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Product Name: Pinaverium Bromide
Chemical Name: 4-(β,β-Diphenyl-γ-piperidinobutyryl) veratrole bromide
Molecular Formula: C22H26BrNO4
Molecular Weight: 448.35 g/mol
CAS Number: 53251-94-8
SYNONYMS: Dicetel
Manufacturing Company: [Company’s registered name]
Intended Use: Pharmaceutical ingredient used as a gastrointestinal antispasmodic
Contact Information: Emergency phone numbers and specific contact email for safety queries
Classification: Not classified as hazardous according to GHS criteria under normal handling
Label Elements: No pictogram or signal word required by GHS
Hazard Statements: May cause eye irritation, mild skin irritation, avoid inhalation of dust
Precautionary Statements: Wash hands thoroughly, avoid ingestion, work in well-ventilated area
Routes of Exposure: Eye, skin, inhalation, ingestion
Target Organs: None definitively identified under normal therapeutic doses, could affect gastrointestinal tract if misused
Emergency Overview: White to almost white powder; may cause irritation if improperly handled or exposed
Main Ingredient: Pinaverium Bromide (≥98%)
Impurities: Up to 2% unidentified organic impurities
Formula Components: No hazardous stabilizers present
Molecular Structure: Piperidinobutyryl-based compound
Additives: None used in the raw, active pharmaceutical ingredient
Inhalation: Move person to fresh air, give oxygen if breathing difficulty persists, seek medical attention if symptoms occur
Skin Contact: Remove contaminated clothing, immediately wash area with soap and water, see physician for persistent irritation
Eye Contact: Rinse eyes under running water for at least 15 minutes, keep eyelids open, seek consultation if visual disturbance continues
Ingestion: Do not induce vomiting, seek medical attention, rinse mouth thoroughly with water
Note to Physician: Treat symptomatically, no specific antitoxin known
Suitable Extinguishing Media: Dry chemical, CO2, foam, or water spray
Specific Hazards: May release bromine-containing or nitrogen oxides fumes under fire conditions
Protective Equipment: Firefighters should use self-contained breathing apparatus and protective clothing to prevent skin and eye contact
Fire-Fighting Procedures: Move containers from fire area if it can be done safely
Decomposition Products: Carbon monoxide, carbon dioxide, bromine fumes, nitrogen oxides
Personal Precautions: Wear gloves, mask, goggles; avoid dust formation and inhalation
Environmental Precautions: Prevent product from entering drains, waterways, or soil
Cleaning Methods: Use inert absorbent material (sand, vermiculite); sweep and place in a closeable, labelled container for disposal
Decontamination: Wash area thoroughly after collection
Spillage Response: Ventilate area and minimize dust generation
Handling: Avoid skin and eye contact; minimize dust; practice good hygiene; handle inside fume hood or well-ventilated space
Storage: Store in tightly sealed container, dry and cool location--below 25°C
Separation: Keep away from incompatible substances such as oxidizing agents; store separate from foodstuffs
Packaging: Use containers specifically labelled for pharmaceutical substances
Special Practices: Train staff handling bulk product about potential irritant effects and personal hygiene protocols
Engineering Controls: Use local exhaust or full containment; general room ventilation
Personal Protective Equipment: Chemical-resistant gloves, safety glasses with side-shields, disposable dust mask or half-face respirator if airborne dust possible
Hygiene Measures: Wash hands and face before eating, avoid hand-to-mouth activities during handling, do not smoke
Occupational Exposure Limits: No established threshold limit value (TLV); minimize exposure possible via standard industrial hygiene controls
Environmental Controls: Prevent workplace run-off, maintain closed processes or containment
Physical Form: White to almost white crystalline powder
Odor: Odorless
pH: neutral to weakly acidic (as suspension in water)
Melting Point: 209–213°C
Solubility: Slightly soluble in water, freely soluble in methanol, very soluble in chloroform
Boiling Point: Decomposes before boiling
Density: 1.28-1.33 g/cm³ (at 20°C)
Vapor Pressure: Negligible at ambient temperatures
Partition Coefficient (Log P): 1.9–2.4
Viscosity: Not applicable
Flash Point: Not applicable
Chemical Stability: Stable under recommended handling and storage conditions
Incompatible Materials: Strong oxidizing agents, strong bases
Hazardous Decomposition Products: Bromine compounds, nitrogen oxides
Polymerization: Does not readily polymerize
Conditions to Avoid: Moisture, excessive heat, direct sunlight
Other Reactivity: Non-corrosive, low volatility, low risk of hazardous reactions under normal processing
Likely Routes of Exposure: Inhalation, skin, ingestion, eye contact
Acute Toxicity: LD50 (oral, rat): 4000 mg/kg; negligible dermal toxicity; no significant inhalation data for dust
Chronic Toxicity: No evidence of chronic health effects in therapeutic uses
Carcinogenicity: No known carcinogenic potential as per IARC, NTP, OSHA
Reproductive Toxicity: Absence of observed teratogenic effects in animal studies at unsubstantial exposure levels
Mutagenicity: Not mutagenic based on standard Ames test and in vitro assays
Symptoms of Overexposure: GI discomfort, headache, lightheaded feeling, allergic skin irritation occurs rarely
Aquatic Toxicity: Expected to be low due to limited solubility and non-persistent structure
Persistence and Degradability: Slow hydrolysis, non-bioaccumulative, breaks down over time by standard environmental processes
Mobility in Soil: Moderately immobile; moderate risk of leaching at massive spillage
Bioaccumulation Potential: Low due to molecular properties
Effect on Microorganisms: Minimal impact at therapeutic environmental levels; improper disposal may disrupt local microbiota
Other Environmental Effects: Should be prevented from entering surface water in significant quantities
Disposal Methods: Must be incinerated or disposed of through licensed chemical disposal firm; do not flush to drains or general waste
Packaging Disposal: Contaminated containers require triple rinsing and disposal as hazardous chemical waste
Regulatory Requirements: Comply with municipal, regional, and national waste management statutes
Special Considerations: Avoid runoff, minimize exposure of personnel during transfer, document disposal process
UN Number: Not applicable for non-bulk shipping in standard quantities
Proper Shipping Name: Pinaverium Bromide (Pharmaceutical)
Transport Hazard Class: Not listed as dangerous good
Packing Group: Not applicable
Special Transport Precautions: Shield from physical shock, moisture, and direct sunlight, use sealed, labelled shipping containers
Label Requirements: Product name, batch reference, date of manufacture and expiry, and “For Pharmaceutical Use Only”
Product Classification: Not subject to mandatory hazard labelling under GHS
OSHA Status: Not specifically regulated as hazardous
TSCA: Exempt as pharmaceutical substance
REACH Status (EU): Exempted from registration as active pharmaceutical ingredient
FDA/EMA: Permitted for use with strict adherence to GMP and pharmacopoeia guidelines
Other Local Regulations: Refer to national controlled substances and environmental protection acts for compliance
SARA Title III: Not listed on SARA 302/304/313 lists
WHMIS (Canada): Not a controlled product under WHMIS
Labeling: Must be appropriately labelled for laboratory, manufacturing, and transport purposes
