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Description of key information

In a human patch test the test item was tested in a 20 % suspension in vaseline on 50 persons. No adverse skin irritation reactions were observed. 

Additional information

In a human patch test the skin irritation potential of the test item was tested in a 20 % suspension in vaseline on 50 persons. The test area on the body was the shoulder blade. The test was performed by the patch skin test. As testing patch Leukosilk was used. The time of exposure was 24 hours. The reaction to the test was examined immediately after removal of the testing patch and 24 hours later. The interpretation of the test reaction was based on the criteria of the International Contact Dermatitis Research Group. The preparation was tested on 50 persons (21 female, 29 male). 40 persons had eczema of various kinds. Reactions were read at patch removal and again 24 hours after patch removal.Therefore the test was conducted under especially “hard” conditions. No skin irritation reactions were observed.