# PEG-40 HYDROGENATED CASTOR OIL (peg-40-hydrogenated-castor-oil) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/peg-40-hydrogenated-castor-oil
- **Standard INCI**: `PEG-40 HYDROGENATED CASTOR OIL`
- **KR MFDS Standard Name**: `피이지-40하이드로제네이티드캐스터오일`
- **CAS No.**: `61788-85-0`
- **EC / EINECS No.**: `N/A`
- **Origin**: `synthetic`
- **Functions**: 유화제, 세정제
- **Molecular Formula / MW**: `—` (— g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 피이지-40하이드로제네이티드캐스터오일 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | PEG-40 HYDROGENATED CASTOR OIL |
| US (PCPC / MoCRA INCI) | PEG-40 HYDROGENATED CASTOR OIL |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | PEG-40 氢化蓖麻油 |
| JP (JCIA / MHLW QD) | ＰＥＧ－４０水添ヒマシ油 (QD: ポリオキシエチレン硬化ヒマシ油) |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `none`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `681`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`



## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **cn_iecic_max** (leave_on): ≤ 10% — NMPA IECIC (2025) Entry 00462 (2025)
- **cn_iecic_max** (rinse_off): ≤ 8% — NMPA IECIC (2025) Entry 00462 (2025)

## 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: PEG-40 HYDROGENATED CASTOR OIL | CAS No.: 61788-85-0 | EC No.: N/A
  - Origin: SYNTHETIC | Functions: , 
  - Physicochemical Profile: Formula      | MW /(Polymer/Complex) | /   | Ionic Nature: non-ionic | CosIng/MFDS 
  - Official Regional Label Names: US [PEG-40 HYDROGENATED CASTOR OIL] · EU [PEG-40 HYDROGENATED CASTOR OIL] · CN [PEG-40 氢化蓖麻油] · JP [ＰＥＧ－４０水添ヒマシ油] · JP Quasi-Drug [ポリオキシエチレン硬化ヒマシ油]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Castor oil (Ricinus communis), hydrogenated, ethoxylated (40 mol EO average molar ratio) 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. 681 (PEG-40 氢化蓖麻油))
  - 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): CN_IECIC_2025 (cn_iecic_max, leave_on): Max 10.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 8.0%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [cleanser_rinse] Typical range: 0.5 ~ 6.0% (Median 1.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=9, EVONIK 9)) — Rinse-off cleanser & surfactant system 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: PEG-40 HYDROGENATED CASTOR OIL
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 35335897 (2022, Pharmaceutics): Facile Solvent-Free Preparation of Antioxidant Idebenone-Loaded Nanoparticles for Efficient Wound Healing.
  - PMID 39502637 (2024, Int J Nanomedicine): Penetration Enhancer-Free Mixed Micelles for Improving Eprinomectin Transdermal c Efficiency in Animal Parasitic Infecti
  - PMID 22579578 (2012, Int J Pharm): Investigation of surfactant/cosurfactant synergism impact on ibuprofen solubilization capacity and drug release characte

## 6. Linked PubMed Literature
- [PMID: 35335897] Facile Solvent-Free Preparation of Antioxidant Idebenone-Loaded Nanoparticles for Efficient Wound Healing. — *Pharmaceutics* (2022)
- [PMID: 39502637] Penetration Enhancer-Free Mixed Micelles for Improving Eprinomectin Transdermal c Efficiency in Animal Parasitic Infections Therapy. — *Int J Nanomedicine* (2024)
- [PMID: 22579578] Investigation of surfactant/cosurfactant synergism impact on ibuprofen solubilization capacity and drug release characteristics of nonionic microemulsions. — *Int J Pharm* (2012)
- [PMID: 24471700] Formulation of lyotropic liquid crystal containing mulberry stem extract: influences of formulation ingredients on the formation and the nanostructure. — *Int J Cosmet Sci* (2014)