CETRIMONIUM CHLORIDE
化妆品中 西曲氯铵 (CETRIMONIUM CHLORIDE) 的全球法规限值与配方应用标准是什么?
西曲氯铵(标准 INCI: CETRIMONIUM CHLORIDE,CAS 号: 112-02-7)是化妆品配方中主要用作抗菌剂, 抗静电剂, 防腐剂的核心成分。受中国 NMPA(已使用/准用)、韩国 MFDS(限用)及欧盟 CosIng(限用)等 6 大法域法定标准监管,常规建议添加量为 1.3–8.33%(最佳稳定窗口 pH 4–8)。
全球 7 轨官方全成分标签名称对照表
严格采用各国政府官方目录原名 · 严禁机器翻译| 法域与监管轨道 | 官方公告全成分标准名称 | 一键复制 |
|---|---|---|
| ① 韩国 (MFDS 化妆品标准名称) | CETRIMONIUM CHLORIDE (KR MFDS Registered) | |
| ② 韩国旧名称历史 (301 重定向) | — | — |
| ③ 欧盟 (EU CosIng EC 1223/2009) | CETRIMONIUM CHLORIDE | |
| ④ 美国普通化妆品 (US PCPC / MoCRA INCI) | CETRIMONIUM CHLORIDE | |
| ⑤ 美国 OTC 防晒/祛痘专论活性物名称 (FDA OTC) | — (非美国 OTC 专论活性成分 / 普通化妆品原料) | — |
| ⑥ 中国 (NMPA《已使用化妆品原料目录 IECIC》标准中文名) | 西曲氯铵 | |
| ⑦ 日本普通化妆品 / 医药部外品 (JCIA / MHLW) | CETRIMONIUM CHLORIDE (标准 INCI 参照) |
Layer 1 — 全球 6 大法域法定限值与监管状态
| 法域 | 监管状态 | 法定限值 | 适用条件与法定依据来源 |
|---|---|---|---|
| 韩国 (MFDS) | 限用 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 欧盟 (EU) | 限用 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 美国 (FDA) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 中国 (NMPA) | 已使用/准用 | GMP | IECIC Entry #6886 |
| 日本 (MHLW) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 东盟 (ACD) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
Layer 2 — 毒理评估与历史最高使用量 (CN IECIC / US CIR / EU SCCS)
“欧盟 SCCS 安全评估上限”代表消费者安全科学委员会判定安全边际 (MoS≥100) 的毒理阈值;“美国 CIR 市售最高报告浓度”与“中国 IECIC 最高历史使用量”代表已上市化妆品的最高实际使用浓度。
| 安全评估依据 | 适用范围与剂型 | 评估浓度范围 | 评估结论与文献档案 |
|---|---|---|---|
| 美国 CIR 市售最高报告浓度 | hair_dye | 0.3~0.3% | 安全判定 (MoS≥100)115_draft_trimon.pdf () |
| 美国 CIR 市售最高报告浓度 | leave_on | 0.1~0.1% | 安全判定 (MoS≥100)115_draft_trimon.pdf () |
| 美国 CIR 市售最高报告浓度 | rinse_off | 0.08~3% | 安全判定 (MoS≥100)115_draft_trimon.pdf () |
| 欧盟 SCCS 安全评估上限 (MoS≥100) | rinse_off | ≤ 2.5% | 安全判定 (MoS≥100) () |
| 欧盟 SCCS 安全评估上限 (MoS≥100) | leave_on | ≤ 1% | 安全判定 (MoS≥100) () |
| 欧盟 SCCS 安全评估上限 (MoS≥100) | face_cream | ≤ 0.5% | 安全判定 (MoS≥100) () |
Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit
Layer 3 — 剂型常规配比指南与理化配伍性
| 剂型分类 | Min – Q1 – Median – Q3 – Max (%) | 配方作用与机理 | Source ID |
|---|---|---|---|
| 剂型组 C — 淋洗类洁面 / 洗发水 / 沐浴露 | 1.3% · 1.65% · 3% · 4.985% · 8.33% | Rinse-off cleanser & surfactant system modifier | Global Starter Formulation Library Statistical Distribution (n=7, EVONIK 5 · GRANT 1 · SEPPIC 1) |
Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery
Under passive topical application, molecules diffuse tortuously through intercellular lipids. Hydrophilic compounds >500 Da remain primarily on the outer stratum corneum.
pH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior
Outside pH 4–8, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Thermally stable up to 50°C during standard emulsification.
Cellular & Molecular Target Mechanism Flow
Interactive Synergy Pairings (Solid) & Incompatibility Warnings (Dashed)
Click any green synergy node to jump directly to its monograph, or click a red dashed node to inspect the chemical incompatibility mechanism.
