Final Report on the Safety Assessment of 3-Methylamino-4-Nitrophenoxyethanol as Used in Hair Dyes

Author:

Abstract

3-Methylamino-4-Nitrophenoxyethanol is a semipermanent (direct) hair colorant used in 21 hair dyes and colors at use concentrations up to 0.15%. When applied to human skin in vitro, 0.42% of the applied 3-Methylamino-4-Nitrophenoxyethanol was recovered in the receptor fluid. In an acute toxicity study using rats, 3-Methylamino-4-Nitrophenoxyethanol at 1000 mg/kg resulted in hypoactivity, piloerection, dyspnea, and lateral recumbency in animals that later died. The surviving rats exhibited none of these signs. No abnormalities were found at necropsy. Subchronic toxic-ity tests using rats fed 25, 100, or 400 mg/kg day-1 3-Methylamino-4-Nitrophenoxyethanol for up to 93 days resulted in yellow urine and tails with all three dose levels and yellow fur occurred in the two high-dose groups. The no observed adverse effect level (NOAEL) for 3-Methyl-amino-4-Nitrophenoxyethanol was 100 mg/kg day-1. Two percent 3-Methylamino-4-Nitrophenoxyethanol was a slight ocular irritant but not a dermal irritant using rabbits and it was not a sensitizer using the murine local lymph node Assay. There were no embryotoxic or teratogenic effects observed in doses up to 750 mg/kg day-1 in rats; the NOAEL was defined as 100 mg/kg. 3-Methylamino-4-Nitrophenoxyethanol was not genotoxic in in vitro assays including multiple strains of Salmonela typhimurium and Escherichia coli, Chinese Hamster ovary cells, and human lymphocyte cultures. No carcinogenicity studies were available, nor were any clinical tests reported. As reviewed by the Cosmetic Ingredient Review (CIR) Expert Panel, there are gaps in the data available for of 3-Methylamino-4-Nitrophenoxyethanol. In particular, there is an absence of data from chronic animal studies. The Expert Panel considered that the low percutaneous absorption and that the available developmental toxicity data and the subchronic toxicity data, both of which resulted in relatively high NOAEL values, alleviate concern about the absence of chronic exposure data. In addition, several studies demonstrated that 3-Methylamino-4-Nitrophenoxyethanol is not genotoxic. Direct hair dyes, of which 3-Methylamino-4-Nitro-phenoxyethanol is one, although not the focus in all investigations, appear to have little evidence of an association with adverse events as reported in hair dye epidemiology studies. The lack of phototoxicity data was not considered to be a concern because this is a direct hair dye ingredient, which has little skin contact and residual color is attached to hair, not normally to skin. No human skin sensitization or irritation data were available. However, hair dyes containing 3-Methylamino-4-Nitrophenoxyethanol, as coal tar hair dye products, are exempt from the principal adulteration provision and from the color additive provisions in sections 601 and 706 of the Federal Food, Drug, and Cosmetic Act, when the label bears a caution statement and patch test instructions for determining whether the product causes skin irritation. The Expert Panel expects that following this procedure will prospectively identify individuals who would have an irritation/sensitization reaction and allow them to avoid significant exposures and concluded that 3-Methylamino-4-Nitrophenoxyethanol is safe as a cosmetic ingredient in the practices of use and use concentrations described in this safety report.

Publisher

SAGE Publications

Subject

Toxicology

Cited by 2 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3