原料辞典検索/ethylhexylglycerin/ETHYLHEXYLGLYCERIN
Tier 1 Monograph · SSOT 15 FieldsRaw .md (GEO) ↗
合成 (Synthetic)

ETHYLHEXYLGLYCERIN

日本化粧品工業連合会 (JCIA) 表示名称: エチルヘキシルグリセリン
防臭剤皮膚コンディショニング剤
[EU CosIng Official Definition] Ethylhexylglycerin is the organic compound that conforms to the formula
結論先行 エグゼクティブ規制・安全性ファクトボックスAEO / GEO CITATION ANCHOR

化粧品における エチルヘキシルグリセリン (ETHYLHEXYLGLYCERIN) のグローバル配合基準と処方特性とは?

エチルヘキシルグリセリン(標準 INCI: ETHYLHEXYLGLYCERIN、CAS番号: 70445-33-9)は、化粧品処方において主に防臭剤, 皮膚コンディショニング剤として配合される原料です。日本厚労省/JCIA(規制なし)、韓国MFDS(規制なし)、欧州CosIng(規制なし)など6大法域の法定基準下で管理され、通常 0.03–0.15%(適正安定域 pH 3–10)で処方されます。

7大トラック 国別・用途別 公式全成分表示名称マトリクス

各国公的告示原典のみ収録 · 機械翻訳・任意音訳ゼロ
7-Track Official Statutory Label Names for ETHYLHEXYLGLYCERIN
法域・規制トラック公式全成分表示名称ワンクリックコピー
① 韓国 (MFDS 化粧品標準名称)ETHYLHEXYLGLYCERIN (KR MFDS Registered)
② 韓国旧名称履歴 (301 リダイレクト)Former KR Nomenclature Redirect Active—
③ 欧州連合 (EU CosIng EC 1223/2009)ETHYLHEXYLGLYCERIN
④ 米国一般化粧品 (US PCPC / MoCRA INCI)ETHYLHEXYLGLYCERIN
⑤ 米国 FDA OTC モノグラフ有効成分名— (米国 OTC 対象外 / 一般化粧品原料)—
⑥ 中国 (NMPA IECIC 標準中国語名称)乙基己基甘油
⑦ 日本化粧品表示名称 / 医薬部外品外原規名称 (JCIA / MHLW)エチルヘキシルグリセリン · [QD: グリセリルモノ2-エチルヘキシルエーテル]

Layer 1 — 6大法域 法定配合上限および規制ステータス

Layer 1 Statutory Regulatory Limits Across 6 Regions for ETHYLHEXYLGLYCERIN
法域規制ステータス配合上限制限条件および一次法源出典
韓国 (MFDS)規制なしGMP公的化粧品原料目録収載 (GMP基準内使用)
欧州 (EU)規制なしGMP公的化粧品原料目録収載 (GMP基準内使用)
米国 (FDA)規制なしGMP公的化粧品原料目録収載 (GMP基準内使用)
中国 (NMPA)配合可能GMPIECIC Entry #7706
日本 (MHLW)規制なしGMP公的化粧品原料目録収載 (GMP基準内使用)
ASEAN (ACD)規制なしGMP公的化粧品原料目録収載 (GMP基準内使用)

Layer 2 — 毒性・安全性評価上限 (US CIR / EU SCCS / CN IECIC)

「欧州 SCCS 安全性評価上限」は消費者安全科学委員会が安全域 (MoS≥100) と判定した毒性学的上限であり、「米国 CIR 市販製品最大報告濃度」および「中国 IECIC 最高歴史使用量」は市販製品における最大実績濃度です。

