Acute and Subchronic Toxicity and MutagenicityStudies
on Hydrogenated Isomaltooligosaccharides Mixture,
and Evaluation of Laxative Effect in Humans Jun Tsunehiro1, KatsuyukiOkamoto2, Shouji Awamoto1,
Tsuneya Yatake2, Toshiyuki Kaneko2, AkinoriHirao3
and Masayosi Kanisawa4 1Research and Development Center,Kashima Laboratory, Showa Sangyo Co. Ltd.,
2Research and Development Center, Showa Sangyo Co.Ltd.
3Omiya Research Laboratory, Nikken Chemicals Co.Ltd.
4Department of Pathology, Yokohama City UniversitySchool of Medicine Hydrogenated isomaltooligosaccharide (IMO-H), akind of sugar alcohols, is expected to be available for sugarlessfoods as a sweetener. In the context of the safety evaluation ofIMO-H, subchronic and acute toxicity studies, mutagenicity assayand laxative effects in humans were summarized as follows. 1. MaleSprague-Dawley rats were fed a diet containing 3% or 10% IMO-H for16 weeks ad libitum. No dose-related and toxic change of IMO-Hfeeding was observed in treated rats as regards the body weight,hematological and blood biochemical tests, and anatomical andhistopathological examinations. 2. At a single dose level of 15.3,21.7, 30.7 or 43.4 g/kg of IMO-H was orally administered in maleWistar rats, the mortality increased as the dose increased and theLD50 was estimated 32.4 g/kg. 3. A mutagenicity test (Ames assay)and a chromosome aberration test using Chinese hamster lung (CHL)cells gave no indication that IMO-H possessed any genotoxicpotential. 4. Twenty healthy men were divided randomly into 4groups and orally administered the different doses of IMO-H andmaltitol. Both of sweeteners caused diarrhea regularly at thehigher dose and the maximum non-effective dose of IMO-H wasestimated to be about 0.6 g/kg and that of maltitol was 0.3 g/kg.Based on these results, it is found that IMO-H is a less toxicsugar substitute and the laxative effect in humans is lower thanthat of general sugar alcohols.
Key Words: hydrogenated isomaltooligosaccharide, toxicity,mutagenicity, laxative effect |
Return
|
