Evaluation of the genotoxic potential and acute oral toxicity of standardized extract of Andrographis paniculata (KalmCold™)

Andrographis paniculata is used in the traditional medicine for cold and influenza remedy. The main endeavor in this study was to assess the genotoxicity of the standardized extract of A. paniculata (KalmCold™) through three different in vitro tests: Ames, chromosome aberration (CA), and micronucleus (MN). Ames test was performed at 5000 μg/ml, 1581 μg/ml, 500 μg/ml, 158 μg/ml, 50 μg/ml, 16 μg/ml, while the clastogenicity tests were performed at 80 μg/ml, 26.6 μg/ml, 8.8 μg/ml for short-term treatment without S9; 345 μg/ml, 115 μg/ml, 38.3 μg/ml for short-term treatment with S9; and 46 μg/ml, 15.3 μg/ml, 5.1 μg/ml for long-term without S9 using DMSO as a vehicle control. Results of Ames test confirmed that KalmCold™ did not induce mutations both in the presence and absence of S9 in Salmonella typhimurium mutant strains TA98 and TAMix. In CA and MN, KalmCold™ did not induce clastogenicity in CHO-K1 cells in vitro. Based on our results, it is evident that KalmCold™ is genotoxically safe.Additionally in acute oral toxicity study, female rats were treated at 5000 mg/kg of KalmCold™ and observed for signs of toxicity for 14 days. KalmCold™ did not produce any treatment-related toxic effects in rats.