ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER
化妆品中 丙烯酸(酯)类/C10-30 烷醇丙烯酸酯交联聚合物 (ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER) 的全球法规限值与配方应用标准是什么?
丙烯酸(酯)类/C10-30 烷醇丙烯酸酯交联聚合物(标准 INCI: ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER,CAS 号: N/A)是化妆品配方中主要用作成膜剂, 粘度调节剂, 乳化稳定剂的核心成分。受中国 NMPA(未列管)、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 0.1–0.8%(最佳稳定窗口 pH 5–9)。
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) | ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (KR MFDS Registered) | |
| ② 韩国旧名称历史 (301 重定向) | — | — |
| ③ 欧盟 (EU CosIng EC 1223/2009) | ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER | |
| ④ 美国普通化妆品 (US PCPC / MoCRA INCI) | ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER | |
| 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) | 丙烯酸(酯)类/C10-30 烷醇丙烯酸酯交联聚合物 | |
| ⑦ 日本普通化妆品 / 医药部外品 (JCIA / MHLW) | ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (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) | 未列管 | GMP | IECIC Entry #1423 |
| 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 |
|---|---|---|---|
| 中国 IECIC 最高历史使用量 | leave_on | ≤ 2.6% | 安全判定 (MoS≥100)NMPA IECIC (2025) Entry 01134 (2025) |
| 中国 IECIC 最高历史使用量 | rinse_off | ≤ 2% | 安全判定 (MoS≥100)NMPA IECIC (2025) Entry 01134 (2025) |
Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit
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 A — 水剂爽肤水 / 精华液 / 安瓶 | 0.1% · 0.15% · 0.25% · 0.35% · 0.8% | Hydrogel thickener & polymeric co-emulsifier | Lubrizol Pemulen TR-1/TR-2 TDS & CIR Assessment |
| 剂型组 B — 乳液 / 面霜 (O/W · W/O) | 0.1% · 0.15% · 0.2% · 0.3% · 0.8% | Surfactant-free polymeric primary/co-emulsifier | Lubrizol Pemulen TDS & CIR Reported Use |
| 剂型组 D — 防晒霜 / 彩妆 / 粉底 | 0.15% · 0.2% · 0.25% · 7.6% · 20% | Sun care & color cosmetics dispersion / sensory modifier | Global Starter Formulation Library Statistical Distribution (n=10, EVONIK 8 · GRANT 2) |
Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery
Under passive topical application, molecules diffuse tortuously through intercellular lipids. Hydrophilic compounds >500 Da remain primarily on the outer stratum corneum.
pH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior
Outside pH 5–9, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Thermally stable up to 80°C during standard emulsification.
Cellular & Molecular Target Mechanism Flow
Interactive Synergy Pairings (Solid) & Incompatibility Warnings (Dashed)
Click any green synergy node to jump directly to its monograph, or click a red dashed node to inspect the chemical incompatibility mechanism.
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。
关联同行评审文献 (NIH PubMed) (3)
Sensitisation to the acrylate co-polymers glyceryl acrylate/acrylic acid co-polymer, sodium polyacrylate and acrylates/C10-30 alkyl acrylate cross-polymer (Carbopol®) is rare [PMID: 39187930 · 2024]
Acrylate polymers and cross-polymers (ACPs) are frequently used cosmetic ingredients. The British Society for Cutaneous Allergy (BSCA) and the UK Cosmetic, Toiletry and Perfumery Association (CTPA) collaborated to investigate the allergenic potential of three commonly-used ACPs. The objective of this study is to determine the prevalence of allergic contact dermatitis (ACD) to three ACPs: glyceryl acrylate/acrylic acid co-polymer, sodium polyacrylate, and acrylates/C10-30 alkyl acrylate cross-polymer (Carbopol®). The BSCA prospectively audited data collected from 20 centres in the UK and Ireland between 1st September 2021 and 1st September 2022. Patients with suspected ACD to (meth)acrylates, with facial dermatitis, or consecutive patients, were patch tested to glyceryl acrylate/acrylic acid co-polymer 10% aqueous (aq.) sodium polyacrylate 2% aq., and to acrylates/C10-30 alkyl acrylate cross-polymer 2% aq. (Carbopol®). The frequencies of positive, irritant, and doubtful reactions were recorded. In total, 1302 patients were patch tested. To glyceryl acrylate/acrylic acid co-polymer, there was one doubtful reaction in a patient allergic to multiple (meth)acrylates, and one irritant. To sodium polyacrylate, there were four irritant reactions, one doubtful, and one positive reaction; in all cases, relevance was unknown and there was no demonstrable (meth)acrylate allergy. There were no reactions to Carbopol®. Sensitisation to these concentrations of the three tested ACPs is rare. Elicitation of dermatitis in (meth)acrylate-sensitised patients by exposure to these three ACPs appears unlikely.