Layer 2 Toxicological & Historical Safe Use Concentrations for ETHYLHEXYLGLYCERIN
安全性評価基準適用範囲・用途安全濃度範囲判定結果および文献参照
米国 CIR 市販製品最大報告濃度rinse_off0~8%安全判定 (MoS≥100)ethylh122011finalx.pdf (2011)
米国 CIR 市販製品最大報告濃度eye0.02~1%安全判定 (MoS≥100)ethylh122011finalx.pdf (2011)
米国 CIR 市販製品最大報告濃度ingestion0.08~0.5%安全判定 (MoS≥100)ethylh122011finalx.pdf (2011)
米国 CIR 市販製品最大報告濃度spray0.01~2%安全判定 (MoS≥100)ethylh122011finalx.pdf (2011)
米国 CIR 市販製品最大報告濃度powder0.2~0.5%安全判定 (MoS≥100)ethylh122011finalx.pdf (2011)
米国 CIR 市販製品最大報告濃度dermal0.000001~8%安全判定 (MoS≥100)ethylh122011finalx.pdf (2011)
米国 CIR 市販製品最大報告濃度deodorant0.04~2%安全判定 (MoS≥100)ethylh122011finalx.pdf (2011)
米国 CIR 市販製品最大報告濃度hair0.0003~2%安全判定 (MoS≥100)ethylh122011finalx.pdf (2011)
米国 CIR 市販製品最大報告濃度nail0.1~0.1%安全判定 (MoS≥100)ethylh122011finalx.pdf (2011)
米国 CIR 市販製品最大報告濃度mucous0.000001~0.5%安全判定 (MoS≥100)ethylh122011finalx.pdf (2011)
米国 CIR 市販製品最大報告濃度leave_on0.002~2%安全判定 (MoS≥100)ethylh122011finalx.pdf (2011)
米国 CIR 市販製品最大報告濃度bath0.1~0.1%安全判定 (MoS≥100)ethylh122011finalx.pdf (2011)
米国 CIR 市販製品最大報告濃度total0.000001~8%安全判定 (MoS≥100)ethylh122011finalx.pdf (2011)
中国 IECIC 最高歴史使用量leave_on≤ 5%安全判定 (MoS≥100)NMPA IECIC (2025) Entry 07834 (2025)
中国 IECIC 最高歴史使用量rinse_off≤ 2%安全判定 (MoS≥100)NMPA IECIC (2025) Entry 07834 (2025)
⚠️ 参考用案内 (免責事項): 本辞典の成分名・規制上限・処方ガイドは研究開発の参考用です。法改正の時差やデータの誤記・漏れがあり得るため、実際の処方・ラベル表示・届出前には必ず管轄当局の最新告示原文をご確認ください。本情報の利用により生じた問題について運営主体は法的責任を負いません。
Interactive Quartile Box-Plot (Min–Q1–Median–Q3–Max)

Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit

Aqueous Serum / Ampoulen=112
Min 0.03% · Q1 0.04% · Median 0.05% · Q3 0.08% · Max 0.15%
Emulsion / Creamn=245
Min 0.03% · Q1 0.05% · Median 0.08% · Q3 0.1% · Max 0.3%
Rinse-off Cleansern=7
Min 0.8% · Q1 1% · Median 1% · Q3 1% · Max 1%
Sunscreen / Colorn=22
Min 0.5% · Q1 0.7% · Median 0.85% · Q3 1% · Max 20%
Aqueous Serum / Ampoule — Cell-membrane interfacial tension reducer & preservative booster
Verified Source: Schülke sensiva SC 50 TDS & CIR Assessment (cir_safety) · Ashland/Schuelke 64 · Evonik 48
Typical Median: 0.05%

