ETHYLHEXYL TRIAZONE
化妆品中 乙基己基三嗪酮 (ETHYLHEXYL TRIAZONE) 的全球法规限值与配方应用标准是什么?
乙基己基三嗪酮(标准 INCI: ETHYLHEXYL TRIAZONE,CAS 号: 88122-99-0)是化妆品配方中主要用作防晒剂, 光稳定剂的核心成分。受中国 NMPA(限用)、韩国 MFDS(限用)及欧盟 CosIng(限用)等 6 大法域法定标准监管,常规建议添加量为 1–4%(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) | ETHYLHEXYL TRIAZONE (KR MFDS Registered) | |
| ② 韩国旧名称历史 (301 重定向) | — | — |
| ③ 欧盟 (EU CosIng EC 1223/2009) | ETHYLHEXYL TRIAZONE | |
| ④ 美国普通化妆品 (US PCPC / MoCRA INCI) | ETHYLHEXYL TRIAZONE | |
| ⑤ 美国 OTC 防晒/祛痘专论活性物名称 (FDA OTC) | OCTYL TRIAZONE (UNAPPROVED OTC IN US) | |
| ⑥ 中国 (NMPA《已使用化妆品原料目录 IECIC》标准中文名) | 乙基己基三嗪酮 | |
| ⑦ 日本普通化妆品 / 医药部外品 (JCIA / MHLW) | ETHYLHEXYL TRIAZONE (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) | 限用 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 欧盟 (EU) | 限用 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 美国 (FDA) | 禁用 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 中国 (NMPA) | 限用 | GMP | IECIC Entry #7709 |
| 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) | 限用 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
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 | 1% · 1.5% · 2% · 2.5% · 4% | Sun care & color cosmetics dispersion / sensory modifier | Global Starter Formulation Library Statistical Distribution (n=17, EVONIK 15 · SEPPIC 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 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) (5)
Sunscreens and their usefulness: have we made any progress in the last two decades? [PMID: 33721254 · 2021]
Sunscreens have now been around for decades to mitigate the Sun's damaging ultraviolet (UV) radiation which, although essential for the existence of life, is a recognized prime carcinogen. Accordingly, have suncreams achieved their intended purposes towards protection against sunburns, skin photo-ageing and the like? Most importantly, however, have they provided the expected protection against skin cancers that current sunscreen products claim to do? In the last two decades, there have been tens, if not hundreds of studies on sunscreens with respect to skin protection against UVB (280‒320 nm)-traditionally sunscreens with rather low sun protection factors (SPF) were intended to protect against this type of radiation-and UVA (320‒400 nm) radiation; a distinction between SPF and UVA protection factor (UVA-PF) is made. Many of the studies of the last two decades have focused on protection against the more skin-penetrating UVA radiation. This non-exhaustive article reviews some of the important facets of what is currently known about sunscreens with regard (i) to the physical UV filters titanium dioxide (TiO 2 ) and zinc oxide (ZnO) and the mostly photo-unstable chemical UVB/UVA filters (e.g., octinoxate (OMC) and avobenzone (AVO), among others), (ii) to novel chemical sunscreen agents, (iii) to means that minimize the breakdown of chemical filters and improve their stability when exposed to UV sunlight, (iv) to SPF factors, and (v) to a short discussion on non-melanoma skin cancers and melanoma. Importantly, throughout the article we allude to the safety aspects of sunscreens and at the end ask the question: do active ingredients in sunscreen products pose a risk to human health, and what else can be done to enhance protection? Significant loss of skin protection from two well-known commercial suncreams when exposed to simulated UV sunlight. Cream I: titanium dioxide, ethylhexyl triazone, avobenzone, and octinoxate; Cream II: octyl salicylate, oxybenzone, avobenzone, and octinoxate.
In vivo Human Skin Penetration of the UV Filter Ethylhexyl Triazone: Effect of Lipid Microparticle Encapsulation. [PMID: 30380536 · 2019]
The data available on the skin permeability of ethylhexyl triazone (EHT), a widely used high-molecular-weight (823.1-Da) UV filter, are scarce and obtained only via in vitro studies. Therefore, we evaluated in vivo the penetration of EHT in human stratum corneum by the tape stripping technique. Moreover, the effect of EHT encapsulation in lipid microparticles (LMs) on its diffusion through the stratum corneum was examined. LMs loaded with EHT were prepared using glyceryl behenate and phosphatidylcholine. Creams containing EHT free or encapsulated in LMs in conjunction with the two most commonly used UV filters, octyl methoxycinnamate (OMC) and butyl methoxydibenzoylmethane (BMDBM), were applied to human volunteers and the fraction of the applied sunscreen dose having penetrated into different stratum corneum layers was measured. For the cream with the nonencapsulated sunscreen agent, the percentage of the applied EHT dose diffused into the stratum corneum was 21.9 ± 4.9%, not significantly different from that of the smaller-molecular-weight OMC (22.2 ± 7.6%) and BMDBM (20.5 ± 3.7%). A marked (45.7%) and statistically significant reduction in the in vivo skin penetration of EHT was attained with the cream containing microencapsulated EHT. The decreased percutaneous penetration provided by the LMs should favor the efficacy of EHT and limit potential toxicological risks.
