vvEPA
REVISED DRAFT - DO NOT CITE OR QUOTE
United States	Office of Chemical Safety and
Environmental Protection Agency	Pollution Prevention
Revised Draft Risk Evaluation for
C.I. Pigment Violet 29
(Anthra[2,l,9-def:6,5,10-d'eT]diisoquinoline-
1,3,8,10(2H,9H)-tetrone)
Systematic Review Supplemental File:
Data Quality Evaluation of Environmental Fate and Transport
Studies
CASRN: 81-33-4
October 2020

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This document is a compilation of tables for the data extraction and evaluation for C.I. Pigment Violet
29 (CASRN 81-33-4). Each table shows the data point or set or information element that was extracted
and evaluated from a data source in accordance with Appendix D of the Application of Systematic
Review in TSCA Risk Evaluations U.S. EPA (20.1.8). If the source contains more than one data set or
information element, the review provides an overall confidence score for each data set or information
element that is found in the source. Therefore, it is possible that a source may have more than one
overall quality/confidence score.
Table of Contents
Table 1. EPI Suite™ Modeling Program, U.S. EPA (2012)	
Table 2. Activated Sludge Study for C.I. Pigment Violet 29, BASF (1999b)
Table 3. Biodegradability Study for C.I. Pigment Violet 29, BASF (1999a).
3
6
9
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Table 1. F.PI Suite™ Modeling Program. ' c'
Sludj
Reference:
I .S. I.PA l.sliin;ili(in Programs Interface SuileIM lor Microsoft u Windows. \ 4.11. 2012.
Domain
Metric
Qualitative
Determination
[i.e., High,
Medium,
Low,
Unacceptable,
or Not rated]
Comments
Metric
Score
Metric
Weighting
Factor
Weighted
Score
Test Substance
1. Test
substance
identity
High
The test substance was
identified by chemical
structure.
1
2
2
2. Test
substance
purity
Not rated
The metric is not
applicable to this study
type (SAR).
NR
NR
NR
Test Design
3. Study
Controls
Not rated
The metric is not
applicable to this study
type (SAR).
NR
NR
NR
4. Test
Substance
stability
Not rated
The metric is not
applicable to this study
type (SAR).
NR
NR
NR
Test
Conditions
5. Test Method
Suitability
Not rated
The metric is not
applicable to this study
type (SAR).
NR
NR
NR
6. Testing
Conditions
Not rated
The metric is not
applicable to this study
type (SAR).
NR
NR
NR
7. Testing
Consistency
Not rated
The metric is not
applicable to this study
type (SAR).
NR
NR
NR
8. System
Type and
Design
Not rated
The metric is not
applicable to this study
type (SAR).
NR
NR
NR
Test
Organisms
9. Test
Organism
Degradation
Not rated
The metric is not
applicable to this study
type (SAR).
NR
NR
NR
10. Test
Organism
Partitioning
Not rated
The metric is not
applicable to this study
type (SAR).
NR
NR
NR
Outcome
Assessment
11. Outcome
Assessment
Methodology
Not rated
The metric is not
applicable to this study
type (SAR).
NR
NR
NR
12. Sampling
Methods
Not rated
The metric is not
applicable to this study
type (SAR).
NR
NR
NR
Confounding/
Variable
Control
13.
Confounding
Variables
Not rated
The metric is not
applicable to this study
type (SAR).
NR
NR
NR
14. Outcomes
Not rated
The metric is not
NR
NR
NR
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Sludj
Reference:
I .S. I.PA I'.siiinalion Programs Interlace Sui(eIM lor Microsoft u Windows. \ 4.11. 2012.

Unrelated to
Exposure

applicable to this study
type (SAR).