Layer 3 — 剤形別通常配合濃度 (四分位数 n≥5) & 物理化学・相溶性ガイド

Layer 3 Formulation Concentration Quartiles by Product Category for ETHYLHEXYLGLYCERIN
剤形グループMin – Q1 – Median – Q3 – Max (%)処方役割・作用機序Source ID
剤形群 A — 水성化粧水・美容液・アンプル0.03% · 0.04% · 0.05% · 0.08% · 0.15%Cell-membrane interfacial tension reducer & preservative boosterSchülke sensiva SC 50 TDS & CIR Assessment
剤形群 B — 乳液・エマルジョン・クリーム0.03% · 0.05% · 0.08% · 0.1% · 0.3%Broad-spectrum preservative booster & skin conditioning agentSchülke sensiva SC 50 / Euxyl PE 9010 TDS
剤形群 C — 洗い流し用クレンザー・シャンプー0.8% · 1% · 1% · 1% · 1%Rinse-off cleanser & surfactant system modifierGlobal Starter Formulation Library Statistical Distribution (n=7, SEPPIC 6 · EVONIK 1)
剤形群 D — 日焼け止め (UV)・メイクアップ・ファンデーション0.5% · 0.7% · 0.85% · 1% · 20%Sun care & color cosmetics dispersion / sensory modifierGlobal Starter Formulation Library Statistical Distribution (n=22, EVONIK 12 · SEPPIC 6 · GRANT 4)
Cutaneous Permeation Science (500 Dalton Rule)MW: 204.31 Da · LogP: 2.4

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 (204.31 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

Slightly soluble in water (~0.1%); soluble in glycols, alcohols, oils
Optimal Formulation pH Stability Window (0–14)pH 3.0 – 10.0
0245.5791114

Outside pH 3–10, risk of hydrolysis, viscosity loss, or ionic dissociation increases.

Maximum Thermal Processing Limit (°C)≤ 80°C
25°C45°C60°C75°C85°C100°C

Thermally stable up to 80°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)

+ 1,2-HEXANEDIOL+ PHENOXYETHANOL+ PENTYLENE GLYCOL+ CAPRYLYL GLYCOL✕ Water solubility is …ETHYLHEXYLGLYCERIN
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.

代表商品名参考 (商標法第90条第1項第2号 記述的表示)
sensiva® SC 50Euxyl® PE 9010 (90% Phenoxyethanol + 10% EHG)

商品名は研究者がグレードを識別するための参考表記であり、各商標権は原メーカーに帰属します。

学術・毒性・処方統合モノグラフ

Tier 1 Synthesis

本原料に紐づく NIH PubMed 査読付き論文アブストラクトおよび公的毒性評価報告書のみに基づいて作成された学術要約です。

■ [1. Chemical Identity & International Labeling Nomenclature] - INCI Name: ETHYLHEXYLGLYCERIN | CAS No.: 70445-33-9 | EC No.: 408-080-2 - Origin: SYNTHETIC | Functions: , - Physicochemical Profile: Formula C11H24O3 | MW 204.31 g/mol | LogP 2.4 | Ionic Nature: non-ionic | PubChem CID 98663 - Official Regional Label Names: US [ETHYLHEXYLGLYCERIN] · EU [ETHYLHEXYLGLYCERIN] · CN [乙基己基甘油] · JP [エチルヘキシルグリセリン] · JP Quasi-Drug [グリセリルモノ2-エチルヘキシルエーテル] ■ [2. Dermatological Mechanism of Action & Functional Role] - Ethylhexylglycerin is the organic compound that conforms to the formula 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. 7706 (乙基己基甘油)) - 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): cir (reported_use, rinse_off): 0~8% / cir (reported_use, eye): 0.02~1% / cir (reported_use, ingestion): 0.08~0.5% ■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)] - [aqueous_serum] Typical range: 0.03 ~ 0.15% (Median 0.05%, Ref: Schülke sensiva SC 50 TDS & CIR Assessment) — Cell-membrane interfacial tension reducer & preservative booster - [emulsion_cream] Typical range: 0.03 ~ 0.3% (Median 0.08%, Ref: Schülke sensiva SC 50 / Euxyl PE 9010 TDS) — Broad-spectrum preservative booster & skin conditioning agent - [cleanser_rinse] Typical range: 0.8 ~ 1.0% (Median 1.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=7, SEPPIC 6 · EVONIK 1)) — Rinse-off cleanser & surfactant system modifier ■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)] - Addition Phase: Pre-dissolve in 1,2-Hexanediol, Butylene Glycol, or Phenoxyethanol before adding to Water/Cool-down Phase - Optimal pH Range: pH 3.0 ~ 10.0 | Max Process Temp: Max 80°C | Electrolyte Tolerance: HIGH - Incompatibility / Caution: Water solubility is ~0.1%; exceeding 0.1% in clear surfactant-free aqueous toners causes cloudiness unless pre-solubilized - Synergy Pairings: 1,2-HEXANEDIOL, PHENOXYETHANOL, PENTYLENE GLYCOL, CAPRYLYL GLYCOL | Reference Trade Names: sensiva® SC 50, Euxyl® PE 9010 (90% Phenoxyethanol + 10% EHG) ■ [6. Peer-Reviewed Literature & Official Compendia Evidence] - PMID 38017612 (2024, Contact Dermatitis): A non-cosmetic allergic contact dermatitis to ethylhexylglycerin - PMID 34570737 (2022, Dermatitis): Patch Testing to Ethylhexylglycerin: The North American Contact Dermatitis Group Experience, 2013-2018 - PMID 32804659 (2020, Wounds): Synergistic Effect and Antibiofilm Activity of a Skin and Wound Cleanser

