Teratogenicity study (segment II) of recombinant granulocyte-macrophage colony stimulating factors (LBD-005) in rats

A teratogenicity study was carried out in Sprague-Dawley rats subcutaneously injected recombinant Granulocyte-Macrophage Colony Stimulating Factors (LBD-005), the growth of stem cell and the development of the hematopoietic cell, at dose levels of 250, 500 and 1000 micrograms/kg/day for a period of 11 days from day 7 to day 17 of gestation. Two-thirds of the pregnant females in each group were sacrificed on day 20 of gestation and their fetuses were examined. The remaining dams were allowed to litter naturally, and the postnatal development of the offspring was observed. The incidences of external, internal and skeletal anomalies were not significantly increased in the fetuses of any treated groups. Recombinant GM-CSF caused no effects on parturition, lactation, postnatal growth and reproductive ability of the male and female offsprings.