Module 3R    Draize test replacement    Problems
The problematical side of the Draize test A A A
A test with high variability in various laboratories,as a measurement norm for alternative methods
The picture shows the evaluation of three substances by Draize tests in 24 different test laboratories (Weil C.S. and Scala R.A. 1971). The area marked red, is the threshold level (MAS up to 25) for the classification R36 (risk of eye irritation). The enormous variability between the different laboratories brings up the question, whether it has not been the case, that in the past classification errors on the basis of the Draize test have been made. Even for substances with a limited variable test result within the Draize test, the question still arises and supports the assumption of whether, in principle the data achieved from tests on the rabbits eyes have any relevance for the human eye. A direct comparison of Draize tests made on rabbits and Rhesus monkeys shows a very poor correlation.The test on apes when considered, would not strictly speaking, fulfil the quality criteria, that are required for the validation of alternative methods.





Reference
Weil C.S. and Scala R.A., Study of Intra- and Interlaboratory Variability in the Results of Rabbit Eye and Skin Irritation Tests, TOXICOLOGY AND APPLIED PHARMACOLOGY 19, 276-360 (1971)
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