SODIUM ETHYL PARABEN

CAS Number: 35285-68-8
Synonyms:
Sodium ethyl 4-hydroxybenzoate
Sodium 4-(ethoxycarbonyl)phenolate
Ethylparaben sodium salt
Sodium ethylparaben
4-Hydroxybenzoic acid ethyl ester sodium salt
Benzoic acid, 4-hydroxy-, ethyl ester, sodium salt (1:1)
Sodium p-hydroxybenzoate ethyl ester
E 215 (European food additive code)
Chemical Profile:
Molecular Formula: C₉H₉NaO₃
Molecular Weight: 188.16 g/mol
IUPAC Name: Sodium 4-(ethoxycarbonyl)phenolate
EC Number: 252-487-6
MDL Number: MFCD00016467
PubChem CID: 23678578
SMILES: CCOC(=O)C1=CC=C(C=C1)[O-].[Na+]
InChI Key: QYNMSPKSYXPZHG-UHFFFAOYSA-M
Physical Properties:
Appearance: White to off-white crystalline powder
Odor: Practically odorless or with a faint aromatic odor
Solubility: Freely soluble in water (significantly more soluble than ethylparaben itself); soluble in ethanol and propylene glycol; slightly soluble in oils and fats
pH (1% solution): 9.5-10.5 (alkaline due to the sodium salt form)
Melting Point: Decomposes upon heating; the parent ethylparaben melts at 115-118°C
Stability: Stable under normal conditions. Hygroscopic. Aqueous solutions are alkaline and may be unstable at extreme pH values, hydrolyzing to release paraben and ethanol.
Mechanism of Action:
 As a paraben ester, sodium ethyl paraben exerts its antimicrobial effect by disrupting microbial cell membranes and inhibiting key enzymes involved in DNA and RNA synthesis, as well as nutrient transport . Its primary mechanism is the disruption of the transmembrane proton gradient, leading to the uncoupling of oxidative phosphorylation and inhibition of nutrient uptake. This leads to growth inhibition and cell death. As the sodium salt, it dissociates in water to release the active ethylparaben anion, which is in equilibrium with the protonated, more active form at lower pH values.
Antimicrobial Spectrum:
Effective against: Broad spectrum of yeasts, molds, and Gram-positive bacteria
Less effective against: Gram-negative bacteria (especially Pseudomonas species), which may require higher concentrations or combination with other preservatives
Optimal pH: Most effective at pH 4-8, with activity decreasing as pH increases above 8, as the concentration of the active, undissociated form decreases
Advantages over Ethylparaben:
Enhanced Water Solubility: The sodium salt form is dramatically more water-soluble than the parent ethylparaben, making it much easier to incorporate into aqueous-based formulations without the need for heating or co-solvents
Rapid Dissolution: Dissolves quickly in water, allowing for cold processing of cosmetic and pharmaceutical products
Ease of Use: Simplifies manufacturing processes, especially for clear aqueous formulations like toners, gels, and syrups
Applications:
Cosmetic and Personal Care Industry (Primary Application):
Preservative: Widely used as a water-soluble preservative in a vast array of cosmetic and personal care products, including:
Shampoos, conditioners, and hair styling products
Facial cleansers, toners, and makeup removers
Creams, lotions, and moisturizers (particularly water-based formulations)
Liquid soaps, body washes, and shower gels
Wet wipes and baby care products
Antiseptic Agent: Acts as a mild antiseptic in some formulations
Typical Use Concentration: 0.1% to 0.8% (calculated as ethylparaben equivalent)
Pharmaceutical Industry:
Excipient and Preservative: Used as an antimicrobial preservative in:
Oral liquid pharmaceuticals (syrups, suspensions, solutions)
Topical preparations (creams, ointments, gels)
Ophthalmic preparations (eye drops, often in combination with other preservatives)
Rectal and vaginal preparations
Typical Use Concentration: 0.02% to 0.3%
Food Industry:
Food Additive: Historically used as a preservative in foods such as processed vegetables, sauces, dressings, and beverages. However, its use in food has declined significantly in many regions (including the EU and USA) due to consumer concerns and regulatory restrictions on parabens in food products . Its food additive code is E215, but it is less common than methyl and propyl parabens in food.
Industrial Applications:
Adhesives and Binders: Used as a preservative in water-based adhesives, glues, and binders to prevent microbial spoilage
Textile and Leather Processing: Occasionally used in aqueous processing solutions to prevent microbial growth
Cutting Fluids and Lubricants: Can be found in some industrial fluids to extend their usable life
Regulatory Status and Safety:
Regulatory Acceptance: Considered safe for use in cosmetics and pharmaceuticals at specified concentrations by major regulatory bodies, including the FDA (USA), Health Canada, and the European Medicines Agency (EMA)
EU Cosmetic Regulation: Allowed as a preservative in cosmetics with a maximum authorized concentration of 0.4% (as acid) for a single ester and 0.8% for mixtures of esters
Acceptable Daily Intake (ADI): The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has established an ADI for parabens (including ethylparaben) of 0-10 mg/kg body weight per day
Endocrine Disruption Concerns: Like other parabens, ethylparaben has been shown in some in vitro and animal studies to have weak estrogenic activity. However, the estrogenic potency is significantly lower than that of natural estradiol, and the relevance to human health at typical exposure levels from cosmetics is a subject of ongoing scientific debate. Regulatory reviews generally conclude that parabens are safe for use in cosmetics at authorized concentrations .

