Toxicological Research

Korean Society of Toxicology & Korea Environmental Mutagen Society (한국독성학회)
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Single Dose Toxicity Studies of C.1-50005 (Hepatitis A virus Vaccine) in Rats and Dogs

CJ-50005(A형 간염백신)의 Rat 및 Dog에서의 단회투여독성

  • 김종호 (제일제당 종합기술원 제약연구소) ;
  • 이성학 (제일제당 종합기술원 제약연구소) ;
  • 최재목 (제일제당 종합기술원 제약연구소) ;
  • 김달현 (제일제당 종합기술원 제약연구소) ;
  • 김현석 (제일제당 종합기술원 제약연구소) ;
  • 정용주 (제일제당 종합기술원 제약연구소)
  • Published : 2001.12.01
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Abstract

The acute toxicity of CJ-50005, an inactivated whole virus vaccine derived from hepatitis A virus (HM175) grown in human MRC-5 diploid fibroblast culture, was tested in Sprague Dawley (SD) rats and beagle dogs. CJ-50005 was orally and intramuscularly administered up to the maximum dose of 81$\mu\textrm{g}$/kg. as much as 3,000 times of the expected clinical dose, in SD rats and was intramuscularly administered up to 27 $\mu\textrm{g}$/kg, as much as 1,000 times of the expected clinical dose, in beagle dogs. In these experiments, there were no death and clinical changes which were related to CJ-50005 administration. In addition, there were no significant changes between control and treated groups in body weights and autopsy findings. In conclusion, the administration of CJ-50005 over 81$\mu\textrm{g}$/kg in SD rats and over 27$\mu\textrm{g}$/kg in beagle dogs was proved to be safe, and it is thought that CJ-50005 may not show any toxicity in its clinical use.

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References

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