Safety evaluation of Eugenia jambolana seed extract

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) 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.