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首页> 外文期刊>Food and Chemical Toxicology: An International Journal Published for the British Industrial Biological Research >One year oral Toxicity of D-004, a lipid extract from Roystonea regia fruits, in Sprague Dawley rats.
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One year oral Toxicity of D-004, a lipid extract from Roystonea regia fruits, in Sprague Dawley rats.

机译：D-004（一种来自贵妃（Roystonea regia）果实的脂质提取物）对Sprague Dawley大鼠的一年口服毒性。

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摘要

D-004, a lipid extract of royal palm (Roystonea regia) fruits that contains a reproducible mixture of fatty acids, has been shown to prevent testosterone and phenylephrine-induced prostate hyperplasia in rodents. This study investigated the long-term oral toxicity of D-004 in rats. Rats from both sexes were randomized into four groups (20 rats sex/group): a control and three treated with D-004 (800, 1500 or 2000 mg/kg/day, respectively). At study completion, rats were sacrificed under anaesthesia. Determinations of blood biochemical and haematological parameters and organ weight were done. Also, necropsy and histopathological studies were performed. Four of 160 rats died before study completion. No clinical signs of toxicity were observed throughout the study. Food and water consumption, bodyweight, blood biochemical and haematological parameters, organ weight ratios and histopathological findings were similar in control and treated groups. The histological lesions found in treated animals are commonly present in this specie and strain according to literature and our historical data. In conclusion, long-term (12 months) oral treatment of rats with D-004 (800-2000 mg/kg/day) did not show evidences of D-004-related toxicity under our conditions. The highest dose tested (2000 mg/kg) was a no-observed adverse effect level in this study.
机译：D-004是王室棕榈（Roystonea regia）果实的脂质提取物，其中含有可再现的脂肪酸混合物，已被证明可预防啮齿动物的睾丸激素和去氧肾上腺素引起的前列腺增生。这项研究调查了D-004在大鼠中的长期口服毒性。将来自两种性别的大鼠随机分为四组（每组20个性别）：一个对照组和三组用D-004（分别为800、1500或2000 mg / kg /天）治疗。研究完成时，在麻醉下处死大鼠。测定血液的生化和血液学参数以及器官重量。此外，进行了尸检和组织病理学研究。 160只大鼠中有4只在研究完成前死亡。在整个研究中均未观察到毒性的临床迹象。对照组和治疗组的食物和水消耗量，体重，血液生化和血液学参数，器官重量比和组织病理学发现相似。根据文献和我们的历史数据，在被治疗动物中发现的组织学病变通常存在于该物种和品系中。总之，在我们的条件下，长期（12个月）用D-004（800-2000 mg / kg /天）对大鼠进行口服治疗未显示D-004相关毒性的证据。在这项研究中，最高测试剂量（2000 mg / kg）为未观察到的不良反应水平。

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