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Vaseline, Paraffin jelly, Petroleum Jelly, Cream White, Soft Paraffin, Mineral Jelly, 8009-03-8

Vaseline, Paraffin jelly, Petroleum Jelly, Cream White, Soft Paraffin, Mineral Jelly, 8009-03-8

PETROLATUM (VASELINE / PETROLEUM JELLY)

SECTION 1: PRODUCT IDENTITY AND CHEMICAL IDENTIFICATION

Parameter Description
Chemical Name Petrolatum
Common Name Vaseline, Petroleum Jelly, Petrolatum Jelly
CAS Number 8009-03-8
EC Number (EINECS) 232-373-2
REACH Registration Number Available (varies by manufacturer)
Chemical Structure Complex mixture of long-chain saturated and unsaturated hydrocarbons (C₂₅ and above, semi-solid mixture)
Appearance Semi-solid, translucent, white or slightly yellowish/amber colored jelly
Odor Neutral or slight hydrocarbon odor
Origin By-product of petroleum refining; produced from high-purity white paraffinic hydrocarbons
Chemical Class Aliphatic hydrocarbon mixture; mineral-derived
Molecular Weight Variable (average ~400-600 g/mol)

Note: Petrolatum (Vaseline) is a chemically inert, semi-solid, waxy substance produced by high-temperature refining, decolorization, deodorization, filtration, and sterilization of heavy hydrocarbon fractions obtained during base oil production from petroleum refining. It is approved by the U.S. Food and Drug Administration (FDA) as an over-the-counter (OTC) skin protectant and is widely used in cosmetic skin care, as a pharmaceutical ointment base, and in a wide variety of industrial applications.

SECTION 2: PHYSICAL AND CHEMICAL PROPERTIES

Property Value / Description Test Method / Note
Physical Form Semi-solid, translucent or opaque white-yellowish jelly Visual
Melting Point 38 – 60 °C (varies by grade) ASTM D127
Density (20°C) ~0.83 – 0.88 g/cm³ ASTM D4052
Color White, yellowish, amber (depending on purity grade) Visual / ASTM D1500
Odor Neutral or slight hydrocarbon Olfactometric
Solubility in Water Insoluble General Method
Solubility in Organic Solvents Soluble in hot organic solvents and oils General Method
Stability Chemically inert; highly resistant to oxidation and atmospheric effects -
Viscosity (100°C) 5 – 15 cSt (grade dependent) ASTM D445
Flash Point >200°C ASTM D92
Autoignition Temperature >300°C -
Dielectric Constant ~2.0 – 2.5 -
pH (Aqueous) Neutral (approximately 7) pH Meter
Refining Degree High (USP/EP grade) to Low (Technical grade) -

SECTION 3: CHEMICAL STRUCTURE AND COMPOSITION

Parameter Description
Main Components Saturated and unsaturated high molecular weight hydrocarbons (paraffinic, naphthenic, and aromatic components)
Hydrocarbon Chain Length Generally in the range of C₂₅ – C₅₀
Paraffin Content ~65-75% (linear and branched alkanes)
Naphthenic Content ~20-30% (cycloalkanes)
Aromatic Content <5% (negligible in highly refined products)
Microcrystalline Wax Content Variable (depending on product grade)
Mineral Oil Content Generally <5% (quality dependent)
Sulfur Content <0.1% (in refined products)
Nitrogen Content Trace amounts
Oxygen Content Trace amounts (oxidized compounds)
Metals (heavy metals) Trace amounts (<1 ppm)
Additives Antioxidants (BHT, BHA, etc.) may be present in some formulations

