EPA United States Office of Chemical Safety and Environmental Protection Agency Pollution Prevention Final Risk Evaluation for Asbestos Part 1: Chrysotile Asbestos Systematic Review Supplemental File: Data Quality Evaluation of Ecological Hazard Studies December 2020 ------- EPA's Office of Pollution Prevention and Toxics (OPPT) developed data quality criteria for ecological hazard studies, presented in the Application of Systematic Review in TSCA Risk Evaluations document (EPA Document #740-P 1-8001). This document presents data quality evaluation results for ecological hazard studies evaluated for the Asbestos Risk Evaluation. Page 2 of 24 ------- Table of Contents HERO Data Type ID 621276 Chronic (>21 days); Aquatic; Plants 3080106 Chronic (>21 days); Aquatic; Plants 3093600 Chronic (>21 days); Aquatic; In- vertebrates 3093856 Chronic (>21 days); Aquatic; In- vertebrates 3584231 Chronic (>21 days); Aquatic; Fish 3585046 Chronic (>21 days); Aquatic; Fish Reference 1 Trivedi, A. K.,Ahmad, I.,Musthapa, M. S.,Ansari, F. A.. 2007. Environmental 4 contamination of chrysotile asbestos and its toxic effects on antioxidative system of Lemna gibba. Archives of Environmental Contamination and Toxicology 52:355-362 Trivedi, A. K.,Ahmad, I.,Musthapa, M. S.,Ansari, F. A.,Rahman, Q.. 2004. En- 7 vironmental contamination of chrysotile asbestos and its toxic effects on growth and physiological and biochemical parameters of Lemna gibba. Archives of Environmental Contamination and Toxicology 47:281-289 Belanger, S. E.,Cherry, D. S.,Cairns J, J. R.. 1986. UPTAKE OF 11 CHRYSOTILE ASBESTOS FIBERS ALTERS GROWTH AND REPRODUC- TION OF ASIATIC CLAMS. Canadian Journal of Fisheries and Aquatic Sci- ences 43:43-52 Belanger, S. E.,Cherry, D. S.,Cairns J, J. R.. 1986. SEASONAL BEHAVIORAL 15 AND GROWTH CHANGES OF JUVENILE CORBICULA-FLUMINEA EX- POSED TO CHRYSOTILE ASBESTOS. Water Research 20:1243-1250 Belanger, S. E.,Schurr, K.,Allen, D. J.,Gohara, A. F.. 1986. Effects of chrysotile 18 asbestos on coho salmon and green sunfish: evidence of behavioral and patho- logical stress. Environmental Research 39:74-85 Belanger, S. E.,Cherry, D. S.,Cairns, J.. 1990. FUNCTIONAL AND PATHO- 22 LOGICAL IMPAIRMENT OF JAPANESE MEDAKA (ORYZIAS-LATIPES) BY LONG-TERM ASBESTOS EXPOSURE. Aquatic Toxicology 17:133-154 Page 3 of 24 ------- Study Citation: Trivedi, A. K.,Ahmad, I.,Musthapa, M. S.,Ansari, F. A.. 2007. Environmental contamination of chrysotile asbestos and its toxic effects on antioxidative system of Lemna gibba. Archives of Environmental Contamination and Toxicology 52:355-362 Data Type: Chronic (>21 days); Aquatic; Plants Hero ID: 621276 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 High Low Low X 2 2 The test substance was identified definitively. X 1 3 Although the test material source not defined there is no indication this impacted the results of the study. X 1 3 Although the purity was not reported, there is no indication that this had an effect on the results. Domain 2: Test Design Metric 4: Negative Controls Medium Metric 5: Negative Control Response Metric 6: Randomized Allocation Medium Low x 2 x 1 x 1 Although aquatic plants used as controls were cul- tured in nutrient mediumwithout chrysotile fiber, they were from the third generation of plants ob- tained from a natural habitat in an aquatic body that was contaminated with asbestos. There are un- certainties (e.g., due to epigenetics) around how the initial exposure to asbestos at the parent generation would affect the plants from the third generation. There were minor uncertainties or limitations re- garding the biological responses of the negative con- trol group(s). Researchers did not report how organisms were al- located to study group. Domain 3: Exposure Characterization Metric 7: Experimental System/Test Media Prepara- Unacceptable x 2 tion The test organisms were cultured in a media contain- ing asbestos, while also being exposed at a rate that is reported in terms of exposure per frond. The au- thors did not provide sufficient detail about the test organisms or exposure regime (ex. how many fronds per plant? Does excess test media applied to fronds enter the test suspension?) to allow the reviewer to confirm the scientific validity of this study. Continued on next page . . . Page 4 of 24 ------- . continued from previous page Study Citation: Trivedi, A. K.,Ahmad, I.,Musthapa, M. S.,Ansari, F. A.. 2007. Environmental contamination of chrysotile asbestos and its toxic effects on antioxidative system of Lemna gibba. Archives of Environmental Contamination and Toxicology 52:355-362 Data Type: Chronic (>21 days); Aquatic; Plants Hero ID: 621276 Domain Metric Rating^ MWF* Score Comments^ Metric 8: Consistency of Exposure Administration Unacceptable x 1 Metric 9: Measurement of Test Substance Concentra- N/A tion Metric 10: Exposure Duration and Frequency High Metric 11: Number of Exposure Groups/Spacing of Ex- Low posure Levels Metric 12: Testing at or Below Solubility Limit N/A x 1 x 1 N/A N/A There were serious flaws in how the aquatic plants were exposed to asbestos. The authors described the test media as containing asbestos, while describ- ing the exposure of asbestos to the fronds. This led the reviewer to question the source of the effects ob- served in this study and whether it was due to as- bestos in the media or the asbestos