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Historical control data from 13-week repeated toxicity studies in Crj:CD (SD) rats
Authors:Jung-Min Lee  Min-Ah Lee  Hyeon-Nam Do  Yun-Ik Song  Re-Ji-Na Bae  Hye-Yeong Lee  Sun Hee Park  Jin Seok Kang  Jong-Koo Kang
Affiliation:Department of Pathology, Biotoxtech Co., Ltd, Ochang Scientific Industrial Complex, Cheongwon-gun, Korea.
Abstract:Reference ranges of standard experimental parameters are useful for comparisons in toxicology. The aim of this study was to collect data from 13-week repeated toxicity studies in Crl:CD (SD) rats, a strain widely used for toxicity and efficacy research, for establishing domestic reference values. Data on body weight, food consumption; urinalysis, hematological, and blood biochemical parameters; and organ weights were collected from 11 toxicity studies in 220 Crl:CD (SD) rats (110 males and 110 females). The studies had been performed at a single testing facility over the last 5 years and involved animals sourced from a single breeder. The findings were collated as means, standard deviations, percentages, and ranges. Urine volume, uterus weight, eosinophil, and basophil counts, and triglyceride, total bilirubin, and gamma-glutamyl transpeptidase levels showed standard deviations of 30% or more. These historical control data would help to interpret the effects of test substances in routine toxicity and efficacy studies.
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