"ERA HMW. ^0 ImI 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 Physical and Chemical Property Studies CASRN: 81-33-4 o H 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 (I S hT \ ( 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. Melting Point Study for C.I. Pigment Violet 29 Table 2. Log Kow Study for C.I. Pigment Violet 29 Table 3. Density Study for C.I. Pigment Violet 29 Table 4. Vapor Pressure Study for C.I. Pigment Violet 29 Table 5. Solubility in n-Octanol Study for C.I. Pigment Violet 29 Table 6. Solubility in Water Study for C.I. Pigment Violet 29 3 4 5 6 7 8 Page 2 of 9 ------- Table 1. Melting Point Study for C.I. Pigment Violet 29 Study Reference: BASF. 2013. Physical-Chemical properties of "Paliogen Violet 5011". BASF Study No. 111.00105. Competence Center Analytics. BASF SF. D-67056 Liidwigshafcn. l est Completion Date: November 28. 2011. IIFUO II): 4731544 Note: ) reported various physical-chemical properties and only the confidence of the melting point is evaluated here. Domain/Metric Description/ Definition Qualitative Determination [i.e., High, Medium, Low, Unacceptable, or Not rated] Comment The information or data The data was measured for the substance of interest. Representativeness reflects the data and chemical substance type. High Appropriateness The information or data reflects anticipated results based on chemical structural features or behaviors. High The measured value is consistent with the nature of the substance. Evaluation/ Review The information or data reported has reliable review. Medium The data is from a source that is not described as poor-reviewed by experts in the field or are broadly available to the public for review and use but is known. EPA plans to refine the criteria to clearly indicate the circumstances would make the data source to be of medium confidence for this domain/metric. Reliability/ Unbiased (Method Objectivity) The method for producing the data/information is not biased towards a particular product or outcome. High The methodology is designed to determine the endpoint of interest. Reliability/ Analytic Method The information or data reported is from a reliable method. High The study used a standard and generally accepted method for this type of study. Overall Quality Level High Page 3 of 9 ------- Table 2. Log Kow Study for C.I. Pigment Violet 29 Study Reference: BASI-". 2013. Physical-Chemical properties of "Paliogen Violet 5011". BASF Study No. 111.00105. Competence Center Analytics. IJASK SK. D-67056 l.udwigshafen. l est Completion Date: November 28. 2011. IIKKO II): 4731544 Note: JO 13) reported various phvsical-chemical properties and onlv the confidence of the Log Kow (octanol/water partition coefficient) is evaluated here. Domain/Metric Description/ Definition Qualitative Determination [i.e., High, Medium, Low, Unacceptable, or Not rated] Comment The information or data The data was measured for the substance of interest. Representativeness reflects the data and chemical substance type. High Appropriateness The information or data reflects anticipated results based on chemical structural features or behaviors. Unacceptable The substance is not soluble in either octanol or water. Therefore, partitioning between the media cannot be determined. Evaluation/ Review The information or data reported has reliable review. Medium The data is from a source that is not described as poor-reviewed by experts in the field or are broadly available to the public for review and use, but is known. EPA plans to refine the criteria to clearly indicate the circumstances would make the data source to be of medium confidence for this domain/metric. Reliability/ Unbiased (Method Objectivity) The method for producing the data/information is not biased towards a particular product or outcome. Not Rated Data source does not provide information to determine the method objectivity (unbiased method). Thus the domain/ metric was not rated. Reliability/ Analytic Method The information or data reported is from a reliable method. Unacceptable The substance is not soluble in either octanol or water. Therefore, partitioning between the media cannot be determined. This analytical method is not appropriate. Overall Quality Level Unacceptable Page 4 of 9 ------- Table 3. Density Study for C.I. Pigment Violet 29 Study Reference: IJASI-". 2013. Physical-Chemical properties of "Paliogen Violet 5011". IJASI-" Study No. 111.00105. Competence Center Analytics. IJASI-" SK. D-67056 l.udwigshafen. l est Completion Dale: November 28. 2011. Note: JO 13) reported the relative density of PV-29. Domain/Metric Description/ Definition Qualitative Determination [i.e., High, Medium, Low, Unacceptable, or Not rated] Comment Representativeness The information or data reflects the data and chemical substance type. High The data was measured for the substance of interest. Appropriateness The information or data reflects anticipated results based on chemical structural features or behaviors. High The measured value is consistent with the nature of the substance. Evaluation/ Review The information or data reported has reliable review. Medium From a source, Competence Center Analytics, BASF SE, D-67056 Ludwigshafen, that is not described as High, but is known; where High corresponds to a recognized data collection/repository where data are peer-reviewed by experts in the field, are broadly available to the public for review and use, and include references to the original sources. Reliability/ Unbiased (Method Objectivity) The method for producing the data/information is not biased towards a particular product or outcome. High The methodology is designed to determine the endpoint of interest. Reliability/ Analytic Method The information or data reported is from a reliable method. High The study used a standard and generally accepted method for this type of study. Overall Quality Level High Page 5 of 9 ------- Table 4. Vapor Pressure Study for C.I. Pigment Violet 29 Si udv Reference: IJASI-". 2013. Physical-Chemical properties of "Paliogen Yiolel 5011". IJASI-" Study No. 111.00105. Com pot once Center Analytics. IJASI-" SK. D-67056 l.udwigshafen. l est Completion Dale: November 28. 