Registration Dossier
Registration Dossier
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EC number: 940-284-1 | CAS number: 1591782-62-5
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:
Due to its surfactant properties and in line with OECD test guidelines, the potential contact hypersensitivity of Glucamide 810 (Test material E185/2012 PC W; 85.5%) was assessed in guinea pig maximization test according to Magnusson and Kligman (OECD TG 406). After intradermal induction using a 0.5 % (w/v) test concentration (vehicle water), dermal induction and challenge treatment was performed with a 5% (w/v) test concentration. No skin reactions occurred after challenge exposure (sensitization rate = 0%) indicating that Glucamide 810 is not a skin sensitizer.
The same conclusion was reached for the read-across compound Glucamide 24 which supports a.m. result. Using OECD TG 406 (1981, Modified Buehler, Test material E-4086.01, 45% active gel adjusted for a.i.) as well as the guinea pig maximization test according to Magnusson and Kligman following OECD TG 406 (1992, Test material 10000506, 96.7%), Glucamide 24 was not a skin sensitizer.
Migrated from Short description of key information:
The registered substance does not induce any signs of skin sensitization in animals when evaluated in the guinea pig maximization test according to OECD TG 406. The sensitization incidence was 0%.
Justification for selection of skin sensitisation endpoint:
Guideline study according to GLP. No derivations and/or confounders. Klimisch rating 1 representing reliability without restrictions. Information is valid and meet data requirements.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
The registration substance is not a skin sensitizer. Also no sensitizing potential was revealed for structural and biological close analogues. None of the available toxicological data and known exposure conditions indicates concern that Glucamide 810 may possess respiratory sensitization properties.
Migrated from Short description of key information:
The registration substance is not a skin sensitizer. Also no sensitizing potential was revealed for structural and biological close analogues. None of the available toxicological data and known exposure conditions indicates concern that it may pose a respiratory sensitization risk.
Justification for classification or non-classification
Based on all available data the registered substance is not a skin sensitiser and therefore is not subject for classification and labelling requirements with regard to this endpoint.
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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