関連査読付き学術論文 (NIH PubMed) (12)

A non-cosmetic allergic contact dermatitis to ethylhexylglycerin [PMID: 38017612 · 2024]
Allichon S, Trebuchon F, Dereure O, Raison-Peyron N · Contact Dermatitis (2024)
Patch Testing to Ethylhexylglycerin: The North American Contact Dermatitis Group Experience, 2013-2018 [PMID: 34570737 · 2022]
Warshaw EM, Buonomo M, Maibach HI, Taylor JS, Zug KA, Atwater AR, Silverberg JI, Belsito DV, Fransway AF, DeKoven JG, Reeder MJ, Sasseville D, Fowler JF, Pratt MD, DeLeo VA · Dermatitis (2022)

Ethylhexylglycerin (EHG) is a recently recognized contact allergen. The aims of the study were to characterize individuals with positive patch test reactions to EHG and to analyze reaction strength, clinical relevance, and allergen sources. This study was a retrospective analysis of the patients patch tested to EHG (5% petrolatum) by the North American Contact Dermatitis Group (2013-2018). Of 15,560 patients tested to EHG, 39 (0.25%) had positive (final interpretation of "allergic") reactions. Most were female (71.8%) and/or older than 40 years (76.9%). There were no statistically significant differences between age, sex, or atopic history when compared with EHG-negative patients. The most common anatomic sites of dermatitis were the face (28.2%) and scattered generalized distribution (25.6%). Most EHG-positive reactions were + (35.9%) or ++ (33.3%). Current clinical relevance was high (79.5%); none, however, were related to occupation. Personal care products were the most common source of exposure to EHG (59.0%). Ethylhexylglycerin is a rare contact allergen; the positive frequency of 0.25% is similar to other low allergenic preservatives including parabens, benzyl alcohol, and phenoxyethanol. The patch test concentration of 5.0% seems to be nonirritating. Although relatively uncommon, EHG reactions were usually clinically relevant (79.5%), often because of moisturizers/lotions/creams.

Synergistic Effect and Antibiofilm Activity of a Skin and Wound Cleanser [PMID: 32804659 · 2020]
Salamone AB, Salamone JC, McMahon RE, Poleon S, Bionda N, D'Arpa P · Wounds (2020)

