A genotoxicity study is designed to detect compounds that cause genetic damage either directly or indirectly in cells exposed to the toxic substrates. Genotoxicity studies may be performed in vitro or in vivo.
Compounds which are positive in tests that detect such damage have the potential to cause cancer and/or heritable defects. No single test is capable of detecting all relevant genotoxic agents; therefore, the usual approach is to carry out a battery of tests that are complementary rather than representing different levels of hierarchy.
A standard study battery has the following tests:
- A test for gene mutation in bacteria,
- An in vitro test with cytogenetic (concerned with the study of the structure and function of the cell) evaluation of chromosomal damage with mammalian cells,
- An in vivo test for chromosomal damage using rodent haematopoietic (blood or blood cell forming) cells.