E*ii^3j#X United States LhI i^Wk Environmental Protection Agency Office of Chemical Safety and Pollution Prevention Final Risk Evaluation for 1,4-Dioxane Systematic Review Supplemental File: Data Quality Evaluation of Environmental Hazard Studies CASRN: 123-91-1 December 2020 ------- This document is a compilation of tables for the data extraction and evaluation for 1,4-Dioxane. 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. 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. Page 2 of27 ------- Page 5 7 9 11 13 16 18 20 22 24 Table of Contents Data Type Acute (0-96 hour); Aquatic; Fish Acute (0-96 hour); Aquatic; Inverte- brates Other; Aquatic; Plants Acute (0-96 hour); Aquatic; Inverte- brates Acute (0-96 hour); Aquatic; Inverte- brates Acute (0-96 hour); Aquatic; other Fish and Daphnia Acute (0-96 hour); Aquatic; Inverte- brates Acute (0-96 hour); Aquatic; Fish Chronic (>21 days); Aquatic; Fish Acute (0-96 hour); Aquatic; Fish Reference Dawson, G. W.,Jennings, A. L.,Drozdowski, D.,Rider, E.. 1977. The acute toxicity of 47 industrial chemicals to fresh and saltwater fishes. Journal of Hazardous Materials 1:303-318 G. Bringmann, R. Kuehn. 1982. Ergebnisse der Schadwirkung wassergefaehrdender Stoife gegen Daphnia magna in einem weiterentwickelten standardisierten Testver- fahren [Results of toxic action of water pollutants on Daphnia magna Straus tested by an improved standardized procedure]. Wasser und Abwasser in Forschung und Praxis 15 G. Bringmann, R. Kuhn. 1978. Grenzwerte der Schadwirkung wassergefahrden- der Stoife gegen Blaualgen (Microcystis aeruginosa) und Grunalgen (Scenedesmus quadricauda) im Zellvermehrungshemmtest [Limiting values for the noxious eifects of water pollutant material to blue algae (Microcystis aeruginosa) and green algae (Scenedesmus quadricauda) in cell propagation inhibition tests].. Vom Wasser 50:45- 60 G. Bringmann, R. Kuhn. 1977. The eifects of water pollutants on Daphnia magna. Wasser und Abwasser in Forschung und Praxis 10:161-166 G. Bringmann, R. Kuehn. 1982. Results of Toxic Action of Water Pollutants on Daphnia magna Straus Tested by an Improved Standardized Procedure. 15:1-6(GER) (ENG ABS) (OECDG Data File) Brooke, L.. 1987. Report of the Flow-Through and Static Acute Test Comparisons with Fathead Minnows and Acute Tests with an Amphipod and a Cladoceran. Brooke, L.. 1987. Report of the Flow-Through and Static Acute Test Comparisons with Fathead Minnows and Acute Tests with an Amphipod and a Cladoceran. Geiger, D. L.,Brooke, L. T.,Call, D. J.. 1990. Acute toxicities of organic chemicals to fathead minnows (Pimephales promelas): Volume V. R. Johnson, J. Tietge, G. Stokes, D. Lothenbach. 1993. The Medaka Carcinogenesis Model. Dow Chemical. 1989. 1,4-Dioxane: Embryo-larval toxicity test with the Fathead minnow, Pimephales promelas Rafinesque. Page 3 of27 ------- 4438934 Other; Aquatic; Plants G. Bringman, R. Kuhn. 1977. Limiting values of the harmful action of water endan- gering substances on bacteria (Pseudomonas putida) and green algae (Scenedesmus quadricauda) in the cell multiplication inhibition test. Zeitschrift fuer Wasser- und Abwasser-Forschung 10:87-98 Page 4 of 27 ------- Study Citation: Dawson, G. W.,Jennings, A. L.,Drozdowski, D.,Rider, E.. 1977. The acute toxicity of 47 industrial chemicals to fresh and saltwater fishes. Journal of Hazardous Materials 1:303-318 Data Type: Acute (0-96 hour); Aquatic; Fish Hero ID: 18670 Domain Metric Ratingt MWF* Score Commentstt Domain 1: Test Substance Metric 1: Test Substance Identity High X 2 2 Metric 2: Test Substance Source Low X 1 3 Test source was not reported. Metric 3: Test Substance Purity Low X 1 3 The test purity was not reported Domain 2: Test Design Metric 4 Metric 5 Metric 6 Negative Controls High Negative Control Response High Randomized Allocation Medium x 2 2 x 1 1 X 1 2 Not specified, the information was implied for this metric. Domain 3: Exposure Characterization Metric 7: Experimental System/Test Media Prepara- Low x 2 6 tion Metric 8: Consistency of Exposure Administration High x 1 1 Metric 9: Measurement of Test Substance Concentra- High x 2 2 tion Metric 10: Exposure Duration and Frequency High x 1 1 Metric 11: Number of Exposure Groups/Spacing of Ex- Low x 1 3 posure Levels Metric 12: Testing at or Below Solubility Limit High x 1 1 limited information provided Information was provided for this metric. No information was reported; however, an LC50 was derived. Domain 4: Test Organism Metric 13 Metric 14 Metric 15 Test Organism Characteristics High x 2 2 Acclimitization and Pretreatment Conditions High x 1 1 Number of Organisms and Replicates per Medium x 1 2 Limited info provided Group Continued on next page . . . Page 5 of27 ------- . continued from previous page Study Citation: Dawson, G. W.,Jennings, A. L.,Drozdowski, D.,Rider, E.. 1977. The acute toxicity of 47 industrial chemicals to fresh and saltwater fishes. Journal of Hazardous Materials 1:303-318 Data Type: Acute (0-96 hour); Aquatic; Fish Hero ID: 18670 Domain Metric Rating^ MWF* Score Comments^ Metric 16: Adequacy of Test Conditions High X 1 1 Domain 5: Outcome Assessment Metric 17: Outcome Assessment Methodology Metric 18: Consistency of Outcome Assessment High High x 2 x 1 2 1 Domain 6: Confounding / Variable Control Metric 19: Confounding Variables in Test Design and Procedures Metric 20: Outcomes Unrelated to Exposure High High x 2 x 1 2 Information was reported for this metric. 