Robinson M K, Perkins M A, Basketter D A
Procter & Gamble Co., Cincinnati, OH 45253, USA.
Contact Dermatitis. 1998 Apr;38(4):194-202. doi: 10.1111/j.1600-0536.1998.tb05706.x.
A human 4-h patch test has recently been developed for testing the irritation hazard potential of chemicals. The original method was developed for comparative irritation assessments relative to benchmark irritants using simple statistical tests. In this context, the method has been shown to be robust in intralaboratory testing over time. Recent interlaboratory testing has also established the consistency of the method in assessment of the relative irritation potential of selected chemicals. These data help to position the method as a suitable replacement for animal test methods in assessment of skin irritation hazard. In addition, the method has great utility for investigating different parameters of clinical skin irritation. Using kinetic response patterns and curve fitting analysis, we have compared the relative irritation potential of chemicals in greater detail, using as a basis the time required for test subjects to respond as well as the incidence of positive responses. Also, using the response to 20% sodium dodecyl sulfate (SDS) as a benchmark, we've been able to examine the intersubject variation in clinical skin irritation responses. In general, subjects most reactive to 20% SDS, in terms of the exposure time required to produce a positive response, were relatively more sensitive to a 2nd irritant chemical as well. However, this was not an absolute correlation in that some test subjects showed divergent patterns of response. The method was also used to compare directly the relative skin reactivity of different populations, based on race (Caucasian versus Asian) or on neurosensory skin sensitivity. Our results using this acute exposure test method indicate little difference in visually assessed skin irritation among these diverse human subpopulations.
最近开发了一种人体4小时斑贴试验，用于测试化学品的刺激危害潜力。最初的方法是为了通过简单的统计测试，相对于基准刺激物进行比较刺激评估而开发的。在这种情况下，该方法已被证明在实验室内部随时间的测试中是可靠的。最近的实验室间测试也证实了该方法在评估选定化学品相对刺激潜力方面的一致性。这些数据有助于将该方法定位为评估皮肤刺激危害时动物试验方法的合适替代方法。此外，该方法在研究临床皮肤刺激的不同参数方面具有很大的实用性。通过动力学反应模式和曲线拟合分析，我们以测试对象做出反应所需的时间以及阳性反应的发生率为基础，更详细地比较了化学品的相对刺激潜力。此外，以对20%十二烷基硫酸钠（SDS）的反应为基准，我们能够研究临床皮肤刺激反应中的个体间差异。一般来说，就产生阳性反应所需的暴露时间而言，对20% SDS反应最强烈的受试者对第二种刺激性化学品也相对更敏感。然而，这并非绝对相关，因为一些测试对象表现出不同的反应模式。该方法还用于直接比较不同人群基于种族（白种人与亚洲人）或神经感觉皮肤敏感性的相对皮肤反应性。我们使用这种急性暴露试验方法的结果表明，在这些不同的人类亚群体中，视觉评估的皮肤刺激差异很小。
