Cha Seung-Beom, Kim Seong-Sook, Oh Jeong-Ja, Lee Woo-Joo, Song Si-Whan, Lim Je-Oh, Kim Jong-Choon
Nonclinical Research Center, ChemOn Inc., Yongin, 17162 Korea.
College of Veterinary Medicine (BK21 Plus Project Team), Chonnam National University, 77 Yongbong-ro, Buk-gu, Gwangju, 61186 Korea.
Toxicol Res. 2021 Jan 2;37(3):385-393. doi: 10.1007/s43188-020-00077-8. eCollection 2021 Jul.
is commonly used in traditional herbal medicines for the treatment of diabetes, hyperthyroidism, liver damage, neuropathy, and asthma. Here, we investigated the genotoxicity potential of water extract (DRWE) using three standard battery systems in accordance with the test guidelines of the Organisation for Economic Cooperation and Development and Ministry of Food and Drug Safety as well as the principles of Good Laboratory Practice. A bacterial reverse mutation test (Ames test) was performed using the direct plate incorporation method in the presence or absence of a metabolic activation system (S9 mixture). The tester strains used included four histidine auxotrophic strains of , TA100, TA1535, TA98, and TA1537, along with a tryptophan auxotrophic strain of , WP2 A. An in vitro chromosome aberration test was performed using CHL/IU cells originally derived from the lung of a female Chinese hamster in the presence or absence of the S9 mixture. An in vivo mouse bone marrow micronucleus test was performed using male ICR mice. The micronucleus was confirmed after observation of the micro-nucleated polychromatic. The Ames test showed that DRWE did not induce gene mutations at any dose level in any of the tested strains. Additionally, DRWE did not result in any chromosomal aberrations specified in the in vitro chromosomal aberration and in vivo micronucleus tests. These results showed that DRWE exhibited neither mutagenic nor clastogenic potential in either the in vitro or in vivo test systems.
常用于传统草药中治疗糖尿病、甲状腺功能亢进、肝损伤、神经病变和哮喘。在此,我们根据经济合作与发展组织以及食品药品安全部的测试指南以及良好实验室规范原则,使用三种标准检测系统研究了水提取物(DRWE)的遗传毒性潜力。采用直接平板掺入法在有或无代谢活化系统(S9混合物)的情况下进行细菌回复突变试验(Ames试验)。所使用的测试菌株包括四种组氨酸营养缺陷型菌株,TA100、TA1535、TA98和TA1537,以及一种色氨酸营养缺陷型菌株,WP2 A。在有或无S9混合物的情况下,使用最初源自中国雌性仓鼠肺的CHL/IU细胞进行体外染色体畸变试验。使用雄性ICR小鼠进行体内小鼠骨髓微核试验。在观察到含微核的多色红细胞后确认微核。Ames试验表明,DRWE在任何测试菌株的任何剂量水平下均未诱导基因突变。此外,在体外染色体畸变试验和体内微核试验中,DRWE均未导致任何特定的染色体畸变。这些结果表明,DRWE在体外或体内测试系统中均未表现出诱变或断裂潜力。