A 90-day oral toxicity study of glycolipids from Dacryopinax spathularia in CD® rats.

The subchronic toxicity of jelly mushroom glycolipids from Dacryopinax spathularia (herein referred to as "AM-1") was studied in Crl:CD(SD) rats. The test item was administered via the drinking water at concentrations of 1.5, 5.0 or 15 mg/mL for 90 days with an additional 4-week recovery period. No test article-related deaths, clinical observations or neurological effects were noted. Decreased drinking water consumption for mid- and high-dose groups was attributable to the reduced palatability of drinking water containing higher test article concentrations. Mean body weights of high-dose males were slightly reduced beginning study week 1 due to decreased food and drinking water intake, but were not statistically significant by week 7. No test article-related adverse effects were noted for hematological or clinical chemistry, or urinalysis parameters. Statistically significant changes in select parameters were within historical control data ranges, lacked histopathological correlates, and did not occur in a consistent pattern that would suggest biological significance. Microscopic examination did not reveal any test article-related morphological changes. The no-observed-adverse-effect level (NOAEL) was considered to be 15 mg/mL (1201 and 1423 mg AM-1/kg bw/day for male and female rats, respectively). These results support the safety assessment of jelly mushroom glycolipids for potential use in food.