GLP OECD 471 Ames Test

The OECD 471 Ames test, a bacterial reverse mutation assay, has been used for decades and is the most commonly requested genotoxicity study in regulatory testing frameworks. The test investigates the ability of test substances to cause specific mutations in Salmonella or E. coli strains that allow them to grow on selective agar plates. Used to detect DNA reactive mutagens, which have the potential to be highly potent in vivo, Ames positive results are taken very seriously when assessing safety.

Gentronix has conducted these studies for GLP since 2014, and our senior study director has been working on Ames tests for over 40 years, meaning we have exceptional experience in this area.

How Can We Support You?

If you would like more details on how Gentronix can support your project through the conduct of the OECD 471 Ames Test, please contact a team member or submit an enquiry at enquiries@gentronix.co.uk.

The standard test conditions recommended in the Ames OECD 471 guideline are reported to have reduced sensitivity when assessing some N-nitrosamines or N-nitrosamine drug substance related impurities (NDSRIs). In order to reliably detect mutagenic potential of N-nitrosamines and NDSRIs, the FDA recommends that a negative result in a standard bacterial reverse mutation assay is followed by a second Ames test with enhanced testing conditions.

Gentronix has optimised the OECD 471 Ames Test with Enhanced Conditions, which has involved generation of historical control data for rat and hamster S9 at 30% concentration, and full validation of two N-nitrosamines as additional positive controls.