Genotoxic evaluation of recombinant human erythropoietin (rHu-EPO) in shod-term assays.

인체 재조합 적혈구 조혈인자, rHu-EPO의 유전독성 평가

  • 김형식 (성균관대학교 약학대학 독성학교실) ;
  • 곽승준 (성균관대학교 약학대학 독성학교실) ;
  • 천선아 (성균관대학교 약학대학 독성학교실) ;
  • 임소영 (성균관대학교 약학대학 독성학교실) ;
  • 안미영 (성균관대학교 약학대학 독성학교실) ;
  • 김원배 (동아제약 중앙연구소) ;
  • 김병문 (동아제약 중앙연구소) ;
  • 안병옥 (동아제약 중앙연구소) ;
  • 서동상 (성균관대학교 생명자원과학대 유전공학과)
  • Published : 1996.09.01


The mutagenic potential of rHu-EPO was evaluated using the short-term genotoxicity tests including Ames, chromosome aberration and micronuclei tests. In Salmonella typhimurium assay, rHu-EPO did not show any mutagenic response in the absence or presence of S9 mix with TA98, TA100, TA1535, and TA1537. In chromosome aberration test, rHu-EPO did not show any significant effect on Chinese Hamster Ovary(CHO) cells compared with control. In micronucleus test using male ICR mice, a dose-dependence increase in the frequency of micronucleuted polychromatic erythrocytes(MNPCEs) was observed in bone marrow cells treated with rHu-EPO. However, it was related to the secondary effect of rHu-EPO and the number of MNPCEs was equal to spontaneous frequency. These results indicate that rHu-EPO does not show any positive response in short-term genotoxicity assays.