Safety Assessment of Total Phenols From Deoiled Leaves.

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.