
(Screening Information Data Setl'2) endpoints that are screening-level indicators of potential
hazards (toxicity) for humans or the environment.
The Environmental Protection Agency's Office of Pollution Prevention and Toxics (OPPT) is
evaluating the data submitted in the HPV Challenge Program on approximately 1400 sponsored
chemicals by developing hazard characterizations (HCs). These HCs consist of an evaluation of
the quality and completeness of the data set provided in the Challenge Program submissions.
They are not intended to be definitive statements regarding the possibility of unreasonable risk of
injury to health or the environment.
The evaluation is performed according to established EPA guidance2'3 and is based primarily on
hazard data provided by sponsors; however, in preparing the hazard characterization, EPA
considered its own comments and public comments on the original submission as well as the
sponsor's responses to comments and revisions made to the submission. In order to determine
whether any new hazard information was developed since the time of the HPV submission, a
search of the following databases was made from one year prior to the date of the HPV
Challenge submission to the present: (ChemID to locate available data sources including
Medline/PubMed, Toxline, HSDB, IRIS, NTP, AT SDR, IARC, EXTOXNET, EPA SRS, etc.),
STN/CAS online databases (Registry file for locators, ChemAbs for toxicology data, RTECS,
1	U.S. EPA. High Production Volume (HPV) Challenge Program; http://www.epa.gov/chemrtk/index.htm.
2	U.S. EPA. HPV Challenge Program - Information Sources; http://www.epa.gov/chemrtk/pubs/general/guidocs.htm.
3	U.S. EPA. Risk Assessment Guidelines; http://cfpub.epa.gov/ncea/raf/rafguid.cfm.

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U.S. Environmental Protection Agency
Hazard Characterization Document
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Merck, etc.), Science Direct and ECHA4. OPPT's focus on these specific sources is based on
their being of high quality, highly relevant to hazard characterization, and publicly available.
OPPT does not develop HCs for those HPV chemicals which have already been assessed
internationally through the HPV program of the Organization for Economic Cooperation and
Development (OECD) and for which Screening Initial Data Set (SIDS) Initial Assessment
Reports (SIAR) and SIDS Initial Assessment Profiles (SIAP) are available. These documents are
presented in an international forum that involves review and endorsement by governmental
authorities around the world. OPPT is an active participant in these meetings and accepts these
documents as reliable screening-level hazard assessments.
These hazard characterizations are technical documents intended to inform subsequent decisions
and actions by OPPT. Accordingly, the documents are not written with the goal of informing the
general public. However, they do provide a vehicle for public access to a concise assessment of
the raw technical data on HPV chemicals and provide information previously not readily
available to the public.
4 European Chemicals Agency, http://echa.europa.eu.
2

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U.S. Environmental Protection Agency September, 2014
Hazard Characterization Document	
Chemical Abstract
Service Registry Number
(CASRN)
Sponsored Chemicals
7023-61-2
7585-41-3
17852-99-2
Supporting Chemicals
5281-04-9
5280-66-0
Chemical Abstract Index
Name
Sponsored Chemicals
2-Naphthalenecarboxylic acid, 4-[(5-chloro-4-methyl-2-
sulfophenyl) azo]-3-hydroxy-, calcium salt (1:1)
2-Naphthalenecarboxylic acid, 4-[(5-chloro-4-methyl-2-
sulfophenyl) azo]-3-hydroxy-, barium salt (1:1)
2-Naphthalenecarboxylic acid, 4-[(4-chloro-5-methyl-2-
sulfophenyl) azo]-3-hydroxy-, calcium salt (1:1)
Supporting Chemicals
2-Naphthalenecarboxylic acid, 3-hydroxy-4-[(4-methyl-2-
sulfophenyl) azo]-, calcium salt (1:1)
Manganate(l-), [4-[[5-chloro-4-methyl-2-(sulfo-.kappa.O)
phenyl] azo-.kappa.N l]-3-(hydroxy-.kappa.O)-2-
naphthalenecarboxylato(3-)] -, hydrogen
Structural Formula
See Appendix
Summary
The C.I. Pigment Red 48 and 52 category is composed of three substances: 2-
naphthalenecarboxylic acid, 4-[2-(5-chloro-4-methyl-2-sulfophenyl)diazenyl]-3-hydroxy-,
calcium salt (1:1) (C.I. Pigment Red 48 Calcium); 2-naphthalenecarboxylic acid, 4-[2-(5-
chloro-4-methyl-2-sulfophenyl)diazenyl]-3-hydroxy-, barium salt (1:1) (C.I. Pigment Red 48
Barium); and 2-naphthalenecarboxylic acid, 4-[2-(4-chloro-5-methyl-2-sulfophenyl)diazenyl]-
3-hydroxy-, calcium salt (1:1) (C.I. Pigment Red 57). The substances are red solids possessing
negligible vapor pressure and low water solubility. They are expected to have low mobility in
soil. A surrogate substance, 2-naphthalenecarboxylic acid, 3-hydroxy-4-[2-(4-methyl-2-
sulfophenyl) diazenyl]-, calcium salt (1:1) (C.I. Pigment Red 57) is expected to be not readily
biodegradable. In general, azo dyes and pigments are considered recalcitrant under aerobic
conditions; however, a variety of microorganisms can reduce the azo bond under anaerobic
conditions. Volatilization is expected to be low given that these are ionic substances. The rate
of hydrolysis is negligible. These substances may be subject to direct and indirect photolysis
in sunlit surface waters. The rate of atmospheric photooxidation is moderate; however, this is
3

