Abstract
Hydrogenated isomaltooligosaccharide (IMO-H), a kind of sugar alcohols, is expected to be available for sugarless foods as a sweetener. In the context of the safety evaluation of IMO-H, subchronic and acute toxicitystudies, mutagenicity assay and laxative effects in humans were summarized as follows. (1) Male Sprague-Dawley rats were fed a diet containing 3% or 10% IMO-H for 16 weeks ad libitum. No dose-related and toxic change of IMO-H feeding was observed in treated rats as regards the body weight, hematological and blood biochemical tests, and anatomical and histopathological 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 male Wistar rats, the mortality increased as the dose increased and the LD50 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 genotoxic potential. (4)Twenty healthy men were divided randomly into 4 groups and orally administered the different doses of IMO-H and maltitol. Both of sweeteners caused diarrhea regularly at the higher dose and the maximum non-effective dose of IMO-H was estimated 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 toxic sugar substitute and the laxative effect in humans is lower than that of general sugar alcohols.
