Genotoxicity refers to any deleterious change in the genetic material within a cell.
Genotoxicity in vitro and in vivo tests are designed to detect compounds that induce genetic damage by various mechanisms.
Basic genotoxicity tests:
- Bacterial reverse gene mutation test (Ames test)
- Genotoxicity evaluated in mammalian cells in vitro and/or in vivo
Guidance for Industry: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (FDA, 2010)