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Description of key information

Three human patch tests investigating the skin irritation potential of the test item were performed. Under the conditions of a 24 hour patch test according to the COLIPA standard, the skin irritation potential of both the undilluted test item, the test item dilluted in differend solvents and the test item at different concentrations were assessed. The results reveal that the undilluted test material and the test material dilluted in different solvents did not indicate a potential for dermal irritation on the intact human skin. The test item showed a good skin compatibility. The solution of the test item in eutanol induced less flakings than the solution of the test item in alcohole used in cosmetics. The test item in different concentrations induced only slight skin irritation symptoms.

Additional information

Three human patch tests investigating the skin irritation potential of the test item were performed.

Under the conditions of the first 24 hour patch test according to the COLIPA standard, the skin irritation potential of the test item was assessed. The test substance was applied occlusively to the intact skin (back) of 20 humans (male and female) for an exposure period of 24 hours.

The sites were evaluated for changes (erythema, edema, flaking, scissure) after 6, 24, 48, 72 hours. Observations of all treated areas remained negative throughout the test interval. The results reveal that the undilluted test material did not indicate a potential for dermal irritation on the intact human skin. The test item showed a good skin compatibility.

Under the conditions of the second 24 hour patch test according to the COLIPA standard, the skin irritation potential of the test item dilluted in different solvents was assessed. The test substance was applied occlusively to the intact skin (back) of 20 humans (male and female) for an exposure period of 24 hours. The sites were evaluated for changes (erythema, edema, flaking, scissure) after 6, 24, 48, 72 hours. The test item 50 % in eutanol G induced two times light erythema and one light flaking. The test item 20 % in alcohole used in cosmetics induced two times light erythema, a light edema and ten times light flaking. Di-n-octylcarbonate showed a good skin compatibility. The solution of the test item in eutanol induced less flakings than the solution of the test item in alcohole used in cosmetics.

Under the conditions of the third 24 hour patch test according to the COLIPA standard, the skin irritation potential of the test item at different concentrations (10 % and 20 %) was assessed. The test substance was applied occlusively to the intact skin (back) of 20 humans (male and female) for an exposure period of 24 hours. The sites were evaluated for changes (erythema, edema, flaking, scissure) after 6, 24, 48, 72 hours.

The test item (10 % PV) induced light erythema. The test item (20 % PV) caused light erythema and light flaking.

Concerning the parameters erythem and flaking the comparison of the test substance with the standard tenside (Texapon N28) showed that the test item (10 % PV) has a significant better skin compatibility. Concerning the parameters erythema the sum-weighted scoring system refered to the standard tenside Texapon 28 revealed that the test item (10 % PV) has 3.3 % and the test item (20 % PV) has 6.7 %.