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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
not expected to be an important environmental fate process since these substances are not
likely to exist in the vapor phase in the ambient atmosphere. The constituents of the C.I.
Pigment Red 48 and 52 category are expected to have high (P3) persistence except in
anaerobic environments and low (Bl) bioaccumulation potential.
The acute oral toxicity of C.I. Pigment Red 48 and 52 category members in rats is low. No
data are available for the repeated-dose/reproductive/developmental toxicity endpoints. C.I.
Pigment Red 48 barium and C.I. Pigment Red 48 calcium were not mutagenic in bacteria in
vitro and are not irritating to rabbit skin or eyes.
Based on the supporting chemical (C.I. Pigment Red 57), the fish 96-h LCso for the sponsored
chemicals (C.I. Pigment Red 48 Calcium, C.I. Pigment Red 48 Barium, and C.I. Pigment Red
52 Calcium) is 33 mg/L. Based on the supporting chemical, the 72-h ECso for the sponsored
chemicals to aquatic plants is 190 mg/L (biomass),. There are no adequate data available for
acute toxicity to aquatic invertebrates.
Data gaps for repeated-dose, reproductive, developmental and genetic (gene mutations and
chromosomal aberrations) toxicity and acute toxicity to aquatic invertebrates were identified
under the HPV Challenge Program.
4

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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
The sponsor, Color Pigments Manufacturers Association, Inc., submitted a Test Plan and Robust
Summaries to EPA for the C.I. Pigment Red 48 and 52 category on August 15, 2006. EPA
posted the submission on the ChemRTK HPV Challenge website on August 29, 2006
(http://www.epa.gov/hpv/pubs/summaries/cird4852/cl6302tc.htm). EPA comments on the
original submission were posted to the website on March 31, 2009. Public comments were also
received and posted to the website. The sponsor submitted a response to EPA comments and the
Organisation for Economic Cooperation and Development (OECD) SIDS Initial Assessment
Report (SIAR) for the supporting chemical, C.I. Pigment Red 57 on May 27, 2009.
Category Justification
C.I. Pigment Red 48 Calcium (CASRN 7023-61-2) and C.I. Pigment Red 48 Barium (CASRN
7023-41-3) are different salts of the same organic compound (2-naphthalenecarboxylic acid, 4-
[(5-chloro-4-methyl-2-sulfophenyl) azo]-3-hydroxy-). The structure of the organic portion of
C.I. Pigment Red 52 Calcium (CASRN 17852-99-2) differs from the organic portion of C.I.
Pigment Red 48 only by the position of the chlorine atom and methyl group on one of the rings.
Because the three sponsored chemicals are expected to have similar physicochemical and
toxicological properties, EPA agrees with the grouping of these 3 chemicals into a category.
Justification for Supporting Chemicals
The sponsor proposed the use of two supporting chemicals, C.I. Pigment Red 57 (CASRN 5281-
04-9) and C.I. Pigment Red 48:4 (Manganese), (CASRN 5280-66-0). EPA accepted the use of
melting point data for C.I. Pigment Red 48:4 (Manganese) due to its structural similarity to the
sponsored substance. C.I. Pigment Red 48:4 (Manganese), (CASRN 5280-66-0) was not used as
an analog for either the health or eco endpoints. EPA accepted the use of C.I. Pigment Red 57
to satisfy aquatic toxicity endpoints because it shares a similar chemical structure with the
category members and has a similar octanol/water partition coefficient, which influences toxicity
to aquatic species. EPA did not accept the use of C.I. Pigment Red 57 for the human health
endpoints because it does not possess the chlorine substituent that is present in all of the category
members. The chlorine substituent may influence the toxicity of the sponsored substances such
that toxicity differs between C.I. Pigment Red 57 and the category members. EPA has requested
that the sponsor provide evidence that the chlorine substituent will not alter the basic biological
effects of the sponsored chemicals (e.g., pharmacokinetic or metabolism data; comparative
repeated-dose toxicity data). The comparative data for acute toxicity to mammals was not
sufficient to determine whether or not C.I. Pigment Red 57 and the category members can be
expected to produce similar toxicity in repeated-dose, reproductive or developmental toxicity
studies or in genotoxicity studies. Although the sponsor, in their response to EPA's comments
on the original submission, claimed that C.I. Pigment Red 57 is more reactive than the sponsored
substances and therefore represents a worst-case scenario for toxicity, the sponsor provided no
evidence to support this claim, other than higher solubility of C.I. Pigment Red 57 in water and
octanol. Given that the toxicity of a substance to humans is not merely dependent upon its
solubility, EPA did not accept this argument for the use of C.I. Pigment Red 57 as a supporting
chemical for human health endpoints. Furthermore, the sponsor's argument that the breakdown
products of C.I. Pigment Red 57 are similar to those of the category members was not an
5

