This study was conducted in order to investigate repeated-dose toxicities of Magnolia ovobata ethanol extract (MEE). MEE was administered orally to male and female Sprague Dawley rats at dose levels of 0, 500, 1,000, or 2,000 mg/kg for four weeks. Repeated administration of MEE did not induce abnormalities in general signs, body weight gain, feed and water consumption, necropsy findings, or organ weights. In addition, no abnormality was observed in hematological analyses; red blood cells and their indices, white blood cells, platelets, and coagulation times. In male rats, BUN and creatinine showed an increase at doses of 2,000 mg/kg and 500-1,000 mg/kg, respectively, while in female rats, lactate dehydrogenase and creatine phosphokinase showed a decrease at 2,000 mg/kg, the upper-limit dose of repeated-dose toxicity studies. However, there were no dose-dependent increases or gender-relationship. In addition, other parameters of the hepatic and muscular toxicities as well as energy and lipid metabolism were not affected. In microscopic examination, no considerable pathological findings were observed. The results indicate the safety of oral administration of MEE to the upper-limit dose.
Four-week repeated-dose toxicity of Misaengtang (MST) was evaluated according to Toxicity Test Guideline of Korea Food and Drug Administration using 6-week-old Sprague-Dawley rats. Based on the results of preliminary single-dose toxicity study, confirming safety up to an upper-limit dose, MST was dissolved in drinking water and orally administered at doses of 500, 1,000, or 2,000 mg/kg for 28 days. All doses including the upper-limit limited dose (2,000 mg/kg) of MST did not cause any abnormalities of rats, including mortality, clinical signs, body weight gain, feed/water consumption, necropsy findings, organ weights, hematology and blood biochemistry. Rather, high doses (1,000-2,000 mg/kg) of MST reduced the serum levels of alanine transaminase, aspartate transaminase, creatinine phosphokinase, lactate dehydrogenase and triglycerides, in addition to an increase in glucose, indicative of protective effects on hepatic and muscular injuries. Both maximum-tolerable dose and no-observed-adverse-effect level were not determined. The results indicate that long-term intake of high-dose MST might not induce general adverse-effects.