Yu Changwoo, Hong So-Hye, Lee Jin Hee, Jung Ki Kyung, Oh Jae-Ho, Jeong Jayoung, Kwon HoonJeong, Kang Jong-Koo, Yang Jun-Young
Toxicology Research Division, Ministry of Food and Drug Safety, National Institute of Food and Drug Safety Evaluation, 187, Osongsaengmyeong 2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do 28159 Republic of Korea.
Department of Food and Nutrition, Seoul National University, 1, Gwanak-ro, Gwanak-gu, Seoul, 08826 Republic of Korea.
Food Sci Biotechnol. 2022 Apr 19;31(6):759-766. doi: 10.1007/s10068-022-01072-5. eCollection 2022 Jun.
Sub-chronic toxicity studies using rats have been conducted for (Maxim.) Hemsley (CW) and Royle ex Wight (CA). CW water extract didn't show any adverse effects whereas administering CW powder decreased body weights in complication with decreased food consumptions. In the case of CA water extract, triglyceride and absolute/relative liver weights were elevated and vacuolation was observed in liver. Treated CA powder in male rats increased alanine aminotransferase and aspartate aminotransferase and induced single cell necrosis and multinucleated hepatocyte in liver. As for female rats, increased absolute/relative weights and hypertrophy/vacuolation in adrenal glands and vacuolation in ovaries were observed when administered CA powder. In conclusion, no observed adverse effect level (NOAEL) of CW water extract was over 5000 mg/kg/day, while NOAEL of CW powder was 700 mg/kg/day for female and 150 mg/kg/day for male. In case of CA, NOAEL of water extract was 1500 mg/kg/day for male and 2000 mg/kg/day for female, while NOAEL of powder was 150 mg/kg/day for both gender. To the best of our knowledge, this is the first sub-chronic toxicity study on the adverse effects, target organs and its dose levels of (Maxim.) Hemsley and Royle ex Wight following GLP protocols.
已对(Maxim.)Hemsley(CW)和Royle ex Wight(CA)进行了使用大鼠的亚慢性毒性研究。CW水提取物未显示任何不良反应,而给予CW粉末会导致体重下降,并伴有食物摄入量减少。就CA水提取物而言,甘油三酯以及肝脏的绝对/相对重量升高,且在肝脏中观察到空泡化。雄性大鼠经CA粉末处理后,丙氨酸转氨酶和天冬氨酸转氨酶升高,并在肝脏中诱导单细胞坏死和多核肝细胞。对于雌性大鼠,给予CA粉末后,观察到肾上腺的绝对/相对重量增加以及肥大/空泡化,卵巢中出现空泡化。总之,CW水提取物的未观察到不良反应水平(NOAEL)超过5000毫克/千克/天,而CW粉末对雌性的NOAEL为700毫克/千克/天,对雄性为150毫克/千克/天。对于CA,水提取物对雄性的NOAEL为1500毫克/千克/天,对雌性为2000毫克/千克/天,而粉末对两性的NOAEL均为150毫克/千克/天。据我们所知,这是首次按照GLP方案对(Maxim.)Hemsley和Royle ex Wight的不良反应、靶器官及其剂量水平进行的亚慢性毒性研究。