Long-Term Safety Evaluation of Fluorescent Gold Nanoclusters Conjugated with α-Lipoic Acid: Insights from a Six-Month In Vivo Study

Background: 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...

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Main Authors: Yu-Wei Lai, Yi-Nan Lee, Hung-I Yeh, Yih-Jer Wu, Wen-Hsiung Chan, Shih-Wei Wang, Chao-Feng Lin, Chun-Hsuan Lin, Yun-Fang Chen, Ching-Hu Chung
Format: Article
Language:English
Published: MDPI AG 2025-03-01
Series:Journal of Functional Biomaterials
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Online Access:https://www.mdpi.com/2079-4983/16/3/89
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Summary:Background: 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. Aim of study: This study used oral administration of FANCs to determine the long-term safety profile and adverse effects in ICR mice. Methods: 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. Results: 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. Conclusions: 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.
ISSN:2079-4983