applied to the frond. In addition, the lack of detail about the pro- cedure used to apply asbestos to the fronds meant that the exposure cannot be adequately understood from the information provided in this study. Exposure concentrations to fronds in the plants were not measured due to the insoluble nature of asbestos fibers. Experiments were carried out for a test duration of 28 days. EPA determined this to be acceptable. There were no Justifications provided for the selec- tion of the test concentrations. Test media was left in suspension because asbestos is an insoluble particle. . Domain 4: Test Organism Metric 13: Test Organism Characteristics Medium x 2 Metric 14: Acclimitization and Pretreatment Conditions Unacceptable x 1 Metric 15: Number of Organisms and Replicates per High Group Metric 16: Adequacy of Test Conditions x 1 Unacceptable x 1 4 There are minor reservations or uncertainties about the source of test organisms. 4 Plants were cultured in a media containing asbestos which may interfere with the ability of the authors to adequately quantify the effects of the test material. 1 The numbers of test organisms and replicates were reported and sufficient to characterize toxicological effects. 4 Plants were cultured in a media containing asbestos in addition to having suspensions containing as- bestos applied to their fronds. Domain 5: Outcome Assessment Metric 17: Outcome Assessment Methodology Low x 2 The results were sufficiently reported, but uncertain- ties regarding the exposure led the reviewer to ques- tion the applicability of the results. Continued on next page . . . Page 5 of 24 ------- . continued from previous page Study Citation: Trivedi, A. K.,Ahmad, I.,Musthapa, M. S.,Ansari, F. A.. 2007. Environmental contamination of chrysotile asbestos and its toxic effects on antioxidative system of Lemna gibba. Archives of Environmental Contamination and Toxicology 52:355-362 Data Type: Chronic (>21 days); Aquatic; Plants Hero ID: 621276 Domain Metric Rating^ MWF* Score Comments^ Metric 18: Consistency of Outcome Assessment Medium X 1 2 There were incomplete reporting of minor details of outcome assessment protocol execution, but these uncertainties or limitations are unlikely to have sub- stantial impact on results. Domain 6: Confounding / Variable Control Metric 19: Confounding Variables in Test Design and Medium X 2 4 The study reported minor differences among the Procedures study groups with respect to environmental con- ditions or other non-treatment-related factors, but these are unlikely to have a substantial impact on results. Metric 20: Outcomes Unrelated to Exposure High X 1 1 There were no differences among groups that could influence the outcome assessment. Domain 7: Data Presentation and Analysis Metric 21: Statistical Methods High X 1 1 Statistical methods were clearly described and ap- propriate for dataset(s). Metric 22: Reporting of Data Unacceptable X 2 8 Results were reported in terms of asbestos applied to each frond, but there were critical details lack- ing about the characteristics of the test organisms, particularly regarding the number of fronds /plant. Metric 23: Explanation of Unexpected Outcomes High X 1 1 There were no unexpected outcomes, or unexpected outcomes were satisfactorily explained. Overall Quality Determination"'" Unacceptable 4.0 Extracted No ** Consistent with our Application of Systematic Review in TSCARisk Evaluations document, if a metric for a data source receives a score of Unacceptable (score = 4), EPA will determine the study to be unacceptable. In this case, five of the metrics were rated as unacceptable. As such, the study is considered unacceptable and the score is presented solely to increase transparency. * 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 24 ------- Study Citation: Trivedi, A. K.,Ahmad, I.,Musthapa, M. S.,Ansari, F. A.,Rahman, Q.. 2004. Environmental contamination of chrysotile asbestos and its toxic effects on growth and physiological and biochemical parameters of Lemna gibba. Archives of Environmental Contamination and Toxicology 47:28f-289 Data Type: Chronic (>21 days); Aquatic; Plants Hero ID: 3080106 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 High Low Low X 2 2 The test substance was identified definitively. X 1 3 Although the test material source not defined there is no indication this impacted the results of the study. X 1 3 Although the purity was not reported, there is no indication that this had an effect on the results. Domain 2: Test Design Metric 4: Negative Controls Medium Metric 5: Negative Control Response Metric 6: Randomized Allocation Medium Low x 2 x 1 x 1 Although aquatic plants used as controls were cul- tured in nutrient mediumwithout chrysotile fiber, they were from the third generation of plants ob- tained from a natural habitat in an aquatic body that was contaminated with asbestos. There are un- certainties (e.g., due to epigenetics) around how the initial exposure to asbestos at the parent generation would affect the plants from the third generation. There were minor uncertainties or limitations re- garding the biological responses of the negative con- trol group(s). Researchers did not report how organisms were al- located to study group. Domain 3: Exposure Characterization Metric 7: Experimental System/Test Media Prepara- Unacceptable