Historical control data on developmental toxicity studies in rodents

Ema, Makoto; Endoh, Katsumi; Fukushima, Ryou; Fujii, Sakiko; Hara, Hiroaki; Hirata-Koizumi, Mutsuko; Hirose, Akihiko; Hojo, Hitoshi; Horimoto, Masao; Hoshino, Nobuhito; Hosokawa, Yoshinori; Imai, Yuki; Ishiguro, Hiroshi; Inawaka, Kunifumi; Itoh, Keiichi; Katsumata, Yoshihiro; Hayashi, Izumi; Kato, Harubumi; Maeda, Maki; Matsumoto, Kiyoshi; Matsuo, Seiki; Matsuoka, Toshifumi; 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, Toshiyuki; Yokoi, Ryohei

doi:10.1111/cga.12050

Cited by 14 publications

(25 citation statements)

References 13 publications

(46 reference statements)

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“…Hannover rats observed in the present survey were not observed in the previous survey. 3 The incidences of all skeletal malformations were very low, with the number of types of malformations being lower in Wistar Hannover rats than in Crl:CD(SD) rats. Moreover, the incidences of some malformations in two surveys differed in Crl:CD (SD) rats (Table S13), but not in Wistar Hannover rats (Table S14).…”

Section: More Than Half Of the Skeletal Malformations In Sd And Wistarmentioning

confidence: 91%

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Historical control data on developmental toxicity studies in rats

Kuwagata

Sakai

Tanaka

et al. 2018

Congenital Anomalies

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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.

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Section: More Than Half Of the Skeletal Malformations In Sd And Wistarmentioning

confidence: 91%

“…These results are in good agreement with those of previous studies. 3,7,[9][10][11]14 Fetal weights varied among laboratories and were dependent on the gestational day of cesarean section.…”

Section: Mating and Cesarean Section Datamentioning

confidence: 99%

Historical control data on developmental toxicity studies in rats

Kuwagata

Sakai

Tanaka

et al. 2018

Congenital Anomalies

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“…Second, different observational criteria, parameters and selection of experimental methods might induce large inter-laboratory variations [220, 221]. For example, the MTT assay always fails to accurately predict graphene toxicity because the spontaneous reduction results in a false positive signal.…”

Section: Data Gaps and Future Studiesmentioning

confidence: 99%

Toxicity of graphene-family nanoparticles: a general review of the origins and mechanisms

et al. 2016

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Due to their unique physicochemical properties, graphene-family nanomaterials (GFNs) are widely used in many fields, especially in biomedical applications. Currently, many studies have investigated the biocompatibility and toxicity of GFNs in vivo and in intro. Generally, GFNs may exert different degrees of toxicity in animals or cell models by following with different administration routes and penetrating through physiological barriers, subsequently being distributed in tissues or located in cells, eventually being excreted out of the bodies. This review collects studies on the toxic effects of GFNs in several organs and cell models. We also point out that various factors determine the toxicity of GFNs including the lateral size, surface structure, functionalization, charge, impurities, aggregations, and corona effect ect. In addition, several typical mechanisms underlying GFN toxicity have been revealed, for instance, physical destruction, oxidative stress, DNA damage, inflammatory response, apoptosis, autophagy, and necrosis. In these mechanisms, (toll-like receptors-) TLR-, transforming growth factor β- (TGF-β-) and tumor necrosis factor-alpha (TNF-α) dependent-pathways are involved in the signalling pathway network, and oxidative stress plays a crucial role in these pathways. In this review, we summarize the available information on regulating factors and the mechanisms of GFNs toxicity, and propose some challenges and suggestions for further investigations of GFNs, with the aim of completing the toxicology mechanisms, and providing suggestions to improve the biological safety of GFNs and facilitate their wide application.

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“…Traditional toxicity testing requires data collection on one chemical at a time using common laboratory animal species, such as rat or rabbit (Ema et al. , ). Developing a new drug requires a large number of rodents for a teratogenicity safety assessment.…”

Section: Introductionmentioning

confidence: 99%

“…According to international regulatory guidelines, each drug in development for administration to women of childbearing potential must be tested for developmental toxicity in rodent and non-rodent species (ICH 2005;ICH 2015). Traditional toxicity testing requires data collection on one chemical at a time using common laboratory animal species, such as rat or rabbit (Ema et al 2012(Ema et al , 2014. Developing a new drug requires a large number of rodents for a teratogenicity safety assessment.…”

Section: Introductionmentioning

confidence: 99%

Using zebrafish in systems toxicology for developmental toxicity testing

Nishimura

Inoue

Sasagawa

et al. 2016

Congenital Anomalies

165

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With the high cost and the long-term assessment of developmental toxicity testing in mammals, the vertebrate zebrafish has become a useful alternative model organism for high-throughput developmental toxicity testing. Zebrafish is also very favorable for the 3R perspective in toxicology; however, the methodologies used by research groups vary greatly, posing considerable challenges to integrative analysis. In this review, we discuss zebrafish developmental toxicity testing, focusing on the methods of chemical exposure, the assessment of morphological abnormalities, housing conditions and their effects on the production of healthy embryos, and future directions. Zebrafish as a systems toxicology model has the potential to elucidate developmental toxicity pathways, and to provide a sound basis for human health risk assessments.

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Historical control data on developmental toxicity studies in rodents

Cited by 14 publications

References 13 publications

Historical control data on developmental toxicity studies in rats

Historical control data on developmental toxicity studies in rats

Toxicity of graphene-family nanoparticles: a general review of the origins and mechanisms

Using zebrafish in systems toxicology for developmental toxicity testing

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