A critical analysis of the rabbit eye irritation test variability and its impact on the validation of alternative methods

Toxicology in Vitro : an International Journal Published in Association with BIBRA
L K EarlM J Rowson

Abstract

Determining the validity of alternative methods as replacements for the rabbit eye irritation tests is a goal of the scientific, regulatory and political communities and is being evaluated in several studies. The results from the Draize rabbit eye test are used as a standard against which to compare the performance of the in vitro methods. However, the quantitative performance of the modern Draize eye test is unknown. This paper is a review of the findings of a previous study to estimate the historical variability and a comparison with more contemporary data in order to estimate the performance of the modern methods. The question of whether it is practical to obtain an accurate description of in vivo variability of the modern Draize test is considered by calculating the size of the interlaboratory study that would be required to determine whether variability had changed since 1971. The impact that in vivo variability has on the validation of alternative methods is then discussed. The authors conclude that validation studies have a greater chance of success if the alternative methods are soundly based on mechanisms of toxicity operating in vivo, the Draize data are well defined with regard to their variability, the goals of the ...Continue Reading

References

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Citations

Jun 1, 2005·Toxicology in Vitro : an International Journal Published in Association with BIBRA·C Van den BergheD Compan
Apr 1, 1999·Toxicology in Vitro : an International Journal Published in Association with BIBRA·P A JonesH Kojima
Feb 11, 2010·Toxicology in Vitro : an International Journal Published in Association with BIBRA·Gina M YanochkoBart A Jessen
Jun 27, 2020·Cutaneous and Ocular Toxicology·Neepa ChoksiDavid Allen
Oct 18, 2001·Alternatives to Laboratory Animals : ATLA·A P Worth, M T Cronin
Dec 17, 2004·Alternatives to Laboratory Animals : ATLA·Anne HuhtalaHannu Uusitalo
Jun 3, 2021·International Journal of Environmental Research and Public Health·Tiziana PetrachiElena Veronesi

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