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KMID : 0379520070230040383
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한국독성학회지
2007 Volume.23 No. 4 p.383 ~ p.389
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Intravenous Single and Two Week Repeated Dose Toxicity Studies of Rice Cells-derived Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor on Rats
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Ji Jung-Eun
Lee Jung-Min
Choi Jong-Min
Kim Seok-Kyun
Ahn Kyong-Hoon
Lee Dong-Hoon
Kim Ha-Hyung
Han Kyu-Boem
Kim Dae-Kyong
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Abstract
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Recombinant human granulocyte-macrophage colony stimulating factor (hGM-CSF) regulates proliferation and differentiation of hematopoietic progenitor cells and modulates function of the mature hematopoietic cells. In the previous study, we reported that hGM-CSF could be produced in transgenic rice cell suspension culture, termed rhGM-CSF. In the present study we examined the single and repeated dose toxicity of rice cells-derived hGM-CSF in SD rats. During single dose toxicity study for 7 days, there were no any toxic effects at any dose of from 10 to 1000 ㎍/㎏. The lethal dose (LD??) was not found in this range. Moreover, repeated dose toxicity study of 14-days period and at the doses of 50 and 200 ㎍/㎏ (i.v.) of rhGM-CSF did not show any changes in food and water intake. There were also no significant changes in both body and organ weights between the control and the test groups. The hematological and blood biochemical parameters were statistically not different in all the groups. These results suggest that rhGM-CSF has no toxicity in SD rats.
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KEYWORD
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Recombinant hGM-CSF, Rice cells, Single dose toxicity, Repeated dose toxicity, SD rats
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