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Send EmailBenzocaine, Ethyl 4-Aminobenzoate, 94-09-7
BENZOCAINE
PRODUCT IDENTIFIER INFORMATION
| Parameter | Information |
|---|---|
| Product Name | Benzocaine |
| Chemical Name (IUPAC) | Ethyl 4-aminobenzoate |
| CAS Number | 94-09-7 |
| EC Number (EINECS) | 202-303-5 |
| Molecular Formula | C9H11NO2 |
| Molecular Weight | 165.19 g/mol |
SECTION 1: CHEMICAL IDENTITY AND DESCRIPTION
| Parameter | Information |
|---|---|
| Chemical Name (IUPAC) | Ethyl 4-aminobenzoate |
| Systematic Name | 4-Aminobenzoic Acid Ethyl Ester |
| Synonyms | Benzocaine, Ethyl 4-Aminobenzoate, p-Aminobenzoic Acid Ethyl Ester, Anaesthesin, Anesthone |
| Trade Names | Anbesol, Orajel, Lanacane, Solarcaine, Dermoplast |
| CAS Number | 94-09-7 |
| EC Number (EINECS) | 202-303-5 |
| Molecular Formula | C9H11NO2 |
| Molecular Weight | 165.19 g/mol |
| Chemical Class | Ester-type local anesthetic (para-aminobenzoic acid ester) |
| Physical State (20°C) | Solid (white crystalline powder) |
| Odor | Odorless |
| Taste | Slightly bitter; temporary numbness on tongue |
SECTION 2: PHYSICAL AND CHEMICAL PROPERTIES
| Property | Value | Test Method |
|---|---|---|
| Appearance | White crystalline powder | Visual |
| Odor | Odorless | Olfactometric |
| Taste | Slightly bitter; temporary numbness | Sensory |
| Molecular Weight | 165.19 g/mol | Calculated |
| Melting Point | 88 – 90°C | DSC / Capillary Tube |
| Boiling Point | 172°C (decomposes) | TGA |
| Density | ~1.17 g/cm3 | ASTM D4052 |
| pKa (25°C) | ~2.5 (aromatic amine) | Potentiometric |
| Solubility in Water (25°C) | Slightly soluble (~1.3 g/L) | Gravimetric |
| Solubility in Ethanol | Soluble | General Method |
| Solubility in Ether | Soluble | General Method |
| Solubility in Chloroform | Soluble | General Method |
| Solubility in Oils | Soluble | General Method |
| Solubility in Dilute Acids | Soluble (amine group protonated) | General Method |
| pH (Saturated Solution, 25°C) | Neutral – Slightly basic | pH Meter |
| Flash Point | Non-flammable | Not applicable |
| Stability | Stable under normal conditions; light-sensitive |
SECTION 3: CHEMICAL PROPERTIES AND REACTIVITY
| Parameter | Information |
|---|---|
| Chemical Character | Ester-type local anesthetic; weak base (aromatic amine pKa ~2.5) |
| Stability | Stable under normal conditions; light-sensitive |
| Hydrolysis | Hydrolyzed at alkaline pH and by plasma esterases → para-aminobenzoic acid (PABA) + ethanol |
| Decomposition Products (Heating) | Decomposes at 172°C; CO, CO2, NOx |
| Incompatible Materials | Strong oxidizing agents, strong alkalis, silver nitrate, mercury salts |
| Reaction with Acids | Soluble in dilute acids due to protonation of amine group |
| Light Sensitivity | Slowly yellows upon exposure to light |
| Hazardous Polymerization | Does not occur |
SECTION 4: LOCAL ANESTHETICS COMPARISON
| Property | Benzocaine | Lidocaine | Procaine | Tetracaine | Bupivacaine |
|---|---|---|---|---|---|
| CAS Number | 94-09-7 | 137-58-6 | 59-46-1 | 94-24-6 | 38396-39-3 |
| Class | Ester | Amide | Ester | Ester | Amide |
| Onset of Action | Fast (topical) | Fast (2-5 min) | Moderate (5-10 min) | Slow (5-10 min) | Slow (5-10 min) |
| Duration of Action | Short-Medium | Medium (1-2 hrs) | Short (30-60 min) | Long (2-3 hrs) | Long (3-8 hrs) |
| pKa | 2.5 | 7.9 | 8.9 | 8.5 | 8.1 |
