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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Bacterial Reverse Mutation Assay: Non-mutagenic when tested according to OECD 471.

Chromosome Aberration: Negative when tested according to OECD 473

Mammalian Cell Gene Mutation: Negative when tested according to OECD 476

Additional information

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 chromosomes.

Justification for classification or non-classification

The test results do not meet the criteria for classifying FC-770 as a Germ Cell Mutagen.