A 13 Week Subcutaneous Toxicity Study of Recombinant Human Epidermal Growth Factor (DWP401) in Mice

Recombinant Human Epidermal Growth Factor (DWP401)의 마우스를 이용한 피하투여 아급성독성시험

  • 송시환 (한국화학연구소 안전성연구센터) ;
  • 강부현 (한국화학연구소 안전성연구센터) ;
  • 신천철 (한국화학연구소 안전성연구센터) ;
  • 김희연 (한국화학연구소 안전성연구센터) ;
  • 강진석 ((주)대웅제약 중앙연구소) ;
  • 심점순 ((주)대웅제약 중앙연구소) ;
  • 한상섭 (한국화학연구소 안전성연구센터) ;
  • 노정구 (한국화학연구소 안전성연구센터)
  • Published : 1996.06.01

Abstract

DWP401, a recombinant human epidermal growth factor, was subcutaneously administered to ICR mice at the dose levels of 0, 0.04, 0.2 and 1.0 mg/kg/day (15rats/sex/group) in order to evaluate the subchronic toxicity. General observations, examinations for food and water consumption, ophthalmoscopy and urinalysis were carried out during the study. For the complete gross and microscopic examinations, 10 mice/ sex/group were sacrificed at the ends of the dosing period, and the remaining animals were sacrificed with a 5 week recovery period. Examinations for hematology and blood biochemistry were also carried out at the time of recovery period. Based on the results, it was thought that the target tissue or organs were mesothelial cell, injection site, spleen, adrenal gland, ovary and transitional epithelial cell of urinary tract, and no observed toxic level of DWP401 was 0.04 mg/kg while definite toxic dose level might be 0.2 mg/kg.

Keywords