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U.S. Environmental Protection Agency
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Hazard Characterization Document
acceptable justification for the use of C.I. Pigment Red 57 as a supporting chemical because the
breakdown products would still differ by the absence of the chlorine substituent.
1.	Chemical Identity
1.1	Identification and Purity
The purity of the substance for the health effects studies was not stated.
1.2	Physical-Chemical Properties
The physical-chemical properties of the three constituents of the C.I. Pigment Red 48 and 52
category and two supporting chemicals are summarized in Table 1. The structures of these
compounds are provided in the Appendix.
2-Naphthalenecarboxylic acid, 4-[2-(5-chloro-4-methyl-2-sulfophenyl)diazenyl]-3-hydroxy-,
calcium salt (1:1) (C.I. Pigment Red 48 Calcium); 2-naphthalenecarboxylic acid, 4-[2-(5-chloro-
4-methyl-2-sulfophenyl)diazenyl]-3-hydroxy-, barium salt (1:1) (C.I. Pigment Red 48 Barium);
and 2-naphthalenecarboxylic acid, 4-[2-(4-chloro-5-methyl-2-sulfophenyl)diazenyl]-3-hydroxy-,
calcium salt (1:1) (C.I. Pigment Red 57) are red solids possessing negligible vapor pressure and
low water solubility. These substances are used as pigments in inks, paints, and other materials.
2.	General Information on Exposure
2.1 Production Volume and Use Pattern
The C.I. Pigment Red 48 & 52 Category chemicals had an aggregated production and/or import
volume in the United States between 2 and 11.5 million pounds during calendar year 2005.
CASRN 7023-61-2:
Non-confidential information in the IUR indicated that the industrial processing and uses of the
chemical include synthetic dye and pigment manufacturing as coloring agents, pigments. Non-
confidential commercial and consumer uses of this chemical include rubber and plastic products
and "other."
CASRN 7585-41-3:
No industrial processing and use, and commercial and consumer uses were reported for the
chemical.
•	CASRN 7023-61-2:
•	CASRN 7585-41-3:
•	CASRN 17852-99-2:
1 to < 10 million pounds ;
< 500,000 pounds ;
1 to < 10 million pounds ;
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Table 1. Physical-Chemical Properties of C.I. Pigment Red 48 and 521
Property
SPONSORED
CHEMICAL
2-
Naphthalenecarboxylic
acid, 4-[2-(5-chloro-4-
methyl-2-
sulfophenyl)diazenyl|-
3-hydroxy-, calcium
salt (1:1)
SPONSORED
CHEMICAL
2-
Naphthalenecarboxylic
acid, 4-[2-(5-chloro-4-
methyl-2-
sulfophenyl)diazenyl|-
3-hydroxy-, barium
salt (1:1)
SPONSORED
CHEMICAL
2-
Naphthalenecarboxylic
acid, 4-[2-(4-chloro-5-
methyl-2-
sulfophenyl)diazenyl|-
3-hydroxy-, calcium
salt (1:1)
SUPPORTING
CHEMICAL
Manganate(l-), [4-[2-[5-
chloro-4-methyl-2-(sulfo-
.kappa.O)phenyl|diazenyl-
.kappa.N 1 |-3-(hydroxy-
.kappa.O)-2-
naphthalenecarboxylato(3-
)|-, hydrogen (1:1)
SUPPORTING
CHEMICAL
2-
Naphthalenecarboxylic
acid, 3-hydroxy-4-[2-
(4-methyl-2-
sulfophenyl)diazenyl|-,
calcium salt (1:1)
CASRN
7023-61-2
7585-41-3
17852-99-2
5280-66-0
5281-04-9
Molecular
Weight
458.89
556.14
458.89
473.75
424.44
Physical
State
Red solid
Red solid
Red solid
Red solid
Red solid
Melting
Point
No data2
No data2
No data2
360°C (measured)
357.5 (measured)
Boiling
Point
No data2
No data2
No data2
No data2
No data2
Vapor
Pressure
<1.0xl0"10mm Hg at
25°C (estimated)3'4
<1.0xl0"10mm Hg at
25°C (estimated)3'4
<1.0xl0"10mm Hg at
25°C (estimated)3'4
<1.0><10"10mm Hg at 25°C
(estimated)3'4
<1.0xl0"10mm Hg at
25°C (estimated)3'4
Dissociation
Constant
pKa = 9.07 (estimated
for phenol moiety)5
pKa = 9.07 (estimated
for phenol moiety)5
pKa = 9.00 (estimated
for phenol moiety)5
pKa = 9.07 (estimated for
phenol moiety)5
pKa = 9.24 (estimated
for phenol moiety)5
7