商品名仅供配方师识别原料规格参考,商标权归各原厂商所有。
学术与毒理综合摘要
Tier 1 Synthesis本综述严格基于与该原料关联的 NIH PubMed 同行评审文献摘要及官方毒理学评估档案编写。
关联同行评审文献 (NIH PubMed) (7)
Quaternary Ammonium Compounds and Contact Dermatitis: A Review and Considerations During the COVID-19 Pandemic [PMID: 37409071 · 2023]
The recent global pandemic has resulted in increased use of quaternary ammonium compounds (QACs). Currently, QACs are active ingredients in 292 disinfectants recommended by the US EPA for use against SARS-CoV-2. Among QACs, benzalkonium chloride (BAK), cetrimonium bromide (CTAB), cetrimonium chloride (CTAC), didecyldimethylammonium chloride (DDAC), cetrimide, quaternium-15, cetylpyridinium chloride (CPC), and benzethonium chloride (BEC) were all identified as potential culprits of skin sensitivity. Given their widespread utilization, additional research is needed to better classify their dermal effects and identify other cross-reactors. In this review, we aimed to expand our knowledge about these QACs to further dissect its potential allergic and irritant dermal effects on healthcare workers during COVID-19.
Simple and rapid analytical method for the simultaneous determination of cetrimonium chloride and alkyl alcohols in hair conditioners [PMID: 19889043 · 2010]
A simple method for the simultaneous determination of a cationic surfactant (cetrimonium chloride) and four non-ionic surfactants (1-tetradecanol, 1-hexadecanol, 1-octadecanol and 1-eicosanol) has been developed. Direct extraction of the analytes from the sample with methanol and a subsequent separation using reversed-phase high-performance liquid chromatography with refractive index detection are the steps followed in the procedure. The column used was a Luna C18 and the mobile phase consisted of a 0.1 M KClO(4) solution prepared on a 95:5 mixture of methanol and water. This solution was adjusted to pH 2.8 with phosphoric acid. Recoveries close to 100% were obtained in spiked commercial hair conditioner samples for the surfactants assayed using this method. Limits of detection were 10.4, 16.7 and 22.9 mg kg(-1) of cetrimonium chloride, 1-hexadecanol, 1-hexadecanol and 1-1-octadecanol respectively. The methodology was successfully applied to nine commercial hair conditioners of several types and different brands. All hair conditioners but one contained at least two of the surfactants included in this study.
Allergic or Not: Final Interpretation of Doubtful Patch Test Reactions From the North American Contact Dermatitis Group, 2019-2020 [PMID: 38320244 · 2024]
Background: Doubtful patch test reactions generally do not meet criterion for positivity in patch testing. However, the North American Contact Dermatitis Group (NACDG) allows for doubtful reactions to be coded with a final determination of "allergic/positive" based on the temporal pattern, appearance, known characteristics of the allergen, and/or other supportive patch test reactions. Objectives: To analyze NACDG data from the 2019-2020 patch test cycle to identify patterns in the interpretation and relevance of doubtful reactions. Methods: The frequency and proportions of doubtful reactions were tabulated and analyzed for patterns. Statistical analyses were limited to allergens with ≥30 doubtful reactions to ensure adequate sample size. Results: Of patch-tested patients, 31.9% (1315/4121) had ≥1 doubtful reaction. Of 2538 total doubtful reactions, 46% (n = 1167) had a final interpretation of "allergic/positive." The allergens with the highest proportion of doubtful reactions at the final visit were hydroperoxides of linalool 1% (4.5%), fragrance mix I 8.0% (3.9%), and cetrimonium chloride 0.5% (3.4%). Methylchloroisothiazolinone/methylisothiazolinone (MCI/MI) 0.02% ( P  < 0.001), MI 0.2% ( P  < 0.001), nickel sulfate hexahydrate 2.5% ( P  = 0.001), and neomycin sulfate 20.0% ( P  = 0.003) doubtful reactions were more likely to be interpreted as allergic than nonallergic. Methyldibromoglutaronitrile/phenoxyethanol 0.2% ( P  < 0.001), oleamidopropyl dimethylamine 0.1% ( P  < 0.001), formaldehyde 2.0% ( P  < 0.001), cetrimonium chloride 0.5% ( P  < 0.001), benzophenone-4 (sulisobenzone) 10% ( P  < 0.001), iodopropynyl butylcarbamate 0.5% ( P  < 0.001), cocamidopropyl betaine 1.0% ( P  = 0.002), and benzisothiazolinone 0.1% ( P  = 0.012) doubtful reactions were less likely to be interpreted as allergic. Of the 1167 doubtful reactions interpreted as allergic, 84.9% had current relevance. Conclusions: Doubtful reactions were common and approximately one half were coded with a final interpretation of "allergic/positive." Of those, most were clinically relevant. MCI/MI, MI, nickel, and neomycin were more likely to be interpreted as allergic.
