Genetic toxicology aims to determine whether or not a given compound will induce mutations or chromosomal damage in humans. Today, new insights into the mechanisms of mutagenicity has opened up new possibilities for testing and predicting mutagenicity.
For more than 40 years, ERBC scientists conduct standard screening and regulatory assays as well as customized testing strategies to accurately assess the genotoxicity risk of any compounds (pharmaceutical ingredients, pharmaceutical impurities, human metabolites and chemicals) and help pharmaceutical and chemical companies to take better account of ICH-and OECD guidelines They also support studies lead by other safety assessment internal teams through genetic toxicology biomarkers and mechanistic explorations.
- Bacterial mutation assay
- Photogenotoxicity - Ames Test
- Gene mutation in Chinese hamster V79 cells (HPRT)
- Mutation in L5178Y TK+/- mouse lymphoma cells (fluctuation method)
- In vitro chromosome aberrations in Chinese hamster cells (V79 CHO) and human lymphocytes
- In vitro micronucleus test on human lymphocytes or Chinese hamster cells (V79 CHO)
- In vivo micronucleus test (single dose or multiple dose) in mouse and rat
- In vivo chromosomal aberration test (single dose or multiple dose) in rat
- Unscheduled DNA synthesis (UDS) in primary rat hepatocytes after in vivo treatment
- In vivo comet assay in rat
- Combined comet assay and micronucleus test after repeated dosing in rat
Screening for lead compound identification using standard and miniaturized methods:
- Modified 6-well bacterial mutation assay
- In vitro micronucleus test in Chinese hamster cells (V79 CHO) or mouse lymphoma cells
- In vitro comet assay on human leukocytes, Chinese hamster cells (V79 CHO) or mouse lymphoma cells
- Oxidative stress: determination of 8-OH-dG (8-oxo-7,8-dihydro-2’deoxyguanosine) by LC/MS after in vivo or in vitro treatment
- Replicative DNA Synthesis study (RDS) in primary rat hepatocytes after in vivo treatment
- Inhibition of topoisomerase II
- Stabilization of cleavable complex (in vitro chromosome aberration assay)
Mouse
Rat
Dog
Rabbit
Marmoset
Ferret
Cynomolgus Monkeys
Guinea Pig