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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Table 1. Physical-Chemical Properties of C.I. Pigment Red 48 and 521
Property
SPONSORED
CHEMICAL
2-
Naphthalenecarboxylic
acid, 4-[2-(5-chloro-4-
methyl-2-
sulfophenyl)diazenyl|-
3-hydroxy-, calcium
salt (1:1)
SPONSORED
CHEMICAL
2-
Naphthalenecarboxylic
acid, 4-[2-(5-chloro-4-
methyl-2-
sulfophenyl)diazenyl|-
3-hydroxy-, barium
salt (1:1)
SPONSORED
CHEMICAL
2-
Naphthalenecarboxylic
acid, 4-[2-(4-chloro-5-
methyl-2-
sulfophenyl)diazenyl|-
3-hydroxy-, calcium
salt (1:1)
SUPPORTING
CHEMICAL
Manganate(l-), [4-[2-[5-
chloro-4-methyl-2-(sulfo-
.kappa.O)phenyl|diazenyl-
.kappa.N 1 |-3-(hydroxy-
.kappa.O)-2-
naphthalenecarboxylato(3-
)|-, hydrogen (1:1)
SUPPORTING
CHEMICAL
2-
Naphthalenecarboxylic
acid, 3-hydroxy-4-[2-
(4-methyl-2-
sulfophenyl)diazenyl|-,
calcium salt (1:1)
Henry's
Law
Constant
<1.0><10"10 atm-m3/mol
(estimated)3'4
<1.0><10"10 atm-m3/mol
(estimated)3'4
<1,0x 10"10 atm-m3/mol
(estimated)3'4
<1.0xl0"10 atm-m3/mol
(estimated)3'4
<1.0xl0"10 atm-m3/mol
(estimated)3'4
Water
Solubility
3.6xl0"3 mg/L at 25°C
(estimated)3'4
1.8xl0"4 mg/L at 25°C
(estimated)3'4
3.6xl0"3 mg/L at 25°C
(estimated)3'4
6.1xl0"4 mg/L at 25°C
(estimated)3'4
8.9 mg/L at 25°C
(measured);
0.02 mg/L at 25°C
(estimated)3'4
Log Kow
5.38 (estimated)3'4
6.18 (estimated)3'4
5.38 (estimated)3'4
6.18 (estimated)3'4
2.5 at pH 3 (measured);
1.1 at pH 7 (measured);
4.73 (estimated)3'4
'Color Pigment Manufacturers Association. 2007. Revised Test Plan and Robust Summary for CI Pigment Red 48 and 52. Available online
at http://www.epa. gov/hpv/pubs/summaries/cird4852/c 16302tc.htm as of August 14, 2012.
2Azo pigments tend to thermally decompose; if they melt, the melting point would most likely be above 300°C. Similarly, any boiling points
for these substances would be well above 300°C.
3U.S. EPA. 2012. Estimation Programs Interface Suite™ for Microsoft® Windows, v4.10. U.S. Environmental Protection Agency,
Washington, DC, USA. Available online at http://www.epa. gov/opptintr/exposure/pubs/episuitedl.htm as of August 14, 2012.
4Salts are typically outside the estimation domain of EPIWIN.
5SPARC; pKa/property server. Ver 4.6, Oct. 2011. Available at http://archemcalc.com/sparc as of August 14, 2012.
8

