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支持推导纳米颗粒最坏情况皮肤渗透值的综述。

A review to support the derivation of a worst-case dermal penetration value for nanoparticles.

机构信息

Leitat Technological Center, Innovació 2, 08225, Terrassa, Spain.

German Federal Institute for Risk Assessment (BfR), Department of Chemical and Product Safety, Max- Dohrn- Strasse 8-10, 10589, Berlin, Germany.

出版信息

Regul Toxicol Pharmacol. 2021 Feb;119:104836. doi: 10.1016/j.yrtph.2020.104836. Epub 2020 Nov 26.

Abstract

Data on dermal penetration of nanoparticles (NPs) was reviewed with the goal to establish a worst-case dermal penetration value for NPs. To this aim, the main focus was on studies providing quantitative dermal penetration data (29 studies). In vivo dermal penetration studies and ex vivo studies based on skin explants were included. These studies used NPs with different compositions, dimensions, and shapes. The overall results showed that skin is an efficient barrier for NPs, indistinctly of their properties. However, some studies reported that a small percentage of the applied NP dose penetrated the skin surface and reached deeper skin layers. The integrity of the skin layer and the product formulation were more critical determinants of dermal penetration than the NP properties. Most quantitative studies were based on elemental analysis such that it cannot be concluded if detected levels are attributable to a dissolved fraction or to the penetration of particles as such. Results of qualitative imaging studies suggest that at least a fraction of the levels reported in quantitative studies could be due to particle penetration. Altogether, based on the data compiled, we propose that 1% could be used as a worst-case dermal penetration value for nanoparticles within the boundaries of the properties of those included in our analysis.

摘要

对纳米粒子(NPs)的经皮渗透数据进行了回顾,目的是建立纳米粒子的最坏情况经皮渗透值。为此,主要重点是提供定量经皮渗透数据的研究(29 项研究)。体内经皮渗透研究和基于皮肤标本的离体研究均包括在内。这些研究使用了具有不同组成、尺寸和形状的 NPs。总体结果表明,皮肤对 NPs 是一种有效的屏障,与 NPs 的性质无关。然而,一些研究报告称,应用的 NP 剂量中有一小部分穿透了皮肤表面并到达了更深的皮肤层。皮肤层的完整性和产品配方是经皮渗透的更关键决定因素,而不是 NP 的性质。大多数定量研究基于元素分析,因此不能得出检测到的水平是归因于溶解部分还是颗粒本身的渗透。定性成像研究的结果表明,在定量研究中报告的至少一部分水平可能是由于颗粒渗透造成的。总的来说,根据汇编的数据,我们建议在我们分析中包含的那些 NPs 性质的范围内,1%可以用作纳米粒子最坏情况经皮渗透值。

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