化学合成 (Synthetic)
ETHYLHEXYL STEARATE
中国 NMPA《已使用化妆品原料目录 (IECIC)》标准中文名: 硬脂酸乙基己酯 (序号 #8039)
柔润剂
[EU CosIng Official Definition] 2-Ethylhexyl stearate
核心法规与安全结论 (Executive Fact Box)AEO / GEO CITATION ANCHOR
化妆品中 硬脂酸乙基己酯 (ETHYLHEXYL STEARATE) 的全球法规限值与配方应用标准是什么？
硬脂酸乙基己酯（标准 INCI: ETHYLHEXYL STEARATE，CAS 号: 22047-49-0）是化妆品配方中主要用作柔润剂的核心成分。受中国 NMPA（已使用/准用）、韩国 MFDS（未列管）及欧盟 CosIng（未列管）等 6 大法域法定标准监管，常规建议添加量为 0.8–8%（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| 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) | ETHYLHEXYL STEARATE (KR MFDS Registered) | |
| ② 韩国旧名称历史 (301 重定向) | Former KR Nomenclature Redirect Active | — |
| ③ 欧盟 (EU CosIng EC 1223/2009) | ETHYLHEXYL STEARATE | |
| ④ 美国普通化妆品 (US PCPC / MoCRA INCI) | ETHYLHEXYL STEARATE | |
| 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) | 硬脂酸乙基己酯 | |
| ⑦ 日本普通化妆品 / 医药部外品 (JCIA / MHLW) | ETHYLHEXYL STEARATE (标准 INCI 参照) |
Layer 1 — 全球 6 大法域法定限值与监管状态
| 法域 | 监管状态 | 法定限值 | 适用条件与法定依据来源 |
|---|---|---|---|
| 韩国 (MFDS) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 欧盟 (EU) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 美国 (FDA) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 中国 (NMPA) | 已使用/准用 | GMP | IECIC Entry #8039 |
| 日本 (MHLW) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 东盟 (ACD) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
⚠️ 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
Aqueous Serum / Ampoulen=7
Min 0.8% · Q1 4.5% · Median 5% · Q3 7.5% · Max 8%
Emulsion / Creamn=89
Min 0.4% · Q1 3.3% · Median 5% · Q3 7.5% · Max 11.8%
Sunscreen / Colorn=5
Min 0.8% · Q1 4.5% · Median 5% · Q3 5% · Max 15.5%
Aqueous Serum / Ampoule — Aqueous serum, toner & hydrogel matrix formulation component
Verified Source: Global Starter Formulation Library Statistical Distribution (n=7, EVONIK 7) (cir_safety) · EVONIK 7
Typical Median: 5%
Layer 3 — 剂型常规配比指南与理化配伍性
| 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 | 0.8% · 4.5% · 5% · 7.5% · 8% | Aqueous serum, toner & hydrogel matrix formulation component | Global Starter Formulation Library Statistical Distribution (n=7, EVONIK 7) |
| 剂型组 B — 乳液 / 面霜 (O/W · W/O) | 0.4% · 3.3% · 5% · 7.5% · 11.8% | Emulsion cream & lotion structural / conditioning agent | Global Starter Formulation Library Statistical Distribution (n=89, EVONIK 89) |
| 剂型组 D — 防晒霜 / 彩妆 / 粉底 | 0.8% · 4.5% · 5% · 5% · 15.5% | Sun care & color cosmetics dispersion / sensory modifier | Global Starter Formulation Library Statistical Distribution (n=5, EVONIK 5) |
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
Water or glycol phase soluble/dispersiblepH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior
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)
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.
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)
ETHYLHEXYL STEARATE
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: ETHYLHEXYL STEARATE | CAS No.: 22047-49-0 | EC No.: 244-754-0
- Origin: SYNTHETIC | Functions:
- Physicochemical Profile: Formula | MW /(Polymer/Complex) | / | Ionic Nature: non-ionic | CosIng/MFDS
- Official Regional Label Names: US [ETHYLHEXYL STEARATE] · EU [ETHYLHEXYL STEARATE] · CN [硬脂酸乙基己酯] · JP [-] · JP Quasi-Drug [-]
■ [2. Dermatological Mechanism of Action & Functional Role]
- 2-Ethylhexyl stearate Classified under origin 'synthetic', it acts within the cosmetic vehicle or stratum corneum to deliver performance and structural formulation stability.
■ [3. Global 6-Jurisdiction Regulatory Status & Safety Limits (Layer 1 & Layer 2)]
- Regional Summary: KR: NONE | EU: NONE | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. 8039 (硬脂酸乙基己酯))
- No specific Annex prohibition or numeric restriction across the 6 major jurisdictions (Permitted under general GMP safety assessment).
- Official Safety & Historical Use Concentration (Layer 2): Quantum satis (QS) within standard cosmetic safety margins
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
- [aqueous_serum] Typical range: 0.8 ~ 8.0% (Median 5.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=7, EVONIK 7)) — Aqueous serum, toner & hydrogel matrix formulation component
- [emulsion_cream] Typical range: 0.4 ~ 11.8% (Median 5.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=89, EVONIK 89)) — Emulsion cream & lotion structural / conditioning agent
- [sun_color] Typical range: 0.8 ~ 15.5% (Median 5.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=5, EVONIK 5)) — Sun care & color cosmetics dispersion / sensory modifier
■ [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: ETHYLHEXYL STEARATE
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
- PMID 32788510 (2020, J Oleo Sci): Ultrasound Assisted Green Synthesis of 2-Ethylhexyl Stearate: A Cosmetic Bio-lubricant.
关联同行评审文献 (NIH PubMed) (1)
Ultrasound Assisted Green Synthesis of 2-Ethylhexyl Stearate: A Cosmetic Bio-lubricant. [PMID: 32788510 · 2020]
Gawas SD, Rathod VK · J Oleo Sci (2020)
The 2-ethylhexyl stearate is used as a bio-lubricant in various cosmetic products. The present study is focused on the biocatalyzed esterification of 2-ethylhexanol and stearic acid to form 2-ethylhexyl stearate catalyzed by Fermase CALB 10000 in the presence of ultrasound treatment. The maximum conversion (95.87%) was obtained at molar ratio of 2-ethylhexanol to stearic acid 2:1, enzyme amount of 2 % (w/w), power 80 W, duty cycle 50 % and temperature 50°C in comparatively short reaction time (3 h) in the presence of Fermase as a catalyst. At optimum conditions, it is observed that in the presence of ultrasound; the reaction time minimizes up to 4 h as compared to mechanical stirring method (7 h). The physiochemical properties for the 2-ethylhexyl palmitate were also evaluated.
常见问题解答 (FAQ)
- Q1. 硬脂酸乙基己酯 (ETHYLHEXYL STEARATE) 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 '硬脂酸乙基己酯'，美国 PCPC 与欧盟 CosIng 标准 INCI 为 'ETHYLHEXYL STEARATE'，日本 JCIA 表示名称为 'ETHYLHEXYL STEARATE'。
- Q2. 硬脂酸乙基己酯 (ETHYLHEXYL STEARATE) 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): none，美国(US): none，日本(JP): none，东盟(ASEAN): none。
- Q3. 硬脂酸乙基己酯 (ETHYLHEXYL STEARATE) 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 0.8%–8%（中位数 5%），最佳稳定 pH 范围为 4–8。
- Q4. 硬脂酸乙基己酯 (ETHYLHEXYL STEARATE) 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。