1 Domain 7: Data Presentation and Analysis Metric 21: Statistical Methods Metric 22: Reporting of Data Metric 23: Explanation of Unexpected Outcomes High High N/A x 1 x 2 1 2 N/A Overall Quality Determination"'" High 1.4 Extracted No * MWF = Metric Weighting Factor t High = 1; Medium = 2; Low = 3; Unacceptable = 4; N/A has no value. $ The overall rating is calculated as necessary. EPA may not always provide a comment for a metric that has been categorized as High. Overall rating = ^ (Metric Score; x MWF,) / ^ MWFj if any metric is Unacceptable (round to the nearest tenth) otherwise where High: > 1 to < 1.7; Medium: > 1.7 to < 2.3; Low: > 2.3 to < 3. If the reviewer determines that the overall rating needs adjustment, the original rating is crossed out and an arrow points to the new rating, ft Metrics that are rated 'High' met the criteria for high confidence as expected for this type of study, and may not require additional comments. Page 6 of 27 ------- Study Citation: G. Bringmann, R. Kuehn. 1982. Ergebnisse der Schadwirkung wassergefaehrdender Stoffe gegen Daphnia magna in einem weiteren- twickelten standardisierten Testverfahren [Results of toxic action of water pollutants on Daphnia magna Straus tested by an improved standardized procedure]. Wasser und Abwasser in Forschung und Praxis 15 Data Type: Acute (0-96 hour); Aquatic; Invertebrates Hero ID: 18804 Domain Metric Rating^ MWF* Score Comments^ Domain 1: Test Substance Metric 1 Test Substance Identity Low x 2 6 Only the chemical name was provided. Metric 2 Test Substance Source Low x 1 3 The source of the chemical was not reported Metric 3 Test Substance Purity Low x 1 3 The information for this metric was provided in the report. Domain 2: Test Design Metric 4 Negative Controls High x 2 2 Metric 5 Negative Control Response High x 1 1 Metric 6 Randomized Allocation High x 1 1 Domain 3: Exposure Characterization Metric 7 Experimental System/Test Media Prepara- High x 2 2 tion Metric 8 Consistency of Exposure Administration High x 1 1 Metric 9 Measurement of Test Substance Concentra- High x 2 2 The information for this metric was provided in the tion report. Metric 10: Exposure Duration and Frequency High x 1 1 Metric 11: Number of Exposure Groups/Spacing of Ex- High x 1 1 posure Levels Metric 12: Testing at or Below Solubility Limit High x 1 1 Domain 4: Test Organism Metric 13: Test Organism Characteristics High x 2 2 Metric 14: Acclimitization and Pretreatment Conditions High x 1 1 Metric 15: Number of Organisms and Replicates per High x 1 1 Group Continued on next page . . . Page 7 of27 ------- . continued from previous page Study Citation: G. Bringmann, R. Kuehn. 1982. Ergebnisse der Schadwirkung wassergefaehrdender Stoffe gegen Daphnia magna in einem weiteren- twickelten standardisierten Testverfahren [Results of toxic action of water pollutants on Daphnia magna Straus tested by an improved standardized procedure]. Wasser und Abwasser in Forschung und Praxis 15 Data Type: Acute (0-96 hour); Aquatic; Invertebrates Hero ID: 18804 Domain Metric Rating^ MWF* Score Comments^ Metric 16: Adequacy of Test Conditions High X 1 1 Domain 5: Outcome Assessment Metric 17: Outcome Assessment Methodology Metric 18: Consistency of Outcome Assessment High High x 2 x 1 2 1 Domain 6: Confounding / Variable Control Metric 19: Confounding Variables in Test Design and Procedures Metric 20: Outcomes Unrelated to Exposure High N/A x 2 2 N/A Domain 7: Data Presentation and Analysis Metric 21: Statistical Methods Metric 22: Reporting of Data Metric 23: Explanation of Unexpected Outcomes Medium High N/A x 1 x 2 2 Limited information was provided for this metric. 