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原料词典检索/tromethamine/TROMETHAMINE
Tier 1 Monograph · SSOT 15 FieldsRaw .md (GEO) ↗
化学合成 (Synthetic)

TROMETHAMINE

中国 NMPA《已使用化妆品原料目录 (IECIC)》标准中文名: 氨丁三醇 (序号 #1041)
pH调节剂香精 / 香料缓冲剂
核心法规与安全结论 (Executive Fact Box)AEO / GEO CITATION ANCHOR

化妆品中 氨丁三醇 (TROMETHAMINE) 的全球法规限值与配方应用标准是什么？

氨丁三醇（标准 INCI: TROMETHAMINE，CAS 号: 77-86-1）是化妆品配方中主要用作pH调节剂, 香精 / 香料, 缓冲剂的核心成分。受中国 NMPA（已使用/准用）、韩国 MFDS（未列管）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 0.1–0.8%（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
7-Track Official Statutory Label Names for TROMETHAMINE
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)TROMETHAMINE (KR MFDS Registered)
② 韩国旧名称历史 (301 重定向)——
③ 欧盟 (EU CosIng EC 1223/2009)TROMETHAMINE
④ 美国普通化妆品 (US PCPC / MoCRA INCI)TROMETHAMINE
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)氨丁三醇
⑦ 日本普通化妆品 / 医药部外品 (JCIA / MHLW)TROMETHAMINE (标准 INCI 参照)

Layer 1 — 全球 6 大法域法定限值与监管状态

Layer 1 Statutory Regulatory Limits Across 6 Regions for TROMETHAMINE
法域监管状态法定限值适用条件与法定依据来源
欧盟 (EU)限用≤ 0.5%
Permitted within statutory scope
Source: Regulation (EC) No 1223/2009 Annex III — via CosIng (EU Commission)

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。

Layer 2 Toxicological & Historical Safe Use Concentrations for TROMETHAMINE
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
中国 IECIC 最高历史使用量leave_on≤ 4%安全判定 (MoS≥100)NMPA IECIC (2025) Entry 00088 (2025)
中国 IECIC 最高历史使用量rinse_off≤ 3%安全判定 (MoS≥100)NMPA IECIC (2025) Entry 00088 (2025)
⚠️ 仅供参考 (免责声明): 本词典中的原料名称、法规限值与配比指南仅供研发参考。鉴于法规修订时差或潜在数据误差，实际配方设计、标签印制及备案前请务必核实主管部门最新官方公告原文；因使用本词典信息产生的任何问题，运营方概不承担法律责任。
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 — 剂型常规配比指南与理化配伍性

Layer 3 Formulation Concentration Quartiles by Product Category for TROMETHAMINE
剂型分类Min – Q1 – Median – Q3 – Max (%)配方作用与机理Source ID
剂型组 A — 水剂爽肤水 / 精华液 / 安瓶0.1% · 0.1% · 0.2% · 0.3% · 0.8%Aqueous serum, toner & hydrogel matrix formulation componentGlobal Starter Formulation Library Statistical Distribution (n=13, GRANT 11 · SEPPIC 2)
剂型组 C — 淋洗类洁面 / 洗发水 / 沐浴露0.46% · 1% · 1% · 1% · 1.5%Rinse-off cleanser & surfactant system modifierGlobal Starter Formulation Library Statistical Distribution (n=5, GRANT 3 · SEPPIC 2)
剂型组 B — 乳液 / 面霜 (O/W · W/O)0.1% · 0.2% · 0.2% · 0.5% · 1%Emulsion cream & lotion structural / conditioning agentGlobal Starter Formulation Library Statistical Distribution (n=13, GRANT 10 · SEPPIC 3)
剂型组 D — 防晒霜 / 彩妆 / 粉底0.3% · 0.44% · 1.3% · 1.65% · 3%Sun care & color cosmetics dispersion / sensory modifierGlobal 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

Stratum Corneum (Brick & Mortar Barrier · 10–20 µm)500 Da Molecular Weight Cutoff BarrierViable Epidermis (Keratinocytes & Melanocytes · 50–100 µm)Target for Brightening (Tyrosinase/Melanosome) & Barrier LipidsPapillary Dermis (Fibroblasts & ECM Collagen · 150–300 µm)Target for Collagen I/III Synthesis, Peptides, PDRN & ExosomesEpidermal Passive Permeation (<500 Da)
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
0245.5791114

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

Maximum Thermal Processing Limit (°C)≤ 50°C
25°C45°C60°C75°C85°C100°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)
HLB 11.5
W/O (3–6)Lamellar (8–10.5)O/W Emulsion (11–15)Solubilizer (15–19)O/W Droplet
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)

+ GLYCERIN+ CAPRYLIC/CAPRIC TR…+ TOCOPHEROL✕ Verify phase compati…TROMETHAMINE
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
代表性商品名参考 (商标法第90条第1款第2项说明性标示)
TROMETHAMINE

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。

■ [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.

关联同行评审文献 (NIH PubMed) (0)

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

常见问题解答 (FAQ)

Q1. 氨丁三醇 (TROMETHAMINE) 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 '氨丁三醇'，美国 PCPC 与欧盟 CosIng 标准 INCI 为 'TROMETHAMINE'，日本 JCIA 表示名称为 'TROMETHAMINE'。
Q2. 氨丁三醇 (TROMETHAMINE) 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): none，欧盟(EU): restricted，美国(US): none，日本(JP): none，东盟(ASEAN): none。
Q3. 氨丁三醇 (TROMETHAMINE) 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 (aqueous_serum) 中常规添加量为 0.1%–0.8%（中位数 0.2%），最佳稳定 pH 范围为 4–8。
Q4. 氨丁三醇 (TROMETHAMINE) 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。