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Genetic Toxicology

Genetic toxicology is a global Regulatory Agency driven component of toxicology studies for pharmaceuticals, chemicals, devices and certain biotechnology products. The Life Sciences Group at the IIT Research Institute (IITRI) has over twenty years of experience in this area of regulatory submission requirements and offers the complete genetic toxicology test battery conducted under Good Laboratory Practice (GLP) guidelines. The Life Sciences Group at IITRI conducts the standard in vitro and in vivo genetic toxicology tests using protocols that meet harmonized international (ICH) guidelines and has the capacity and expertise to design and carry out non-traditional non-GLP in vitro genetic toxicology testing to screen sets of compounds or to investigate mechanisms of action. In addition to genetic toxicology testing our scientific staff also conducts in vitro cytotoxicity testing in numerous cells lines. These studies are used as stand alone cytotoxicity tests or as dose range studies for other in vitro investigations.

IITRI also conducts studies for other market sectors, including foods, food additives, degradation products, and products geared for EPA and OECD submission.

Areas of Expertise Include:

  • Ames Bacterial Mutagenesis Testing
  • In Vivo Micronucleus Assays - Mouse, Rat (Bone Marrow and Peripheral Blood)
  • Structural Chromosome Aberration Assay
  • Mouse Lymphoma
  • Cytotoxicity Assay
  • In Vitro Micronucleus Assays
  • Comet Assay