Registration Dossier

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
Reference
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:
data waiving: supporting information
Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed

Justification for classification or non-classification