Final Risk Evaluation for C.I. Pigment Violet 29
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United States Office of Chemical Safety and
Environmental Protection Agency Pollution Prevention
Final Risk Evaluation for
C.I. Pigment Violet 29
(Anthra[2,1,9-def:6,5,10-d'e'f']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
January 2021This 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 (2018). 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) ......................................................................................3
Table 2. Activated Sludge Study for C.I. Pigment Violet 29, BASF (1999b)............................................................6
Table 3. Biodegradability Study for C.I. Pigment Violet 29, BASF (1999a) .............................................................9
Page 2 of 12Table 1. EPI Suite™ Modeling Program, U.S. EPA (2012)
Study
U.S. EPA Estimation Programs Interface Suite™ for Microsoft® Windows, v 4.11. 2012.
Reference:
Qualitative
Determination
[i.e., High, Metric
Metric Weighted
Domain Metric Medium, Comments Weighting
Score Score
Low, Factor
Unacceptable,
or Not rated]
1. Test The test substance was
substance High identified by chemical 1 2 2
identity structure.
Test Substance
2. Test The metric is not
substance Not rated applicable to this study NR NR NR
purity type (SAR).
The metric is not
3. Study
Not rated applicable to this study NR NR NR
Controls
type (SAR).
Test Design
4. Test The metric is not
Substance Not rated applicable to this study NR NR NR
stability type (SAR).
The metric is not
5. Test Method
Not rated applicable to this study NR NR NR
Suitability
type (SAR).
The metric is not
6. Testing
Not rated applicable to this study NR NR NR
Conditions
Test type (SAR).
Conditions The metric is not
7. Testing
Not rated applicable to this study NR NR NR
Consistency
type (SAR).
8. System The metric is not
Type and Not rated applicable to this study NR NR NR
Design type (SAR).
9. Test The metric is not
Organism Not rated applicable to this study NR NR NR
Test Degradation type (SAR).
Organisms 10. Test The metric is not
Organism Not rated applicable to this study NR NR NR
Partitioning type (SAR).
11. Outcome The metric is not
Assessment Not rated applicable to this study NR NR NR
Outcome Methodology type (SAR).
Assessment The metric is not
12. Sampling
Not rated applicable to this study NR NR NR
Methods
type (SAR).
13. The metric is not
Confounding/ Confounding Not rated applicable to this study NR NR NR
Variable Variables type (SAR).
Control
14. Outcomes Not rated The metric is not NR NR NR
Page 3 of 12Study
U.S. EPA Estimation Programs Interface Suite™ for Microsoft® Windows, v 4.11. 2012.
Reference:
Unrelated to applicable to this study
Exposure type (SAR).
The metric is not
15. Data
Not rated applicable to this study NR NR NR
Reporting
Data type (SAR).
Presentation 16. Statistical
and Analysis The metric is not
Methods and
Not rated applicable to this study NR NR NR
Kinetic
type (SAR).
Calculations
17.
The metric is not
Verification or
Not rated applicable to this study NR NR NR
Plausibility of
type (SAR).
Results
The models in EPI
SuiteTM have defined
endpoints. Chemical
domain and
performance statistics
for each model are
known, and
unambiguous
algorithms are
available in the EPI
SuiteTM documentation
and/or cited references
to establish their
scientific validity.
Other Many EPI SuiteTM
models have
18. QSAR correlation coefficients
High 1 1 1
Models >0.7, cross-validated
correlation coefficients
>0.5, and standard
error valuesStudy
U.S. EPA Estimation Programs Interface Suite™ for Microsoft® Windows, v 4.11. 2012.
Reference:
Overall
≥1 andTable 2. Activated Sludge Study for C.I. Pigment Violet 29, BASF (1999b)
BASF. 1999. 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
Study
and ICO 9002. Study conducted by BASF Aktiengesellschaft Ecology and Environmental
Reference:
Analytics Laboratory of Ecology D-67056 Ludwigshafen (Study Completion Date: March 1999).
HERO ID: 4731542
Note: Conducted according to OECD Guideline 209
Qualitative
Determination
Metric
[i.e., High, Metric Weighted
Domain Metric Comments Weighting
Medium, Low, Score Score
Factor
Unacceptable,
or Not rated]
CAS, chemical name,
production number and
1. Test
date, as well as the
substance High 1 2 2
specific form of the test
Test identity
substance are all
Substance reported.
2. Test
Purity 98.9% reported
substance High 1 1 1
by analysis
purity
Blank Control was
included and deviation
3. Study of blank control was
High 1 2 2
Controls reported asBASF. 1999. 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
Study
and ICO 9002. Study conducted by BASF Aktiengesellschaft Ecology and Environmental
Reference:
Analytics Laboratory of Ecology D-67056 Ludwigshafen (Study Completion Date: March 1999).
HERO ID: 4731542
8. System This metric is not
Type and Not Rated applicable as this is not NR NR NR
Design an equilibrium test
Inoculum source was a
laboratory wastewater
plant treating municipal
9. Test
and synthetic sewage;
Organism High 1 2 2
the dry substance
Test Degradation
concentration of the
Organisms inoculum was reported
as 1 g/L
10. Test This metric is not
Organism Not Rated applicable as this is not a NR NR NR
Partitioning partitioning study
The outcome assessment
methodology is
11. Outcome
acceptable to determine
Assessment High 1 1 1
the inhibition of oxygen
Methodology
consumption by
activated sludge.
Outcome Sampling methods were
Assessment not specifically
discussed, but the results
12. Sampling of daily analysis of the
Medium 2 1 2
Methods test variables were
reported so this is not
expected to impact the
results of the test.
One study group was
used as this was
13. conducted as a limit test.
