Registration Dossier
Registration Dossier
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EC number: 225-004-1 | CAS number: 4602-84-0
Endpoint summary
Administrative data
Description of key information
Supporting data only is available for skin sensitisation effects in humans. From the 107 subjects completing the study, only three subjects exhibited a mild but time limited (transient) response during the induction phase. The results showed no evidence of an allergic reaction. The test item applied at a 15% formulation is not considered to be a skin sensitiser.
Additional information
The test item was applied as impregnated patches at 15% concentration to the same area of skin in 115 volunteers, 3 times per week for 3 weeks (24 hour contact time for each application) (2013). A total of 9 applications were made, each of which were scored approximately 24 hours later. Two weeks after the last application, a challenge patch was applied to a virgin test site. The patch was removed and the site was scored 24 and 72 hours after application. 107 subjects completed the study and reactions were seen in three participants. One response was not treatment-related (reaction to adhesive tape) and the other two responses were mild and transient (three occasions during induction). A participant with a mild response to the challenge did not react similarly on retesting in a further challenge application. The results show no evidence of an allergic response and can be considered idiosyncratic in origin. This study is reliable with restrictions (Klimisch 2) as it was well-designed and GCP-compliant, however no standard guideline was followed.
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