Ingredient Dictionary/ethylhexylglycerin/ETHYLHEXYLGLYCERIN
Tier 1 Monograph · SSOT 15 FieldsRaw .md (GEO) ↗
Synthetic

ETHYLHEXYLGLYCERIN

DeodorantSkin Conditioning
[EU CosIng Official Definition] Ethylhexylglycerin is the organic compound that conforms to the formula
Executive Regulatory & Safety Fact BoxAEO / GEO CITATION ANCHOR

What is ETHYLHEXYLGLYCERIN (CAS 70445-33-9) in cosmetics and what are its global regulatory limits?

ETHYLHEXYLGLYCERIN (CAS No. 70445-33-9) is a verified cosmetic ingredient primarily functioning as Deodorant, Skin Conditioning in topical formulations. Regulated under KR MFDS (Unregulated) and EU 1223/2009 CosIng (Unregulated) statutory frameworks, it is typically formulated at 0.03–0.15% within an optimal stability window of pH 3–10.

7-Track Official Regulatory Label Names Matrix

Primary Statutory Gazette Only · Zero Machine Translation
7-Track Official Statutory Label Names for ETHYLHEXYLGLYCERIN
Jurisdiction TrackOfficial Statutory Label NameOne-Click Copy
1. Korea (MFDS Standard Name)ETHYLHEXYLGLYCERIN (KR MFDS Registered)
2. Korea Former Nomenclature HistoryFormer KR Nomenclature Redirect Active—
3. European Union (EU CosIng Glossary)ETHYLHEXYLGLYCERIN
4. United States (US PCPC / MoCRA INCI)ETHYLHEXYLGLYCERIN
5. US FDA OTC Monograph Active Name— (Cosmetic Inactive / Non-OTC)—
6. China (NMPA IECIC Standard Name)乙基己基甘油
7. Japan (JCIA Standard / MHLW Quasi-Drug)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 — Statutory Regulatory Limits Across 6 Regions

Layer 1 Statutory Regulatory Limits Across 6 Regions for ETHYLHEXYLGLYCERIN
RegionStatusMax LimitConditions & Statutory Source
Korea (MFDS)UnregulatedGMPListed in official cosmetic inventory
Europe (EU)UnregulatedGMPListed in official cosmetic inventory
United States (FDA)UnregulatedGMPListed in official cosmetic inventory
China (NMPA)Listed / AllowedGMPIECIC Entry #7706
Japan (MHLW)UnregulatedGMPListed in official cosmetic inventory
ASEAN (ACD)UnregulatedGMPListed in official cosmetic inventory

Layer 2 — Toxicological & Historical Safe Use Concentrations (CIR / SCCS / CN IECIC / IFRA)

“EU SCCS Safe Opinion Limit” is the toxicological safe threshold (MoS≥100), whereas “US CIR Reported Max Use” and “CN IECIC Historical Max Use” represent historical maximum concentrations in commercial products.

Layer 2 Toxicological & Historical Safe Use Concentrations for ETHYLHEXYLGLYCERIN
Assessment BasisApplication ScopeConcentration RangeVerdict & Dossier Reference
US CIR Reported Max Userinse_off0~8%Safe (MoS≥100)ethylh122011finalx.pdf (2011)
US CIR Reported Max Useeye0.02~1%Safe (MoS≥100)ethylh122011finalx.pdf (2011)
US CIR Reported Max Useingestion0.08~0.5%Safe (MoS≥100)ethylh122011finalx.pdf (2011)
US CIR Reported Max Usespray0.01~2%Safe (MoS≥100)ethylh122011finalx.pdf (2011)
US CIR Reported Max Usepowder0.2~0.5%Safe (MoS≥100)ethylh122011finalx.pdf (2011)
US CIR Reported Max Usedermal0.000001~8%Safe (MoS≥100)ethylh122011finalx.pdf (2011)
US CIR Reported Max Usedeodorant0.04~2%Safe (MoS≥100)ethylh122011finalx.pdf (2011)
US CIR Reported Max Usehair0.0003~2%Safe (MoS≥100)ethylh122011finalx.pdf (2011)
US CIR Reported Max Usenail0.1~0.1%Safe (MoS≥100)ethylh122011finalx.pdf (2011)
US CIR Reported Max Usemucous0.000001~0.5%Safe (MoS≥100)ethylh122011finalx.pdf (2011)
US CIR Reported Max Useleave_on0.002~2%Safe (MoS≥100)ethylh122011finalx.pdf (2011)
US CIR Reported Max Usebath0.1~0.1%Safe (MoS≥100)ethylh122011finalx.pdf (2011)
US CIR Reported Max Usetotal0.000001~8%Safe (MoS≥100)ethylh122011finalx.pdf (2011)
CN IECIC Historical Max Useleave_on≤ 5%Safe (MoS≥100)NMPA IECIC (2025) Entry 07834 (2025)
CN IECIC Historical Max Userinse_off≤ 2%Safe (MoS≥100)NMPA IECIC (2025) Entry 07834 (2025)
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 — Formulation Usage Guide (Quartiles n≥5) & Physicochemical Compatibility

