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EC number: - | CAS number: -
The mutagenic potential of TFEE-5 (MTDID 21721, lot TFEE5-276/12/09-1) was evaluated in the Bacterial Reverse Mutation Assay with S. typhimurium strains TA98, TA100, TA1535 and TA1537 and E. coli strain WP2 uvrA in both the presence and absence of a metabolic activation system (S9-mix: phenobarbital- and beta-naphthoflavone-induced rat liver).
METHODS: This study was performed in compliance with OECD GLP (1997). The homogeneity, stability and concentration of the test substance were not analyzed. The study design was based on OECD 471 (1997), EC 440/2008 B13/14 L142 (2008) and Japan MHLW guidelines (2004). TFEE-5 was prepared in 100% ethanol for addition to the test system. TFEE-5 was tested at up to 5000 ug per plate in the first experiment and up to 3330 ug per plate in the second experiment. Both experiments were performed in the presence and absence of S9-mix. Strain-specific positive controls were included in all tests.
RESULTS: No increase in revertant colonies was observed in either the presence or absence of S9-mix for any strain. All criteria for a valid study were met as described in the protocol.
CONCLUSION: Under the conditions of this study, TFEE-5 was not mutagenic in the Bacterial Reverse Mutation Assay in either the presence or absence of metabolic activation.
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