Registration Dossier
Registration Dossier
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EC number: 619-079-3 | CAS number: 949109-75-5
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:
In a well conducted OECD 406 study to assess the sensitising potential of Plant sterols on the skin of guinea pigs by epicutaneous application under an occlusive patch following an induction period. The results indicated that under the conditions of the study, Plant sterols are not sensitising by skin contact. (Pitterman 1994).
In a clinical investigation of the allergenic potential of vegetable oils derived phytosterols from soybean, 32 soy allergic patients when challenged with soy based phytosterols gave no evidence of an allergic reaction. It can therefore be concluded that phytosterols are not allergenic to individuals with a clinical history of soy allergy. (Niggemann 2006)
Migrated from Short description of key information:
In a well conducted OECD 406 study to assess the sensitising potential of Plant sterols on the skin of guinea pigs by epicutaneous application under an occlusive patch following an induction period. The results indicated that under the conditions of the study, Plant sterols are not sensitising by skin contact.
Justification for selection of skin sensitisation endpoint:
OECD 406 study
Justification for classification or non-classification
On the basis of the OECD 406 skin sensitsation study, Plant sterols are not sensitising by skin contact and do not fulfil the classification criteria laid down by the CLP Regulation. (1272/2008).
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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