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EC number: 200-929-3
CAS number: 76-05-1
No studies for determination the
sensitisation properties of TFA have been performed and none are
proposed based on scientific considerations and for animal welfare
accordance with section 8.3, column 2, Annex VII of Regulation (EC) No.
1907/2006, the skin sensitisation study does not
need to be conducted as the substance is a strong acid (pH =0.45;
see § 4.20).
However, a study performed with Ethyl
Trifluoroacetate was identified as supporting study (Sire, 2007). The
study with Ethyl Trifluoroacetate was performed according to the OECD
guideline No. 429 in compliance with the GLP guidelines. Ethyl
Trifluoroacetate (CAS 383-63-1) was identified as an analogue of TFA
based on the similarity of its structure (ethyl group is bounded to the
acid function) and considered as relevant to assess the sensitising
potential of TFA since the ethyl group was not known to induce
sensitisation in the literature. Moreover, this analogue is not
irritating which allowed to study the sensitization potential at any
Ethyl trifluoroacetate was administered to
mice and the Lymph node proliferative responses were measured as
described by Kimber and Dearman (1991). No clinical signs and no
mortality were observed during the study. Furthermore, no irritation of
the skin was noted following the application of the test item. The LLNA
gave negative results, as the SI is lower than 1 in the animals treated
whatever the concentration of the test item. Under the test conditions,
the ethyl trifluoroacetate is not a dermal sensitizer in the murine
Local Lymph Node Assay. Therefore, we can conclude that Trifluoroacetic
acid is not skin sensitizing. This study is considered as acceptable as
it satisfies the main criteria of OECD guideline No. 429.
No classification is proposed in the absence
of any indication that Trifluoroacetic acid can cause sensitisation.
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