Registration Dossier

Administrative data

Description of key information

Human Patch Test (24 h): not irritating

Additional information

There is additional data available on the skin irritating potential of D-Glucopyranose, oligomeric, undecyl glycoside in humans. In an in vivo occlusive patch test performed in compliance with GCP 11 female and 1 male Caucasian volunteers (18 to 27 years of age) were administered to the test material (10% a.i.) under occlusive conditions (patch test) for an exposure period of 24 h. The patch was applied to the left upper back which had not received any treatment before. A solution of 2% sodium lauryl sulfate was used as a positive control and was applied the same way on a different skin area. The second cup containing distilled water was used as negative control. Thirty minutes and 24 h after removal of the patch the skin area was observed for erythema, edema, dryness, vesicle, wrinkling and glazing. Slight to clear erythema formation was recorded in 11/12 volunteers (grade 1-2), whereas edema formation was only recorded in 4/12 volunteers (grade 1-2) 30 min after patch removal containing the positive control. Wrinkling (grade 1) was noted in 1/12 volunteers and neither glazing nor dryness was recorded in any volunteer. 1/12 volunteers did not show any skin reaction when treated with the positive control substance. 24 h after patch removal containing the positive control 11/12 volunteers showed erythema (grade 1-2), 2/12 edema (grade 1) and 7/12 wrinkling (grade 1-2). No vesicles, glazing and dryness were detected. Volunteers treated with the vehicle (distilled water) did not show edema, vesicles wrinkling, glazing and dryness, either 30 min or 24 h after patch removal. 1/12 volunteers showed slight erythema formation (grade 1) 24 h after application which was fully reversible within 24 h after patch removal. Due to their reaction to the application of controls, two volunteers were excluded from the study. 9/10 volunteers did not show any skin reaction when treated with the test material either 30 min or 24 h after patch removal. Slight erythema and wrinkling (grade 1) was present in only 1/10 volunteers 30 min after patch removal with the test material. The erythema was still present after 24 h after patch removal, whereas wrinkling was fully reversible at this time point.In summary, the test material is considered not to be irritating to human skin under the experimental conditions when applied as 18.2% (10% a.i.) formulation.