AMESplus1: OECD 471 Bacterial Reverse Mutation Test + Confirmatory Test
Identifying substances capable of inducing mutations is a global safety evaluation concern. Placing any kind of chemical substance on the market requires confirmation that it is not genotoxic. The initial approach for assessing a new compound’s genotoxic risk to human health or the environment is an in vitro assay, the Ames test, also known as a bacterial reverse mutation test.
Chemical substances occur in a vast diversity of forms and are ubiquitous in our daily life, many improving the quality of human life. The Ames test is suitable to evaluate the mutagenic potential of any chemical substances, including pharmaceuticals, pesticides, cosmetics, food additives and industrial chemicals (e.g. housewares, hair dye or paints).
Vivotecnia has designed a complete and robust bacterial reverse mutation test, called AMESplus1, which includes two independent Ames tests. This design covers a more complete scenario for testing a new substance in vitro with the bacterial reverse mutation test, according to OECD 471 and ICH S2 guidelines:
- Five bacterial strains (four Salmonella sp and one Escherichia coli or five Salmonella sp).
- Preliminary test: to check the compound’s sterility, solubility, and cytotoxicity.
- Ames test: to test in the short-term the genotoxic potential of the compound using the direct incorporation method (with and without metabolic activation) and to test its carcinogenic potential. This assay uses histidine-dependent strains to detect mutations when the mutagenic chemical agent is added.
- Confirmatory test: conducted using the preincubation method (with and without metabolic activation) to confirm results obtained in the Ames test.
- For chemical, pharmaceutical, cosmetic and pesticide products.
- To screen new substances simply, quickly and economically.
A full GLP report is delivered six weeks after the experimental phase of the study begins.
Fast, reliable and economical.