Data
Presentation
and Analysis
15. Data
Reporting
Not rated
The metric is not
applicable to this study
type (SAR).
NR
NR
NR
16. Statistical
Methods and
Kinetic
Calculations
Not rated
The metric is not
applicable to this study
type (SAR).
NR
NR
NR
Other
17.
Verification or
Plausibility of
Results
Not rated
The metric is not
applicable to this study
type (SAR).
NR
NR
NR
18. QSAR
Models
High
The models in EPI
Suite™ have defined
endpoints. Chemical
domain and
performance statistics
for each model are
known, and
unambiguous
algorithms are
available in the EPI
Suite™ documentation
and/or cited references
to establish their
scientific validity.
Many EPI Suite™
models have
correlation coefficients
>0.7, cross-validated
correlation coefficients
>0.5, and standard
error values <0.3;
however, correlation
coefficients (r2, q2) for
the regressions of some
environmental fate
models {i.e., BIO WIN)
are lower, as expected,
compared to
regressions which have
specific experimental
values such as water
solubility or log Kow
(octanol-water partition
coefficient).
1
1
1



Sum of scores:
2
3
3
High
Medium
Low
Overall Score = Sum
of Weighted
Scores/Sum of Metric
Weighting Factors:
1
Overall
Score
(Rounded):
1
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Sliulj
Reference:
1 .S. I.PA l.slimnlion Programs Interlace Sui(eIM lor Microsoft i< Windows. \ 4.11. 2012.
>1 and <1.7
>1.7 and <2.3
>2.3 and <3


Overall
Quality
Level:
High
Note: The reviewer agreed with this study's overall quality level.
Page 5 of 12

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Table 2. Activated Sludge Study for C.T. Pigment Violet 29. ™ ^ """"" J
Sludj
Reference:
I5ASI-". 1«)«)'). Delei'ininalion oil lie Inhihit ion ol' ()\\gen ( onsiiniplion In Acli\aled Sludge In
Penlimid I- in llic Acli\aled Sludge Respiration Inhibition lesl according lo CI.I\ I.N 45001
and l('()'J002. Sludj conducted l)\ I5AS1- Akiiengesellschari l.colog\ and l'.n\ ironmenlal
Analytics Laboratory of Hcologj IMi^O^h l.udwigshafcn (Siud\ Completion Dale: March 1
iiiro id: 4^3i542
Note:
Conducted according to OECD Guideline 209
Domain
Metric
Qualitative
Determination
[Le., High,
Medium, Low,
Unacceptable,
or Not rated]
Comments
Metric
Score
Metric
Weighting
Factor
Weighted
Score
Test
Substance
1. Test
substance
identity
High
CAS, chemical name,
production number and
date, as well as the
specific form of the test
substance are all
reported.
1
2
2

2. Test
substance
purity
High
Purity 98.9% reported
by analysis
1
1
1
Test Design
3. Study
Controls
High
Blank Control was
included and deviation
of blank control was
reported as <15%. A
reference substance was
also included.
1
2
2
4. Test
Substance
stability
High
Homogeneity, storage
conditions, instability
control were all reported
and appeared to be
appropriate for the test
substance.
1
1
1
Test
Conditions
5. Test
Method
Suitability
Medium
Media concentrations
were provided in terms
of nominal
concentrations (1000
mg/L) and were not
measured. The reported
limit of solubility (2800
mg/L) was not
consistent with the limit
of solubility of this
chemical.
2
1
2

6. Testing
Conditions
High
Testing conditions were
recorded and were
suitable for the test
substance
1
2
2

7. Testing
Consistency
High
Three blank controls, the
test substance were
conducted under the
same conditions.
1
1
1
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Sludj
Reference:
I5ASI-". I1)1)1). Delei'ininalion of (lie Inhibition of 0\>gcn Consumption In Acli\alcd Sludge In
Pcnlimid 1- in llie Acli\alcd Sludge Respiration Inhihilion lesl according lo (.I P. I.N 45001
and l('() 9002. Sludj conducled In I5AS1- Aklicngcscllschafl Hcolog\ and l'.n\ ironmenlal
.\nal> 1 ics l.ahoralon of l'lcolog\ l.udwigshafcn (S(ud\ Completion Dale: March I')1)')).
lll-iKO II): 4"73I542

8. System
Type and
Design
Not Rated
This metric is not
applicable as this is not
an equilibrium test
NR
NR
NR
Test
Organisms
9. Test
Organism
Degradation
High
Inoculum source was a
laboratory wastewater
plant treating municipal
and synthetic sewage;
the dry substance
concentration of the
inoculum was reported
as 1 g/L
1
2
2

