The Journal of Toxicological Sciences
Online ISSN : 1880-3989
Print ISSN : 0388-1350
ISSN-L : 0388-1350
Original Article
Relation between statistics and treatment-related changes obtained from toxicity studies in rats: if detected a significant difference in low or middle dose for quantitative values, this change is considered as incidental change?
Katsumi KobayashiYuki SakurataniTakemaru AbeSatoshi NishikawaJun YamadaAkihiko HiroseEiichi KamataMakoto Hayashi
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2010 Volume 35 Issue 1 Pages 79-85

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Abstract

The purpose of a toxicity test is to determine the no-observed-effect level (NOEL) of test substance through biological and pharmacological techniques. If the low dose not does show statistically significant and biologically relevant changes in the data evaluated in a study, the usual practice is to consider this dose as the NOEL. To overcome this, 6 types of techniques that seemed to be appropriate are presented in this paper by investigating the results of several domestic and foreign theses on toxicology. The most appropriate techniques appear to be the trend test, comparison between treatment group and historical control by t-test, and confirmation that all individual values lie within the 95% confidence interval (2 SD) of the historical control value, if a significant difference is admitted in the low dose.

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© 2010 The Japanese Society of Toxicology
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