Acute Oral Toxicity Assessment of Naath Pottali (a Traditional Mercurial Formulation) in Female Wistar Albino Rats

Background: Naath Pottali is a formulation containing Hingulottha Parada (mercury extracted from cinnabar), Shuddha Gandhaka (purified sulfur), Rajata Bhasma (silver ash) and Swarna Makshika Bhasma (copper pyrite ash) processed in Ahiphena Beeja Kashaya (poppy seeds decoction). Due to potential toxicity of heavy metals, acute oral toxicity study was conducted. The study evaluated acute oral response to a single dose of 2000 mg/kg of Naath Pottali in female Wistar rats. Methods and Materials: After approval of Institutional Animal Ethics Committee, two groups of female (nulliparous, non-pregnant) Wistar Albino rats (n=3 per group) were selected. Group 1 (vehicle control) received 0.5% carboxymethyl cellulose; Group 2 received single dose of Naath Pottali (2000 mg/kg) suspended in 0.5% carboxymethyl cellulose. Animals were observed for body weight, clinical and behavior signs like convulsions or tremors, piloerection, salivation, diarrhea etc. over 14 days. On 15th day, animals were euthanized and the brain, heart, liver, kidney, stomach and intestine were examined for gross and histopathological signs. Results: All three animals in trial group as well as in control group survived, and no signs of mortality or severe clinical side effects were observed. Body weight trajectories were normal. On gross necropsy, no macroscopic abnormalities were observed. In histopathological examination of all three treated animals, moderate (grade 3) lesions were noted: periportal inflammation with steatosis in the liver, focal tubular necrosis with hydropic change in the kidney, coronary congestion without ischemic change in the heart, and hypertrophy of mucosal glands in the stomach. Brain and intestine showed no such signs. Conclusion: Naath Pottali, at the single dose of 2000 mg/kg caused no mortality; this finding cannot be extrapolated to the overall safety of the formulation and histopathological changes in the liver, kidney, heart and stomach indicate potential organ-level stress. Comprehensive dose-response and repeated-dose studies are required to establish safety.