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Product Name: Gadobutrol Injection
Chemical Name: Gadobutrol
CAS Number: 138071-82-6
Manufacturer: Bayer HealthCare Pharmaceuticals Inc.
Recommended Use: Diagnostic imaging (MRI contrast agent)
Contact Information: Emergency contact number provided on manufacturer’s label
Synonyms: Gadovist, Gadovist 1.0
Packaging: Single-use vials or pre-filled syringes in various concentrations
Uses: Radiological use only, not for therapeutic administration
Restrictions: Healthcare professionals only, strict compliance with labeling required
GHS Classification: Not classified as hazardous according to OSHA Hazard Communication Standard
Potential Health Effects: May cause irritation to eyes, skin, respiratory tract; rare chance of allergic reaction
Symptoms: Headache, nausea, localized rash, rare anaphylactic response
Signal Word: No signal word mandated
Pictograms: Not applicable
Hazard Statements: Prolonged or repeated exposure might aggravate pre-existing conditions by ion interference
Precautionary Statements: Immediate medical attention required if allergic response occurs; seek advice for accidental exposure
Gadobutrol: 604.71 g/mol, complex organic structure with gadolinium core
Active Ingredient Concentration: 1.0 mmol gadobutrol per milliliter
Inactive Components: Trometamol, hydrochloric acid (adjusts pH), water for injection
CAS Numbers: Trometamol: 77-86-1, Hydrochloric acid: 7647-01-0, Water: 7732-18-5
Content: Non-ionic, macrocyclic gadolinium chelate
Impurities: Residual solvents maintained below regulatory limits per batch analysis
Inhalation: Move to fresh air, observe for respiratory distress, provide oxygen if breathing is impaired, seek prompt medical attention
Skin Contact: Remove contaminated clothing, wash thoroughly with soap and water; consult a physician if irritation or rash develops
Eye Contact: Rinse eyes immediately with plenty of running water for 15 minutes, lift eyelids; urgent medical help if discomfort persists
Ingestion: Rinse mouth, do not induce vomiting, drink plenty of water, get urgent medical advice
Most Important Symptoms: Allergic symptoms including swelling, difficulty breathing, cardiovascular irregularities
Advice for Physicians: Monitor cardiac and renal function in exposed persons, symptomatic and supportive treatment as needed
Suitable Extinguishing Media: Use dry chemical, CO2, water spray, or foam for fires involving this product
Unsuitable Extinguishing Media: Direct water stream may spread product contamination
Special Hazards: Heated container may rupture under fire conditions, combustion produces toxic gases including NOx, CO, HCl
Protective Equipment: Firefighters should use self-contained breathing apparatus and full protective gear
Explosion Data: Product does not present an explosion hazard under normal conditions
Firefighting Measures: Cool containers with plenty of water, keep unnecessary personnel away, avoid inhaling fumes
Personal Precautions: Avoid skin and eye contact, ventilate area, use appropriate personal protective equipment including gloves and safety glasses
Environmental Precautions: Prevent liquid from entering drains, soil, surface waters, and groundwater systems; notify authorities if large spill contaminates environment
Cleanup Methods: Absorb with inert material (sand, earth), transfer to labeled containers for disposal; wash area with water and detergent
Spill Handling Equipment: Use non-sparking tools, ensure adequate ventilation in clean-up area
Disposal: Dispose of according to local, regional, and national regulations for medical or chemical waste
Decontamination: Flush area with lots of water after removal of main contamination bulk
Handling Precautions: Handle only with proper training, use in designated workspaces, minimize aerosol and mist generation, keep away from incompatible materials
Hygiene Measures: Wash hands after handling, remove soiled clothing promptly, avoid eating or drinking in work area
Storage Conditions: Store in tightly closed original containers at 15–30°C; protect from freezing and sunlight, keep in controlled areas restricted to authorized personnel
Incompatibilities: Strong oxidizing agents, certain acids and bases
Storage Classification: Medical products and diagnostics, secure from outreach of unauthorized individuals
Shelf Life: Refer to product labeling for expiration; discard unused portions safely
