Toxicological Research
- Volume 14 Issue 3
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- Pages.415-425
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- 1998
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- 1976-8257(pISSN)
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- 2234-2753(eISSN)
Toxicity of Recombinant Human Erythropoietin [rHuEPO] in Rats for 13 Weeks
랫드에서 인체 재조합 적혈구 조혈인자, rHuEPO의 13주 정맥투여 아만성독성에 관한 연구
- Kim, Hyung-Sik (Division of Toxicology, School of Pharmacy, Sungkyunkwan University) ;
- Kwack, Seung-Jun (Division of Toxicology, School of Pharmacy, Sungkyunkwan University) ;
- Chun, Sun-Ah (Division of Toxicology, School of Pharmacy, Sungkyunkwan University) ;
- Park, Hyun-Sun (Division of Toxicology, School of Pharmacy, Sungkyunkwan University) ;
- Han, 한하수 (Division of Toxicology, School of Pharmacy, Sungkyunkwan University) ;
- Lim, So-Young (Division of Toxicology, School of Pharmacy, Sungkyunkwan University) ;
- Ahn, Mi-Young (Division of Toxicology, School of Pharmacy, Sungkyunkwan University) ;
- Kim, Won-Bae (Dong-A Pharm. Co., LTD.) ;
- Ahn, Byoung-Ok (Dong-A Pharm. Co., LTD.) ;
- Hong, Sung-Youl (Department of Genetic Engineering, Sungkyunkwan University) ;
- Lee, Byung-Mu (Division of Toxicology, School of Pharmacy, Sungkyunkwan University)
- 김형식 (성균관대학교 약학대학) ;
- 곽승준 (성균관대학교 약학대학) ;
- 천선아 (성균관대학교 약학대학) ;
- 박현선 (성균관대학교 약학대학) ;
- 한하수 (성균관대학교 약학대학) ;
- 임소영 (성균관대학교 약학대학) ;
- 안미영 (성균관대학교 약학대학) ;
- 김원배 (동아제약(주)연구소) ;
- 안병옥 (동아제약(주)연구소) ;
- 홍성렬 (성균관대학교 생명과학대학) ;
- 이병무 (성균관대학교 약학대학)
- Published : 1998.09.01
Abstract
A recombinant human erythropoietin (rHuEPO) was administered intravenously at dosage levels of 0, 100, 500, and 2500IU/kg/day for a period of 3 weeks. There were no observed clinical signs and deaths related to treatment in all groups tested. Decreases in body weight gain and food consumption were observed only in males of 2,5000IU/kg group after 2 weeks. In hematological parameters, erythrocyte content, hematocrit values and hemoglobin concentration were dose- dependently increased in rHuEPO treated groups. The ratio between kidney weight and whole body weight was significantly increased in females of 500 and 2,500IU/kg groups. The spleen weight was also increased in both sexes of 500 and 2,500IU/kg groups. However, the absolute weight change of other organs was not observed. In histopathological examinations, the renal tubular basophilia was observed only in males and females of 2,500IU/kg groups. From these results, it is concluded that the no-observed adverse effect level (NOAEL) of rHuEPO is 100 IU/kg in rats in the present study.