Clinical safety

   The clinical study on  KALMCOLD^TM had low level of adverse events in both  KALMCOLD^TM and placebo groups.

Preclinical safety

   Salmonella reverse mutation assay (Ames test)

 KALMCOLD^TM did not induce mutations in S. typhimurium (TA98 and TAMix) up to the maximum concentration of 5000 µg/ml.

   In vitro mammalian chromosome aberration test

 KALMCOLD^TM did not induce significant number of chromosome aberrations in Chinese hamster ovary cell line (CHO-K1) in both short term treatment (80, 26.6 and 8.8 µg/ml without metabolic activation and 345, 115 and 38.3 µg/ml with metabolic activation; 4 hrs) and long term treatment (46, 15.3 and 5.1 µg/ml without metabolic activation; 24 hrs), indicating it is non-genotoxic.

   In vitro micronucleus test

 KALMCOLD^TM did not induce micronuclei formation in CHO-K1 in both short term treatment (80, 26.6 and 8.8 µg/ml without metabolic activation and 345, 115 and 38.3 µg/ml with metabolic activation; 4 hrs) and long term treatment (46, 15.3 and 5.1 µg/ml without metabolic activation; 24 hrs), indicating it is non-genotoxic.

   Acute oral toxicity study

Acute oral toxicity study was conducted on  KALMCOLD^TM in female albino Wistar rats. The study neither showed mortality nor abnormal clinical signs, at the dose level tested.
 KALMCOLD^TM was found to be safe after oral administration as a single dose up to 5000 mg/kg b.w.