2 N/A Overall Quality Determination"'" High 1.3 Extracted Yes * MWF = Metric Weighting Factor t High = 1; Medium = 2; Low = 3; Unacceptable = 4; N/A has no value. * The overall rating is calculated as necessary. EPA may not always provide a comment for a metric that has been categorized as High. Overall rating = ^ (Metric Score; x MWF;) / ^ MWFj if any metric is Unacceptable (round to the nearest tenth) otherwise where High: > 1 to < 1.7; Medium: > 1.7 to < 2.3; Low: > 2.3 to < 3. If the reviewer determines that the overall rating needs adjustment, the original rating is crossed out and an arrow points to the new rating. ^ Metrics that are rated 'High' met the criteria for high confidence as expected for this type of study, and may not require additional comments. Page 8 of 27 ------- Study Citation: G. Bringmann, R. Kuhn. 1978. Grenzwerte der Schadwirkung wassergefahrdender Stoffe gegen Blaualgen (Microcystis aeruginosa) und Grunalgen (Scenedesmus quadricauda) im Zellvermehrungshemmtest [Limiting values for the noxious effects of water pollutant material to blue algae (Microcystis aeruginosa) and green algae (Scenedesmus quadricauda) in cell propagation inhibition tests].. Vom Wasser 50:45-60 Data Type: Other; Aquatic; Plants Hero ID: 51735 Domain Metric Rating^ MWF* Score Comments"^ Domain 1: Test Substance Metric 1: Test Substance Identity Low X 2 6 Only the chemical name was provided. Metric 2: Test Substance Source Low X 1 3 The source of the chemical was not reported. Metric 3: Test Substance Purity Low X 1 3 Information about the test purity was not reported Domain 2: Test Design Metric 4: Negative Controls High X 2 2 Metric 5: Negative Control Response High X 1 1 Metric 6: Randomized Allocation High X 1 1 Domain 3: Exposure Characterization Metric 7: Experimental System/Test Media Prepara- High x 2 tion Metric 8: Consistency of Exposure Administration High x 1 Metric 9: Measurement of Test Substance Concentra- High x 2 tion Metric 10: Exposure Duration and Frequency High x 1 Metric 11: Number of Exposure Groups/Spacing of Ex- High x 1 posure Levels Metric 12: Testing at or Below Solubility Limit N/A N/A The solubility for 1,4-dioxane was not a factor. Domain 4: Test Organism Metric 13 Metric 14 Metric 15 Test Organism Characteristics High x 2 2 Acclimitization and Pretreatment Conditions High x 1 1 Number of Organisms and Replicates per High x 1 1 Group Continued on next page . . . Page 9 of 27 ------- . . . continued from previous page Study Citation: G. Bringmann, R. Kuhn. 1978. Grenzwerte der Schadwirkung wassergefahrdender Stoffe gegen Blaualgen (Microcystis aeruginosa) und Grunalgen (Scenedesmus quadricauda) im Zellvermehrungshemmtest [Limiting values for the noxious effects of water pollutant material to blue algae (Microcystis aeruginosa) and green algae (Scenedesmus quadricauda) in cell propagation inhibition tests].. Vom Wasser 50:45-60 Other; Aquatic; Plants 51735 Data Type: Hero ID: Domain Metric Ratingt MWF* Score Commentstt Metric 16: Adequacy of Test Conditions N/A N/A Domain 5: Outcome Assessment Metric 17: Outcome Assessment Methodology Metric 18: Consistency of Outcome Assessment High High x 2 x 1 2 1 Domain 6: Confounding / Variable Control Metric 19: Confounding Variables in Test Design and Procedures Metric 20: Outcomes Unrelated to Exposure High High x 2 x 1 2 1 Domain 7: Data Presentation and Analysis Metric 21: Statistical Methods Metric 22: Reporting of Data Metric 23: Explanation of Unexpected Outcomes Medium High N/A x 1 x 2 2 Limited information was provided for this metric. 2 N/A Overall Quality Determination"'" High 1.3 Extracted Yes * MWF = Metric Weighting Factor I High = 1; Medium = 2; Low = 3; Unacceptable = 4; N/A has no value. ^ The overall rating is calculated as necessary. EPA may not always provide a comment for a metric that has been categorized as High. Overall rating = (Metric Score; X MWF;) / ]T\ MWF, if any metric is Unacceptable (round to the nearest tenth) otherwise where High: > 1 to < 1.7; Medium: > 1.7 to < 2.3; Low: > 2.3 to < 3. If the reviewer determines that the overall rating needs adjustment, the original rating is crossed out and an arrow points to the new rating. It Metrics that are rated 'High' met the criteria for high confidence as expected for this type of study, and may not require additional comments. Page 10 of 27 ------- Study Citation: G. Bringmann, R. Kuhn. 1977. The effects of water poiiutants on Daphnia magna. Wasser und Abwasser in Forschung und Praxis 10:161-166 Data Type: Acute (0-96 hour); Aquatic; Invertebrates Hero ID: 73652 Domain Metric Ratingt MWF* Score Commentstt Domain 1: Test Substance Metric 1: Test Substance Identity Low X 2 6 No chemical identity information was provided for any of the chemicals including 1,4-Dioxane in this report. Only the chemical names were provided. Metric 2: Test Substance Source Low X 1 3 The report source did not provide any information about the manufacturer of the chemicals tested. Metric 3: Test Substance Purity Low X 1 3 Information about the purity was not provided. Domain 2: Test Design Metric 4: Negative Controls High X 2 2 Metric 5: Negative Control Response High X 1 1 Metric 6: Randomized Allocation High X 1 1 Domain 3: Exposure Characterization Metric 7: Experimental System/Test Media Prepara- High X 2 2 tion Metric 8: Consistency of Exposure Administration High X 1 1 Metric 9: Measurement of Test Substance Concentra- Low X 2 6 No information was provided for this metric. tion