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| An old test from the 1940’s which is not getting any better, but is useful as a reference for new in vitro tests. |
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The Draize* test for eye irritation which was developed in the 1940’s has grown to become a toxicological standard test. However inadequacies of the test have already been known for a long period.
- The assessment of the clinical parameters on the eye of the rabbit, is very subjective (inability to have a handling norm for the test, subjective scoring).
- Between different laboratories, the same substances will be graded very differently.
- The predictibility of the effect on the human eye is not good.
- The tests can provide a lot of stress for the animals tested and result in considerable pain for them.
The irritation potential of substances and formulations is in Europe not officially provided through MAS (Maximum Average Score) values, but instead as R36 (risk of eye irritation) or R41 (risk of serious eye damage). The assessment is not officially based only on the Draize test. Up to this point, official validation studies have been considered as having the same value as the Draize test, but no alternative methods have been validated. The alternative should have a good predictability on the effect on the human eye, and not be primarily to show a good correlation with the Draize test. The testing of substances on the human eye is due to understandable grounds almost never possible. Due to a lack of data on the actual effect on the human eye, all new test methods for eye irritation, up to this point were solely measured against the Draize test.
* named after John Henry Draize (1900 - 1992), an American toxicologist/pharmacologist with the US Food and Drug Administration; introduced this test for cosmetics in 1944.
DRAIZE, J. H., WOODARD, G., and CALVERY, H. 0. (1944). Methods for the study of irritationand toxicity of substances applied topically to the skin and mucous membranes. J. Pharmacol. Exp. Ther. 82, 377-389. |
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