SECTION 4: FUNCTIONAL PROPERTIES AND MECHANISM OF ACTION

Property Description
Occlusive Skin Protectant & Moisturizer Petrolatum forms a waterproof, lipophilic barrier film on the skin surface. This occlusive layer physically prevents water evaporation (transepidermal water loss - TEWL) by up to 99%. This allows the skin to hydrate and repair itself; particularly effective on dry, cracked skin, diaper rash, and minor wounds.
Inert Ointment & Cream Base Due to its chemical inertness and lack of reactivity, it serves as an ideal carrier and base for active ingredients (e.g., antibiotics, disinfectants, vitamins) in pharmaceutical and cosmetic formulations. It does not destabilize active substances and ensures homogeneous application to the skin.
Protective Barrier & Lubricant In industrial applications, it protects metal surfaces from corrosion (rust), insulates electrical contacts, and serves as an effective, long-lasting lubricant for mechanical parts (bicycle chains, gears).
Mold Release Agent & Processing Aid Its non-stick properties make it useful as a mold release agent in the production of plastics, rubber, and wax.
Makeup Remover & Fixative It effectively dissolves and removes makeup, especially waterproof products. It can also be used as a fixative to increase the longevity of lipsticks and blushes.
Moisture Barrier Not only on skin but also on wood, leather, and other porous surfaces, it forms a protective layer that prevents moisture loss.
Emollient Softens and smooths the skin, reducing flaking and cracking.
Diluent & Carrier Carries oil-soluble active ingredients in formulations and ensures homogeneous distribution.

SECTION 5: COMMERCIAL GRADES AND VARIANTS

Grade / Type Purity Color Melting Point Primary Application
White Petroleum Jelly USP/EP Highest (Pharmaceutical) Pure White, Clear 45-55°C Pharmaceuticals (ointment base, eye ointment), baby products, lip balm
Cosmetic Grade White High (Cosmetic) White 42-52°C Cosmetic creams, lotions, hair pomades
White Mineral Jelly High (Technical) White 40-50°C Food machinery lubrication, light industrial
Yellow / Amber Grade Technical Yellowish – Amber 38-48°C Industrial protective (Cosmoline type), rust preventive, mold release
Technical Grade Technical Variable 38-60°C General industrial lubrication, electrical insulation, thermal actuators
Food Grade (White) High White 42-52°C Food equipment lubrication, protective coating
Pharmaceutical Grade Highest Pure White 45-55°C Prescription and OTC pharmaceutical formulations

SECTION 6: INDUSTRY APPLICATIONS AND USAGE AREAS

Industry / Sector Application Details
Cosmetics & Personal Care Moisturizing base Key ingredient in creams, lotions, lip balm formulations
Cosmetics & Personal Care Skin barrier protectant Protects dry and sensitive skin from external factors
Cosmetics & Personal Care Baby products Diaper rash preventive creams and lotions
Cosmetics & Personal Care Hair styling Pomades and hair jellies for shine and hold
Cosmetics & Personal Care Makeup remover Gently dissolves waterproof makeup
Cosmetics & Personal Care Lipstick & blush As a fixative and glossifier
Pharmaceutical & Medical Ointment carrier Base for antibiotic, antiviral, antifungal ointments
Pharmaceutical & Medical Tissue protectant Wound, burn, and tattoo aftercare
Pharmaceutical & Medical Eye ointments As a sterile, inert carrier
Pharmaceutical & Medical Nasal dryness preventive Nasal ointments and jellies
Pharmaceutical & Medical Laxative Stool softening (rectal)
Industrial & Technical Rust preventive Protective coating on metal surfaces (Cosmoline type)
Industrial & Technical Electrical insulation Insulator for cables and electrical contacts
Industrial & Technical Lubricant Bicycle chains, gears, bearings
Industrial & Technical Mold release agent Plastic, rubber, wax molds
Industrial & Technical Thermal actuators Thermal expansion medium
Laboratory & Analytical Histology Tissue embedding medium (paraffin blocks)
Laboratory & Analytical Forensic analysis Nitric residue testing
Laboratory & Analytical Electronics Component encapsulation, neutron shielding
Leather Care Shoe protection Polishing and moisturizing leather shoes and bags
Sports & Health Ear protection Protection of the auricle against cold weather and wind

SECTION 7: PHARMACOPOEIA COMPLIANCE

Pharmacopoeia Standard Specifications
USP (United States Pharmacopeia) White Petrolatum USP White color, specified melting range, acidity/alkalinity test, hydrocarbon composition
EP (European Pharmacopoeia) White Petrolatum EP Similar to USP standards; additional purity and microbiological tests
JP (Japanese Pharmacopoeia) White Petrolatum JP Specific quality requirements for Asian market
BP (British Pharmacopoeia) White Petrolatum BP British Pharmacopoeia standards
FDA OTC Monograph Skin Protectant Approved as an over-the-counter skin protectant
Microbiological Limits USP <61> Total aerobic microbial count <10² CFU/g
Heavy Metal Limits USP <231> Lead <2 ppm, Arsenic <1 ppm, Mercury <0.5 ppm
Polycyclic Aromatic Hydrocarbons (PAH) EP / USP ≤ 1 ppm (including benzo(a)pyrene)

