A 28-day oral (dietary) toxicity study of sucromalt in Sprague--Dawley rats.

A new sweetener, sucromalt, was produced via enzymatic conversion of sucrose and maltose to a mixture of fructose, leucrose and gluco-oligosaccharides. The present study evaluated the safety of this sweetener when administered as a dietary admix at concentrations of 50, 100 and 200 g/kg to Sprague-Dawley rats for 28 days. There were no treatment-related effects on the general condition and behavior as determined by clinical observations, functional observational battery and locomotor activity assessments. Evaluation of clinical pathology parameters revealed no toxicologically-relevant treatment-related effects on hematology, serum chemistry or urinalysis. Macroscopic and microscopic findings revealed no treatment-related effects on any organ evaluated. A treatment-related increase in mean food consumption was observed resulting in slightly higher body weight gains (2-4%) for both the male and female rats, which was not toxicologically relevant. Results of this study clearly demonstrate that consumption of high concentrations of sucromalt for 28 days is not associated with obvious signs of toxicity.