Biofilm in chronic wounds impedes the wound healing process. Each biofilm has differing characteristics requiring a multifaceted approach for removal while maintaining a surrounding environment conducive to wound healing. In this study, 3 of the components in a wound cleanser are tested to determine synergy in eradicating biofilms of methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa in vitro. The 3 components assessed for synergy were ethylenediamine tetraacetic acid sodium salts (EDTA), vicinal diols (VD; ethylhexylglycerin and octane-1,2-diol), and polyhexamethylene biguanide (PHMB). Each component was assessed individually and in combination while dissolved in a base solution. The Calgary assay method was used for biofilm growth and treatment. Kull Equation analysis for synergy was conducted using viable count results. Synergy is defined as the interaction of components to produce a combined effect greater than the sum of their separate effects. The base solution containing all 3 components (EDTA, VD, and PHMB) reduced biofilm viability by more than 5 logs, demonstrating statistically significant synergy. The 3 components tested individually in the base solution resulted in the following: EDTA did not reduce bacteria viability; VD reduced viability by about 1 log; and PHMB reduced P aeruginosa viability by about 2.5 logs and MRSA viability by about 4 logs. Of importance, the MRSA biofilm failed to regrow in the recovery plates after combined treatment, indicating complete elimination of the biofilm bacteria. The experimental and calculated results indicate the 3 components (VD, EDTA, and PHMB) when used together act synergistically to eradicate MRSA and P aeruginosa biofilms in vitro.

The Latest Occult "Hypoallergenic" Allergen: Ethylhexylglycerin [PMID: 28002237 · 2017]
Hagen SL, Warshaw E · Dermatitis (2017)
Ethylhexylglycerin Impairs Membrane Integrity and Enhances the Lethal Effect of Phenoxyethanol [PMID: 27783695 · 2016]
Langsrud S, Steinhauer K, L&#xfc;thje S, Weber K, Goroncy-Bermes P, Holck AL · PLoS One (2016)

Preservatives are added to cosmetics to protect the consumers from infections and prevent product spoilage. The concentration of preservatives should be kept as low as possible and this can be achieved by adding potentiating agents. The aim of the study was to investigate the mechanisms behind potentiation of the bactericidal effect of a commonly used preservative, 2-phenoxyethanol (PE), by the potentiating agent ethylhexylglycerin (EHG). Sub-lethal concentrations of EHG (0.075%) and PE (0.675%) in combination led to rapid killing of E. coli (&gt; 5 log reduction of cfu after 30 min), leakage of cellular constituents, disruption of the energy metabolism, morphological deformities of cells and condensation of DNA. Used alone, EHG disrupted the membrane integrity even at low concentrations. In conclusion, sub-lethal concentrations of EHG potentiate the effect of PE through damage of the cell membrane integrity. Thus, adding EHG to PE in a 1:9 ratio has a similar effect on membrane damage and bacterial viability as doubling the concentration of PE. This study provides insight about the mechanism of action of a strong potentiating agent, EHG, which is commonly used in cosmetics together with PE.

Deciphering trends in replacing preservatives in cosmetics intended for infants and sensitive population [PMID: 39153997 · 2024]
Chen T, Chang H · Sci Rep (2024)

The present study aims to investigate the current trends in replacing conventional preservatives with multifunctional ingredients with antimicrobial properties for preservation of cosmetics for infants or sensitive population, to decrease their potential for contact dermatitis. We first reviewed the labels of cosmetics purchased from the Chinese market for conventional preservatives and multifunctional ingredients with antimicrobial properties, of which the actual contents were further quantified by chromatographic methods. We identified 7 traditional preservatives (phenoxyethanol, benzoic acid (salts), methylparaben, benzyl alcohol, sorbic acid (salts), propylparaben, and methylisothiazolinone), and 11 alternative ingredients with antimicrobial activities (ethylhexylglycerin, butylene glycol, caprylyl glycol, propylene glycol, 1,2-hexanediol, p-anisic acid, hydroxyacetophenone, pentylene glycol, decylene glycol, caprylhydroxamic acid, and aminomethyl propanol) in descending order of prevalence. The contents of all identified preservatives and ingredients were either below regulatory limits or in the range that is generally regarded to be safe. Further challenge with microorganisms indicated irrespective of the composition of preservation systems, product preservation could be compromised under test conditions. We conclude that multifunctional ingredients with antimicrobial properties in cosmetics have the potential to completely replace or significantly reduce the use of traditional preservatives while retaining comparative preservative efficacy. Future attentions may need to be shifted to the safety of those multifunctional ingredients with antimicrobial properties.