SECTION 8: MANUFACTURING PROCESS

Step Description Temperature / Conditions
Raw Material Preparation Selection of heavy hydrocarbon fractions from petroleum refining Ambient temperature
Vacuum Distillation Separation of fractions with desired viscosity and melting range 200-350°C / Vacuum
Decolorization (Color Removal) Treatment with activated clay, activated carbon, or silica gel 100-200°C
Deodorization (Odor Removal) Removal of odor-causing compounds by steam distillation or hydrogenation 200-300°C / Hydrogen
Hydrogenation Saturation of unsaturated hydrocarbons; stability enhancement 200-300°C / H₂ pressure / Catalyst
Filtration Removal of fine particles, clay, and other impurities 100-150°C / Pressure filter
Sterilization High-temperature heat treatment; ensuring microbiological safety 150-200°C
Quality Control Melting point, color, odor, viscosity, purity tests -
Packaging Hot or cold filling; packaging under inert atmosphere -

SECTION 9: ALTERNATIVES AND COMPARISON

Alternative Source Comparison with Petrolatum Advantages Disadvantages
Lanolin Animal (Wool wax) Natural, better absorption; higher allergy potential Nourishing, emulsifying Allergy risk, heavy feel
Shea Butter Plant-based Natural, vitamin-rich; less occlusive Skin nourishing, anti-inflammatory More expensive, less protective
Beeswax Natural Harder, less occlusive; used with petrolatum Natural, good hardness Heavy feel on skin, low protection
Cocoa Butter Plant-based Natural, chocolate-scented; more brittle Nourishing, pleasant scent Shorter shelf life, more expensive
Dimethicone Synthetic (Silicone) Lighter feel, volatile; petrolatum more economical Light feel, good spreadability More expensive, less long-lasting
Mineral Oil (Liquid Paraffin) Mineral Liquid form; forms less persistent film Light, easy application Shorter duration of protection
Coconut Oil Plant-based Natural, antimicrobial; less protective Light, pleasant scent Liquid at room temperature, less persistent
Squalane Plant/Animal-based Natural, skin-compatible; much more expensive Light, good absorption, non-comedogenic Very high cost

SECTION 10: SAFETY PROFILE

Parameter Information
GHS Classification Not classified as hazardous substance or mixture. Chemically inert and compatible with skin.
Acute Oral Toxicity (LD50, Rat) >5000 mg/kg (low toxicity)
Acute Dermal Toxicity (LD50, Rabbit) >2000 mg/kg (low toxicity)
Acute Inhalation Toxicity Low toxicity; very low vapor pressure
Skin Irritation May cause mild irritation (rare)
Eye Irritation May cause mechanical irritation; low chemical irritation
Skin Sensitization Does not cause sensitization (non-sensitizing)
Carcinogenicity Not classified as carcinogenic; IARC Group 3 (Not classifiable)
Mutagenicity Not mutagenic
Reproductive Toxicity Reproductive toxicity not known
Target Organ Toxicity (STOT) No target organ toxicity known with repeated exposure
Aspiration Hazard May be an aspiration hazard in liquid form (low risk in solid/semi-solid form)
Comedogenicity Non-comedogenic in refined USP grade; may be comedogenic in lower grades
FDA Approval Approved as OTC skin protectant (21 CFR 347)
Cosmetics Regulation (EC 1223/2009) Usage permitted; specific purity requirements apply

SECTION 11: TOXICOLOGICAL ASSESSMENT

Parameter Value / Description
Acute Oral Toxicity (LD50) >5000 mg/kg (rat)
Acute Dermal Toxicity (LD50) >2000 mg/kg (rabbit)
Skin Irritation Score: 0-1/8 (mildly irritating)
Eye Irritation Score: 0-1/110 (mild mechanical irritation)
Skin Sensitization Negative (Buehler test)
Subchronic Toxicity (90 days) NOAEL: >1000 mg/kg/day (rat)
Carcinogenicity Negative (in tested animal species)
Genotoxicity Negative (Ames test, micronucleus test)
Reproductive Developmental Toxicity Negative (rat)
Bioaccumulation Potential Low (hydrocarbon chains are biodegradable)
Dermal Absorption Very low (high molecular weight, lipophilic)
Immunotoxicity Not known (low potential)
Neurotoxicity Not known (low potential)
EC50 (Daphnia magna) >100 mg/L (low toxicity)
LC50 (Fish) >100 mg/L (low toxicity)

