原料词典检索/peg-40-hydrogenated-castor-oil/PEG-40 HYDROGENATED CASTOR OIL
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化学合成 (Synthetic)

PEG-40 HYDROGENATED CASTOR OIL

中国 NMPA《已使用化妆品原料目录 (IECIC)》标准中文名: PEG-40 氢化蓖麻油 (序号 #681)
乳化剂清洁剂
[EU CosIng Official Definition] Castor oil (Ricinus communis), hydrogenated, ethoxylated (40 mol EO average molar ratio)
核心法规与安全结论 (Executive Fact Box)AEO / GEO CITATION ANCHOR

化妆品中 PEG-40 氢化蓖麻油 (PEG-40 HYDROGENATED CASTOR OIL) 的全球法规限值与配方应用标准是什么?

PEG-40 氢化蓖麻油(标准 INCI: PEG-40 HYDROGENATED CASTOR OIL,CAS 号: 61788-85-0)是化妆品配方中主要用作乳化剂, 清洁剂的核心成分。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 0.5–6%(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
7-Track Official Statutory Label Names for PEG-40 HYDROGENATED CASTOR OIL
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)PEG-40 HYDROGENATED CASTOR OIL (KR MFDS Registered)
② 韩国旧名称历史 (301 重定向)——
③ 欧盟 (EU CosIng EC 1223/2009)PEG-40 HYDROGENATED CASTOR OIL
④ 美国普通化妆品 (US PCPC / MoCRA INCI)PEG-40 HYDROGENATED CASTOR OIL
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)PEG-40 氢化蓖麻油
⑦ 日本普通化妆品 / 医药部外品 (JCIA / MHLW)PEG-40水添ヒマシ油 · [QD: ポリオキシエチレン硬化ヒマシ油]

Layer 1 — 全球 6 大法域法定限值与监管状态

Layer 1 Statutory Regulatory Limits Across 6 Regions for PEG-40 HYDROGENATED CASTOR OIL
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GMPIECIC Entry #681
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。

Layer 2 Toxicological & Historical Safe Use Concentrations for PEG-40 HYDROGENATED CASTOR OIL
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
中国 IECIC 最高历史使用量leave_on≤ 10%安全判定 (MoS≥100)NMPA IECIC (2025) Entry 00462 (2025)
中国 IECIC 最高历史使用量rinse_off≤ 8%安全判定 (MoS≥100)NMPA IECIC (2025) Entry 00462 (2025)
⚠️ 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

Rinse-off Cleansern=9
Min 0.5% · Q1 0.5% · Median 1% · Q3 3.7% · Max 6%
Rinse-off Cleanser — Rinse-off cleanser & surfactant system modifier
Verified Source: Global Starter Formulation Library Statistical Distribution (n=9, EVONIK 9) (cir_safety) · EVONIK 9
Typical Median: 1%

Layer 3 — 剂型常规配比指南与理化配伍性

Layer 3 Formulation Concentration Quartiles by Product Category for PEG-40 HYDROGENATED CASTOR OIL
剂型分类Min – Q1 – Median – Q3 – Max (%)配方作用与机理Source ID
剂型组 C — 淋洗类洁面 / 洗发水 / 沐浴露0.5% · 0.5% · 1% · 3.7% · 6%Rinse-off cleanser & surfactant system modifierGlobal Starter Formulation Library Statistical Distribution (n=9, EVONIK 9)
Cutaneous Permeation Science (500 Dalton Rule)MW: Macro/Complex · LogP: N/A

Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery

Stratum Corneum (Brick & Mortar Barrier · 10–20 µm)500 Da Molecular Weight Cutoff BarrierViable Epidermis (Keratinocytes & Melanocytes · 50–100 µm)Target for Brightening (Tyrosinase/Melanosome) & Barrier LipidsPapillary Dermis (Fibroblasts & ECM Collagen · 150–300 µm)Target for Collagen I/III Synthesis, Peptides, PDRN & ExosomesEpidermal Passive Permeation (<500 Da)
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

pH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior

Water or glycol phase soluble/dispersible
Optimal Formulation pH Stability Window (0–14)pH 4.0 – 8.0
0245.5791114

Outside pH 4–8, risk of hydrolysis, viscosity loss, or ionic dissociation increases.