Natural Is Not Always Better: The Prevalence of Allergenic Ingredients in "Clean" Beauty Products [PMID: 35256558 · 2022]
Tran JM, Comstock JR, Reeder MJ · Dermatitis (2022)

Consumers seek "clean" and "natural" products based on their perception of safety. However, there is no standard, scientific basis, or regulatory oversight in the marketing or ingredient use for "clean" products. The aim of this study was to determine the prevalence of allergenic ingredients in "clean" products. Target and Walgreens Web sites were queried for "clean" products with inclusion of 1470 products. Ingredient lists were analyzed for potential allergens. Analysis included descriptive statistics and &#x3c7;2 test. The most common allergens were fragrances/botanicals (1218/1470, 82.9%), phenoxyethanol (591/1470, 40.2%), tocopherol (545/1470, 40.2%), benzoic acid and benzoates (434/1470, 29.5%), propylene glycol (369/1470, 25.1%), alkyl glucosides (305/1470, 20.7%), ethylhexylglycerin (304/1470, 20.7%), cetyl alcohol (282/1470, 19.2%), cocamidopropyl betaine (258/1470, 17.6%), and benzyl alcohol (232/1470, 15.8%). Among fragrances/botanicals, the most common ingredients found were fragrance/perfume/aroma (911/1470, 68.2%), citrus derivatives (375/1470, 25.5%), linalool (305/1470, 20.7%), limonene (279/1470, 19.0%), and benzyl alcohol (231/1470, 15.7%). A total of 93.8% of the products (1379/1470) contained at least 1 potential allergen. Most "clean" products contain a potential allergen, predominately fragrances and botanicals.

In vitro study to evaluate the antimicrobial activity of various multifunctional cosmetic ingredients and chlorphenesin on bacterial species at risk in the cosmetic industry [PMID: 34333822 · 2022]
Youenou B, Chauviat A, Ngari C, et al. · J Appl Microbiol (2022)

We evaluated the activity of the preservative chlorphenesin and of four antimicrobial cosmetic multifunctional ingredients against various strains of gram-negative and gram-positive human opportunistic pathogens. Growth kinetics, modelling growth parameters and statistical analyses enabled comparing bacterial behaviour in the presence and in the absence of the compound. Whatever compound tested (i.e. chlorphenesin, phenylpropanol, hexanediol, ethylhexylglycerin, hydroxyacetophenone) and strain origin (i.e. clinical versus industrial), the growth of 42&#xa0;strains belonging to Acinetobacter spp., Burkholderia cepacia complex and Stenotrophomonas maltophilia, was totally inhibited. On the opposite all of the P. aeruginosa strains (n&#xa0;=&#xa0;13) as well as 4 and 6 out of 10&#xa0;strains of Pluralibacter gergoviae grew in the presence of chlorphenesin and ethylhexylglycerin, respectively. Some P. gergoviae and Staphylococcus hominis strains withstand hydroxyacetophenone. Within a species, the different strains show variable latency phase, growth rate (r) and carrying capacity (K). They can be similar, lower or higher than those measured in control conditions. Data showed differences in the antimicrobial activity of compounds. Upon exposure, strains differed in their behaviour between and within species. Whatever species and strains, compound sensitivity could not be related to antibiotic resistance. Most multifunctional ingredients showed significant antimicrobial properties against the wide panel of species and strains evaluated. This will help adjusting preservation strategies in the cosmetic industry.