Metric 10: Exposure Duration and Frequency High X 1 1 Metric 11: Number of Exposure Groups/Spacing of Ex- High X 1 1 posure Levels Metric 12: Testing at or Below Solubility Limit High X 1 1 Domain 4: Test Organism Metric 13: Test Organism Characteristics High X 2 2 Metric 14: Acclimitization and Pretreatment Conditions High X 1 1 Metric 15: Number of Organisms and Replicates per High X 1 1 Group Continued on next page .. . Page 11 of 27 ------- . . .continued from previous page Study Citation: G. Bringmann, R. Kuhn. 1977. The effects of water pollutants on 10:161-166 Data Type: Acute (0-96 hour); Aquatic; Invertebrates Hero ID: 73652 Daphnia magna. Wasser und Abwasser in Forschung und Praxis Domain Metric Rating^ MWF* Score Comments^ Metric 16: Adequacy of Test Conditions High X 1 1 Domain 5: Outcome Assessment Metric 17: Outcome Assessment Methodology Metric 18: Consistency of Outcome Assessment High High x 2 x 1 2 1 This metric was completely characterized. Domain 6: Confounding / Variable Control Metric 19: Confounding Variables in Test Design and Procedures Metric 20: Outcomes Unrelated to Exposure High High x 2 x 1 2 1 Domain 7: Data Presentation and Analysis Metric 21: Statistical Methods Metric 22: Reporting of Data Metric 23: Explanation of Unexpected Outcomes Low High N/A x 1 x 2 3 2 N/A No statistical methods were provided. Overall Quality Determination"'" High 1.4 Extracted Yes * MWF = Metric Weighting Factor t High = 1; Medium = 2; Low = 3; Unacceptable = 4; N/A has no value. $ The overall rating is calculated as necessary. EPA may not always provide a comment for a metric that has been categorized as High. Overall rating = ^ (Metric Score; x MWF,) / ^ MWFj if any metric is Unacceptable (round to the nearest tenth) otherwise where High: > 1 to < 1.7; Medium: > 1.7 to < 2.3; Low: > 2.3 to < 3. If the reviewer determines that the overall rating needs adjustment, the original rating is crossed out and an arrow points to the new rating, ft Metrics that are rated 'High' met the criteria for high confidence as expected for this type of study, and may not require additional comments. Page 12 of 27 ------- Study Citation: G. Bringmann, R. Kuehn. 1982. Results of Toxic Action of Water Pollutants on Daphnia magna Straus Tested by an Improved Standardized Procedure. 15:1-6(GER) (ENG ABS) (OECDG Data File) Data Type: Acute (0-96 hour); Aquatic; Invertebrates Hero ID: 3616460 Domain Metric Ratingt MWF* Score Commentstt Domain 1: Test Substance Metric 1: Metric 2: Test Substance Identity Test Substance Source Metric 3: Test Substance Purity Low x 2 Low x 1 Low x 1 The study only listed the test substance name. How- ever, this reporting source was for multiple chemicals thus detail information could have been omitted be- cause of publication requirements. Also, this study was published in 1983 from Germany. The study only listed the test substance name. How- ever, this reporting source was for multiple chemicals thus detail information could have been omitted be- cause of publication requirements. Also, this study was published in 1983 from Germany. The study only listed the test substance name. How- ever, this reporting source was for multiple chemicals thus detail information could have been omitted be- cause of publication requirements. Also, this study was published in 1983 from Germany. Domain 2: Test Design Metric 4: Negative Controls High X 2 2 Metric 5: Negative Control Response High X 1 1 Metric 6: Randomized Allocation High X 1 1 Domain 3: Exposure Characterization Metric 7: Experimental System/Test Media Prepara- tion High X 2 2 Metric 8: Consistency of Exposure Administration High X 1 1 Metric 9: Measurement of Test Substance Concentra- tion High X 2 2 Metric 10: Exposure Duration and Frequency N/A N/A This information was reported for this metric. Metric 11: Number of Exposure Groups/Spacing of Ex- posure Levels High X 1 1 Continued on next page . . . Page 13 of 27 ------- . . . continued from previous page Study Citation: G. Bringmann, R. Kuehn. 1982. Results of Toxic Action of Water Pollutants on Daphnia magna Straus Tested by an Improved Standardized Procedure. 15:1-6(GER) (ENG ABS) (OECDG Data File) Data Type: Acute (0-96 hour); Aquatic; Invertebrates Hero ID: 3616460 Domain Metric Rating^ MWF* Score Comments^ Metric 12: Testing at or Below Solubility Limit High X 1 1 Domain 4: Test Organism Metric 13: Test Organism Characteristics N/A N/A Metric 14: Acclimitization and Pretreatment Conditions High X 1 1 Metric 15: Number of Organisms and Replicates per N/A N/A Group Metric 16: Adequacy of Test Conditions High X 1 1 Domain 5: Outcome Assessment Metric 17: Outcome Assessment Methodology High X 2 2 Metric 18: Consistency of Outcome Assessment High X 1 1 Domain 6: Confounding / Variable Control Metric 19: Confounding Variables in Test Design and High X 2 2 Procedures Metric 20: Outcomes Unrelated to Exposure High X 1 1 This information was reported for this metric. Domain 7: Data Presentation and Analysis Metric 21: Statistical Methods Low X 1 3 Limited information was provided for this metric. Only effects results were reported. Metric 22: Reporting of Data High X 2 2 Metric 23: Explanation of Unexpected Outcomes N/A N/A Overall Quality Determination"'" High 1.4 Extracted Yes Continued on next page . . . Page 14 of 27 ------- .continued from previous page Study Citation: G. Bringmann, R. Kuehn. 