ASTM E1439-12(2019)
Standard Guide for Conducting the Frog Embryo Teratogenesis Assay-Xenopus (FETAX)

Standard No.

ASTM E1439-12(2019)

Release Date

2019

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM E1439-12(2019)

Scope

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 procedures. Any test that is conducted using modified procedures should be reported as having deviated from the guide. 1.3 These procedures are applicable to all chemicals either individually or in formulations, commercial products or mixtures that can be measured accurately at the necessary concentrations in water. With appropriate modification these procedures can be used to conduct tests on the effects of temperature, dissolved oxygen, pH, physical agents, and on materials such as aqueous effluents (see Guide E1192), surface and ground waters, leachates, aqueous and solid phase extracts, and solid phase samples, such as soils and sediments, particulate matter, sediment, and whole bulk soils and sediment. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This guide is arranged as follows: Section Referenced Documents 2 Terminology 3 Summary of Guide 4 Significance and Use 5 Safety Precautions 6 Apparatus 7 Water for Culturing Xenopus adults 8 Requirements 8.1 Source 8.2 Treatment 8.3 Characterization 8.4 FETAX Solution Water 9 Requirements 9.1 Formulation 9.2 Test Material 10 General 10.1 Stock Solution 10.2 Test Organisms 11 Species 11.1 Source 11.2 Adults 11.3 Breeding 11.4 Embryos 11.5 Procedure 12 Experimental Design 12.1 Temperature and pH Requirements 12.2 Beginning the Test 12.3 Renewal 12.4 Duration of Test 12.5 Exogenous Metabolic Activation System (MAS) 12.6 Biological Data 12.7 Analytical Methodology 13 Acceptability of the Test 14 Documentation 15 Keywords 16 Appendixes 17 X1. List of Alternative Species Appendix X1 X2. Additional Endpoints and Alternative Exposures Appendix X2 X3. Concentration Steps for Range-Finding Tests Appendix X3 X4. Microsome Isolation Reagents and NADPH Generating System Components, Appendix X4 References 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. 1 This guide is under the jurisdiction of ASTM Committee E50 on Environmental Assessment, Risk Management and Corrective Action and is the direct responsibility of Subcommittee E50.47 on Biological Effects and Environmental Fate. A standard guide is a document, developed using the consensus mechanisms of ASTM, that provides guidance for the selection of procedures to accomplish a specific test but which does not stipulate specific procedures. Current edition approved Feb. 1, 2019 Published February 2019. Originally approved in 1991. Last previous edition approved in 2012 as E1439 – 12. DOI: 10.1520/E1439-12R19. 2 The boldface numbers in parentheses refer to the list of references at the end of the text. Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. 1 2. Referenced Documents

ASTM E1439-12(2019) 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*， 2020-04-01 Update
• 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*， 2023-06-01 Update
• IEEE/ASTM SI 10 American National Standard for Metric Practice

ASTM E1439-12(2019) 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)