PEER REVIEW DRAFT, DO NOT CITE OR QUOTE United States Office of Chemical Safety and LhI Jl^lk. Environmental Protection Agency Pollution Prevention Risk Evaluation for 1,4-Dioxane Systematic Review Supplemental File: Data Quality Evaluation of Environmental Hazard Studies CASRN: 123-91-1 June 2019 ------- PEER REVIEW DRAFT, DO NOT CITE OR QUOTE Table of Contents Table No. Hero ID. End- point(s) Reference Page Number 1 18670 Aquatic Vertebrates Dawson, G. W., Jennings, A. L., Drozdowski, D., Rider, E. The acute toxicity of 47 industrial chemicals to fresh and saltwater fishes. Journal of Hazardous Materials. 1977. 1 2 3616460 Aquatic Invertebrates 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) 3 23 51735 Aquatic Plants 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 5 4 73652 Aquatic Invertebrates G. Bringmann, R. Kuhn. 1977. The effects of water pollutants on Daphnia magna. Wasser und Abwasser in Forschung und Praxis 10:161-166 7 5 3616460 Aquatic Invertebrates 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) 9 6 3634436 Aquatic Invertebrates and Vertebrates Brooke, L. 1987. Report of the Flow-Through and Static Acute Test Comparisons with Fathead Minnows and Acute Tests with Amphipod and a Cladoceran. 11 7 3660853 Aquatic Vertebrates Geiger, D. L., Brooke, L. T., Call, D. J. 1990. Acute toxicities of organic chemicals to fathead minnows (Pimephales promelas)'. Volume V. 13 8 3661129 Aquatic Vertebrates R. Johnson, J. Tietge, G. Stokes, D. Lothenbach. 1993. The Medaka Carcinogenesis Model. 15 9 4158026 Aquatic Vertebrates Dow Chemical. 1989. 1,4-Dioxane: Embryo-larval toxicity test with the Fathead minnow, Pimephales promelas Ra nesque. 17 12 4438934 Aquatic Plants 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 19 ------- PEER REVIEW DRAFT, DO NOT CITE OR QUOTE 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^ 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 Negative Controls High X 2 2 Metric 5 Negative Control Response High X 1 1 Metric 6 Randomized Allocation Medium 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 limited information provided tion Metric 8: Consistency of Exposure Administration High X 1 1 Metric 9 Measurement of Test Substance Concentra- High X 1 1 tion Metric 10: Exposure Duration and Frequency High X 2 2 Information was provided for this metric. Metric 11: Number of Exposure Groups/Spacing of Ex- Low X 1 3 No information was reported; however, an LC50 was posure Levels derived. 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 Medium X 1 2 Limited info provided 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 Continued on next page 1 of 20 ------- PEER REVIEW DRAFT, DO NOT CITE OR QUOTE . . . 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^ 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;) / ]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. Ifthe reviewer determines that the overall rating needs adjustment, the original rating is crossed out and an arrow points to the new rating. This metric met the criteria for high confidence as expected for this type of study. 2 of 20 ------- PEER REVIEW DRAFT, DO NOT CITE OR QUOTE 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 1 1 The information for this metric was provided in the tion report. Metric 10: Exposure Duration and Frequency High X 2 2 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 Domain 5: Outcome Assessment Metric 17: Outcome Assessment Methodology High X 2 2 Continued on next page . . . 3 of 20 ------- PEER REVIEW DRAFT, DO NOT CITE OR QUOTE . . . 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 18: Consistency of Outcome Assessment High X 1 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;) / 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. Ifthe reviewer determines that the overall rating needs adjustment, the original rating is crossed out and an arrow points to the new rating. This metric met the criteria for high confidence as expected for this type of study. 4 of 20 ------- PEER REVIEW DRAFT, DO NOT CITE OR QUOTE 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 Ratingt MWF* Score Commentstt 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 2 tion Metric 8 Consistency of Exposure Administration High x 1 1 Metric 9 Measurement of Test Substance Concentra- High x 1 1 tion Metric 10: Exposure Duration and Frequency High x 2 2 Metric 11: Number of Exposure Groups/Spacing of Ex- High x 1 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: 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 N/A N/A Domain 5: Outcome Assessment Metric 17: Outcome Assessment Methodology High x 2 2 Continued on next page . . . 