A ninety-day feeding, subchronic toxicity study of oligo-N-acetylglucosamine in Fischer 344 rats.

Oligo-N-acetylglucosamine (OAG) is a hydrolyzed derivative of chitin that has been used as a sweetener in foods. Since, no information has been published about the safety of OAG, a 90-day feeding study was conducted, using F344 Fischer rats of both sexes, to characterize and evaluate the toxicity of OAG, and the results of the study are presented here. Dietary levels of 0% (control), 0.2%, 1%, and 5% OAG did not change any measurements in ophthalmological examinations, clinical signs, body weights, food consumption, hematology, blood biochemistry, urinalysis, necropsies, organ weights or histological examinations. The sole finding, which could not be clarified to be attributed to OAG or not, was a decrease in the relative weight of the submaxillary gland to body weight in the male animals given the 5% OAG diet. Although no lesions were found in either gross or histological examination in the present study, further studies using OAG levels higher than 5% might provide a clue to the mechanisms underlying the decreased organ weight observed here. Taken together, under the conditions in the present study, the No Observed Adverse Effect Level (NOAEL) for males was found to be 1% (0.641 g/kg/day); and that for females, 5% (3.64 /kg/day) or more, based on the lack of toxicological effects.