Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #682216

    IATE #3510060
    genotoxic impurity | DNA reactive impurity | mutagenic impurity
    en
    Definition impurity - for which there are test data or sufficient evidence - that has the potential to damage DNA at any level of exposure, with such damage possibly leading/contributing to tumour development Reference "COM-Terminology Coordination, based on:: EMEA. CHMP. 'Guideline on the limits of genotoxic impurities' (10.12.2024). London, 28 June 2006 CPMP/SWP/5199/02 EMEA/CHMP/QWP/251344/2006"
    Comment "This type of mutagenic carcinogen is usually detected in a bacterial reverse mutation (mutagenicity) assay. Other types of genotoxicants that are non-mutagenic typically have threshold mechanisms and usually do not pose carcinogenic risk in humans at the level ordinarily present as impurities. Therefore to limit a possible human cancer risk associated with the exposure to potentially mutagenic impurities, the bacterial mutagenicity assay is used to assess the mutagenic potential and the need for controls. Structure-based assessments are useful for predicting bacterial mutagenicity outcomes based upon the established knowledge."