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- W4366172068 abstract "Nickel is the leading cause of contact allergy worldwide. A regulation to limit nickel exposure from consumer products that come in prolonged direct contact with skin was implemented in Europe over two decades ago. In 2014, the European Chemicals Authority (ECHA) defined “prolonged contact with the skin” in the context of this regulation, with regards to articles releasing Ni above the threshold of 0.5 μg Ni/cm2 /week, as a minimum of 1) 10 minutes on three or more occasions within two weeks, or 2) 30 minutes on one or more occasions within two weeks. Earlier clinical studies using metallic discs with high nickel release by nickel-allergic individuals showed longer contact time required to elicit skin reaction. This pilot study aims to provide objective clinical data for further research using nickel sulfate hexahydrate (NSH) 2.5% (∼1 mg/cm2), at a concentration used for diagnostic patch testing in the US, as a conservative measure to explore the prolonged contact time needed to elicit nickel allergy. A total of 10 individuals with known history of nickel contact allergy underwent patch testing with NSH 2.5% in petrolatum using allergEAZE Skin Patch Test Chambers (SmartPractice, Phoenix, AZ, USA). Each participant received 4 series of 2-chambered patch tests applied on the volar aspect of one forearm and subsequently removed after 30, 60,120 minutes, and 8 hours of occlusion, respectively. Each series included one chamber of 20 mg of NSH 2.5% and the other chamber of 100% petrolatum as a control. Results were assessed twice, on days 2-3 and 4-5 following application. Two out of the 10 participants (20%) had weak positive reactions after 8 hours of exposure to NSH 2.5%. None of the participants had a positive reaction to patch test with NSH 2.5% after 30, 60, and 120 minutes of exposure. These results support that of most previous studies suggesting that the contact time needed to elicit nickel allergy is longer than the ECHA guidance definition. This study is limited by the small sample size." @default.
- W4366172068 created "2023-04-19" @default.
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- W4366172068 date "2023-05-01" @default.
- W4366172068 modified "2023-09-28" @default.
- W4366172068 title "656 Clinical testing of prolonged contact time required for nickel allergy elicitation; phase III study" @default.
- W4366172068 doi "https://doi.org/10.1016/j.jid.2023.03.663" @default.
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