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KMID : 0606919980060010056
Biomolecules & Therapeutics
1998 Volume.6 No. 1 p.56 ~ p.62
Mutagenicity Study of Recombinant Human Erythropoietin(rhEPO)
°­°æ±¸/Kang, Kyung Koo
Á¶Çö/±èµ¿È¯/¹é³²±â/±è¿ø¹è/Cho, Hyeon/Kim, Dong Hwan/Baik, Nam Gi/Kim, Won Bae
Abstract
Mutagenicity of recombinant human erythropoietin (rhEPO) was examined in the reverse mutation test on bacteria, in the chromosomal aberration test on cultured mammalian cells and in the micronucleus test on mice. The reverse mutation test was performed by a plate incorporation method with or wothout a metabolic activation system (S9 Mix) using Salmonella typhimurium strain TA100, TA1535, TA98 and TA 1537. The rhEPO did not significantly increase revertant colonies in any of the test strains under any conditions at dose levels ranging from 1000 IU/ml to 62.5 lU/plate, compared with the vehicle control. In the chromosomal aberration test using cultured Chinese Hamster Lung (CHL) cells, the number of aberrant cells was not increased in the presence or absence of S9 Mix at concentrations of 1000 xU/ml to 250 1U/ml, compared with the vehicle control. In the micronucleus test, ma)e JCR mice were given rhEPO intraperi¡©toneally at a dose level of 25000, 12500 and 6250 lU/kg. The incidence of bone marrow micronucleated polychromatic erythrocytes was not different from that of the vehicle control. From these results, rhEPO is considered to be non-mutagenic under the present test conditions.
Keywords0 rhEPO, Mutagenicity
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