# OCTYLDODECANOL (octyldodecanol) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/octyldodecanol
- **Standard INCI**: `OCTYLDODECANOL`
- **KR MFDS Standard Name**: `옥틸도데칸올`
- **CAS No.**: `5333-42-6`
- **EC / EINECS No.**: `226-242-9`
- **Origin**: `synthetic`
- **Functions**: 향료, 용제, 에모리엔트
- **Molecular Formula / MW**: `—` (— g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 옥틸도데칸올 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | OCTYLDODECANOL |
| US (PCPC / MoCRA INCI) | OCTYLDODECANOL |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 辛基十二醇 |
| JP (JCIA / MHLW QD) | OCTYLDODECANOL  |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `none`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `7177`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`



## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- Listed within general cosmetic GMP safety thresholds.

## 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: OCTYLDODECANOL | CAS No.: 5333-42-6 | EC No.: 226-242-9
  - Origin: SYNTHETIC | Functions: , , 
  - Physicochemical Profile: Formula      | MW /(Polymer/Complex) | /   | Ionic Nature: non-ionic | CosIng/MFDS 
  - Official Regional Label Names: US [OCTYLDODECANOL] · EU [OCTYLDODECANOL] · CN [辛基十二醇] · JP [-] · JP Quasi-Drug [-]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Octyldodecanol is an aliphatic alcohol that conforms generally to the formula: 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. 7177 (辛基十二醇))
  - 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)]
  - [anhydrous_balm] Typical range: 2.0 ~ 30.0% (Median 15.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=11, EVONIK 5 · ELEMENTIS 2 · GRANT 2 · SEPPIC 2)) — Anhydrous balm, oil & stick structural emollient
  - [aqueous_serum] Typical range: 0.5 ~ 5.0% (Median 2.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=16, SEPPIC 6 · EVONIK 5 · GRANT 3 · ELEMENTIS 2)) — Aqueous serum, toner & hydrogel matrix formulation component
  - [emulsion_cream] Typical range: 0.5 ~ 10.0% (Median 4.5%, Ref: Global Starter Formulation Library Statistical Distribution (n=20, SEPPIC 9 · GRANT 7 · EVONIK 4)) — 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: OCTYLDODECANOL
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 40545374 (2025, Contact Dermatitis): Allergic Contact Dermatitis to Octyldodecanol in a Men's Anti-Aging Cream: A Case Report
  - PMID 26361953 (2016, AAPS PharmSciTech): Antioxidant Effect of Nanoemulsions Containing Extract of Achyrocline satureioides (Lam) D.C.-Asteraceae
  - PMID 22515085 (2012, J Biomed Nanotechnol): Development of topical hydrogels containing genistein-loaded nanoemulsions

## 6. Linked PubMed Literature
- [PMID: 40545374] Allergic Contact Dermatitis to Octyldodecanol in a Men's Anti-Aging Cream: A Case Report — *Contact Dermatitis* (2025)
- [PMID: 26361953] Antioxidant Effect of Nanoemulsions Containing Extract of Achyrocline satureioides (Lam) D.C.-Asteraceae — *AAPS PharmSciTech* (2016)
- [PMID: 22515085] Development of topical hydrogels containing genistein-loaded nanoemulsions — *J Biomed Nanotechnol* (2012)
- [PMID: 40427501] Topical Delivery of Ceramide by Oil-in-Water Nanoemulsion to Retain Epidermal Moisture Content in Dermatitis — *Biomolecules* (2025)
- [PMID: 34240435] Meadowfoam seed oil as a natural dispersing agent for colorants in lipstick — *Int J Cosmet Sci* (2021)
- [PMID: 33920061] Complying with the Guideline for Quality and Equivalence for Topical Semisolid Products: The Case of Clotrimazole Cream — *Pharmaceutics* (2021)
- [PMID: 25609377] Investigating transdermal delivery of vitamin D3 — *AAPS PharmSciTech* (2015)
- [PMID: 20099516] Development of topical nanoemulsions containing quercetin and 3-O-methylquercetin — *Pharmazie* (2009)
- [PMID: 19216228] Development of topical nanoemulsions containing the isoflavone genistein — *Pharmazie* (2009)
- [PMID: 18236774] Development and validation of a LC method for determination of genistein in topical nanoemulsions — *Pharmazie* (2007)
- [PMID: 17557742] Studies on the lipophilicity of vehicles (or co-vehicles) and botanical oils used in cosmetic products — *Pharmazie* (2007)
- [PMID: 17540529] Validation of an isocratic LC method for determination of quercetin and methylquercetin in topical nanoemulsions — *J Pharm Biomed Anal* (2007)