vvEPA United States Environmental Protection Agency Office of Chemical Safety and Pollution Prevention Final 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 Hazard Studies CASRN: 81-33-4 January 2021 ------- 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 (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. Fish Acute Toxicity Study with C.I. Pigment Violet 29, BASF (1988) Table 2. Aquatic Plant with C.I. Pigment Violet 29, BASF (2012b) Table 3. Acute Aquatic Invertebrate Study with C.I. Pigment Violet 29, BASF (2012a) ..3 ..7 10 Page 2 of 13 ------- Table 1. Fish Acute Toxicity Study with C.I. Pigment Violet 29, BASF (1988) Study Reference: BASF. 1988. Testing the acute toxicity in the fish model Zebra danio (Brachydanio rerio) over the course of 96 hours. Study conducted by Pharma Research Toxicology and Pathology, Hoechst Corporation (Study Completion Date: July 1st, 1988), Frankfurt, Germany. HERO ID: 4731539 Note: Conducted according to the OECD 203 Test Guideline (1984) Domain Metric Qualitative Determination [i.e., High, Medium, Low, Unacceptable, or Not rated] Comments Metric Score Metric Weighting Factor Weighted Score 1. Test substance identity High Test substance was reported as perylimid, which is an European name for PV 29. 1 2 2 Test Substance 2. Test substance source Medium Test substance source was not indicated. See note at the bottom of the table. 2 1 2 3.Test substance purity High Purity was reported as > 95%. 1 1 1 4. Negative controls HighA 1 2 2 Test setup 5. Negative control response High No mortality was reported in the controls. 1 1 1 6. Randomized allocation High Section 4.7 indicated that individuals were randomly allocated among the test vessels. 1 1 1 7. Experimental System/Test Media Preparation HighA 1 2 2 Exposure characterization 8. Consistency of Exposure administration HighA 1 1 1 9. Exposure Duration and Frequency HighA 1 2 2 10. Measurement of Test Substance Concentration Medium Test concentration was reported in terms of nominal test concentration and was not 2 1 2 Page 3 of 13 ------- Study Reference: BASF. 1988. Testing the acute toxicity in the fish model Zebra danio (Brachydanio rerio) over the course of 96 hours. Study conducted by Pharma Research Toxicology and Pathology, Hoechst Corporation (Study Completion Date: July 1st, 1988), Frankfurt, Germany. HERO ID: 4731539 measured. This study was a limit test and the nominal concentration was far above the limit of solubility. 11. Number of exposure groups and dose spacing High This study was a limit test with one test concentration. 1 1 1 12. Testing at or Below Solubility Limit Medium This study was conducted as a limit test. There was undissolved test material reported in the test vessel. The reported test material solubility was 670 mg/L. This was far higher than the 0.010 mg/L solubility limit the ECHA Database reported. 2 1 2 13. Test organism characteristics High Test organism description was available in Section 4.2 of the study. 1 2 2 14. Acclimatization and Pretreatment Conditions High There was a 14- day conditioning period. 1 1 1 Test organisms 15. Number of Organisms and Replicates per group High There were 10 fish/group. 1 1 1 16. Adequacy of Housing Conditions High Aquaria size: 10 litres consisted of glass (length 30 cm, width 22 cm, height 24 cm) and stood in a water bath made from Hostalit ZR with a 1 1 1 Page 4 of 13 ------- Study Reference: BASF. 1988. Testing the acute toxicity in the fish model Zebra danio (Brachydanio rerio) over the course of 96 hours. Study conducted by Pharma Research Toxicology and Pathology, Hoechst Corporation (Study Completion Date: July 1st, 1988), Frankfurt, Germany. HERO ID: 4731539 Plexiglas viewing window. Outcome Assessment 17. Outcome assessment methodology Medium Mortality was quantified, but discoloration of the test vessels prevented the observation of sublethal effects. 2 2 4 18. Consistency of outcome assessment High The outcome assessment protocols and results were consistently reported for all test concentrations. 1 1 1 Confounding/ 19. Confounding variables in test setup and procedures High There were no reported confounding variables in the experiments that could influence the outcome assessment. 1 2 2 variable control 20. Outcomes unrelated to exposure High There were no reported differences among the test groups that could influence the outcome assessment. 1 1 1 Data presentation and analysis 21. Statistical methods Not Rated Given that no effects were observed for the one test concentration used in the experiment, no statistics were necessary. NR NR NR 22. Reporting of data Medium Mortality was quantified, but discoloration of the test vessels prevented the observation of sublethal effects. 