Safety profile of a food dextrin: acute oral, 90-day rat feeding and mutagenicity studies.

Nutriose is a glucose polysaccharide produced by the chromatographic separation of a dextrin fraction derived from maize, wheat or other edible starches. Animal safety studies conducted on Nutriose FB are reported. They include an acute oral and a 90-day study in rats and short-term in bacteria (Ames test) and a mutation assay at the TK locus in L5178Y mouse lymphoma cells. An acute oral study in Sprague-Dawley rats established the LD(50) as greater than 2000 mg/kg. In a 90-day, oral subchronic study, Sprague-Dawley rats were administered Nutriose FB in their diet at doses of 0, 1.25%, 2.5% or 5% for 13 weeks. Neither mortality nor significant behavioral changes occurred during the study. The consumption of Nutriose FB did not have any effect on body weight or on feed or water consumption. Blood coagulation and hematology and blood and urine biochemistry did not reveal any toxic effect of the compound. No treatment-related histopathological differences were observed between control and test groups. Adverse clinical observations, including ophthalmological observations, were marginal and not considered treatment-related. There was no effect of Nutriose FB on relative or absolute organ weight of rats of either sex, except for the increase in caecum content and caecum mucosa. The increase in caecum weight is considered a physiological adaptation seen after the ingestion of indigestible carbohydrates and is not considered a toxicological effect. The No-Observed-Adverse-Effect-Levels (NOAELs) were established by the highest tested doses: 4.4 g/kg bw/day in males and 6.5 g/kg bw/day in females. Mutation assays in bacteria (Ames tests) and in mammalian cells (tk locus in mouse lymphoma cells) were negative with Nutriose FB.