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13-Week oral toxicity study with isomaltulose (Palatinose®) in rats

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Author: Jonker, D. · Lina, B.A.R. · Kozianowski, G.
Type:article
Date:2002
Institution: TNO Voeding Centraal Instituut voor Voedingsonderzoek TNO
Source:Food and Chemical Toxicology, 10, 40, 1383-1389
Identifier: 236722
doi: doi:10.1016/S0278-6915(02)00106-0
Keywords: Toxicology and Applied Pharmacology · Isomaltulose · Oral administration · Rat · Safety · Subchronic toxicity study · Palatinose · Animal experiment · Animal tissue · Behavior · Blood analysis · Body weight · Carbohydrate analysis · Chronic toxicity · Clinical chemistry · Controlled study · Diet · Female · Fluid intake · Food analysis · Food intake · Histopathology · Immunotoxicity · Ingestion · Male · Motor activity · Neurologic examination · Nonhuman · Cphthalmoscopy · Organ weight · Rat · Safety · Urinalysis · Animals · Blood Coagulation · Body Weight · Diet · Eating · Erythrocyte Count · Erythrocyte Indices · Female · Isomaltose · Leukocyte Count · Male · Organ Size · Rats · Rats, Wistar · Rattus norvegicus

Abstract

The potential subchronic oral toxicity of isomaltulose (Palatinose®) was examined by administering this substance in the diet to groups of 20 male and 20 female Wistar rats at levels of 0, 2.5, 5 and 10% for 13 consecutive weeks. Daily clinical observations, body weight, food conversion efficiency, food and water consumption were not affected at any stage of the study. Ophthalmoscopy, haematology, clinical chemistry, urinalysis, organ weights, gross and histopathological examination, neurobehavioural observations, motor activity assessment and the results of an immunotoxicity screen did not reveal any abnormalities related to the ingestion of the test substance. In conclusion, the administration of isomaltulose at dietary levels up to 10% for 13 consecutive weeks was well tolerated without any signs of toxicity. The overall intake at this level corresponded to 7.0 and 8.1 g/kg body weight/day in male and female rats, respectively. © 2002 Elsevier Science Ltd. All rights reserved. Chemicals/CAS: Isomaltose, 499-40-1; isomaltulose, 13718-94-0