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

ABSTRACT

The fungal b-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-b-glucan (SGL) from insoluble b-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-b-D-glucan 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.