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化妆品中使用的改性对苯二甲酸酯聚合物的安全性评估。

Safety assessment of modified terephthalate polymers as used in cosmetics.

作者信息

Becker Lillian C, Bergfeld Wilma F, Belsito Donald V, Hill Ronald A, Klaassen Curtis D, Liebler Daniel C, Marks James G, Shank Ronald C, Slaga Thomas J, Snyder Paul W, Andersen F Alan

机构信息

Cosmetic Ingredient Review Scientific Analyst/Writer, Washington, DC, USA.

Cosmetic Ingredient Review Expert Panel Member, Washington, DC, USA.

出版信息

Int J Toxicol. 2014 Sep-Oct;33(3 Suppl):36S-47S. doi: 10.1177/1091581814537001.

Abstract

The safety of 6 modified terephthalate polymers as cosmetic ingredients was assessed. These ingredients mostly function as exfoliants, bulking agents, hair fixatives, and viscosity-increasing agents-nonaqueous. Polyethylene terephthalate (PET) is used in leave-on products up to 100% and in rinse-off products up to 2%. The Cosmetic Ingredient Review Expert Panel (Panel) considered that the PET used in cosmetics is chemically equivalent to that used in medical devices. The Panel determined that the Food and Drug Administration's determination of safety of PET in several medical devices, which included human and animal safety data, can be used as the basis for the determination of safety of PET and related polymers used in cosmetics. Use studies of cosmetic eye products that contain PET demonstrated no ocular irritation or dermal sensitization. The Panel concluded that modified terephthalate polymers were safe as cosmetic ingredients in the practices of use and concentration described in this safety assessment.

摘要

对6种改性对苯二甲酸酯聚合物作为化妆品成分的安全性进行了评估。这些成分主要用作去角质剂、填充剂、头发固定剂和非水性增稠剂。聚对苯二甲酸乙二酯(PET)在免洗产品中的使用含量最高可达100%,在冲洗型产品中的使用含量最高可达2%。化妆品成分审查专家小组(专家小组)认为,化妆品中使用的PET在化学性质上与医疗器械中使用的PET相当。专家小组认定,美国食品药品监督管理局对PET在多种医疗器械中的安全性判定,其中包括人和动物的安全数据,可作为判定化妆品中使用的PET及相关聚合物安全性的依据。对含有PET的化妆品眼部产品的使用研究表明,未出现眼部刺激或皮肤致敏现象。专家小组得出结论,在本安全性评估所述的使用方法和浓度下,改性对苯二甲酸酯聚合物作为化妆品成分是安全的。

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