1982. Results of Toxic Action of Water Pollutants on Daphnia magna Straus Tested by an Improved Standardized Procedure. 15:1-6(GER) (ENG ABS) (OECDG Data File) Data Type: Acute (0-96 hour); Aquatic; Invertebrates Hero ID: 3616460 Domain Metric Rating^" MWF* Score Comments^ * MWF = Metric Weighting Factor t High = 1; Medium = 2; Low = 3; Unacceptable = 4; N/A has no value. * The overall rating is calculated as necessary. EPA may not always provide a comment for a metric that has been categorized as High. Overall rating = (Metric Score; x MWF;) / J] . MWFj if any metric is Unacceptable (round to the nearest tenth) otherwise where High: > 1 to < 1.7; Medium: > 1.7 to < 2.3; Low: > 2.3 to < 3. If the reviewer determines that the overall rating needs adjustment, the original rating is crossed out and an arrow points to the new rating, ft Metrics that are rated 'High' met the criteria for high confidence as expected for this type of study, and may not require additional comments. Page 15 of 27 ------- Study Citation: Brooke, L.. 1987. Report of the Flow-Through and Static Acute Test Comparisons with Fathead Minnows and Acute Tests with an Amphipod and a Cladoceran. Data Type: Acute (0-96 hour); Aquatic; other Fish and Daphnia Hero ID: 3634436 Domain Metric Ratingt MWF* Score Commentstt Domain 1: Test Substance Metric 1 Test Substance Identity High X 2 2 Metric 2 Test Substance Source High X 1 1 Metric 3 Test Substance Purity High X 1 1 Domain 2: Test Design Metric 4 Negative Controls High X 2 2 Metric 5 Negative Control Response High X 1 1 Metric 6 Randomized Allocation High X 1 1 Domain 3: Exposure Characterization Metric 7 Experimental System/Test Media Prepara- High X 2 2 tion Metric 8 Consistency of Exposure Administration High X 1 1 Metric 9 Measurement of Test Substance Concentra- High X 2 2 tion Metric 10: Exposure Duration and Frequency High X 1 1 Metric 11: Number of Exposure Groups/Spacing of Ex- High X 1 1 posure Levels Metric 12: Testing at or Below Solubility Limit High X 1 1 Domain 4: Test Organism Metric 13: Test Organism Characteristics High X 2 2 Metric 14: Acclimitization and Pretreatment Conditions High X 1 1 Metric 15: Number of Organisms and Replicates per High X 1 1 Group Metric 16: Adequacy of Test Conditions High X 1 1 Continued on next page . . . Page 16 of 27 ------- . . .continued from previous page Study Citation: Brooke, L.. 1987. Report of the Flow-Through and Static Acute Test Comparisons with Fathead Minnows and Acute Tests with an Amphipod and a Cladoceran. Data Type: Acute (0-96 hour); Aquatic; other Fish and Daphnia Hero ID: 3634436 Domain Metric Rating^ MWF* Score Comments^ Domain 5: Outcome Assessment Metric 17: Outcome Assessment Methodology High X 2 2 Metric 18: Consistency of Outcome Assessment High X 1 1 Domain 6: Confounding / Variable Control Metric 19: Confounding Variables in Test Design and High X 2 2 Procedures Metric 20: Outcomes Unrelated to Exposure High X 1 1 Domain 7: Data Presentation and Analysis Metric 21: Statistical Methods High X 1 1 Metric 22: Reporting of Data High X 2 2 Metric 23: Explanation of Unexpected Outcomes N/A N/A Overall Quality Determination"'" High 1.0 Extracted Yes * MWF = Metric Weighting Factor t High = 1; Medium = 2; Low = 3; Unacceptable = 4; N/A has no value. $ The overall rating is calculated as necessary. EPA may not always provide a comment for a metric that has been categorized as High. 4 if any metric is Unacceptable Overall rating = J]. (Metric Score; x MWF,) / J] . MWFj (round to the nearest tenth) otherwise where High: > 1 to < 1.7; Medium: > 1.7 to < 2.3; Low: > 2.3 to < 3. If the reviewer determines that the overall rating needs adjustment, the original rating is crossed out and an arrow points to the new rating, ft Metrics that are rated 'High' met the criteria for high confidence as expected for this type of study, and may not require additional comments. Page 17 of 27 ------- Study Citation: Brooke, L.. 1987. Report of the Flow-Through and Static Acute Test Comparisons with Fathead Minnows and Acute Tests with an Amphipod and a Cladoceran. Data Type: Acute (0-96 hour); Aquatic; Invertebrates Hero ID: 3634436 Domain Metric Ratingt MWF* Score Commentstt Domain 1: Test Substance Metric 1 Test Substance Identity High X 2 2 Metric 2 Test Substance Source High X 1 1 Metric 3 Test Substance