Genotoxicity

The ability of a substance to damage DNA, chromosomes, or the mitotic apparatus, potentially leading to mutations, chromosomal aberrations, or carcinogenesis. Assessed through a standard battery of tests including the Ames test (bacterial reverse mutation), in vitro chromosomal aberration or micronucleus assay, and in vivo bone marrow micronucleus test. ICH S2(R1) guidelines define the regulatory framework.

Beispiele

• Ames test detecting mutagenicity of aromatic amines
• Cyclophosphamide positive in micronucleus assay
• Nitrosamine impurities (NDMA) in ranitidine/valsartan recalls