 |
Frog Embryo Teratogenesis Assay--Xenopus Background Review Document |
|
| |
|
Frog Embryo Teratogenesis Assay--Xenopus Background Review Document |
|
| |
Table of ContentsComplete BRD in PDF FormatDownload Adobe Acrobat Reader Title Page Acknowledgements Table of Contents List of Tables List of Figures List of Appendices List of Abbreviations and Acronyms Executive Summary General Introduction FETAX FOR HUMAN DEVELOPMENTAL HAZARD IDENTIFICATION1.0 Introduction and Rationale of FETAX 2.0 FETAX Test Method Protocol 3.0 Characterization of Substances Tested in FETAX 4.0 Reference Data Used for an Assessment of FETAX Performance Characteristics 5.0 FETAX Test Method Data and Results 6.0 6.0 Performance Characteristics of FETAX 7.0 Test Method Reliability (Repeatability/Reproducibility) 9.0 Other Scientific Reports and Reviews 10.0 Animal Welfare Considerations 11.0 Other Considerations FETAX FOR ECOTOXOLOGICAL HAZARD ASSESSMENT USING WATER/SOIL/SEDIMENT SAMPLES13.0 FETAX Test Method Protocol 14.0 Characterization of Environmental Water/Soil/Sediment Samples Tested in FETAX 15.0 Reference Data Used for an Assessment of FETAX Performance Characteristics 16.0 FETAX Test Method Data and Results 17.0 Performance Characteristics of FETAX with Water/Soil/Sediment Samples 18.0 Test Method Reliability (Repeatability/Reproducibility) 20.0 Other Scientific Reports and Reviews 21.0 Animal Welfare Considerations 22.0 Other Considerations 23.0 Other Applications for Xenopus 24.0 References AppendicesAppendix 1Chemical and Product Class Information for Substances Tested in FETAX Appendix 2 Study Results for substances Tested in FETAX, without Metabolic Activation, excluding Environmental Samples Appendix 3 Study Results for substances Tested in FETAX, with Metabolic Activation, excluding Environmental Samples Appendix 4 Laboratory Mammal and Human Teratogenicity Data for Substances Tested in FETAX Appendix 5 Calls Used by NICEATM in the Assessments of the Performance Characteristics of FETAX Appendix 6 Substances Tested in FETAX in Multiple Laboratories or Studies, excluding Environmental Samples Appendix 7 Test Method Reliability (Repeatability and Reproducibility) Assessed for the FETAX Validation Studies using ASTM E691-92: Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method FETAX Validation Study Phase I FETAX Validation Study Phase II FETAX Validation Study Phase III.1 FETAX Validation Study Phase III.2 FETAX Validation Study Phase III.3 Appendix 8 Environmental Samples Tested in FETAX Appendix 9 U.S. EPA Letter Requesting that ICCVAM Evaluate the Validation Status of FETAX Appendix 10 ASTM E1439-91: Standard Guide for Conducting the Frog Embryo Teratogenesis Assay-Xenopus (FETAX) [Please see Appendix 11, ASTM E1439-98] Appendix 11 ASTM E1439-98: Standard Guide for Conducting the Frog Embryo Teratogenesis Assay-Xenopus (FETAX) [Priced Publication] Appendix 12 ASTM E691-92: Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method [Priced Publication - this link for E691-99] Appendix 13 Guidelines for Developmental Toxicity Risk Assessment. Federal Register 56(231):63798-63826 - U.S. EPA. 1991. Appendix 14 U.S. EPA Whole Effluent Toxicity: Guidelines Establishing Test Procedures for the Analysis of Pollutants Appendix 15 Evaluation of the Validation Status of Toxicological Methods: General Guidelines for Submissions to the Interagency Coordinating Committee on the Validation of Alternative Methods, NIH Publication No. 99-4496; rev. Oct. 20, 1999 Appendix 16 Bantle, J.A., D.T. Burton, D.A. Dawson, J.N. Dumont, R.A. Finch, D.J. Fort, G. Linder, J.R. Rayburn, D. Buchwalter, M.A. Maurice, and S.D. Turley. 1994. Initial interlaboratory validation study of FETAX: Phase I testing. J. Appl. Toxicol. 14:213-223 [reference only] Appendix 17 Bantle, J.A., D.T. Burton, D.A. Dawson, J.N. Dumont, R.A. Finch, D.J. Fort, G. Linder, J.R. Rayburn, D. Buchwalter, A.M. Gaudet-Hull, M.A. Maurice, and S.D. Turley. 1994. FETAX interlaboratory validation study: Phase II testing. Environ. Toxicol. Chem. 13:1629-1637 [reference only] Appendix 18 Bantle, J.A., R.A. Finch, D.T. Burton, D.J. Fort, D.A. Dawson, G. Linder, J.R. Rayburn, M. Hull, M. Kumsher-King, A. M. Gaudet-Hull, and S.D. Turley. 1996. FETAX interlaboratory validation study: Phase III, part 1 testing. J. Appl. Toxicol. 16:517-528 [reference only] Appendix 19 Fort, D.J., E.L. Stover, J.A. Bantle, J.R. Rayburn, M.A. Hull, R.A. Finch, D.T. Burton, S.D. Turley, D.A. Dawson, G. Linder, D. Buchwalter, M. Kumsher-King, and A.M. Gaudet-Hull. 1998. Phase III interlaboratory study of FETAX, part 2: Interlaboratory study of an exogenous metabolic activation system for Frog Embryo Teratogenesis Assay-Xenopus (FETAX). Drug Chem. Toxicol. 21:1-14 [reference only] Appendix 20 Bantle, J.A., R.A. Finch, D.J. Fort, E.L. Stover, M. Hull, M. Kumsher-King, and A.M. Gaudet-Hull. 1999. Phase III interlaboratory study of FETAX, part 3-FETAX validations using twelve compounds with and without an exogenous activation system. J. Appl. Toxicol. 19:447-472 [reference only] |