Li Shuting, Zhou Xi, Jiang Yu, Fu Manling, Yuan Yefei, Ou Xianhong
Department of Pharmaceutical Sciences School of Pharmacy, Southwest Medical University Luzhou Sichuan China.
Science and Technology Department Southwest Medical University Luzhou Sichuan China.
Food Sci Nutr. 2025 May 13;13(5):e70008. doi: 10.1002/fsn3.70008. eCollection 2025 May.
Total phenols from the deoiled leaves (DCL-TP) is a phenolic compound that exhibits a variety of strong biological activities, especially antioxidant activity due to their phenolic hydroxyl structure characteristics, so DCL-TP is attaining improved relevance and acceptance. However, a lack of toxicological information limits its application. The present study aimed to assess the toxicological profile of DCL-TP, through an acute toxicity study, 28-day oral toxicity study, and three genetic toxicity tests, which laid a foundation for the development of DCL-TP as an antilipid oxidant and provided a basis for pharmacological application. In the acute toxicity study, 10 female and 10 male KM mice were administered by oral gavage 10 g/kg body weight (bwt) of DCL-TP for 14 days. In the bacterial reverse mutation test (Ames test), the mutagenicity of DCL-TP was investigated by the plate infiltration method with the number of bacterial reverse mutations as the observation index. Mammal erythrocytes micronucleus test in 25 female and 25 male KM mice and spermatocyte chromosomal aberrations test in 25 male KM mice were randomly assigned to five groups (daily oral dose of 5, 2.5 and 1.25 g/kg bwt). In the 28-day oral toxicity study, 20 female and 20 male SD rats were randomly assigned to four groups (daily oral dose of 2.5, 1.25 and 0.625 g/kg bwt). No death occurred, poisoning and no adverse effects were observed, indicating the LD50 was higher than 10 g/kg bwt. The Ames test suggested that DCL-TP had no mutagenicity. There was no significant difference in the number of mammal erythrocytes micronucleus and spermatocyte chromosomes between DCL-TP and the negative control group ( > 0.05). In the 28-day oral toxicity study, no significant damage or organ abnormalities were observed compared to negative control. Food consumption, body weight, organ weight, urinalysis, blood routine index, blood biochemical index, and histopathology showed normal histology comparable to the control group ( > 0.05). This study revealed that DCL-TP showed no significant toxic effects and no mutagenicity potential genotoxicity. Further chronic toxicological evaluation would be needed to determine its safety and application value.
脱油叶片中的总酚（DCL - TP）是一种酚类化合物，因其酚羟基结构特征而具有多种强大的生物活性，尤其是抗氧化活性，因此DCL - TP的相关性和认可度日益提高。然而，毒理学信息的缺乏限制了其应用。本研究旨在通过急性毒性研究、28天经口毒性研究和三项遗传毒性试验来评估DCL - TP的毒理学特征，为将DCL - TP开发为抗脂质氧化剂奠定基础，并为其药理应用提供依据。在急性毒性研究中，10只雌性和10只雄性KM小鼠经口灌胃给予10 g/kg体重的DCL - TP，持续14天。在细菌回复突变试验（Ames试验）中，采用平板渗入法以细菌回复突变数为观察指标研究DCL - TP的致突变性。将25只雌性和25只雄性KM小鼠的哺乳动物红细胞微核试验以及25只雄性KM小鼠的精母细胞染色体畸变试验随机分为五组（每日经口剂量为5、2.5和1.25 g/kg体重）。在28天经口毒性研究中，20只雌性和20只雄性SD大鼠随机分为四组（每日经口剂量为2.5、1.25和0.625 g/kg体重）。未发生死亡、中毒现象，也未观察到不良反应，表明半数致死量高于10 g/kg体重。Ames试验表明DCL - TP无致突变性。DCL - TP组与阴性对照组之间哺乳动物红细胞微核数和精母细胞染色体数无显著差异（P＞0.05）。在28天经口毒性研究中，与阴性对照组相比，未观察到明显损伤或器官异常。食物摄入量、体重、器官重量、尿液分析、血常规指标、血液生化指标和组织病理学检查显示组织学正常，与对照组相当（P＞0.05）。本研究表明DCL - TP无明显毒性作用，也无潜在的致突变性和遗传毒性。需要进一步进行慢性毒理学评估以确定其安全性和应用价值。
