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EC number: 701-290-8 | CAS number: -
Inseminated female New Zealand White SPF rabbits randomly assigned to one control and three treatment groups of 16 animals each were used to determine the teratogenic potential of Sucrose Acetate Isobutyrate (SAIB). Dosage levels of 250, 425 and 600 mg/kg body weight/dose at volumes of SAIB of 0.685, 0.84, and 1.0 ml/kg body weight, respectively, were administered orally by gavage twice daily on days 7 through 19 of gestation to yield total daily doses of 500, 850 and 1,200 mg/kg body weight/day at total daily volumes of 1.37 1.68, and 2.00 ml/kg body weight, respectively (contained in a volume of 0.92 ml/kg body weight corn oil). The control group received the vehicle only, corn oil, on a comparable regimen at a total daily volume of 0.92 ml/kg. Cesarean sections were performed on all surviving females on gestation day 29 and the fetuses were removed for teratologic evaluation. Two high dose animals died on gestation day 17. One death was determined to be due to mucoid enteritis and the other was from unknown cause(s). The remaining animals on study survived to scheduled sacrifice. There was a slight increase in the incidence of labored breathing in all treated groups. No other meaningful differences in maternal antemortem and necropsy observations, body weight gain, food consumption or Cesarean section observations relative to those of the control group were seen at 1,200 mg/kg/day or less. No evidence of an adverse effect on fetal morphology was seen at any tested level. In conclusion, the 1,200 mg/kg/day level was determined to be the "no observable effect level" with respect to developmental toxicity, including teratogenesis, in this study.
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