A 90-Day Repeated Oral Dose Toxicity Study of Alismatis Rhizoma Aqueous Extract in Rats. 2019

Mu-Jin Lee, and Ho-Kyung Jung, and Ki-Ho Lee, and Ji-Hun Jang, and Mi-Ok Sim, and Tea-Gyeong Seong, and Byung-Kwan Ahn, and Jin-Han Shon, and Seong-Ho Ham, and Hyun-Woo Cho, and Yong-Min Kim, and Sung-Jin Park, and Ji-Young Yoon, and Je-Won Ko, and Jong-Choon Kim
Division of Tradition Korean Medicine Research, National Development Institute of Korean Medicine, Jangheung, Korea.

Alismatis rhizoma (AR), the dried rhizome of Alisma orientale (Sam.) Juzep, is a well-known, traditional medicine that is used for the various biological activities including as a diuretic, to lower cholesterol and as an anti-inflammatory agent. The present study was carried out to investigate the potential toxicity of the Alismatis rhizoma aqueous extract (ARAE) following 90-day repeated oral administration to Sprague-Dawley rats. ARAE was administered orally to male and female rats for 90 days at 0 (control), 500, 1,000 and 2,000 mg/kg/day (n = 10 for male and female rats for each dose). Additional recovery groups from the control group and high dose group were observed for a 28-day recovery period. Chromatograms of ARAE detected main compounds with four peaks. Treatment-related effects including an increase in the red blood cells, hemoglobin, hematocrit, albumin, total protein, and urine volume were observed in males of the 2,000 mg/kg/day group (p < 0.05). However, the diuretic effect of ARAE was considered, a major cause of hematological and serum biochemical changes. The oral no-observed-adverse-effect level (NOAEL) of the ARAE was > 2,000 mg/kg/day in both genders, and no target organs were identified.

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