CETRIMONIUM CHLORIDE
What is CETRIMONIUM CHLORIDE (CAS 112-02-7) in cosmetics and what are its global regulatory limits?
CETRIMONIUM CHLORIDE (CAS No. 112-02-7) is a verified cosmetic ingredient primarily functioning as Antimicrobial, Antistatic, Preservative in topical formulations. Regulated under KR MFDS (Restricted) and EU 1223/2009 CosIng (Restricted) statutory frameworks, it is typically formulated at 1.3–8.33% within an optimal stability window of pH 4–8.
7-Track Official Regulatory Label Names Matrix
Primary Statutory Gazette Only · Zero Machine Translation| Jurisdiction Track | Official Statutory Label Name | One-Click Copy |
|---|---|---|
| 1. Korea (MFDS Standard Name) | CETRIMONIUM CHLORIDE (KR MFDS Registered) | |
| 2. Korea Former Nomenclature History | — | — |
| 3. European Union (EU CosIng Glossary) | CETRIMONIUM CHLORIDE | |
| 4. United States (US PCPC / MoCRA INCI) | CETRIMONIUM CHLORIDE | |
| 5. US FDA OTC Monograph Active Name | — (Cosmetic Inactive / Non-OTC) | — |
| 6. China (NMPA IECIC Standard Name) | 西曲氯铵 | |
| 7. Japan (JCIA Standard / MHLW Quasi-Drug) | CETRIMONIUM CHLORIDE (Standard INCI Reference) |
Layer 1 — Statutory Regulatory Limits Across 6 Regions
| Region | Status | Max Limit | Conditions & Statutory Source |
|---|---|---|---|
| Korea (MFDS) | Restricted | GMP | Listed in official cosmetic inventory |
| Europe (EU) | Restricted | GMP | Listed in official cosmetic inventory |
| United States (FDA) | Unregulated | GMP | Listed in official cosmetic inventory |
| China (NMPA) | Listed / Allowed | GMP | IECIC Entry #6886 |
| Japan (MHLW) | Unregulated | GMP | Listed in official cosmetic inventory |
| ASEAN (ACD) | Unregulated | GMP | Listed in official cosmetic inventory |
Layer 2 — Toxicological & Historical Safe Use Concentrations (CIR / SCCS / CN IECIC / IFRA)
“EU SCCS Safe Opinion Limit” is the toxicological safe threshold (MoS≥100), whereas “US CIR Reported Max Use” and “CN IECIC Historical Max Use” represent historical maximum concentrations in commercial products.
| Assessment Basis | Application Scope | Concentration Range | Verdict & Dossier Reference |
|---|---|---|---|
| US CIR Reported Max Use | hair_dye | 0.3~0.3% | Safe (MoS≥100)115_draft_trimon.pdf () |
| US CIR Reported Max Use | leave_on | 0.1~0.1% | Safe (MoS≥100)115_draft_trimon.pdf () |
| US CIR Reported Max Use | rinse_off | 0.08~3% | Safe (MoS≥100)115_draft_trimon.pdf () |
| EU SCCS Safe Opinion Limit | rinse_off | ≤ 2.5% | Safe (MoS≥100) () |
| EU SCCS Safe Opinion Limit | leave_on | ≤ 1% | Safe (MoS≥100) () |
| EU SCCS Safe Opinion Limit | face_cream | ≤ 0.5% | Safe (MoS≥100) () |
Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit
Layer 3 — Formulation Usage Guide (Quartiles n≥5) & Physicochemical Compatibility
| Formulation Group | Min – Q1 – Median – Q3 – Max (%) | Role & Mechanism | Source ID |
|---|---|---|---|
| Group C — Rinse-Off Cleanser / Shampoo / Body Wash | 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.
Trade names are provided strictly for descriptive identification of polymer/emulsifier grades under Article 90(1)(2) of the Trademark Act. All trademarks belong to their respective owners.
Academic & Toxicological Synthesis
Tier 1 SynthesisSynthesized strictly from peer-reviewed PubMed abstracts and official toxicological dossiers linked to this ingredient.
Linked Peer-Reviewed Literature (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.
Frequently Asked Questions (AEO Position 0)
- Q1. What are the official 7-track regulatory label names for CETRIMONIUM CHLORIDE?
- Standard label names are US PCPC INCI: 'CETRIMONIUM CHLORIDE', EU CosIng: 'CETRIMONIUM CHLORIDE', KR MFDS: 'CETRIMONIUM CHLORIDE (KR MFDS Registered)', CN NMPA IECIC: '西曲氯铵', and JP JCIA: 'CETRIMONIUM CHLORIDE'.
- Q2. Is CETRIMONIUM CHLORIDE restricted or permitted in EU, US, KR, CN, and JP cosmetics?
- Regulatory status summary across 6 jurisdictions — KR: restricted, EU: restricted, US: none, CN: allowed, JP: none, ASEAN: none.
- Q3. What is the typical formulation concentration and optimal pH window for CETRIMONIUM CHLORIDE?
- In cleanser_rinse systems, CETRIMONIUM CHLORIDE is typically formulated between 1.3% and 8.33% (median 3%), with an optimal stability window of pH 4–8.
- Q4. What are the known formulation incompatibilities and synergy pairings for CETRIMONIUM CHLORIDE?
- Recommended synergy pairings include GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL. Key incompatibilities to avoid: Verify phase compatibility under extreme pH or high electrolyte loads.