ASTM E1439-12
Standard Guide for Conducting the Frog Embryo Teratogenesis Assay-Xenopus (FETAX)

Standard No.

ASTM E1439-12

Release Date

2012

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM E1439-12(2019)

Latest

ASTM E1439-12(2019)

Scope

5.1 FETAX is a rapid test for identifying potential developmental toxicity. Data may be extrapolated to other species including mammals. FETAX might be used to prioritize samples for further tests which use mammals. Validation studies using compounds with known mammalian or human developmental toxicity, or both, suggest that the predictive accuracy will exceed 858201;% (2) . When evaluating a test material for mammalian developmental toxicity, FETAX must be used with and without a metabolic activation system (MAS). Use of this exogenous MAS should increase the predictive accuracy of the assay to approximately 958201;%. The accuracy rate compares favorably with other currently available ??? in vitro teratogenesis screening assays??? (3). Any assay employing cells, parts of embryos, or whole embryos other than in vivo mammalian embryos is considered to be an in vitro assay.

5.2 It is important to measure developmental toxicity because embryo mortality, malformation, and growth inhibition can often occur at concentrations far less than those required to affect adult organisms.

5.3 Because of the sensitivity of embryonic and early life stages, FETAX provides information that might be useful in estimating the chronic toxicity of a test material to aquatic organisms.

5.4 Results from FETAX might be useful when deriving water quality criteria for aquatic organisms (4).

5.5 FETAX results might be useful for studying structure-activity relationships between test materials and for studying bioavailability.

1.1 This guide covers procedures for obtaining laboratory data concerning the developmental toxicity of a test material. The test utilizes embryos of the African clawed frog, Xenopus laevis and is called FETAX (Frog Embryo Teratogenesis Assay-Xenopus) (1).² Some of these procedures will be useful for conducting developmental toxicity tests with other species of frogs although numerous modifications might be necessary. A list of alternative anurans is presented in Appendix X1.

1.2 A renewal exposure regimen and the collection of the required mortality, malformation, and growth-inhibition data are described. Special needs or circumstances might require different types of exposure and data concerning other effects. Some of these modifications are listed in Appendix X2 although other modifications might also be necessary. Whenever these procedures are altered or other species used, the results of tests might not be comparable between modified and unmodified pr......

ASTM E1439-12 Referenced Document

• ASTM D1193 Standard Specification for Reagent Water
• ASTM E1023 Standard Guide for Assessing the Hazard of a Material to Aquatic Organisms and Their Uses
• ASTM E1192 Standard Guide for Conducting Acute Toxicity Tests on Aqueous Ambient Samples and Effluents with Fishes, Macroinvertebrates, and Amphibians
• ASTM E1391 Standard Guide for Collection, Storage, Characterization, and Manipulation of Sediments for Toxicological Testing
• ASTM E1525 Standard Guide for Designing Biological Tests with Sediments
• ASTM E1706 Standard Test Method for Measuring the Toxicity of Sediment-Associated Contaminants with Freshwater Invertebrates
• ASTM E729 Standard Guide for Conducting Acute Toxicity Tests on Test Materials with Fishes, Macroinvertebrates, and Amphibians
• ASTM E943 Standard Terminology Relating to Biological Effects and Environmental Fate
• IEEE/ASTM SI 10 American National Standard for Metric Practice

ASTM E1439-12 history

• 2019 ASTM E1439-12(2019) Standard Guide for Conducting the Frog Embryo Teratogenesis Assay-Xenopus (FETAX)
• 2012 ASTM E1439-12 Standard Guide for Conducting the Frog Embryo Teratogenesis Assay-Xenopus (FETAX)
• 1998 ASTM E1439-98(2004) Standard Guide for Conducting the Frog Embryo Teratogenesis Assay-Xenopus (FETAX)
• 1998 ASTM E1439-98 Standard Guide for Conducting the Frog Embryo Teratogenesis Assay-Xenopus (FETAX)