2 2 4 Page 5 of 13 ------- Study Reference: BASF. 1988. Testing the acute toxicity in the fish model Zebra danio (Brachydanio rerio) over the course of 96 hours. Study conducted by Pharma Research Toxicology and Pathology, Hoechst Corporation (Study Completion Date: July 1st, 1988), Frankfurt, Germany. HERO ID: 4731539 23. Explanation of Unexpected Outcomes Not Rated There were no unexplained outcomes and no effects observed up to the highest test concentration. NR NR NR Sum of scores: 26 29 36 High Medium Low Overall Score = Sum of Weighted Scores/Sum of Metric Weighting Factors: 1.241 Overall Score (Rounded): 1.2 >1 and <1.7 >1.7 and <2.3 >2.3 and <3 Overall Quality Level: High Footnote A: This metric met the criteria for high confidence as expected for this type of study. Page 6 of 13 ------- Table 2. Aquatic Plant with C.I. Pigment Violet 29, BASF (2012b) Study Reference: BASF (2012). H-28548: Paliogen Violet 5011, Lemna gibba L. CPCC 310 Growth Inhibition Test according to OECD Guideline No. 221. Study conducted by Institute of Industrial Organic Chemistry, Branch Pszczyna Department of Ecotoxicology. (Study Completion Date: October 2012), Pszczyna, Poland. HERO ID: 4731540 Note: Conducted according to OECD TG 221 (2006) Domain Metric Qualitative Determination [i.e., High, Medium, Low, Unacceptable, or Not rated] Comments Metric Score Metric Weighting Factor Weighted Score 1. Test substance identity High Test substance was reported as Paliogen Violet 5011, which shares the same chemical name withPV29. 1 2 2 Test Substance 2. Test substance source High Test material was provided by the study sponsor and reported. 1 1 1 3.Test substance purity Medium Although the test substance purity was not reported in the study, the test concentrations were adequately quantified throughout the test. 2 1 2 4. Negative controls HighA 1 2 2 Test setup 5. Negative control response High No effects were seen in the negative controls. 1 1 1 6. Randomized allocation High Study report mentioned that replicates were arranged at random and rearranged repeatedly. 1 1 1 Exposure 7. Experimental System/Test Media Preparation HighA 1 2 2 characterization 8. Consistency of Exposure administration HighA 1 1 1 Page 7 of 13 ------- Study Reference: BASF (2012). H-28548: Paliogen Violet 5011, Lemna gibba L. CPCC 310 Growth Inhibition Test according to OECD Guideline No. 221. Study conducted by Institute of Industrial Organic Chemistry, Branch Pszczyna Department of Ecotoxicology. (Study Completion Date: October 2012), Pszczyna, Poland. HERO ID: 4731540 9. Exposure Duration and Frequency HighA 1 2 2 10. Measurement of Test Substance Concentration High Measured concentrations of all test concentrations reported. 1 1 1 11. Number of exposure groups and dose spacing HighA 1 1 1 12. Testing at or Below Solubility Limit High Study authors conducted the experiments above the solubility limit with no solvent and quantified the test concentrations. 1 1 1 13. Test organism characteristics High Test organism was Lemna gibba obtained from a laboratory. 1 2 2 Test organisms 14. Acclimatization and Pretreatment Conditions Medium Although details about the acclimatization and pretreatment conditions were not reported, this is unlikely to affect the study results. 2 1 2 15. Number of Organisms and Replicates per group HighA 1 1 1 16. Adequacy of Housing Conditions HighA 1 1 1 Outcome 17. Outcome assessment methodology HighA 1 2 2 Assessment 18. Consistency of outcome assessment HighA 1 1 1 Page 8 of 13 ------- Study Reference: BASF (2012). H-28548: Paliogen Violet 5011, Lemna gibba L. CPCC 310 Growth Inhibition Test according to OECD Guideline No. 221. Study conducted by Institute of Industrial Organic Chemistry, Branch Pszczyna Department of Ecotoxicology. (Study Completion Date: October 2012), Pszczyna, Poland. HERO ID: 4731540 Confounding/ variable control 19. Confounding variables in test setup and procedures HighA 1 2 2 20. Outcomes unrelated to exposure Not Rated No unexpected outcomes were reported. NR NR NR Data presentation and analysis 21. Statistical methods High Probit analysis was used to calculate slope of the dose response. 