Registration Dossier

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.