AMES Bacterial Reverse Mutation

1. Biological Effect: Genotoxicity / Mutagenicity Tests
2. Turnaround time: 6 weeks
3. Sample Requirements:

ISO

240 cm² (test item < 0.5 mm thick);
120 cm² (test item ≥ 0.5 mm thick);
8 grams;
40 ml;
at least 2 test items;

MHLW

20 mL or 8 grams or 120 cm2 or 240 cm2

ISO 10993-3 and ISO 10993-33

The purpose of the study is to determine the potential mutagenic effect of the medical device extract on a panel of bacterial strains (five strains). The test item is extracted and bacteria are exposed to the extract via plate incorporation in the presence or absence of metabolic activation, and then selected for the generation of mutant cells via their lack of requirement for specific amino-acid. For each strain and condition, the numbers of colonies after exposure to the test item are compared to those of a negative control.