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EC number: 473-390-7
CAS number: -
Bacterial Reverse Mutation Assay: Non-mutagenic when tested according to
Chromosome Aberration: Negative when tested according to OECD 473
Mammalian Cell Gene Mutation: Negative when tested according to OECD 476
3 Genetic Toxicity studies were conducted with and without activation
according to the guidelines noted above. In all cases, no evidence of
mutagenic activity was seen. Control materials induced the appropriate
responses in all tests so the tests are considered valid.
The Mammalian Cell Gene Mutation study used Mouse Lymphoma L5178Y cells
and was tested at concentrations up to 300 micrograms/ml in ethanol.
Only one data point showed any significance in any assay. The treatment
group concerned was the 30 ug/mL group in the second assay in the
presence of S9 mix (Assay 4). The mutant fraction obtained was within
the historical vehicle control range and the increase in mutant fraction
was well below the value of 126 mutants per million required to signify
biological relevance. No dose trend was established in this treatment
group. Therefore, FC-770 was evaluated to be non-mutagenic in this assay
The Bacterial Mutation Assay usedS. typhimurium TA 1535, TA 1537, TA 98
and TA 100 and WP2 uvrA at concentrations up to 5000 micrograms per
plate. FC-770did not induce a significant dose-related increase in the
number of revertant colonies in each of the 4 tester strains (TA1535,
TA1537, TA98, and TA100) and in the tester strain WP2uvrA both in the
presence and absence of S-9 mix.
The Chromosome Aberration Study used peripheral human lymphocytes and
was tested at a concentration up to 100 micrograms/ml. FC-770 did not
induce a statistically significant or biologically relevant number of
chromosome aberrations or polyploidy cells/cells with endoreduplicated
The test results do not meet the criteria for classifying FC-770 as a
Germ Cell Mutagen.
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