Genotoxicity Testing Strategy
The testing strategy for genotoxicity covers three main areas:
- Gene mutations
- Chromosome aberration or breakage (clastogenicity)
- Chromosome loss or gain (aneuploidy)
Current general strategy consists of in vitro assays capable of detecting all of these endpoints:
- Gene mutations:
- AMES (OECD 471) [link], Mouse Lymphoma Assay (OECD 490) [link], HPRT Test (OECD 476) [link]
- Chromosome aberration or breakage :
- Chromosome aberration Test (OECD 473, 475) [link]
- Chromosome loss or gain:
- Micronucleus Assay (OECD 478, 474) [link]
Possible follow-up evaluation (in case of positive results):
- in vivo micronucleus test (OECD 474)
- in vivo chromosome aberration test (OECD 475)
- in vivo UDS Test (OECD 486)
- transgenic mutagenicity tests (OECD 488)
- in vivo Comet Assay (OECD 489) [link]
- Comet with 3D-reconstructed human skin model
- MNT with 3D-reconstructed human skin model
