Abstract
Recombinant human granulocyte-macrophage colony stimulating factor (hGM-CSF) is a glycoprotein and hematopoietic growth factors that regulates the proliferation of myeloid precursor cells and activates mature granulocytes and macrophages. In a 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 repeated dose toxicity of rhGM-CSF in SD rats. The repeated dose toxicity study was performed at each dose of 50 and 200 µg/kg subcutaneous administration of rhGM-CSF everyday for 28-days period. The results 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 tested groups. The hematological and blood biochemical parameters were statistically not different in all groups. These results suggest that rhGM-CSF may show no repeated dose toxicity in SD rats under the conditions.
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Abbreviations
- hGM-CSF:
-
Recombinant human granulocyte-macrophage colony stimulating factor
- LD50:
-
50% lethal dose
- E. coli:
-
Escherichia coli
- CHO:
-
Chinese hamster ovary
- rhGM-CSF:
-
rice cells-derived hGM-CSF
- PBS:
-
phosphate buffered saline
- EDTA:
-
ethylenediaminetetraacetic acid
- RBC:
-
red blood cell
- WBC:
-
white blood cell
- NEU:
-
neutrophil
- LYM:
-
lymphocyte
- MONO:
-
monocyte
- EOS:
-
eosinophil
- BASO:
-
basophil
- PLT:
-
platelet
- HCT:
-
hematocrit
- MCV:
-
mean corpuscular volume
- HGB:
-
hemoglobin
- MCH:
-
mean corpuscular hemoglobin
- MCHC:
-
mean corpuscular hemoglobin concentration
- AST:
-
aspartate aminotransferase
- ALT:
-
alanine aminotransferase
- ALP:
-
alkaline phosphatase
- BUN:
-
blood urea nitrogen
- CRE:
-
creatinine
- GLU:
-
glucose
- CHO:
-
total cholesterol
- PRO:
-
total protein
- CPK:
-
creatine phosphokinase
- ALB:
-
albumin
- BIL:
-
total bilirubin
- yhGM-CSF:
-
yeast-derived hGMCSF
- s.c.:
-
subcutaneous
- b.wt.:
-
body weight
- SD:
-
standard deviation
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Ji, J.E., Lee, J.M., Choi, J.M. et al. Subcutaneous Four-Week Repeated Dose Toxicity Studies of Rice Cell-Derived Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor in Rats. Toxicol Res. 24, 315–320 (2008). https://doi.org/10.5487/TR.2008.24.4.315
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DOI: https://doi.org/10.5487/TR.2008.24.4.315