ASTM E1263-97(2003)
Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes

Standard No.

ASTM E1263-97(2003)

Release Date

1997

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM E1263-97(2008)

Latest

ASTM E1263-97(2008)

Scope

This guide provides guidelines for the selection of animal species, dosage and sampling conditions, sampling and scoring methods, statistical design, and analysis of genotoxicity assays in which the endpoint measured is the frequency of micronucleated erythrocytes in mammalian bone marrow.

1.1 This guide provides recommended guidelines for performing the mammalian in vivo bone marrow micronucleus assay. Under appropriate test conditions, measurement of the frequency of newly formed micronucleated erythrocytes in bone marrow provides a convenient index of chromosomal damage in nucleated erythrocyte precursor cells. The rationale for the occurrence of micronuclei in conjunction with chromosomal damage has been described previously (1). This guide describes conditions under which the frequency of micronucleated erythrocytes in mammalian bone marrow is an appropriate measure of in vivo chromosomal damage, and provides guidelines for the design and technical execution of assays employing this endpoint.

1.2 The following guidelines for mammalian bone marrow erythrocyte micronucleus assays have been published by organizations concerned with the evaluation of genotoxicity test data. These references should be consulted for recommendations on details not covered in depth by this guide and for requirements of specific organizations or government agencies (2-6).

1.3 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 and health practices and determine the applicability of regulatory limitations prior to use.

ASTM E1263-97(2003) history

• 1997 ASTM E1263-97(2008) Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes
• 1997 ASTM E1263-97(2003) Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes
• 1997 ASTM E1263-97 Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes