Safety Evaluation Studies of Leucrose

Abstract

Leucrose, D-glucopyranosyl-α(l 5)-D-fructopyranose, is produced by treatment of sucrose with the α(1 6)-glucosyltransferase isolated from Leuconostoc mesenteroides, a nonpathogenic, nontoxigenic microorganism. Rats, dogs, and humans metabolize leucrose efficiently and rapidly in the jejunum by enzymatic hydrolysis into its constituent glucose and fructose. Only traces of leucrose appear in plasma and urine of rats and humans, whereas somewhat larger amounts are seen in plasma and urine of dogs. No toxic or other biological effects were detected in 13-week studies in rats and dogs. Leucrose is not teratogenic in rats and rabbits, and is not genotoxic. It is noncariogenic in humans and rats, and resists attack by the microorganisms present in the human oral cavity.