Layer 3 Formulation Concentration Quartiles by Product Category for ETHYLHEXYLGLYCERIN
Formulation GroupMin – Q1 – Median – Q3 – Max (%)Role & MechanismSource ID
Group A — Aqueous Toner / Serum / Ampoule0.03% · 0.04% · 0.05% · 0.08% · 0.15%Cell-membrane interfacial tension reducer & preservative boosterSchülke sensiva SC 50 TDS & CIR Assessment
Group B — O/W & W/O Emulsion / Lotion / Cream0.03% · 0.05% · 0.08% · 0.1% · 0.3%Broad-spectrum preservative booster & skin conditioning agentSchülke sensiva SC 50 / Euxyl PE 9010 TDS
Group C — Rinse-Off Cleanser / Shampoo / Body Wash0.8% · 1% · 1% · 1% · 1%Rinse-off cleanser & surfactant system modifierGlobal Starter Formulation Library Statistical Distribution (n=7, SEPPIC 6 · EVONIK 1)
Group D — Sunscreen (UV) / Color Cosmetics / Foundation0.5% · 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.

Nominative Trade Name References (Trademark Act Art. 90(1)(2))
sensiva® SC 50Euxyl® PE 9010 (90% Phenoxyethanol + 10% EHG)

Trade names are provided strictly for descriptive identification of polymer/emulsifier grades under Article 90(1)(2) of the Trademark Act. All trademarks belong to their respective owners.

Academic & Toxicological Synthesis

Tier 1 Synthesis

Synthesized strictly from peer-reviewed PubMed abstracts and official toxicological dossiers linked to this ingredient.

■ [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

Linked Peer-Reviewed Literature (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.

Frequently Asked Questions (AEO Position 0)

Q1. What are the official 7-track regulatory label names for ETHYLHEXYLGLYCERIN?
Standard label names are US PCPC INCI: 'ETHYLHEXYLGLYCERIN', EU CosIng: 'ETHYLHEXYLGLYCERIN', KR MFDS: 'ETHYLHEXYLGLYCERIN (KR MFDS Registered)', CN NMPA IECIC: '乙基己基甘油', and JP JCIA: 'エチルヘキシルグリセリン'.
Q2. Is ETHYLHEXYLGLYCERIN restricted or permitted in EU, US, KR, CN, and JP cosmetics?
Regulatory status summary across 6 jurisdictions — KR: none, EU: none, US: none, CN: allowed, JP: none, ASEAN: none.
Q3. What is the typical formulation concentration and optimal pH window for ETHYLHEXYLGLYCERIN?
In aqueous_serum systems, ETHYLHEXYLGLYCERIN is typically formulated between 0.03% and 0.15% (median 0.05%), with an optimal stability window of pH 3–10.
Q4. What are the known formulation incompatibilities and synergy pairings for ETHYLHEXYLGLYCERIN?
Recommended synergy pairings include 1,2-HEXANEDIOL, PHENOXYETHANOL, PENTYLENE GLYCOL, CAPRYLYL GLYCOL. Key incompatibilities to avoid: Water solubility is ~0.1%; exceeding 0.1% in clear surfactant-free aqueous toners causes cloudiness unless pre-solubilized.