Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

No studies for determination the sensitisation properties of TFA have been performed and none are proposed based on scientific considerations and for animal welfare reasons. โ€‹In 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 ยง 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 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 acid is not skin sensitizing. This study is considered as acceptable as it satisfies the main criteria of OECD guideline No. 429.

Justification for classification or non-classification

No classification is proposed in the absence of any indication that Trifluoroacetic acid can cause sensitisation.