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Single Oral Dose Toxicity Studies of PGB-2, a Novel Polyglucosamine Polymer Produced from Citrobacter sp. BL-4 in Mice

  • Lee, Yong-Hyun (Department of Genetic Engineering, College of Natural Sciences, Kyungpook National University) ;
  • Son, Mi-Kyung (Department of Genetic Engineering, College of Natural Sciences, Kyungpook National University) ;
  • Jung, Young-Mi (ENZ Bio Co., Ltd.) ;
  • Kim, Tae-Kwon (ENZ Bio Co., Ltd.) ;
  • Park, Dong-Chan (ENZ Bio Co., Ltd.) ;
  • Kim, Pan-Soo (Department of Technical Support, Gyeonggi Bio-center) ;
  • Ku, Sae-Kwang (Pharmacology & Toxicology Lab., Central Research Laboratories, Dong Wha Pharmaceutical Industrial Co.)
  • Published : 2007.03.31

Abstract

This study was conducted to obtain information of the oral dose acute toxicity of PGB-2, a novel polyglucosamine polymer produced from Citrobacter sp. BL-4 (a new strain) in male and female mice. Mortality, body weight changes, clinical signs were monitored during 14 days after single oral dose of test article at dose levels of 2000, 1000, 500, 250 and 125 ml/kg. Gross lesions, organ weight and histopathology of principal organs were examined after necropsy. As the results, we could not find any mortalities, clinical signs, changes in the body weight and gross findings except for white foci in the liver. In addition, no PGB-2-treatment related abnormal changes on the organ weight and histopathology of principle organs were detected except for atypical signs of liver. White liver foci were confirmed as focal infiltration of inflammatory cells. The results suggest that the PGB-2 is relatively safe in mice but the possibility of hepatotoxicity could not be excluded. The $LD_{50}$ and approximate LD in mice after single oral dose of PGB-2 were considered over 2000 mg/kg, respectively. In future, the potential hepatotoxicity of PGB-2 should be evaluated through the repeat dose toxicity test prior to develop as a new agent.

Keywords

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