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关于氨甲基丙醇和氨甲基丙二醇安全评估的最终修订报告。

Final amended report on safety assessment on aminomethyl propanol and aminomethyl propanediol.

机构信息

Cosmetic Ingredient Review, 1101 17th Street, NW, Suite 412, Washington, DC 20036, USA.

出版信息

Int J Toxicol. 2009 Nov-Dec;28(6 Suppl):141S-61S. doi: 10.1177/1091581809350932.

DOI:10.1177/1091581809350932
PMID:19966147
Abstract

Aminomethyl propanol and aminomethyl propanediol are substituted aliphatic alcohols that function as pH adjusters in cosmetic products at concentrations less than 10%; additionally, aminomethyl propanediol is a fragrance. Extensive oral toxicity data are reviewed, with fewer inhalation toxicity data. Dermal toxicity data are presented that demonstrate, for example, that a mascara with 1.92% aminomethyl propanediol does not cause dermal irritation or allergic contact sensitization, suggesting that the maximum reported use concentration of 2% in mascara would be safe. Although these ingredients are primary amines that are not substrates for N-nitrosation, they may contain secondary amines as impurities in finished products that may undergo N-nitrosation. These ingredients should not be included in cosmetic formulations containing N-nitrosating agents. The Cosmetic Ingredient Review Expert Panel concludes that aminomethyl propanol and aminomethyl propanediol are safe as cosmetic ingredients in the practices of use and concentrations as described in this safety assessment.

摘要

氨甲基丙醇和氨甲基丙二醇是取代的脂肪族醇,在浓度小于 10%的情况下,作为化妆品中的 pH 值调节剂;此外,氨甲基丙二醇也是一种香料。本文综述了大量的口服毒性数据,吸入毒性数据较少。本文提供了皮肤毒性数据,例如,含有 1.92%氨甲基丙二醇的睫毛膏不会引起皮肤刺激或过敏性接触致敏,这表明睫毛膏中报告的最大使用浓度 2%是安全的。尽管这些成分是不适合亚硝化的伯胺,但它们可能在成品中含有作为杂质的仲胺,这些仲胺可能会发生亚硝化。这些成分不应包含在含有亚硝化剂的化妆品配方中。化妆品成分评估专家小组的结论是,氨甲基丙醇和氨甲基丙二醇在本安全性评估中所述的使用方式和浓度下,作为化妆品成分是安全的。

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