Registration Dossier
Registration Dossier
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EC number: 211-748-4 | CAS number: 693-33-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
In oral reproductive and developmental toxicity studies of cetyl betaine in rats, the LOAEL for the dams was 50 mg/kg due to decreased body weight gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because a pre-natal developmental toxicity study is available
- Justification for type of information:
- In view of the absence of effects to reproductive organs in a 90 day study on this substance and in view of the absence of effects in development studies, further animal work cannot be justifed.
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
Justification for classification or non-classification
Additional information
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.
