ACUTE AND SUB ACUTE TOXICITY STUDIES WITH GINGER EXTRACT IN RATS

The dry ginger rhizome was extracted with ethyl acetate, and gingerol content was enriched by liquid-liquid extraction. The extract was analyzed for the percentage of 6-gingerol, 8-gingerol, 10-gingerol, and 6-shogaol by HPLC. The acute toxicity was evaluated as per OECD guidelines 423. Ginger extract was fed at 2000 mg/kg body weight to overnight fasted female rats (8-10 weeks old; 160-180 g). The animals were observed daily for clinical signs of abnormality/mortality. After 14 days, animals were sacrificed, and gross pathological changes were recorded. Sub-acute toxicity of ginger extract was studied by feeding the extract at 100, 500, and 1000 mg/kg daily to rats as per OECD guidelines 407. The total gingerols content in the purified viscous extract was 36-43%. The finished formulation of ginger extract used for the toxicity studies had 8% total gingerols. In the acute toxicity study, no mortality or clinical signs of toxicity were observed at a maximum recommended dose level of 2000 mg/kg; therefore, the LD50 is >2000 mg/kg in rats. The repeated administration of ginger extract for 28 days in rats at the maximum dose level of 1000 mg/kg did not induce any observable toxic effects when compared to its corresponding control animals. The hematology and biochemistry profile of treated rats was similar to control animals, and the difference was non-significant (p>0.05). The histopathology of major organs of all the control and treated animals was normal. In this study, the NOAEL (No Observed Adverse Effect Level) was calculated as 1000 mg/kg daily for rats.