Department of Applied Chemistry, Kumoh National Institute of Technology, Gumi, 39177, South Korea; Institute of Natural Science, Keimyung University, Daegu, 42601, South Korea.
R&D Center, BTC Corporation, Sangnok-gu, Ansan, 15588, South Korea.
Regul Toxicol Pharmacol. 2022 Aug;133:105220. doi: 10.1016/j.yrtph.2022.105220. Epub 2022 Jul 2.
Zizania latifolia Turcz. has long been used as a food source in Southeast Asia. The grains, stems, and leaves of Z. latifolia and its major component, tricin, have also been studied to determine their biological activities. Previously, we hydrolyzed the aerial part of Z. latifolia using an enzyme mixture to maximize the tricin content of the Z. latifolia extract. However, the safety of enzyme-treated Z. latifolia extract (ETZL; DermaNiA™) has not yet been determined. In this study, we performed an in vivo 90-day repeated-dose evaluation and genotoxicity study to assess the toxicological potential of ETZL. EZTL did not exhibit genotoxicity in the bacterial reverse mutation test, in vitro chromosomal aberration assay, or in vivo micronucleus test. Moreover, no changes in body weight or hematological and serum biological parameters were observed in male or female rats under high-dose EZTL treatment (5000 mg/kg body weight (bw)/day) for 90 days with a 4-week recovery period. Significant changes were noted in the forestomach, kidneys, and adrenal glands in the test groups, but these changes, or tendency for recovery, were not observed in the recovery group. Based on these data, the no adverse effect level was determined to be 1250 mg/kg bw/day in rats.
长喙黍（Zizania latifolia Turcz.）在东南亚长期以来一直被用作食物来源。长喙黍的谷物、茎和叶及其主要成分荞麦乙素也被研究以确定其生物活性。以前，我们使用酶混合物水解长喙黍的地上部分，以最大限度地提高长喙黍提取物中的荞麦乙素含量。然而，酶处理的长喙黍提取物（ETZL；DermaNiA™）的安全性尚未确定。在这项研究中，我们进行了为期 90 天的重复剂量体内评估和遗传毒性研究，以评估 ETZL 的毒理学潜力。ETZL 在细菌回复突变试验、体外染色体畸变试验或体内微核试验中均未表现出遗传毒性。此外，在 90 天的高剂量 ETZL （5000mg/kg 体重/天）治疗和 4 周恢复期内，雄性或雌性大鼠的体重或血液学和血清生物学参数均未发生变化。在试验组中观察到胃、肾脏和肾上腺的显著变化，但在恢复期未观察到这些变化或恢复趋势。根据这些数据，在大鼠中，无不良影响水平确定为 1250mg/kg bw/天。
