Four-week oral toxicity study of functional food containing superfine dispersed Lentinan (β-1,3-glucan) in rats

摘要

An immune adjuvant, Lentinan (β-1,3-glucan), derived from Lentinus edodes (Shiitake), has been approved as an anticancer drug (intravenous injection) against unresectable and recurrent gastric cancer. Recently, functional food containing a certain amount of superfine dispersed Lentinan in Shiitake extract, was researched and developed for oral administration. In order to evaluate the possible toxicity of this functional food, we investigated 4-week oral toxicity study in water in SD (Crj:CD (SD) IGS) rats. Because the test article was liquid, the highest dose was an undiluted solution. The intermediate dose was set at 3 times the diluted solution, and the lowest dose was set at 10 times the diluted solution, respectively. There were no changes related to administration of the test article in clinical signs, body weight, food consumption, water consumption, hematology, coagulation, blood chemistry, electrophoresis, urinalysis, ophthalmological examination, organ weight, organ weight per body weight, necropsy and histopathology. It was concluded that the test food had no toxicities for rats.