Genetic Toxicology Studies


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Genetic Toxicology Studies


Genetic toxicology studies are required for any new drug in early development to identify compounds that can potentially cause mutations or chromosal damage in humans. Evaluation of genetic toxicology is also required for the registration of new chemicals for the European Union REACH (Registration, Evaluation, Authorization and Restriction of Chemical Substances) regulation.

IITRI offers the standard battery of in vitro and in vivo genetic toxicology tests required for new pharmaceuticals or for the testing of new chemicals. We have over 40 years of experience performing these studies, and our protocols meet ICH and OECD guidelines to support US EPA and FDA regulatory submissions. Each study includes dose analysis performed by our on-site bioanalytical laboratory. We also offer biodistribution studies which are critical for determining vector distribution and persistence in both target and non-target tissues. 


Study Types

Ames Bacterial Mutation Test
(OECD 471)
Bacterial reverse gene mutation E. coli, Salmonella In vitro
Mammalian Cell Mutation Test
(OECD 476)
Gene mutations at the thymidine kinase (Tk) locus Mouse lymphoma L5178Y tk+/-3.7.2C In vitro
Mammalian Structural Chromosome Aberration Assay (OECD 473) Chromosomal abnormalities CHO, HPBL* In vitro
Mammalian Cell Micronucleus Assay Micronuclei in cells that have undergone mitosis Mouse or rat, 1 or 2 sex assays In vivo
Micronucleus Assay Micronuclei in cells that have undergone mitosis CHO, HPBL* In vitro
Neutral Red Cytotoxicity Assay (OECD 432) Cell viability due to cytotoxicity BALB/c-3T3 mouse fibroblasts In vitro

*CHO, Chinese hamster ovary; HPBL, human peripheral blood lymphocyte.


The IITRI Advantage

  • Direct interaction with highly experienced study directors
  • Flexible programs available to meet your specific needs, from complete GLP test battery to non-GLP assays and individual test options
  • Technical advisory and support regarding interpretation of study results

Download Genetic Toxicology Brochure