Acute and oral subchronic toxicity of D-003 in rats

D-003 is a mixture of higher aliphatic primary acids purified from sugar ca ne wax (Saccharum officinarum) with cholesterol-lowering and antiplatelet e ffects experimentally proven. The present work reports the results of two s tudies investigating the acute and subchronic oral toxicity of D-003 in rat s. Oral acute toxicity of D-003 (2000 mg/kg) was investigated according to the Acute Toxic Class (ATC) method (an alternative for the classical LD50 t est), which was performed in Wistar rats. The results obtained in this stud y defined D-003 oral acute toxicity as unclassified. In the subchronic stud y, rats of both sexes were orally treated with D-003 at 50, 200 and 1250 mg /kg for 90 days. At this time. animals were sacrificed. No evidence of trea tment-related toxicity was detected during the study. Thus. data analysis o f body weight gain, food consumption, clinical observations. blood biochemi cal, haematology, organ weight ratios and histopathological findings did no t show significant differences between control and treated groups. It is co ncluded that D-003 orally administered to rats was safe and that no drug-re lated toxicity was detected even at the highest doses investigated in both acute (2000 mg:kg) and subchronic (1250 mg/kg) studies. (C) 2000 Elsevier S cience ireland Ltd. All rights reserved.