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Certification of reference material for short-term mutagenicity tests

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The most widely used bacterial mutagenicity assay is the Salmonella assay also known as the 'Ames Test'. Mutations can either be caused by chemicals which act directly on the bacterial DNA or which first require metabolic activation. The assay provides a rapid in vitro test for chemicals which cause mutations in bacterial DNA. The assay is used to screen chemicals for potential human mutagenicity and carcinogenicity as part of the EC's directive 79/831. The assay is also increasingly being used to study and monitor the genotoxicity of complex mixtures in water, soil, air and other environmental sources.

A collaborative project between 15 European laboratories involved in the Ames test was organised using three highly pure direct-acting reference mutagens. This showed that there was considerable variability between laboratories in the results obtained despite the use of a standard protocol.

Further studies have been carried out to try to identify those aspects of the protocol which were not defined and contributed to this inter-laboratory variability. A further intercomparison of the Ames test will start end of 1994, this time including a metabolic activation system and testing two further pure reference mutagens: benzo[a]pyrene and 2-aminoanthracene.

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