Genetic Toxicology Testing
Genetox studies are conducted to assess the mutagenic potential of various products prior to widespread use in humans. Since DNA-reactive substances may initiate the carcinogenic process, screening strategies with built-in mode of action information are becoming more useful for biologically assessing potential human risk. The operable mechanisms (i.e., biological key events) can then be evaluated in the context of an adverse outcome pathway to identify a probable molecular initiating event that is responsible for the positive test results. While genetox testing is required for all classes of chemicals and drugs, the testing strategy should be tailored to the applicable regulatory requirements and responses observed in vitro. While most studies are performed in vitro, we also incorporate in vivo genetic toxicology studies when necessary.
For more than 30 years, Charles River has been helping clients to develop custom testing strategies and conduct appropriate assays to meet the unique requirements of their chemicals and drugs. With three sites in North America and Europe, our team includes scientists and staff who are dedicated to the field of genetic toxicology, as well as regulatory consultants and program managers who can support our clients’ studies with strategic advice. Our ongoing involvement with regulatory working groups (e.g., OECD Expert Working Groups) and international societies (e.g., Genetic Toxicology Association and HESI’s Genetic Toxicology Technical Committee) ensures that our clients have access to the latest developments in science and its and applications within a regulatory environment.
Our team works closely with other Safety Assessment groups to enrich study results and integrity with supplementary services such as formulation and analytical chemistry, pathology, and bioanalysis. Additionally, we can support and enhance other studies by evaluating genetic toxicology biomarkers and determining mechanism of action identification using in situ hybridization, flow cytometry and determining apoptosis if needed.
Genotoxicity Assays for Genetic Toxicology Studies
In Vitro Genotoxicity Assays
- Ames MPF, Ames II, mini Ames
- Bacterial Mutation Test (Ames, OECD 471)
- Mammalian Cell Gene Mutation Test (HPRT Gene, OECD 476)
- Mammalian Chromosome Aberration Test (OECD 473)
- Mammalian Cell Gene Mutation Test (TK Gene, OECD 490)
- Mammalian Cell Micronucleus Assay (OECD 487)
- Fluorescence In Situ Hybridization (FISH)
- In Vivo Genotoxicity Assays