Choi Jae-Suk, Kim Joo-Wan, Kim Ki-Young, Ku Sae-Kwang, Sohn Jae Hak
RIS Center,IACF, Silla University, Gwaebup-dong, Sasang-gu, Busan, Republic of Korea.
Glucan corp. #305 Marine Bio-Industry Development Center, Hoenggye-ri 27, Ilgwang-myeon, Gijan-gun, Busan, Republic of Korea.
Pak J Pharm Sci. 2014 Jan;27(1):129-37.
The aim of present research was to determine the acute oral toxicity of fermented rice extracts (FREs), in female and male ICR mice. To investigate the toxicity and identify target organs, FREs were orally administered once to male and female ICR mice at doses of 0 (vehicle control), 500, 1000, or 2000 mg/kg body weight (BW). Effects on mortality, BW, and clinical signs were monitored over 14 days, including changes in the weights and histopathological characteristics of 14 organs, as described in the Korea Food and Drug Administration (KFDA) Guidelines (2009-116, 2009). No treatment-related mortality was observed during the 14-day observation period in either gender. In addition, no FRE-related change was observed in BW or organ weight (OW), clinical indicators, or histopathological findings in this study. Our results suggest that the FRE is non-toxic in mice and is therefore likely to be safe for clinical use. The approximate LD and LD50 in mice after single oral dose of FRE are greater than 2000 mg/kg in female and male ICR mice. Additionally, no specific target organ or negative clinical indicator was detected in this study.
本研究的目的是测定发酵米提取物（FREs）对雄性和雌性ICR小鼠的急性经口毒性。为了研究其毒性并确定靶器官，以0（赋形剂对照）、500、1000或2000mg/kg体重（BW）的剂量对雄性和雌性ICR小鼠单次经口给予FREs。按照韩国食品药品管理局（KFDA）指南（2009 - 116, 2009）所述，在14天内监测对死亡率、体重和临床体征的影响，包括14个器官的重量和组织病理学特征的变化。在14天的观察期内，两种性别均未观察到与治疗相关的死亡。此外，在本研究中，未观察到与FRE相关的体重、器官重量（OW）、临床指标或组织病理学结果的变化。我们的结果表明，FRE对小鼠无毒，因此临床使用可能是安全的。单次经口给予FRE后，雌性和雄性ICR小鼠的近似LD和LD50均大于2000mg/kg。此外，本研究未检测到特定的靶器官或负面临床指标。
