YAKHAK HOEJI (약학회지)

The Pharmaceutical Society of Korea (대한약학회)
권호 표지

Embryo and Fetal Developmental toxicity Study on Recombinant Human Epidermal Growth Factor (rhEGF) in Rats

재조합 인간상피세포 성장인자(rhEGF, DWP401)의 배${\cdot}$태자발달 독성 연구

  • Park, Kui-Le (Department of Toxicolgy, National Institute of Toxicological Research, KFDA) ;
  • Han, Soon-Young (Department of Toxicolgy, National Institute of Toxicological Research, KFDA) ;
  • Shin, Jae-Ho (Department of Toxicolgy, National Institute of Toxicological Research, KFDA) ;
  • Lee, Yoo-Mie (Pusan National University) ;
  • Park, Hee-Jung (Department of Toxicolgy, National Institute of Toxicological Research, KFDA) ;
  • Jang, Seung-Jae (Department of Toxicolgy, National Institute of Toxicological Research, KFDA)
  • 박귀례 (식품의약품안전청 국립독성연구소) ;
  • 한순영 (식품의약품안전청 국립독성연구소) ;
  • 신재호 (식품의약품안전청 국립독성연구소) ;
  • 이유미 (부산대학교) ;
  • 박희정 (식품의약품안전청 국립독성연구소) ;
  • 장성재 (식품의약품안전청 국립독성연구소)
  • Published : 1998.10.01
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Abstract

Effect of recombinant human epidermal growth factor (rhEGF, DWP401) on fetal external, visceral and skeletal malformation during organogenesis was examined. Pregnant Sprauge-Daw ley rats were administered with 0.2, 1 and 5mg/kg/day subcutaneously on gestation day 6 through 16. Dams were sacrified at 20th day of gestation. Materal body weight, food consumption and clinical observation were not changed. Significant dose-dependent increase of relative and absolute liver weight were observed in the treatment group, whereas other organ weights were not changed. Placental weight of 1 and 5mg/kg/day group and number of resorption in 5mg/kg/day treatment group were significantly increased. External and visceral malformation of fetuses were not observed with treatment. However, skeletal variations(increase of asymmetry sternebrae, decrease of dumb-bell and asymmetry sternbrae at 5mg/kg/day, and fused stemebrae at 5mg/kg/day) were observed. These results showed that rhEGF (DWP401) may not have embryo and/or fetal developmental toxicity effect in rats.

Keywords

References

  1. Proc. Natl. Acad. Sci. USA v.46 Cohen, S.
  2. Invest. Dermatol. v.40 Cohen, S.;Elliot, G. J.
  3. Peptide Proteins Res. v.9 The primary structure of human urogastron Int. Gregory, H.;Preston, B. M.
  4. Proc. Natl. Acad. Sci. USA v.84 protein nuclar magnetic resonance study on the solution conformation of human epidermal growth factor. Makino, K.;Morimoto, M.;Nishi, M.;Sakamoto, S.;Tamura, A.;Inooka, H.;Akasaka, K.
  5. Irataet al life science. v.31 Age-relate decrease of urinary excretion of human epidermal growth factor (HEGF). Uchihashi M.;Hirata Y.;Fujita T.;Matsukura S
  6. J. biol. Chem. v.265 Epidermal growth factor. Carpenter, G.;Cohen, S.
  7. in peptide growth factors and their receptors. (Sporn, M. and Roberts, A. B. eds.) Carpenter, G.;Wahl, M. I.
  8. Ophtalmic Res. v.20 Effect of epidermal growth factor in severe experimental alkli burns Reim, M.;Busse, S.;Leber, M.;Schulz, C.
  9. J. Lab. Clin. Med. v.108 Acceleration of wound healing by recombinant human urogestrone(epidermal growth factor) Franklin, T. J.;Gregory, H.;Morris, W. P.
  10. Gastroenterology v.94 Role of epidermal growth factor in healing of chronic gastroduodenal ulcers in rats. Konturek, S. J.;Dembinski, A.;Warzecha, Z.;Brzozowski, T.;Gregory, H.
  11. J. endocrinology v.109 Properties of synthetic-gene recombinant human epidermal growth factor: comparison with the natural growth factor from human urine and milk. Read, L. C.;Summer, L.;Gale, S. M.;GeorgeNascimento, C.;Ballard, F. J.;Wallace, J. C.
  12. 식품의약품안전본부 고시 제96-8호(의약품등의 독성 시험법기준 : 96. 4. 16).
  13. S. Cong. Anom. v.16 Differential staining of cartilage and bone in fetal mouse skeleton by alcian blue and alizarin red Inouye, M.
  14. Teratology, Principles and techniques. v.1 Wilson, J. G.;Warkany, J.
  15. Cong. Anom. v.14 A microdissection method for detecting thoracic visceral malformation in mouse and rat fetuses. Nishimura, K.