Acute and oral subchronic toxicity of D-003 in rats.
D-003 is a mixture of higher aliphatic primary acids purified from sugar cane wax (Saccharum officinarum) with cholesterol-lowering and antiplatelet effects experimentally proven. The present work reports the results of two studies investigating the acute and subchronic oral toxicity of D-003 in rats. Oral acute toxicity of D-003 (2000 mg/kg) was investigated according to the Acute Toxic Class (ATC) method (an alternative for the classical LD(50) test), which was performed in Wistar rats. The results obtained in this study defined D-003 oral acute toxicity as unclassified. In the subchronic study, 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 treatment-related toxicity was detected during the study. Thus, data analysis of body weight gain, food consumption, clinical observations, blood biochemical, haematology, organ weight ratios and histopathological findings did not show significant differences between control and treated groups. It is concluded that D-003 orally administered to rats was safe and that no drug-related toxicity was detected even at the highest doses investigated in both acute (2000 mg/kg) and subchronic (1250 mg/kg) studies.
Gámez
R
R
Center of Natural Products, National Center for Scientific Research, PO Box 6880, 198 Ave. and 19 St. Cubanacan, Playa, Havana City, Cuba. dalmer@ip.etecsa.cu
Mas
R
R
Noa
M
M
Menéndez
R
R
Alemán
C
C
Acosta
P
P
García
H
H
Hernández
C
C
Amor
A
A
Pérez
J
J
Goicochea
E
E
D000284:Administration, Oral; D000818:Animals; D000924:Anticholesteremic Agents / Q000633:toxicity*; D001835:Body Weight / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D005227:Fatty Acids / Q000627:therapeutic use*; D005260:Female; D007928:Lethal Dose 50; D008297:Male; D010975:Platelet Aggregation Inhibitors / Q000633:toxicity*; D051381:Rats; D017207:Rats, Sprague-Dawley; D017208:Rats, Wistar
D000924:Anticholesteremic Agents; C418063:D-003 sugarcane wax acid mixture; D005227:Fatty Acids; D010975:Platelet Aggregation Inhibitors