13-Week oral toxicity study with isomaltulose (Palatinose®) in rats
article
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
Topics
Toxicology and Applied PharmacologyIsomaltuloseOral administrationRatSafetySubchronic toxicity studyPalatinoseAnimal experimentAnimal tissueBehaviorBlood analysisBody weightCarbohydrate analysisChronic toxicityClinical chemistryControlled studyDietFemaleFluid intakeFood analysisFood intakeHistopathologyImmunotoxicityIngestionMaleMotor activityNeurologic examinationNonhumanCphthalmoscopyOrgan weightRatSafetyUrinalysisAnimalsBlood CoagulationBody WeightDietEatingErythrocyte CountErythrocyte IndicesFemaleIsomaltoseLeukocyte CountMaleOrgan SizeRatsRats, WistarRattus norvegicus
TNO Identifier
236722
ISSN
02786915
Source
Food and Chemical Toxicology, 40(10), pp. 1383-1389.
Pages
1383-1389
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