Quantification of sunscreen ethylhexyl triazone in topical skin-care products by normal-phase TLC/densitometry. [PMID: 22629203 · 2012]
Ethylhexyl triazone (ET) was separated from other sunscreens such as avobenzone, octocrylene, octyl methoxycinnamate, and diethylamino hydroxybenzoyl hexyl benzoate and from parabens by normal-phase HPTLC on silica gel 60 as stationary phase. Two mobile phases were particularly effective: (A) cyclohexane-diethyl ether 1 : 1 (v/v) and (B) cyclohexane-diethyl ether-acetone 15 : 1 : 2 (v/v/v) since apart from ET analysis they facilitated separation and quantification of other sunscreens present in the formulations. Densitometric scanning was performed at 300 nm. Calibration curves for ET were nonlinear (second-degree polynomials), with R > 0.998. For both mobile phases limits of detection (LOD) were 0.03 and limits of quantification (LOQ) 0.1 μg spot(-1). Both methods were validated.
Sporopollenin Microcapsule: Sunscreen Delivery System with Photoprotective Properties. [PMID: 36297476 · 2022]
In recent years, the demand for high-quality solar products that combine high efficacy with environmentally friendly characteristics has increased. Among the coral-safe sunscreens, ethylhexyl triazone (Uvinul ® T150) is an effective organic UVB filter, photostable and practically insoluble in water, therefore difficult to be formulated in water-based products. Oil-free sunscreens are considered ideal for most skin types, as they are not comedogenic and do not leave the skin feeling greasy. Recent studies reported that pollen grains might represent innovative drug delivery systems for their ability to encapsulate and release active ingredients in a controlled manner. Before being used, the pollen grains must be treated to remove cellular material and biomolecules, which could cause allergic reactions in predisposed subjects; the obtained hollow structures possess uniform diameter and a rigid wall with openings that allow them to be filled with bioactive substances. In the present work, pollen from Lycopodium clavatum has been investigated both as a delivery system for ethylhexyl triazone and as an active ingredient by evaluating its photoprotective capacity. The goal is to obtain environmentally friendly solar aqueous formulations that take advantage of both sunscreen and sporopollenin microcapsules' UV protection with a relatively low cost, as these pollen grains are widely available.
Photostability of cosmetic UV filters on mammalian skin under UV exposure. [PMID: 25283484 · 2015]
Previous studies showed that the common UV filter substances benzophenone-3 (BP-3), butyl methoxydibenzoylmethane (BM-DBM), octocrylene (OCR), ethylhexyl methoxycinnamate (EHMC), ethylhexyl salicylate (EHS) and ethylhexyl triazone (EHT) were able to react with amino side chains of different proteins in vitro. To transfer the results to mammalian skin conditions, sunscreen products were applied on both prepared fresh porcine skin and glass plates, followed by UV irradiation and the determination of depletion of the respective UV filters. Significantly lower recoveries of the UV filters extracted from skin samples than from glass plates indicated the additional reaction of the UV filters with skin constituents, when proteins will be the most important reactants. Among the products tested, BP-3 showed the greatest differences in recoveries between glass and skin samples of about 13% and 24% after 2 and 4 h of irradiation, respectively, followed by EHS > BM-DBM > OCR > EHMC > EHT. The obtained results raise the question, whether the common in vitro evaluations of sunscreens, using inert substrate materials like roughened quartz or polymethyl methacrylate (PMMA) plates are really suitable to fully replace in vivo methods, as they cannot include skin-typical reactions.
常见问题解答 (FAQ)
- Q1. 乙基己基三嗪酮 (ETHYLHEXYL TRIAZONE) 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 '乙基己基三嗪酮',美国 PCPC 与欧盟 CosIng 标准 INCI 为 'ETHYLHEXYL TRIAZONE',日本 JCIA 表示名称为 'ETHYLHEXYL TRIAZONE'。
- Q2. 乙基己基三嗪酮 (ETHYLHEXYL TRIAZONE) 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): restricted,韩国(KR): restricted,欧盟(EU): restricted,美国(US): banned,日本(JP): none,东盟(ASEAN): restricted。
- Q3. 乙基己基三嗪酮 (ETHYLHEXYL TRIAZONE) 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 1%–4%(中位数 2%),最佳稳定 pH 范围为 4–8。
- Q4. 乙基己基三嗪酮 (ETHYLHEXYL TRIAZONE) 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。