DICAPRYLYL CARBONATE
化妆品中 碳酸二辛酯 (DICAPRYLYL CARBONATE) 的全球法规限值与配方应用标准是什么？
碳酸二辛酯（标准 INCI: DICAPRYLYL CARBONATE，CAS 号: 1680-31-5）是化妆品配方中主要用作皮肤调理剂, 柔润剂的核心成分。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 2.5–12.8%（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| 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) | DICAPRYLYL CARBONATE (KR MFDS Registered) | |
| ② 韩国旧名称历史 (301 重定向) | Former KR Nomenclature Redirect Active | — |
| ③ 欧盟 (EU CosIng EC 1223/2009) | DICAPRYLYL CARBONATE | |
| ④ 美国普通化妆品 (US PCPC / MoCRA INCI) | DICAPRYLYL CARBONATE | |
| 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) | 碳酸二辛酯 | |
| ⑦ 日本普通化妆品 / 医药部外品 (JCIA / MHLW) | DICAPRYLYL CARBONATE (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) | 已使用/准用 | GMP | IECIC Entry #6577 |
| 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 | ≤ 35% | 安全判定 (MoS≥100)NMPA IECIC (2025) Entry 06319 (2025) |
| 中国 IECIC 最高历史使用量 | rinse_off | ≤ 15% | 安全判定 (MoS≥100)NMPA IECIC (2025) Entry 06319 (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 D — 防晒霜 / 彩妆 / 粉底 | 2.5% · 5.3625% · 6.325% · 7.9625% · 12.8% | Sun care & color cosmetics dispersion / sensory modifier | Global Starter Formulation Library Statistical Distribution (n=8, GRANT 8) |
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 4–8, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Thermally stable up to 50°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) (1)
Effect of emollients on UV filter absorbance and sunscreen efficiency. [PMID: 32065958 · 2020]
The idea of increasing the performance of sunscreens without adding more UV-filters is very attractive. Early studies reported an influence of solvents on the absorbing properties of UV-absorbers which was shown to be connected to the solvent polarity. However, the polarity differed a lot between tested solvents and most were unsuitable UV-filter solubilizers. The aim of the present study was to focus exclusively on emollients pertinent for sunscreens and investigate their impact on the performance of UV-filter combinations. The UV absorbance of Bis-ethylhexyloxyphenol Methoxyphenyl Triazine, Ethylhexyl Triazone, Diethylamino Hydroxybenzoyl Hexyl Benzoate, and Ethylhexyl Methoxycinnamate was measured in suncare relevant emollients comprising C12-15 Alkyl Benzoate, Dibutyl Adipate, Caprylic/Capric Triglyceride, Coco-caprylate, Isopropyl Myristate, Dicaprylyl Carbonate. The wavelength of maximum absorbance (λmax) and specific extinction at λmax (E1,1 (λmax) ) were assessed for each UV-filter - emollient system. The performance of market relevant UV-filter combinations based on the studied UV-filters was simulated for each emollient with a computational method using the absorbance values measured for each UV-filter - emollient system. The difference in polarity of emollients led to a 2-3 nm bathochromic shift and a variation of the E1,1 (λmax) ranging from 4 to 20% for tested UV-filters. The emollient type showed nearly no influence on the sun protection factor (SPF) of market relevant UV-filter combinations probably due to a different influence an emollient shows on the UVB filters resulting in cancelling of the corresponding effect. Conversely, for all UV-filter combinations the UVA protection decreased with a decrease in the emollient polarity. Whilst the SPF was not impacted by standardly used cosmetic oils, the results advocate to use polar emollients to optimize the UVA protection. This is of advantage since polar emollients better dissolve crystalline UV-filters. From tested emollients, Dibutyl Adipate performed the best for both SPF and PPD factors.
常见问题解答 (FAQ)
- Q1. 碳酸二辛酯 (DICAPRYLYL CARBONATE) 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 '碳酸二辛酯'，美国 PCPC 与欧盟 CosIng 标准 INCI 为 'DICAPRYLYL CARBONATE'，日本 JCIA 表示名称为 'DICAPRYLYL CARBONATE'。
- Q2. 碳酸二辛酯 (DICAPRYLYL CARBONATE) 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. 碳酸二辛酯 (DICAPRYLYL CARBONATE) 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 (sun_color) 中常规添加量为 2.5%–12.8%（中位数 6.325%），最佳稳定 pH 范围为 4–8。
- Q4. 碳酸二辛酯 (DICAPRYLYL CARBONATE) 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。