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Bacterial Reverse Mutation assay:

In a reverse gene mutation assay in bacteria, performed similarly to the OECD guideline No.471, strains TA1535, TA1537, TA1538, TA98 and TA100 ofS. typhimurium were exposed to Sodium Trifluoroacetate diluted in DMSO at concentrations of 0.1, 0.5, 1.0, 5.0 and 10 mg/plate in the presence and absence of mammalian metabolic activation (fraction of S9 from the liver of Sprague-Dawley male rats treated by intraperitoneal injection with Aroclor 1254 dissolved in maize oil). The method of direct incorporation was used in this study.

Sodium Trifluoroacetate was tested up to limit concentration recommended in the guideline (5 mg/plate).

The positive controls induced the appropriate responses in the corresponding strains.

Under the test conditions, the test item Sodium trifluoroacetate did not show mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium as there was no evidence of induced mutant colonies over background.

In this study the sodium Trifluoroacetate was used instead of the Trifluoroacetic acid (TFA) according to a reliable analogue approach (TFA salt) in order to be free of the cytotoxic effect on bacteria due to the extreme acid pH of the TFA.

Therefore, the Trifluoroacetic acid is not considered as mutagenic in the bacterial reverse mutation test.

This study is considered as acceptable as it satisfied the main criteria of the OECD guideline No. 471.

In vitro Mammalian Chromosome Aberration test:

In an in vitro chromosome aberration test performed according to OECD guideline No 473 and in compliance with GLP, human primary lymphocyte cultures were exposed to Sodium trifluoroacetate as 55.6 % aqueous solution. In the fist experiment cells were exposed both in the presence and absence of S-9 to concentrations of 0, 1000, 1250, 1360 µg/mL for 3 hours and sampled at 20 hours after the beginning of treatment. In the second experiment, cells were exposed continuously for 20 hours in the absence of S-9 (0, 750, 1200 and 1360 µg/mL) or 3 hours in the presence of S-9 (0, 1050, 1200 and 1360 µg/mL).

Positive controls induced the appropriate response.

Chromosome aberrations were not induced over background at any tested concentrations (up to limit concentration of 10mM) in the absence and the presence of activation system in both experiments.

Under the test conditions, aqueous solution of Sodium trifluoroacetate (56% purity) was not clastogenic in human lymphocytes exposed in vitro.

In this study the sodium Trifluoroacetate was used instead of the Trifluoroacetic acid (TFA) according to a reliable analogue approach in order to be free of the cytotoxic effect on bacteria due to the extreme acid pH of the TFA (pH = 0.45 for 10% aqueous aolution, see § 4.2).

Therefore, the Trifluoroacetic acid is not considered as clastogenic in humans cells exposed in vitro.

This study is considered as acceptable and satisfies the requirement for the cytogenicity endpoint.

In vitro Mammalian Cell Gene Mutation test:

In an in vitro mammalian cell gene mutation test performed according to the OECD test guideline No. 476 and in compliance with GLP, Sodium trifluoracetate as a 55.6% aqueous solution was assayed for its ability to induce mutation at the hprt locus (thio-6 -guanine resistance) in mouse lymphoma L5178Y cells. In the cytotoxicity range-finder experiment, 6 concentrations were tested in the absence and presence of S-9, ranging from 42.5 to 1360 µg/mL. There was no evidence of marked toxicity at concentrations up to and including 1360 µg/mL (equivalent to 10 mM) in the absence and presence of S-9. In Experiment 1 seven concentrations, ranging from 200 to 1360 µg/mL, were tested in the absence and presence of S 9. In Experiment 2 seven concentrations, ranging from 150 to 1360 µg/mL were tested in the absence and presence of S-9.

When tested up to the limit concentration of 1360 µg/mL (10 mM) in the absence and presence of S-9 in Experiments 1 and 2, no significant increases in mutant frequency were observed at any concentration analysed and there were no significant linear trends.

In the presence of S-9 in Experiment 1, the positive controls did not meet the acceptance criteria stated in the protocol. However, both positive control concentrations showed clear increases in mutant frequency which were outside the historical negative control ranges generated by the last 20 studies, updated at the time of each experiment. The data were therefore considered acceptable and valid on this basis.

Negative controls were valid for both experiments.

It is therefore conclude that sodium trifluoroacetate (55.6% aq solution) was not mutagenic when tested up to 10 mM in the absence and presence of S-9.

In this study the sodium Trifluoroacetate was used instead of the Trifluoroacetic acid (TFA) according to a reliable analogue approach in order to be free of the cytotoxic effect on bacteria due to the extreme acid pH of the TFA (see §4.2).

Therefore, Trifluoroacetic acid is not considered as mutagenic in the mammalian cell gene mutation test.

This study is considered as acceptable and satisfies the requirement for the mutagenicity endpoint in mammalian cells.

Regarding the overall negative results from the in vitro genotoxicity studies, it is likely that Trifluoroacetic acide, as relevant substance for trifluoroacetic anhydride (see § 7.1), doesn't induce any genotoxic activity potential.


Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Harmonised classification:

No harmonized classification is available according to the Regulation (EC) No 1272/2008 including ATP1.

Self classification:

Based on the available data, no self-classification for genotoxicity is proposed for Trifluoroacetic anhydride according to the Directive 67/548/EEC and the CLP Regulation.

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