Kothari Shil C, Shivarudraiah Prasad, Venkataramaiah Suresh Babu, Gavara Swapna, Arumugam Shri Natrajan, Soni Madhu G
Gateway Health Alliances Inc., 4769 Mangels Blvd, Fairfield, CA 94534, USA.
Anthem Biosciences Pvt. Ltd., #49, Canara Bank Road, Bommasandra Industrial Area, Phase I, Hosur Road, Bangalore 560099, Karnataka, India.
Food Chem Toxicol. 2014 Jul;69:120-31. doi: 10.1016/j.fct.2014.03.045. Epub 2014 Apr 5.
In western Cameroon, edible fruits and seeds from the plant Dichrostachys glomerata are commonly used as spices. Extract from the fruit pods has been reported as a good natural source of antioxidants and may provide health benefits. The objective of the present study was to investigate potential adverse effects, if any, of D. glomerata fruit pod extract (Dyglomera™) in a subchronic toxicity study and in genotoxicity studies. In the toxicity study, Sprague Dawley rats (20/sex/group) were gavaged with D. glomerata extract at dose levels of 0, 100, 1000 and 2500 mg/kg body weight (bw)/day for 90-days. Dyglomera™ administration did not result in mortality or show treatmentrelated changes in clinical signs of toxicity, body weights, body weight gain or feed consumption. Similarly, no toxicologically significant treatment-related changes in hematological, clinical chemistry, urine analysis parameters, and organ weights were noted. Macroscopic and microscopic examinations did not reveal treatment-related abnormalities. Mutagenic and clastogenic potentials as evaluated by Ames assay, in vitro and in vivo chromosomal aberration test and in vivo micronucleus test did not reveal any genotoxicity of the extract. The results of subchronic toxicity study supports the no-observed-adverse-effect level (NOAEL) for D. glomerata extract as 2500 mg/kg bw/day, the highest dose tested.
在喀麦隆西部，球穗 Dichrostachys 植物的可食用果实和种子常被用作香料。据报道，该植物果荚提取物是一种良好的天然抗氧化剂来源，可能对健康有益。本研究的目的是在亚慢性毒性研究和遗传毒性研究中，调查球穗 Dichrostachys 果荚提取物（Dyglomera™）是否存在潜在的不良影响。在毒性研究中，将 Sprague Dawley 大鼠（每组雌雄各 20 只）按体重 0、100、1000 和 2500 mg/kg 体重（bw）/天的剂量水平灌胃给予球穗 Dichrostachys 提取物，持续 90 天。给予 Dyglomera™ 未导致死亡，也未显示出与治疗相关的毒性临床体征、体重、体重增加或饲料消耗变化。同样，在血液学、临床化学、尿液分析参数和器官重量方面，未观察到与治疗相关的具有毒理学意义的变化。大体和显微镜检查未发现与治疗相关的异常。通过 Ames 试验、体外和体内染色体畸变试验以及体内微核试验评估的诱变和断裂潜力未显示该提取物具有任何遗传毒性。亚慢性毒性研究结果支持球穗 Dichrostachys 提取物的未观察到有害作用水平（NOAEL）为 2500 mg/kg bw/天，即所测试的最高剂量。
