Politano Valerie T, Api Anne Marie
Research Institute for Fragrance Materials, Inc., Woodcliff Lake, NJ 07677, USA.
Regul Toxicol Pharmacol. 2008 Oct;52(1):35-8. doi: 10.1016/j.yrtph.2007.11.004. Epub 2007 Nov 28.
With implementation of the dermal sensitization QRA approach for fragrance ingredients, IFRA/RIFM are recommending use of the RIFM standard human repeated insult patch test (HRIPT) protocol for generation of confirmatory human data for the induction of dermal sensitization in a normal human population. Details of this standard HRIPT protocol are provided in this paper. The study protocol consists of two phases--Induction and Challenge. In the Induction phase, patches treated with fragrance ingredients in 75% diethyl phthalate/25% ethanol are applied to backs of volunteers for 24h. Following patch removal there is a 24-h rest period and volunteers are patched again at the same site. This procedure is repeated to achieve 9 applications over a 3-week period. There is an approximate 2-week rest period followed by a Challenge phase of a single 24-h patch application of test article applied to a naïve site on the back. Skin reactions at the naïve site observed at Challenge may be suggestive of dermal sensitization, and a Rechallenge is performed to confirm the nature of the reactivity. This study is designed to confirm the No-Observed-Effect-Level for induction of dermal sensitization in a normal human population.
随着对香料成分实施皮肤致敏定量风险评估方法，国际日用香料协会（IFRA）/香料成分毒理评估专家小组（RIFM）建议采用RIFM标准人体重复性损伤斑贴试验（HRIPT）方案，以获取在正常人群中诱发皮肤致敏的验证性人体数据。本文提供了该标准HRIPT方案的详细信息。研究方案包括两个阶段——诱导阶段和激发阶段。在诱导阶段，将用75%邻苯二甲酸二乙酯/25%乙醇配制的香料成分处理过的贴片贴在志愿者背部24小时。去除贴片后有24小时的休息期，然后在同一部位再次给志愿者贴片。重复此过程，在3周内进行9次贴片。之后有大约2周的休息期，随后进入激发阶段，将受试物单次24小时贴片应用于背部一个未接触过受试物的部位。在激发阶段观察到的未接触过受试物部位的皮肤反应可能提示皮肤致敏，然后进行再激发以确认反应性的性质。本研究旨在确定在正常人群中诱发皮肤致敏的未观察到效应水平。
