Registration Dossier
Registration Dossier
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EC number: 206-851-6 | CAS number: 383-63-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
One in vitro study was available to assess the genotoxicity of Ethyl trifluoroacetate: an Ames test on the registered substance (Sire, 2007). The study was in compliance with the GLP and presented a good reliability (Kr. 1).
In a reverse gene mutation assay in bacteria, performed according to the OECD No.471 and EC No.B13/14 guidelines, strains TA1535, TA1537, TA100, TA98 and TA102 of S. typhimurium were exposed to ethyl trifluoroacetate (99.94%) diluted in DMSO in the presence and absence of mammalian metabolic activation (fraction of S9 from the liver of rats treated with Aroclor 1254). Since the test item was freely soluble and non-toxic in the preliminary test, the highest selected dose-level for the two independent main tests was 5000 µg/plate, according to the criteria specified in the international guidelines. Three replicates were realized per concentration of Ethyl trifluoroacetate (10, 100, 500, 1000, 2500 and 5000 µg/plate) in the main test.
Furthermore, method of direct incorporation and protocol with a preincubation step were tested. The positive controls induced the appropriate responses in the corresponding strains. Ethyl Trifluoroacetate was tested therefore up to limit concentration (5000 µg/plate) and no cytotoxicity was observed. No significant increase of the number of revertants was observed in any bacterial strains tested with Ethyl trifluoroacetate (at any concentrations). Under these test conditions, Ethyl 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.
This study is considered as acceptable and satisfy the requirement for the mutagenicity endpoint.
Ethyl trifluoroacetate is not considered as mutagenic in bacteria.
Justification for selection of genetic toxicity endpoint
This key study is considered as acceptable and satisfy the requirement for the mutagenicity endpoint.
Short description of key information:
in vitro: Ames negative (Key study, reliability Kr. 1, OECD 471),
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Harmonized classification:
No harmonized classification is available for human health according to the Regulation (EC) No. 1272/2008 including the ATP2.
Self classification:
Based on the available data, Ethyl trifluoroacetate is not classified for genetic toxicity according to the criteria of the Annex I of the Regulation (EC) No 1272/2008 (CLP) and to the criteria of the Annex VI of the Directive 67/548/EEC.
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