Potassium trifluoroacetate

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The in vitro mutagenicity studies used for potassium trifluoroacetate evaluation were performed with a reaction mass of potassium trifluoroacetate (TFAK) and potassium trifluoromethanesulphinate (TFSK). Since this reaction mass consists of 50% TFAK, the results are considered appropriate to evaluate the mutagenic effects of potassium trifluoroacetate. The reaction mass of potassium trifluoroacetate and potassium trifluoromethanesulphinate was tested in vitro for genetic mutations induction the bacterial reverse mutation assay and in mammalian cells and for clastogenic effects in a chromosomal aberration test. Based on the results it is concluded that the Reaction Mass of TFSK/TFAK does not exhibit any potential for mutagenicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The three genetic toxicity studies used for potassium trifluoroacetate evaluation were actually performed with a reaction mass of potassium trifluoroacetate (TFAK) and potassium trifluoromethanesulphinate (TFSK). Since this reaction mass consists of 50% TFAK, the results are considered appropriate to evaluate the mutagenic effects of potassium trifluoroacetate.

In vitro gene mutation study in bacteria

The Reaction mass of TFSK/TFAK was examined for mutagenic activity in the Ames test (OECD guideline 471 and GLP compliant) using Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and the tryptophan-requiring Escherichia coli strain WP2 uvrA, in the absence and presence of metabolic activation. All strains were treated with seven concentrations of the test substance, ranging from 5 to 5000 µg/plate. Negative controls and positive controls were run simultaneously with the test substance. The mean number of his+ and trp+ revertant colonies of the negative controls were within the acceptable range and the positive controls gave the expected increase in the mean number of revertant colonies. The test substance was not toxic to any strain, in both the absence and presence of S9-mix, as neither a decrease in the mean number of revertants nor a clearing of the background lawn of bacterial growth compared to the negative controls was observed. In both the absence and presence of S9-mix in all strains, Reaction mass of TFSK/TFAK did not induce a minimal 2-fold and/or dose related increase in the mean number of revertant colonies compared to the background spontaneous reversion rate observed with the negative control. 

In vitro gene mutation study in mammalian cells

In a study according to OECD guideline 490 and in compliance with GLP, the Reaction mass of TFSK/TFAK was examined for its potential to induce gene mutations at the TK-locus of cultured mouse lymphoma L5178Y cells. No test-substance induced increase in the number of mutations was observed when tested up to limit concetntrations in the presence and absence of metabolic activation. The results of the frst experimen, 3-hour exposure, with and without metabolic activation was confirmed in a second experiment, 24-hour exposure without metabolic activation. Appropriate solvent and postive controls were induced and gave expected results. It is concluded that the test substance is negative for mutagenicity to mammalian cells under the conditions of the study.  

In vitro cytogenicity / chromosome aberration study in mammalian cells

The Reaction mass of TFSK/TFAK was tested In a Chromosome Aberration Assay using Chinese hamster V79 lung cells performed according to OECD Guideline 473 and GLP. Two independent assays were conducted in the presence and absence of metabolic activation. The negative and positive controls gave valid results. No induction of chromosome aberrations in Chinese hamster V79 cells was observed following treatment with Reaction mass of TFSK/TFAK up to 5000 μg active ingredients/mL concentration; thus, there was no evidence of any genotoxic activity of the test item under the conditions of this study.

In vivo Micronucleus test

A GLP-compliant erythrocyte micronucleus test was performed according OECD guideline 474. Four groups of 5 to 15 male animals were dosed via oral gavage with vehicle or with the Reaction mass of TFSK/TFAK at doses of 500, 1000 and 2000 mg/kg bw. A positive control group (cyclophosphamide) was included. It was concluded that, under the conditions used in this study, no induction of micronuclei in bone marrow erythrocytes was observed following administration of Reaction mass of TFSK/TFAK to mice at up to and including 2000 mg active ingredients/kg bw/day; thus, there was no evidence of any genotoxic activity of the test item under the conditions of this study.

Regarding the overall negative results from the in vitro genotoxicity studies, potassium trifluoroacetate is considered to present no genotoxic activity potential.

Justification for classification or non-classification

Based on the available data, no classification for genotoxicity is proposed for potassium trifluoroacetate according to the CLP 1272/2008 Regulation.