x 2 tion The test organisms were cultured in a media contain- ing asbestos, while also being exposed at a rate that is reported in terms of exposure per frond. The au- thors did not provide sufficient detail about the test organisms or exposure regime (ex. how many fronds per plant? Does excess test media applied to fronds enter the test suspension?) to allow the reviewer to confirm the scientific validity of this study. Continued on next page . . . Page 7 of 24 ------- . continued from previous page Study Citation: Trivedi, A. K.,Ahmad, I.,Musthapa, M. S.,Ansari, F. A.,Rahman, Q.. 2004. Environmental contamination of chrysotile asbestos and its toxic effects on growth and physiological and biochemical parameters of Lemna gibba. Archives of Environmental Contamination and Toxicology 47:28f-289 Data Type: Chronic (>21 days); Aquatic; Plants Hero ID: 3080106 Domain Metric Rating^ MWF* Score Comments^ Metric 8: Consistency of Exposure Administration Unacceptable x 1 Metric 9: Measurement of Test Substance Concentra- N/A tion Metric 10: Exposure Duration and Frequency High Metric 11: Number of Exposure Groups/Spacing of Ex- Low posure Levels Metric 12: Testing at or Below Solubility Limit N/A x 1 x 1 N/A N/A There were serious flaws in how the aquatic plants were exposed to asbestos. The authors described the test media as containing asbestos, while describ- ing the exposure of asbestos to the fronds. This led the reviewer to question the source of the effects ob- served in this study and whether it was due to as- bestos in the media or the asbestos applied to the frond. In addition, the lack of detail about the pro- cedure used to apply asbestos to the fronds meant that the exposure cannot be adequately understood from the information provided in this study. Exposure concentrations to fronds in the plants were not measured due to the insoluble nature of asbestos fibers. Experiments were carried out for a test duration of 28 days. EPA determined this to be acceptable. There were no Justifications provided for the selec- tion of the test concentrations. Test media was left in suspension because asbestos is an insoluble particle. Domain 4: Test Organism Metric 13: Test Organism Characteristics Medium x 2 Metric 14: Acclimitization and Pretreatment Conditions Unacceptable x 1 Metric 15: Number of Organisms and Replicates per High Group Metric 16: Adequacy of Test Conditions x 1 Unacceptable x 1 4 There are minor reservations or uncertainties about the source of test organisms. 4 Plants were cultured in a media containing asbestos which may interfere with the ability of the authors to adequately quantify the effects of the test material. 1 The numbers of test organisms and replicates were reported and sufficient to characterize toxicological effects. 4 Plants were cultured in a media containing asbestos in addition to having suspensions containing as- bestos applied to their fronds. Domain 5: Outcome Assessment Continued on next page . . . Page 8 of 24 ------- . . . continued from previous page Study Citation: Data Type: Hero ID: Trivedi, A. K.,Ahmad, I.,Musthapa, M. S.,Ansari, F. A.,Rahman, Q.. 2004. Environmental contamination of chrysotile asbestos and its toxic effects on growth and physiological and biochemical parameters of Lemna gibba. Archives of Environmental Contamination and Toxicology 47:281-289 Chronic (>21 days); Aquatic; Plants 3080106 Domain Metric Rating^ MWF* Score Comments^ Metric 17: Outcome Assessment Methodology Low X 2 6 The results were sufficiently reported, but uncertain- ties regarding the exposure led the reviewer to ques- tion the applicability of the results. Metric 18: Consistency of Outcome Assessment Medium X 1 2 There were incomplete reporting of minor details of outcome assessment protocol execution, but these uncertainties or limitations are unlikely to have sub- stantial impact on results. Domain 6: Confounding / Variable Control Metric 19: Confounding Variables in Test Design and Medium X 2 4 The study reported minor differences among the Procedures study groups with respect to environmental con- ditions or other non-treatment-related factors, but these are unlikely to have a substantial impact on results. Metric 20: Outcomes Unrelated to Exposure High X 1 1 There were no differences among groups that could influence the outcome assessment. Domain 7: Data Presentation and Analysis Metric 21: Statistical Methods High X 1 1 Statistical methods were clearly described and ap- propriate for dataset(s). Metric 22: Reporting of Data Unacceptable X 2 8 Results were reported in terms of asbestos applied to each frond, but there were critical details lack- ing about the characteristics of the test organisms, particularly regarding the number of fronds /plant. Metric 23: Explanation of Unexpected Outcomes High X 1 1 There were no unexpected outcomes, or unexpected outcomes were satisfactorily explained. Overall Quality Determination"'" Unacceptable 4.0 Extracted No Continued on next page . . . Page 9 of 24 ------- . .. continued from previous page Study Citation: Trivedi, A. K.,Ahmad, I.,Musthapa, M. S.,Ansari, F. A.,Rahman, Q.. 2004. Environmental contamination of chrysotile asbestos and its toxic effects on growth and physiological and biochemical parameters of Lemna gibba. Archives of Environmental Contamination and Toxicology 47:281-289 Data