Why Evaluate the Sunscreen Active Oxybenzone (Benzophenone-3) for Carcinogenicity and Reproductive Toxicology or Consider it Unsafe for Human Use?

DiNardo Jc, Downs Ca
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引用次数: 3

Abstract

On February 26, 2019, the Food & Drug Administration (FDA) published an update to the Sunscreen Drug Products for Overthe-Counter Human Use in the Federal Register [1], requesting additional information on 12 petroleum-based sunscreen actives (cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone and avobenzone). This is because the public record does not currently contain sufficient data to support that these drugs are Generally Recognized as Safe and Effective (GRASE). The FDA went on to conduct and publish a small clinical trail [2] to determine whether four of these drugs (avobenzone, oxybenzone, octocrylene, and ecamsule) absorb into the systemic circulation and whether they would exceed the FDA level for toxicological concern (0.5 ng/mL). The data collected demonstrated that all four sunscreen drugs absorbed through the skin and into the blood, and accumulated above the 0.5 ng/mL level within the first day (4 applications) of the study. Oxybenzone exceeded the level of concern after the first application demonstrating an overall maximum plasma concentration between 169.3 and 209.6 ng/mL for concentrations ranging from 4% to 6% in products, respectively.
为什么对防晒剂活性氧苯酮(二苯甲酮-3)的致癌性和生殖毒理学评价或认为其对人类使用不安全?
2019年2月26日,美国食品和药物管理局(FDA)在联邦公报上发布了一份关于非处方人用防晒药物产品的更新[1],要求提供关于12种石油基防晒活性物质的额外信息(辛诺酸盐、二氧苯酮、乙磺唑、同盐酸盐、甲氧膦酸盐、辛氧膦酸盐、辛氧膦酸盐、辛氧膦酸盐、辛氧膦酸盐、辛氧膦酸盐、辛氧苯酮、辛氧苯酮)。这是因为公共记录目前没有足够的数据来支持这些药物被普遍认为是安全有效的(GRASE)。FDA继续进行并发表了一项小型临床试验[2],以确定其中四种药物(阿苯酮、氧苯酮、奥克瑞林和胶囊)是否被体循环吸收,以及它们是否会超过FDA的毒理学标准(0.5 ng/mL)。收集的数据表明,所有四种防晒药物通过皮肤吸收并进入血液,并在研究的第一天(4次应用)内积累超过0.5 ng/mL的水平。在第一次应用后,氧苯酮超出了关注水平,表明在产品浓度范围为4%至6%时,总体最大血浆浓度分别为169.3至209.6 ng/mL。
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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