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Environmental Protection Agency
Hazard Characterization Document
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CASRN 17852-99-2:
Non-confidential information in the IUR indicated that the industrial processing and uses of the
chemical include printing and printing ink manufacturing as coloring agents, pigments. Non-
confidential commercial and consumer uses of this chemical include glass and ceramic products,
paper products, and rubber and plastic products.
2.2 Environmental Exposure and Fate
The constituents of the C.I. Pigment Red 48 and 52 category are expected to have low mobility
in soil. A surrogate substance, 2-naphthalenecarboxylic acid, 3-hydroxy-4-[2-(4-methyl-2-
sulfophenyl)diazenyl]-, calcium salt (1:1) (C.I. Pigment Red 57) achieved 9-12% of its
theoretical biochemical oxygen demand (BOD) over a 28-day incubation period using an
activated sludge inoculum and the MITI (OECD 301C) test. In general, azo dyes and pigments
are considered recalcitrant under aerobic conditions; however, a variety of microorganisms can
reduce the azo bond in the absence of oxygen. Volatilization is expected to be low given that
these are ionic substances. The rate of hydrolysis is negligible. The rate of atmospheric
photooxidation is moderate; however, this is not likely to be an important environmental fate
process since these substances are not likely to exist in the vapor phase in the ambient
atmosphere. Direct and indirect photolysis studies have been conducted on a number of azo
dyes. The azo dyes were susceptible to indirect photolysis in natural waters containing humic
acid. The direct photolysis half-life of supporting chemical 2-naphthalenecarboxylic acid, 3-
hydroxy-4-[2-(4-methyl-2-sulfophenyl) diazenyl]-, calcium salt (1:1) was estimated to be about
18 days in water. Therefore, photolysis in sunlit natural waters containing humic materials may
be an important environmental fate process for category members. The constituents of the C.I.
Pigment Red 48 and 52 category are expected to have high (P3) persistence and low (Bl)
bioaccumulation potential.
The environmental fate properties are provided in Table 2.
Conclusion: The C.I. Pigment Red 48 and 52 category is composed of three substances: 2-
naphthalenecarboxylic acid, 4-[2-(5-chloro-4-methyl-2-sulfophenyl)diazenyl]-3-hydroxy-,
calcium salt (1:1) (C.I. Pigment Red 48 Calcium); 2-naphthalenecarboxylic acid, 4-[2-(5-chloro-
4-methyl-2-sulfophenyl)diazenyl]-3-hydroxy-, barium salt (1:1) (C.I. Pigment Red 48 Barium);
and 2-naphthalenecarboxylic acid, 4-[2-(4-chloro-5-methyl-2-sulfophenyl)diazenyl]-3-hydroxy-,
calcium salt (1:1) (C.I. Pigment Red 57). The substances are red solids possessing negligible
vapor pressure and low water solubility. They are expected to have low mobility in soil. A
surrogate substance, 2-naphthalenecarboxylic acid, 3-hydroxy-4-[2-(4-methyl-2-sulfophenyl)
diazenyl]-, calcium salt (1:1) (C.I. Pigment Red 57) is expected to be not readily biodegradable.
In general, azo dyes and pigments are considered recalcitrant under aerobic conditions; however,
a variety of microorganisms can reduce the azo bond under anaerobic conditions. Volatilization
is expected to be low given that these are ionic substances. The rate of hydrolysis is negligible.
9

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Table 2. Environmental Fate Properties of C.I. Pigment Red 48 and 521
Property
SPONSORED
CHEMICAL
2-
Naphthalenecarboxylic
acid, 4-[2-(5-chloro-4-
methyl-2-
sulfophenyl)diazenyl|-
3-hydroxy-, calcium
salt (1:1)
SPONSORED
CHEMICAL
2-
Naphthalenecarboxylic
acid, 4-[2-(5-chloro-4-
methyl-2-
sulfophenyl)diazenyl|-
3-hydroxy-, barium
salt (1:1)
SPONSORED
CHEMICAL
2-
Naphthalenecarboxylic
acid, 4-[2-(4-chloro-5-
methyl-2-
sulfophenyl)diazenyl|-
3-hydroxy-, calcium
salt (1:1)
SUPPORTING
CHEMICAL
Manganate(l-), [4-[2-[5-
chloro-4-methyl-2-(sulfo-
.kappa.O)phenyl|diazenyl-
.kappa.N 1 ]-3-(hydroxy-
.kappa.O)-2-
naphthalenecarboxylato(3-
)|-, hydrogen (1:1)
SUPPORTING
CHEMICAL
2-
Naphthalenecarboxylic
acid, 3-hydroxy-4-[2-
(4-methyl-2-
sulfophenyl)diazenyl|-,
calcium salt (1:1)
CASRN
7023-61-2
7585-41-3
17852-99-2
5280-66-0
5281-04-9
Photodegradati on
Half-life
11.5 hours (estimated)2'3
11.5 hours (estimated)2'3
11.5 hours (estimated)2'3
11.5 hours (estimated)2'3
11.2 hours (estimated)2'3
Hydrolysis Half-
life
Stable
Stable
Stable
Stable
Stable
Biodegradation
No data. This class of
pigments are considered
resistant to
biodegradation under
aerobic conditions, but
microorganisms have
been identified which
reduce the azo bond
under anaerobic
conditions4
No data. This class of
pigments are considered
resistant to
biodegradation under
aerobic conditions, but
microorganisms have
been identified which
reduce the azo bond
under anaerobic
conditions4
No data. This class of
pigments are considered
resistant to
biodegradation under
aerobic conditions, but
microorganisms have
been identified which
reduce the azo bond
under anaerobic
conditions4
No data. This class of
pigments are considered
resistant to biodegradation
under aerobic conditions,
but microorganisms have
been identified which
reduce the azo bond under
anaerobic conditions4
9-12% after 28 days
(not readily
biodegradable)
Bioaccumulation
Factor
BAF = 65.2
(estimated)2'3
BAF = 51.8
(estimated)2'3
BAF = 65.2
(estimated)2'3
BAF = 83.8 (estimated)2'3
BCF = 0.7-1.8
(measured in carp at
0.3 ppb);
BAF = 40.8
(estimated)2'3
Log Koc
4.1 (estimated)2'3
4.1 (estimated)2'3
4.1 (estimated)2'3
4.1 (estimated)2'3
3.9 (estimated)2'3
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Hazard Characterization Document
September, 2014
Table 2. Environmental Fate Properties of C.I. Pigment Red 48 and 521
Property
SPONSORED
SPONSORED
SPONSORED
SUPPORTING
SUPPORTING