Purity High X 1 1 Domain 2: Test Design Metric 4 Negative Controls High X 2 2 Metric 5 Negative Control Response High X 1 1 Metric 6 Randomized Allocation Low X 1 3 Allocation not reported Domain 3: Exposure Characterization Metric 7 Experimental System/Test Media Prepara- High X 2 2 tion Metric 8 Consistency of Exposure Administration High X 1 1 Metric 9 Measurement of Test Substance Concentra- High X 2 2 tion Metric 10: Exposure Duration and Frequency High X 1 1 Metric 11: Number of Exposure Groups/Spacing of Ex- High X 1 1 posure Levels Metric 12: Testing at or Below Solubility Limit High X 1 1 Domain 4: Test Organism Metric 13: Test Organism Characteristics High X 2 2 Metric 14: Acclimitization and Pretreatment Conditions High X 1 1 Metric 15: Number of Organisms and Replicates per High X 1 1 Group Metric 16: Adequacy of Test Conditions High X 1 1 Continued on next page . . . Page 18 of 27 ------- . . .continued from previous page Study Citation: Brooke, L.. 1987. Report of the Flow-Through and Static Acute Test Comparisons with Fathead Minnows and Acute Tests with an Amphipod and a Cladoceran. Data Type: Acute (0-96 hour); Aquatic; Invertebrates Hero ID: 3634436 Domain Metric Rating^ MWF* Score Comments^ Domain 5: Outcome Assessment Metric 17: Outcome Assessment Methodology High X 2 2 Metric 18: Consistency of Outcome Assessment High X 1 1 Domain 6: Confounding / Variable Control Metric 19: Confounding Variables in Test Design and High X 2 2 Procedures Metric 20: Outcomes Unrelated to Exposure High X 1 1 Domain 7: Data Presentation and Analysis Metric 21: Statistical Methods High X 1 1 Metric 22: Reporting of Data High X 2 2 Metric 23: Explanation of Unexpected Outcomes High X 1 1 Overall Quality Determination"'" High 1.1 Extracted Yes * MWF = Metric Weighting Factor t High = 1; Medium = 2; Low = 3; Unacceptable = 4; N/A has no value. $ The overall rating is calculated as necessary. EPA may not always provide a comment for a metric that has been categorized as High. if any metric is Unacceptable Overall rating = J]. (Metric Score; x MWF,) / J] . MWFj (round to the nearest tenth) otherwise where High: > 1 to < 1.7; Medium: > 1.7 to < 2.3; Low: > 2.3 to < 3. If the reviewer determines that the overall rating needs adjustment, the original rating is crossed out and an arrow points to the new rating, ft Metrics that are rated 'High' met the criteria for high confidence as expected for this type of study, and may not require additional comments. Page 19 of 27 ------- Study Citation: Geiger, D. L.,Brooke, L. T.,Call, D. J.. 1990. Acute toxicities of organic chemicals to fathead minnows (Pimephales promelas): Volume V. Data Type: Acute (0-96 hour); Aquatic; Fish Hero ID: 3660853 Domain Metric Ratingt MWF* Score Commentstt Domain 1: Test Substance Metric 1 Test Substance Identity High X 2 2 Metric 2 Test Substance Source High X 1 1 Metric 3 Test Substance Purity High X 1 1 Domain 2: Test Design Metric 4 Negative Controls High X 2 2 Metric 5 Negative Control Response High X 1 1 Metric 6 Randomized Allocation High X 1 1 Domain 3: Exposure Characterization Metric 7 Experimental System/Test Media Prepara- High X 2 2 tion Metric 8 Consistency of Exposure Administration High X 1 1 Metric 9 Measurement of Test Substance Concentra- High X 2 2 tion Metric 10: Exposure Duration and Frequency High X 1 1 Metric 11: Number of Exposure Groups/Spacing of Ex- High X 1 1 posure Levels Metric 12: Testing at or Below Solubility Limit High X 1 1 Domain 4: Test Organism Metric 13: Test Organism Characteristics High X 2 2 Metric 14: Acclimitization and Pretreatment Conditions High X 1 1 Metric 15: Number of Organisms and Replicates per High X 1 1 Group Metric 16: Adequacy of Test Conditions High X 1 1 Continued on next page . . . Page 20 of 27 ------- . . .continued from previous page Study Citation: Geiger, D. L.,Brooke, L. T.,Call, D. J.. 1990. Acute toxicities of organic chemicals to fathead minnows (Pimephales promelas): Volume V. Data Type: Acute (0-96 hour); Aquatic; Fish Hero ID: 3660853 Domain Metric Rating^ MWF* Score Comments^ Domain 5: Outcome Assessment Metric 17: Outcome Assessment Methodology High X 2 2 Metric 18: Consistency of Outcome Assessment High X 1 1 Domain 6: Confounding / Variable Control Metric 19: Confounding Variables in Test Design and High X 2 2 Procedures Metric 20: Outcomes Unrelated to Exposure High X 1 1 Domain 7: Data Presentation and Analysis Metric 21: Statistical Methods High X 1 1 Metric 22: Reporting of Data High X 2 2 Metric 23: Explanation of Unexpected Outcomes N/A N/A Overall Quality Determination"'" High 1.0 Extracted Yes * MWF = Metric Weighting Factor t High = 1; Medium = 2; Low = 3; Unacceptable = 4; N/A has no value. $ The overall rating is calculated as necessary. EPA may not always provide a comment for a metric that has been categorized as High. 4 if any metric is Unacceptable Overall rating = J]. (Metric Score; x MWF,) / J] . MWFj (round to the nearest tenth) otherwise where High: > 1 to < 1.7; Medium: > 1.7 to < 2.3; Low: > 2.3 to < 3. If the reviewer determines that the overall rating needs adjustment, the original rating is crossed out and an arrow points to the new rating, ft Metrics that are rated 'High' met the criteria for high confidence as expected for this type of study, and may not require additional comments. Page 21 of 27 ------- Study Citation: R. Johnson, J. Tietge, G. Stokes, D. Lothenbach. 