Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Skin sensitiser
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The skin sensitisation potential of the substance was evaluated according a local lymph node assay following OECD 429 Guideline. In the present study Stimulation Indices (S.I.) of 6.42, 5.48, and 6.33 were determined with the test item at concentrations of 6.25, 12.5, and 25% in dimethyl formamide, respectively. The test item was found to be a skin sensitizer. However as there was no dose response the test result is somewhat ambigous; moreover a structurally very closely related substance is not classified as a sensitizer based on a guinea pig sensitizing test. Due to these diverting results it was decided to perform a G.P.M.T. to clarify the result of the LLNA.
In order to assess the cutaneous allergenic potential of the test item, the Maximization- Test was performed in 15 (10 test and 5 control) female albino Dunkin Hartley guineapigs, in accordance with OECD Guideline No. 406. No toxic signs were evident in the guinea pigs of the control or test group. Discrete/patchy to moderate confluent erythema with or without scaling was observed in eight out of ten test animals at the 24- and 48-hour reading after the challenge treatment with test item at 25 % in PEG 300. No erythematous or oedematous reaction was observed in the test animals treated with PEG only.
Based on the abovementioned results the test item has to be classified as a skin sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data a classification as Skin Sens.1 (H317) as per the CLP Regulation (EC) No. 1272/2008 is proposed for the substance.
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