Updated Guidance on testing for mutagenicity

Updated Guidance on testing for mutagenicity

ECHA/NA/14/38

ECHA has published an update of the Guidance on Information Requirements and Chemical Safety Assessment – Chapter R.7a.

Helsinki, 19 August 2014 – The Guidance on Information Requirements and Chemical Safety Assessment – Chapter R.7a has been updated to take into account the recent adoption or revision of several OECD test guidelines (TGs) for genotoxicity testing. This update involved a complete revision of sub-sections R.7.7.1 to R.7.7.7, which are related to mutagenicity. In particular, information on the OECD TG 488 (Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays) and OECD TG 489 (in vivo Mammalian Alkaline Comet Assay) has been updated and guidance on when and how to use these tests has been expanded upon. The revised text also reflects the status of development of other test methods as well as non-testing methods for mutagenicity. Further to this, the recommended testing strategy for mutagenicity has been updated.