Lai Yu-Wei, Lee Yi-Nan, Yeh Hung-I, Wu Yih-Jer, Chan Wen-Hsiung, Wang Shih-Wei, Lin Chao-Feng, Lin Chun-Hsuan, Chen Yun-Fang, Chung Ching-Hu
Center of General Education, University of Taipei, Taipei 100, Taiwan.
Division of Urology, Taipei City Hospital Renai Branch, Taipei 106, Taiwan.
J Funct Biomater. 2025 Mar 5;16(3):89. doi: 10.3390/jfb16030089.
Fluorescent gold nanoclusters conjugated with α-lipoic acid (FANCs) have shown great promise for drug development. In a previous study, FANCs did not show any acute or subacute toxicity under 0.6-20 μM/100 μL/25 g body weight in male and female ICR mice. However, the chronic toxicity of FANCs has not been studied.
This study used oral administration of FANCs to determine the long-term safety profile and adverse effects in ICR mice.
In vivo chronic toxicity was examined via oral administration of FANCs to male and female ICR mice. The daily food consumption, body weight, hematological profile, serum biochemical profile, organ coefficient, histopathological changes, and survival rate of the mice were calculated.
FANCs did not result in mortality due to chronic toxicity in both male and female mice. The animal behavior, body weight, hematological profile, serum biochemical profile, and organ coefficient showed no treatment-related malignant changes. This indicates that FANCs do not cause liver, renal, or other organ damage.
These results indicate that the no-observed-adverse-effect level (NOAEL) is 20 μM/100 μL/25 g for 6 months of treatment in male and female ICR mice.
与α-硫辛酸共轭的荧光金纳米团簇（FANCs）在药物开发方面显示出巨大潜力。在先前的一项研究中，在雄性和雌性ICR小鼠中，FANCs在0.6 - 20 μM/100 μL/25 g体重剂量下未显示任何急性或亚急性毒性。然而，FANCs的慢性毒性尚未得到研究。
本研究通过口服给予FANCs来确定ICR小鼠的长期安全性概况和不良反应。
通过对雄性和雌性ICR小鼠口服给予FANCs来检测体内慢性毒性。计算小鼠的每日食物消耗量、体重、血液学指标、血清生化指标、器官系数、组织病理学变化和存活率。
FANCs在雄性和雌性小鼠中均未因慢性毒性导致死亡。动物行为、体重、血液学指标、血清生化指标和器官系数均未显示与治疗相关的恶性变化。这表明FANCs不会引起肝脏、肾脏或其他器官损伤。
这些结果表明，在雄性和雌性ICR小鼠中，连续6个月给予FANCs的未观察到有害作用水平（NOAEL）为20 μM/100 μL/25 g。
