ABSTRACT
Guidelines for the assessment of the genotoxic potential of chemicals are based on the premise that DNA damage and its fi xation in the form of gene mutation and chromosomal damage is generally considered to be essential in the multistep process of carcinogenesis, even if genetic damage may play only a part in this complex process. The current guidelines for genotoxicity testing of pharmaceuticals (1-3) indicate a standard three-test battery that consists of (i) a test for gene mutation in bacteria, (ii) an in vitro test with cytogenetic evaluation of chromosomal damage with mammalian cells or an in vitro mammalian cells gene mutation assay, (iii) an in vivo test for chromosomal damage using rodent hematopoietic cells. The recommended genotoxicity tests for cosmetic ingredients (4) consist of (i) a bacterial test for gene mutation, (ii) an in vitro test for clastogenicity and aneuploidy (metaphase analysis or micronucleus test), and (iii) an in vitro mammalian cell mutation assay (mouse lymphoma assay as the preferred choice): further in vivo testing may be justifi ed when concern is raised over positive results in in vitro tests.