1 1 1 22. Reporting of data HighA 1 2 2 23. Explanation of Unexpected Outcomes Not Rated No unexplained outcomes were reported. NR NR NR Sum of scores: 23 29 31 High Medium Low Overall Score = Sum of Weighted Scores/Sum of Metric Weighting Factors: 1.069 Overall Score (Rounded): 1.0 >1 and <1.7 >1.7 and <2.3 >2.3 and <3 Overall Quality Level: High Footnote A: This metric met the criteria for high confidence as expected for this type of study. Page 9 of 13 ------- Table 3. Acute Aquatic Invertebrate Study with C.I. Pigment Violet 29, BASF (2012a) Study Reference: BASF (2012). H-28548: Paliogen Violet 5011, Daphttia magna, Acute immobilization test. Study conducted by Institute of Industrial Organic Chemistry, Branch Pszczyna Department of Ecotoxicology. (Study Completion Date: May 2012), Pszczyna, Poland. HERO ID: 4731541 Note: Conducted according to the OECD 202 Test Guideline (2004) Domain Metric Qualitative Determination [i.e., High, Medium, Low, Unacceptable, or Not rated] Comments Metric Score Metric Weighting Factor Weighted Score 1. Test substance identity High Pages 37 and 46 indicated Paliogen Violet, the reported test substance, is comprised of PV 29 as indicated by the CASRN. 1 2 2 Test Substance 2. Test substance source High Pages 37 and 46 indicated test material was sourced from the manufacturer. 1 1 1 3.Test substance purity Medium Study report indicated that the Test material is PV 29, but does not specify the chemical purity. The test concentration of the definitive test was analytically verified by mass spectroscopy 2 1 2 4. Negative controls High Negative controls and reference test were used. 1 2 2 Test setup 5. Negative control response High No immobilization/ mortality was observed. 1 1 1 6. Randomized allocation Low There was only one test concentration, but it was not mentioned whether individuals were randomly allocated. 3 1 3 Exposure characterization 7. Experimental System/Test Media Preparation HighA 1 2 2 Page 10 of 13 ------- Study Reference: BASF (2012). H-28548: Paliogen Violet 5011, Daphnia magna, Acute immobilization test. Study conducted by Institute of Industrial Organic Chemistry, Branch Pszczyna Department of Ecotoxicology. (Study Completion Date: May 2012), Pszczyna, Poland. HERO ID: 4731541 8. Consistency of Exposure administration High Conducted as a limit test, concentrations were measured at start and termination of the test to quantify degradation. 1 1 1 9. Exposure Duration and Frequency HighA 1 2 2 10. Measurement of Test Substance Concentration HighA 1 1 1 11. Number of exposure groups and dose spacing High Test was conducted as a limit test based on results of range- finding test. 1 1 1 12. Testing at or Below Solubility Limit High Test was conducted as a limit test based on results of range- finding test. As a result, test was conducted as a limit test and test concentrations were analytically confirmed to match the reported limit of solubility for the test material. 1 1 1 13. Test organism characteristics HighA 1 2 2 Test organisms 14. Acclimatization and Pretreatment Conditions HighA 1 1 1 15. Number of Organisms and Replicates per group HighA 1 1 1 16. Adequacy of Housing Conditions HighA 1 1 1 Outcome Assessment 17. Outcome assessment methodology HighA 1 2 2 Page 11 of 13 ------- Study Reference: BASF (2012). H-28548: Paliogen Violet 5011, Daphnia magna, Acute immobilization test. Study conducted by Institute of Industrial Organic Chemistry, Branch Pszczyna Department of Ecotoxicology. (Study Completion Date: May 2012), Pszczyna, Poland. HERO ID: 4731541 18. Consistency of outcome assessment HighA 1 1 1 Confounding/ variable control 19. Confounding variables in test setup and procedures High There were no reported confounding variables in the experiments that could influence the outcome assessment. 1 2 2 20. Outcomes unrelated to exposure High There were no reported differences among the test groups that could influence the outcome assessment. 1 1 1 Data presentation and analysis 21. Statistical methods Not Rated No statistics necessary because the test was conducted as a limit test. NR NR NR 22. Reporting of data HighA 1 2 2 23. Explanation of Unexpected Outcomes Not Rated No unexplained outcomes and no effects were observed up to the highest test concentration. NR NR NR Sum of scores: 24 29 32 High Medium Low Overall Score = Sum of Weighted Scores/Sum of Metric Weighting Factors: 1.103 Overall Score (Rounded): 1.1 >1 and <1.7 >1.7 and <2.3 >2.3 and <3 Overall Quality Level: High Footnote A: This metric met the criteria for high confidence as expected for this type of study. Page 12 of 13 ------- References 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. BASF. (2012a). H-28548: Paliogen violet 5011, Daphnia magna, acute immobilization test. Pszczyna, Poland: Institute of Industrial Organic Chemistry, Branch Pszcyna Department of Ecotoxicology. 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. 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. Page 13 of 13 ------- |