Single dose toxicity studies of sulfated water soluble beta-D-glucan in Sprague-Dawley rats

Abstract

The fungal beta-D-glucan is a biological response modifier (BRM), but a major obstacle to the clinical utilization of these BRMs is their relative insolubility in aqueous media. We made soluble sulfated-beta-glucan (SGL) from insoluble beta-glucan (IGL) by sulfation method. In single dose toxicity study of SGL for 7 days, no negative effects on body weight or food consumption of rats were evident below a dose rate of 2,000 mg kg(-1) SGL. No clinical pathology, functional/behavioral, or gross observations indicating toxicity were detected. In hematology and biochemistry, statistically significant increases of WBC and neutrophils (P<0.01) in male and increase of MCV (P<0.05) in females was observed. However, since the changes were not dose responsive, the effects were considered to be of no toxicological significance. These results suggest that chemically modified sulfated-beta-Dglucan was less toxic than the insoluble b-glucan and not considered acutely toxic following peritoneal exposure to 2,000mg kg(-1) day(-1) in Sprague-Dawley rats.