Registration Dossier
Registration Dossier
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EC number: 261-818-3 | CAS number: 59587-38-1
Endpoint summary
Administrative data
Description of key information
OECD 442D, in vitro sensitization ARE-Nrf2 Luciferase test. Predicted to be a non-sensitizer. Reliability = 1
OECD 442C, in chemico sensitization Direct Peptide Reactivity assay. Predicted to be a skin sensitizer. Reliability = 1
Read accross with similar substance OECD 429, in vivo LLNA (mice). Not sensitising. Reliability=2
WOE - Weight of evidence documentation for Non-Classification for skin sensitization;
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
All the data and model predictions were assessed to inform whether or not the substance has potential to sensitise the skin.
1)First the in-silico data indicate no alerts for skin sensitisation and no metabolism is anticipated for the target substance.
2)The OECD 442D in-vitro assay was negative for skin sensitization indicating AOP 2, inflammatory response in Keratinocytes, was not a likely event, for the target substance.
3)The OECD 442C in-vitro assay was tested in both lysine and cysteine models. For both models the % mean peptide depletion was less than 3.2 which indicates minimal reactivity. According to the DPRA prediction model, the test substance, potassium 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonate, was considered a skin sensitizer based on the positive response detected for the Lysine % Mean Peptide Depletion results. However it was not considered a skin sensitizer for the Cysteine model. It is possible that the positive for lysine could be a false positive
4) The LNAA results on the acid (source substance) indicate the analogous substance is not a skin sensitizer.
Based on the combined weight of evidence, the LLNA results are considered the most relevant and skin sensitization for this substance is not expected. It is demonstrated that the absence of skin sensitisation reported for the source substance (the acidic form of the target substance), is based on robust and reliable scientific evidences and allows to make a reliable prediction of the lack of skin sensitisation of the target substance (the salt form of the source substance)
The data is conclusive but not sufficient for classification. Therefore, the target substance is not classified for skin sensitization according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and its amendments.
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