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Phenoxyethanol | CAS No: 122-99-6 | GMP-certified suppliers
A medication that acts as a broad-spectrum antimicrobial preservative, preventing bacterial and fungal growth in cosmetic and pharmaceutical formulations.
Therapeutic categories
AlcoholsAnestheticsAnti-Infective AgentsAnti-Infective Agents, LocalCentral Nervous System AgentsCentral Nervous System Depressants
Generic name
Phenoxyethanol
Molecule type
small molecule
CAS number
122-99-6
DrugBank ID
DB11304
Approval status
Approved drug
Primary indications
- Antimicrobial agent used as a preservative in cosmetics , ,
Product Snapshot
- Phenoxyethanol is available in multiple topical formulations including liquids, gels, sprays, and dressings
- It is primarily used as an antimicrobial preservative in cosmetic and personal care products
- The ingredient holds regulatory approval for use in the US and Canadian markets
Clinical Overview
Phenoxyethanol (CAS 122-99-6) is a colorless, clear, oily liquid with a faint aromatic odor, classified chemically as a phenol ether. It exists both naturally, notably in green tea, and is synthetically produced via the reaction of phenol with ethylene oxide under elevated temperature and pressure conditions. Widely used in pharmaceutical and cosmetic industries, phenoxyethanol serves primarily as an antimicrobial preservative.
Clinically, phenoxyethanol is indicated for use as a broad-spectrum antimicrobial agent, effectively inhibiting growth of various bacteria, yeasts, and molds. It is commonly incorporated into cosmetic formulations up to a concentration of 1.0%, consistent with regulatory frameworks such as the European Union Cosmetics Regulation (EC) No. 1223/2009. Health Canada also recognizes phenoxyethanol as an antimicrobial preservative. Additionally, it has been utilized in vaccines for bacterial and fungal inactivation.
Pharmacodynamically, phenoxyethanol exhibits bactericidal activity, displaying efficacy against Pseudomonas aeruginosa even in the presence of serum proteins. However, activity against other gram-negative organisms like Proteus vulgaris, and numerous gram-positive bacteria is comparatively reduced. Its preservative efficacy is often enhanced when combined with hydroxybenzoates, broadening the antimicrobial spectrum. Topical formulations containing phenoxyethanol at concentrations near 2% have been applied in superficial wound, burn, or abscess management, particularly targeting Pseudomonas aeruginosa infections. Derivatives of phenoxyethanol may be combined with cyclic acids or zinc undecenoate for skin infection treatments.
Absorption, distribution, metabolism, and excretion (ADME) characteristics show that phenoxyethanol is primarily eliminated renally. Its chemical stability and low volatility facilitate its use in diverse formulation matrices, including cosmetics, pharmaceuticals, and lubricants.
Safety considerations include adherence to concentration limits to mitigate potential irritation or sensitization. Regulatory guidance mandates restriction of phenoxyethanol content to 1% in cosmetic products for consumer safety. Toxicity data indicate a generally favorable profile when used within approved limits, although care should be taken in formulations intended for sensitive populations.
For API procurement, sourcing should ensure compliance with pharmacopeial standards and regulatory requirements. Purity specifications must confirm absence of residual phenol, ethylene oxide, and related impurities. Batch-to-batch consistency and traceability are critical for formulation reliability, and suppliers should provide certificates of analysis aligned with global quality standards.
Clinically, phenoxyethanol is indicated for use as a broad-spectrum antimicrobial agent, effectively inhibiting growth of various bacteria, yeasts, and molds. It is commonly incorporated into cosmetic formulations up to a concentration of 1.0%, consistent with regulatory frameworks such as the European Union Cosmetics Regulation (EC) No. 1223/2009. Health Canada also recognizes phenoxyethanol as an antimicrobial preservative. Additionally, it has been utilized in vaccines for bacterial and fungal inactivation.
Pharmacodynamically, phenoxyethanol exhibits bactericidal activity, displaying efficacy against Pseudomonas aeruginosa even in the presence of serum proteins. However, activity against other gram-negative organisms like Proteus vulgaris, and numerous gram-positive bacteria is comparatively reduced. Its preservative efficacy is often enhanced when combined with hydroxybenzoates, broadening the antimicrobial spectrum. Topical formulations containing phenoxyethanol at concentrations near 2% have been applied in superficial wound, burn, or abscess management, particularly targeting Pseudomonas aeruginosa infections. Derivatives of phenoxyethanol may be combined with cyclic acids or zinc undecenoate for skin infection treatments.
