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Sensitisation data (humans) : no sensitisation at 2.4% in vehicle in 108/108 humans, HRIPT, 2018

Additional information

Supporting study : Sensitisation data (humans) - HRIPT, 2018 : The study was conducted as a human repeat insult patch test under occlusive dressing according or equivalent or similar to to: US FDA Regulation: CFR Title 21, Parts 50, 56 and 312. Applicant assessment indicates that the test protocol could be considered: equivalent or similar to the RFIM human repeated insult patch test protocol cited in: V.T. Politano & A.M. Api, Regulatory Toxicology and Pharmacology 52 (2008) 35–38. The test article (consisting of the test substance at 2.4% concentration) was tested was to determine the irritation and/or sensitisation potential of the test article after repeated application under occlusive patch test conditions to the skin of human subjects (exclusive panel). A total of 117 volunteer subjects, 44 males and 73 females ranging in age from 20 to 69 years, were empanelled for the test which were a sufficient number to provide 100 completed subjects ; 1 discontinued due to a protocol deviation and 8 discontinued for personal reasons; no subjects discontinued due to test material / test item reaction. The induction phase consisted of placing 0.3 mL test item onto the occlusive patch and applied to the left side of the back with the test site indelibly marked and the test site recorded on the subjects individual data form. Each subject was instructed that the patch was to remain in place and kept dry for approximately 24 hours, at which time the patch was to be removed by the subject. An approximately 24-hour period, during which no test material was applied, followed the weekday patch removals; an approximately 48-hour period followed the weekend patch removals. A series of nine (9) Induction patchings were completed over a period of approximately three weeks. The challenge phase was conducted after a rest phase of ca. 2 weeks (no applications) whereby, the challenge patch was applied to a previously unpatched (virgin) site typically the opposite side of the back. The site was scored at 24 , 48, 72 and 96 hours after application. 108 out of 108 subjects that concluded the study indicated a maximum score zero (0) during challenge with only one other observation noted: faint, minimal erythema during induction reading 9 in one subject. No adverse reactions or adverse events were reported in any of the subjects. Under the conditions of this study, there was no evidence of sensitisation and of irritation to the test item (which consisted of the test substance at 2.4% concentration in vehicle).

Cross reference to Section: 7.4.1 : Skin Sensitisation

Further literature references:

(1) V.T. Politano & A.M. Api, Regulatory Toxicology and Pharmacology 52 (2008) 35–38

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