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

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  • Hayakawa Kazuhiro
    Kawashima Drug Safety, Global Drug Safety, Biopharmaceutical Assessment Core Function Unit, Eisai Co., Ltd., Present address; Preclinical Safety Research Laboratories, Sunplanet Co., Ltd.
  • Mimura Yuichi
    Developmental Research Center, Aska Pharmaceutical Co., Ltd.
  • Tachibana Shigehiro
    Hatano Research Institute, Food and Drug Safety Center
  • Furuya Mami
    Hatano Research Institute, Food and Drug Safety Center
  • Kodama Terutaka
    Toxicology & Pathology, Development Research Laboratories, Research Center, Ajinomoto Pharmaceuticals Co., Ltd.
  • Aoki Toyohiko
    Tsukuba Drug Safety, Global Drug Safety, Biopharmaceutical Assessments Core Function Unit, Eisai Co., Ltd.
  • Hosokawa Satoru
    Tsukuba Drug Safety, Global Drug Safety, Biopharmaceutical Assessments Core Function Unit, Eisai Co., Ltd.
  • Fukui Motoko
    Developmental Research Center, Aska Pharmaceutical Co., Ltd.
  • Shibata Seiji
    Developmental Research Center, Aska Pharmaceutical Co., Ltd.
  • Yoshida Masanao
    Toxicology & Pathology, Development Research Laboratories, Research Center, Ajinomoto Pharmaceuticals Co., Ltd.
  • Masuyama Takeshi
    Toxicology & Pathology, Development Research Laboratories, Research Center, Ajinomoto Pharmaceuticals Co., Ltd.
  • Narita Takahiro
    Toxicology & Pathology, Development Research Laboratories, Research Center, Ajinomoto Pharmaceuticals Co., Ltd.
  • Kuwagata Makiko
    Hatano Research Institute, Food and Drug Safety Center
  • Hisada Shigeru
    Developmental Research Center, Aska Pharmaceutical Co., Ltd.
  • Maki Eiji
    Consultant on Drug Safety Assessment

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Description

The purpose of the present study was to collect background data from repeated dose toxicity studies in Wistar Hannover [Crl:WI(Han)] (hereafter Wistar Han) rats with dosing periods of 4, 13 and 26 weeks from four safety research facilities of pharmaceutical companies and contract research organizations participating in the International Genetic Standardization (IGS) rat forum supported by Charles River Laboratories Japan, Inc. The data from Wistar Han rats were compared with those from Sprague Dawley Crl:CD(SD) rats. In addition, the effects of restricted feeding of SD rats were also investigated by one facility. As a result, body weights and food consumption in Wistar Han rats were lower than those of SD rats. White blood cell (WBC), neutrophil, lymphocyte, monocyte and eosinophil counts were almost half of those noted for SD rats and platelet counts were almost 20% less than those in SD rats. Minimal strain differences were noted in several biochemical parameters including aspartate aminotransferase (AST), alanine aminotransferase, total cholesterol, triglyceride and phospholipids, and in thymus, ovary and testis weights. Ophthalmologic or histopathologic examinations revealed a higher incidence of corneal opacities or corneal mineralization in Wistar Han rats. Restricted feeding of SD rats resulted in intermediate values for body weights and food consumption between the ad libitum fed SD and Wistar Han rats, and WBC and AST were lower than those in the ad libitum fed SD rats. Based on these results, some strain differences might be ascribable to reduced food consumption and associated body weight changes in Wistar Han rats.

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