CHEMICAL
CHEMICAL
CHEMICAL
CHEMICAL
CHEMICAL

2-
2-
2-
Manganate(l-), [4-[2-[5-
2-

Naphthalenecarboxylic
Naphthalenecarboxylic
Naphthalenecarboxylic
chloro-4-methyl-2-(sulfo-
Naphthalenecarboxylic

acid, 4-[2-(5-chloro-4-
acid, 4-[2-(5-chloro-4-
acid, 4-[2-(4-chloro-5-
.kappa.O)phenyl|diazenyl-
acid, 3-hydroxy-4-[2-

methyl-2-
methyl-2-
methyl-2-
.kappa.N 1 ]-3-(hydroxy-
(4-methyl-2-

sulfophenyl)diazenyl|-
sulfophenyl)diazenyl|-
sulfophenyl)diazenyl|-
.kappa.O)-2-
sulfophenyl)diazenyl|-,

3-hydroxy-, calcium
3-hydroxy-, barium
3-hydroxy-, calcium
naphthalenecarboxylato(3-
calcium salt (1:1)

salt (1:1)
salt (1:1)
salt (1:1)
)|-, hydrogen (1:1)

Fugacity





(Level III





Model)2'3






<0.1
<0.1
<0.1
<0.1
<0.1
Air (%)
4.3
4.5
4.3
4.5
8.9
Water (%)
88.9
88.7
88.9
88.8
88.5
Soil (%)
6.8
6.7
6.8
6.7
5.6
Sediment (%)