| Water Solubility | Slightly soluble | Practically insoluble | Very soluble (HCl) | Slightly soluble | Slightly soluble |
| Route | Topical only | Injection, topical | Injection, topical | Injection, topical | Injection |
| Injectable | Not suitable | Yes | Yes | Yes | Yes |
| Vasodilation | None (exception) | Yes | Yes | Yes | Yes |
| Maximum Dose | Topical limited | 4.5 mg/kg | 10 mg/kg | 1.5 mg/kg | 2 mg/kg |
| Allergy Risk | Low | Very Low | Moderate (PABA) | Moderate (PABA) | Very Low |
SECTION 5: PHARMACOLOGICAL PROPERTIES AND MECHANISM OF ACTION
| Property | Description |
|---|---|
| Mechanism of Action | Blocks voltage-gated sodium (Na+) channels; prevents action potential generation and conduction in nerve cells |
| Anesthetic Class | Ester-type local anesthetic (PABA ester) |
| Onset of Action | Fast (30 seconds – 2 minutes for topical application) |
| Duration of Action | Short-Medium (15-45 minutes); varies depending on formulation |
| Vasodilator Effect | None (exception among local anesthetics); does not require epinephrine |
| Absorption | Absorbed from mucosa and damaged skin; minimal absorption through intact skin |
| Metabolism | Hydrolyzed by plasma pseudocholinesterases and liver esterases → PABA + ethanol |
| PABA Formation | Hydrolysis releases para-aminobenzoic acid (PABA) |
| Injectable Use | Not suitable for injection due to very low water solubility; topical use only |
| Methemoglobinemia Risk | May cause methemoglobinemia at high doses or when applied to large surfaces (especially in children) |
SECTION 6: PRIMARY APPLICATION AREAS
| Sector / Application | Use | Typical Concentration |
|---|---|---|
| Oral Care / Dental | Toothache, teething, oral ulcers, denture irritation | 5 – 20% gel/cream/lozenge |
| Throat Lozenges | Sore throat, pharyngitis, cough | 5 – 10% |
| Dermatological | Itching, insect bites, sunburn, minor burns, skin irritation | 5 – 20% cream/gel/spray |
| Hemorrhoid Treatment | Hemorrhoid pain and itching | 5 – 20% ointment |
| Ear Drops | Ear pain (otitis media, otitis externa) | 5 – 10% |
| Cosmetic | Laser hair removal, tattoo removal, pre-filler topical anesthesia | 5 – 20% cream |
| Veterinary | Superficial anesthetic (skin, mucosa) | 5 – 10% |
| Medical Devices | Lubricating and anesthetic gel for endoscopy, intubation tubes | 2 – 10% |
SECTION 7: QUALITY SPECIFICATIONS (PHARMACEUTICAL GRADE - USP/EP)
| Parameter | Specification | Test Method |
|---|---|---|
| Appearance | White crystalline powder | Visual |
| Odor | Odorless | Olfactometric |
| Purity (C9H11NO2, Dry Basis) | 98.0 – 102.0% | HPLC / Titrimetric |
| Melting Range | 88 – 90°C | DSC / Capillary Tube |
| Loss on Drying (105°C, 2 hours) | ≤ 0.5% | Gravimetric |
| pH (Saturated Solution) | Neutral – Slightly basic | pH Meter |
| Chloride (Cl-) | ≤ 0.01% | Argentometric |
| Sulfate (SO4 2-) | ≤ 0.02% | Turbidimetric |
| Sulfated Ash | ≤ 0.1% | Gravimetric |
| Heavy Metals (as Pb) | ≤ 10 ppm | ICP-MS / USP <231> |
| Lead (Pb) | ≤ 3 ppm | ICP-MS |
| Arsenic (As) | ≤ 1 ppm | ICP-MS |
| Mercury (Hg) | ≤ 1 ppm | ICP-MS |
| Cadmium (Cd) | ≤ 1 ppm | ICP-MS |
| 4-Aminobenzoic Acid (PABA) | ≤ 0.5% | HPLC |
| Related Substances (Total) | ≤ 1.0% | HPLC |
| Water Insoluble Matter | ≥ 99.0% | Gravimetric |
| Total Microbial Count | ≤ 100 CFU/g | USP <61> |
| Yeast and Mold | ≤ 10 CFU/g | USP <61> |
| E. coli | Negative in 1g | USP <62> |
| Salmonella spp. | Negative in 25g | USP <62> |
