anx_II__cpt_1__cpt_1__cpt_1__table_1__row_88

8.6. In vivo genotoxicity study The assessment of this endpoint shall comprise the following consecutive steps: If there is a positive result in any of the in vitro genotoxicity studies and there are no results available from an in vivo study already, an appropriate in vivo somatic cell genotoxicity study shall be proposed/conducted by the applicant If either of the in vitro gene mutation tests is positive, an in vivo test to investigate unscheduled DNA synthesis shall be conducted A second in vivo somatic cell test may be necessary, depending on the results, quality and relevance of all the available data If there is a positive result from an in vivo somatic cell study available, the potential for germ cell mutagenicity should be considered on the basis of all available data, including toxicokinetic evidence to demonstrate that the substance reached the tested organ. If no clear conclusions about germ cell mutagenicity can be made, additional investigations shall be considered ADS The study/ies do(es) not generally need to be conducted if: the results are negative for the three in vitro tests and if no metabolites of concern are formed in mammals or valid in vivo micronucleus data is generated within a repeat dose study and the in vivo micronucleus test is the appropriate test to be conducted to address this information requirement the substance is known to be carcinogenic category 1A or 1B or mutagenic category 1A, 1B or 2.

← anx_II__cpt_1__cpt_1__cpt_1__table_1__row_87__cell_3 · All articles · anx_II__cpt_1__cpt_1__cpt_1__table_1__row_88__cell_1 →

Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.