Final Report on the Safety Assessment of Cetethyl Morpholinium Ethosulfate
Final Report on the Safety Assessment of Cetethyl Morpholinium Ethosulfate
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十六烷基吗啉乙硫酸盐安全性评估最终报告
DOI：
10.1080/10915810152630774
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发表时间：
2001
影响因子：
2.2
通讯作者：
Johnson Rs
中科院分区：
文献类型：
--
作者：
Johnson Rs
乙硫化十六烷基吗啉是一种季铵盐，用作几种护发产品的抗静电剂和表面活性剂。使用这种成分的浓度尚不清楚，尽管1984年报告的数据显示最高浓度为1%。在一项吸入毒性研究中，乙硫化十六烷基吗啉的近似致死浓度为0.403毫克/毫米~3。在一项动物研究中，这种成分被证明是一种严重的眼睛刺激性物质。没有关于这种成分的其他安全测试数据。这些数据显然不足以支持乙基吗啡乙硫酸盐在化妆品中的安全性。对有关吗啡的现有数据进行了总结，但这些数据本身不足以支持安全性。为完成对乙基吗啉乙硫酸盐的安全性评估所需的数据包括：生产方法和杂质，尤其是亚硝胺；当前的使用浓度；皮肤渗透性；如果有明显的皮肤渗透，则需要进行为期28天的皮肤毒性研究，以评估一般皮肤和系统的毒性，以及生殖和发育毒性研究；如果呈阳性，可能需要两项基因毒性研究，如呈阳性，可能需要使用国家毒理学计划(NTP)的方法进行为期2年的皮肤致癌研究；紫外线(UV)吸收数据，如果显著吸收，则需要光敏数据；皮肤刺激和致敏；以及眼睛毒性(如果可用)。
Cetethyl Morpholinium Ethosulfate is a quaternary salt used as an antistatic agent and as a surfactant in several hair care products. The concentration at which this ingredient is used is unknown, although data reported in 1984 indicated a maximum concentration of 1%. In an inhalation toxicity study, the approximate lethal concentration of Cetethyl Morpholinium Ethosulfate was 0.403 mg/mm3. This ingredient was shown to be a severe ocular irritant in an animal study. No other safety test data on this ingredient were available. These data were clearly insufficient to support the safety of Cetethyl Morpholinium Ethosulfate in cosmetics. Data available on Morpholine were summarized, but these data themselves were insufficient to support safety. The data needed in order to complete the safety assessment of Cetethyl Morpholinium Ethosulfate include: methods of manufacture and impurities, especially nitrosamines; current concentration of use; skin penetration; if there is significant skin penetration, then both a 28-day dermal toxicity study to assess general skin and systemic toxicity and a reproductive and developmental toxicity study are needed; two genotoxicity studies, at least one in a mammalian system, if positive, then a 2-year dermal carcinogenisis study using National Toxicology Program (NTP) methods may be needed; ultraviolet (UV) absorption data, if significantly absorbed, then photosensitization data are needed; dermal irritation and sensitization; and ocular toxicity, if available.