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Perfluorotributylamine Results

An Ames assay was conducted on the test article to determine mutagenicity. Selective agar plates containing the bacterial cells Salmonella typhimurium stains: TA-1535, TA-1537, TA-1538, TA-98, TA-100, and Saccharomyces cerevisiae strain D4, and activation system (omit in case of nonactivation) were prepared. Agar with biotin and a trace of histidine was used. Approximately 10^8 cells from an overnight culture of indicator strain were added. Just prior to pouring an aliquot of reaction mixture, (0.5 mL containing the 9000 x g liver homogenate), was added (omitted in case of nonactivation assays) to each of the overlay tubes. The contents were mixed and allowed to solidify. Appropriate amounts of the test article (10, 25, 50, or 100 microliters) were spotted in the culture of this selective agar plate containing the indicator organisms with the presence or absence of metabolic activation. Plates were incubated at 37°C for 48 hours and revertants were counted. The test article did not demonstrate mutagenic activity in any of the assays conducted in this evaluation and was considered as not mutagenic under these test conditions.

FC-770 Results

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 used S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and WP2 uvrA at concentrations up to 5000 micrograms per plate. FC-770 did 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.

 

Perfluorohexane Results

A modified Ames assay was conducted on the test article. A closed exposure system containing the vapor phase of the test article was used to determine if the test article demonstrated genotoxic properties. Conclusions could not be drawn as the test article did not demonstrate cytotoxicity to the tester strain TA100 up to a dose of 1000 microliters per plate in the presence and absence of the S9 fraction. Based on the volatile nature of the test article and the inability to demonstrate, by cytotoxicity, that the test system had been suitably dosed, it is concluded that this test article cannot be adequately tested using the Salmonella Mutation Assay.

Because these substances exhibit similarity in their physicochemical properties and toxicological properties in mammals, and because available data indicates that parent molecules are not reactive toward biological molecules and cannot undergo bioactivation by normal enzymatic processes, they can be considered members of a chemical category. Data gaps for partitioning properties, mammalian and ecological toxicity can therefore be addressed by read-across and/or trend analysis between category members. Please see IUCLID section 13 for the category justification and a matrix of genetic toxicity data for members of the Perfluorinated Organic Chemicals C5-C18 category.

Based on these results, perfluoro-N-methylmorpholine is not expected to be mutagenic in any of the genetic toxicity assays.


Short description of key information:
No Genetic Toxicity studies have been conducted on Perfluoro-N-methylmorpholine (FC-3284). Five studies have been conducted on other Fluoroinert Category members. A Bacterial Reverse Mutation Assay has been conducted on Perfluorotributylamine, three in vitro studies have been conducted on Fluoroinert Category member Perfluoroisopropylmorpholine (FC-770) and a Bacterial Reverse Mutation Assay has been conducted on Fluoroinert Category member perfluorohexane. These results are considered to be applicable to perfluoro-N-methylmorpholine.

Perfluorotributylamine (FC-40/43) Results
Bacterial Reverse Mutation Assay: Non mutagenic

(FC-770) Results
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

Perfluorohexane Results:
Bacterial Reverse Mutation Assay: Inconclusive due to the lack of cytotoxicity and test article volatility

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The test results do not meet the criteria for classifying perfluo-N-methylmorpholine as a Germ Cell Mutagen.