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Historical control data on developmental toxicity studies in rodents
Author(s) -
Ema Makoto,
Endoh Katsumi,
Fukushima Ryou,
Fujii Sakiko,
Hara Hiroaki,
HirataKoizumi Mutsuko,
Hirose Akihiko,
Hojo Hitoshi,
Horimoto Masao,
Hoshino Nobuhito,
Hosokawa Yoshinori,
Imai Yukari,
Inada Hiroshi,
Inawaka Kunifumi,
Itoh Keiichi,
Katsumata Yoshihiro,
Izumi Hiroyuki,
Kato Hirohito,
Maeda Maki,
Matsumoto Kiyoshi,
Matsuo Seiki,
Matsuoka Toshiki,
Matsuura Ikuo,
Mineshima Hiroshi,
Miwa Yoji,
Nakano Nao,
Naya Masato,
Noyori Hiroko,
Ohta Takafumi,
Oku Harutaka,
Ono Atsushi,
Shimizu Tatsuya,
Shimomura Kazuhiro,
Takakura Ikuro,
Tanaka Ryota,
Tateishi Taishi,
Tominaga Yuko,
Uesugi Tohru,
Urakawa Chizuru,
Yabe Kaoru,
Yamashita Akihito,
Yamauchi Toshiaki,
Yokoi Ryohei
Publication year - 2014
Publication title -
congenital anomalies
Language(s) - English
Resource type - Journals
eISSN - 1741-4520
pISSN - 0914-3505
DOI - 10.1111/cga.12050
Subject(s) - developmental toxicity , fetus , physiology , toxicity , terminology , reproductive toxicity , teratology , biology , rodent , medicine , pregnancy , toxicology , genetics , ecology , philosophy , linguistics
Historical control data on rodent developmental toxicity studies, performed between 1994 and 2010, were obtained from 19 laboratories in J apan, 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.