Confounding High No confounding 1 1 1
Variables variables were observed
Confounding/ or reported by the study
Variable authors.
Control
Deviation of blank
14. Outcomes controls were reported to
Unrelated to High beBASF. 1999. 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
Study
and ICO 9002. Study conducted by BASF Aktiengesellschaft Ecology and Environmental
Reference:
Analytics Laboratory of Ecology D-67056 Ludwigshafen (Study Completion Date: March 1999).
HERO ID: 4731542
16. Statistical Statistical analysis was
Methods and not conducted as no
Not Rated NR NR NR
Kinetic adverse effects were
Calculations reported.
Reported values were
17.
within expected range as
Verification or
High defined by the reference 1 1 1
Plausibility of
substance, 3,5-
Results
dichlorophenol.
QSAR models were not
Other used as part of this
study. *Note that this
metric has been updated,
18. QSAR
Not Rated as it was originally NR NR NR
Models
evaluated for a metric
that is not part of the
data quality criteria for
fate data.
Sum of scores: 16 19 21
Overall Score = Sum of
Overall
Weighted Scores/Sum 1.105
High Medium Low Score 1.1
of Metric Weighting
(Rounded):
Factors:
Overall
≥1 andTable 3. Biodegradability Study for C.I. Pigment Violet 29, BASF (1999a)
BASF. 1999. Determination of the Biodegradability of Perylimid F in the Manometric
Study Respirometry Test according to GLP, EN 45001 and ISO 9002. Study conducted by BASF
Reference: Aktiengesellschaft Ecology and Environmental Analytics Laboratory of Ecology D-67056
Ludwigshafen (Study Completion Date: July 1999). HERO ID: 4731543
Note: Conducted according to OECD Guideline 301F
Qualitative
Determination
[i.e., High, Metric
Metric Weighted
Domain Metric Medium, Comments Weighting
Score Score
Low, Factor
Unacceptable,
or Not rated]
CAS, chemical name,
1. Test
production number, state
substance High 1 2 2
and date of production
Test identity
were all reported
Substance
2. Test
substance High Purity reported as 98.9%. 1 1 1
purity
Blank control and
reference substance were
included (Aniline);
3. Study
High deviation and control 1 2 2
Controls
chemical were acceptable
Test Design according to test validity
criteria of the guideline.
4. Test Homogeneity, storage
Substance High conditions, instability 1 1 1
stability controls were all reported.
Media concentrations
were provided in terms of
5. Test
nominal concentrations
Method Medium 2 1 2
(100 mg/L) which was far
Suitability
higher than the limit of
solubility.
Biodegradation values
were measured and
reported (28 days)
according to reporting
recommendations of
Test
Guideline. Test
Conditions 6. Testing
High temperatures throughout 1 2 2
Conditions
the test were not
explicitly reported, but
the study authors
indicated that the test was
conduicted "at room
temperature".
Five control samples and
7. Testing seven test samples were
High 1 1 1
Consistency conducted under the same
condition.
Page 9 of 12BASF. 1999. Determination of the Biodegradability of Perylimid F in the Manometric
Study Respirometry Test according to GLP, EN 45001 and ISO 9002. Study conducted by BASF
Reference: Aktiengesellschaft Ecology and Environmental Analytics Laboratory of Ecology D-67056
Ludwigshafen (Study Completion Date: July 1999). HERO ID: 4731543
8. System
Type and Not Rated Not an equilibrium test. NR NR NR
Design
Inoculum source reported
as municipal activated
9. Test sludge from laboratory
Organism High wastewater treatment 1 2 2
Test Degradation plants fed with municipal
Organisms sewage which is
appropriate.
10. Test
This is not a partitioning
Organism Not Rated NR NR NR
test.
Partitioning
The test methodology
addressed the intended
11. Outcome
outcome of interest
Assessment High 1 1 1
(biodegradation
Methodology
according to the
Outcome parameters measured).
Assessment
Sampling methods were
not specifically discussed,
12. Sampling
Medium but the results of daily 2 1 2
Methods
analysis of the test
variables were reported.
The result (Measured
BOD) of one blank
13. sample deviated from
Confounding Medium other 6 test samples. The 2 1 2
Variables authors acknowledged
and disregarded this
sample.
Confounding/ 6 out of 7 test samples
Variable showed similar results,
Control the degradation rate of all
test samples did not show
14. Outcomes any inhibition from the
Unrelated to Medium test substance; One blank 2 1 2
Exposure sample showed
anomalous results
discussed by the authors.
The viability of organism
was well maintained.
15. Data The study received a high
High 1 2 2
Reporting rating for this metric
Data
Presentation 16. Statistical No statistical analyses
and Analysis Methods and were conducted;
Medium 2 1 2
Kinetic however, sufficient data
Calculations were provided to conduct
Page 10 of 12BASF. 1999. Determination of the Biodegradability of Perylimid F in the Manometric
Study Respirometry Test according to GLP, EN 45001 and ISO 9002. Study conducted by BASF
Reference: Aktiengesellschaft Ecology and Environmental Analytics Laboratory of Ecology D-67056
Ludwigshafen (Study Completion Date: July 1999). HERO ID: 4731543
an independent statistical
analysis.
17. Reported values were
Verification within expected range as
High 1 1 1
or Plausibility defined by reference
Other of Results substance(s); Aniline.
18. QSAR QSAR models were not
Not Rated NR NR NR
Models used as part of this study.
Sum of scores: 20 20 25
Overall Score = Sum of
Overall
Weighted Scores/Sum of 1.250
High Medium Low Score 1.3
Metric Weighting
(Rounded):
Factors:
Overall
≥1 andReferences
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 4.11 [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/documents/final_application_of_sr_in_tsca_05-31-18.pdf.
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