Reproductive toxicity was performed in peri- and postnatal periods for LBD-009. The Sprague-Dawley rats were used and maximum tolerant dosage(10IU/㎏) of clinical dose was considered high dosage and with 3 experimental groups including high dose(10IU/㎏), medium dose(3IU/㎏), low dose(1IU/㎏) and negative control group were established. Each group was consist of 20 pregnant rats, from pregnancy 16 days after to 21 days after delivery LBD-008 was injected through subcutaneous of mother(F0) a time a day, observing whether it raised reproductivity toxicity in mother and the fetus.
In F0, no abnomality in general symptom, body weigbt, food consumption, pregnancy period, delivery and lactation was observed thought to be caused by this material, autopsy findings of F0 and reproductive ability test, but the appearance was independent on dosage and the trend through whole experimental period was not consistent, so, we could there was no differences thought to be related to the material.
Therefore, LBD-009 being injected with dosage lower than 10IU/㎏/day was concluded to have no effect in peri- and post-natal periods.
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