Calcipotriol (MC903)の生殖・発生毒性試験 (第4報) : ラット皮下投与による周産期および授乳期投与試験

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  • REPRODUCTIVE AND DEVELOPMENTAL TOXICITY STUDIES OF CALCIPOTRIOL (MC903):(4) : A Perinatal and Postnatal Study in Rats by Subcutaneotis Administration
  • Calcipotriol MC903 ノ セイショク ハッセイ ドクセイ シケ

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Perinatal and postnatal toxicity of calcipotriol (MC903), an anti-psoriasic agent, was studied. MC903 at doses of 6:25, 12.5 and 25 μg/kg/day were subcutaneously administered to pregnant Slc:SD rats from day 17 of gestation to day 21 after delivery. 1. Administration of MC903 at any doses did not adversely affect pregnant animals in regard to gestations delivery and maternal behavior. In dams administered MC903 25 μg/kg/day, food consumption and body weight gain were marginally lower than those of control animals during lactation period. 2. In group administered MC903 25 μg/kg/day, body weight gain in F1 offsprings was significantly lower as compared with those of control group. The drug did not have any adverse effects on the postnatal development of the offspring such as differentiation, functional development, emotionality, motor ability, learning ability or reproductive performance. 3. On the basis of results obtained in the present study, it is considered that the no-toxic dose level for general toxicity and reproduction in the dams was estimated to be 12.5 and 25 μg/kg/day, respectively, the no-toxic dose levels in the offspring was also estimated to be 12.5 μg/kg/day.

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