Abstract

Maternal and embryo‐fetal historical background control data supports improved interpretation of lesions in reproductive toxicity studies. A maternal and embryo‐fetal toxicity study was performed to generate historical background control data in the Hsd:Sprague Dawley®SD® rat model. One hundred previously nulliparous and virgin time‐mated female Sprague Dawley rats, allotted in four subsets of 25 rats each, were housed under standard housing and husbandry conditions with ad libitum access to a standard diet (18% protein, 6% fat) and water. Rats were administered tap water (10 mL/kg body weight) by oral gavage once daily from gestational day 6 to 17. Body weight, food consumption, and clinical observations were monitored throughout the in‐life phase of the study. On gestational day 20, animals were euthanized and submitted for Cesarean section and necropsy. A macroscopic postmortem evaluation was performed on all animals, including counts of corpora lutea and implantations and uterine weights. Fetuses were removed, weighed, sexed, and examined externally for defects as well as soft tissue abnormalities and skeletal abnormalities. Placentas were examined and weighed. One hundred dams were pregnant and 100 litters were evaluated. There were 1,488 fetuses examined externally; 698 had fixed visceral evaluations and 790 fetuses had skeletal evaluations. A detailed analysis of maternal data, including body weight, food consumption, and pregnancy outcome will be presented. Fetal data including uterine and placental weights, in addition to fetal examinations, including external, soft tissue (visceral), and skeletal will also be presented. These data support the use of the Hsd:Sprague Dawley®SD® rat as a valuable toxicology model and will assist in interpretation of lesion data in future studies with this model.This abstract is from the Experimental Biology 2018 Meeting. There is no full text article associated with this abstract published in The FASEB Journal.

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