Genotoxicity analysis

Objective of the analysis

Genotoxicity analysis assesses the potential of an ingredient, finished product, or contaminant to damage DNA. It is essential in health safety, regulatory registration (REACH, biocides, cosmetics), and the development of new substances.

This assessment is required for raw materials, active substances, consumer products or natural extracts suspected of mutagenic, clastogenic or aneugenic effects.

Methodology

Genotoxicity tests can be carried out in vitro or in vivo , according to international standards (OECD, ICH, ISO, etc.). The analysis plan is defined according to the regulatory status, the type of product and the associated obligations:

• Ames test (OECD 471) Salmonella typhimurium strains
• Chromosomal Aberration Test (OECD 473) : Detection of chromosomal breaks or rearrangements
• Micronucleus assay (OECD 487) : detection of genetic damage in mammalian cells
• Comet or HPRT tests (special cases)

Depending on the needs, the analysis may include:

• Presence or absence of metabolism (S9 mix)
• Different concentrations or formulations of the product
• Conditions of prolonged or single exposure

Associated analytical techniques

• Cell culture
• Fluorescence microscopy or staining
• Bacterial colony count
• Cytogenetic image analysis
• Cytometry (option depending on test)

Application examples

• Substances to be registered under REACH or in a biocide dossier
• Plant extracts or natural active ingredients for cosmetic use
• Additives, contaminants or impurities in industrial formulations
• Dietary supplements, medical devices or nutraceutical ingredients
• Verification of non-genotoxicity in extraction or purification processes

At YesWeLab, we collaborate with laboratories specialized in regulatory toxicology , certified GLP (Good Laboratory Practices) and accredited ISO 17025. We select our partners according to the type of product, the matrices to be analyzed and the specific requirements of the OECD or ICH protocol.

Our team helps you define the most relevant testing plan based on your regulatory status, formulation constraints, and deadlines.
Since 2020, we have been supporting chemical, cosmetic, nutraceutical, and biotechnology manufacturers in their compliance efforts.

Need an OECD test or a comprehensive genotoxicity study? Contact our scientific experts now.