Genetic Toxicology Studies

Genetic toxicology studies are conducted to assess the potential for induction of genetic mutations or chromosomal damage. Genetic toxicity testing is an important component of a complete safety assessment profile for all new products (e.g., pharmaceutical ingredients, pharmaceutical impurities, agrochemicals, pesticide plant residues/metabolites, industrial chemicals etc.).

Adgyl Lifesciences is performing Genetic Toxicology Studies from 30+ years in compliance to GLP and has completed more than 1500 studies and successfully submitted to various regulatory authorities across the world. Adgyl Scientists provide assistance to sponsor in developing testing strategies and conduct right studies to meet the regulatory requirements.

  • Bacterial Reverse Mutation Test (Ames Test) (OECD 471)
  • In Vitro Mammalian Chromosomal Aberration Test (CHO cells) (OECD 473)
  • In Vitro Mammalian Chromosomal Aberration Test (Human Peripheral Blood Lymphocytes-HPBL) (OECD 473)
  • In Vitro Mammalian Cell Gene Mutation Test Using the Hprt and xprt genes (OECD 476)
  • In Vitro Mammalian Cell Micronucleus Test (Human Peripheral Blood Lymphocytes-HPBL) (OECD 487)
  • In Vitro Mammalian Cell Gene Mutation Test Using the Thymidine Kinase Gene (OECD 490)
  • Mammalian Erythrocyte Micronucleus Test (OECD 474)
  • Mammalian Bone Marrow Chromosomal Aberration Test (OECD 475)