Ames Mutagenicity Testing (OECD 471)
The Ames Mutagenicity Assay (Bacterial Reverse Mutation Assay) is used to detect potential mutagenic activity in chemicals, medical device extracts, and other types of samples. The test is typically performed according to OECD Test Guideline No. 471. The test utilizes combinations of at least five amino-acids requiring bacterial strains of Salmonella typhimurium TA97, TA97a, TA98, TA100, TA102, TA1535, TA1537, and/or one strain of E. coli strains WP2urvA pKM101 to detect point mutations caused by mutagenic compounds. If a mutation occurs, it restores the bacterial strains’ ability to synthesize the missing amino acid and grow on the media which is deficient in that amino acid (a revertant colony). This mutation involves substitution, addition or deletion of one or more DNA base pairs. The testing is performed with and without the presence of S9 rat liver enzyme. The S9 system simulates mammalian metabolic liver enzyme systems and is used to detect mutations activated by metabolic systems. Testing is performed using five concentrations of the sample, each tested in triplicate. A mutagenic response is confirmed when the number of revertants is 2 to 3 times higher than the solvent control.
How Can CPT℠ Labs Assist with Your Ames Mutagenicity Testing?
CPT Labs Microbiological Division routinely performs Ames Mutagenicity Testing according to the OECD 471 guidelines. Contact us today to get started.
Our Departments
Based on the individual needs of our clients, we offer a wide range of support across various departments. Since initial product testing can be fairly complex in terms of a high-quality, safe and trusted product, our clients typically explore the benefits of numerous departments and areas of expertise, including:
- Clinical — Efficacy trials can be performed for safety, consumer in-use, and to support claims such as ‘dermatologist-tested’ and ‘ophthalmologist-tested.’
- In-Vitro Toxicology — Our In-Vitro Toxicology department assists clients when they are looking to perform non-animal (animal-free) toxicology testing.
- Microbiology — Microbial contamination and preservative efficacy testing are key to cosmetic and OTC drug products.
- Photobiology — From SPF and Water-Resistant claims to Photoallergy and Phototoxicity studies, CPT℠ is the world leader in sunscreen testing.
- Analytical — From raw materials, product batch release, and stability shelf-life testing to “free-of” and low-level detection claims, our analytical department ensures that all requirements are met based on industry standards.
- Consulting – Our consulting staff can perform GMP and GLP audits of your facilities or vendors, help create SOPs, develop testing programs, etc.
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Please Note: CPT℠ only performs testing for companies. We do not perform product testing for the general public.