Evaluation of Acute Oral Toxicity of the Emblica officinalis Phytosome Formulation in Wistar Rats

Abstract

Emblica officinalis, commonly known as amla, belongs to the Euphorbiaceae family. The herbal medicine phytosome was used to create a novel drug delivery system to extract E. officinalis fruit. E. officinalis fruit extract phytosome (EOP) formulation was tested for toxicity, and the LD50 cut-off value was determined using female wistar rats weighing 95 to 105 g. Acute toxicity testing was performed on a total of 12 female wistar rats, with three rats in each of the four groups as per 423 organisation for economic co-operation and development (OECD) guidelines. A single oral dose of the EOP formulation at 300, 300, 2000, and 2000 mg/kg body weight was administered to groups I, II, III, and IV. For 14 days, we monitored all of the animals to see if any of them died, developed any clinical symptoms, or put on any significant weight. There were no fatalities among the animals, and notable distinctions between the two groups were not found in terms of observed clinical symptoms or animal body weight. At the time of the gross necropsy, no abnormalities were discovered. The phytosome (EOP) formulation of E. officinalis has been shown to be non-lethal and tolerable at 2000 mg/kg bw. 5000 mg (mg/kg) of LD50 were selected for this investigation.