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Material Safety Data Sheet: Procaine Benzylpenicillin G Hydrate

1. Identification

Product Name: Procaine Benzylpenicillin G Hydrate
Chemical Name: Benzylpenicillin procaine, hydrate
Synonyms: Procaine Penicillin G, Penicillin G procaine monohydrate
CAS Number: 6130-64-9
Manufacturer: [Manufacturer Information]
Emergency Phone Contact: [Emergency Number]
Recommended Use: Antibiotic for veterinary and medical applications

2. Hazard Identification

Classification: Skin sensitizer (Category 1), Respiratory sensitizer (Category 1), Acute toxicity (Category 4, oral)
Label Elements: Hazard pictograms, Signal word: Warning, Hazard statements: May cause allergic skin reaction, May cause respiratory irritation, Harmful if swallowed
Routes of Exposure: Inhalation, ingestion, skin contact, eye contact
Target Organs: Skin, respiratory system, gastrointestinal tract
Potential Health Effects: Irritation, sensitization, allergic reactions, possible anaphylactic shock
Environmental Hazards: Potential risk to aquatic environments

3. Composition / Information on Ingredients

Component: Procaine Benzylpenicillin G Hydrate
Chemical Formula: C29H38N6O9S·H2O
Concentration: ≥90%
Impurities: Minor organic or inorganic compounds related to fermentation and synthesis
Other Ingredients: Water of hydration
Molecular Weight: 592.7 g/mol (monohydrate)

4. First Aid Measures

Inhalation: Move to fresh air, keep at rest, seek medical attention if symptoms persist or worsen
Skin Contact: Wash thoroughly with soap and water, remove contaminated clothing, seek care for irritation or allergic reaction
Eye Contact: Rinse immediately with plenty of water for several minutes, remove contact lenses if present and easy, seek medical attention
Ingestion: Rinse mouth, seek immediate medical advice, do not induce vomiting
Symptoms: Rashes, irritation, respiratory distress, swelling, hives, anaphylaxis in sensitive individuals

5. Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, dry chemical, foam, carbon dioxide
Special Hazards: May emit toxic fumes under fire conditions, including carbon oxides, nitrogen oxides, sulfur oxides
Protective Equipment: Wear self-contained breathing apparatus, chemical resistant clothing
Precautions: Prevent run-off from entering drains or waterways, ventilate area after fire suppression
Unusual Hazards: Powder can form explosive mixtures with air if dispersed; avoid dust accumulation

6. Accidental Release Measures

Personal Precautions: Use personal protective equipment, avoid breathing dust, avoid contact with skin and eyes, evacuate unnecessary personnel
Environmental Precautions: Prevent further leakage or spillage if safe, keep away from drains, surface and ground water
Spill Clean-Up: Scoop or sweep up without generating dust, place in appropriate chemical waste container, wipe area with damp absorbent material
Decontamination: Wash spill site after cleanup, ventilate area

7. Handling and Storage

Handling: Wear protective gloves, eye protection, use in a well-ventilated area, avoid dust generation
Hygiene Practices: Do not eat, drink, or smoke when handling, wash hands thoroughly after use
Storage Conditions: Store in a tightly closed container, in a cool, dry, well-ventilated place, protect from light and moisture
Incompatibilities: Avoid strong oxidizers, acids, and bases

8. Exposure Controls and Personal Protection

Engineering Controls: Use local exhaust ventilation, enclose process to avoid dust formation
Personal Protection: Wear chemical-resistant gloves, safety goggles, protective clothing
Respiratory Protection: Use approved respirator for dusts if ventilation is inadequate
Occupational Exposure Limit: No established limit, treat as sensitizer and handle with care
Other Protection: Emergency eyewash stations and showers in work area

9. Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless
pH: 5.0–7.5 (aqueous solution)
Melting Point: Decomposes before melting
Boiling Point: Not applicable
Solubility: Slightly soluble in water, practically insoluble in ethanol and chloroform
Partition Coefficient: Not available
Vapor Pressure: Not measurable at room temperature
Specific Gravity: Not determined
Flammability: Non-flammable under normal conditions
Stability: Stable under normal storage conditions, sensitive to heat and moisture

10. Stability and Reactivity

Chemical Stability: Stable in unopened container under recommended conditions
Reactivity: Not reactive under normal handling and storage
Conditions to Avoid: Exposure to moisture, direct sunlight, excessive heat
Incompatible Materials: Strong oxidizers, acids, bases; dehydration agents
Hazardous Decomposition: Decomposes into toxic or irritating vapors, including nitrogen oxides, sulfur oxides
Possibility of Hazardous Reactions: None under recommended usage

11. Toxicological Information

Acute Toxicity: Harmful if swallowed (oral LD50 in rats: 300–1000 mg/kg estimated)
Skin & Eye Contact: May cause irritation, redness, swelling; can sensitize skin with repeated exposure
Inhalation: May cause respiratory irritation, asthma-like symptoms in sensitized individuals
Chronic Exposure: Repeated contact can cause dermatitis, prolonged inhalation may worsen respiratory conditions
Allergic Effects: May cause severe allergic reactions including anaphylaxis in sensitive subjects
Mutagenicity/Carcinogenicity: No data indicating carcinogenicity or mutagenicity; antibiotics have caused allergic reactions in humans
Reproductive Toxicity: No evidence in laboratory animals with normal use levels

12. Ecological Information

Ecotoxicity: Harmful to aquatic organisms with possible long-term effects
Mobility in Soil: Persistence expected, binds moderately to soil
Biodegradability: May persist; slow microbial degradation reported due to antimicrobial activity
Bioaccumulation: Unlikely to bioaccumulate, limited fat solubility
Other Harmful Effects: Antibiotic residues may adversely affect environmental microbial populations, disrupt wastewater treatment processes

13. Disposal Considerations

Waste Treatment: Disposal in accordance with local, regional, and national regulations
Methods of Disposal: Incinerate in a chemical incinerator with afterburner and scrubber, do not release to the sewer or general waste streams
Contaminated Packaging: Treat as product, dispose as hazardous chemical waste, ensure complete decontamination prior to recycling or disposal
Special Instructions: Prevent discharge to the environment as much as possible, consult environmental authorities for guidance

14. Transport Information

UN Number: Not classified as dangerous goods for transport
Shipping Name: Not regulated
Hazard Class: Not assigned
Packing Group: None
Transport Precautions: Protect from physical damage, transport in tightly closed, labeled containers away from incompatible materials
Environmental Hazards During Transport: Avoid uncontrolled release, minimize dust formation

15. Regulatory Information

Labeling Requirements: Label with hazard statements regarding sensitization and allergic potential
Inventory Status: Listed or exempt on the major chemical registries (TSCA, EINECS, AICS as relevant)
Worker Safety: Subject to OSHA/HCS requirements concerning workplace exposure and communication
International Regulations: Subject to veterinary pharmaceutical/cosmetic use restrictions, labeling, and reporting in some territories
Other Regulations: Complies with regulations governing antibiotic distribution and antimicrobial residues; special medical surveillance may apply in pharmaceutical environments