Abstract
A new animal test for evaluating the skin-irritant capacity of cosmetic and drug preparations and ingredients intended for repeated application is presented. The test is patterned on the 21-day occlusive test on man. Substances are applied 16 times (uncovered) to the skin of rabbits over a 3-wk period. The two parameters of the inflammatory response evaluated (16 times) throughout the test as indices of skin irritation are redness (cumulative irritation score) and fluid accumulation (changes in skinfold thickness). Measurements of these two parameters are highly correlated ( r = 0·86; P < 0·001). Results on 60 test materials showed a significant correlation ( r = 0·30; P < 0·02) between the cumulative irritation scores obtained on rabbits and those obtained on man. The usefulness and limitations of single-application (Draize type) and multiple-application tests for skin irritation are discussed. Exploratory results with hairless rats and hairless hamsters suggested that these species were not sufficiently responsive to be useful in skin-irritation studies. A radioimmunoassay of skin prostaglandin E disclosed no differences between irritated and control skin, suggesting that this technique cannot be used as an objective measure of skin irritation.
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