Maximum Thermal Processing Limit (°C)≤ 50°C
25°C45°C60°C75°C85°C100°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
W/O (3–6)Lamellar (8–10.5)O/W Emulsion (11–15)Solubilizer (15–19)O/W Droplet
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)

+ GLYCERIN+ CAPRYLIC/CAPRIC TR…+ TOCOPHEROL✕ Verify phase compati…PEG-40 HYDROGENATE…
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)
PEG-40 HYDROGENATED CASTOR OIL

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: 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

关联同行评审文献 (NIH PubMed) (4)

Facile Solvent-Free Preparation of Antioxidant Idebenone-Loaded Nanoparticles for Efficient Wound Healing. [PMID: 35335897 · 2022]
Yang H, Yu S, Kim J, Baek K, Lee YR, Lee HS, Choi WI, Sung D · Pharmaceutics (2022)

The excessive production of reactive oxygen species (ROS) causes harmful effects, including biomolecular damage and inflammation. ROS due to ultraviolet rays, blue light, and fine dust harm the skin, causing urban-related aging. Therefore, a strong antioxidant that relieves oxidative stress in the skin and removes ROS is required. Idebenone (IB) is a powerful antioxidant but is poorly soluble and thus has low solubility in water, resulting in low bioavailability. In this study, IB-loaded nanoparticles (IB@NPs) were synthesized by loading IB without an organic solvent into nanoparticles that can provide high loading efficiency and stability for solubilization. Indeed, the synthesized IB@NPs exhibited long-term stability through dynamic light scattering, methylene blue staining, and redispersion assays, and IB@NPs prepared with a 5 wt% IB loading content were found to be optimal. The antioxidant activity of IB@NPs evaluated using the 2,2-diphenyl-1-picrylhydrazyl (DPPH) assay was significantly higher than that of unloaded IB. In addition, IB@NPs showed excellent biocompatibility, inhibited oxidative damage to mouse NIH-3T3 fibroblasts, and reduced intracellular ROS generation according to an in vitro DPPH antioxidant assay. Most notably, IB@NPs significantly promoted wound healing in vitro, as demonstrated by scratch assays. Therefore, as carriers with excellent stability, IB@NPs have potential cosmetic and pharmaceutical applications.

Penetration Enhancer-Free Mixed Micelles for Improving Eprinomectin Transdermal c Efficiency in Animal Parasitic Infections Therapy. [PMID: 39502637 · 2024]
Mao Y, Hao T, Zhang H, Gu X, Wang J, Shi F, Chen X, Guo L, Gao J, Shen Y, Zhang J, Yu S · Int J Nanomedicine (2024)

Eprinomectin offers promise against parasitic infections. This study develops Eprinomectin (EPR) mixed micelles for transdermal delivery, aiming to enhance efficacy and convenience against endoparasites and ectoparasites. Physicochemical characterization and pharmacokinetic studies were conducted to assess its potential as an effective treatment for parasitic infections. Blank and EPR mixed micelles were prepared using PEG-40 Hydrogenated castor oil (RH-40) and Nonyl phenol polyoxyethylene ether 40 (NP-40). Critical micelle concentrations (CMC) determined using the pyrene fluorescence probe method. Particle size, EE, DL, in vitro release, permeation, and skin irritation were evaluated. In vivo pharmacokinetic studies were conducted in male Sprague-Dawley rats. Results show that EPR mixed micelles present suitable stability, physicochemical properties, and safety. Moreover, the rapid release and high bioavailability of EPR mixed micelles have also been verified in the study. Pharmacokinetic experiments in vivo showed that an improvement in the transdermal absorption and bioavailability of EPR after encapsulation in mixed micelles formulations. The results proved that the novel mixed micelles are safe and effective and are expected to become a promising veterinary nano-delivery system.

Investigation of surfactant/cosurfactant synergism impact on ibuprofen solubilization capacity and drug release characteristics of nonionic microemulsions. [PMID: 22579578 · 2012]
Djekic L, Primorac M, Filipic S, Agbaba D · Int J Pharm (2012)

