Gutiérrez MA, Gámez MR, Noa PM, Mas FR, Valle CM, Goicochea CE

Language: Spanish
References: 25
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ABSTRACT

Introduction: D-004 is a lipid extract from the Cuban royal palm tree (Roystonea regia) fruits, containing a mixture of fatty acids, mainly oleic, palmitic, lauric and mirystic. This mixture has proved to prevent prostatic hyperplasia induced with testosterone and phenylephrine in rodents.
Objective: to determine toxic effects of D-004 orally administered at doses up 2 000 mg/kg, to Sprague Dawley rats from both sexes.
Methods: oral acute toxicity of D-004 (2 000 mg/kg) was investigated according to the Acute Toxic Class Method. In the subchronic study, rats were treated with D-004 at 500, 1 000 and 2 000 mg/kg for 90 days while in the chronic study, animals were administered with D-004 at 800, 1 500 and 2 000 mg/kg/day during twelve months.
Results: no evidence of treatment-related toxicity was detected. Thus, clinical observations, control of body weight and food consumption, blood biochemical and haematological parameters, organ weight ratios and histopathological findings showed no significant differences between control and treated groups.
Conclusions: these studies showed no evidences of D-004-related oral toxicity, even at the highest dose investigated (2 000 mg/kg). Hence, this dose represents a nontoxic dose level in rats.

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