What are the official 7-track regulatory label names for TROMETHAMINE?

Standard label names are US PCPC INCI: 'TROMETHAMINE', EU CosIng: 'TROMETHAMINE', KR MFDS: 'TROMETHAMINE (KR MFDS Registered)', CN NMPA IECIC: '氨丁三醇', and JP JCIA: 'TROMETHAMINE'.

Is TROMETHAMINE restricted or permitted in EU, US, KR, CN, and JP cosmetics?

Regulatory status summary across 6 jurisdictions — KR: none, EU: restricted, US: none, CN: allowed, JP: none, ASEAN: none.

What is the typical formulation concentration and optimal pH window for TROMETHAMINE?

In aqueous_serum systems, TROMETHAMINE is typically formulated between 0.1% and 0.8% (median 0.2%), with an optimal stability window of pH 4–8.

What are the known formulation incompatibilities and synergy pairings for TROMETHAMINE?

Recommended synergy pairings include GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL. Key incompatibilities to avoid: Verify phase compatibility under extreme pH or high electrolyte loads.

Synthetic

TROMETHAMINE

pH AdjusterFragranceBuffering

Executive Regulatory & Safety Fact BoxAEO / GEO CITATION ANCHOR

What is TROMETHAMINE (CAS 77-86-1) in cosmetics and what are its global regulatory limits?

TROMETHAMINE (CAS No. 77-86-1) is a verified cosmetic ingredient primarily functioning as pH Adjuster, Fragrance, Buffering in topical formulations. Regulated under KR MFDS (Unregulated) and EU 1223/2009 CosIng (Restricted) statutory frameworks, it is typically formulated at 0.1–0.8% within an optimal stability window of pH 4–8.

7-Track Official Regulatory Label Names Matrix

Primary Statutory Gazette Only · Zero Machine Translation

7-Track Official Statutory Label Names for TROMETHAMINE
Jurisdiction Track	Official Statutory Label Name	One-Click Copy
1. Korea (MFDS Standard Name)	TROMETHAMINE (KR MFDS Registered)
2. Korea Former Nomenclature History	—	—
3. European Union (EU CosIng Glossary)	TROMETHAMINE
4. United States (US PCPC / MoCRA INCI)	TROMETHAMINE
5. US FDA OTC Monograph Active Name	— (Cosmetic Inactive / Non-OTC)	—
6. China (NMPA IECIC Standard Name)	氨丁三醇
7. Japan (JCIA Standard / MHLW Quasi-Drug)	TROMETHAMINE (Standard INCI Reference)

Layer 1 — Statutory Regulatory Limits Across 6 Regions

Layer 1 Statutory Regulatory Limits Across 6 Regions for TROMETHAMINE
Region	Status	Max Limit	Conditions & Statutory Source
Europe (EU)	Restricted	≤ 0.5%	Permitted within statutory scope Source: Regulation (EC) No 1223/2009 Annex III — via CosIng (EU Commission)

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.

Layer 2 Toxicological & Historical Safe Use Concentrations for TROMETHAMINE
Assessment Basis	Application Scope	Concentration Range	Verdict & Dossier Reference
CN IECIC Historical Max Use	leave_on	≤ 4%	Safe (MoS≥100)NMPA IECIC (2025) Entry 00088 (2025)
CN IECIC Historical Max Use	rinse_off	≤ 3%	Safe (MoS≥100)NMPA IECIC (2025) Entry 00088 (2025)

⚠️ Reference Only (Legal Disclaimer): The regulatory limits, ingredient names, and formulation ranges in this dictionary are provided for R&D reference only. Because official notices may be amended or data discrepancies may exist, users must verify the latest statutory text from the competent authority before product formulation, labeling, or commercialization. UNIZ LAB assumes no legal liability for the use of this information.

