FETAX Background Review Document

FETAX frog embryo picture Frog Embryo Teratogenesis Assay — Xenopus

Background Review Document: March 2000

Complete Report

Front Matter

FETAX for Human Developmental Hazard Identification

  1. Introduction and Rationale of FETAX
  2. FETAX Test Method Protocol
  3. Characterization of Substances Tested in FETAX
  4. Reference Data Used for an Assessment of FETAX Performance Characteristics
  5. FETAX Test Method Data and Results
  6. Performance Characteristics of FETAX
  7. Test Method Reliability (Repeatability/Reproducibility)
  8. Test Method Data Quality
  9. Other Scientific Reports and Reviews
  10. Animal Welfare Considerations
  11. Other Considerations

FETAX for Ecotoxicological Hazard Assessment Using Water/Soil/Sediment Samples

  1. Introduction and Rationale for the Use of FETAX in Assessing Developmental Hazards in Water/Soil/Sediment Samples
  2. FETAX Test Method Protocol
  3. Characterization of Environmental Water/Soil/Sediment Samples Tested in FETAX
  4. Reference Data Used for an Assessment of FETAX Performance Characteristics
  5. FETAX Test Method Data and Results
  6. Performance Characteristics of FETAX with Water/Soil/Sediment Samples
  7. Test Method Reliability (Repeatability/Reproducibility)
  8. Test Method Data Quality
  9. Other Scientific Reports and Reviews
  10. Animal Welfare Considerations
  11. Other Considerations
  12. Other Applications for Xenopus
  13. References

Appendix 1 Chemical 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: See reference, Appendix 16
  • FETAX Validation Study Phase II: See reference, Appendix 17
  • FETAX Validation Study Phase III.1: See reference, Appendix 18
  • FETAX Validation Study Phase III.2: See reference, Appendix 19
  • FETAX Validation Study Phase III.3: See reference, Appendix 20

Appendix 8 Environmental Samples Tested in FETAX

Appendix 9 U.S. EPA Letter Requesting that ICCVAM Evaluate the Validation Status of FETAX

Appendices 10-20 Key References

  • 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
    Superseded by NIH Publication 03-4508, September 2003
  • 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
  • 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 
  • 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
  • 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 
  • 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