Strategy for Germ Cell Testing

Where germ cell testing is required, judgment should be used to select the most appropriate test strategy. There are a number of tests available, which fall into two classes (1) tests in germ cells per se ( class 1 ) and (2) tests to detect effects in the offspring (or potential offspring) of exposed animals ( class 2 ). Three 

EUROPEAN UNION GUIDELINE FOR TESTING OF CHEMICALS UNDER THE REGISTRATION, 

Genotoxicity is a broader term and refers to processes which alter the structure, information content or segregation of DNA and are not necessarily associated with mutagenicity. Thus, tests for genotoxicity include tests which provide an indication of induced damage to DNA (but not direct evidence of mutation) via effects such as unscheduled DNA synthesis (UDS), sister chromatid exchange (SCE), DNA strand breaks, DNA adduct formation or mitotic recombination, as well as tests for mutagenicity. 

AU ehgible chemicals under REACH require the conductance of a bacterial reverse mutation (Ames) test (Annex Vll, 8.4.1) (EC 2006). For compounds 10t/a, an additional mammalian in vitro cytogenetic test is required (Aimex VIII, 8.4.2) (EC 2006). For the latter, both the chromosome aberration test and the micronucleus test in vitro are considered acceptable. In the case of a negative result in the mammalian in vitro cytogenetic test and in the in vitro gene mutation test in bacteria, data from an in vitro gene mutation study in mammahan ceUs are required (Annex 

Category 3 (label Xn R68 or R40) Substances that cause concern to man owing to possible mutagenic effects. For compounds in this category, there is evidence from appropriate mutagenicity studies, but this is insufficient to place the substance in Category 2 (EC 1967, 1999). 

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