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 Matsumoto; Seiki 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

doi:10.1111/cga.12050

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

Research output: Contribution to journal › Article › peer-review

9 Citations (Scopus)

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 language	English
Pages (from-to)	150-161
Number of pages	12
Journal	Congenital Anomalies
Volume	54
Issue number	3
DOIs	https://doi.org/10.1111/cga.12050
Publication status	Published - Aug 2014
Externally published	Yes

Keywords

Developmental toxicity
Fetal malformation
Historical control data
Reproductive toxicity
Rodent

ASJC Scopus subject areas

Pediatrics, Perinatology, and Child Health
Embryology
Developmental Biology

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10.1111/cga.12050

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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

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, Matsumoto, K, Matsuo, S, Matsuoka, T, Matsuura, I, Mineshima, H, Miwa, Y, Nakano, N, Naya, M, Noyori, H, Ohta, T, Oku, H, Ono, A, Shimizu, T, Shimomura, K, Takakura, I, Tanaka, R, Tateishi, T, Tominaga, Y, Uesugi, T, Urakawa, C, Yabe, K, Yamashita, A, Yamauchi, T & Yokoi, R 2014, 'Historical control data on developmental toxicity studies in rodents', Congenital Anomalies, vol. 54, no. 3, pp. 150-161. https://doi.org/10.1111/cga.12050

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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.",

keywords = "Developmental toxicity, Fetal malformation, Historical control data, Reproductive toxicity, Rodent",

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

year = "2014",

month = aug,

doi = "10.1111/cga.12050",

language = "English",

volume = "54",

pages = "150--161",

journal = "Congenital Anomalies",

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AU - Ema, Makoto

AU - Endoh, Katsumi

AU - Fukushima, Ryou

AU - Fujii, Sakiko

AU - Hara, Hiroaki

AU - Hirata-Koizumi, Mutsuko

AU - Hirose, Akihiko

AU - Hojo, Hitoshi

AU - Horimoto, Masao

AU - Hoshino, Nobuhito

AU - Hosokawa, Yoshinori

AU - Imai, Yukari

AU - Inada, Hiroshi

AU - Inawaka, Kunifumi

AU - Itoh, Keiichi

AU - Katsumata, Yoshihiro

AU - Izumi, Hiroyuki

AU - Kato, Hirohito

AU - Maeda, Maki

AU - Matsumoto, Kiyoshi

AU - Matsuo, Seiki

AU - Matsuoka, Toshiki

AU - Matsuura, Ikuo

AU - Mineshima, Hiroshi

AU - Miwa, Yoji

AU - Nakano, Nao

AU - Naya, Masato

AU - Noyori, Hiroko

AU - Ohta, Takafumi

AU - Oku, Harutaka

AU - Ono, Atsushi

AU - Shimizu, Tatsuya

AU - Shimomura, Kazuhiro

AU - Takakura, Ikuro

AU - Tanaka, Ryota

AU - Tateishi, Taishi

AU - Tominaga, Yuko

AU - Uesugi, Tohru

AU - Urakawa, Chizuru

AU - Yabe, Kaoru

AU - Yamashita, Akihito

AU - Yamauchi, Toshiaki

AU - Yokoi, Ryohei

PY - 2014/8

Y1 - 2014/8

N2 - 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.

AB - 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.

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KW - Fetal malformation

KW - Historical control data

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KW - Rodent

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ER -

Historical control data on developmental toxicity studies in rodents

Abstract

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