Registration Dossier
Registration Dossier
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EC number: 211-669-5 | CAS number: 683-10-3
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 hours on occluded skin
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Remarks:
- No details given in the review report.
- Test type:
- standard acute method
Test material
- Reference substance name:
- (carboxylatomethyl)hexadecyldimethylammonium
- EC Number:
- 211-748-4
- EC Name:
- (carboxylatomethyl)hexadecyldimethylammonium
- Cas Number:
- 693-33-4
- Molecular formula:
- C20H41NO2
- IUPAC Name:
- (Carboxylatomethyl)hexadecyldimethylammonium
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- 94.9% pure
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Groups of 5 male Sprague-Dawley rats received the test material dermally on clipped trunks; test sites were occluded for 24 h, after which the test sites were wiped clean of the test material
- Duration of exposure:
- 24 hours
- Doses:
- not specified
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 16 other: g/kg
- Based on:
- test mat.
- Clinical signs:
- other: Erythema, edema, desquamation, necrosis, and scab formation observed on test sites for test material, as was sluggishness and reddish nasal and ocular discharges; body weight gains within normal parameters; no treatment-related changes due to either test
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Cetyl betaine is not harmful by skin absorption.
Lauryl betaine has a very similar structure to cetyl betaine, the only difference being in the chain length of the alkyl grouping, i.e. C16 9cetyl) vs C12 (lauryl).
The CIR 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'
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