Absorption, distribution, metabolism, and excretion (ADME) characteristics show that phenoxyethanol is primarily eliminated renally. Its chemical stability and low volatility facilitate its use in diverse formulation matrices, including cosmetics, pharmaceuticals, and lubricants.
Safety considerations include adherence to concentration limits to mitigate potential irritation or sensitization. Regulatory guidance mandates restriction of phenoxyethanol content to 1% in cosmetic products for consumer safety. Toxicity data indicate a generally favorable profile when used within approved limits, although care should be taken in formulations intended for sensitive populations.
For API procurement, sourcing should ensure compliance with pharmacopeial standards and regulatory requirements. Purity specifications must confirm absence of residual phenol, ethylene oxide, and related impurities. Batch-to-batch consistency and traceability are critical for formulation reliability, and suppliers should provide certificates of analysis aligned with global quality standards.
Identification & chemistry
| Generic name | Phenoxyethanol |
|---|---|
| Molecule type | Small molecule |
| CAS | 122-99-6 |
| UNII | HIE492ZZ3T |
| DrugBank ID | DB11304 |
Pharmacology
| Summary | Phenoxyethanol exhibits antimicrobial activity primarily targeting Pseudomonas aeruginosa, with reduced efficacy against other gram-negative and gram-positive bacteria. It functions as a broad-spectrum preservative agent effective against bacteria, yeasts, and molds, often used alone or in combination with other preservatives to enhance antimicrobial coverage. Its pharmacodynamic profile supports its application in both topical antimicrobial formulations and cosmetic preservation. |
|---|---|
| Mechanism of action | Phenoxyethanol has antibacterial properties and is effective against strains of Pseudomonas aeruginosa even in the presence of 20% serum. It not as effective against Proteus vulgaris, other gram-negative organisms, and gram-positive organisms. Phenoxyethanol has been used as a preservative at a concentration of 1%. A wider spectrum of antimicrobial activity is achieved with preservative mixtures of phenoxyethanol and hydroxybenzoates. Phenoxyethanol may be used as a 2.2% solution or a 2% cream for the treatment of superficial wounds, burns, or abscesses infected by Pseudomonas aeruginosa. In skin infection, derivatives of phenoxyethanol are used in combination with either cyclic acid or zinc undecenoate . |
| Pharmacodynamics | This substance has broad-spectrum antimicrobial activity against bacteria, yeasts, and mold . |
ADME / PK
| Metabolism | The fate of phenoxyethanol in rats and humans has been investigated . The rate of intestinal absorption was rapid, with 60-70% of the excreted (14)C detected at 3 hours and > 95% of the total 4-day urinary (14)C detected within the first 24 hr. Trace amounts of radioactivity were detected in feces. Four days after dosing, only trace amounts of radioactivity remained in the carcass, primarily in the liver (< 0.2% of the dose), fat and muscle. At the 4 day point, the (14)C concentration in blood was measured to be only 0.001 . The major metabolite of phenoxyethanol is phenoxyacetic acid . |
|---|---|
| Route of elimination | The fate of phenoxyethanol in rats and humans has been investigated. More than 90% of an oral dose of 16, 27 or 160 mg/kg body weight of (2-(14)C)phenoxyethanol administered to male Colworth rats by was excreted in the urine within 24 hours of administration. A female rat also excreted about 90% of a dose of 27 mg/kg body weight in the urine within 24 hours. About 2% and 1.3% of the ingested dose was recovered from the exhaled air of female and male rats, respectively . |
| Volume of distribution | A pharmacokinetic study of phenoxyethanol was performed using a mass spectrometry model for simultaneous analysis of phenoxyethanol (PE) and its major metabolite, phenoxyacetic acid (PAA), in rat plasma, urine, and 7 different tissues . The absolute topical bioavailability of PE was 75.4% and 76.0% for emulsion and lotion, respectively. Conversion of PE to PAA was extensive, with the average AUCPAA-to-AUCPE ratio being 4.4 and 5.3 for emulsion and lotion, respectively. The steady-state tissue-to-plasma PE concentration ratio (Kp) was higher than unity for kidney, spleen, heart, brain, and testis and was lower (0.6) for lung and liver, while the metabolite Kp ratio was higher than unity for kidney, liver, lung, and testis and was lower (0.3) for other tissues . |
Formulation & handling
- Phenoxyethanol is a small molecule suitable for topical and cutaneous formulations and is not indicated for oral or injectable use.
