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