Conventional Test Method:

No specific conventional test method is superseded

Alternative Test Method:

Name & Description:

In Vitro Mammalian Cell Gene Mutation Test

This test can be used to detect gene mutations induced by chemical substances. In the cell lines, the most commonly used genetic endpoints measure mutation at thymidine kinase (TK) and hypoxanthine-guanine phosphoribosyl transferase (HPRT), and a transgene of xanthineguanine phosphoribosyl transferase (XPRT). Cells in suspension or monolayer culture are exposed to at least four analysable concentrations of the test substance, both with and without metabolic activation. Cytotoxicity is usually determined by measuring the relative cloning efficiency (survival) or relative total growth of the cultures after the treatment period. Mutant frequency is determined by seeding known numbers of cells in medium containing the selective agent to detect mutant cells, and in medium without selective agent to determine the cloning efficiency (viability). After a suitable incubation time, colonies are counted.

Validation Status:

No information

Regulatory Status:

OECD: TG 476 (1997)

US: EPA Health Effects Test Guideline OPPTS 870.5300 (1996)

Effect or Potential Effect on Animal Use:

(part of a tiered testing strategy that results in use of  fewer animals)

Information Last Reviewed:
May 2012