Damour O, Augustin C, Black A F
Laboratoire des Substituts Cutanés (CNRS UPR 412), Hôpital Edouard Herriot, Lyon, France.
Med Biol Eng Comput. 1998 Nov;36(6):825-32. doi: 10.1007/BF02518890.
The development of new cosmetic formulations requires precise assessment of their safety and efficacy. Today, legislation demands quality control combined with severe safety measures, as well as a limited use of animals for such testing (European Community directive 93/35/EEC). Consequently, safety assessment protocols are oriented towards in vivo tests on human volunteers and in vitro alternative methods to animal use, especially tissue engineered skin substitutes. In this paper, dermal and skin equivalents developed in the laboratory are described. The applications of reconstructed epidermis and skin substitutes for pharmaco-toxicological trials are also discussed. These tissue models have been shown to be very useful tools to assess cutaneous irritation, phototoxicity, photoprotection and to perform efficacy tests of cosmetic molecules and finished products. In conclusion, the authors are confident that these in vitro models can contribute to reduce animal use for routine toxicity testing.
新型化妆品配方的研发需要对其安全性和功效进行精确评估。如今，法规要求进行质量控制并采取严格的安全措施，同时限制在此类测试中使用动物（欧洲共同体指令93/35/EEC）。因此，安全性评估方案倾向于对人类志愿者进行体内试验以及采用替代动物使用的体外方法，尤其是组织工程皮肤替代物。本文描述了在实验室中研发的真皮和皮肤等效物。还讨论了重建表皮和皮肤替代物在药物毒理学试验中的应用。这些组织模型已被证明是评估皮肤刺激性、光毒性、光防护以及进行化妆品分子和成品功效测试的非常有用的工具。总之，作者相信这些体外模型有助于减少用于常规毒性测试的动物数量。