Occupational Exposure Limits: No established workplace exposure limit for gadobutrol
Engineering Controls: Local exhaust ventilation advised for large volume use
Personal Protection: Laboratory coat, safety goggles, impervious gloves recommended for all handling
Respiratory Protection: Use a suitable respirator if airborne concentrations exceed comfort thresholds or in case of emergency
Environmental Controls: Medical disposal system for waste materials, keep all drains protected
Hygiene Practices: Immediate removal of contaminated clothing, regular cleaning of work surfaces
Appearance: Clear, colorless to slightly yellow solution
Odor: Odorless
Odor Threshold: Not applicable
pH: 6.5–8.0
Melting Point / Freezing Point: Not determined for solution
Boiling Point: Approximately 100°C (related to solvent, water)
Flash Point: Not flammable
Evaporation Rate: Comparable to water
Flammability: Not flammable
Solubility: Completely soluble in water
Vapor Pressure: Not established
Viscosity: 4.96 mPa·s at 37°C (1.0 mol/L solution)
Relative Density: 1.3–1.4 g/cm³
Partition Coefficient (log Kow): Not applicable, strong hydrophilicity
Decomposition Temperature: No data, stable at recommended temperatures
Chemical Stability: Stable under standard temperatures and conditions for clinical products
Conditions to Avoid: Strong heating, freezing, exposure to strong acids or bases, incompatibles
Incompatible Materials: Oxidizing agents, strong acid chlorides, alkali metals
Hazardous Decomposition Products: Toxic fumes of CO, NOx, HCl on combustion or strong chemical attack
Polymerization: Will not occur
Reactivity: Non-reactive under storage and handling conditions as specified for medical products
Acute Toxicity: Low single-dose toxicity by oral, dermal, and inhalation routes; intravenous administration only
Chronic Toxicity: No substantial evidence of carcinogenicity or mutagenicity
Target Organs: Kidneys identified as organs of concern for gadolinium retention
Routes of Exposure: Skin, eyes, inhalation for occupational exposure; intravenous for intended usage
Potential Effects: Rare cases of nephrogenic systemic fibrosis in patients with impaired renal function
Allergic Sensitization: Some risk, especially in susceptible individuals
Reproductive Toxicity: Animal studies showed no teratogenic effects, insufficient data in humans
Aquatic Toxicity: Minimal acute ecological risk, but persistent in aquatic environments
Persistence and Degradability: Chemical structure is highly stable, not readily biodegradable
Bioaccumulation Potential: Unlikely to bioaccumulate due to hydrophilic properties and rapid excretion in mammals
Mobility: High mobility in water, reaches wastewater treatment systems
Ecotoxicological Concerns: Gadolinium-containing contrast agents have been detected in hospital effluents and downstream water bodies, raising questions about possible chronic effects
Other Adverse Effects: Absence of data on long-term ecological impacts, ongoing research into trace gadolinium species in the environment
Waste Disposal Methods: Dispose via licensed hazardous chemical waste contractor; do not discharge to drains or environment
Contaminated Packaging: Treat as pharmaceutical waste, incinerate or landfill according to regional policy
Unused Product: Handle as chemical waste, return to authorized collection facility
Special Precautions: Comply with all national and local regulations, maintain documentation for waste transfer
UN Number: Not regulated as dangerous goods under international transport codes
DOT/ADR/RID/IMDG/IATA Classification: Not hazardous for transportation
Packaging Requirements: Ship in leak-proof packaging, maintain original labeling
Special Transport Precautions: Protect containers from damage, temperature extremes
Environmental Hazards: No specific labeling required, but accidental spillage prevention is important
US TSCA Status: Exempt as a pharmaceutical product
FDA: Approved for use as imaging contrast agent under prescription use only
OSHA: Not classified as hazardous chemical
European Union: Authorized under the EMA for clinical MRI contrast use, subject to prescription and reporting requirements
Other Regulations: Complies with REACH registration for medicinal products, includes hazard communication for healthcare providers
Restrictions: Use limited to registered medical professionals, subject to governing country healthcare law and risk management protocols
