DOI: 10.36347/sajb.2016.v04i02.010

Pages: 132-143

Kariuppu Mezhugu (NIS KM) is a Herbo mineral Siddha medicinal formulation featured in the treatise, Anuboga Vaithya Navaneetham. The objective of this study is to carry out acute and repeated dose 28-day oral toxicity study of Kariuppu Mezhugu (NIS KM) in Wistar albino rats. In acute study (OECD 423), NIS KM was administered orally at 2000mg/kg/bw and animals were observed for toxic signs at 0.5, 1, 4, 24 hours and for the following 13 days. In repeated dose-28 day toxicity study (OECD 407), NIS KM was administered at 200, 400 and 800mg/kg body weight/day to 6 groups of rats, including vehicle control and satellite control. Mortality, toxic signs, body weight, food and water consumption, haematological, serum electrolytes and plasma biochemical parameters, gross necropsy, relative organ weights and histopathology were performed to substantiate No-Observed Adverse Effect Level (NOAEL) and lowest observed adverse effect level (LOAEL). A satellite group for NIS KM high dose (800 mg/kg) was also included in the study to determine the delayed occurrence of toxic effects. Students‘t’ test was used for statistical analyses. NIS KM at single 2000mg/kg dose produced no treatment related toxic signs or mortality during study. In the repeated dose study, no significant differences in body weights, haematological, serum electrolyte and biochemical parameters were observed between Palm Jaggery solution control and NIS KM rats. Relative organs weights, gross necropsy and histopathological examination revealed no abnormalities with NIS KM treatment.: Results of the present study suggest that LD50 of NIS KM >2000mg/kg and NOAEL >800mg/kg/day in rats and hence 100 mg/kg/day administered in humans is validated as safe therapeutic dosage.