Registration Dossier
Registration Dossier
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EC number: 700-515-7 | CAS number: 1236007-63-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on developmental toxicity
Description of key information
An embryotoxicity/teratogenicity study was conducted in which isomaltulose was administered orally in the diet from day 0 to day 21 of pregnancy. No significant effects were observed on any maternal or developmental measure. Isomaltulose is not toxic.
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 7 000 mg/kg bw/day
Additional information
An embryotoxicity/teratogenicity study was conducted in which isomaltulose was administered orally in the diet from day 0 to day 21 of pregnancy. Doses were control, 2.5%, 5% and 10% isomaltulose in the feed. No maternal toxicity occurred during the study, and no effects on reproductive performance, embryotoxicity, fetal development, or teratogenicity were observed. Therefore the dietary level of 10% isomaltulose, which is equivalent to approximately 7000 mg/kg bw/day, is considered a no effect level.
Justification for classification or non-classification
A developmental study was conducted on isomaltulose and resulted in no effects.
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.
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