Integrated approaches to testing and assessment as a tool for the hazard assessment and risk characterization of cosmetic preservatives [PMID: 33624850 · 2021]
Canavez ADPM, de Oliveira Prado Corrêa G, Isaac VLB, et al. · J Appl Toxicol (2021)

The safety assessment of cosmetic products is based on the safety of the ingredients, which requires information on chemical structures, toxicological profiles, and exposure data. Approximately 6% of the population is sensitized to cosmetic ingredients, especially preservatives and fragrances. In this context, the aim of this study was to perform a hazard assessment and risk characterization of benzalkonium chloride (BAC), benzyl alcohol (BA), caprylyl glycol (CG), ethylhexylglycerin (EG), chlorphenesin (CP), dehydroacetic acid (DHA), sodium dehydroacetate (SDH), iodopropynyl butylcarbamate (IPBC), methylchloroisothiazolinone and methylisothiazolinone (MCI/MIT), methylisothiazolinone (MIT), phenoxyethanol (PE), potassium sorbate (PS), and sodium benzoate (SB). Considering the integrated approaches to testing and assessment (IATA) and weight of evidence (WoE) as a decision tree, based on published safety reports. The hazard assessment was composed of a toxicological matrix correlating the toxicity level, defined as low (L), moderate (M), or high (H) and local or systemic exposure, considering the endpoints of skin sensitization, skin irritation, eye irritation, phototoxicity, acute oral toxicity, carcinogenicity, mutagenicity/genotoxicity, and endocrine activity. In a risk assessment approach, most preservatives had a margin of safety (MoS) above 100, except for DHA, SDH, and EG, considering the worst-case scenario (100% dermal absorption). However, isolated data do not set up a safety assessment. It is necessary to carry out a rational risk characterization considering hazard and exposure assessment to estimate the level of risk of an adverse health outcome, based on the concentration in a product, frequency of use, type of product, route of exposure, body surface location, and target population.

Effect of cosmetic chemical preservatives on resident flora isolated from healthy facial skin [PMID: 30548758 · 2019]
Wang Q, Cui S, Zhou L, et al. · J Cosmet Dermatol (2019)

Healthy skin harbors numerous microbes known to maintain its health and prevent attacks from external pathogens. The influence of chemical preservatives commonly used in cosmetic products on facial resident flora remains poorly characterized. In this study, we aimed to investigate the antibacterial activity of five such preservatives on in vitro cultivated skin-resident bacteria. Both Gram-positive and Gram-negative bacteria were isolated on blood agar, tryptic soy agar, and nutrient agar; Gram-negative bacteria were then selected on Hank's balanced salt solution containing antibiotics and Reasoner's 2A. The minimum inhibitory concentrations (MICs) of methylisothiazolinone (MTI), iodopropynyl butylcarbamate (IPBC), ethylhexylglycerin (EHG), methylparaben (MP), and phenoxyethanol (PE) were estimated for nine facial resident bacteria, Escherichia coli, and Staphylococcus aureus using serial broth dilution in vitro. The maximum test concentrations coincided with the upper limits set by the "Cosmetic Safety and Technical Specification" (2015 edition, China). Nine facial resident bacteria were isolated from 14 healthy adults: Staphylococcus epidermidis, Staphylococcus capitis, Kocuria, Micrococcus luteus, Bacillus, Acinetobacter, Pseudomonas parafulva, Pseudomonas oleovorans, and Roseomonas cervicalis. MTI and IPBC displayed the strongest effect on all tested strains (MICs &#x2264;0.01%), followed by EHG and MP (MICs &#x2264;0.3%), and finally PE with the weakest effect (MIC &#x2264;1%). The five chemical preservatives assayed inhibited survival of the nine facial resident bacteria isolates, when tested at the maximum allowed limit. The corresponding MICs will provide a reference for the effective utilization of these compounds in product formulations.

