Cosmetic Genotoxicity Testing

Any cosmetic product must be safe for human health, and its safety is based on the safety of the ingredients. The Cosmetics Regulation (EC) No 1223/2009 is the main regulatory framework when finished products are placed on the EU market and requires the assessment of the safety and toxicological characteristics of cosmetic products. Toxicity studies are an important way to identify toxic potential, and the major endpoints that may be associated with toxicological profile include eye and skin irritation, skin sensitization, phototoxicity, skin penetration, and genotoxicity. Among them, genotoxicity is one of the critical endpoints.

Genotoxicity refers to the phenomenon of altering the genetic material of a cell or its transmission, including mutagenicity, clastogenicity and aneugenicity. Therefore, genotoxicity assessments for cosmetic products need to include tests capable of detecting these three endpoints: mutagenicity at the gene level, chromosome breakage and/or rearrangements, and numerical chromosome change (aneugenicity).

Our Services

The EU has banned animal testing for cosmetic products since 2013. The ban applies to all new cosmetics and their ingredients sold in the EU, regardless of where in the world testing on animals was carried out. The Cosmetics Regulation 1223/2009 contains the same provisions (Article 18). As a professional high-tech company, Creative BioMart has accumulated a lot of successful experience in cosmetic toxicity testing. We recommend two tests for basic level testing of cosmetic substances:

• Ames test (OECD 471) as a test covering genetic mutations
• In vitro Micronucleus test (OECD 487) as a test for structural (clastogenicity) and numerical (aneugenicity) chromosome aberrations.

Both our comet assay and micronucleus test are performed in 3D-reconstructed human skin models. No matter what your product is, genotoxicity is a key element of safety assessment, and we can tailor a proper test program according to the sample type and your needs, and conduct a comprehensive and scientific analysis of the experimental results.

Creative BioMart is a professional cosmetic analysis company, which aims to provide comprehensive analysis, development and manufacturing support services for the cosmetics industry. Our rich experience, numerous successful cases, and powerful data analysis systems make us confident to provide customers with excellent, high quality and precise services, and help customers meet regulatory requirements while deepening the understanding of raw materials and ensuring safer products.

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For R&D and Further Manufacturing ONLY.