Oral Single Dose Toxicity Study of Low Molecular Fucoidan in Mice. 2008

Young-Mi Jung, and Kang Min Yoo, and Dong-Chan Park, and Tae-Kwon Kim, and Hyeung-Sik Lee, and Sae-Kwang Ku
ENZ Bio Co., Ltd., Daegu, 702-832 Korea.

This study was conducted to obtain information of the oral dose toxicity of low molecular fucoidan (LMF) in male and female mice. In order to calculate 50% lethal dose (LD50) and approximate lethal dose (LD), test material was once orally administered to male and female ICR mice at dose levels of 2000, 1000, 500, 250, 125 and 0 (vehicle control) mg/kg (body wt.). The mortality and the changes on body weight, clinical signs, gross observation and organ weight and histopathology of principle organs were monitored 14 days after LMF treatment. We could not find any mortalities, clinical signs, body weight changes and gross findings. In addition, significant changes in the organ weight and histopathology of principal organs were not observed except for some sporadic findings. The results obtained in this study suggest that LMF may not be toxic in mice and may be therefore safe for clinical use. The LD50 and approximate LD in mice after single oral dose of LMF were considered over 2000 mg/kg in both female and male mice.

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