SECTION 12: STORAGE AND SHELF LIFE

Parameter Information
Storage Conditions Store in a cool (<30°C), dry, and well-ventilated area in tightly sealed containers.
Temperature Limits 15-30°C (ideal); do not exceed 40°C
Humidity Low humidity environment (not hygroscopic)
Light Protect from direct sunlight and UV rays (accelerates oxidation)
Incompatible Materials Keep away from strong oxidizing agents (e.g., chlorine, hydrogen peroxide, nitric acid)
Container Requirements Tightly sealed, inert material containers (glass, aluminum, stainless steel, HDPE)
Shelf Life 3-5 years (under proper storage conditions); FDA USP grade: 5 years
Signs of Oxidation Color change (yellowing), odor change (rancid/burnt), viscosity increase
Stability Warning Prolonged exposure to high temperature (>60°C) and UV light may cause oxidation
Antioxidant Additives Some formulations contain BHT, BHA, or Vitamin E (to prevent oxidation)
Reprocessing Reprocessing/refining possible at the end of shelf life (industrial grade)

SECTION 13: REGULATORY AND LEGISLATIVE STATUS

Region / Authority Status Description
USA (FDA) Approved 21 CFR 347 (OTC Skin Protectant); 21 CFR 172.880 (Food Grade)
USA (TSCA) Listed Registered under Toxic Substances Control Act
European Union (EC) Approved EC 1223/2009 (Cosmetics); EC 1907/2006 (REACH registered)
Turkey (KKDIK) Registered Subject to the Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals
IARC Group 3 Not classifiable as to carcinogenicity to humans
NTP (USA) Not Listed Not classified as carcinogenic by the National Toxicology Program
OSHA (USA) Regulated Subject to Occupational Safety and Health Administration standards
California Prop 65 Not Listed Not listed as carcinogen or reproductive toxin
ECHA Approved Registered under the European Chemicals Agency
Kosher Certification Suitable (certain manufacturers) Can obtain Kosher certification (depending on product source)
Halal Certification Suitable (certain manufacturers) Can obtain Halal certification (depending on product source)

SECTION 14: PACKAGING OPTIONS

Packaging Type Quantity / Capacity Material Application Area
Plastic Jar 50 g, 100 g, 250 g, 500 g HDPE / PP (food and pharmaceutical grade) Retail, pharmacy, cosmetics
Metal Tin 50 g, 100 g, 500 g Tin / Aluminum (internal coated) Retail, traditional packaging
Plastic Tube 15 g, 30 g, 50 g, 100 g LDPE / PP Travel sizes, cosmetics
Plastic Drum 25 kg, 50 kg, 100 kg, 200 kg HDPE (Industrial grade) Industrial use, bulk supply
Metal Drum 25 kg, 50 kg, 100 kg, 200 kg Stainless steel / Lined steel Food and pharmaceutical industry
IBC Container 500 kg, 1000 kg Corrosion-resistant HDPE / Steel Large-scale industrial supply
Glass Jar 30 g, 50 g, 100 g Amber glass / Clear glass Pharmaceutical, premium cosmetics
Liquid Filling (Hot) Variable Various (suitable for hot filling) Industrial processes

SECTION 15: TRANSPORTATION INFORMATION

Parameter Information
UN Number Not applicable (not classified as dangerous substance)
Hazard Class Not applicable
Packing Group Not applicable
ADR/RID Not classified as dangerous goods
IMDG Code Not classified as dangerous goods; not marine pollutant
IATA (Air) Not classified as dangerous goods; can be transported by air
Transport Temperature Ambient temperature (temperate); protect from freezing (brittleness)
Hot Transport Can be transported as liquid above melting point (insulated tanker)
Spill Cleanup Collect mechanically; clean with absorbent material; do not let enter water or sewers
Precautions Keep away from heat sources, direct sunlight, and oxidizing agents
Labeling Not hazardous; but "Industrial Use" or "Food Grade" labeling required
Marine Pollutant No

