Oral acute toxicity study of d-005, lipid extract from the fruits of acrocomia crispa (corojo palm tree) in rabbits

Abstract

D-005, is a lipid extract from the fruits of Acrocomia crispa (corojo palm tree) (Arecaceae), palm specie endemic from Cuba that contains a reproducible mixture of fatty acids, as lauric, oleic, mirystic and palmitic acids, while stearic, caprylic, capric and palmitoleic acids are at lower concentrations. Oral treatment with D-005 reduced prostate enlargement induced with testosterone in rats. In the preclinical evaluation of a new drug the acute study in non-rodents species usually is included. This study determined the toxic effects of D-005 orally administered at doses of 2 000 mg/kg, to White New Zealand rabbits from both sexes in accordance with the acute toxic class method. Oral acute toxicity of D-005 was researched in rabbits in accordance with the acute toxic class method. Animals after a single administration were observed daily during 14 d. Body weight data measured at the beginning and the end of the study were also recorded. Data analysis of mortality, clinical observations, body weight, food consumption and gross pathological changes did not show significant differences between control and treated groups in any sex. The oral acute toxicity of D-005 was considered as unclassified according to the acute toxic class method, since a dose of 2 000 mg/kg did not induce deaths or signs of toxicity.