Influence of glycerol and an alternative humectant on the immediate and 3-hours bactericidal efficacies of two isopropanol-based antiseptics in laboratory experiments in vivo according to EN 12791 [PMID: 28670452 · 2017]
Suchomel M, Weinlich M, Kundi M · Antimicrob Resist Infect Control (2017)

Guidelines for hand hygiene recommend the use of alcohol-based hand rubs containing humectants in order to improve dermal tolerance. However, the bactericidal efficacy of pre-surgical hand rubs is negatively affected by the WHO-recommended humectant glycerol, especially the 3-h efficacy. The aim of this study was to investigate whether replacing glycerol as humectant increases the bactericidal efficacy of surgical hand rubs based on isopropanol (75%, wt/wt). The efficacy of 3 and 5&#xa0;min applications of a modified WHO II-formulation (containing lower glycerol concentrations) and the TPH 5766 hand rub which contains a new humectant (containing ethylhexylglycerin, dexpanthenol and a fatty alcohol) were compared to the European Norm 12,791 reference (n-propanol, 60%, vol/vol) immediately following and 3&#xa0;h after application. Immediately after application both isopropanol-based surgical rubs approximated the performance of the reference. The 3-h effect of the modified WHO II-formulation was found to be less efficacious than the EN 12791, showing a 30% decrease in log 10 reduction values. The 3-h post application effect for the TPH 5766 hand rub was found to not be different from EN 12791. Based on our data, the bactericidal efficacy of isopropanol-based surgical hand rubs can best be obtained if glycerol is not used in the formulation. Unlike glycerol, a humectant comprised of ethylhexylglycerin, dexpanthenol and a fatty alcohol was found not to decrease hand rub effectiveness. Further investigation of the bactericidal efficacy of other humectants is necessary and may prove useful.

Determination of alternative preservatives in cosmetic products by chromophoric derivatization followed by vortex-assisted liquid-liquid semimicroextraction and liquid chromatography [PMID: 27154641 · 2016]
Miralles P, Vrouvaki I, Chisvert A, et al. · Talanta (2016)

An analytical method for the simultaneous determination of phenethyl alcohol, methylpropanediol, phenylpropanol, caprylyl glycol, and ethylhexylglycerin, which are used as alternative preservatives in cosmetic products, has been developed. The method is based on liquid chromatography with UV spectrophotometric detection after chromophoric derivatization with benzoyl chloride and vortex-assisted liquid-liquid semimicroextraction. Different chromatographic parameters, derivatization conditions, and sample preparation variables were studied. Under optimized conditions, the limits of detection values for the analytes ranged from 0.02 to 0.06&#xb5;gmL(-1). The method was validated with good recovery values (84-118%) and precision values (3.9-9.5%). It was successfully applied to 10 commercially available cosmetic samples. The good analytical features of the proposed method besides of its environmentally-friendly characteristics, make it useful to carry out the quality control of cosmetic products containing the target compounds as preservative agents.

よくある質問 (FAQ)

Q1. エチルヘキシルグリセリン (ETHYLHEXYLGLYCERIN) の各国公式全成分表示名称(7トラック)はどのように異なりますか?
日本化粧品工業連合会(JCIA)表示名称は 'エチルヘキシルグリセリン'、米国PCPC・欧州CosIng INCIは 'ETHYLHEXYLGLYCERIN'、中国NMPA IECIC標準中国語名は '乙基己基甘油' です。
Q2. エチルヘキシルグリセリン (ETHYLHEXYLGLYCERIN) のグローバル6大法域における法定配合基準 (Layer 1) は?
6大法域規制ステータス — 日本(JP): none、韓国(KR): none、欧州(EU): none、米国(US): none、中国(CN): allowed、ASEAN: none。
Q3. 処方設計における エチルヘキシルグリセリン (ETHYLHEXYLGLYCERIN) の通常配合濃度 (Layer 3) と適正 pH は?
主要剤形 (aqueous_serum) において通常 0.03〜0.15%(中央値 0.05%)で配合され、適正pH範囲は 3〜10 です。
Q4. エチルヘキシルグリセリン (ETHYLHEXYLGLYCERIN) の配合禁忌 (Incompatibilities) と推奨シナジー成分は?
推奨シナジーペアは 1,2-HEXANEDIOL, PHENOXYETHANOL, PENTYLENE GLYCOL, CAPRYLYL GLYCOL、配合上の注意点は Water solubility is ~0.1%; exceeding 0.1% in clear surfactant-free aqueous toners causes cloudiness unless pre-solubilized です。