Type: Chronic (>21 days); Aquatic; Plants Hero ID: 3080106 Domain Metric Rating^ MWF* Score Comments^ ** Consistent with our Application of Systematic Review in TSCARisk Evaluations document, if a metric for a data source receives a score of Unacceptable (score = 4), EPA will determine the study to be unacceptable. In this case, five of the metrics were rated as unacceptable. As such, the study is considered unacceptable and the score is presented solely to increase transparency. * 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;) / ^ 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. ^ 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 24 ------- Study Citation: Belanger, S. E.,Cherry, D. S.,Cairns J, J. R.. 1986. UPTAKE OF CHRYSOTILE ASBESTOS FIBERS ALTERS GROWTH AND REPRODUCTION OF ASIATIC CLAMS. Canadian Journal of Fisheries and Aquatic Sciences 43:43-52 Data Type: Chronic (>21 days); Aquatic; Invertebrates Hero ID: 3093600 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 High X 2 2 Grade 5 chrysotile asbestos mined ore was used. Low X 1 3 The study authors did not report the specific com- mercial supplier or batch/lot # used to obtain the test substance. Low X 1 3 The study authors mentioned "Grade 5 chrysotile asbestos" was used but did not define what the "Grade 5" represents. Domain 2: Test Design Metric 4: Negative Controls High X 2 2 The study authors used an appropriate concurrent negative control groups for all experiments,. Metric 5: Negative Control Response High X 1 1 The biological responses of the negative control groups were reported and had acceptable variations. Metric 6: Randomized Allocation Low X 1 3 Study authors obtained clams from New River, Vir- ginia and transported these clams to their lab at Virginia Tech. There were no discussions about sep- arating these clams into formal randomized groups. Domain 3: Exposure Characterization Metric 7: Experimental System/Test Media Prepara- High x 2 tion Metric 8: Consistency of Exposure Administration Low x 1 The experimental system and methods for prepara- tion of test media were described in adequate de- tail and appropriately accounted for the physical- chemical properties of the test substance. Specifi- cally, the exposure system used for the asbestos ex- periments kept the asbestos fibers in suspension by employing a raised plexiglass tray above a stir bar. Difficulties with measuring asbestos accurately posed challenges in consistent administration of test substance. Study authors used nominal concen- trations of asbestos in their experiments and men- tioned that the detection limits for all concentra- tions ranged from 1.79E4 to 6.91E4 fibers. However, they tested concentrations up to 10E8. This issue is an inherent challenge to asbestos, a difficult to test chemical. Continued on next page . . . Page 11 of 24 ------- . continued from previous page Study Citation: Belanger, S. E.,Cherry, D. S.,Cairns J, J. R.. 1986. UPTAKE OF CHRYSOTILE ASBESTOS FIBERS ALTERS GROWTH AND REPRODUCTION OF ASIATIC CLAMS. Canadian Journal of Fisheries and Aquatic Sciences 43:43-52 Data Type: Chronic (>21 days); Aquatic; Invertebrates Hero ID: 3093600 Domain Metric Rating^ MWF* Score Comments^ Metric 9: Measurement of Test Substance Concentra- N/A tion Metric 10: Exposure Duration and Frequency High x 1 Metric 11: Number of Exposure Groups/Spacing of Ex- High posure Levels x 1 Metric 12: Testing at or Below Solubility Limit N/A N/A Due to the physical chemical properties and diffi- cult to test nature of asbestos, the nominal values of asbestos are highly variable, i.e., the effect con- centrations reported in this study may misrepresent the actual effect concentrations. Consequently, this metric is not applicable. 1 For the 96-hr and 30 day experiments, the duration of exposures and exposure frequency were reported and appropriate. 1 The number of exposure groups and spacing of expo- sure levels were justified and adequate to observe the short-term and long-term effects of asbestos effects in Corbicula. N/A Asbestos fibers are insoluble in water and organic solvents. The study authors cannot test the asbestos fibers at or below the solubility limit. Domain 4: Test Organism Metric 13: Test Organism Characteristics High x 2 Metric 14: Acclimitization and Pretreatment Conditions High x 1 Metric 15: Number of Organisms and Replicates per Medium x 1 Group The Corbicula test organism was adequately de- scribed and obtained from a reliable source. Cor- bicula was an appropriate test organism to evalu- ate the environmental effects posed by asbestos to aquatic invertebrates for the following four reasons: 1) it resides in every major river system in the U.S and, therefore, is likely to be found within several chrysotile-contaminated waterways; 2) mollusks are known to accumulate asbestos; 3) clams are easy to collect and observe in laboratory environments; and 4) known effects of other toxicants on clams allow comparisons. Clams were acclimatized to laboratory conditions for 1-2 weeks prior to experiments and all pretreatment conditions were the same for control and exposed populations Minor uncertainties or limitations were identified re- garding the number of test organisms and replicates used for each experiments. These uncertainties are unlikely to have a substantial impact on the test re- sults. Continued