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口红中的元素杂质:对葡萄牙和巴西市场的调查结果。

Elemental impurities in lipsticks: Results from a survey of the Portuguese and Brazilian markets.

机构信息

LAQV, REQUIMTE, Department of Chemical Sciences, Faculty of Pharmacy, University of Porto, Rua de Jorge Viterbo Ferreira 228, 4050-313 Porto, Portugal; Department of Environmental Health, School of Health, Polytechnic Institute of Porto, CISA/Research Center in Environment and Health, R. Dr. António Bernardino de Almeida 400, 4200-072 Porto, Portugal.

LAQV, REQUIMTE, Department of Chemical Sciences, Faculty of Pharmacy, University of Porto, Rua de Jorge Viterbo Ferreira 228, 4050-313 Porto, Portugal; Department of Pharmaceutical Sciences, Health Sciences Centre - Vitória, Federal University of Espírito Santo, Avenida Fernando Ferrari 514, 29075-910 Vitória, Espírito Santo, Brazil.

出版信息

Regul Toxicol Pharmacol. 2018 Jun;95:307-313. doi: 10.1016/j.yrtph.2018.04.009. Epub 2018 Apr 7.

Abstract

For safety reasons, European regulations prohibit the use of a long list of metal(loid)s as ingredients of cosmetic products. However, their presence as impurities in finished products is virtually unavoidable, even under GMP conditions. This study aimed at determining the elemental profile of lipsticks available in the Portuguese and Brazilian markets. A total of 96 lipsticks were purchased in Brazil (n = 53; 9 brands) and Portugal (n = 43; 7 brands) and the content of 44 elements was determined. Results ranged from <1 μg/g to several tens of μg/g (e.g., Sn, Mn, Zn). Significant differences were found between Portuguese and Brazilian products for several elements, particularly for Pb. For the elements of major toxicological concern (Pb, Cd, As, Sb, Hg), mean values were always below the current limits set by the German competent authority. However, a significant percentage of exceedances were observed for Pb (24%) and Cd (21%). A safety assessment was carried out for the toxicologically relevant elements. Results showed that, except for Pb, the systemic exposure resulting from lipstick use represents less than 0.2% (ca. 3% for Pb) of the respective permitted daily exposure even in the worst-case scenario (i.e., ingestion of the total amount of product applied).

摘要

出于安全原因,欧洲法规禁止将一长串金属(类)物质用作化妆品的成分。然而,即使在 GMP 条件下,这些物质作为杂质存在于成品中也是不可避免的。本研究旨在确定在葡萄牙和巴西市场上可获得的口红的元素特征。在巴西(n=53;9 个品牌)和葡萄牙(n=43;7 个品牌)共购买了 96 支口红,并测定了 44 种元素的含量。结果范围从<1μg/g 到数十μg/g(例如 Sn、Mn、Zn)。对于一些元素,特别是 Pb,葡萄牙和巴西的产品之间存在显著差异。对于主要毒理学关注的元素(Pb、Cd、As、Sb、Hg),其平均值始终低于德国主管当局设定的现行限值。然而,对于 Pb(24%)和 Cd(21%),观察到了显著的超标率。对毒理学相关元素进行了安全评估。结果表明,除 Pb 外,即使在最坏的情况下(即,摄入涂抹的全部产品),使用口红所导致的系统暴露也低于各自允许的每日暴露量的 0.2%(约为 Pb 的 3%)。

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