Persistence5
P3 (high)
P3 (high)
P3 (high)
P3 (high)
P3 (high)
Bioaccumulation5
B1 (low)
B1 (low)
B1 (low)
B1 (low)
B1 (low)
'Color Pigment Manufacturers Association. 2007. Revised Test Plan and Robust Summary for CI Pigment Red 48 and 52. Available online at
http://www.epa.gov/hpv/pubs/summaries/cird4852/cl6302tc.htm as of August 14, 2012.
2U.S.EPA. 2012. Estimation Programs Interface Suite™ for Microsoft® Windows, v4.10. U.S. Environmental Protection Agency, Washington, DC, USA. Available online at
http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of August 14, 2012.
3Salts are typically outside the estimation domain of EPIWIN.
4LynchD. 2000. Estimating properties of synthetic organic dyes. In: Handbook of Property Estimation for Chemicals. Boethling RS; Mackay D. (eds.). Lewis Publishers,
Boca Raton, FL. pp 447-467.
5Federal Register. 1999. Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances. Inderal Register 64. Number 213 (November4, 1999) pp. 60194-
60204.
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These substances may be subject to direct and indirect photolysis in sunlit surface waters. The
rate of atmospheric photooxidation is moderate; however, this is not expected to be an important
environmental fate process since these substances are not likely to exist in the vapor phase in the
ambient atmosphere. The constituents of the C.I. Pigment Red 48 and 52 category are expected
to have high (P3) persistence and low (Bl) bioaccumulation potential.
3. Human Health Hazard
A summary of health effects data submitted for SIDS endpoints is provided in Table 3.
Acute Oral Toxicity
C.I. Pigment Red 48 Barium (CASRN 7585-41-3)
Rats (strain, sex and number per dose not specified) were administered C.I. Pigment Red 48
(barium) (purity unknown) via gavage at unspecified doses. No other details were provided.
LDso > 5000 mg/kg
C.I. Pigment Red 48 Calcium (CASRN 7023-61-2) and C.I. Pigment Red 52 Calcium (CASRN
17852-99-2)
Rats (strain, sex and number per dose not specified) were administered C.I. Pigment Red 48
Calcium and C.I. Pigment Red 52 Calcium (purities unknown) via gavage at unspecified doses.
It is not clear if the substances were tested as a mixture or individually. No other details were
provided.
LD50 > 5000 mg/kg
Repeated-Dose Toxicity
No data are available.
Reproductive Toxicity
No data are available.
Developmental Toxicity
No data are available.
Genetic Toxicity - Gene Mutation
In vitro
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
C.I. Pigment Red 48 Barium (CASRN 7585-41-3) and C.I. Pigment Red 48 Calcium (CASRN
7023-61-2)
Salmonella typhimurium (strains not specified) were exposed to C.I. Pigment Red 48 Barium and
C.I. Pigment Red 48 Calcium (purities not stated) with and without activation to test for
mutagenicity. It is not clear if the substances were tested as a mixture or individually. Use of
controls was not specified. No further details were provided. No evidence of mutagenicity was
observed.
C.I. Pigment Red 48 Barium and C.I. Pigment Red 48 Calcium were not mutagenic in this
assay.
Genetic Toxicity — Chromosomal Aberrations
No data are available.
Additional Information
Skin Irritation
C.I. Pigment Red 48 Barium (CASRN 7585-41-3) and C.I. Pigment Red 48 Calcium (CASRN
7023-61-2)
Rabbits (strain, sex and number per dose not specified) were administered C.I. Pigment Red 48
Barium and C.I. Pigment Red 48 Calcium (purities not stated) via the dermal route at unspecified
doses. It is not clear if the substances were tested as a mixture or individually. No further details
were provided.
C.I. Pigment Red 48 Barium and C.I. Pigment Red 48 Calcium were not irritating to rabbit
skin in these studies.
Eye Irritation
C.I. Pigment Red 48 Barium (CASRN 7585-41-3) and C.I. Pigment Red 48 Calcium (CASRN
7023-61-2)
Rabbits (strain, sex and number per dose not specified) were administered C.I. Pigment Red 48
Barium and C.I. Pigment Red 48 Calcium (purities not stated) in the eye at unspecified doses. It
is not clear if the substances were tested as a mixture or individually. No further details were
provided.
C.I. Pigment Red 48 Barium and C.I. Pigment Red 48 Calcium were not irritating to rabbit
eyes in these studies.
Conclusion: The acute oral toxicity of C.I. Pigment Red 48 and 52 category members in rats is
low. No data are available for the repeated-dose/reproductive/developmental toxicity endpoints.
C.I. Pigment Red 48 barium and C.I. Pigment Red 48 calcium were not mutagenic in bacteria in
vitro and are not irritating to rabbit skin or eyes.
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Table 3. Summary of Screening Information Data Set under the U.S. HPV Challenge
Program - Human Health Data
Endpoints
SPONSORED
CHEMICAL
C.I. Pigment Red 48
Calcium
(7023-61-2)
SPONSORED
CHEMICAL
C.I. Pigment Red 48
Barium
(7585-41-3)
SPONSORED
CHEMICAL
C.I. Pigment Red 52
Calcium
(17852-99-2)
Acute Oral Toxicity
LDso (mg/kg)
>5000
>5000
>5000
Repeated-Dose
Toxicity
Oral (mg/kg-day)
No Data
No Data
No Data
Reproductive Toxicity
Oral (mg/kg-day)
No Data
No Data
No Data
Developmental
Toxicity
Oral (mg/kg-day)
No Data
No Data
No Data
Genetic Toxicity -
Gene Mutation
Negative
Negative
No Data
Negative
(RA)
Genetic Toxicity -
Chromosomal
Aberrations
No Data
No Data
No Data
Additional
Information
Skin Irritation
Eye Irritation
Not Irritating
Not Irritating
Not Irritating
Not Irritating
-
Measured data in bold text; (RA) = Read Across; - endpoint not addressed for this chemical
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4. Hazard to the Environment
A summary of aquatic toxicity data submitted for SIDS endpoints is provided in Table 4. The
table also indicates where data for the supporting chemical are read-across (RA) to untested
members of the category.
Acute Toxicity to Fish
C.I. Pigment Red 57 (CASRN 5281-04-9; supporting chemical)
(1)	Japanese killifish (Oryzias latipes) were exposed to C.I. Pigment Red 57 at five nominal
concentrations from 17.1 - 180 mg/L under static renewal conditions for 96 hours, using
dimethyl sulfoxide (DMSO) as a dispersant.
96-h LCso = 33 mg/L
(2)	Japanese killifish (Oryzias latipes) were exposed to C.I. Pigment Red 57 at unspecified
concentrations under flow-through conditions for 48 hours.
48-h LC50 = 50 mg/L
Acute Toxicity to Aquatic Invertebrates
No adequate data are available.
Toxicity to Aquatic Plants
C.I. Pigment Red 57 (CASRN 5281-04-9; supporting chemical)
Green algae (Pseudokirchneriella subcapitata) were exposed to C.I. Pigment Red 57 at 13
nominal concentrations from 1 - 1000 mg/L under unspecified conditions for 72 hours.
72-h EC50 (biomass) = 190 mg/L
Conclusion: Based on the supporting chemical (C.I. Pigment Red 57), the fish 96-h LC50 for the
sponsored chemicals (C.I. Pigment Red 48 Calcium, C.I. Pigment Red 48 Barium, and C.I.
Pigment Red 52 Calcium) is 33 mg/L. Based on the supporting chemical, the 72-h EC50 for the
sponsored chemicals to aquatic plants is 190 mg/L (biomass),. There are no adequate data
available for acute toxicity to aquatic invertebrates.
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Table 4. Summary of Screening Information Data Set under the U.S. HPV Challenge
Program - Aquatic Toxicity Data
Endpoints
SPONSORED
CHEMICAL
C.I. Pigment
Red 48 Calcium
SPONSORED
CHEMICAL
C.I. Pigment
Red 48 Barium
SPONSORED
CHEMICAL
C.I. Pigment
Red 52 Calcium
SUPPORTING
CHEMICAL
C.I. Pigment
Red 57

