Division 5.4 Genotoxicity testing
United Kingdom
The aim of genotoxicity testing shall be to:
predict genotoxic potential,
identify genotoxic carcinogens at an early stage,
elucidate the mechanism of action of some carcinogens.
Appropriate dose levels, depending on the test requirements, shall be used in either in vitro or in vivo assays. A tiered approach shall be adopted, with selection of higher tier tests being dependent upon interpretation of results at each stage.
Special testing requirements in relation to photomutagenicity may be indicated by the structure of a molecule. If the Ultraviolet/visible molar extinction/absorption coefficient of the active substance and its major metabolites is less than 1 000 L × mol–1 × cm–1, photomutagenicity testing is not required.