Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
5857778 | Regulatory Toxicology and Pharmacology | 2010 | 10 Pages |
Abstract
An enzymatically-synthesized glycogen (ESG), intended for use as a food ingredient, was investigated for potential toxicity. ESG is synthesized in vitro from short-chain amylose by the co-operative action of branching enzyme and amylomaltase. In an acute toxicity study, oral administration of ESG to Sprague-Dawley rats at a dose of 2000Â mg/kg body weight did not result in any signs of toxicity. ESG did not exhibit mutagenic activity in an in vitro bacterial reverse mutation assay. In a subchronic toxicity study, increased cecal weights noted in the mid- (10%) and high-dose (30%) animals are common findings in rodents fed excess amounts of carbohydrates that increase osmotic value of the cecal contents, and thus were considered a physiological rather than toxicological response. The hematological and histopathological effects observed in the high-dose groups were of no toxicological concern as they were secondary to the physiological responses resulting from the high carbohydrate levels in the test diets. The no-observed-adverse-effect level for ESG in rats was therefore established to be 30% in the diet (equivalent to approximately 18 and 21Â g/kg body weight/day for male and female rats, respectively). These results support the safety of ESG as a food ingredient for human consumption.
Related Topics
Life Sciences
Environmental Science
Health, Toxicology and Mutagenesis
Authors
Shahrzad Tafazoli, Andrea W. Wong, Hideki Kajiura, Ryo Kakutani, Takashi Furuyashiki, Hiroki Takata, Takashi Kuriki,