Genetic toxicology studies are performed early in a safety evaluation program to assess the potential for induction of genetic mutations or chromosomal damage. These studies are conducted in a tiered approach so that the toxicological relevance of any earlier observations can be assessed.
Charles River offers a range of standard genetic toxicology studies, including the in vitro Ames test, chromosomal aberration assays, mouse lymphoma assays and the in vivo rodent micronucleus assay.
In addition, the following studies are also available:
Comet Assay- This in vivo test now replaces the UDS assay for the detection of DNA damage in various organs (primarily liver or stomach glandular tissue) and is used to complement bone marrow assays when there are additional concerns (e.g., based on results of in vitro studies). Any DNA damage is quantified by image analysis using direct data capture systems.
In vitro Micronucleus Assay- Primary human lymphocyte cultures are stimulated into division and then treated with the test article. Cell division is arrested using cytochalasin B, then binucleate cells are examined for micronuclei.
For more information about our genetic toxicology studies, contact us at askcharlesriver@crl.com.