on next page . . . Page 12 of 24 ------- . continued from previous page Study Citation: Belanger, S. E.,Cherry, D. S.,Cairns J, J. R.. 1986. UPTAKE OF CHRYSOTILE ASBESTOS FIBERS ALTERS GROWTH AND REPRODUCTION OF ASIATIC CLAMS. Canadian Journal of Fisheries and Aquatic Sciences 43:43-52 Data Type: Chronic (>21 days); Aquatic; Invertebrates Hero ID: 3093600 Domain Metric Rating^ MWF* Score Comments^ Metric 16: Adequacy of Test Conditions High x 1 Clams were adequately housed and fed in a specially designed exposure system that employed a raised plexiglass tray above a stir bar that was used to keep the asbestos fibers in suspension. Domain 5: Outcome Assessment Metric 17: Outcome Assessment Methodology High X 2 2 The outcome assessment methodology addressed the intended biological effects. Metric 18: Consistency of Outcome Assessment High X 1 1 Details of the outcome assessment protocol were reported and outcomes were assessed consistently across study groups (e.g., at the same time after ini- tial exposure) using the same protocol in all study groups. Domain 6: Confounding / Variable Control Metric 19: Confounding Variables in Test Design and High X 2 2 There were no reported differences among the study Procedures groups in environmental conditions or other factors that could influence the outcome assessment. Metric 20: Outcomes Unrelated to Exposure High X 1 1 Mortality of adult claims were not observed in the 96-hours experiments and not statistically signifi- cant in the 30-days experiments. Domain 7: Data Presentation and Analysis Metric 21: Statistical Methods High X 1 1 Kruskal-Wallis test used was adequate for test ob- jectives. Statistical methods were clearly described and appropriate for datasets. Metric 22: Reporting of Data High X 2 2 Data for exposure-related findings were presented for each treatment and control group and were ad- equate to determine values for the endpoint(s) of interest. Metric 23: Explanation of Unexpected Outcomes High X 1 1 All unexpected outcomes were satisfactorily ex- plained. Overall Quality Determination"'" High 1.3 Extracted Yes Continued on next page . . . Page 13 of 24 ------- . continued from previous page Study Citation: Belanger, S. E.,Cherry, D. S.,Cairns J, J. R.. 1986. UPTAKE OF CHRYSOTILE ASBESTOS FIBERS ALTERS GROWTH AND REPRODUCTION OF ASIATIC CLAMS. Canadian Journal of Fisheries and Aquatic Sciences 43:43-52 Data Type: Chronic (>21 days); Aquatic; Invertebrates Hero ID: 3093600 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;) / ^ 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 14 of 24 ------- Study Citation: Belanger, S. E.,Cherry, D. S.,Cairns J, J. R.. 1986. SEASONAL BEHAVIORAL AND GROWTH CHANGES OF JUVENILE CORBICULA-FLUMINEA EXPOSED TO CHRYSOTILE ASBESTOS. Water Research 20:1243-1250 Data Type: Chronic (>21 days); Aquatic; Invertebrates Hero ID: 3093856 Domain Metric Rating^ MWF* Score Comments^ Domain 1: Test Substance Metric 1: Test Substance Identity High X 2 2 Chrysotile asbestos Metric 2: Test Substance Source Low X 1 3 Source of asbestos not specified Metric 3: Test Substance Purity High X 1 1 Test is conducted with a fiber; Asbestos fiber stocks used in exposures were prepared by lightly milling 400 mg of asbestos, followed by sonicating 500 ml of a 0.060mgl -j chrysotile stock for 2h with a Fisher ul- trasonic cleaner to eliminate large blocks and cleav- age fragments. Micrographs were taken of the first 15-25 fibers encountered and subsequently measured for length, width and aspect ratio. Domain 2: Test Design Metric 4 Metric 5 Metric 6 Negative Controls Negative Control Response Randomized Allocation High High Medium x 2 x 1 x 1 randomization procedure not specified, no evidence that this affected the results of the study Domain 3: Exposure Characterization Metric 7: Experimental System/Test Media Prepara- High x 2 tion Metric 8: Consistency of Exposure Administration High x 1 Asbestos fiber stocks used in exposures were pre- pared by lightly milling 400 mg of asbestos, followed by sonicating 500 ml of a 0.060mgl -j chrysotile stock for 2h with a Fisher ultrasonic cleaner to eliminate large blocks and cleavage fragments. Suspension of asbestos fibers was maintained through magnetic stirring. Clams were exposed to 0, 102, 104, 105, 106 and 108 fibers -1 m chrysotile asbestos, aquaria situated above a magnetic stirrer that kept asbestos in sus- pension. Continued on next page . . . Page 15 of 24 ------- . . . continued from previous page Study Citation: Belanger, S. E.,Cherry, D. S.,Cairns J, J. R.. 1986. SEASONAL BEHAVIORAL AND GROWTH CHANGES OF JUVENILE CORBICULA-FLUMINEA EXPOSED TO CHRYSOTILE ASBESTOS. Water Research 20:1243-1250 Data Type: Chronic (>21 days); Aquatic; Invertebrates Hero ID: 3093856 Domain Metric Rating^ MWF* Score Comments^ Metric 9: Measurement of Test Substance Concentra- High tion Metric 10: Exposure Duration and Frequency High Metric 11: Number of Exposure Groups/Spacing of Ex- High posure Levels Metric 12: Testing at or Below Solubility Limit N/A x 2 x 1 x 1 Asbestos fiber concentrations in water were deter- mined by the TEM method described above except that water samples were directly filtered onto Nude- pore filters. Background and blanks were processed simultaneously. Measured asbestos concentration for 0, 102, 104, 105, 106 and 108 fibers/L were below detection at 0, 104, 5.7 x 105, 1.3 x 107 and2.1 " 108 fibers/L, respectively. 