Registration Dossier
Registration Dossier
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EC number: 203-597-8 | CAS number: 108-59-8
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 Buehler test was performed in female guinea pigs according to OECD TG 406 (adopted 1981), with the restriction, that only 10 instead of 20 animals were used in the treatment group. No skin reactions were observed 24, 48, and 72 hours after challenge procedure. Furthermore a maximisation test was performed with 25 human subjects. The test substance was administered as a 8% solution in petrolatum. No sensitization was observed. Thus, the test substance is not sensitizing to the skin.
Migrated from Short description of key information:
The test substance showed no sensitizing potential in a Buehler test in guinea pigs (OECD TG 406, adopted 1981). Furthermore no sensitization was observed in a maximisation test performed in 25 human subjects with a 8% test substance solution.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
- No classification required for skin sensitization.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008 (last amended by EC/286/2008 (2011-03-10)):
- No classification required for skin sensitization.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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