Dodda Sundararaju, Alluri Venkata Krishnaraju, Golakoti Trimurtulu, Sengupta Krishanu
Laila Nutraceuticals R&D Center, Vijayawada, Andhra Pradesh, India.
J Toxicol. 2020 Jul 30;2020:1435891. doi: 10.1155/2020/1435891. eCollection 2020.
The present communication describes a battery of toxicity studies that include an acute oral toxicity, a subacute twenty-eight-day repeated oral dose toxicity, and genotoxicity studies on a herbal formulation CinDura® (GMCT). This proprietary herbal composition contains the extracts of the fruit rind (GM) and the leaf (CT). The toxicological evaluations were performed following the Organization for Economic Cooperation and Development (OECD) guidelines. The acute oral toxicity study in Wistar rats suggests that the median lethal dose of CinDura® is at least 2000 mg/kg body weight. Acute dermal and eye irritation tests in New Zealand white rabbits indicate that the test item is nonirritant to the skin and eyes. A twenty-eight-day repeated dose oral toxicity study was conducted in male and female Wistar rats using daily doses of 250, 500, and 1000 mg/kg body weight, followed by a fourteen-day reversal period for two satellite groups. The CinDura®-supplemented animals did not show any sign of toxicity on their body weights, organ weights, and on the hematobiochemical parameters. The gross pathology and histopathological examinations indicated no treatment-related changes in the experimental animals. Overall, the no-observed-adverse-effect level (NOAEL) of the herbal blend is 1000 mg/kg body weight, the highest tested dose. Also, the results of the bacterial reverse mutation test and the erythrocyte micronucleus assay in mouse bone marrow suggest that CinDura® (GMCT) is neither mutagenic nor clastogenic.
本报告描述了一系列毒性研究，包括急性经口毒性、亚急性28天重复经口给药毒性以及对一种草药配方CinDura®（GMCT）的遗传毒性研究。这种专利草药组合物含有果皮（GM）和叶子（CT）的提取物。毒理学评估按照经济合作与发展组织（OECD）指南进行。在Wistar大鼠中进行的急性经口毒性研究表明，CinDura®的半数致死剂量至少为2000毫克/千克体重。在新西兰白兔中进行的急性皮肤和眼睛刺激性试验表明，受试物对皮肤和眼睛无刺激性。在雄性和雌性Wistar大鼠中进行了为期28天的重复给药经口毒性研究，每日剂量分别为250、500和1000毫克/千克体重，随后两个卫星组有14天的恢复期。补充CinDura®的动物在体重、器官重量和血液生化参数方面未表现出任何毒性迹象。大体病理学和组织病理学检查表明，实验动物未出现与治疗相关的变化。总体而言，该草药混合物的未观察到有害作用水平（NOAEL）为1000毫克/千克体重，即最高测试剂量。此外，小鼠骨髓细菌回复突变试验和红细胞微核试验结果表明，CinDura®（GMCT）既无诱变性也无染色体断裂性。