30-day exposure N/A Insoluble fiber maintained in a suspension Domain 4: Test Organism Metric 13: Test Organism Characteristics Medium x 2 Metric 14: Acclimitization and Pretreatment Conditions High x 1 Metric 15: Number of Organisms and Replicates per High x 1 1 Group Metric 16: Adequacy of Test Conditions High x 1 1 Juvenile Corbicula (5.2-8.6 mm shell length) were collected from the New River, Va, by dip net adja- cent to an industrial pumphouse station (Celanese Fibers Corp., Narrows, Va). It was uncertain if the collection site was polluted, but the controls showed no ill effects, or accumulated fibers so it was assumed that this collection site was appropriate. Juvenile clams were sorted from adults and sed- iment in the field and returned to Virginia Tech where they were acclimated to constant tempera- ture ( 20"C)laboratory conditions for 7 days in 40-1. aquaria. 10 clams/group Groups of 10 clams were placed in a raised plexiglass platform of 315 cm2 surface area in each tank. Domain 5: Outcome Assessment Metric 17: Outcome Assessment Methodology Metric 18: Consistency of Outcome Assessment High High x 2 x 1 Domain 6: Confounding / Variable Control Continued on next page . . . Page 16 of 24 ------- . continued from previous page Study Citation: Belanger, S. E.,Cherry, D. S.,Cairns J, J. R.. 1986. SEASONAL BEHAVIORAL AND GROWTH CHANGES OF JUVENILE CORBICULA-FLUMINEA EXPOSED TO CHRYSOTILE ASBESTOS. Water Research 20:1243-1250 Data Type: Chronic (>21 days); Aquatic; Invertebrates Hero ID: 3093856 Domain Metric Rating^ MWF* Score Comments^ 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 Metric 22: Reporting of Data Metric 23: Explanation of Unexpected Outcomes High High x 1 x 2 x 1 Nonparametric statistical techniques were applied in allanalyses. The one-way analysis of variance rank- analogue,the Kruskal-Wallis Test, was used for one- way layout data. If significant differences were indi- cated ( = 0.05), a rank-like Least Significant Differ- ences Procedure was used to determine the relation- ships betweengroups. In cases of two sample data (e.g. planimetricanalysis of gill tissue), Wilcoxon's Rank Sum Test was usedto test differences between groups 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. 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 17 of 24 ------- Study Citation: Belanger, S. E.,Schurr, K.,Allen, D. J.,Gohara, A. F.. 1986. Effects of chrysotile asbestos on coho salmon and green sunfish: evidence of behavioral and pathological stress. Environmental Research 39:74-85 Data Type: Chronic (>21 days); Aquatic; Fish Hero ID: 3584231 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 High X 2 2 Asbestos was in the form of mined chrysotile. Medium X 1 2 Asbestos used in this study was a gift from a major asbestos producer. Low X 1 3 Purity and/or grade of test substance were not re- ported. The test chemical was in the form of mined chrysotile. Domain 2: Test Design Metric 4: Negative Controls Metric 5: Negative Control Response Metric 6: Randomized Allocation High X 2 2 Study authors reported using an appropriate con- current negative control group. High X 1 1 The biological responses of the negative control group(s) were adequate (e.g., mortality of control fish "20 percent in the chronic tests). High X 1 1 The study reported that organisms were randomly allocated into study groups. Domain 3: Exposure Characterization Metric 7: Experimental System/Test Media Prepara- High x 2 tion Metric 8: Consistency of Exposure Administration High Metric 9: Measurement of Test Substance Concentra- N/A tion Metric 10: Exposure Duration and Frequency High x 1 x 1 2 The experimental system and methods for prepara- tion of test media were described in adequate de- tail and appropriately accounted for the physical- chemical properties of the test substance. 1 Test organisms were consistently dosed with as- bestos (i.e., only once at the beginning of the ex- periment). N/A Nominal values are highly uncertain due to the na- ture of the test substance. As a result, the effect concentrations reported in this study may misrepre- sent the actual effect concentrations. 1 Test organisms were dosed with asbestos only once at the beginning of the experiment. This is sufficient because asbestos fibers are insoluble and the possi- bility of the fibers degrading during the experiment is low. The length of exposure was adequate for the objectives of the experiments. Continued on next page . . . Page 18 of 24 ------- . continued from previous page Study Citation: Belanger, S. E.,Schurr, K.,Allen, D. J.,Gohara, A. F.. 1986. Effects of chrysotile asbestos on coho salmon and green sunfish: evidence of behavioral and pathological stress. Environmental Research 39:74-85 Data Type: Chronic (>21 days); Aquatic; Fish Hero ID: 3584231 Domain Metric Rating^" MWF* Score Comments^ Metric 11: Number of Exposure Groups/Spacing of Ex- High posure Levels Metric 12: Testing at or Below Solubility Limit N/A X 1 1 Two levels of exposure were used (i.e., 1.5E6 and 3E6 fibers/liter). These concentrations are similar to concentrations found in many aquatic environ- ments at the time of the study. N/A Asbestos fibers are insoluble in water and organic solvents. Nominal values are highly uncertain due to the nature of