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Administrative data

Description of key information

The test substance was evaluated as supplied under semi-occlusive conditions to determine its ability to sensitize the skin of volunteer subjects with normal skin using a repeated insult patch study respectively. One hundred six (106) subjects completed the study. Under the conditions employed in this study, there was no evidence of sensitization to the test substance.

Additional information

One hundred twenty-three (123) subjects between the ages of 18 and 68 were enrolled and 106 completed this repeated insult patch study. The material was applied under semi-occlusive patch conditions to a 2 cm x 2 cm Webril ™ pad, which delivered approximately 0.2 mL of study material. The pad was affixed to the skin with hypoallergenic tape (Micropore). The patches were applied to the infrascapular area of the back, either to the right or left of the midline. Sodium lauryl sulfate, 0.1% aqueous solution, served as a control to assess subject compliance. The induction phase consisted of 9 applications of the test substance (three times a week for three weeks) for 24 hours and subsequent evaluations of the patch sites. Following the ninth evaluation, the subjects were dismissed for a rest period of approximately 10-15 days. The challenge phase was initiated during the sixth week of the study. Identical patches were applied to sites previously unexposed to the study material. The patches were removed by subjects after 24 hours and the sites graded after additional 24-hour and 48-hour periods. No evidence of sensitization to the test substance was observed in this study.