Allergic contact dermatitis secondary to the use of a bandage impregnated with benzalkonium chloride [PMID: 30094863 · 2018]
Histopathological effects of topical ophthalmic preservatives on rat corneoconjunctival surface [PMID: 9561834 · 1998]
Long term use of topical drugs has clearly been shown to induce toxic immunopathological changes in the ocular surface. However, little is known concerning the respective roles of active compounds and preservatives. Benzalkonium chloride (BAC) is the most used preservative and its cytotoxicity is well known, but other preservatives have not yet been clearly evaluated. We thus performed a comparative study to investigate toxic side effects induced in the rat ocular surface by applications of various preservatives, with special attention to inflammatory infiltrates. A total of 35 brown Norway rats were divided into seven groups of five each. They received, for one month, in both eyes, either 0.01% cetrimonium chloride, 0.01% benzalkonium chloride, 0.01% benzododecinium bromide, 0.004% thiomersal, 0.05% methyl parahydroxybenzoate or phosphate-buffered saline (PBS), the last group remaining untreated. Then, animals were sacrificed and eyes were processed for histological and immunological procedures with monoclonal antibodies to rat immunocompetent cells. When compared to controls, all preservative-treated eyes consistently showed corneal and conjunctival damage, including epithelial alterations, various degrees of keratinization and inflammatory infiltrates at the limbus and within the conjunctival stroma and epithelium. No difference was found between the five tested drugs. This study confirms that most preservatives used in ophthalmic eyedrops may similarly induce strong histopathological and inflammatory changes in the ocular surface after short term use. Although obtained in animal model, these results confirm strong toxic side effects in patients with preexisting ocular surface disorders and/or receiving topical drugs for long periods.
The effect of preservatives and antiglaucomatous medication on the histopathology of the conjunctiva [PMID: 7959096 · 1994]
Topical medication applied chronically for the treatment of glaucoma changes the cellular profile of the conjunctiva. We wanted to determine the role of preservatives, which are usually combined with the drugs, on this effect. We applied metipranolol 0.3% and pilocarpine 2% with and without benzalkonium chloride 0.01% and cetrimonium chloride 0.004%, respectively. Twenty-four rabbits, divided into four groups, were treated for 3 months. The complete globes and the adherent bulbar conjunctiva were examined histopathologically and immunohistochemically. With special stains for collagen, a slight increase of the thickness of subepithelial collagen of the conjunctiva was present in both groups treated with medication and preservative compared with eyes treated with medication alone. This effect was also true for special antibodies for collagen type IV and alpha-smooth muscle actin in the eyes treated with pilocarpine, but not in the eyes treated with metipranolol. The results suggest that preservatives may have an additional adverse effect on the conjunctiva in addition to the effects of the medications alone.
MPF-mediated anion-π(+) interaction for high-efficiency aggregation-induced electrochemiluminescence system: application in trace cetrimonium chloride analysis [PMID: 42119435 · 2026]
Owing to its remarkable capability to address the core challenges of poor water-solubility and aggregation-caused quenching (ACQ) for organic luminescent probes, aggregation-induced electrochemiluminescence (AIE-ECL) has emerged as a focus of intensive research interest. Nevertheless, AIE-ECL systems still suffer from low efficiency, primarily stemming from the poor inefficient electron transfer capability, and inadequate water solubility of organic emitters. In this pioneering study, we incorporated the anion-π + compound MPF into the AIE-ECL system, leveraging MPF's well-documented excellent electron transfer properties. It was found that the ECL intensity of MPF is approximately 1.6-fold higher than that of its structural analogues. This significant enhancement can be attributed to its superior electrical conductivity, strong AIE activity, and unique anionic-π + structure. Furthermore, the MPF-based ECL system was successfully applied to the high-sensitivity detection of trace surfactant cetrimonium chloride (CC) with a low detection limit of 24.2 nM. This work not only overcomes the long-standing challenge of low luminescence efficiency induced by insufficient electron transfer in AIE-ECL systems but also substantially expands the research and application scope of ECL technology.
常见问题解答 (FAQ)
- Q1. 西曲氯铵 (CETRIMONIUM CHLORIDE) 在全球 7 大法域的官方全成分标签名称是什么?
- 中国 NMPA《已使用化妆品原料目录 (IECIC)》标准中文名为 '西曲氯铵',美国 PCPC 与欧盟 CosIng 标准 INCI 为 'CETRIMONIUM CHLORIDE',日本 JCIA 表示名称为 'CETRIMONIUM CHLORIDE'。
- Q2. 西曲氯铵 (CETRIMONIUM CHLORIDE) 在中、韩、欧、美、日、东盟的法定监管状态 (Layer 1) 如何?
- 6 大法域监管汇总 — 中国(CN): allowed,韩国(KR): restricted,欧盟(EU): restricted,美国(US): none,日本(JP): none,东盟(ASEAN): none。
- Q3. 西曲氯铵 (CETRIMONIUM CHLORIDE) 的常规配方添加量 (Layer 3) 与最佳稳定 pH 窗口是多少?
- 在代表性剂型 (cleanser_rinse) 中常规添加量为 1.3%–8.33%(中位数 3%),最佳稳定 pH 范围为 4–8。
- Q4. 西曲氯铵 (CETRIMONIUM CHLORIDE) 有哪些配伍禁忌 (Incompatibilities) 与协同增效组合?
- 推荐协同组合包括 GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL;配伍禁忌注意:Verify phase compatibility under extreme pH or high electrolyte loads。