the test substance. The effect concen- trations reported in these studies may misrepresent the actual effect concentrations. Domain 4: Test Organism Metric 13: Test Organism Characteristics High x 2 Metric 14: Acclimitization and Pretreatment Conditions High x 1 Metric 15: Number of Organisms and Replicates per Medium x 1 Group Metric 16: Adequacy of Test Conditions High x 1 This study was designed to evaluate the effects of chrysotile asbestos on recentlyhatched coho salmon larvae (Oncorhynchus kisutch) and juvenile green- sunfish (Lepomis cyanellus). These species and life stages were chosen due tothe importance of salmonids (e.g., coho) in the Great Lakes ecosys- tem and theprobable susceptibility of young fish to asbestos intoxication. The test organisms were ade- quately described and were obtained from a reliable source. Fish were allowed to acclimate for 5 days at room temperature (20.0 + 2.0"C) and were randomly di- vided into six groups of 20 fish each. The test or- ganisms were acclimatized to test conditions and all pretreatment conditions were the same for control and exposed populations, such that the only differ- ence was exposure to test substance. The numbers of test organisms and replicates were sufficient to characterize toxicological effects, but minor uncertainties or limitations were identified re- garding the number of test organisms and/or repli- cates that are unlikely to have a substantial impact on results. Organism housing, environmental conditions, food, water, and nutrients were conducive to maintenance of health and biomass loading was appropriate. Domain 5: Outcome Assessment Continued on next page . . . Page 19 of 24 ------- . continued from previous page Study Citation: Belanger, S. E.,Schurr, K.,Allen, D. J.,Gohara, A. F.. 1986. Effects of chrysotile asbestos on coho salmon and green sunfish: evidence of behavioral and pathological stress. Environmental Research 39:74-85 Data Type: Chronic (>21 days); Aquatic; Fish Hero ID: 3584231 Domain Metric Rating^ MWF* Score Comments^ Metric 17: Outcome Assessment Methodology Metric 18: Consistency of Outcome Assessment High x 2 Medium x 1 The outcome assessment methodology addressed or reported the intended outcome(s) of interest and was sensitive for the outcomes(s) of interest. Details of the outcome assessment protocol were re- ported but the outcomes were not assessed consis- tently across study. The experiments with higher concentrations of asbestos occurred for a lesser du- ration compare to the experiments with lower con- centrations of asbestos. Domain 6: Confounding / Variable Control Metric 19: Confounding Variables in Test Design and High x 2 Procedures Metric 20: Outcomes Unrelated to Exposure Medium x 1 There were no reported differences among the study groups in environmental conditions or other factors that could influence the outcome assessment. Data on attrition and/or outcomes unrelated to ex- posure were not reported for each study group, but this deficiency is not likely to have a substantial im- pact on results. Domain 7: Data Presentation and Analysis Metric 21: Statistical Methods Metric 22: Reporting of Data Metric 23: Explanation of Unexpected Outcomes High X 1 1 Statistical methods were clearly described and ap- propriate for dataset(s). High X 2 2 Data for exposure-related findings were presented for each treatment and control group and were ade- quate to determine values for the endpoint(s) of in- terest. Negative findings were reported qualitatively or quantitatively. High X 1 1 There were no unexpected outcomes, or unexpected outcomes were satisfactorily explained. Overall Quality Determination"'" High 1.2 Extracted Yes Continued on next page . . . Page 20 of 24 ------- . continued from previous page Study Citation: Belanger, S. E.,Schurr, K.,Allen, D. J.,Gohara, A. F.. 1986. Effects of chrysotile asbestos on coho salmon and green sunfish: evidence of behavioral and pathological stress. Environmental Research 39:74-85 Data Type: Chronic (>21 days); Aquatic; Fish Hero ID: 3584231 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;) / ^ 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 21 of 24 ------- Study Citation: Belanger, S. E.,Cherry, D. S.,Cairns, J.. 1990. FUNCTIONAL AND PATHOLOGICAL IMPAIRMENT OF JAPANESE MEDAKA (ORYZIAS-LATIPES) BY LONG-TERM ASBESTOS EXPOSURE. Aquatic Toxicology 17:133-154 Data Type: Chronic (>21 days); Aquatic; Fish Hero ID: 3585046 Domain Metric Rating^ MWF* Score Comments^ Domain 1: Test Substance Metric 1: Test Substance Identity Metric 2: Test Substance Source Metric 3: Test Substance Purity Medium x 2 Low x 1 Low x 1 Study authors mentioned "Grade 5 chrysotile as- bestos" but did not define what the "Grade 5" means. Study authors did not report the specific commer- cial supplier or batch/lot # used to obtain the test substance. In addition, they only used nominal con- centrations of asbestos in their experiments. Purity and/or grade of test substance were not re- ported. Domain 2: Test Design Metric 4: Negative Controls Metric 5: Negative Control Response Metric 6: Randomized Allocation High x 2 High x 1 Medium x 1 Study authors reported using an appropriate concur- rent negative control group (i.e., all conditions equal except chemical exposure). The biological responses of the negative control group(s) were adequate (e.g., mortality of control fish "20 percent in the chronic tests). The study reported methods of allocation of organ- isms to study groups, but there were minor limita- tions in the allocation method. Domain 3: Exposure Characterization Metric 7: Experimental System/Test Media Prepara- High x 2 tion Metric 8: Consistency of Exposure Administration High x 1 The experimental system and methods for prepara- tion of test media were described in adequate de- tail and appropriately accounted for the physical- chemical properties of the test substance. Water and asbestos were completely changed every other week and loading (wet weight of fish per liter) did not exceed 0.33 g/1. Analyses of asbestos concen- trations were performed before and after one water exchange every 4 weeks for 4 months of exposures, and 1 month of recovery following exposure (n = 20 for each concentration). Details of exposure administration were reported and exposures were administered consistently across study groups. Continued on next page . . . Page 22 of 24 ------- . continued from previous page Study Citation: Belanger, S. E.,Cherry, D. S.,Cairns, J.. 1990. FUNCTIONAL AND PATHOLOGICAL IMPAIRMENT OF JAPANESE MEDAKA (ORYZIAS-LATIPES) BY LONG-TERM ASBESTOS EXPOSURE. Aquatic Toxicology 17:133-154 Data Type: Chronic (>21 days); Aquatic; Fish Hero ID: 3585046 Domain Metric Rating^ MWF* Score Comments^ Metric 9: Measurement of Test Substance Concentra- N/A tion Metric 10: Exposure Duration and Frequency High Metric 11: Number of Exposure Groups/Spacing of Ex- High posure Levels Metric 12: Testing at or Below Solubility Limit N/A N/A Nominal values are highly uncertain due to the na- ture of the test substance. As a result, the effect concentrations reported in this study may misrepre- sent the actual effect concentrations. X 1 1 The duration of exposure and/or exposure frequency were reported and appropriate for the study type and/or outcome(s) of interest. X 1 1 The number of exposure groups and spacing of ex- posure levels were justified by study authors and ad- equate to address the purpose of the study N/A Asbestos fibers are insoluble in water and organic solvents. Nominal values are highly uncertain due to the nature of the test substance. The effect concen- trations reported in these studies may misrepresent the actual effect concentrations. Domain 4: Test Organism Metric 13: Test Organism Characteristics High Metric 14: Acclimitization and Pretreatment Conditions High Metric 15: Number of Organisms and Replicates per High Group Metric 16: Adequacy of Test Conditions High x 2 x 1 x 1 x 1 The test organisms were adequately described and were obtained from a reliable source. The test species, strain, sex, age, size, life stage, and/or em- bryonic stage of the test organisms reported and appropriate for the evaluation of the specific out- come^) of interest The test organisms were acclimatized to test condi- tions and all pretreatment conditions were the same for control and exposed populations, such that the only difference was exposure to test substance. The numbers of test organisms and replicates were reported and sufficient to characterize toxicological effects. Organism housing, environmental conditions, food, water, and nutrients were conducive to maintenance of health and biomass loading was appropriate. Domain 5: Outcome Assessment Metric 17: Outcome Assessment Methodology High x 2 The outcome assessment methodology addressed or reported the intended outcome(s) of interest and was sensitive for the outcomes(s) of interest. Continued on next page . . . Page 23 of 24 ------- . continued from previous page Study Citation: Belanger, S. E.,Cherry, D. S.,Cairns, J.. 1990. FUNCTIONAL AND PATHOLOGICAL IMPAIRMENT OF JAPANESE MEDAKA (ORYZIAS-LATIPES) BY LONG-TERM ASBESTOS EXPOSURE. Aquatic Toxicology 17:133-154 Data Type: Chronic (>21 days); Aquatic; Fish Hero ID: 3585046 Domain Metric Rating^ MWF* Score Comments^ Metric 18: Consistency of Outcome Assessment High x 1 Details of the outcome assessment protocol were reported and outcomes were assessed consistently across study groups (e.g., at the same time after ini- tial exposure) using the same protocol in all study groups. Domain 6: Confounding / Variable Control Metric 19: Confounding Variables in Test Design and High x 2 Procedures Metric 20: Outcomes Unrelated to Exposure Medium x 1 2 There were no reported differences among the study groups in environmental conditions or other factors that could influence the outcome assessment. 2 Data on attrition and/or outcomes unrelated to ex- posure were not reported for each study group, but this deficiency is not likely to have a substantial im- pact on results. Domain 7: Data Presentation and Analysis Metric 21: Statistical Methods High X 1 1 Statistical methods were clearly described and ap- propriate for dataset(s) (e.g., ANOVA). Metric 22: Reporting of Data High X 2 2 Data for exposure-related findings were presented for each treatment and control group and were ade- quate to determine values for the endpoint(s) of in- terest. Negative findings were reported qualitatively or quantitatively. Metric 23: Explanation of Unexpected Outcomes High X 1 1 There were no unexpected outcomes, or unexpected outcomes were satisfactorily explained. 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 24 of 24 ------- |