L’Oreal Life Science Research, 90 rue du général Roguet, 92583 Clichy Cedex, France.
Int J Cosmet Sci. 2000 Dec;22(6):409-19.
The development and validation of alternative methods to animal testing is one of the major priorities for the cosmetic industry. These methods must be reproducible and predictive of the effect of cosmetics during normal use by the consumer. Among alternative methods recently proposed, those using reconstructed human epidermis kits are the most promising approach for this purpose, as these models mimic the site of product application, allow topical application and the assessment of some clinical reactions. However, the realistic use of these models requires reproducibility and relevance of the results. The achievement of these conditions could allow the evaluation of large amounts of products, their comparisons and the generation of data banks on finished products and their ingredients. Only kits manufactured on an industrial scale and in stringent conditions of quality assurance can meet these requirements. As an example, both the criteria for industrial scale usage and the results of reproducibility of results obtained over a 4-year period (135 batches) are reported here, in terms of histological and biochemical criteria (generally used to assess the efficacy or tolerance), for a reconstructed human epidermis elaborated as a kit, EPISKIN(R). These results may provide the framework for a validation and recognition of the model, within guidelines for the assessment of the efficacy and tolerance of cosmetics.
开发和验证替代动物测试的方法是化妆品行业的主要优先事项之一。这些方法必须具有可重复性，并能够预测化妆品在消费者正常使用过程中的效果。在最近提出的替代方法中，使用重建人体表皮试剂盒的方法是最有前途的方法，因为这些模型模拟了产品应用的部位，允许进行局部应用和某些临床反应的评估。然而，这些模型的实际应用需要结果的可重复性和相关性。达到这些条件可以允许对大量产品进行评估、比较，并生成关于成品及其成分的数据库。只有在工业规模和严格的质量保证条件下制造的试剂盒才能满足这些要求。作为一个例子，本文报告了在 4 年期间（135 批）获得的结果的工业规模使用标准和可重复性的结果，这些结果是根据组织学和生化标准（通常用于评估功效或耐受性）来评估作为试剂盒开发的重建人体表皮 EPISKIN（R）。这些结果可能为在化妆品功效和耐受性评估指南内对该模型的验证和认可提供框架。
