Acute and sub-acute toxicity of Amalakyadi Churna

Abstract

The acute and sub-acute toxicity of ethanolic extract of Amalakyadi churna (AC) was undertaken to assess its safety and tolerability profile in long term treatment. AC is one of the Ayurvedic formulations, widely used as carminative, appetizer, purgative etc. Acute toxicity (72-hours) and sub-acute toxicity (30-days) studies with AC were done on Swiss albino mice to determine its consequences on morphological, body-weight, organ-weight changes, histopathological, biochemical, mutational, hematological variations and mortality. Acute toxicity determination indicated that, AC is a moderatively toxic (LD50 =313mg/kg b.wt. ip). The sub-acute toxicity studies of AC (25 and 40mg/kg b.wt for 30 days ip.) did not induce any significant changes in different parameters studied, except a mild hematotoxic effect and lowering lipid metabolism. The results of the present study strongly suggested that, there was increase in the drug tolerance in mice by dose fractionation and wide margin of safety at its therapeutic dose levels.