Interactive Quartile Box-Plot (Min–Q1–Median–Q3–Max)

Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit

Statutory Max: 0.5%

Aqueous Serum / Ampoulen=13

Min 0.1% · Q1 0.1% · Median 0.2% · Q3 0.3% · Max 0.8%

Rinse-off Cleansern=5

Min 0.46% · Q1 1% · Median 1% · Q3 1% · Max 1.5%

Emulsion / Creamn=13

Min 0.1% · Q1 0.2% · Median 0.2% · Q3 0.5% · Max 1%

Sunscreen / Colorn=19

Min 0.3% · Q1 0.44% · Median 1.3% · Q3 1.65% · Max 3%

Aqueous Serum / Ampoule — Aqueous serum, toner & hydrogel matrix formulation component

Verified Source: Global Starter Formulation Library Statistical Distribution (n=13, GRANT 11 · SEPPIC 2) (cir_safety) · GRANT 11 · SEPPIC 2

Typical Median: 0.2%

Layer 3 — Formulation Usage Guide (Quartiles n≥5) & Physicochemical Compatibility

Layer 3 Formulation Concentration Quartiles by Product Category for TROMETHAMINE
Formulation Group	Min – Q1 – Median – Q3 – Max (%)	Role & Mechanism	Source ID
Group A — Aqueous Toner / Serum / Ampoule	0.1% · 0.1% · 0.2% · 0.3% · 0.8%	Aqueous serum, toner & hydrogel matrix formulation component	Global Starter Formulation Library Statistical Distribution (n=13, GRANT 11 · SEPPIC 2)
Group C — Rinse-Off Cleanser / Shampoo / Body Wash	0.46% · 1% · 1% · 1% · 1.5%	Rinse-off cleanser & surfactant system modifier	Global Starter Formulation Library Statistical Distribution (n=5, GRANT 3 · SEPPIC 2)
Group B — O/W & W/O Emulsion / Lotion / Cream	0.1% · 0.2% · 0.2% · 0.5% · 1%	Emulsion cream & lotion structural / conditioning agent	Global Starter Formulation Library Statistical Distribution (n=13, GRANT 10 · SEPPIC 3)
Group D — Sunscreen (UV) / Color Cosmetics / Foundation	0.3% · 0.44% · 1.3% · 1.65% · 3%	Sun care & color cosmetics dispersion / sensory modifier	Global Starter Formulation Library Statistical Distribution (n=19, EVONIK 9 · GRANT 9 · SEPPIC 1)

Cutaneous Permeation Science (500 Dalton Rule)MW: Macro/Complex · LogP: N/A

Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery

Molecular Weight & LogP Permeation Diagnosis

Low Molecular Weight (320 Da ≤ 500 Da) — Passive Permeation Feasible

Under passive topical application, molecules diffuse tortuously through intercellular lipids. Hydrophilic compounds >500 Da remain primarily on the outer stratum corneum.

Estimated Target Depth

40–90 µm

Optimal Delivery System

Polyol Enhancer / Serum

Colloid Interface, pH Spectrum & Thermal Stability

pH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior

Water or glycol phase soluble/dispersible

Optimal Formulation pH Stability Window (0–14)pH 4.0 – 8.0

Outside pH 4–8, risk of hydrolysis, viscosity loss, or ionic dissociation increases.

Maximum Thermal Processing Limit (°C)≤ 50°C

Thermally stable up to 50°C during standard emulsification.

HLB Scale (0–20) & Colloidal Micelle / Lamellar Phase Simulator

O/W Oil-in-Water Micelle Emulsion (Lotion / Cream)

Simulate HLB:HLB 11.5

Biochemical Signaling & Mechanism Pathway

Cellular & Molecular Target Mechanism Flow

1. Epidermal Interaction→ Upregulation / Activation

Intercellular Lipid & Hydration Matrix

→

TEWL Reduction & Barrier Conditioning

2. Homeostasis Modulation⊣ Inhibition / Blockade

Oxidative Stress (ROS) & Irritant Cascade

⊣

Cutaneous Soothing & Homeostasis

Formulation Ontology Radial Graph

Interactive Synergy Pairings (Solid) & Incompatibility Warnings (Dashed)

Interactive Node Guide

Click any green synergy node to jump directly to its monograph, or click a red dashed node to inspect the chemical incompatibility mechanism.

