Vinardell M P, Mitjans M
Department of Fisiologia, Facultat de Farmàcia, Universitat de Barcelona, Av. Joan XXIII s/n, 08028 Barcelona, Spain.
J Pharm Sci. 2008 Jan;97(1):46-59. doi: 10.1002/jps.21088.
The evaluation of eye and skin irritation potential is essential to ensuring the safety of individuals in contact with a wide variety of substances designed for industrial, pharmaceutical or cosmetic use. The Draize rabbit eye and skin irritancy tests have been used for 60 years to attempt to predict the human ocular and dermal irritation of such products. The Draize test has been the standard for ocular and dermal safety assessments for decades. However, several aspects of the test have been criticised. These include: the subjectivity of the method; the overestimation of human responses; and the method's cruelty. The inadequacies of the Draize test have led to several laboratories over the last 20 years making efforts to develop in vitro assays to replace it. Protocols that use different types of cell cultures and other methods have been devised to study eye and skin irritation. Different commercial kits have also been developed to study eye and skin irritation, based on the action of chemicals on these tissues. This article presents a review of the main alternatives developed to replace the use of animals in the study of chemical irritation. Particular attention is paid to the reproducibility of each method.
评估眼睛和皮肤的刺激潜能对于确保接触各种工业、制药或化妆品用途物质的个人安全至关重要。Draize兔眼和皮肤刺激试验已使用60年,试图预测此类产品对人类眼睛和皮肤的刺激性。几十年来,Draize试验一直是眼睛和皮肤安全性评估的标准。然而,该试验的几个方面受到了批评。这些包括:方法的主观性;对人类反应的高估;以及该方法的残忍性。Draize试验的不足之处导致在过去20年里,几个实验室努力开发体外试验来取代它。已经设计出使用不同类型细胞培养和其他方法的方案来研究眼睛和皮肤刺激。基于化学物质对这些组织的作用,还开发了不同的商业试剂盒来研究眼睛和皮肤刺激。本文综述了为取代在化学刺激研究中使用动物而开发的主要替代方法。特别关注每种方法的可重复性。