Synthetic
STEARYL HEPTANOATE
Skin ConditioningEmollient
Executive Regulatory & Safety Fact BoxAEO / GEO CITATION ANCHOR
What is STEARYL HEPTANOATE (CAS 66009-41-4) in cosmetics and what are its global regulatory limits?
STEARYL HEPTANOATE (CAS No. 66009-41-4) is a verified cosmetic ingredient primarily functioning as Skin Conditioning, Emollient in topical formulations. Regulated under KR MFDS (Unregulated) and EU 1223/2009 CosIng (Unregulated) statutory frameworks, it is typically formulated at 1–8% within an optimal stability window of pH 4–8.
7-Track Official Regulatory Label Names Matrix
Primary Statutory Gazette Only · Zero Machine Translation| Jurisdiction Track | Official Statutory Label Name | One-Click Copy |
|---|---|---|
| 1. Korea (MFDS Standard Name) | STEARYL HEPTANOATE (KR MFDS Registered) | |
| 2. Korea Former Nomenclature History | — | — |
| 3. European Union (EU CosIng Glossary) | STEARYL HEPTANOATE | |
| 4. United States (US PCPC / MoCRA INCI) | STEARYL HEPTANOATE | |
| 5. US FDA OTC Monograph Active Name | — (Cosmetic Inactive / Non-OTC) | — |
| 6. China (NMPA IECIC Standard Name) | 硬脂醇庚酸酯 | |
| 7. Japan (JCIA Standard / MHLW Quasi-Drug) | STEARYL HEPTANOATE (Standard INCI Reference) |
Layer 1 — Statutory Regulatory Limits Across 6 Regions
| Region | Status | Max Limit | Conditions & Statutory Source |
|---|---|---|---|
| Korea (MFDS) | Unregulated | GMP | Listed in official cosmetic inventory |
| Europe (EU) | Unregulated | GMP | Listed in official cosmetic inventory |
| United States (FDA) | Unregulated | GMP | Listed in official cosmetic inventory |
| China (NMPA) | Listed / Allowed | GMP | IECIC Entry #7975 |
| Japan (MHLW) | Unregulated | GMP | Listed in official cosmetic inventory |
| ASEAN (ACD) | Unregulated | GMP | Listed in official cosmetic inventory |
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.
| Assessment Basis | Application Scope | Concentration Range | Verdict & Dossier Reference |
|---|---|---|---|
| US CIR Reported Max Use | total | 0.07~8% | Safe (MoS≥100)115_draft_steary.pdf () |
| US CIR Reported Max Use | leave_on | 0.07~8% | Safe (MoS≥100)115_draft_steary.pdf () |
| US CIR Reported Max Use | rinse_off | 0.7~3% | Safe (MoS≥100)115_draft_steary.pdf () |
| US CIR Reported Max Use | eye | 0.5~8% | Safe (MoS≥100)115_draft_steary.pdf () |
| US CIR Reported Max Use | ingestion | 3~8% | Safe (MoS≥100)115_draft_steary.pdf () |
| US CIR Reported Max Use | spray | 0.7~0.7% | Safe (MoS≥100)115_draft_steary.pdf () |
| US CIR Reported Max Use | dermal | 0.07~8% | Safe (MoS≥100)115_draft_steary.pdf () |
| US CIR Reported Max Use | deodorant | 0.07~0.07% | Safe (MoS≥100)115_draft_steary.pdf () |
| US CIR Reported Max Use | mucous | 0~0% | Safe (MoS≥100)116_final_stehep.pdf () |
⚠️ 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
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 — Formulation Usage Guide (Quartiles n≥5) & Physicochemical Compatibility
| Formulation Group | Min – Q1 – Median – Q3 – Max (%) | Role & Mechanism | Source ID |
|---|---|---|---|
| Group E — Anhydrous Oil / Stick Balm / Lip Care | 1% · 5.75% · 8% · 8% · 8% | Anhydrous balm, oil & stick structural emollient | Global Starter Formulation Library Statistical Distribution (n=6, EVONIK 6) |
| Group B — O/W & W/O Emulsion / Lotion / Cream | 1% · 1.5% · 3% · 3% · 3% | Emulsion cream & lotion structural / conditioning agent | Global Starter Formulation Library Statistical Distribution (n=7, EVONIK 7) |
| Group D — Sunscreen (UV) / Color Cosmetics / Foundation | 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.
Nominative Trade Name References (Trademark Act Art. 90(1)(2))
STEARYL HEPTANOATE
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 SynthesisSynthesized strictly from peer-reviewed PubMed abstracts and official toxicological dossiers linked to this ingredient.
■ [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.
Linked Peer-Reviewed Literature (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.
Frequently Asked Questions (AEO Position 0)
- Q1. What are the official 7-track regulatory label names for STEARYL HEPTANOATE?
- Standard label names are US PCPC INCI: 'STEARYL HEPTANOATE', EU CosIng: 'STEARYL HEPTANOATE', KR MFDS: 'STEARYL HEPTANOATE (KR MFDS Registered)', CN NMPA IECIC: '硬脂醇庚酸酯', and JP JCIA: 'STEARYL HEPTANOATE'.
- Q2. Is STEARYL HEPTANOATE restricted or permitted in EU, US, KR, CN, and JP cosmetics?
- Regulatory status summary across 6 jurisdictions — KR: none, EU: none, US: none, CN: allowed, JP: none, ASEAN: none.
- Q3. What is the typical formulation concentration and optimal pH window for STEARYL HEPTANOATE?
- In anhydrous_balm systems, STEARYL HEPTANOATE is typically formulated between 1% and 8% (median 8%), with an optimal stability window of pH 4–8.
- Q4. What are the known formulation incompatibilities and synergy pairings for STEARYL HEPTANOATE?
- Recommended synergy pairings include GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL. Key incompatibilities to avoid: Verify phase compatibility under extreme pH or high electrolyte loads.