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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In accordance with column 2 of REACH annex VII, the skin sensitisation study (required in section 8.3) does not need to be conducted as the substance is corrosive (see §7.3.1).

However, a study performed with Ethyl Trifluoroacetate (TFAE)was identified as the key study (Sire, 2007). This study was performed according to the OECD guideline No. 429 in compliance with the GLP. 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 concentrations.

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 anhydride which is very rapidly hydrolysed into TFA, analogue of TFAE, is not skin sensitizing.

This study is considered as acceptable as it satisfies the main criteria of OECD guideline No. 429.


Migrated from Short description of key information:
Trifluoroacetic anhydride which is very rapidly hydrolysed into TFA, is not skin sensitizing according to a read-across approach with Ethyl trifluoroacetate which showed no sentising potential in a Local Lymph node assay (K, Reliability: 2).

Justification for classification or non-classification

Harmonised classification:

No harmonised classification is available for Trifluoroacetic anhydride.

Self-classification proposed:

Trifluoroacetic anhydride is not classified as skin sensitiser according to the Regulation (EC) No1272/2008 including ATP1 and the Directive 67/548/EEC.

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