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In genetic toxicology testing the positive findings of the result is very common. It is critical to have the accurate analysis of the implications of the results.

Genetic toxicology studies are conducted for assessing the potential for induction of genetic mutations or chromosomal damage. For all classes of chemicals and drugs the Genetic toxicology testing is required but variations in conducts are possible. This may vary from compound to compound on account of regulatory requirements or depending on the choice and design of assays.

Since many years, IIRT Institute for Industrial Research & Toxicology has been helping clients with the customized testing strategies to provide appropriate assays to meet the requirements which are unique and varies as per chemicals and drugs. Our huge, dedicated, experienced and well-versed staff is dedicated for the genetic toxicology testing. We have the regulatory consultants and program managers which support the clients’ studies with strategic advice. We believe in upgrading ourselves with knowledge and technology with regulatory working groups and international societies ensuring that our clients are exposed to latest science and its and applications.

To determine the compound’s potential genotoxicity is an important component to assure complete safety assessment of all new launch of products in various categories  like pharmaceutical ingredients, pharmaceutical impurities, unique human metabolites, industrial chemicals, agrochemicals, cosmetics etc. Earlier the testing the better it is for the companies. As it helps in the determination of the product well-being if it’s without any adulteration and if not then the scope of further development is discussed. We do the additional testing to investigate and characterize the relevance of any observed adverse effects. Since most studies are performed in vitro, we at IIRT Institute for Industrial Research & Toxicology also incorporate vivo genetic toxicology studies if necessary.

The safety is an important concern at IIRT Institute for Industrial Research & Toxicology. Our team works closely assuring to take care of all the Safety Assessment groups to enrich study results. Also, the team works with complete integrity for the provision of supplementary services in chemistry, pathology and bio analysis. Addition support to enhance other studies is provided by evaluating genetic toxicology biomarkers and determining mechanism of action. 

Genetic toxicology studies are conducted early in the safety testing program of pharmaceuticals, medical devices, chemicals, food additives, etc., IIRT Labs offers comprehensive range of in vitro and in vivo Genetic toxicology studies in compliance with GLP principles as per OECD, US-EPA (OPPTS), EEC guidelines.

Services - Regulatory Genetic toxicology/Mutagenicity Studies

§  Bacterial Reverse Mutation Test (Ames test) - OECD 471.

§  In Vitro Mammalian Chromosome Aberration Test in Cultured Human Peripheral Blood Lymphocytes/CHO cell line - OECD 473.

§  In Vitro Mammalian Cell Gene Mutation Test (using mouse lymphoma L5178Y tk +/- cells) - OECD 476.

§  In Vitro Micronucleus Test - OECD 487.

§  In Vivo Mammalian Erythrocyte Micronucleus Test - OECD 474.

§  In Vivo Mammalian Bone Marrow Chromosome Aberration Test - OECD 475.

Screening Studies :

In addition, we offer various screening versions of the genotoxicity tests, which are useful during the early development of new products/early stages of drug development. These can be designed to meet the specific requirements of each sponsor.

§  Fluctuation AMES Test/AMES II Test.

§  Mini AMES Test.

§  In Vitro Micronucleus Test - Miniature Version.