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ALT-SPF环研究——体外与体内SPF(ISO24444)及体外UVA-PF(ISO24443)的相关性

The ALT-SPF ring study-Correlation in silico versus in vivo SPF ISO24444 and in vitro UVA-PF ISO24443.

作者信息

Kunze Gernot, Sohn Myriam, Giesinger Jochen, Quass Katja, Prigl Yvonne, Schleiger Caithlyn, Schlifke Alexander, Ens Waldemar, Wilfert Frauke, Vollhardt Jürgen, Colson Bertrand, Herzog Bernd

机构信息

dsm-firmenich Schwitzerland AG, DSM Nutritional Products, Kaiseraugst, Switzerland.

BASF Grenzach GmbH, Grenzach-Whylen, Germany.

出版信息

Int J Cosmet Sci. 2025 Sep;47 Suppl 1:78-95. doi: 10.1111/ics.13086.

Abstract

This paper presents the results of the Alt-SPF consortium ring test, obtained by the in-silico methodology, and discusses these results in the context of existing standards. To evaluate the effectiveness of the in-silico methodology in correlating with these standards, a comparison was made between the in-silico sun protection factor (SPF) and the UVA protection factor (UVA-PF) and the values derived by standard in vivo SPF (ISO24444) and in vitro UVA-PF (ISO24443). The model utilises the same algorithm as in vitro measurements of SPF and UVA-PF, with the measured UV transmission substituted by calculated transmission simulated through an applied sunscreen film. The in-silico approach necessitates quantitative UV absorbance data of all UV-filters, their photodegradation and photointeraction properties, oil/water phase synergies and a model describing the irregular distribution of the film thickness on the skin. The performance factors are calculated using an initial analytical evaluation of the 32 test formulations of the ring test, to ascertain the presence and concentration of individual UV absorbers. The filter concentrations obtained are then processed via computational analysis to calculate the SPF and UV-PF values. It has been demonstrated that, in accordance with defined statistical parameters to characterize the ability of a method to correlate with the in vivo SPF standard, the in-silico methodology is a highly reproducible and accurate tool for SPF prediction. The alignment with the lowest measured in vivo SPF values serves to ensure the safety of the end consumer and is not a weakness of the method. Additionally, it has been demonstrated that the methodology facilitates precise prediction of UVA protection in comparison to the in vitro standard ISO 24443. These calculations can be employed to engineer novel sunscreens, thereby diminishing the necessity for ethically questionable and extensive laboratory measurements. In case still in-vivo measurements are needed, the methodology can deliver the frequently required SPF/UVA-PF values and may also support functions such as those of responsible persons, including safety assessors, in their evaluations.

摘要

本文介绍了通过计算机模拟方法获得的Alt-SPF联盟环形测试结果,并结合现有标准对这些结果进行了讨论。为了评估计算机模拟方法与这些标准的相关性,对计算机模拟防晒系数(SPF)和UVA防护系数(UVA-PF)与通过标准体内SPF(ISO24444)和体外UVA-PF(ISO24443)得出的值进行了比较。该模型使用与SPF和UVA-PF体外测量相同的算法,通过应用防晒膜模拟计算得出的透过率替代实测的紫外线透过率。计算机模拟方法需要所有紫外线过滤剂的定量紫外线吸收数据、它们的光降解和光相互作用特性、油/水相协同作用以及描述皮肤表面膜厚度不规则分布的模型。使用环形测试的32种测试配方的初始分析评估来计算性能因子,以确定各个紫外线吸收剂的存在和浓度。然后通过计算分析对获得的过滤剂浓度进行处理,以计算SPF和UV-PF值。结果表明,根据定义的统计参数来表征一种方法与体内SPF标准的相关性,计算机模拟方法是一种用于SPF预测的高度可重复且准确的工具。与最低实测体内SPF值的一致性有助于确保最终消费者的安全,而不是该方法的弱点。此外,已经证明,与体外标准ISO 24443相比,该方法有助于精确预测UVA防护。这些计算可用于设计新型防晒霜,从而减少进行存在伦理问题且广泛的实验室测量的必要性。如果仍然需要进行体内测量,该方法可以提供经常需要的SPF/UVA-PF值,还可以支持包括安全评估员在内的负责人在评估中的职能。

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