OECD 471 | Ames Test

The Bacterial Reverse Mutation Test (Ames test) according to OECD 471 is a straight-forward in vitro assay widely used to assess mutagenicity of substances, mixtures or formulations. The simplicity of the test makes it the most common entry level mutagenicity test for regulatory purposes, such as chemicals under REACH, biocides, agrochemicals, pharmaceuticals, food contact materials, novel food, cosmetic products or ingredients.

As a cornerstone for the experimental determination of mutagenicity the Ames test is recognized by agencies worldwide, such as ECHA, EFSA, EMA, EPA, FDA, USDA, as well as the national authorities.

LAUS has been performing the Ames Test since 1999 in accordance with the principles of Good Laboratory Practice (GLP) following OECD Test Guideline 471. In addition to GLP-compliant studies, we also offer screening tests and customized solutions tailored to your specific requirements.

Our test variants at a glance:

• OECD 471: Bacterial Reverse Mutation Test – Standard procedure
• Ames Treat & Wash: modified procedure for amino acid-containing material, biological samples, test substances containing proteins, peptides and histidine itself
• Ames Test according to MITI (Japanese Ministry of International Trade and Industry)
• Ames Test according to ICH M7 for pharmaceutical impurities
• Ames MPF: Miniaturized procedure using microtiter plates – ideal for very small sample quantities
• Screening Test with two strains (non-GLP)

Test principle

The principle of the test is simple: reverse mutations restore the ability of amino acid–requiring bacterial strains to synthesize a specific amino acid. The occurrence of growing colonies on selective media is interpreted as a mutagenic event.

Test scope

The test includes two independent experiments carried out using the plate incorporation method and the pre-incubation method – each performed with and without metabolic activation (S9).

Bacteria strains

Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA 102, optional: Escherichia coli

Endpoint

Mutagenicity

Most standard test batteries for regulatory purposes typically include also the in vitro assessment of genotoxicity in mammalian cells in addition to the Ames test. Thanks to many years of experience and the consistent application of GLP standards, LAUS ensures valid and internationally recognized results. Specific details on study design, test strategies, and additional testing options are available on request, contact us for more information!