Genetic Toxicology

CiToxLAB group provides over 25 years of experience and expertise in the performance of standard genotoxicity studies in our modern facility, along with testing of pharmaceuticals, biopharmaceuticals, cosmetics, industrial chemicals, agrochemicals, feed and food additives, as well as other types of test item including medical devices.  We can make the appropriate recommendations on how to proceed on a case-by-case basis and how to test even the most unusual products.

 

Our tests comply with the latest versions of the guidelines issued by the ICH and OECD and are performed in accordance with the current OECD Good Laboratory Practice regulations to ensure their  acceptability to regulatory authorities worldwide.

 

Study Types

 

  • GLP Genotoxicity:
    • Bacterial reverse mutation test (the Ames test) - OECD 471
    • Mammalian chromosome aberration (cytogenetic) in vitro test using cultured human lymphocytes - OECD 473
    • Mammalian cell gene mutation in vitro test using mouse lymphoma
    • L5178Y tk +/- cells - OECD 476
    • Mammalian erythrocyte micronucleus in vivo test in mice and rats - OECD 474

 

 

  • Screening Genotoxicity:
We offer screening versions of the genotoxicity tests, which are useful during the early development of new products. These can be designed to meet the specific requirements of each sponsor.

 

    • Mini-Ames
    • Mini-micronucleus