10. Test
Organism
Partitioning
Not Rated
This metric is not
applicable as this is not a
partitioning study
NR
NR
NR

11. Outcome
Assessment
Methodology
High
The outcome assessment
methodology is
acceptable to determine
the inhibition of oxygen
consumption by
activated sludge.
1
1
1
Outcome
Assessment
12. Sampling
Methods
Medium
Sampling methods were
not specifically
discussed, but the results
of daily analysis of the
test variables were
reported so this is not
expected to impact the
results of the test.
2
1
2
Confounding/
Variable
Control
13.
Confounding
Variables
High
One study group was
used as this was
conducted as a limit test.
No confounding
variables were observed
or reported by the study
authors.
1
1
1
14. Outcomes
Unrelated to
Exposure
High
Deviation of blank
controls were reported to
be <15%, which
demonstrated the health
of the test organism.
1
1
1
Data
Presentation
and Analysis
15. Data
Reporting
High
Study was conducted as
a limit test, so no effects
were observed in the
study group. Study
authors calculated and
reported EC20, EC50,
and EC80 of reference
substance as well as the
control.
1
2
2
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Sludj
Reference:
I5ASI-". I1)1)1). Dclerminalion ol'llie Inhibition nl'Owiien ( onsii in pi ion In Acli\aled Sludge In
Penlimid 1- in (lie Acli\aled Sludge Respiration Inhibition lost according lo (.I P. I.N 45001
iind l('() 9002. Sludj conducted In I5AS1- Aklicngcscllschari Hcnlngj and l'.n\ immncnlal
An;il\lies l.ahoralon of l-'.colog\ IMi^O^ft l.udw igshalcn (S(ud\ ( <1111 plot ion Dale: March 1')«)«) i.
lll-iKO II): 4"73I542

16. Statistical
Methods and
Kinetic
Calculations
Not Rated
Statistical analysis was
not conducted as no
adverse effects were
reported.
NR
NR
NR

17.
Verification or
Plausibility of
Results
High
Reported values were
within expected range as
defined by the reference
substance, 3,5-
dichlorophenol.
1
1
1
Other
18. QSAR
Models
Not Rated
QSAR models were not
used as part of this
study. *Note that this
metric has been updated,
as it was originally
evaluated for a metric
that is not part of the
data quality criteria for
fate data.
NR
NR
NR



Sum of scores:
16
19
21
High
Medium
Low
Overall Score = Sum of
Weighted Scores/Sum
of Metric Weighting
Factors:
1.105
Overall
Score
(Rounded):
1.1
>1 and <1.7
>1.7 and <2.3
>2.3 and <3


Overall
Quality
Level:
High
Page 8 of 12

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Table 3. Tiiodegrndnhilitv Study for C.T. Pigment Violet 29. ™ ^	)
Sludj
Reference:
I5ASI-". I«W«). Delei'ininalion oil lie liiodegradahililt of Penlimid I- in llie Mannmelric
Kespirnmeln lost according lo CI.P. I.N 45001 and IS()*)002. Sludj conducted In I5AS1-
Aklicngcsellschafl l-'.colog\ and l-'.n\ ironnienlal \nal> 1 ics Laboratory of l-'.colog\ D-G^OSh
1 .imIwi^shaleii (Mud> Completion Dale: .Inl> W)). HIIRO II): 4"\5I543
Note:
Conducted according to OECD Guideline 30IF
Domain
Metric
Qualitative
Determination
[Le., High,
Medium,
Low,
Unacceptable,
or Not rated]
Comments
Metric
Score
Metric
Weighting
Factor
Weighted
Score
Test
Substance
1. Test
substance
identity
High
CAS, chemical name,
production number, state
and date of production
were all reported
1
2
2
2. Test
substance
purity
High
Purity reported as 98.9%.
1
1
1
Test Design
3. Study
Controls
High
Blank control and
reference substance were
included (Aniline);
deviation and control
chemical were acceptable
according to test validity
criteria of the guideline.
1
2
2

4. Test
Substance
stability
High
Homogeneity, storage
conditions, instability
controls were all reported.
1
1
1

5. Test
Method
Suitability
Medium
Media concentrations
were provided in terms of
nominal concentrations

1


(100 mg/L) which was far
higher than the limit of
solubility.
A
A
Test
Conditions
6. Testing
Conditions
High
Biodegradation values
were measured and
reported (28 days)
according to reporting
recommendations of
Guideline. Test
temperatures throughout
the test were not
explicitly reported, but
the study authors
indicated that the test was
conduicted "at room
temperature".
l
2
2

