Registration Dossier
Registration Dossier
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EC number: 268-407-8 | CAS number: 68083-58-9
Endpoint summary
Administrative data
Description of key information
A volunteer patch test in 56 subjects conducted with the read-across substance.
Additional information
The study was conducted to determine by repetitive epidermal contact the potential for the read-across substance to induce primary or cumulative irritation and/or allergic contact sensitisation.
Patches were applied three times a week (at least 48 hour intervals) for total of 9 applications. The application site (upper back between the scapulae) was marked to ensure continuity of application.
The read-across substance, approximately 0.2 mL, was applied to a 0.75 x 0.75 inch adhesive dressing which was then applied to each of 56 test subjects as an occlusive patch. Following application, removal and scoring of the first patch, participants were instructed to remove patches at home 24 hours after application. Approximately 2 weeks after the final induction phase of 9 applications, a challenge patch was applied to a virgin site adjacent to the original induction patch. Patches were removed after 24 hours and scored 24 hours and 72 hours after application. The following evaluation scheme was used : 0 = No visible skin reaction ; + = Barely perceptible or spotty erythema ; 1 = Mild erythema covering most of the test site ; 2 = Moderate erythema, possible presence of mild edema ; 3 = Marked erythema, possible edema; 4 = Severe erythema, possible edema, vesiculation, bullae and/or ulceration
All participants, those completing and those who did not complete the study, recorded scores of zero (0) either during the induction phase (10 observations) or challenge phase (2 observations). The read-across substance did not indicate a potential for dermal irritation or allergic contact sensitisation.
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