Texture analysis of cosmetic/pharmaceutical raw materials and formulations [PMID: 24575934 · 2014]
The purpose of this work was to quantify textural properties of cosmetic and pharmaceutical raw materials. Textural parameters such as hardness, consistency, cohesiveness, index of viscosity, stickiness and resilience were evaluated. The measurements were performed using texture analyser - a tensile metre equipped with special probes (in the form of acrylic cylinder and stainless steel sphere), which can penetrate the measured sample of a product recording the force, distance and time. The instrument simulates the action of a human finger touching the surface and probing the properties of an object. The set-up has been previously shown to quantify the rheological/textural properties of cosmetic and pharmaceutical products such as creams, lotion and gels as well as rheological behaviour of human skin. The results include the analysis of water, glycerine and mineral oil as well as aqueous solutions of thickeners such as Acrylates/C10-30 Alkyl Acrylate Crosspolymer (Ultrez-20 obtained from Noveon) and carbomer. Solutions of common surfactants and complex surfactant formulations such as shampoos have also been investigated. The results, in the form plots of force as a function of time or distance, resulting from slow bidirectional probe movement (submergence and desubmergence) in the analysed fluid, were interpreted by considering buoyancy, drag and viscous drag force given by Stokes equation. The data can be used to correlate with tactile evaluations of products by trained panel evaluations.
Inactivation of chlorhexidine gluconate on skin by incompatible alcohol hand sanitizing gels [PMID: 19398245 · 2009]
Incompatibility of leave-on products with an antimicrobial residual can negate the efficacy benefits of chlorhexidine gluconate (CHG) persistence. Two marketed alcohol products containing Carbomer were tested using a pigskin substrate model against Staphylococcus aureus. The CHG residual achieved a 4.22 log(10) reduction (standard deviation [SD] = 0.32) in this study, which was dramatically reduced to a 0.54 (SD = 0.50) and 0.46 (SD = 0.56) after subsequent treatment with incompatible alcohol gel products. A marketed alcohol product containing a nonionic thickener maintained the efficacy of the CHG chemical reservoir (log(10) reduction = 4.26, SD = 0.00). Similar findings were demonstrated when alcohol solutions containing the individual thickening agents were tested as simple formulations. An in vivo test using human forearms and Serratia marcescens similarly demonstrated that the activity of a CHG reservoir (log(10) reduction = 3.73, SD = 0.86) was not reduced by a nonionic thickened product (log(10) reduction = 3.98, SD = 0.72) but was significantly reduced by treatment with alcohol products containing anionic thickeners carbomer (log(10) reduction = -0.32, SD = 0.34) or acrylates/C10-30 alkyl acrylate crosspolymer (log(10) reduction = -0.20, SD = 0.32). The use of anionic thickeners or emulsifiers in leave-on products, including alcohol hand sanitizers, may inactivate the persistent antibacterial activity of CHG.
常见问题解答 (FAQ)
- Q1. 丙烯酸(酯)类/C10-30 烷醇丙烯酸酯交联聚合物 (ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER) 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 '丙烯酸(酯)类/C10-30 烷醇丙烯酸酯交联聚合物',美国 PCPC 与欧盟 CosIng 标准 INCI 为 'ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER',日本 JCIA 表示名称为 'ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER'。
- Q2. 丙烯酸(酯)类/C10-30 烷醇丙烯酸酯交联聚合物 (ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER) 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): none,韩国(KR): none,欧盟(EU): none,美国(US): none,日本(JP): none,东盟(ASEAN): none。
- Q3. 丙烯酸(酯)类/C10-30 烷醇丙烯酸酯交联聚合物 (ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER) 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 (aqueous_serum) 中常规添加量为 0.1%–0.8%(中位数 0.25%),最佳稳定 pH 范围为 5–9。
- Q4. 丙烯酸(酯)类/C10-30 烷醇丙烯酸酯交联聚合物 (ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER) 有哪些配伍禁忌 (Incompatibilities) 与协同增效组合?
- 推荐协同组合包括 TROMETHAMINE, ARGININE, CAPRYLIC/CAPRIC TRIGLYCERIDE;配伍禁忌注意:Viscosity loss at pH < 4.5 or high multivalent electrolyte levels; Incompatible with cationic conditioning agents。