7. Testing
Consistency
High
Five control samples and
seven test samples were
conducted under the same
condition.
l
1
1
Page 9 of 12

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Sludj
Reference:
I5ASI-". I«)«)«). Dclcrminalion oil lie liiodegradal>ilil> olPcnlimid I- in llie Mannmelric
Respironiellest according lo CI.P. I.N 45001 and ISO')002. Sludj conducted In I5AS1-
AkliciiiiCNcllschiil'l l-lcologj and Hn\ ironmenlal \nal> 1 ics Laboratory of l-'.colog\ I)-(i705(i
l.udwigsharen (Sludj ( omplclion Dale: Jul* I')')')). III.KO II): 4"\5I543

8. System
Type and
Design
Not Rated
Not an equilibrium test.
NR
NR
NR
Test
Organisms
9. Test
Organism
Degradation
High
Inoculum source reported
as municipal activated
sludge from laboratory
wastewater treatment
plants fed with municipal
sewage which is
appropriate.
1
2
2

10. Test
Organism
Partitioning
Not Rated
This is not a partitioning
test.
NR
NR
NR
Outcome
Assessment
11. Outcome
Assessment
Methodology
High
The test methodology
addressed the intended
outcome of interest
(biodegradation
according to the
parameters measured).
1
1
1
12. Sampling
Methods
Medium
Sampling methods were
not specifically discussed,
but the results of daily
analysis of the test
variables were reported.
2
1
2

13.
Confounding
Variables
Medium
The result (Measured
BOD) of one blank
sample deviated from
other 6 test samples. The
authors acknowledged
and disregarded this
sample.
2
1
2
Confounding/
Variable
Control
14. Outcomes
Unrelated to
Exposure
Medium
6 out of 7 test samples
showed similar results,
the degradation rate of all
test samples did not show
any inhibition from the
test substance; One blank
sample showed
anomalous results
discussed by the authors.
The viability of organism
was well maintained.
2
1
2
Data
Presentation
and Analysis
15. Data
Reporting
High
The study received a high
rating for this metric
1
2
2
16. Statistical
Methods and
Kinetic
Calculations
Medium
No statistical analyses
were conducted;
however, sufficient data
were provided to conduct
2
1
2
Page 10 of 12

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Sliulj
Reference:
I5ASI-". I«)«)«). Dclerminalion oil lie liiodegradal>ilil> of Pen limid I- in (lie Mannmelric
Respironiellest according lo CLP. I.N 45001 and IS()')002. Sliulj conducted In I5AS1-
Aklicngcscllschafl l-lcologj and l-'n\ ir«uiiiieiil;il \n;il> 1 ics Laboratory of Lcolog\ I)-(i705(i
Ludwigshafen (Sliulj ( omplclion l);i(e: .1 ul> l«),)«)). III.KO II): 4"\5I543



an independent blaliblieal
analysis.



Other
17.
Verification
or Plausibility
of Results
High
Reported values were
within expected range as
defined by reference
substance(s); Aniline.
1
1
1
18. QSAR
Models
Not Rated
QSAR models were not
used as part of this study.
NR
NR
NR



Sum of scores:
20
20
25
High
Medium
Low
Overall Score = Sum of
Weighted Scores/Sum of
Metric Weighting
Factors:
1.250
Overall
Score
(Rounded):
1.3
>1 and <1.7
>1.7 and <2.3
>2.3 and <3


Overall
Quality
Level:
High
Page 11 of 12

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References
REVISED DRAFT - DO NOT CITE OR QUOTE
BASF. (1999a). 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.
BASF. (1999b). 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. Ludwigshafen: BASF Aktiengesellschaft Ecology and Environmental Analytics
Laboratory of Ecology D-67056.
U.S. EPA. (2012). Estimation Programs Interface Suite™ for Microsoft® Windows, v 4.1 1 [Computer
Program], Washington, DC. Retrieved from https://www.epa.gov/tsca-screening-tools/epi-
suitetm-estimation-program-interface
U.S. EPA. (2018). Application of systematic review in TSCA. risk evaluations. (740-P1-8001).
Washington, DC: U.S. Environmental Protection Agency, Office of Chemical Safety and
Pollution Prevention, https://www.epa.gov/sites/production/files/2018-
06/documetrts/final application of sr in ts<	df.
Page 12 of 12

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