The current study investigates the performances of the multicomponent mixtures of nonionic surfactants regarding the microemulsion stabilisation, drug solubilization and in vitro drug release kinetic. The primary surfactant was PEG-8 caprylic/capric glycerides (Labrasol). The cosurfactants were commercially available mixtures of octoxynol-12 and polysorbate 20 without or with the addition of PEG-40 hydrogenated castor oil (Solubilisant gamma 2421 and Solubilisant gamma 2429, respectively). The oil phase of microemulsions was isopropyl myristate. Phase behaviour study of the pseudo-ternary systems Labrasol/cosurfactant/oil/water at surfactant-to-cosurfactant weight ratios (K(m)) 40:60, 50:50 and 60:40, revealed a strong synergism in the investigated tensides mixtures for stabilisation of microemulsions containing up to 80% (w/w) of water phase at surfactant +cosurfactant-to-oil weight ratio (SCoS/O) 90:10. Solubilization of a model drug ibuprofen in concentration common for topical application (5%, w/w) was achieved at the water contents below 50% (w/w). Drug free and ibuprofen-loaded microemulsions M1-M6, containing 45% (w/w) of water phase, were prepared and characterized by polarized light microscopy, conductivity, pH, rheological and droplet size measurements. In vitro ibuprofen release kinetics from the microemulsions was investigated using paddle-over-enhancer cell method and compared with the commercial 5% (w/w) ibuprofen hydrogel product (Deep Relief, Mentholatum Company Ltd., USA). The investigated microemulsions were isotropic, low viscous Bingham-type liquids with the pH value (4.70-6.61) suitable for topical application. The different efficiency of the tensides mixtures for microemulsion stabilisation was observed, depending on the cosurfactant type and K(m) value. Solubilisant gamma 2429 as well as higher K(m) (i.e., lower relative content of the cosurfactant) provided higher surfactant/cosurfactant synergism. The drug molecules were predominantly solubilized within the interface film. The amount of drug released from the formulations M3 (10.75%, w/w) and M6 (13.45%, w/w) (K(m) 60:40) was limited in comparison with the reference (22.22%, w/w) and follows the Higuchi model. Microemulsions M2 and M5 (K(m) 50:50) gave zero order drug release pattern and &#x223c;15% (w/w) ibuprofen released. The release profiles from microemulsions M1 and M4 (K(m) 40:60) did not fit well with the models used for analysis, although the amounts of ibuprofen released (24.47%, w/w) and 17.99% (w/w), respectively) were comparable to that of the reference hydrogel. The drug release mechanism was related with the surfactant/cosurfactant synergism, thus the lower efficiency of the tensides corresponded to the faster drug release.

Formulation of lyotropic liquid crystal containing mulberry stem extract: influences of formulation ingredients on the formation and the nanostructure. [PMID: 24471700 · 2014]
Yhirayha C, Soontaranon S, Wittaya-Areekul S, Pitaksuteepong T · Int J Cosmet Sci (2014)

This study focused on the formulation of lamellar lyotropic liquid crystal (LLC) loaded with mulberry stem extract (MSE). The LLC formulation tested used two oils: n-dodecane or tridecyl salicylate, a co-solvent (propylene glycol) and a single (PEG-7 glyceryl cocoate) or mixed surfactant system. The mixed surfactant was PEG-7 glyceryl cocoate/PEG-40 hydrogenated castor oil/glyceryl monooleate. The LLC formation and phase behaviour were observed by polarized optical microscopy (POM) before and after MSE loading. Nanostructure determinations on these formulations following MSE loading used small angle X-ray scattering (SAXS) at 25-40&#xb0;C. Lamellar LLCs are formed more easily with n-dodecane than tridecyl salicylate. Propylene glycol, in the aqueous phase (1 : 1), failed to form LLC due to suboptimal critical packing parameter (CPP) value. A single or mixed surfactant system also influenced the formation of lamellar LLC according to the chemical structure of both oils and especially the surfactants used. The four lamellar LLC formulations selected for MSE loading were PEG-7 glyceryl cocoate/tridecyl salicylate/water; mixed surfactant/tridecyl salicylate/water; PEG-7 glyceryl cocoate/n-dodecane/water and mixed surfactant/n-dodecane/water, named F1, F2, F3 and F4, respectively. MSE in F1 and F3 did not affect the lamellar structure, while MSE in F2 and F4 enlarged the lamellar structure. The SAXS data confirmed that the LLC formulations obtained were lamellar and the structure persisted with MSE. These lamellar formulations should find widespread application for MSE and perhaps other similar herbal cosmetics.

常见问题解答 (FAQ)

Q1. PEG-40 氢化蓖麻油 (PEG-40 HYDROGENATED CASTOR OIL) 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 'PEG-40 氢化蓖麻油',美国 PCPC 与欧盟 CosIng 标准 INCI 为 'PEG-40 HYDROGENATED CASTOR OIL',日本 JCIA 表示名称为 'PEG-40水添ヒマシ油'。
Q2. PEG-40 氢化蓖麻油 (PEG-40 HYDROGENATED CASTOR OIL) 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. PEG-40 氢化蓖麻油 (PEG-40 HYDROGENATED CASTOR OIL) 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 (cleanser_rinse) 中常规添加量为 0.5%–6%(中位数 1%),最佳稳定 pH 范围为 4–8。
Q4. PEG-40 氢化蓖麻油 (PEG-40 HYDROGENATED CASTOR OIL) 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。