Registration Dossier

Administrative data

Description of key information

A 13-week (90-day) oral toxicity study was conducted in rats under GLP conditions.  No effects were observed in any animal in any dose.  Isomaltulose greens is not toxic to rats at doses up to and including 10% in the diet.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
7 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

A subchronic toxicity test was conducted in which the substance was administered orally in the diet to male and female rats. Four groups of 20 rats per sex per dose were fed the treatment diets daily for 13-weeks at doses of 0, 2.5%, 5%, and 10%. All of the usual clinical parameters were measured. All rats survived until scheduled necropsy and appeared healthy throughout the study. All parameters measured were normal throughout the study. No effects or signs of toxicity were observed in any animal in any dose. The test substance is not toxic to rats at doses up to 10% in the diet given daily for 13 weeks. This dose is equivalent to about 7000 mg/kg bw/day.

Justification for classification or non-classification

No effects were observed in rats given oral doses in the diet for 13 weeks. Isomaltulose greens is not classified as toxic.