SECTION 16: QUALITY CONTROL AND ANALYTICAL METHODS

Parameter Test Method Specification
Melting Point USP <741> / ASTM D127 45-55°C (USP grade)
Color ASTM D1500 / Visual White (USP) / Yellow (Technical)
Odor Olfactometric Neutral or slight hydrocarbon
Acidity / Alkalinity USP <401> / EP Neutral (titration)
Density (20°C) ASTM D4052 0.83-0.88 g/cm³
Viscosity (100°C) ASTM D445 5-15 cSt
Water Solubility USP / EP Insoluble
Loss on Heating USP <731> <0.5%
Heavy Metals USP <231> / ICP-MS Pb <2 ppm, As <1 ppm, Hg <0.5 ppm
Polycyclic Aromatic Hydrocarbons EP / USP / HPLC Benzo(a)pyrene <1 ppm; total PAH <10 ppm
Microbiological Purity USP <61> TAMC <10² CFU/g; TYMC <10¹ CFU/g
Antioxidant Content (BHT/BHA) HPLC (optional) As per specification (if present)
Flash Point ASTM D92 >200°C
Residue on Ignition USP <281> <0.05%
Absorption Spectroscopy UV-VIS Absorption limits at specific wavelengths

SECTION 17: ENVIRONMENTAL IMPACT AND DISPOSAL

Parameter Information
Biodegradability Limited; slowly biodegradable (mineral oil derivative)
Aquatic Toxicity (EC50) >100 mg/L (Daphnia magna) - low toxicity
Aquatic Toxicity (LC50) >100 mg/L (fish) - low toxicity
Soil Mobility Low; high soil adsorption; low risk of groundwater contamination
Bioaccumulation Potential Low-Medium; long-chain hydrocarbons may bioaccumulate
Persistence Medium-High; persistent in the environment (hydrocarbon mixture)
Disposal Method Dispose of in accordance with local, regional, and national regulations
Incineration Controlled incineration facilities; energy recovery possible
Landfill Not hazardous waste (refined products); disposal in accordance with regulations
Recycling Recovery and re-refining possible (industrial grade)
Sewer Discharge Do not discharge into sewers, water resources, or soil
Environmental Precautions Prevent environmental spread during spills; collect with absorbent material
Ecotoxicity Note May form a film on water surfaces at high concentrations, hindering oxygen transfer

SECTION 18: FIRST AID MEASURES

Route of Exposure Action
Inhalation Vapor or aerosol formation is not expected. If respiratory discomfort occurs, move to fresh air. Seek medical attention if symptoms persist.
Skin Contact Normally does not irritate. Remove contaminated clothing. Wash with plenty of soap and water. Seek medical attention if irritation occurs.
Eye Contact Rinse thoroughly with plenty of water for at least 15 minutes. Keep eyelids open. Remove contact lenses if present. Seek medical attention if irritation persists.
Ingestion Seek medical attention if swallowed. Do NOT induce vomiting. Inducing vomiting is not recommended due to aspiration risk. Clean any remaining material from the mouth.
In Case of Aspiration Seek immediate emergency medical attention if breathing difficulties, coughing, or cyanosis occurs.
Note to Physician Aspiration pneumonitis risk with massive ingestion. Symptomatic treatment is administered.
Note Since the product is semi-solid, the risk of aspiration is lower than in liquid form. However, if melted (liquid), there is an aspiration hazard.

