Abstract
The present study was conducted to evaluate the safety profile of Janma Ghunti Honey in Wistar rats on oral administration for 28 consecutive days. Animals were randomized on the basis of body weight into 6 groups. Three groups received test item (TI) at three different dose levels (3 mL/k g, 6 mL/kg and 12 mL/kg body weight). One group served as high dose satellite reversal group (12 mL/kg). One group each served as the control and satellite control group. Animals were observed for clinical signs of toxicity and mortality at least once daily. Animals from satellite groups were observed for further 14 days without treatment to evaluate delayed occurrence or reversibility of any signs/toxicity. At the end of the study, animals were studied through clinical pathology and necropsy examination. No treatment related mortality was observed in any group. Except in female low dose and female high dose satellite groups, all the treated groups exhibited weight gain and no statistically significant alterations were observed. No TI related toxicity was found on hematological investigation, blood biochemistry parameters and absolute and relative organ weights among treated groups. 'No Observed Adverse Effect Level' of TI in male and female Wistar rats was found to be above 12 mL/kg body weight.
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