Registration Dossier

Administrative data

Description of key information

1. Under the conditions of this 48 hour range finding patch test, 10%, 25%, 50% dilutions, as well as 100% concentration of the test material did not indicate a potential for dermal irritation on the intact human skin. No difference in the irritation potential could be identified for the single concentrations.
2. Under the conditions of a sensitisation patch test, the test material did not indicate a clinically significant potential for dermal irritation or allergic contact sensitization on the intact human skin.

Additional information

1.The objective was to determine the primary irritation potential of the test substance by epidermal contact and additionally compare the irritation potential of several dilutions of the test item. The test substance was applied occlusively to the intact skin of 23 subjects (male and female, ranging in age from 34 to 78 years) for an exposure period of 48 hours. 0.2 mL of the following dilutions with mineral oil were used: 10%, 25%, 50% and 100%. The sites were evaluated for gross changes after 48 hours and re-evaluated after 72 hours.

22 subjects completed the study. One subject discontinued the participation due to personal reasons unrelated to the test material. Observations of all treated areas remained negative throughout the test interval. (BPCN, 2006)

2. The objective was to determine the potential of a test material to induce primary or cumulative irritation and/or allergic contact sensitisation by repetitive epidermal contact. Therefore 115 qualified subjects, male and female, ranging in the age of 16 to 78 years were selected. In a Patch test 0.2 mL of the test substance were occlusively applied three times a week for a total of 9 applications in the induction phase. Approximately two weeks after the final Induction application a Challenge patch was applied and the site was scored in a clinic 24 and 72 hours post-application. With one exception, observations remained within normal limits throughout the test interval. This reactive subject was requested to retum for follow-up (Rechallenge) investigation to better define the nature and reproducibility of the response. Observations for all treated areas remained negative throughout this test interval. Since the originally observed responses were not reproducible, it is the Laboratory's opinion that they were idiosyncratic in nature and can be considered as clinically insignificant. Under the conditions of this study, test material did not indicate a clinically significant potential for dermal irritation or allergic contact sensitization. (BPCN, 2007)