Registration Dossier
Registration Dossier
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EC number: 947-036-1 | CAS number: -
Endpoint summary
Administrative data
Description of key information
This substance is used exclusively in personal care products. Because of this, it was not possible to find a laboratory to perform a new OECD TG 422 study in Europe. For this reason, use was made of existing data on an analogue substance.
A study was reported in the literature in which rats were dosed with cetyl betaine (the main constituent of the registered substance) for 91 days at 0, 50, 150 or 350 mg/kg bw/day using a method similar to OECD TG 408. 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. The NOAEL was established at 350 mg/kg bw/day.
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 91 days
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- not specified
- GLP compliance:
- yes
- Limit test:
- no
- Specific details on test material used for the study:
- cetyl betaine tested at 32% active adjusted to be delivered at doses of 0, 0.05, 0.15, 0.35 g/kg/day
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 150 mg/kg bw/day (nominal)
- Dose / conc.:
- 350 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- attributed to palatability problems of diet
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- slight clinical chemistry signs noted but not detailed
- Gross pathological findings:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- 350 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- not specified
- Basis for effect level:
- clinical biochemistry
- Critical effects observed:
- no
- Conclusions:
- Although the details in the CIR review are brief and the primary data source is unpublished (Hazleton Laboratories America Inc. 1990. 91-Day subchronic oral toxicity study in rats with Cetyl Betaine. Unpublished data submitted by Personal Care Products Council. 74 pages), the CIR panel consider the result valid.
There appears to be no specifc target organ
Reference
All animals survived until end of treatment period; no treatment-related clinical observations; mean body weights and body weight gains significantly decreased in high dose males which was accompanied by significantly decreased total feed consumption – these observations were attributed to palatability problems of diet than toxic effects of test material; slight clinical chemistry changes observed in high dose animals; no gross or histologic alterations, including to reproductive organs, attributed to test material observed.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 350 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
