CETRIMONIUM CHLORIDE
化粧品における CETRIMONIUM CHLORIDE のグローバル配合基準と処方特性とは?
CETRIMONIUM CHLORIDE(CAS番号: 112-02-7)は、化粧品処方において主に抗菌剤, 帯電防止剤, 防腐剤として配合される原料です。日本厚労省/JCIA(規制なし)、韓国MFDS(配合制限)、欧州CosIng(配合制限)など6大法域の法定基準下で管理され、通常 1.3–8.33%(適正安定域 pH 4–8)で処方されます。
7大トラック 国別・用途別 公式全成分表示名称マトリクス
各国公的告示原典のみ収録 · 機械翻訳・任意音訳ゼロ| 法域・規制トラック | 公式全成分表示名称 | ワンクリックコピー |
|---|---|---|
| ① 韓国 (MFDS 化粧品標準名称) | CETRIMONIUM CHLORIDE (KR MFDS Registered) | |
| ② 韓国旧名称履歴 (301 リダイレクト) | — | — |
| ③ 欧州連合 (EU CosIng EC 1223/2009) | CETRIMONIUM CHLORIDE | |
| ④ 米国一般化粧品 (US PCPC / MoCRA INCI) | CETRIMONIUM CHLORIDE | |
| ⑤ 米国 FDA OTC モノグラフ有効成分名 | — (米国 OTC 対象外 / 一般化粧品原料) | — |
| ⑥ 中国 (NMPA IECIC 標準中国語名称) | 西曲氯铵 | |
| ⑦ 日本化粧品表示名称 / 医薬部外品外原規名称 (JCIA / MHLW) | CETRIMONIUM CHLORIDE (標準INCI参照 · 任意カタカナ音訳排除) |
Layer 1 — 6大法域 法定配合上限および規制ステータス
| 法域 | 規制ステータス | 配合上限 | 制限条件および一次法源出典 |
|---|---|---|---|
| 韓国 (MFDS) | 配合制限 | GMP | 公的化粧品原料目録収載 (GMP基準内使用) |
| 欧州 (EU) | 配合制限 | GMP | 公的化粧品原料目録収載 (GMP基準内使用) |
| 米国 (FDA) | 規制なし | GMP | 公的化粧品原料目録収載 (GMP基準内使用) |
| 中国 (NMPA) | 配合可能 | GMP | IECIC Entry #6886 |
| 日本 (MHLW) | 規制なし | GMP | 公的化粧品原料目録収載 (GMP基準内使用) |
| ASEAN (ACD) | 規制なし | GMP | 公的化粧品原料目録収載 (GMP基準内使用) |
Layer 2 — 毒性・安全性評価上限 (US CIR / EU SCCS / CN IECIC)
「欧州 SCCS 安全性評価上限」は消費者安全科学委員会が安全域 (MoS≥100) と判定した毒性学的上限であり、「米国 CIR 市販製品最大報告濃度」および「中国 IECIC 最高歴史使用量」は市販製品における最大実績濃度です。
| 安全性評価基準 | 適用範囲・用途 | 安全濃度範囲 | 判定結果および文献参照 |
|---|---|---|---|
| 米国 CIR 市販製品最大報告濃度 | hair_dye | 0.3~0.3% | 安全判定 (MoS≥100)115_draft_trimon.pdf () |
| 米国 CIR 市販製品最大報告濃度 | leave_on | 0.1~0.1% | 安全判定 (MoS≥100)115_draft_trimon.pdf () |
| 米国 CIR 市販製品最大報告濃度 | rinse_off | 0.08~3% | 安全判定 (MoS≥100)115_draft_trimon.pdf () |
| 欧州 SCCS 安全性評価上限 (MoS≥100) | rinse_off | ≤ 2.5% | 安全判定 (MoS≥100) () |
| 欧州 SCCS 安全性評価上限 (MoS≥100) | leave_on | ≤ 1% | 安全判定 (MoS≥100) () |
| 欧州 SCCS 安全性評価上限 (MoS≥100) | face_cream | ≤ 0.5% | 安全判定 (MoS≥100) () |
Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit
Layer 3 — 剤形別通常配合濃度 (四分位数 n≥5) & 物理化学・相溶性ガイド
| 剤形グループ | Min – Q1 – Median – Q3 – Max (%) | 処方役割・作用機序 | Source ID |
|---|---|---|---|
| 剤形群 C — 洗い流し用クレンザー・シャンプー | 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.
商品名は研究者がグレードを識別するための参考表記であり、各商標権は原メーカーに帰属します。
学術・毒性・処方統合モノグラフ
Tier 1 Synthesis本原料に紐づく NIH PubMed 査読付き論文アブストラクトおよび公的毒性評価報告書のみに基づいて作成された学術要約です。
関連査読付き学術論文 (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.
よくある質問 (FAQ)
- Q1. CETRIMONIUM CHLORIDE の各国公式全成分表示名称(7トラック)はどのように異なりますか?
- 日本化粧品工業連合会(JCIA)表示名称は 'CETRIMONIUM CHLORIDE (標準INCI準拠)'、米国PCPC・欧州CosIng INCIは 'CETRIMONIUM CHLORIDE'、中国NMPA IECIC標準中国語名は '西曲氯铵' です。
- Q2. CETRIMONIUM CHLORIDE のグローバル6大法域における法定配合基準 (Layer 1) は?
- 6大法域規制ステータス — 日本(JP): none、韓国(KR): restricted、欧州(EU): restricted、米国(US): none、中国(CN): allowed、ASEAN: none。
- Q3. 処方設計における CETRIMONIUM CHLORIDE の通常配合濃度 (Layer 3) と適正 pH は?
- 主要剤形 (cleanser_rinse) において通常 1.3〜8.33%(中央値 3%)で配合され、適正pH範囲は 4〜8 です。
- Q4. CETRIMONIUM CHLORIDE の配合禁忌 (Incompatibilities) と推奨シナジー成分は?
- 推奨シナジーペアは GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL、配合上の注意点は Verify phase compatibility under extreme pH or high electrolyte loads です。