Registration Dossier
Registration Dossier
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EC number: 938-458-7 | CAS number: 1443751-77-6
Endpoint summary
Administrative data
Description of key information
LD50 acute oral rat: > 2000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Due to legal reasons it is not justified to perform this study. The substance is used solely for cosmetic uses. According to Directive 76/768/EEC (Cosmetics Directive) and in Regulation 1223/2009/EC (Cosmetics Regulation) it is not allowed to perform animal tests, although cosmetic raw materials are subject to restriction (marketing ban). Therefore the test on acute oral toxicity has to be waived.
In one acute oral toxicity OECD guideline study, two dose levels of 506 and 2006 mg/kg bw of the similar substance N-(2-Hydroxypropyl)stearamide administered to rats, resulted in no mortalities, no signs of systemic toxicity, no abnormalities or macroscopic changes in the organs at necropsy, therefore the oral LD50 of N-(2-Hydroxypropyl)stearamide in rats was established to be > 2,000 mg/kg bw (1993).
N-(2-Hydroxypropyl)stearamide is an amide of isostearic acid and isopropanolamine. The structural similarity of Amides, C8-10 (even numbered), N-hydroxyethyl and N-(2 -Hydroxypropyl)stearamide results in similar acute oral toxicity. Therefore it is justified to use this data for classification and labeling.
Justification for classification or non-classification
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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