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The assessment of this endpoint shall comprise the following consecutive steps: an assessment of the available in vivo genotoxicity data an in vitro test for gene mutations in bacteria, an in vitro cytogenicity test in mammalian cells and an in vitro gene mutation test in mammalian cells are required appropriate in vivo genotoxicity studies shall be considered in case of a positive result in any of the in vitro genotoxicity studies

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