化学合成 (Synthetic)
STEARYL HEPTANOATE
中国 NMPA《已使用化妆品原料目录 (IECIC)》标准中文名: 硬脂醇庚酸酯 (序号 #7975)
皮肤调理剂柔润剂
核心法规与安全结论 (Executive Fact Box)AEO / GEO CITATION ANCHOR
化妆品中 硬脂醇庚酸酯 (STEARYL HEPTANOATE) 的全球法规限值与配方应用标准是什么？
硬脂醇庚酸酯（标准 INCI: STEARYL HEPTANOATE，CAS 号: 66009-41-4）是化妆品配方中主要用作皮肤调理剂, 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 1–8%（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) | STEARYL HEPTANOATE (KR MFDS Registered) | |
| ② 韩国旧名称历史 (301 重定向) | — | — |
| ③ 欧盟 (EU CosIng EC 1223/2009) | STEARYL HEPTANOATE | |
| ④ 美国普通化妆品 (US PCPC / MoCRA INCI) | STEARYL HEPTANOATE | |
| 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) | 硬脂醇庚酸酯 | |
| ⑦ 日本普通化妆品 / 医药部外品 (JCIA / MHLW) | STEARYL HEPTANOATE (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 #7975 |
| 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) |
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。
| 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 |
|---|---|---|---|
| 美国 CIR 市售最高报告浓度 | total | 0.07~8% | 安全判定 (MoS≥100)115_draft_steary.pdf () |
| 美国 CIR 市售最高报告浓度 | leave_on | 0.07~8% | 安全判定 (MoS≥100)115_draft_steary.pdf () |
| 美国 CIR 市售最高报告浓度 | rinse_off | 0.7~3% | 安全判定 (MoS≥100)115_draft_steary.pdf () |
| 美国 CIR 市售最高报告浓度 | eye | 0.5~8% | 安全判定 (MoS≥100)115_draft_steary.pdf () |
| 美国 CIR 市售最高报告浓度 | ingestion | 3~8% | 安全判定 (MoS≥100)115_draft_steary.pdf () |
| 美国 CIR 市售最高报告浓度 | spray | 0.7~0.7% | 安全判定 (MoS≥100)115_draft_steary.pdf () |
| 美国 CIR 市售最高报告浓度 | dermal | 0.07~8% | 安全判定 (MoS≥100)115_draft_steary.pdf () |
| 美国 CIR 市售最高报告浓度 | deodorant | 0.07~0.07% | 安全判定 (MoS≥100)115_draft_steary.pdf () |
| 美国 CIR 市售最高报告浓度 | mucous | 0~0% | 安全判定 (MoS≥100)116_final_stehep.pdf () |
⚠️ 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
Anhydrous Balm / Oiln=6
Min 1% · Q1 5.75% · Median 8% · Q3 8% · Max 8%
Emulsion / Creamn=7
Min 1% · Q1 1.5% · Median 3% · Q3 3% · Max 3%
Sunscreen / Colorn=10
Min 1% · Q1 3% · Median 4.5% · Q3 6% · Max 7%
Anhydrous Balm / Oil — Anhydrous balm, oil & stick structural emollient
Verified Source: Global Starter Formulation Library Statistical Distribution (n=6, EVONIK 6) (cir_safety) · EVONIK 6
Typical Median: 8%
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 E — 无水精油 / 固体膏霜 / 唇部护理 | 1% · 5.75% · 8% · 8% · 8% | Anhydrous balm, oil & stick structural emollient | Global Starter Formulation Library Statistical Distribution (n=6, EVONIK 6) |
| 剂型组 B — 乳液 / 面霜 (O/W · W/O) | 1% · 1.5% · 3% · 3% · 3% | Emulsion cream & lotion structural / conditioning agent | Global Starter Formulation Library Statistical Distribution (n=7, EVONIK 7) |
| 剂型组 D — 防晒霜 / 彩妆 / 粉底 | 1% · 3% · 4.5% · 6% · 7% | Sun care & color cosmetics dispersion / sensory modifier | Global Starter Formulation Library Statistical Distribution (n=10, EVONIK 10) |
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)
STEARYL HEPTANOATE
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: STEARYL HEPTANOATE | CAS No.: 66009-41-4 | EC No.: 266-065-4
- Origin: SYNTHETIC | Functions: Skin Conditioning,
- Physicochemical Profile: Formula | MW /(Polymer/Complex) | / | Ionic Nature: non-ionic | CosIng/MFDS
- Official Regional Label Names: US [STEARYL HEPTANOATE] · EU [STEARYL HEPTANOATE] · CN [硬脂醇庚酸酯] · JP [-] · JP Quasi-Drug [-]
■ [2. Dermatological Mechanism of Action & Functional Role]
- STEARYL HEPTANOATE functions primarily as , in dermatological and cosmetic formulations. 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. 7975 (硬脂醇庚酸酯))
- 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): cir (reported_use, total): 0.07~8% / cir (reported_use, leave_on): 0.07~8% / cir (reported_use, rinse_off): 0.7~3%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
- [anhydrous_balm] Typical range: 1.0 ~ 8.0% (Median 8.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=6, EVONIK 6)) — Anhydrous balm, oil & stick structural emollient
- [emulsion_cream] Typical range: 1.0 ~ 3.0% (Median 3.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=7, EVONIK 7)) — Emulsion cream & lotion structural / conditioning agent
- [sun_color] Typical range: 1.0 ~ 7.0% (Median 4.5%, Ref: Global Starter Formulation Library Statistical Distribution (n=10, EVONIK 10)) — 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: STEARYL HEPTANOATE
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
- PMID 23064772 (2012, Int J Toxicol): Safety assessment of stearyl heptanoate and related stearyl alkanoates as used in cosmetics.
关联同行评审文献 (NIH PubMed) (1)
Safety assessment of stearyl heptanoate and related stearyl alkanoates as used in cosmetics. [PMID: 23064772 · 2012]
Fiume MM, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler D, Marks JG, Shank RC, Slaga TJ, Snyder PW, Andersen FA · Int J Toxicol (2012)
Stearyl heptanoate is an ester of stearyl alcohol and heptanoic acid that functions in cosmetics as a skin conditioning agent and is in the general class of chemicals called stearyl alkanoates. Stearyl caprylate, stearyl palmitate, stearyl stearate, stearyl behenate, and stearyl olivate are stearyl alkanoates with similar chemical structures, toxicokinetics, and functions in cosmetics. These water-insoluble stearyl alkanoates, when metabolized, yield stearyl alcohol and a corresponding fatty acid. The available information supports the safety of all of the related stearyl alkanoates. The Expert Panel concluded that stearyl heptanoate, stearyl caprylate, stearyl palmitate, stearyl stearate, stearyl behenate, and stearyl olivate are safe in the present practices of use and concentration.
常见问题解答 (FAQ)
- Q1. 硬脂醇庚酸酯 (STEARYL HEPTANOATE) 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 '硬脂醇庚酸酯'，美国 PCPC 与欧盟 CosIng 标准 INCI 为 'STEARYL HEPTANOATE'，日本 JCIA 表示名称为 'STEARYL HEPTANOATE'。
- Q2. 硬脂醇庚酸酯 (STEARYL HEPTANOATE) 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. 硬脂醇庚酸酯 (STEARYL HEPTANOATE) 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 (anhydrous_balm) 中常规添加量为 1%–8%（中位数 8%），最佳稳定 pH 范围为 4–8。
- Q4. 硬脂醇庚酸酯 (STEARYL HEPTANOATE) 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。