A Study for collecting background data on Wistar Hannover [Crl:WI(Han)] rats in embryo-fetal development studies - comparative data to Sprague Dawley rats -

Noritake, Ken-ichi; Ikeda, Takashi; Ito, Keiichi; Miwa, Yoji; Senuma, Mika; Takashima, Hiromasa; Tateishi, Taishi; Hisada, Shigeru; Maki, Eiji

doi:10.2131/jts.38.847

Cited by 12 publications

(11 citation statements)

References 10 publications

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“…The numbers of corpora lutea, implantations, and live fetuses tended to be lower in Wistar Hannover rats than in SD rats, as did their ranges. These results are in good agreement with those of previous studies . Fetal weights varied among laboratories and were dependent on the gestational day of cesarean section.…”

Section: Resultssupporting

confidence: 92%

“…The incidence of supernumerary ribs was higher in Wistar Hannover rats than that in Crl:CD(SD) rats, in agreement with previous findings. [7][8][9][10][11] The types and incidence of skeletal variation in both Crl:CD (SD) rats (Tables S15A and S15B) and Wistar Hannover rats (Table S16) did not differ between this and the previous surveys.…”

Section: Skeletal Variationsmentioning

confidence: 55%

“…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%

“…2 Historical control data in Japan on reproductive and developmental toxicity studies in laboratory animals, such as rats, mice, guinea pigs, and rabbits, performed from 1998 to 2010, were reported by Ema et al 3 Three previous studies reported histological control data of laboratory animals in Japan Kameyama et al, 4 Morita et al, 5 and Nakatsuka et al 6 Wistar Hannover rats have become more widely used in toxicological studies because of their characteristics, including a lower body weight but comparable reproductive performance when compared with Sprague-Dawley (SD) rats. [7][8][9][10][11][12] Rat breeders in Japan publish in-house reproductive and developmental findings on their websites (CLEA Japan; www.cleajapan.co/index. Charles River Japan; http://www.crj.co.jp/product/ domestic/detail/2), but not on a regular basis.…”

mentioning

confidence: 99%

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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: Resultssupporting

confidence: 92%

Section: Skeletal Variationsmentioning

confidence: 55%

Section: Mating and Cesarean Section Datamentioning

confidence: 99%

mentioning

confidence: 99%

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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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“…Thoracolumbar supernumerary ribs (TSRs) have been classified as less severe skeletal anomalies, with a relatively high spontaneous incidence in rat fetuses. [1][2][3][4] Current historical control data in Japan have shown that the spontaneous incidence of TSR is 0.09% to 15.1% in Sprague-Dawley (SD) rats, and 17.8% to 58.1% in Wistar Hannover rats. 2 TSR can also be induced in rodent fetuses by maternal stress, 5 maternal hypoglycemia, 6 and exposure to chemicals and herbs during pregnancy.…”

Section: Introductionmentioning

confidence: 99%

Induction of a thoracolumbar supernumerary rib in rat developmental toxicity studies: A short discussion on the critical window