5 of 20 ------- PEER REVIEW DRAFT, DO NOT CITE OR QUOTE . . . 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 Data Type: Other; Aquatic; Plants Hero ID: 51735 Domain Metric Ratingt MWF* Score Commentstt Metric 18: Consistency of Outcome Assessment High X 1 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 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] . 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. Ifthe reviewer determines that the overall rating needs adjustment, the original rating is crossed out and an arrow points to the new rating. This metric met the criteria for high confidence as expected for this type of study. 6 of 20 ------- PEER REVIEW DRAFT, DO NOT CITE OR QUOTE 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 Rating^ MWF* Score Comments^ 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 1 3 No information was provided for this metric. tion Metric 10: Exposure Duration and Frequency High X 2 2 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 Domain 5: Outcome Assessment Continued on next page . . . 7 of 20 ------- PEER REVIEW DRAFT, DO NOT CITE OR QUOTE . . . continued from previous page 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 Rating^ MWF* Score Comments^ Metric 17: Outcome Assessment Methodology High X 2 2 This metric was completely characterized. 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 Low X 1 3 No statistical methods were provided. 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 * 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] . 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. Ifthe reviewer determines that the overall rating needs adjustment, the original rating is crossed out and an arrow points to the new rating. This metric met the criteria for high confidence as expected for this type of study. 8 of 20 ------- PEER REVIEW DRAFT, DO NOT CITE OR QUOTE 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^ 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- High X 2 2 tion Metric 8: Consistency of Exposure Administration High X 1 1 Metric 9: Measurement of Test Substance Concentra- High X 1 1 tion 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- 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 N/A N/A Continued on next page . . . 9 of 20 ------- PEER REVIEW DRAFT, DO NOT CITE OR QUOTE . . . 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 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 * 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;) / ]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. Ifthe reviewer determines that the overall rating needs adjustment, the original rating is crossed out and an arrow points to the new rating. This metric met the criteria for high confidence as expected for this type of study. 10 of 20 ------- PEER REVIEW DRAFT, DO NOT CITE OR QUOTE 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 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 1 1 tion Metric 10: Exposure Duration and Frequency High X 2 2 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 Domain 5: Outcome Assessment Metric 17: Outcome Assessment Methodology High X 2 2 Metric 18: Consistency of Outcome Assessment High X 1 1 Continued on next page . . . 11 of 20 ------- PEER REVIEW DRAFT, DO NOT CITE OR QUOTE . . . 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 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 = (Metric Score; X MWF;) / J] . MWF, (round to the nearest tenth) otherwise where High=> 1 to < 1.7; Medium => 1.7 to < 2.3; Low => 2.3 to <= 3. Ifthe reviewer determines that the overall rating needs adjustment, the original rating is crossed out and an arrow points to the new rating. tt This metric met the criteria for high confidence as expected for this type of study. 12 of 20 ------- PEER REVIEW DRAFT, DO NOT CITE OR QUOTE 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 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 1 1 tion Metric 10: Exposure Duration and Frequency High X 2 2 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 Domain 5: Outcome Assessment Metric 17: Outcome Assessment Methodology High X 2 2 Metric 18: Consistency of Outcome Assessment High X 1 1 Continued on next page . . . 13 of 20 ------- PEER REVIEW DRAFT, DO NOT CITE OR QUOTE . . . 