Real Facts about Safety and Efficacy of Zinc Oxide and Titanium Dioxide in Solar Products

J. Hubaud, D. Guérin, M. Salvo, J. Branka, K. Mekideche, Philippe Piccerelle Pr
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Abstract

Background: Titanium dioxide and zinc oxide were often criticized over the last decade because of their supposed noxious effects on human health. Moreover, these compounds which are frequently introduced in sunscreen products as UV filter, are sometimes associated with poor UVA protection factors. So, in order to clarify the real efficacy and safety status of these products, we provide here some bibliographic and experimental data regarding 1) their “real” protective effect against UVA rays and 2) their real harmful effects on human skin notably by studying their capability to penetrate through the human cutaneous tissue. Materials and Methods: We studied here 4 sunscreen products containing titanium dioxide and zinc oxide for 3 of them. First, because the UVA-PF values obtained for these compounds by using the “classical” in vitro ISO 24443 procedure seem to be significantly different from to those obtained by using the in vivo method ISO 24442, we chose to develop a new in vitro methodology in order to more precisely define the UVA-PF of titanium and zinc oxides. This new methodology was then used to lead UVA-PF studies with the 4 selected solar products. We also provide here an evaluation of the toxicological effects of titanium and zinc oxides on human skin based on the SCCS reports and analysis of recent and relevant bibliographic studies. Moreover, as the harmful effects of this type of products are closely linked to their ability to penetrate cutaneous tissue, we tested 7 sunscreen products to precise the skin penetration profiles of titanium dioxide and zinc oxide by using human skin explants mounted on Franz cells. Results: We here demonstrated that our new in vitro methodology gave some UVA-PF values very close to those obtained with in vivo methods and we took advantage of it to define more realistic UVA-PF for titanium dioxide and zinc oxide. Additionally, we here evaluated the human skin permeation and resorption capacities of titanium dioxide and zinc oxide incorporated in the 7 tested products. As it was defined by World Health Organization (WHO) in 2005, permeation consists in the ability for a compound to penetrate into different layers of a tissue, and the resorption consists in the absorption of this compound into the vascular system. In our experimental conditions, we showed 1) that zinc oxide and titanium dioxide permeations did not exceed 8.5 and 5.5 μg/cm2 of skin respectively (i.e. 0.89% and 0.26% of the applied product, respectively), and 2) that their resorptions were not significantly different from zero. As a consequence, we can assume that the supposed harmful effects of titanium dioxide and zinc oxide on cutaneous tissue could not be observed following the use of the tested solar products. Conclusion: Regarding their efficacy, we here provide, by using a new in vitro methodology for UVA-PF measurements (which is also very efficient to determine SPF), new evidence showing that titanium dioxide and zinc oxide could constitute “good” UV filters. In addition, our work with Franz cells reinforces the fact these compounds can be safely used for human skin solar protection.
关于太阳能产品中氧化锌和二氧化钛的安全性和有效性的真实事实
背景:二氧化钛和氧化锌在过去十年中经常受到批评,因为它们被认为对人体健康有害。此外,这些经常作为紫外线过滤器引入防晒产品的化合物有时与较差的UVA防护系数有关。因此,为了阐明这些产品的真正功效和安全状况,我们在这里提供一些参考文献和实验数据:1)它们对UVA射线的“真正”保护作用;2)它们对人体皮肤的真正有害影响,特别是通过研究它们穿透人体皮肤组织的能力。材料与方法:研究了4种防晒产品,其中3种产品含有二氧化钛和氧化锌。首先,由于使用“经典”体外ISO 24443程序获得的这些化合物的UVA-PF值与使用体内ISO 24442方法获得的UVA-PF值似乎有显着差异,因此我们选择开发一种新的体外方法,以便更精确地定义钛和氧化锌的UVA-PF。这种新方法随后被用于4种选定的太阳能产品的UVA-PF研究。基于SCCS报告和对最近相关文献研究的分析,我们还提供了钛和氧化锌对人体皮肤的毒理学影响的评估。此外,由于这类产品的有害影响与它们渗透皮肤组织的能力密切相关,我们测试了7种防晒产品,通过在Franz细胞上植入人体皮肤外植体来精确测量二氧化钛和氧化锌的皮肤渗透特征。结果:我们在这里证明了我们的新体外方法给出了一些与体内方法非常接近的UVA-PF值,我们利用它来确定更真实的二氧化钛和氧化锌的UVA-PF值。此外,我们在这里评估了人体皮肤的渗透和吸收能力的二氧化钛和氧化锌纳入7个测试产品。正如世界卫生组织(世卫组织)在2005年所定义的那样,渗透是指化合物渗透到组织不同层的能力,吸收是指该化合物被吸收到血管系统中。在我们的实验条件下,我们发现1)氧化锌和二氧化钛的渗透性分别不超过皮肤的8.5和5.5 μg/cm2(分别为所涂产品的0.89%和0.26%),2)它们的吸收量与零没有显著差异。因此,我们可以假设,在使用测试的太阳能产品后,无法观察到二氧化钛和氧化锌对皮肤组织的所谓有害影响。结论:关于它们的功效,我们在这里提供了新的证据,通过使用一种新的体外方法来测量UVA-PF(也非常有效地确定SPF),表明二氧化钛和氧化锌可以构成“良好的”紫外线过滤器。此外,我们与弗朗茨细胞的合作强化了这样一个事实,即这些化合物可以安全地用于人体皮肤防晒。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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