Mouse Lymphoma Assay (MLA)

1. Biological Effect: Genotoxicity / Mutagenicity Tests
2. Turnaround time: 12 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 1 test item;

ISO 10993-3 and ISO 10993-33

The purpose of the study is to determine the potential mutagenic of the medical device extract on mammalian cells (mouse lymphoma cells LY5178 TK+/-). The test item is extracted in a polar vehicle and cells are exposed to the extract in the presence and absence of metabolic activation, and then selected for the generation of mutant cells via their resistance to the cytotoxic agent Trifluoro-thymidine (TFT). For each condition, the numbers of colonies after exposure to the test item are compared to those of a negative control.