Evaluation of acute oral toxicity of the Camellia sinensis phytosome formulation in female wistar rats

Acute toxicity study was carried out for evaluation of toxic effect of formulation, safe acute dose for human and potential target organ for toxicity. Tea (Camellia sinensis), a cultivated evergreen plant and belonging to Theaceae family. The goal of present investigation was to perform acute toxicity study of Camellia sinensis phytosome formulation (CSP) for estimation of LD 50 or Median fatal dose and safe acute dose for human. A total of 12 female wistar rats weighing 90 to 100 gm were used in this investigation and divided into four groups, each with three animals, in accordance with 423 OECD guidelines. Group 1, 2, 3 and 4 animals were orally administered with 300 mg/kg bw of CSP, 300 mg/kg bw of CSP, 2000 mg/kg bw of CSP and 2000 mg/kg bw of CSP respectively. All the animals were observed for clinical sign, symptoms, body weight changes and mortality for 14 days. There was no death in any of the animals, and there were no significant variations in clinical signs or body weight in the experimental group. There were no abnormal alterations found during a gross necropsy.