SECTION 19: FREQUENTLY ASKED QUESTIONS

Question Answer
Q1: Does petrolatum clog pores? Highly refined, pure white pharmaceutical grade petrolatum (White Petroleum Jelly USP) is generally considered non-comedogenic (does not clog pores) for most skin types. It forms a barrier on the skin surface but does not penetrate into pores. However, caution is recommended on very oily and acne-prone skin.
Q2: What is the difference between petrolatum and liquid paraffin (mineral oil)? Both are highly refined hydrocarbon mixtures derived from petroleum. The main difference is physical form: petrolatum is semi-solid (longer chain hydrocarbons, C25+), while liquid paraffin is liquid. Petrolatum forms a longer-lasting and more protective film on the skin due to its semi-solid structure.
Q3: Is petrolatum natural? Petrolatum is a by-product of petroleum refining. Therefore, although it is naturally sourced, it is generally not accepted in "natural cosmetic" certifications because it undergoes chemical processing. For those seeking natural alternatives, vegetable oils, shea butter, or beeswax can be recommended.
Q4: Can petrolatum be applied to wounds? Yes, for minor cuts, scrapes, and burns, it can form a protective barrier, protecting the wound from external factors and helping it heal faster by staying moist. However, it should not be used on deep, dirty, or infected wounds; in such cases, medical attention should be sought.
Q5: What is the difference between different colored petrolatums (white, yellow, amber)? Color difference indicates the degree of refining. White petrolatum is of the highest purity and is suitable for pharmaceutical and cosmetic use. Yellow and amber colored ones have lower purity and are used for industrial/technical purposes (e.g., rust preventive, lubricant). Only white, pharmaceutical grade petrolatum should be used for health and skin care.
Q6: Is petrolatum safe for babies? Yes, USP/EP grade white petrolatum is widely used in babies as a diaper rash preventive and skin protectant. However, when applied to babies' hands, they should be prevented from putting it in their mouths, and entry into the respiratory tract should be prevented.
Q7: Can petrolatum be used on lips? Yes, it is the main ingredient in lip balms. It moisturizes lips and prevents dryness and cracking. Pure pharmaceutical grade petrolatum should be preferred.
Q8: How is petrolatum used on burns? For minor, superficial burns (1st degree), it can be applied as a thin layer after cooling. It keeps the burn surface moist and protects against infection. However, it should not be used on 2nd and 3rd degree burns and blistered burns; medical attention must be sought.
Q9: Is petrolatum effective for makeup removal? Yes, it is highly effective for gently dissolving waterproof makeup products (mascara, foundation, liquid eyeliner). It removes makeup without irritating the skin and also moisturizes it.
Q10: What is the difference between petrolatum and moisturizing cream? Petrolatum is not a moisturizing agent, but an occlusive (moisture barrier) agent. Moisturizers draw or add water to the skin; petrolatum prevents the evaporation of water already in the skin. Therefore, petrolatum is most effective when applied to pre-moistened (damp) skin.

SECTION 20: QUICK REFERENCE TABLE

Property Value
CAS Number 8009-03-8
EC Number 232-373-2
Common Names Vaseline, Petrolatum Jelly, Petroleum Jelly
Chemical Class Aliphatic hydrocarbon mixture
Appearance Semi-solid, white – amber jelly
Melting Point 38 – 60 °C
Density ~0.83 – 0.88 g/cm³
Water Solubility Insoluble
Flash Point >200°C
Primary Function Occlusive skin protectant, moisturizer, inert ointment base
Purest Grade White Petroleum Jelly USP/EP (Pharmaceutical Grade)
Main Applications Skin care, pharmaceuticals, industrial protection, cosmetics
Shelf Life 3-5 years
GHS Classification Not hazardous
UN Number Not applicable
FDA Approval OTC Skin Protectant, 21 CFR 347
Comedogenicity Non-comedogenic (USP grade)
Carcinogenicity IARC Group 3 (Not classifiable)
Storage Temperature <30°C

SECTION 21: QUALITY SPECIFICATIONS (TECHNICAL GRADE)

Parameter Specification Test Method
Appearance Semi-solid, homogeneous, translucent or opaque Visual
Color White (USP / Cosmetic); Yellow-amber (Technical) ASTM D1500 / Visual
Melting Point 45-55°C (USP); 38-60°C (Technical) ASTM D127 / USP <741>
Density (20°C) 0.83 - 0.88 g/cm³ ASTM D4052
Viscosity (100°C) 5 - 15 cSt ASTM D445
Flash Point >200°C ASTM D92
Acidity / Alkalinity (Neutrality) Neutral (≤0.05 mg KOH/g) USP <401>
Water Soluble Matter ≤0.1% USP / EP
Residue on Ignition ≤0.05% USP <281>
Loss on Heating ≤0.5% USP <731>
Heavy Metals (Pb) ≤2 ppm USP <231> / ICP-MS
Arsenic (As) ≤1 ppm USP <231> / ICP-MS
Mercury (Hg) ≤0.5 ppm USP <231> / ICP-MS
Polycyclic Aromatic Hydrocarbons (PAH) Benzo(a)pyrene ≤1 ppm; Total PAH ≤10 ppm EP / HPLC
Total Aerobic Microbial Count (TAMC) ≤10² CFU/g USP <61>
Total Yeast & Mold Count (TYMC) ≤10¹ CFU/g USP <61>
Escherichia coli Negative USP <62>
Pseudomonas aeruginosa Negative USP <62>
Staphylococcus aureus Negative USP <62>
Antioxidant (BHT/BHA) As per specification (if present) HPLC

