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        Single Subcutaneous Dose Toxicity of Polycan<SUP>®</SUP>, a β-Glucan Originated from Aureobasidium in Mice

        Jaehyun Lee,Kunju Yang,Hyundong Shin,Bokryeon Park,Changwoo Son,Heejeong Jang,Dongchan Park,Hyeung-Sik Lee,Saekwang Ku 한국실험동물학회 2005 Laboratory Animal Research Vol.21 No.4

        This study was conducted to obtain the acute information of the subcutaneous dose toxicity of Polycan-originated from Aureobasidium pullulans SM-2001 (half of the dry material is β-1,3/1,6-glucans), having various pharmacological effects, in mice. Test articles were once subcutaneously administered to mice at dose levels of 250, 125 and 62.5 ㎎/㎏. The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after dosing. As the results, we could not find mortalities, clinical signs and changes in the body weight except for residuals of test articles and related skin ulcer at injection sites. Hypertrophy of spleen related to the immune modulate effect of Polycan was dose-dependently detected in all dosing groups tested as gross findings, and hyperplasia of lymphatic follicles and increase of number of megakaryocytes in red pulps are dose-dependently observed at histopathological observation of spleen. In addition, infiltration of inflammatory cells in residuals of test articles in injection site were dose dependently detected with skin ulcer in some animals restricted to these injection sites. The skin ulcer detected in the present study was considered to be biting wounds. The results obtained in this study suggest that the Polycan have no systemic toxicity in mice and is therefore likely to be safe for clinical use. The median lethal dose (LD₅₀) and approximate lethal dose in mice after single subcutaneous dose of Polycan were considered over 250 ㎎/㎏, the highest dissolved concentration in distilled water respectively.

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