Desmedt Bart, Ates Gamze, Courselle Patricia, De Beer Jacques O, Rogiers Vera, Hendrickx Benoit, Deconinck Eric, De Paepe Kristien
Division of Food, Medicines and Consumer Safety, Section Medicinal Products, Scientific Institute of Public Health (IPH), Brussels, Belgium.
Skin Pharmacol Physiol. 2016;29(6):300-308. doi: 10.1159/000454719. Epub 2017 Jan 5.
In Europe, hydroquinone is a forbidden cosmetic ingredient. It is, however, still abundantly used because of its effective skin-whitening properties. The question arises as to whether the quantities of hydroquinone used become systemically available and may cause damage to human health. Dermal absorption studies can provide this information. In the EU, dermal absorption has to be assessed in vitro since the Cosmetic Regulation 1223/2009/EC forbids the use of animals. To obtain human-relevant data, a Franz diffusion cell protocol was validated using human skin. The results obtained were comparable to those from a multicentre validation study. The protocol was applied to hydroquinone and the dermal absorption ranged between 31 and 44%, which is within the range of published in vivo human values. This shows that a well-validated in vitro dermal absorption study using human skin provides relevant human data. The validated protocol was used to determine the dermal absorption of illegal skin-whitening cosmetics containing hydroquinone. All samples gave high dermal absorption values, rendering them all unsafe for human health. These results add to our knowledge of illegal cosmetics on the EU market, namely that they exhibit a negative toxicological profile and are likely to induce health problems.
在欧洲,对苯二酚是一种被禁止使用的化妆品成分。然而,由于其有效的美白特性,它仍被大量使用。由此产生的问题是,所使用的对苯二酚量是否会进入全身循环并可能对人体健康造成损害。皮肤吸收研究可以提供这方面的信息。在欧盟,由于《化妆品法规》1223/2009/EC禁止使用动物,必须进行体外皮肤吸收评估。为了获得与人体相关的数据,使用人体皮肤验证了一种弗兰兹扩散池方案。获得的结果与多中心验证研究的结果相当。该方案应用于对苯二酚,皮肤吸收范围在31%至44%之间,这在已发表的人体体内值范围内。这表明,使用人体皮肤进行的经过充分验证的体外皮肤吸收研究能够提供与人体相关的数据。该经过验证的方案用于测定含有对苯二酚的非法美白化妆品的皮肤吸收情况。所有样品的皮肤吸收值都很高,这表明它们对人体健康都不安全。这些结果增加了我们对欧盟市场上非法化妆品的了解,即它们具有负面的毒理学特征,可能会引发健康问题。