SECTION 22: OTHER NAMES AND SYNONYMS

Type Name
Turkish Names Vazelin, Petrol Jeli, Beyaz Vazelin, Sarı Vazelin, Tıbbi Vazelin
English Names Petrolatum, Petroleum Jelly, White Petrolatum, Yellow Petrolatum, Soft Paraffin, Mineral Jelly
Pharmaceutical Names White Petrolatum USP, Petrolatum Album, Vaselinum Album, Vaselinum Flavum
Cosmetic Names Petrolatum, Petrolatum Jelly, Cosmetic Grade Petrolatum
Industrial Names Technical Petrolatum, Industrial Petroleum Jelly, Cosmoline, Rust Preventive Jelly
Trade Marks Vaseline®, K-Y Jelly® (different formulation), Aquaphor® (contains), CeraVe® (contains)
CAS Number 8009-03-8
EC Number 232-373-2
EINECS Name Petrolatum
INDEX Number Not applicable

SECTION 23: CRITICAL WARNINGS AND BEST PRACTICES

CRITICAL WARNINGS:

  1. Avoid prolonged exposure to high temperature (>60°C) and UV light. Oxidation will cause color and odor degradation.

  2. Use only the appropriate grade for the correct application. Always prefer White USP/EP grade for pharmaceutical and cosmetic use. Industrial grade (yellow/amber) should not be used for skin care.

  3. Prevent environmental spread during spills. Do not allow to enter water sources or sewers.

  4. Be careful with temperature when in molten (liquid) state. Molten petrolatum can cause burns due to temperature.

  5. Not flammable but at high temperature, its vapors can react with oxidizers.

  6. Keep away from strong oxidizing agents (chlorine, hydrogen peroxide, nitric acid).

  7. Keep out of reach of children. There is an aspiration risk if large amounts are swallowed.

  8. Use on wounds: Do not use on deep, dirty, or infected wounds, 2nd and 3rd degree burns, and blistered wounds; seek medical attention.

BEST PRACTICE RECOMMENDATIONS:

  1. Correct Grade Selection: Choose the petrolatum grade appropriate for your application. White USP/EP for pharmaceutical/cosmetic, Technical or Yellow grade for industrial use.

  2. Storage: Store in a cool (<30°C), dry place protected from UV light, in tightly sealed containers.

  3. Skin Application: Apply petrolatum to slightly damp skin, not dry skin. This maximizes the occlusive effect and traps moisture in the skin.

  4. Wound Care: For minor wounds, apply a thin layer after cleaning. Provides a moist environment for wound healing.

  5. Makeup Removal: Apply to waterproof makeup using a cotton pad, wait a few seconds, and gently wipe. Then wash with regular cleanser.

  6. Industrial Use: Apply as a thin film layer for rust prevention, lubrication, and as a mold release agent.

  7. Hygiene: Use a spatula or appropriate applicator in shared use to prevent contamination.

  8. Waste Management: Do not pour used petrolatum into sewers. Dispose of as hazardous waste in accordance with regulations or send for recycling/re-refining.

  9. Mixing Warning: When formulating petrolatum with other ingredients, mix at appropriate temperature (above melting point). Ensure continuous mixing for homogeneous mixture.

  10. Microbiological Control: Regularly monitor the microbiological quality (USP <61>) of petrolatum in pharmaceutical and cosmetic formulations.

LEGAL DISCLAIMER:

The information provided in this document is based on our current knowledge and experience and is presented in good faith; however, it does not constitute a binding specification or guarantee as all conditions of use are beyond our control. This Technical Data Sheet is for informational purposes only. Users are responsible for testing suitability for their own applications. For complete safety, storage, use, handling, waste, and regulatory compliance information, please refer to the official Safety Data Sheet (SDS/MSDS) provided by the manufacturer/supplier.

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