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?

• Published in: Journal of toxicological sciences 2010/02/01, Vol.35(1), pp.79-85
• Main Authors: Kobayashi, Katsumi, Sakuratani, Yuki, Abe, Takemaru, Nishikawa, Satoshi, Yamada, Jun, Hirose, Akihiko, Kamata, Eiichi, Hayashi, Makoto
• Format: Article
• Language: English
• Subjects: Animals; Carcinogenicity Tests - methods; Carcinogenicity Tests - statistics & numerical data; Data Interpretation, Statistical; Dose-Response Relationship, Drug; Historical control data; Incidental change; No-Observed-Adverse-Effect Level; Rats; Standard deviation and error; Statistics; Toxicity, Rodents
• ISSN: 0388-1350; 1880-3989
• DOI: 10.2131/jts.35.79

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.