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Guidance on a strategy for testing of chemicals for mutagenicity

This document develops and updates the guidance on strategy for testing potentially mutagenic chemicals published by the Committee on Mutagenicity, Chemicals in Food, consumer Products and the Environment (COM) in 1989. The revised guidance reflects new knowledge but its approach remains consistent with COM's earlier published advice. It reaffirms that there is no one validated test which covers gene mutation, clastogenicity and aneuploidy. As such a range of tests are required. It recommends that these should be informative, well validated and selectively applied. The document sets out the general principles of a testing strategy. It recommends a three-stage approach: (1) in-vitro (2) in-vivo (3) germ cell assays. Each approach is documented and supported by flow chart summaries. An overall summary recaps key points and provides further guidance on the appropriateness of advancing from one stage to the next. Cites numerous references.