Registration Dossier
Registration Dossier
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EC number: 406-550-1 | CAS number: - MDI
Endpoint summary
Administrative data
Description of key information
Based on the results of a Buehler test performed according to OECD 406 (1981), the substance needs to be classified as a skin sensitiser (sub-category 1B).
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 (a solid) was investigated by performing a Buehler test in accordance with OECD 406 (1981) and according to GLP principles. Corn oil was used as vehicle. Test substance concentrations selected for the main study were based on the results of a preliminary study. Reliable positive and negative controls were included. A concentration of 50% was used for the induction (max. attainable concentration) and 25% for the challenge. Six of the 20 test group animals showed sensitisation effects after challenge, resulting therefore in a sensitization rate of 30% in this non adjuvant-type test. As this is ≥15%, the substance needs to be classified as a skin sensitiser in accordance with the CLP Regulation.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the obtained sensitization rate of 30% and the used induction dose in the Buehler test, the substance needs to be classified as a skin sensitiser in sub-category 1B.
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