1993. The Medaka Carcinogenesis Model. Data Type: Chronic (>21 days); Aquatic; Fish Hero ID: 3661129 Domain Metric Rating^ MWF* Score Comments^ Domain 1: Test Substance Metric 1: Test Substance Identity High X 2 2 The chemical identity was provided in this study. Metric 2: Test Substance Source Low X 1 3 The manufacturer was not provided. Metric 3: Test Substance Purity Low X 1 3 The purity was not provided for this study. Domain 2: Test Design Metric 4: Negative Controls High X 2 2 Metric 5: Negative Control Response High X 1 1 Metric 6: Randomized Allocation High X 1 1 Domain 3: Exposure Characterization Metric 7: Experimental System/Test Media Prepara- High x 2 tion Metric 8: Consistency of Exposure Administration High x 1 Metric 9: Measurement of Test Substance Concentra- Low x 2 tion Metric 10: Exposure Duration and Frequency High x 1 Metric 11: Number of Exposure Groups/Spacing of Ex- Medium x 1 posure Levels Metric 12: Testing at or Below Solubility Limit N/A Other chemicals were tested. This could have af- fected the choice for not providing this information. Limited information was provided. N/A This test substance is very soluble. Domain 4: Test Organism Metric 13: Test Organism Characteristics High X 2 2 Metric 14: Acclimitization and Pretreatment Conditions High X 1 1 Metric 15: Number of Organisms and Replicates per High X 1 1 Group Metric 16: Adequacy of Test Conditions High X 1 1 Domain 5: Outcome Assessment Continued on next page . . . Page 22 of 27 ------- . continued from previous page Study Citation: R. Johnson, J. Tietge, G. Stokes, D. Lothenbach. 1993. The Medaka Carcinogenesis Model. Data Type: Chronic (>21 days); Aquatic; Fish Hero ID: 3661129 Domain Metric Ratingt MWF* Score Commentstt Metric 17: Outcome Assessment Methodology Metric 18: Consistency of Outcome Assessment High High x 2 x 1 2 1 Domain 6: Confounding / Variable Control Metric 19: Confounding Variables in Test Design and Procedures Metric 20: Outcomes Unrelated to Exposure High High x 2 x 1 2 1 This endpoint is well characterized. Domain 7: Data Presentation and Analysis Metric 21: Statistical Methods Metric 22: Reporting of Data Metric 23: Explanation of Unexpected Outcomes High High N/A x 1 x 2 1 2 N/A Overall Quality Determination"'" High 1.2 Extracted Yes * MWF = Metric Weighting Factor t High = 1; Medium = 2; Low = 3; Unacceptable = 4; N/A has no value. * The overall rating is calculated as necessary. EPA may not always provide a comment for a metric that has been categorized as High. Overall rating = ^ (Metric Score; x MWF;) / ^ MWFj if any metric is Unacceptable (round to the nearest tenth) otherwise where High: > 1 to < 1.7; Medium: > 1.7 to < 2.3; Low: > 2.3 to < 3. If the reviewer determines that the overall rating needs adjustment, the original rating is crossed out and an arrow points to the new rating. ^ Metrics that are rated 'High' met the criteria for high confidence as expected for this type of study, and may not require additional comments. Page 23 of 27 ------- Study Citation: Dow Chemical. 1989. 1,4-Dioxane: Embryo-larval toxicity test with the Fathead minnow, Pimephales promelas Rafinesque. Data Type: Acute (0-96 hour); Aquatic; Fish Hero ID: 4158026 Domain Metric Rating^ MWF* Score Comments^ Domain 1: Test Substance Metric 1 Test Substance Identity High X 2 2 Metric 2 Test Substance Source High X 1 1 Metric 3 Test Substance Purity High X 1 1 Domain 2: Test Design Metric 4 Negative Controls High X 2 2 Metric 5 Negative Control Response High X 1 1 Metric 6 Randomized Allocation High X 1 1 Domain 3: Exposure Characterization Metric 7 Experimental System/Test Media Prepara- High X 2 2 tion Metric 8 Consistency of Exposure Administration High X 1 1 Metric 9 Measurement of Test Substance Concentra- High X 2 2 tion Metric 10: Exposure Duration and Frequency High X 1 1 Metric 11: Number of Exposure Groups/Spacing of Ex- High X 1 1 posure Levels Metric 12: Testing at or Below Solubility Limit High X 1 1 The information was provided for this metric. Domain 4: Test Organism Metric 13: Test Organism Characteristics High X 2 2 Metric 14: Acclimitization and Pretreatment Conditions High X 1 1 Metric 15: Number of Organisms and Replicates per High X 1 1 Group Metric 16: Adequacy of Test Conditions High X 1 1 Domain 5: Outcome Assessment Continued on next page . . . Page 24 of 27 ------- .continued from previous page Study Citation: Dow Chemical. 