title: Historical control data on developmental toxicity studies in rodents.
abstract: Historical control data on rodent developmental toxicity studies, performed between 1994 and 2010, were obtained from 19 laboratories in Japan, including 10 pharmaceutical and chemical companies and nine contract research organizations. Rats, mice, and hamsters were used for developmental toxicity studies. Data included maternal reproductive findings at terminal cesarean sections and fetal findings including the spontaneous incidences of external, visceral, and skeletal anomalies. No noticeable differences were observed in maternal reproductive data between laboratories. Inter-laboratory variations in the incidences of fetuses with anomalies appeared to be due to differences in the selection of observation parameters, observation criteria, classification of the findings, and terminology of fetal alterations. Historical control data are useful for the appropriate interpretation of experimental results and evaluation of the effects of chemical on reproductive and developmental toxicities.
authors.affiliation: A Study Group for Historical Control Data on Prenatal Developmental Toxicity Studies in Rodents.
authors.forename: Makoto
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authors.lastname: Ema
authors.forename: Katsumi
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authors.lastname: Endoh
authors.forename: Ryou
authors.initials: R
authors.lastname: Fukushima
authors.forename: Sakiko
authors.initials: S
authors.lastname: Fujii
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Hara
authors.forename: Mutsuko
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authors.lastname: Hirata-Koizumi
authors.forename: Akihiko
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authors.lastname: Hirose
authors.forename: Hitoshi
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authors.lastname: Hojo
authors.forename: Masao
authors.initials: M
authors.lastname: Horimoto
authors.forename: Nobuhito
authors.initials: N
authors.lastname: Hoshino
authors.forename: Yoshinori
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authors.lastname: Hosokawa
authors.forename: Yukari
authors.initials: Y
authors.lastname: Imai
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Inada
authors.forename: Kunifumi
authors.initials: K
authors.lastname: Inawaka
authors.forename: Keiichi
authors.initials: K
authors.lastname: Itoh
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Katsumata
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Izumi
authors.forename: Hirohito
authors.initials: H
authors.lastname: Kato
authors.forename: Maki
authors.initials: M
authors.lastname: Maeda
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Matsumoto
authors.forename: Seiki
authors.initials: S
authors.lastname: Matsuo
authors.forename: Toshiki
authors.initials: T
authors.lastname: Matsuoka
authors.forename: Ikuo
authors.initials: I
authors.lastname: Matsuura
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Mineshima
authors.forename: Yoji
authors.initials: Y
authors.lastname: Miwa
authors.forename: Nao
authors.initials: N
authors.lastname: Nakano
authors.forename: Masato
authors.initials: M
authors.lastname: Naya
authors.forename: Hiroko
authors.initials: H
authors.lastname: Noyori
authors.forename: Takafumi
authors.initials: T
authors.lastname: Ohta
authors.forename: Harutaka
authors.initials: H
authors.lastname: Oku
authors.forename: Atsushi
authors.initials: A
authors.lastname: Ono
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Shimizu
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Shimomura
authors.forename: Ikuro
authors.initials: I
authors.lastname: Takakura
authors.forename: Ryota
authors.initials: R
authors.lastname: Tanaka
authors.forename: Taishi
authors.initials: T
authors.lastname: Tateishi
authors.forename: Yuko
authors.initials: Y
authors.lastname: Tominaga
authors.forename: Tohru
authors.initials: T
authors.lastname: Uesugi
authors.forename: Chizuru
authors.initials: C
authors.lastname: Urakawa
authors.forename: Kaoru
authors.initials: K
authors.lastname: Yabe
authors.forename: Akihito
authors.initials: A
authors.lastname: Yamashita
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Yamauchi
authors.forename: Ryohei
authors.initials: R
authors.lastname: Yokoi
mesh_terms: D000818:Animals; D035061:Control Groups; D006224:Cricetinae; D004353:Drug Evaluation, Preclinical / Q000266:history*; D005260:Female; D048788:Growth and Development / Q000187:drug effects; D049673:History, 20th Century; D049674:History, 21st Century; D008297:Male; D051379:Mice; D011247:Pregnancy; D051381:Rats; D015203:Reproducibility of Results; D012107:Research Design
keywords: developmental toxicity; fetal malformation; historical control data; reproductive toxicity; rodent