2011. Note: BASF (2013) reported the vapor pressure of PV-29. Domain/Metric Description/ Definition Qualitative Determination [i.e., High, Medium, Low, Unacceptable, or Not rated] Comment Representativeness The information or data reflects the data and chemical substance type. High The data was measured for the substance of interest. Appropriateness The information or data reflects anticipated results based on chemical structural features or behaviors. High The measured value is consistent with the nature of the substance. Evaluation/ Review The information or data reported has reliable review. Medium From a source, Competence Center Analytics, BASF SE, D-67056 Ludwigshafen, that is not described as High, but is known; where High corresponds to a recognized data collection/repository where data are peer-reviewed by experts in the field, are broadly available to the public for review and use, and include references to the original sources. Reliability/ Unbiased (Method Objectivity) The method for producing the data/information is not biased towards a particular product or outcome. High The methodology is designed to determine the endpoint of interest. Reliability/ Analytic Method The information or data reported is from a reliable method. High The study used a standard and generally accepted method for this type of study; however, a cutoff value was reported because the limit of the most sensitive measurement technique was reached. Overall Quality Level High Page 6 of 9 ------- Table 5. Solubility in n-Octanol Study for C.I. Pigment Violet 29 St udv Reference: Sun Chemical. 2020. Determination ol'llie solubility of C.I. PY29 in l-octanol and nil lor. Sun Chemical Study No. 04-033A-W OS. Colors Technology Analytical Laboratory. Sun Chemical Corporation. 5020 Spring (.ro\e A\enue. Cincinnati Ohio 45232. Test Completion Date: Original: June 1. 2020: Ke\ised: June 22. 2020. Note: Sun Chemicals (2020) reported the solubility in n-octanol of PV-29. Domain/Metric Description/ Definition Qualitative Determination [i.e., High, Medium, Low, Unacceptable, or Not rated] Comment Representativeness The information or data reflects the data and chemical substance type. High The data was measured for the substance of interest. Appropriateness The information or data reflects anticipated results based on chemical structural features or behaviors. High The measured value is consistent with the nature of the substance (high melting solid). It should be noted that the company reported no physical evidence of any solubility; therefore, they reported values were for the LOD (0.0014 mg/L) and the LOQ (0.003 mg/L). Evaluation/ Review The information or data reported has reliable review. Medium From a source, Colors Technology Analytical Laboratory, Sun Chemical Corporation that is not described as High, but is known; a High determination corresponds to a recognized data collection/repository where data are peer-reviewed by experts in the field, are broadly available to the public for review and use, and include references to the original sources. Reliability/ Unbiased (Method Objectivity) The method for producing the data/information is not biased towards a particular product or outcome. High The methodology is designed to determine the endpoint of interest. The company used a method which was agreed upon at the "Analytical Experts Meeting" of ETAD (Basel) on January 12, 2005. Due to the substance's low solubility in all solvents, other methods could not be used. Reliability/ Analytic Method The information or data reported is from a reliable method. High The study used a generally accepted method for this type of study; however, a cutoff value was reported since the test substance solubility in n-octanol was below the limit of quantification and most likely below the limit of detection. Overall Quality Level High Page 7 of 9 ------- Table 6. Solubility in Water Study for C.I. Pigment Violet 29 St udv Reference: Sun C'hoiniciil. 2020. Dolormin:ition (il'llic solubility ol'C.I. I'\ 2() in l-octiinol :uul \\:ilir. Sun C'honiiciil Study No. 04-033A-W OS. Colors Technology An;ilytic:il Liihomtory. Sun Choiniciil Corporation, 5020 Spring (lro\e \\cniic, Cincimiiiti Ohio 45232. l ost Completion Ditto: ()riťin;il: June 1. 2020; Kc\iscd: .lunc 22. 2020. Note: Sun Chemicals (2020) reported the solubility in water of PV-29. Domain/Metric Description/ Definition Qualitative Determination [i.e., High, Medium, Low, Unacceptable, or Not rated] Comment Representativeness The information or data reflects the data and chemical substance type. High The data was measured for the substance of interest. Appropriateness The information or data reflects anticipated results based on chemical structural features or behaviors. High The measured value is consistent with the nature of the substance (high melting solid). It should be noted that the company reported no physical evidence of any solubility; therefore, they reported values were for the LOD (0.0014 mg/L) and the LOQ (0.003 mg/L). Evaluation/ Review The information or data reported has reliable review. Medium From a source, Colors Technology Analytical Laboratory, Sun Chemical Corporation that is not described as High, but is known; a High determination corresponds to a recognized data collection/repository where data are peer- reviewed by experts in the field, are broadly available to the public for review and use, and include references to the original sources. Reliability/ Unbiased (Method Objectivity) The method for producing the data/information is not biased towards a particular product or outcome. High The methodology is designed to determine the endpoint of interest. The method was based on the OECD 105 flask method. Due to the substance's low solubility in all solvents, other methods could not be used. Reliability/ Analytic Method The information or data reported is from a reliable method. High The study used a generally accepted method for this type of study; however, a cutoff value was reported since the test substance solubility in water was below the limit of quantification and most likely below the limit of detection. Overall Quality Level High Page 8 of 9 ------- References f\ (2013). Physical-chemical properties of "Paliogen violet 5011". BASF study no. 11 LOO 105. (11L00105). Ludwigshafen: Competence Center Analytics; BASF SE; D-67056. Sun Chemicals. (2020). Enclosure 1 - EPA request for additional information in response to SACC peer reveiwer and including public comments on the draft C.I. Pigment Violet 20 Risk Evaluation. (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 tsŤ df. Page 9 of 9 ------- |