- It is a liquid with moderate water solubility, facilitating incorporation into aqueous topical vehicles such as gels, liquids, and shampoos.
- Stable under typical storage conditions, phenoxyethanol requires protection from prolonged heat exposure to maintain preservative efficacy.
Regulatory status
| Lifecycle | The API's primary patents have expired in both the US and Canada, allowing for generic competition and indicating a mature market phase. Products containing this API are widely available across these regions. |
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| Markets | US, Canada |
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Supply Chain
| Supply chain summary | The supply landscape for Phenoxyethanol includes several originator manufacturers producing branded products primarily targeting the US and Canadian markets. The presence of multiple branded wipes suggests established product use in these regions. There is no explicit patent data provided, indicating that generic competition is likely present or forthcoming. |
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Safety
| Toxicity | LC50 oral, rat; 1980 mg/kg [MSDS]. LD50 Rabbit dermal 2250 mg/kg . 2-Phenoxyethanol (PhE) has been shown to induce hepatotoxicity, renal toxicity, and hemolysis at dosages ≥ 400 mg/kg/day in subchronic and chronic studies in multiple species . The major hazards encountered in the use and handling of 2-phenoxyethanol stem from its toxicologic properties. Toxic by all routes (inhalation, ingestion, and dermal contact), exposure to this very faintly aromatic, colorless, oily liquid may occur from its use as a fixative for cosmetics, perfumes, and soaps; as a bactericide and insect repellant; as a solvent for cellulose acetate,dyes, stamp pad, ball point, and specialty inks; as a chemical intermediate for carboxylic acid esters (eg, acrylate, maleate) and polymers (eg, formaldehyde, melamine); and as a preservative for human specimens used for dissection and demonstrations in anatomical studies. Effects resulting from exposure to this substance can include eye irritation, headache, tremors, and central nervous system depression. If contact with the eyes occurs, irrigate exposed eyes with copious amounts of tepid water for at least 15 minutes, and wash exposed skin thoroughly with soap and water. 2-Phenoxyethanol must be preheated before ignition can occur . |
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High Level Warnings:
- Toxic via oral, dermal, and inhalation routes
- LC50 oral (rat) 1980 mg/kg, LD50 dermal (rabbit) 2250 mg/kg
- Subchronic and chronic exposure ≥ 400 mg/kg/day linked to hepatotoxicity, renal toxicity, and hemolysis in multiple species
Phenoxyethanol is a type of Anesthetics
Anesthetics are a crucial category of pharmaceutical Active Pharmaceutical Ingredients (APIs) widely used in the field of medicine. These substances play a vital role in inducing a temporary loss of sensation or consciousness, enabling medical procedures to be performed without pain or discomfort. Anesthetics can be classified into two primary types: general anesthetics and local anesthetics.
General anesthetics act on the central nervous system, producing a reversible loss of consciousness. They are administered through inhalation or injection routes and are commonly employed for major surgeries or procedures that require deep sedation. Examples of general anesthetics include sevoflurane, propofol, and isoflurane.
On the other hand, local anesthetics primarily target a specific region or part of the body, temporarily numbing the area and blocking pain signals. These APIs are frequently used in dental procedures, minor surgeries, and childbirth. Common local anesthetics include lidocaine, bupivacaine, and ropivacaine.
Anesthetics work by interfering with the transmission of nerve signals or by altering the activity of certain receptors in the nervous system. They offer precise control over pain management, allowing medical professionals to perform complex procedures with reduced patient discomfort and anxiety.
The development and manufacturing of anesthetics APIs require stringent quality control measures to ensure safety and efficacy. Pharmaceutical companies adhere to strict regulatory guidelines to produce high-quality APIs. The demand for anesthetics remains consistently high, making this category of APIs a critical component of the pharmaceutical industry.
In conclusion, anesthetics are indispensable pharmaceutical APIs used to induce temporary loss of sensation or consciousness. They can be classified into general and local anesthetics, each serving distinct purposes in medical procedures. The proper development and manufacturing of anesthetics APIs are essential to ensure safe and effective pain management in various healthcare settings.
