Genotoxicity

Genetic toxicology studies are conducted to evaluate the mutagenic and carcinogenic potential of consumer products, drugs and agricultural chemicals on DNA or chromosomes focusing on the process of mutagenesis including DNA damage, gene mutatations and chromosome aberrations.

 

Main study options

Bacterial Reverse Mutation Test (AMES Test; according to OECD 471 / OPPTS 870.5100 / EC B.13/14 / GLP)

MICRO Bacterial Reverse Mutation Test (AMES Test; according to OECD 471 / OPPTS 870.5100 / EC B13/14 / GLP)

Chromosome Aberration (In Vitro Mammalian Cell Cytogenetic Test; according to OECD 473 / EC B.10 / GLP)

• Chromosome Aberration (according to OECD 475 / GLP)

In vitro mammalian cell micronucleus assay (V79 cell line; chinese hamster, according to OECD 487 / GLP)

Mouse Micronucleus Assay (according to OECD 474 / OPPTS 870.5395 / EC B.12 / GLP)

Mouse Local Lymph Node Assay (LLNA; according to OECD 429 / OPPTS 870.2600 / EC B.42 / GLP / individual approach)

Mouse Local Lymph Node Assay (LLNA; according to OECD 429 / EC B.42 / GLP / pooled approach)

• Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells (according to OECD 486 / GLP)

In Vitro Gene Mutation Test in Mammalian Cells HPRT (according to OECD 476 / OPPTS 870.5300 / EC B.17 / GLP)

In Vitro Gene Mutation Test in Mammalian Cells Mouse Lymphoma (according to OECD 476 / OPPTS 870.5300 / EC B.17 / GLP / tk-gene mutation in L5178Y 3.7.2 C cells)

• In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene (according to OECD 490 / GLP)

• In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene (according to OECD 490 / GLP)

COMET Assay in vitro (according to EFSA 2977 / GLP)

COMET Assay (according to OECD 489 / GLP)

• Extended One Generation Reproduction Toxicity study (according to OECD 443 / GLP)