Historical control data on developmental toxicity studies in rodents

Makoto Ema, Katsumi Endoh, Ryou Fukushima, Sakiko Fujii, Hiroaki Hara, Mutsuko Hirata-Koizumi, Akihiko Hirose, Hitoshi Hojo, Masao Horimoto, Nobuhito Hoshino, Yoshinori Hosokawa, Yukari Imai, Hiroshi Inada, Kunifumi Inawaka, Keiichi Itoh, Yoshihiro Katsumata, Hiroyuki Izumi, Hirohito Kato, Maki Maeda, Kiyoshi MatsumotoSeiki Matsuo, Toshiki Matsuoka, Ikuo Matsuura, Hiroshi Mineshima, Yoji Miwa, Nao Nakano, Masato Naya, Hiroko Noyori, Takafumi Ohta, Harutaka Oku, Atsushi Ono, Tatsuya Shimizu, Kazuhiro Shimomura, Ikuro Takakura, Ryota Tanaka, Taishi Tateishi, Yuko Tominaga, Tohru Uesugi, Chizuru Urakawa, Kaoru Yabe, Akihito Yamashita, Toshiaki Yamauchi, Ryohei Yokoi

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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.

Original languageEnglish
Pages (from-to)150-161
Number of pages12
JournalCongenital Anomalies
Volume54
Issue number3
DOIs
Publication statusPublished - Aug 2014
Externally publishedYes

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Keywords

  • Developmental toxicity
  • Fetal malformation
  • Historical control data
  • Reproductive toxicity
  • Rodent

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Ema, M., Endoh, K., Fukushima, R., Fujii, S., Hara, H., Hirata-Koizumi, M., Hirose, A., Hojo, H., Horimoto, M., Hoshino, N., Hosokawa, Y., Imai, Y., Inada, H., Inawaka, K., Itoh, K., Katsumata, Y., Izumi, H., Kato, H., Maeda, M., ... Yokoi, R. (2014). Historical control data on developmental toxicity studies in rodents. Congenital Anomalies, 54(3), 150-161. https://doi.org/10.1111/cga.12050