ABSTRACT
Guidelines for 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 multi-step process of carcinogenesis, even if genetic changes may play only a part in this complex process. The standard 3-test battery for the genotoxicity testing of pharmaceuticals [1] consists of: (1) a test for gene mutation in bacteria; (2) an in vitro test with cytogenetic evaluation of chromosomal damage in mammalian cells or an in vitro mouse lymphoma tk assay; and (3) an in vivo test for chromosomal damage using rodent hematopoietic cells. The recommended genotoxicity tests for cosmetic ingredients [2] are: (1) a bacterial test for gene mutation; (2) an in vitro test for clastogenicity and aneuploidy (metaphase analysis or micronucleus test); and (3) 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.
