Registration Dossier
Registration Dossier
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EC number: 206-851-6 | CAS number: 383-63-1
Endpoint summary
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:
A study was identified as the key study (Sire, 2007). In a local lymph node assay performed according to the OECD guideline No.429 and in compliance with the GLP, ethyl trifluoroacetate (purity 99.94%) in acetone/olive oil was administered to female CBA/J mice (4 animals/dose). The test item was non-irritant (ear thickness measurement) in the preliminary test, whatever the concentration. Therefore, the highest concentration retained for the main test was the maximal practicable concentration (100%), according to the criteria specified in the International Guidelines. For the main test the concentrations were 0, 5, 10, 25, 50 and 100% of the test item. The Lymph node proliferative responses were measured as described by Kimber and Dearman (1991). The positive control HCA (α-hexylcinnamaldehyde) at 25% presented a Stimulation Index (SI) of 5.24.Therefore, the positive control gave acceptable positive results and the study can be considered valid. 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 (SImax of 0.96 at 50% ethyl trifluoroacetate) in the animals treated whatever the concentration of the test item.
Under the test conditions, ethyl trifluoroacetate is not a dermal sensitizer in the murine Local Lymph Node Assay.
Migrated from Short description of key information:
Not sensitising: LLNA (SImax=0.96) (Key study, reliability Kr. 1, OECD 429)
Justification for selection of skin sensitisation endpoint:
Key study performed according to the OECD guideline No.429 and in compliance with the GLP,
Respiratory sensitisation
Endpoint conclusion
- Additional information:
No data
Migrated from Short description of key information:
No data
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 skin sensitisation 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.
For the respiratory sensitisation, no data was available.
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