+ GLYCERIN + CAPRYLIC/CAPRIC TRIGLYCERIDE + TOCOPHEROL

Nominative Trade Name References (Trademark Act Art. 90(1)(2))

TROMETHAMINE

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 Synthesis

Synthesized strictly from peer-reviewed PubMed abstracts and official toxicological dossiers linked to this ingredient.

■ [1. Chemical Identity & International Labeling Nomenclature] - INCI Name: TROMETHAMINE | CAS No.: 77-86-1 | EC No.: 201-064-4 - Origin: SYNTHETIC | Functions: pH, , - Physicochemical Profile: Formula | MW /(Polymer/Complex) | / | Ionic Nature: non-ionic | CosIng/MFDS - Official Regional Label Names: US [TROMETHAMINE] · EU [TROMETHAMINE] · CN [氨丁三醇] · JP [-] · JP Quasi-Drug [-] ■ [2. Dermatological Mechanism of Action & Functional Role] - TROMETHAMINE functions primarily as pH, , in dermatological and cosmetic formulations. Classified under origin 'synthetic', it acts within the cosmetic vehicle or stratum corneum to deliver pH, , performance and structural formulation stability. ■ [3. Global 6-Jurisdiction Regulatory Status & Safety Limits (Layer 1 & Layer 2)] - Regional Summary: KR: NONE | EU: RESTRICTED | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. 1041 (氨丁三醇)) - [EU / COMPOSITION / limited] (Max 0.5%): - Official Safety & Historical Use Concentration (Layer 2): CN_IECIC_2025 (cn_iecic_max, leave_on): Max 4.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 3.0% ■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)] - [aqueous_serum] Typical range: 0.1 ~ 0.8% (Median 0.2%, Ref: Global Starter Formulation Library Statistical Distribution (n=13, GRANT 11 · SEPPIC 2)) — Aqueous serum, toner & hydrogel matrix formulation component - [cleanser_rinse] Typical range: 0.46 ~ 1.5% (Median 1.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=5, GRANT 3 · SEPPIC 2)) — Rinse-off cleanser & surfactant system modifier - [emulsion_cream] Typical range: 0.1 ~ 1.0% (Median 0.2%, Ref: Global Starter Formulation Library Statistical Distribution (n=13, GRANT 10 · SEPPIC 3)) — Emulsion cream & lotion structural / conditioning agent ■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)] - Addition Phase: Water Phase or Cool-down Phase (< 45°C) - Optimal pH Range: pH 4.0 ~ 8.0 | Max Process Temp: Max 50°C | Electrolyte Tolerance: MEDIUM - Incompatibility / Caution: Verify phase compatibility under extreme pH or high electrolyte loads - Synergy Pairings: GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL | Reference Trade Names: TROMETHAMINE ■ [6. Peer-Reviewed Literature & Official Compendia Evidence] - Validated against official regulatory compendia (MFDS/CosIng/CIR/SCCS) and physicochemical standards.

Linked Peer-Reviewed Literature (NIH PubMed) (0)

Statutory toxicology dossier verified via CosIng / MFDS / CIR compendia.

Frequently Asked Questions (AEO Position 0)

Q1. What are the official 7-track regulatory label names for TROMETHAMINE?: Standard label names are US PCPC INCI: 'TROMETHAMINE', EU CosIng: 'TROMETHAMINE', KR MFDS: 'TROMETHAMINE (KR MFDS Registered)', CN NMPA IECIC: '氨丁三醇', and JP JCIA: 'TROMETHAMINE'.
Q2. Is TROMETHAMINE restricted or permitted in EU, US, KR, CN, and JP cosmetics?: Regulatory status summary across 6 jurisdictions — KR: none, EU: restricted, US: none, CN: allowed, JP: none, ASEAN: none.
Q3. What is the typical formulation concentration and optimal pH window for TROMETHAMINE?: In aqueous_serum systems, TROMETHAMINE is typically formulated between 0.1% and 0.8% (median 0.2%), with an optimal stability window of pH 4–8.
Q4. What are the known formulation incompatibilities and synergy pairings for TROMETHAMINE?: Recommended synergy pairings include GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL. Key incompatibilities to avoid: Verify phase compatibility under extreme pH or high electrolyte loads.