The bacterial reverse mutation test uses amino-acid requiring strains of Salmonella typhimurium and Escherichia coli to detect point mutations by base substitutions or frameshifts. It detects mutations which revert mutations present in the test strains and restores the functional capability of the bacteria to synthesize an essential amino acid.
| Test model | As per the sponsor’s request, the study will be conducted with 5 strains or 2 strains • Salmonella typhimurium TA 98, TA 100, TA1537,TA97,TA97a, TA1535, TA102, and E.coli WP2 UvrA (5 strains) • Salmonella typhimurium TA 100 and E.coli WP2 UvrA (2 strains) • Procedure: 5 times lesser to regular AMES (plate size, quantity of test item, S9/ PBS, test item/ positive control volume and culture volume) |
| Assay controls | Negative control: Aqueous and organic solvents Positive control: Strain-specific positive controls |
| Exposure time | 48 – 72 hours |
| Test item quantity | 500 mg (Mini AMES) |
| End point | Growth of revertant colonies |
| Data delivery | Mean number of revertant colonies per plate • 2-fold increase with vehicle control (TA 98, TA 100, TA97, TA97a, TA102, and E.coli WP2 UvrA) • 3-fold increase with vehicle control (TA 1535 and TA 1537) |
| Timeline | 2-3 Weeks (Mini AMES) |
