IRRITANCY PATCH TEST COMPARISON 63 12 d of induction, and for base (n = 24) as shown in Table IV. Categories were based on percentages of the maximum possible score for each test site. For the calculation of a total score, an upper limit of three was used because the intent of this test would be to compare material treatments that are relatively mild it would be meaningless in this context to evaluate test materials that cause extreme irritation. For cumulative scoring purposes, any score of three or higher was considered to be a three overall for the remainder of the test and patching was discontinued. The following classifi cation system was used for the interpretation of results. RESULTS One subject had site discontinuation during testing thus, data from 24 of the 25 subjects tested were analyzed. As shown in Table V, the total cumulative irritation score resulting from exposure to each test material on each test day was calculated and scores were ranked orderly. Table VI summarized the mean cumulative irritation data with statistical comparisons of the responses observed for each patch for a given test material. Table VII detailed the mean total cumulative scores with statistical comparisons of the responses observed for each test material for a given patch. Comparing cumulative irritation scores of the three test materials, cream elicited the low- est cumulative irritation score. Based on Table IV, the cream was less irritating than the other materials across all patch types. We can draw a conclusion that cream is a mild Table II Erythema and Elevated Responses Grade Description 0 No evidence of irritation 1 Minimal erythema, barely perceptible 2 Defi nite erythema, readily visible or minimal edema or minimal papular 3 Erythema and papules 4 Defi nite edema 5 Erythema, edema, and papules 6 Vesicular eruption 7 Strong reaction spreading beyond test site Table III Effects on Superfi cial Layers of the Skin Grade Description A Slight glazed appearance B Marked glazing C Glazing with peeling and cracking D Glazing with fi ssures E Film of dried serous exudate covering all or portion of the patch site F Small petechial erosions and/or scab
JOURNAL OF COSMETIC SCIENCE 64 Table IV Classifi cation System Used for the Interpretation of Cumulative Scores of Test Materials Rank Score Indications from test Description of observed response 1 0 to 70.71 Mild material—no experimental irritation Essentially no evidence of cumulative irritation under the conditions of test (i.e., continuous at concentration specifi ed) 2 70.71 to 285 Probably mild in normal use Evidence of slight potential for very mild cumulative irritation under conditions of test 3 285 to 640.71 Possibly mild in normal use Evidence of moderate potential for mild cumulative irritation under conditions of test 4 640.71 to 829.29 Experimental cumulative irritant Evidence of strong potential for mild to moderate cumulative irritation under conditions of test 5 829.29 to 900 Experimental primary irritant Evidence of potential for primary irritation under conditions of test Table V Total Cumulative Scores of Test Materials in Various Types (Standardized Cumulative Score Based on n = 24/25) Patch type Cream Lotion 2% bath cream 1% SLS Blank Score Rank Score Rank Score Rank Score Rank Score Hill Top Chamber occlusive 21.12 1 184.32 2 502.08 3 817.92 4 83.52 Finn Chamber occlusive 25.92 1 192 2 293.76 3 768.96 4 61.44 Band-Aid semiocclusive 15.36 1 56.64 1 245.76 2 722.88 4 61.44 Webril semiocclusive 8.64 1 20.16 1 16.32 1 504.96 3 7.68 Webril occlusive 20.16 1 67.2 1 485.76 3 807.36 4 22.08 material. Lotion was revealed to be “probably mild in normal use” in most patch types, except for Webril semiocclusive. Bath cream was revealed to be “mild material—no ex- perimental irritation” in patch type of Webril semiocclusive, “probably mild in normal use” in patch type of Band-Aid semiocclusive, “possibly mild in normal use” in patch type of Hill Top Chamber occlusive, Finn Chamber occlusive, and Webril occlusive. Comparing cumulative irritation scores of the fi ve patch types, we found that among all patch types (i) the Finn Chamber occlusive showed the highest cumulative irritation scores for cream and lotion. (ii) The Webril occlusive showed the highest cumulative ir- ritation scores for 2% bath cream and 1% SLS. (iii) The Webril semiocclusive showed the lowest cumulative irritation scores for all test materials. DISCUSSION There were two purposes for our study: (i) to determine the cumulative irritation poten- tial of the three test materials by the use of predictive patch test techniques and (ii) to compare the fi ve patch types in terms of their irritancy.
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