Historical control data on developmental toxicity studies in rats

Historical control data on developmental toxicity studies in rats

Historical control data from prenatal developmental toxicity studies in rats have been used to evaluate whether toxicology outcomes were induced by exposure to a chemical or were within the range of spontaneous variation. These data are also important for monitoring animal characteristics. As a foll...

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Bibliographic Details
Published in:Congenital anomalies Vol. 59; no. 4; pp. 125 - 131
Main Authors: Kuwagata, Makiko, Sakai, Yuko, Tanaka, Sho, Takashima, Hiromasa, Katagiri, Ryuichi, Matsuoka, Toshiki, Noritake, Kenichi, Senuma, Mika, Shimizu, Tatsuya, Hojo, Hitoshi, Ibi, Kanata, Kudo, Satoshi, Oota, Takafumi, Ube, Masayuki, Miwa, Yoji, Kajita, Shimpei, Uesugi, Tohru, Yabe, Kaoru, Tateishi, Taishi, Nakano, Nao, Taniguchi, Terumasa, Yamashita, Akihito, Hirano, Takayuki, Kirihata, Yuka, Sakai, Yumi, Nishizawa, Shino, Fujiwara, Michio, Mineshima, Hiroshi, Horimoto, Masao, Ema, Makoto
Format: Journal Article
Language:English
Published: Kyoto, Japan John Wiley & Sons Australia, Ltd 01-07-2019
Wiley Subscription Services, Inc
Subjects:
Animals
Anomalies
Cesarean section
Control data (computers)
Developmental Disabilities - etiology
Developmental Disabilities - pathology
developmental toxicity
Disease Models, Animal
Female
fetal malformation
Fetuses
historical control data
Immunohistochemistry
Laboratories
Male
Organic chemistry
Phenotype
Pregnancy
R&D
rat
Rats
Rats, Sprague-Dawley
Rats, Wistar
Reproducibility of Results
reproductive toxicity
Research & development
Toxicity
Toxicology
fetal malformation
historical control data
rat
developmental toxicity
reproductive toxicity
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Summary:Historical control data from prenatal developmental toxicity studies in rats have been used to evaluate whether toxicology outcomes were induced by exposure to a chemical or were within the range of spontaneous variation. These data are also important for monitoring animal characteristics. As a follow‐up to historical control data from 1998 to 2010, this study analyzed control data from prenatal developmental studies performed in rats from 2011 to 2015. Data were collected from studies performed by 24 Japanese laboratories, including 15 pharmaceutical and chemical companies and nine contract research organizations, in Sprague‐Dawley and two‐sub‐strains of Wistar Hannover rats. The data included maternal reproductive findings at terminal cesarean section and fetal findings, including incidences of spontaneous external, visceral, and skeletal anomalies. No noticeable differences in maternal reproductive data were observed among laboratories. The inter‐laboratory variations in the incidences of fetal anomalies seemed to be due to differences in the selection of observation parameters, observation criteria, and classification of the findings, as well as to differences in terminology of fetal alterations. These historical control data may be helpful for adequate interpretation of experimental results and for evaluating the reproductive and developmental toxicities of various chemicals.
ISSN:0914-3505
1741-4520
DOI:10.1111/cga.12305