Registration Dossier
Registration Dossier
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EC number: 234-147-9 | CAS number: 10563-26-5
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin sensitisation
The test substance was evaluated for its potential to induced skin sensitization in a test protocol conducted according to the OECD Guideline 406 (Skin Sensitization) in Dunkin-Hartley guinea pig. The Buehler test using 5 animals per sex per dose group was conducted with test substance (TS purity 98.3%) concentrations levels in doubly distilled water of 10% (v/v) for induction, and 5.0% (v/v) at challenge (the minimal irritating concentration for induction and the maximal non irritating concentration for challenge were determined in a range-finding study with concentration levels of 1.0, 5.0, 10 and 25%). The test substance was applied epicutaneously (occlusive patch) on days 0, 7 and 14 (0.5 ml; the control group received the vehicle only) for induction, and on day 29 for challenge. Skin reactions were read at 24 and 48 after application of the solutions, and the number of animals with skin findings after the removal of the patch was taken into account for the determination of the sensitization rate. 60% (12/20; 0% in the negative control group) of test animals showed positive reactions 24 hours after challenge and 80% 48 hours thereafter (16/20; 0% in the negative control group). The test substance has therefore to be considered sensitising to the guinea pig skin.
Migrated from Short description of key information:
- Skin sensitisation: OECD TG 406, guinea pig, TS purity 98.3% (BASF AG, 2008; Val1); sensitizing
- Respiratory sensitisation: no data available
Justification for selection of skin sensitisation endpoint:
Only one study available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Respiratory sensitisation
No data available
Justification for classification or non-classification
Based on the available skin sensitisation study, the substance has to be classified as sensitising according to Annex VI of the EU directive 67/548/EEC (R43) and to the EU Regulation (EC) No 1272/2008 (Cat 1A).
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