Safety evaluation of an enzymatically-synthesized glycogen (ESG).
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 2000 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 21 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.
Tafazoli
Shahrzad
S
Cantox Health Sciences International, Mississauga, Ontario, Canada. stafazoli@cantox.com
Wong
Andrea W
AW
Kajiura
Hideki
H
Kakutani
Ryo
R
Furuyashiki
Takashi
T
Takata
Hiroki
H
Kuriki
Takashi
T
D000688:Amylose / Q000737:chemistry*; D000818:Animals; D003257:Consumer Product Safety; D003912:Dextrins / Q000737:chemistry*; D004040:Dietary Carbohydrates / Q000032:analysis / Q000633:toxicity; D004305:Dose-Response Relationship, Drug; D004926:Escherichia coli / Q000187:drug effects / Q000235:genetics; D005260:Female; D006003:Glycogen / Q000138:chemical synthesis / Q000737:chemistry / Q000633:toxicity*; D006004:Glycogen Debranching Enzyme System / Q000737:chemistry*; D006801:Humans; D007517:Isoamylase / Q000737:chemistry*; D008297:Male; D009152:Mutagenicity Tests; D051381:Rats; D017207:Rats, Sprague-Dawley; D012486:Salmonella typhimurium / Q000187:drug effects / Q000235:genetics; D023382:Toxicity Tests, Acute; D036401:Toxicity Tests, Chronic
D003912:Dextrins; D004040:Dietary Carbohydrates; D006004:Glycogen Debranching Enzyme System; D006003:Glycogen; D000688:Amylose; C020569:4 alpha-glucanotransferase; D007517:Isoamylase