Registration Dossier

Administrative data

Description of key information

Acute toxicity data are available from longer-term repeated dose studies conducted on both isomaltulose greens and isomaltulose.  In both studies doses higher than the standard acute toxicity limit dose were given orally by gavage daily for 26 weeks.  No acute toxicity signs were observed in either study, demonstrating that isomaltulose greens are not acute toxic.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
4 500 mg/kg bw

Additional information

Toxicity tests was conducted in which isomaltulose greens or isomaltulose were administered to male and female rats for 26 weeks. Doses (1,500, 3,000 and 4,500 mg/kg) were administered orally via gavage once a day. Random deaths attributable to perforation of the esophagus due to administration failure were observed but were not treatment related. No other mortalities were observed. Since the doses were well above the usual acute toxicity test limit dose, and no mortality or marked clinical signs were observed, the studies demonstrate the lack of acute toxicity.

Justification for classification or non-classification

Isomaltulose greens is not toxic at oral doses up to and including 4,500 mg/kg, therefore isomaltulose greens is not classified.