Oral acute and subchronic toxicity of D-004, a lipid extract from Roystonea regia fruits, in rats.

R Gámez, R Mas, M Noa, R Menéndez, H García, Y Rodríguez, Y Rodríguez, E Felipe, E Goicochea
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Abstract

D-004 is a lipid extract obtained from Cuban royal palm (Rosytonea regia) fruits, consisting of a mixture of fatty acids and esters. D-004 has shown protective effects on prostate hyperplasia induced by testosterone in rodents. We report the results of two studies investigating the acute and subchronic oral toxicity of D004 in rats. Oral acute toxicity of D-004 (2,000 mg/kg) was investigated in Sprague Dawley rats according to the acute toxic class method, and the results showed that D-004 oral acute toxicity was practically absent, being defined as unclassified. In the subchronic study, rats were orally treated with D-004 at 500, 1,000 and 2,000 mg/kg for 90 days. No evidence of treatment-related toxicity was detected. Thus, analysis of body weight gain, clinical observations, blood biochemistry, hematology, organ weight ratios and histopathological data did not show significant differences between control and treated groups. We conclude that D-004 orally administered to rats was safe and that no drug-related toxicity was detected even at the highest dose investigated in both acute and subchronic (2,000 mg/kg) studies. Thus, this dose can be considered as a nonobservable-effect dose in rats.

王氏Roystonea果实脂质提取物D-004对大鼠的急性和亚慢性毒性研究。
D-004是从古巴皇家棕榈(Rosytonea regia)果实中提取的脂质提取物,由脂肪酸和酯的混合物组成。D-004对睾酮所致的啮齿动物前列腺增生有保护作用。我们报告了两项研究的结果,调查了大鼠口服D004的急性和亚慢性毒性。根据急性毒性分级法研究D-004 (2000 mg/kg)对Sprague Dawley大鼠的口服急性毒性,结果表明D-004口服急性毒性几乎不存在,定义为未分级。在亚慢性研究中,大鼠分别以500、1000和2000 mg/kg的剂量口服D-004 90天。未发现治疗相关毒性的证据。因此,体重增加分析、临床观察、血液生化、血液学、器官重量比和组织病理学数据在对照组和治疗组之间没有显着差异。我们得出结论,大鼠口服D-004是安全的,即使在急性和亚慢性研究中最高剂量(2,000 mg/kg)也未检测到药物相关毒性。因此,该剂量在大鼠中可视为不可观察到的效应剂量。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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