SAFETY INFORMATION ABOUT SODIUM ETHYL PARABEN

First aid measures:
Description of first aid measures:
General advice:
Consult a physician. 
Show this safety data sheet to the doctor in attendance.
Move out of dangerous area:
 
If inhaled:
If breathed in, move person into fresh air. 
If not breathing, give artificial respiration.
Consult a physician.
In case of skin contact:
Take off contaminated clothing and shoes immediately. 
Wash off with soap and plenty of water.
Consult a physician.
 
In case of eye contact:
Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician.
Continue rinsing eyes during transport to hospital.
 
If swallowed:
Do NOT induce vomiting. 
Never give anything by mouth to an unconscious person. 
Rinse mouth with water. 
Consult a physician.
 
Firefighting measures:
Extinguishing media:
Suitable extinguishing media:
Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.
Special hazards arising from the substance or mixture
Carbon oxides, Nitrogen oxides (NOx), Hydrogen chloride gas
 
Advice for firefighters:
Wear self-contained breathing apparatus for firefighting if necessary.
Accidental release measures:
Personal precautions, protective equipment and emergency procedures
Use personal protective equipment. 
 
Avoid breathing vapours, mist or gas. 
Evacuate personnel to safe areas.
 
Environmental precautions:
Prevent further leakage or spillage if safe to do so.
Do not let product enter drains.
Discharge into the environment must be avoided.
 
Methods and materials for containment and cleaning up:
Soak up with inert absorbent material and dispose of as hazardous waste. 
Keep in suitable, closed containers for disposal.
 
Handling and storage:
Precautions for safe handling:
Avoid inhalation of vapour or mist.
 
Conditions for safe storage, including any incompatibilities:
Keep container tightly closed in a dry and well-ventilated place. 
Containers which are opened must be carefully resealed and kept upright to prevent leakage.
Storage class (TRGS 510): 8A: Combustible, corrosive hazardous materials
 
Exposure controls/personal protection:
Control parameters:
Components with workplace control parameters
Contains no substances with occupational exposure limit values.
Exposure controls:
Appropriate engineering controls:
Handle in accordance with good industrial hygiene and safety practice.
Wash hands before breaks and at the end of workday.
 
Personal protective equipment:
Eye/face protection:
Tightly fitting safety goggles. 
Faceshield (8-inch minimum). 
Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU).
 
Skin protection:
Handle with gloves. 
Gloves must be inspected prior to use. 
Use proper glove
removal technique (without touching glove's outer surface) to avoid skin contact with this product. 
Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. 
Wash and dry hands.
 
Full contact:
Material: Nitrile rubber
Minimum layer thickness: 0.11 mm
Break through time: 480 min
Material tested:Dermatril (KCL 740 / Aldrich Z677272, Size M)
Splash contact
Material: Nitrile rubber
Minimum layer thickness: 0.11 mm
Break through time: 480 min
Material tested:Dermatril (KCL 740 / Aldrich Z677272, Size M)
It should not be construed as offering an approval for any specific use scenario.
 
Body Protection:
Complete suit protecting against chemicals, The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace.
Respiratory protection:
Where risk assessment shows air-purifying respirators are appropriate use a fullface respirator with multi-purpose combination (US) or type ABEK (EN 14387) respirator cartridges as a backup to engineering controls. 
 
If the respirator is the sole means of protection, use a full-face supplied air respirator. 
Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU).
Control of environmental exposure
Prevent further leakage or spillage if safe to do so. 
Do not let product enter drains.
Discharge into the environment must be avoided.
 
Stability and reactivity:
Chemical stability:
Stable under recommended storage conditions.
Incompatible materials:
Strong oxidizing agents:
Hazardous decomposition products:
Hazardous decomposition products formed under fire conditions. 
Carbon oxides, Nitrogen oxides (NOx), Hydrogen chloride gas.
 
Disposal considerations:
Waste treatment methods:
Product:
Offer surplus and non-recyclable solutions to a licensed disposal company. 
Contact a licensed professional waste disposal service to dispose of this material.
Contaminated packaging:
Dispose of as unused product