Registration Dossier
Registration Dossier
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EC number: 211-669-5 | CAS number: 683-10-3
Endpoint summary
Administrative data
Description of key information
Other than slight clinical chemistry changes observed in high dose animals; no gross or histologic alterations, including to reproductive organs, attributed to test material (cetyl betaine) were observed. In addition, reviews by US EPA on the class of substance (surrogate betaines) demonstrate that toxicity for this class is limited to GI tract irritation with no evidence of specific organ toxicity.
In view of the primary use in cosmetics, further animal testing can not be justifed.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Cetyl betaine (C16) and Lauryl betaine (C12) are very closely related chemical structures. The parent compound, betaine, is a naturally occurringN-trimethylated amino acid.
The individual betaines differ only in chain length. They are generally UVCB substances being manufactured from naturally occurring plant and animal sources.
The Cosmetic Ingredient Review Expert Panel reviewed the product use, formulation and safety data of eleven alkyl betaines, as used in cosmetics. (Final report issued 2014-04-04)
The Panel concluded that the common core chemical structure, similar functions and concentrations in cosmetics, and the predicted physicochemical properties enabled grouping these ingredients and reading across the available toxicological data to support the safety assessment of each individual compound in the entire group.
Therefore it is assessed that it is acceptable to apply the results of this test to lauryl betaine.
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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