SECTION 8: TOXICOLOGICAL PROFILE
| Parameter | Value |
|---|---|
| Acute Oral Toxicity (LD50, Rat) | ~3,042 mg/kg |
| Acute Dermal Toxicity (LD50, Rabbit) | > 2,000 mg/kg |
| Skin Irritation | Mild irritant |
| Eye Irritation | Irritant |
| Respiratory Irritation | Inhalation of dust may cause mechanical irritation |
| Skin Sensitization | Low risk; cross-allergy (PABA) |
| Carcinogenicity | Not classified (IARC, NTP) |
| Mutagenicity | Negative in in vitro tests |
| Reproductive Toxicity | Limited data; use with caution at high doses |
| Methemoglobinemia | Risk at high doses or when applied to large surfaces (especially in children) |
| Allergenicity | Low-Moderate risk (PABA metabolite) |
SECTION 9: GHS CLASSIFICATION AND LABELING
GHS Classification (compliant with 1272/2008/EC):
| Hazard Class | Category | H-Statement |
|---|---|---|
| Skin Irritation | Category 2 | H315 |
| Eye Irritation | Category 2 | H319 |
| Specific Target Organ Toxicity (STOT - SE) | Category 3 | H335 |
Signal Word: WARNING
Hazard Pictograms: GHS07 (Exclamation Mark)
Hazard Statements (H-Codes):
| Code | Statement |
|---|---|
| H315 | Causes skin irritation |
| H319 | Causes serious eye irritation |
| H335 | May cause respiratory irritation |
Precautionary Statements (P-Codes):
| Code | Statement |
|---|---|
| P261 | Avoid breathing dust |
| P280 | Wear protective gloves/eye protection |
| P302+P352 | IF ON SKIN: Wash with plenty of water and soap |
| P305+P351+P338 | IF IN EYES: Rinse cautiously with water for several minutes |
| P312 | Call a POISON CENTER/doctor if you feel unwell |
SECTION 10: FIRST AID MEASURES
| Exposure Route | Action to Take |
|---|---|
| Inhalation | Move to fresh air. Seek medical attention if respiratory irritation persists. |
| Skin Contact | Wash with plenty of water and soap for at least 15 minutes. Seek medical attention if irritation persists. |
| Eye Contact | Rinse immediately with plenty of water for at least 15 minutes. Remove contact lenses if present. Seek medical attention. |
| Ingestion | Rinse mouth with water. If conscious, give 1-2 glasses of water. Do NOT induce vomiting. Seek medical attention. |
SECTION 11: FIREFIGHTING MEASURES
| Parameter | Information |
|---|---|
| Fire Hazard | Non-flammable |
| Hazards During Fire | Decomposes above 172°C; CO, CO2, NOx |
| Suitable Extinguishing Media | Water mist, CO2, dry chemical powder, foam |
| Special Protective Equipment | Self-contained breathing apparatus (SCBA), full protective clothing |
SECTION 12: STORAGE AND SHELF LIFE
| Parameter | Information |
|---|---|
| Storage Conditions | Cool (15-25°C), dry, well-ventilated area; light-protected closed packaging |
| Container Requirements | Tightly closed, light-resistant containers |
| Keep Away From | Light, moisture, alkaline substances, strong oxidizing agents |
| Shelf Life | 48 months (unopened original packaging under appropriate storage conditions) |
| Stability Note | Light-sensitive; hydrolyzes at alkaline pH; store in dry and dark environment |
SECTION 13: PACKAGING OPTIONS
| Packaging Type | Quantity | Material |
|---|---|---|
| Aluminum foil pouch (light-protective) | 1 kg | Laminated aluminum |
| Aluminum foil pouch (light-protective) | 5 kg | Laminated aluminum |
| Fiber drum with PE liner | 25 kg | Fiberboard + PE |
| HDPE drum (light-protected) | 25-50 kg | HDPE |
SECTION 14: TRANSPORTATION INFORMATION
| Parameter | Information |
|---|---|
