原创 评估人: 李锦聪 李锦聪,化妆品违禁词网创始人,知名化妆品法规博主/媒体评论人,广东省日化商会原料安全评估专委会副主任委员等多个化妆品行业协会政策法规专委会委员,在化妆品生产质量管理、新品开发、法律法规、安全评估等领域具有15年从业经验。 日期:2025年08月24日
摘要:鲸蜡硬脂醇聚醚-9(INCI名称:CETEARETH-9 ;CAS号:68439-49-6 ),已被广泛应用于化妆品等个人护理品,在化妆品中使用目的为清洁剂、乳化剂。该原料已收录于《已使用化妆品原料目录(2021年版)》序号为03623,不属于《化妆品安全技术规范(2015年版)》中的禁用物质,参考《化妆品注册和备案检验项目要求》有关规定,对该原料的重金属、微生物、有害物质和稳定性等进行了检测。相关毒理学终点有:经口/经皮急性毒性(LD50)、皮肤和眼刺激性/腐蚀性、皮肤变态反应/致敏性、光毒性、光变态反应/光敏性、遗传毒性、重复剂量毒性/亚慢性(NOAEL/BMD)、生殖发育毒性、慢性毒性/致癌性等。该原料可能含有的风险物质为二噁烷、二甘醇, 按照《化妆品安全评估技术导则》的要求,基于当前科学认知水平,对鲸蜡硬脂醇聚醚-9可能由化妆品原料带入、生产过程中产生或带入的风险物质进行了评估。收录于《<国际化妆品安全评估数据索引>收录的部分原料使用信息》在化妆品中的原料使用信息为全身[淋洗]2% ,在《已使用化妆品原料目录(2021年版)》中淋洗类产品最高历史使用量为3%, 暂时未检索到CIR、SCCS等相关权威机构评估结论数据,当配方中的添加量低于该浓度时,该原料在正常、合理及可预见的使用条件下不会对人体健康造成危害。
关键词:鲸蜡硬脂醇聚醚-9;化妆品原料;安全评估报告;毒理学终点;权威数据;CIR;驻留类;淋洗类;最高历史使用量
评估意见:无 淋洗类产品相关评估数据, 无 驻留类产品相关评估数据, 可根据原料在配方中实际应用浓度进行安全评估。
序号 | 03623 |
INCI英文名称 | CETEARETH-9 |
标准中文名称 | 鲸蜡硬脂醇聚醚-9 |
日本成分名称 | セテアレス-9 |
韩国成分名称 | 세테아레스-9 |
CAS No | 68439-49-6 |
EC No | |
可能含有的风险物质 | 二噁烷、二甘醇 |
常规使用目的 | 清洁剂、乳化剂 |
备注 | |
已上市产品原料使用信息 完整版安评可用20250209 | |
国际化妆品安全评估数据索引 完整版安评可用20250410 | 全身[淋洗]2% |
化妆品安全技术规范要求 | |
标签上必须标印的警告语 | |
牙膏技术规范要求 | |
口腔清洁护理用品工业协会 牙膏最高历史使用量(%) 仅供参考不可用 | |
完整版安全评估报告 | 鲸蜡硬脂醇聚醚-9 完整版安全评估报告.pdf |
ABSTRACT: The CIR Expert Panel assessed the safety of Alkyl PEG Ethers as used in cosmetics. These ingredients primarily function in cosmetics as surfactants, and some have additional functions as skin-conditioning agents, fragrance ingredients, and emulsion stabilizers. The Panel reviewed available relevant animal and clinical data, as well as information from previous CIR reports; when data were not available for individual ingredients, the Panel extrapolated from the existing data to support safety. The Panel concluded that the Alkyl PEG ethers are safe as used when formulated to be nonirritating, and the same applies to future alkyl PEG ether cosmetic ingredients that vary from those ingredients recited herein only by the number of ethylene glycol repeat units.cloinignj
CONCLUSION: The CIR Expert Panel concluded that the alkyl PEG ethers,listed below, are safe in the present practices of use and concentration described in this safety assessment when formulated to be nonirritating.
C11-15 PARETH-12*, C11-15 PARETH-15*, C11-15 PARETH-40*, C11-15 SEC-PARETH-12*, C12-13 PARETH-10*, C12-13 PARETH-15*, C12-13 PARETH-6*, C12-13 PARETH-9*, C12-14 PARETH-5*, C12-14 PARETH-7*, C12-14 PARETH-9*, C12-14 SEC-PARETH-3*, C12-14 SEC-PARETH-9*, C12-15 PARETH-10*, C12-15 PARETH-2*, C12-15 PARETH-4*, C9-11 PARETH-3*, C9-15 PARETH-8*, PEG-4 DISTEARYL ETHER*, PEG-6 METHYL ETHER*, DECETH-3*, DECETH-4*, DECETH-5*, DECETH-8*, ARACHIDETH-20*, METHOXY PEG-7*, CETETH-13*, CETETH-14*, CETETH-150*, CETETH-23*, CETETH-30*, CETETH-4*, CETETH-40*, CETETH-45*, CETETH-5*, CETETH-7*, CETEARETH-100*, CETEARETH-11*, CETEARETH-13*, CETEARETH-14*, CETEARETH-16*, CETEARETH-17*, CETEARETH-18*, CETEARETH-23*, CETEARETH-24*, CETEARETH-27*, CETEARETH-28*, CETEARETH-29*, CETEARETH-34*, CETEARETH-4*, CETEARETH-40*, CETEARETH-5*, CETEARETH-55*, CETEARETH-60*, CETEARETH-8*, CETEARETH-80*, CETEARETH-9*, CETOLETH-10*, CETOLETH-20*, HYDROGENATED TALLOWETH-25*, HYDROGENATED LANETH-25*, MYRETH-2*, BEHENETH-5*, TRIDECETH-15*, TRIDECETH-2*, TRIDECETH-20*, TRIDECETH-50*, TRIDECETH-7*, UNDECETH-8*, OCTYLDODECETH-5*, LANETH-10*, LANETH-60*, LANETH-75*, COCETH-3*, COCETH-6*, ISOCETETH-30*, ISOSTEARETH-25*, STEARETH-11*, STEARETH-13*, STEARETH-15*, STEARETH-3*, STEARETH-5*, STEARETH-7*, STEARETH-8*, OLETH-11*, OLETH-23*, OLETH-40*, OLETH-44*, OLETH-6*, OLETH-7*, OLETH-9*, LAURETH-13*, LAURETH-15*, LAURETH-40*, LAURETH-50*, PALMETH-2*
Were ingredients in this group not in current use (as indicated by *) to be used in the future, the expectation is that they would be used in product categories and at concentrations comparable to others in this group. This assessment is also intended to address future alkyl PEG ether cosmetic ingredients that vary from those ingredients recited herein only by the number of ethylene glycol repeat units.cloinignj
CITE: Safety Assessment of Alkyl PEG Ethers as Used in Cosmetics
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