Registration Dossier
Registration Dossier
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EC number: 249-793-7 | CAS number: 29710-25-6
Categories
- Category name:
- ETHYLHEXYL HYDROXYSTEARATE
Justifications and discussions
- Category definition:
- alkyl esters (group of cosmetic ingredients reviewed in a safety assessment by The Cosmetic Ingredient Review (CIR) Expert Panel (Panel))
- Category description:
- Ethylhexyl hydroxystearate and similar substances
- Category rationale:
- REPORTING FORMAT FOR THE CATEGORY APPROACH
1. CATEGORY HYPOTHESIS
Cetyl esters is a constituent of a broader group of cosmetic ingredients, the alkyl esters, which consist ofthe reaction products of fatty acids and alcohols. The 237 alkyl esters being reviewed in a safety assessment by The Cosmetic Ingredient Review (CIR) Expert Panel (Panel).
The ingredients in this review are alkyl esters. The substance of interest (2-ethylhexyl 12-hydroxyoctadecanoate) is a member of the category group.
The members have the same functions, similar metabolic pathways and similar hazardous profile.
2. CATEGORY JUSTIFICATION
Data considered in the CIR safety assessment of the group of substances were judged as reliabile and adequate for the purpose of the REACH registration and to fill the gap information.
(i) A clear substance characterisation is available: in the category definition (Fiume MM. et al., 2015) a description of the category members is available in the category members are listed in a table. A general chemical structure of the members is also provided. That means the chemical identity of chemicals is sufficiently clear for a meaningful assessment of the proposed read-across. where necessary, the degree of purity is reported.
(ii) description of the substances: a clear and unambiguous description of each member of the category is submitted (Name, CAS and/or EC number and chemical structure for the source substance and for the target)
(iii) similarity (characteristics in common between substances): the members of the category are alkyl esters. The core relationship between these ingredients is a carboxyl ester functional group flanked on both sides by extended alkyl chains.
structural differences: some of these alkyl chains are saturated and some are unsaturated, and some of the chains are straight and some branched.
(iv) The study that was reported for is considered as adequate and reliable for the purpose of the
prediction based on read-across: the study results are adequate for the purpose of classification and labelling and risk assessment.
3. APPLICABILITY DOMAIN OF THE CATEGORY
The 237 alkyl esters being reviewed in a safety assessment by The Cosmetic Ingredient Review (CIR) Expert Panel (Panel).
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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