| UN Number | Not regulated (not hazardous) |
| Hazard Class | Not applicable |
| Packing Group | Not applicable |
| ADR/RID | Not regulated |
| IMDG Code | Not regulated |
| IATA (Air) | Not regulated |
| Marine Pollutant | No |
| Transport Temperature | Ambient |
SECTION 15: REGULATORY STATUS
| Region / Authority | Status |
|---|---|
| USA (USP-NF) | Official monograph (USP Benzocaine) |
| European Pharmacopoeia | Official monograph (Ph. Eur. Benzocaine) |
| USA (FDA) | OTC topical anesthetic; available without prescription |
| WHO Essential Medicines List | Essential medicine (topical anesthetic) |
| Turkey | Licensed pharmaceutical active ingredient; used in OTC products |
SECTION 16: OTHER NAMES AND SYNONYMS
| Type | Name |
|---|---|
| Chemical Names | Ethyl 4-Aminobenzoate; 4-Aminobenzoic Acid Ethyl Ester; p-Aminobenzoic Acid Ethyl Ester |
| Common Names | Benzocaine, Ethyl Aminobenzoate |
| Other Names | Anaesthesin, Anesthone |
| Trade Names | Anbesol, Orajel, Lanacane, Solarcaine, Dermoplast |
| CAS Number | 94-09-7 |
| EC Number | 202-303-5 |
SECTION 17: SUMMARY TABLE
| Parameter | Value |
|---|---|
| Product | Benzocaine |
| CAS Number | 94-09-7 |
| Molecular Formula | C9H11NO2 |
| Molecular Weight | 165.19 g/mol |
| Appearance | White crystalline powder |
| Melting Point | 88 – 90°C |
| pKa | ~2.5 |
| Solubility in Water | Slightly soluble (~1.3 g/L) |
| Primary Function | Ester-type topical local anesthetic |
| Shelf Life | 48 months |
| GHS Signal Word | Warning |
SECTION 18: CRITICAL WARNINGS AND BEST PRACTICES
CRITICAL WARNINGS:
Topical Use Only: Not suitable for injection due to very low water solubility; must be used topically only.
Methemoglobinemia Risk: May cause methemoglobinemia at high doses or when applied to large surfaces, especially in children. Do not exceed recommended dose.
Light Sensitivity: Slowly yellows upon exposure to light; store in light-resistant containers.
Alkaline pH Hydrolysis: Hydrolyzes in alkaline environments; formulate at neutral or slightly acidic pH.
PABA Allergy: May cause allergic reactions in patients sensitive to PABA and ester-type anesthetics.
BEST PRACTICE RECOMMENDATIONS:
Formulation: Due to low water solubility, formulate as cream, gel, ointment, or spray; use appropriate solvents (ethanol, propylene glycol, oils).
Dose Control: Limit total dose, especially in children and large surface applications.
Storage: Store in dry, cool, and dark environment in tightly closed containers.
Combination: Can be combined with other local anesthetics (lidocaine, tetracaine) to increase duration and depth of action.
Allergy Testing: Prefer alternative (amide-type) anesthetic before use in patients with PABA sensitivity.
LEGAL DISCLAIMER:
The information provided in this document is presented in good faith based on our current knowledge and experience; however, since all usage conditions are beyond our control, it does not constitute a binding specification or warranty. This Technical Data Sheet is for informational purposes only and does not constitute medical advice. Users are obligated to test the suitability for their own applications. For complete safety, storage, handling, transportation, disposal, and regulatory compliance information, refer to the official Safety Data Sheet (SDS/MSDS) provided by the manufacturer/supplier. This product is not intended to diagnose, treat, cure, or prevent any disease.