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Three genetic toxicity studies were conducted with and without metabolic activation according to the guidelines noted above. In all cases, no evidence of genotoxicity was seen. Control materials induced the appropriate responses in all tests and the tests were considered valid.
The bacterial reverse mutation assay used S. typhimurium strains TA98, TA100, TA1535 and TA1537 and E. coli strain WP2uvrA at TFEE-5 concentrations up to 5000 micrograms/plate. The number of revertants did not increase more than 2-times (TA 100) or 3-times (other strains) the solvent control values at any TFEE-5 concentration tested.
The chromosome aberration assay used human peripheral lymphocytes at TFEE-5 concentrations up to 100 micrograms/ml (TFEE-5 precipitated at ≥100 micrograms/ml). TFEE-5 did not induce statistically significant increases in the number of cells with chromosome aberrations at any concentration tested.
The mammalian cell gene mutation assay used mouse lymphoma L5178Y cells at TFEE-5 concentrations up to 100 micrograms/ml (TFEE-5 precipitated at ≥100 micrograms/ml). TFEE-5 did not induce reproducible mutant frequencies of at least 126 per million cells greater than the solvent controls.
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