# TROMETHAMINE (tromethamine) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/tromethamine
- **Standard INCI**: `TROMETHAMINE`
- **KR MFDS Standard Name**: `트로메타민`
- **CAS No.**: `77-86-1`
- **EC / EINECS No.**: `201-064-4`
- **Origin**: `synthetic`
- **Functions**: pH조절제, 향료, 완충제
- **Molecular Formula / MW**: `—` (— g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 트로메타민 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | TROMETHAMINE |
| US (PCPC / MoCRA INCI) | TROMETHAMINE |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 氨丁三醇 |
| JP (JCIA / MHLW QD) | TROMETHAMINE  |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `none`
- **EU (1223/2009)**: `restricted`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `1041`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`

- **EU** [limited]: ≤ 0.5% —  (Regulation (EC) No 1223/2009 Annex III — via CosIng (EU Commission))

## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **cn_iecic_max** (leave_on): ≤ 4% — NMPA IECIC (2025) Entry 00088 (2025)
- **cn_iecic_max** (rinse_off): ≤ 3% — NMPA IECIC (2025) Entry 00088 (2025)

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 4 – 8
- **Max Process Temp**: ≤ 50°C
- **Synergy Pairings**: GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL
- **Incompatibilities**: Verify phase compatibility under extreme pH or high electrolyte loads

## 5. Academic Monograph
■ [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.

## 6. Linked PubMed Literature