Kuwagata

Senuma

Todoroki

et al. 2018

Congenital Anomalies

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Thoracolumbar supernumerary ribs (TSRs) are classified as less severe skeletal anomalies in rat developmental toxicity studies, although their incidence is relatively high in rodent studies. To investigate the characteristics of the critical window for chemically-induced TSR, in this study, rats were administered 5-fluorocytocine (5-FC) or sodium salicylate (SAL) at one of three time periods on gestational day (GD) 9, early morning (7:00 AM), midday (12:00 PM to 1:00 PM), or late afternoon (4:00 PM or 7:00 PM). The incidence of TSR and other anomalies were assessed in GD20 fetuses. A single treatment with both chemicals on GD9-induced TSR, with the incidence highest when administered at 7:00 AM, decreasing gradually when administered later. This trajectory was clearer in rats treated with 5-FC than with SAL. The critical period of TSR induction is shorter in rats administered 5-FC than SAL. The characteristics of the critical window may cause variability in the incidence of TSR observed in developmental toxicity studies. K E Y W O R D S 5-fluocytocine, critical period, rats, sodium salicylate, thoracolumbar supernumerary rib 1 | INTRODUCTION Several types of fetal anomalies encountered in developmental toxicity studies can occur spontaneously, and are not because of chemical exposure. Understanding the toxicological characteristics of these anomalies is important to determine whether these anomalies indicate a chemical-induced developmental toxicity or a spontaneous finding.Thoracolumbar supernumerary ribs (TSRs) have been classified as less severe skeletal anomalies, with a relatively high spontaneous incidence in rat fetuses. 1-4 Current historical control data in Japan have shown that the spontaneous incidence of TSR is 0.09% to 15.1% in Sprague-Dawley (SD) rats, and 17.8% to 58.1% in Wistar Hannover rats. 2 TSR can also be induced in rodent fetuses by maternal stress, 5 maternal hypoglycemia, 6 and exposure to chemicals and herbs during pregnancy. 7-11 If the incidence of TSR is dependent on dose of a chemical, the tested item should be regarded as a risk factor for TSR induction.The rates of chemically-induced TSR vary considerably, perhaps because of differences in fertility times of dams. Alternatively, this variability may also be because of the existence of a relatively narrow critical window. This study therefore assessed TSR induced in rat fetuses by a single treatment on gestational day (GD) nine with two teratogenic chemicals, 5-fluorocytocine (5-FC) and sodium salicylate (SAL). 9,12,13 To determine characteristic of critical window for TSR, these chemicals were administered at three different times on GD9. | MATERIALS AND METHODS | AnimalPregnant SLC:SD rats were obtained from SLC Japan, Inc. (Shizuoka, Japan), and housed individually in an environmentally controlled animal room. Lights were on from 7:00 AM to 7:00 PM, and rat chow (CE-2, CLEA Japan Inc., Tokyo, Japan) and drinking water were provided ad libitum. The day on which sperm were observed, was designated as GD0. On GD9, 5-FC or SAL was ad...

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Harmonization of criteria and terminology in fetal rat skeletal evaluations

Posobiec,

Kopp,

Murzyn

et al. 2023

Birth Defects Research

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Background: A survey of laboratories in North American and Europe that routinely conduct fetal skeletal examinations was performed with the purpose of (1) understanding current terminology used for classifying skeletal findings in developmental toxicity (DT) studies and (2) understanding the criteria used to identify relatively common findings that sufficiently deviate from normal.The goal was to promote terminology harmonization and improve interlaboratory consistency in the criteria used to identify developmental anomalies. Methods: The survey, designed based on terminology for developmental anomalies recommended by an international collaboration (Makris et al., Congenital Anomalies, 2009;49(3):123-246), was conducted by a subgroup (authors of this publication) of the Royal Society of Biology's International Register of Fetal Morphologists (IRFM). Results: Individual and summarized anonymized responses are provided here. The authors, who are expert fetal morphologists with experience performing fetal examinations, reviewed the responses and generated recommendations on preferred terminology and criteria for determining when morphological variations deviate from normal and warrant recording of the findings for skeletal observations in Sprague Dawley (SD) fetal rats. The objective of these recommendations is to complement Makris et al. (Congenital Anomalies, 2009;49 (3):123-246). Conclusion:The broad application will improve interlaboratory harmonization of recording fetal skeleton findings in developmental toxicity studies intended for regulatory submissions, including SEND (Standard for Exchange of Nonclinical Data).

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A Study for collecting background data on Wistar Hannover [Crl:WI(Han)] rats in embryo-fetal development studies - comparative data to Sprague Dawley rats -

Cited by 12 publications

References 10 publications

Historical control data on developmental toxicity studies in rats

Historical control data on developmental toxicity studies in rats

Induction of a thoracolumbar supernumerary rib in rat developmental toxicity studies: A short discussion on the critical window

Harmonization of criteria and terminology in fetal rat skeletal evaluations

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