Genetic Toxicology is the study of genetic damage to the hereditary material that results in genetic alterations. Furthermore, Genetic Toxicology studies are conducted to assess the potential for induction of genetic mutations or chromosomal damage, by identifying substances that can cause genetic alterations in somatic and/or germ cells. Additionally, regulatory decisions utilize this information. Genetic toxicity testing is, therefore, 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.). 

Important terms in Genetic Toxicology Assays: 

• Mutagenicity: Mutagenicity results in events that alter the DNA and/ or chromosomal structure and that are passed to subsequent generations. Thus, mutations include the following: (a) changes in a single base pair, partial, single or multiple genes, or chromosomes; (b) breaks in chromosomes that result in the stable (transmissible) deletion, duplication or rearrangement of chromosome segments; (c) a change (gain or loss) in chromosome number (i.e. aneuploidy) resulting in cells that have not an exact multiple of the haploid number; and (d) mitotic recombination. 
• Genotoxicity: It includes mutagenicity (described above). Furthermore, it includes DNA damage, which may or may not result in permanent alterations in the structure or information content in a cell or its progeny. Thus, tests for genotoxicity also include those tests that evaluate induced damage to DNA (but not direct evidence of mutation) via effects such as unscheduled DNA synthesis (UDS), DNA strand breaks, and DNA adduct formation.

Guidelines for Genotoxicity Assessment: 

• for all Agrochemicals, Industrial Chemicals, Cosmetics, Pharmaceuticals 
• ICH guidelines for Pharmaceuticals and its impurities  

Adgyl Lifesciences offers Genetic Toxicology Studies in accordance with OECD and ICH guidelines and in compliance with GLP. The Adgyl Lifesciences team has completed more than 2000 studies over the past 3 decades and successfully submitted this data to a variety of regulatory authorities worldwide. Moreover, the company assists sponsors in developing testing strategies for conducting regulatory studies.

List of In vitro and in vivo Genotoxicity guidelines: 

1. OECD 471: Ames Assay (Test system: Salmonella typhimurium (TA 98, TA 100, TA 1537, TA 1535, TA 102/E.coli Wp2 UVra) 

2. OECD 473: In vitro Chromosomal Aberration Assay (Test system – Human Peripheral Blood Lymphocytes, CHOK1) 

3. OECD 474: In vivo Micronucleus Assay (Test system – Rats/Mice) 

4. OECD 475: In vivo Chromosomal Aberration Assay (Test system – Rats/Mice) 

5. OECD 476: In vitro Cell Gene Mutation Assay, HPRT Assay (Test system – CHOK1) 

6. OECD 487: In vitro Micronucleus Assay (Test system – Human Peripheral Blood Lymphocytes) 

7. OECD 490: In vitro Cell Gene Mutation Assay (Mouse Lymphoma Assay (L5178 Y tk+/-)