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 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;) / 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. Ifthe reviewer determines that the overall rating needs adjustment, the original rating is crossed out and an arrow points to the new rating. tt This metric met the criteria for high confidence as expected for this type of study. 14 of 20 ------- PEER REVIEW DRAFT, DO NOT CITE OR QUOTE 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 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 2 tion Metric 8: Consistency of Exposure Administration High X 1 1 Metric 9 Measurement of Test Substance Concentra- Low X 1 3 Other chemicals were tested. This could have af- tion fected the choice for not providing this information. Metric 10: Exposure Duration and Frequency High X 2 2 Metric 11: Number of Exposure Groups/Spacing of Ex- Medium X 1 2 Limited information was provided. posure Levels Metric 12: Testing at or Below Solubility Limit N/A 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 Metric 17: Outcome Assessment Methodology High X 2 2 Metric 18: Consistency of Outcome Assessment High X 1 1 Domain 6: Confounding / Variable Control Continued on next page . . . 15 of 20 ------- PEER REVIEW DRAFT, DO NOT CITE OR QUOTE . . . continued from previous page Study Citation: Data Type: Hero ID: R. Johnson, J. Tietge, G. Stokes, D. Lothenbach. 1993. The Medaka Carcinogenesis Model. Chronic (>21 days); Aquatic; Fish 3661129 Domain Metric Ratingt MWF* Score Commentstt Metric 19: Metric 20: Confounding Variables in Test Design and High Procedures Outcomes Unrelated to Exposure High X 2 2 X 1 1 This endpoint is well characterized. 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 1.2 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. 4 if any metric is Unacceptable Overall rating = (Metric Score; X MWF;) / J] . MWF, (round to the nearest tenth) otherwise where High=> 1 to < 1.7; Medium => 1.7 to < 2.3; Low => 2.3 to <= 3. Ifthe reviewer determines that the overall rating needs adjustment, the original rating is crossed out and an arrow points to the new rating. tt This metric met the criteria for high confidence as expected for this type of study. 16 of 20 ------- PEER REVIEW DRAFT, DO NOT CITE OR QUOTE 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 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 1 1 tion Metric 10: Exposure Duration and Frequency High X 2 2 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 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 Continued on next page . . . 17 of 20 ------- PEER REVIEW DRAFT, DO NOT CITE OR QUOTE . . . 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 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 Metric 22 Metric 23 Statistical Methods High x 1 1 Reporting of Data High x 2 2 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 = (Metric Score; X MWF;) / J] . MWF, (round to the nearest tenth) otherwise where High=> 1 to < 1.7; Medium => 1.7 to < 2.3; Low => 2.3 to <= 3. Ifthe reviewer determines that the overall rating needs adjustment, the original rating is crossed out and an arrow points to the new rating. tt This metric met the criteria for high confidence as expected for this type of study. 18 of 20 ------- PEER REVIEW DRAFT, DO NOT CITE OR QUOTE 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 1: Test Substance Metric 1 Test Substance Identity Low x 2 6 Only the chemical name was provided for this study. Metric 2 Test Substance Source Low x 1 3 The 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 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 1 1 tion Metric 10: Exposure Duration and Frequency High x 2 2 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 Domain 5: Outcome Assessment Metric 17: Outcome Assessment Methodology High x 2 2 Metric 18: Consistency of Outcome Assessment High x 1 1 Continued on next page . . . 19 of 20 ------- PEER REVIEW DRAFT, DO NOT CITE OR QUOTE . . . continued from previous page 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 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 Medium x 2 4 Limited information was provided for this metric. Metric 23: Explanation of Unexpected Outcomes N/A 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. if any metric is Unacceptable Overall rating = (Metric Score; X MWF;) / ]T\ MWF, (round to the nearest tenth) otherwise where High=> 1 to < 1.7; Medium => 1.7 to < 2.3; Low => 2.3 to <= 3. Ifthe reviewer determines that the overall rating needs adjustment, the original rating is crossed out and an arrow points to the new rating. U This metric met the criteria for high confidence as expected for this type of study. 20 of 20 ------- |