(7023-61-2)
(7585-41-3)
(17852-99-2)
(5281-04-9)
Fish
96-h LCso (mg/L)
33
(RA)
33
(RA)
33
(RA)
33
Aquatic
Invertebrates
48-h ECso (mg/L)
No adequate data.
No adequate data.
No adequate data.

Aquatic Plants
72-h ECso (mg/L)
Biomass
190
(RA)
190
(RA)
190
(RA)
190
Bold = experimentally-derived data; (RA) = Read Across; - endpoint not addressed for this
chemical
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
APPENDIX
Sponsored Chemicals
Chemical Name
CASRN
Structure
2-
Naphthalenecarboxyli
c acid, 4-[2-(5-chloro-
4-methyl-2-
sulfophenyl)diazenyl]-
3-hydroxy-,	calcium
salt (1:1)
7023-61-2
0=^ OH
o" o-s=o
2+ II
Ca o
Representative SMILES:
c 12c(N=Nc3 cc(Cl)c(C)cc3 S(=0)(=0)0[Ca] 5)c(0)c(C(=0)0
5)cclcccc2
2-
Naphthalenecarboxyli
c acid, 4-[2-(5-chloro-
4-methyl-2-
sulfophenyl)diazenyl]-
3-hydroxy-,	barium
salt (1:1)
7585-41-3
0=^ OH
o" o-s=o
2+ II
Ba o
Representative SMILES:
c 12c(N=Nc3 cc(Cl)c(C)cc3 S(=0)(=0)0[Ba] 5)c(0)c(C(=0)0
5)cclcccc2
2-
Naphthalenecarboxyli
c acid, 4-[2-(4-chloro-
5-methyl-2-
sulfophenyl)diazenyl]-
3-hydroxy-,	calcium
salt (1:1)
17852-99-
2
\	/ CH,
0="( OH /=^
o" o-s=o
2+ II
Ca o
Representative SMILES:
c 12c(N=Nc3 cc(C)c(Cl)cc3 S(=0)(=0)0[Ca]4)c(0)c(C(=0)0
4)cclcccc2
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Supporting Chemicals
Chemical Name
CASRN
Structure
Manganate(l-), [4-[2-
[5-chloro-4-methyl-2-
(sulfo-
,kappa.O)phenyl]diaze
nyl-.kappa.Nl]-3-
(hydroxy-.kappa.O)-2-
naphthalenecarboxylat
o(3-)]-, hydrogen
(1:1)
5280-66-0
0=^ OH
o" o-s=o
2+ II
Mn O
Representative SMILES:
c 12c(N=Nc3 cc(Cl)c(C)cc3 S(=0)(=0)0[Mn] 5)c(0)c(C(=0)0
5)cclcccc2
2-
Naphthalenecarboxyli
c acid, 3-hydroxy-4-
[2-(4-methyl-2-
sulfophenyl)diazenyl]-
, calcium salt (1:1)
5281-04-9
0=^ OH
o" o-s=o
2+ II
Ca 0
Representative SMILES:
c 12c(N=Nc3 ccc(C)cc3 S(=0)(=0)0 [Ca] 5)c(0)c(C(=0)05)cc
lcccc2
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