摘要
Objective:To evaluate the safety of ethanolic seed extract of Eugenia jambolana（EJSE） using acute and sub-chronic toxicity assays in Swiss albino mice as per Organisation for Economic Co-operation and Development（OECD） guidelines.Methods:Possible behavioral changes and lethality were observed in mice administered a single dose[1 000,2 000,3 000,4 000 or 5 000mg/kg body weight（BW）]of EJSE,Plasma levels of metabolic,hepatic,cardiac and renal function markers, electrolytes,blood count and histopathology of major organs were monitored in mice chronically treated with EJSE（1 000,2 000 or 3 000 mg/kg BW） for 28 days.Results:Since no mortality was recorded in the acute toxicity evaluation up to a dose of 5 000 mg/kg bodyweight of EJSE,50% lethal dose(LD<sub>50</sub>) was assumed to be 】5 000 mg/kg BW.In the sub-chronic toxicity evaluation, no adverse observations were recorded in mice administered with 2 000 mg/kg BW of EJSE; however at 3 000 mg/kg BW dose,moderately significant increase in the plasma levels of urea and creatinine was observed.Hence,the lowest observable adverse effect level（LOAEL） for EJSE was found to be 3 000 mg/kg BW and the no observable adverse effect level（NOAEL） was adjudged as 2 000 mg/kg BW.Conclusions:It can be concluded from this study that,orally administered EJSE is safe up to a10 fold higher dose than its reported therapeutic dose.
Objective:To evaluate the safety of ethanolic seed extract of Eugenia jambolana(EJSE) using acute and sub-chronic toxicity assays in Swiss albino mice as per Organisation for Economic Co-operation and Development(OECD) guidelines.Methods:Possible behavioral changes and lethality were observed in mice administered a single dose[1 000,2 000,3 000,4 000 or 5 000mg/kg body weight(BW)]of EJSE,Plasma levels of metabolic,hepatic,cardiac and renal function markers, electrolytes,blood count and histopathology of major organs were monitored in mice chronically treated with EJSE(1 000,2 000 or 3 000 mg/kg BW) for 28 days.Results:Since no mortality was recorded in the acute toxicity evaluation up to a dose of 5 000 mg/kg bodyweight of EJSE,50% lethal dose(LD_(50)) was assumed to be >5 000 mg/kg BW.In the sub-chronic toxicity evaluation, no adverse observations were recorded in mice administered with 2 000 mg/kg BW of EJSE; however at 3 000 mg/kg BW dose,moderately significant increase in the plasma levels of urea and creatinine was observed.Hence,the lowest observable adverse effect level(LOAEL) for EJSE was found to be 3 000 mg/kg BW and the no observable adverse effect level(NOAEL) was adjudged as 2 000 mg/kg BW.Conclusions:It can be concluded from this study that,orally administered EJSE is safe up to a10 fold higher dose than its reported therapeutic dose.
基金
University Grants Commission,New Delhi for providing Financial Assistance in the form of RFSMS scholarship
