Registration Dossier
Registration Dossier
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EC number: 265-512-0 | CAS number: 65140-91-2
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:
Skin sensitization
A guinea pig maximization test (GPMT) was performed to assess the skin sensitization potential of the test substance. The test was performed similar to the protocol specified in OECD TG 406 (adopted 1981), with one deviation regarding the first induction application. Due to the insolubility of the test substances in standard vehicles, the test substance was applied epicutaneously at the first induction treatment, instead of intradermally as stated in the guideline. Replacement of the first intradermal injection by epicutaneous treatment is scientifically justified and therefore the study design is fully acceptable (Maurer and Hess, 1989). Ten Pirbright-White guinea pigs per sex were induced twice by epidermal treatment with a 30% (ca. 0.4 g per patch) test item/vaseline preparation (day 0 and 7) for 24 and 48 hours, respectively, accompanied by intradermal injection of a FCA-mixture during the first induction. Two weeks after the end of the second induction period, a challenge was performed, where the test substance was applied epidermally for 24 h (occlusive, 0.3%). Evaluation was performed 24 and 48 hours after removal of the dressings. A control group was treated with the vehicle and adjuvant during induction and with vehicle and the test item during challenge exposure. No skin reactions have been observed in test and control animals at both time points, therefore, under the conditions chosen for this study, the test substance is considered to be not sensitizing to the skin.
Migrated from Short description of key information:
The test substance showed no skin sensitizing potential in a GPMT (similar to OECD TG 406, GLP).
Justification for selection of skin sensitisation endpoint:
comparable to guideline
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
There is no information available on the potential for the test substance to produce respiratory sensitisation in animals or humans.
Migrated from Short description of key information:
There is no information available on the potential for the test substance to produce respiratory sensitisation in animals or humans.
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:
- 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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