Background: The global rise in the usage of herbal medicine has prompted a critical examination of its safety. Despite widespread assumptions of safety, there remains a need for thorough toxicity evaluations to identify potential risks associated with herbal extracts. In traditional Vietnamese medicine, Ardisia silvestris is commonly used for various ailments, yet toxicity assessments specifically focusing on its leaves are lacking. The aim of the study: To assess the acute and sub-chronic toxicity of ethanol extract from A. silvestris leaves (EEAS) in mice via oral administration at varying doses. Materials and methods: This study employed two experimental models to assess toxicity: acute toxicity testing and sub-chronic toxicity testing. Each model comprised six groups, with six mice per group. The control group and the satellite control group received the vehicle, while the test groups and satellite test groups were administered EEAS at doses ranging from 1000 to 5000 mg/kg b.w (in acute toxicity testing) and from 100 to 500 mg/kg b.w (in sub-chronic toxicity testing). All treatments were conducted over 14 and 90 days, following which satellite groups were further monitored for 28 days after cessation of extract administration. Results: The acute toxicity evaluation revealed dose-dependent adverse effects such as elevated respiration rates, increased locomotor activity, sedative effects, and seizures in the initial hours post-administration. However, no mortality was recorded, with observed signs gradually diminishing (p<0.05) over the study period. In acute and sub-chronic tests, significant reductions in food and water intake were noted at higher doses (p<0.05), along with alterations in hematological and biochemical parameters (p<0.05) indicative of physiological stress. Organ weight assessments and macroscopic observations also indicated significant alterations in vital organ morphology at higher doses (p<0.05). Histopathological examinations revealed tissue damage and inflammatory infiltrations in the heart, liver, and kidneys. Urinary parameters displayed significant alterations (p<0.05), particularly in specific gravity, pH, and ketone levels. Nonetheless, these effects were temporary and reversible upon discontinuation of EEAS (p>0.05). Conclusion: Overall, while EEAS exhibited dose-dependent acute and sub-chronic toxicity effects, most adverse outcomes were reversible. This holds significant implications for assessing the safety of EEAS, indicating that the effects are manageable and do not result in prolonged or irreversible consequences.
Background: The global rise in the usage of herbal medicine has prompted a critical examination of its safety. Despite widespread assumptions of safety, there remains a need for thorough toxicity evaluations to identify potential risks associated with herbal extracts. In traditional Vietnamese medicine, Ardisia silvestris is commonly used for various ailments, yet toxicity assessments specifically focusing on its leaves are lacking. The aim of the study: To assess the acute and sub-chronic toxicity of ethanol extract from A. silvestris leaves (EEAS) in mice via oral administration at varying doses. Materials and methods: This study employed two experimental models to assess toxicity: acute toxicity testing and sub-chronic toxicity testing. Each model comprised six groups, with six mice per group. The control group and the satellite control group received the vehicle, while the test groups and satellite test groups were administered EEAS at doses ranging from 1000 to 5000 mg/kg b.w (in acute toxicity testing) and from 100 to 500 mg/kg b.w (in sub-chronic toxicity testing). All treatments were conducted over 14 and 90 days, following which satellite groups were further monitored for 28 days after cessation of extract administration. Results: The acute toxicity evaluation revealed dose-dependent adverse effects such as elevated respiration rates, increased locomotor activity, sedative effects, and seizures in the initial hours post-administration. However, no mortality was recorded, with observed signs gradually diminishing (p<0.05) over the study period. In acute and sub-chronic tests, significant reductions in food and water intake were noted at higher doses (p<0.05), along with alterations in hematological and biochemical parameters (p<0.05) indicative of physiological stress. Organ weight assessments and macroscopic observations also indicated significant alterations in vital organ morphology at higher doses (p<0.05). Histopathological examinations revealed tissue damage and inflammatory infiltrations in the heart, liver, and kidneys. Urinary parameters displayed significant alterations (p<0.05), particularly in specific gravity, pH, and ketone levels. Nonetheless, these effects were temporary and reversible upon discontinuation of EEAS (p>0.05). Conclusion: Overall, while EEAS exhibited dose-dependent acute and sub-chronic toxicity effects, most adverse outcomes were reversible. This holds significant implications for assessing the safety of EEAS, indicating that the effects are manageable and do not result in prolonged or irreversible consequences.