TY - JOUR
T1 - Safety evaluation of Eugenia jambolana seed extract
AU - Sankhari, Jayanta M.
AU - Jadeja, Ravirajsinh N.
AU - Thounaojam, Menaka C.
AU - Devkar, Ranjitsinh V.
AU - AV, Ramachandran
N1 - Funding Information:
The authors (R.N. J and M.C.T) are grateful to University Grants Commission, New Delhi for providing Financial Assistance in the form of RFSMS scholarship.
PY - 2010/12
Y1 - 2010/12
N2 - 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 5 000 mg/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 (LD50) 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 a 10 fold higher dose than its reported therapeutic dose.
AB - 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 5 000 mg/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 (LD50) 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 a 10 fold higher dose than its reported therapeutic dose.
KW - Acute toxicity
KW - Eugenia jambolana
KW - LOAEL
KW - NOAEL
KW - Sub chronic toxicity
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U2 - 10.1016/S1995-7645(11)60014-X
DO - 10.1016/S1995-7645(11)60014-X
M3 - Article
AN - SCOPUS:78651439539
SN - 1995-7645
VL - 3
SP - 982
EP - 987
JO - Asian Pacific Journal of Tropical Medicine
JF - Asian Pacific Journal of Tropical Medicine
IS - 12
ER -