Sirupeellai samoola kudineer (SK), a polyherbal decoction, has been used in Siddha system of medicine for the management of Urolithiasis. Since, there exists no documentation of preclinical toxicological evaluation of SK earlier, in the present study, acute and subacute toxicity of SK was assessed in Sprague Dawley rats as per OECD guideline 423 and 407, respectively. In the acute toxicity study, SK did not produce any toxic signs at a dose level of 50 ml/kg b.wt/p.o. Three doses of SK (4.5, 9.0, 18.0 ml/kg b.wt) were administered and observed for various behavioral, physiological, biochemical, and haematological changes for 28 days in the subacute toxicity study. Low and mid dose of SK (4.5 and 9.0 ml/kg b.wt) did not exhibit any significant physiological and haematological alterations. Whereas, high dose (18.0 ml/kg bw) treatment exhibited significant changes in creatinine, gamma glutamyl transferase (GGT) and acid phosphatase (ACP) levels in serum. Further, histopathological examinations of brain, heart, liver, kidney and sex organs revealed normal architecture signifying no morphological changes upto a dose of 9.0 ml/kg. However, 18.0 ml/kg of SK administration showed few histopathological changes as compared to the control. Based on these results, it can be concluded that Sirupeellai samoola kudineer is safe and non-toxic upto 9.0 ml/kg for 28 days in experimental rats.
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