1989. 1,4-Dioxane: Embryo-larval toxicity test with the Fathead minnow, Pimephales promelas Rafinesque. Data Type: Acute (0-96 hour); Aquatic; Fish Hero ID: 4158026 Domain Metric Ratingt MWF* Score Commentstt Metric 17: Outcome Assessment Methodology High X 2 2 The information was provided for this metric. Metric 18: Consistency of Outcome Assessment High X 1 1 Domain 6: Confounding / Variable Control Metric 19: Confounding Variables in Test Design and High X 2 2 Procedures Metric 20: Outcomes Unrelated to Exposure High X 1 1 Domain 7: Data Presentation and Analysis Metric 21: Statistical Methods High X 1 1 Metric 22: Reporting of Data High X 2 2 Metric 23: Explanation of Unexpected Outcomes N/A N/A Overall Quality Determination"'" High 1.0 Extracted Yes * MWF = Metric Weighting Factor t High = 1; Medium = 2; Low = 3; Unacceptable = 4; N/A has no value. * The overall rating is calculated as necessary. EPA may not always provide a comment for a metric that has been categorized as High. Overall rating = ^ (Metric Score; x MWF;) / ^ MWFj if any metric is Unacceptable (round to the nearest tenth) otherwise where High: > 1 to < 1.7; Medium: > 1.7 to < 2.3; Low: > 2.3 to < 3. If the reviewer determines that the overall rating needs adjustment, the original rating is crossed out and an arrow points to the new rating. ^ Metrics that are rated 'High' met the criteria for high confidence as expected for this type of study, and may not require additional comments. Page 25 of 27 ------- Study Citation: G. Bringman, R. Kuhn. 1977. Limiting values of the harmful action of water endangering substances on bacteria (Pseudomonas putida) and green algae (Scenedesmus quadricauda) in the cell multiplication inhibition test. Zeitschrift fuer Wasser- und Abwasser-Forschung 10:87-98 Data Type: Other; Aquatic; Plants Hero ID: 4438934 Domain Metric Rating^ MWF* Score Comments^ Domain 1: Test Substance Only the chemical name was provided for this study. The source was not reported. The test purity was not reported. Domain 2: Test Design Metric 4: Negative Controls High X 2 2 Metric 5: Negative Control Response High X 1 1 Metric 6: Randomized Allocation High X 1 1 Domain 3: Exposure Characterization Metric 7: Experimental System/Test Media Prepara- High X 2 2 tion Metric 8: Consistency of Exposure Administration High X 1 1 Metric 9: Measurement of Test Substance Concentra- High X 2 2 tion Metric 10: Exposure Duration and Frequency High X 1 1 Metric 11: Number of Exposure Groups/Spacing of Ex- High X 1 1 posure Levels Metric 12: Testing at or Below Solubility Limit High X 1 1 Domain 4: Test Organism Metric 13: Test Organism Characteristics High X 2 2 Metric 14: Acclimitization and Pretreatment Conditions High X 1 1 Metric 15: Number of Organisms and Replicates per High X 1 1 Group Metric 16: Adequacy of Test Conditions High X 1 1 Continued on next page . . . Metric 1: Test Substance Identity Low X 2 6 Metric 2: Test Substance Source Low X 1 3 Metric 3: Test Substance Purity Low X 1 3 Page 26 of 27 ------- . . . continued from previous page Study Citation: Data Type: Hero ID: G. Bringman, R. Kuhn. 1977. Limiting values of the harmful action of water endangering substances on bacteria (Pseudomonas putida) and green algae (Scenedesmus quadricauda) in the cell multiplication inhibition test. Zeitschrift fuer Wasser- und Abwasser-Forschung 10:87-98 Other; Aquatic; Plants 4438934 Domain Metric Rating^ MWF* Score Comments^ Domain 5: Outcome Assessment Metric 17: Outcome Assessment Methodology Metric 18: Consistency of Outcome Assessment High High x 2 x 1 2 1 Domain 6: Confounding / Variable Control Metric 19: Confounding Variables in Test Design and Procedures Metric 20: Outcomes Unrelated to Exposure High High x 2 x 1 2 1 Domain 7: Data Presentation and Analysis Metric 21: Statistical Methods Metric 22: Reporting of Data Metric 23: Explanation of Unexpected Outcomes High Medium N/A x 1 x 2 1 4 Limited information was provided for this metric. N/A Overall Quality Determination"'" High 1.3 Extracted Yes * MWF = Metric Weighting Factor I High = 1; Medium = 2; Low = 3; Unacceptable = 4; N/A has no value. ^ The overall rating is calculated as necessary. EPA may not always provide a comment for a metric that has been categorized as High. Overall rating = (Metric Score; X MWF;) / J] . MWF, if any metric is Unacceptable (round to the nearest tenth) otherwise where High: > 1 to < 1.7; Medium: > 1.7 to < 2.3; Low: > 2.3 to < 3. If the reviewer determines that the overall rating needs adjustment, the original rating is crossed out and an arrow points to the new rating. It Metrics that are rated 'High' met the criteria for high confidence as expected for this type of study, and may not require additional comments. Page 27 of 27 ------- |