title: Study for collecting background data on Wistar Hannover [Crl:WI(Han)] rats in embryo-fetal development studies--comparative data to Sprague Dawley rats.
abstract: The purpose of the present study was to collect the background data on Wistar Hannover [Crl:WI(Han)] (hereafter Wistar Han) rats in embryo-fetal development studies from the 6 safety research facilities of pharmaceutical companies and contract research organizations. In each facility, 20 or 22 female rats were dosed with vehicle solution during the organogenesis period. As a result, no abnormalities in clinical signs and necropsy findings in dams were found. Body weights and food consumption in dams were lower than those in Sprague Dawley (SD) rats. The number of corpora lutea (13.3 vs. 16.0 in SD) and implantations (11.8 vs. 14.7) were fewer, and fetal body weights (3.66 vs. 3.70) and placental weights (0.42 vs. 0.45) tended to be lower than those in SD rats. Regarding the fetal abnormalities, the incidence of several findings such as the persistent left umbilical artery (10.4% vs. 1.1%) and cervical (5.2% vs. 0.4%), full (7.4% vs. 0.9%) or short supernumerary (64.5% vs. 9.9%) and wavy ribs (6.6% vs. 0.3%) was higher than that in SD rats. Our present study showed that they maintained a sufficient number of live fetuses and the difference in the fetal sex ratio was not observed. In conclusion, Wistar Han rats were considered to be a suitable strain for embryo-fetal development toxicity study. Since the incidence of several abnormalities was higher than that in SD rats, it may be said that to accumulate background control data is important to evaluate the embryo-fetal development toxicity study using Wistar Han rats.
authors.affiliation: Medicinal Safety Research Laboratories, Daiichi Sankyo Co., Ltd., Present address; Preclinical Safety Research Laboratories, Sunplanet Co., Ltd.
authors.forename: Ken-ichi
authors.initials: K
authors.lastname: Noritake
authors.forename: Takashi
authors.initials: T
authors.lastname: Ikeda
authors.forename: Keiichi
authors.initials: K
authors.lastname: Ito
authors.forename: Yoji
authors.initials: Y
authors.lastname: Miwa
authors.forename: Mika
authors.initials: M
authors.lastname: Senuma
authors.forename: Hiromasa
authors.initials: H
authors.lastname: Takashima
authors.forename: Taishi
authors.initials: T
authors.lastname: Tateishi
authors.forename: Shigeru
authors.initials: S
authors.lastname: Hisada
authors.forename: Eiji
authors.initials: E
authors.lastname: Maki
mesh_terms: D000818:Animals; D001835:Body Weight; D003338:Corpus Luteum; D004435:Eating; D010064:Embryo Implantation; D005260:Female; D047109:Fetal Development; D020567:Fetal Weight; D023421:Models, Animal; D009139:Musculoskeletal Abnormalities / Q000196:embryology* / Q000453:epidemiology*; D009929:Organ Size; D038081:Organogenesis; D010920:Placenta / Q000033:anatomy & histology; D011247:Pregnancy; D051381:Rats; D017207:Rats, Sprague-Dawley; D017208:Rats, Wistar; D018675:Toxicity Tests; D014116:Toxicology / Q000379:methods*; D014781:Viscera / Q000002:abnormalities* / Q000196:embryology*