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Product Name: Gadodiamide
Chemical Family: Gadolinium complex
CAS Number: 122795-43-3
Synonyms: OMNISCAN, gadodiamide injection
Manufacturer/Supplier: Contact global pharmaceutical producers
Intended Use: Contrast agent for magnetic resonance imaging (MRI)
Emergency Contact: Refer to local emergency services and poison control
Formula: C16H26GdN5O8
Molecular Weight: 573.66 g/mol
Recommended Restrictions: Human diagnostic agent under trained medical supervision
GHS Classification: Not classified as hazardous by GHS criteria
Signal Word: Not applicable
Hazard Statements: Exposure to large quantities may cause kidney issues in specific populations; allergic reaction possible
Hazard Symbols: None for consumer-level handling
Routes of Exposure: Inhalation, ingestion, skin or eye contact
Potential Health Effects: Possible hypersensitivity, nephrogenic systemic fibrosis in renal impairment, mild irritation
Precautionary Statements: Avoid unnecessary exposure; handle according to medical guidelines; be alert to allergic signs
Ingredient: Gadodiamide
Concentration: 0.5 mmol/mL (in standard formulations)
Other Components: Caldiamide sodium, water for injection
Preservatives: Absence of preservatives limits stability after opening
Impurities: None listed above reportable levels in commercial preparations
Inhalation: Move affected person to fresh air; support breathing as necessary; seek medical advice for symptoms
Skin Contact: Remove contaminated clothing; rinse skin thoroughly with water; obtain medical attention for irritation or ongoing reaction
Eye Contact: Rinse gently with plenty of water, lifting upper and lower eyelids; seek medical guidance promptly if irritation persists
Ingestion: Rinse mouth with water; do not induce vomiting unless directed by medical personnel; observe patient and consult poison control or emergency care
Note to Physicians: Watch for delayed hypersensitivity; treat symptoms; be especially vigilant for individuals with compromised renal function
Suitable Extinguishing Media: Water spray, carbon dioxide, dry chemical, foam
Unsuitable Media: None known for the product as supplied
Fire Hazards: Not flammable or combustible; may decompose at high temperature producing toxic fumes (carbon oxides, nitrogen oxides, gadolinium oxides)
Protective Equipment: Firefighters use self-contained breathing apparatus and protective clothing
Special Procedures: Cool containers with water spray; prevent firefighting runoff from entering waterways or sewers; ventilate area after incident
Personal Precautions: Avoid breathing vapor, mist, or spray; ventilate area; use protective gloves and eye/face protection
Environmental Precautions: Prevent release into sewer or water systems; contain spills to prevent environmental contamination
Clean Up Methods: Absorb with inert material (sand, soil, vermiculite); collect in suitable container; wash area thoroughly after cleanup
Disposal: Place waste in appropriate labeled container for disposal according to local regulations
Handling: Use only as directed by prescribing guidelines; avoid unnecessary exposure; maintain good hygiene practices; avoid contact with eyes, skin, clothing
Storage Conditions: Store at 15°C to 30°C (59°F to 86°F); protect from light and freezing; keep container sealed until use
Incompatible Materials: Avoid strong oxidizers and chemotherapeutic agents; no significant reactivity with standard medical supplies
Special Precautions: Only trained medical personnel may administer; monitor for adverse reactions during use; rotate stock to prevent expiration
Occupational Exposure Limits: No threshold limit value established
Engineering Controls: Use in well-ventilated area; biological safety cabinet recommended for compounding
Respiratory Protection: Not needed in normal medical practice; NIOSH-approved mask for aerosol-generating procedures
Hand Protection: Wear disposable medical gloves (nitrile preferred)
Eye Protection: Safety goggles or face shield during preparation and administration
Skin Protection: Laboratory coat or gown to prevent skin exposure
Hygiene: Wash hands thoroughly after handling, before eating or drinking
Appearance: Clear, colorless to pale yellow solution
Odor: Odorless
pH: 6.5–8.0 (in solution)
Boiling Point: >100°C (water-based solution)
Melting Point: Not applicable (aqueous solution)
Flash Point: Not flammable
Solubility: Miscible with water
Specific Gravity: 1.15–1.18
Vapor Pressure: Similar to water
Partition Coefficient: Not determined for mixture
Viscosity: Slightly more viscous than water
Evaporation Rate: Not rapidly volatile
Decomposition Temperature: Above >200°C yields hazardous gases
Chemical Stability: Stable under recommended storage conditions
Reactivity: Inert in standard medical and environmental settings
Hazardous Reactions: None under normal handling and use
Decomposition Products: Thermal decomposition may produce toxic fumes (gadolinium oxides, carbon oxides)
Incompatible Materials: Strong oxidizers, some reducing agents
Polymerization: Will not occur
Acute Toxicity: Low toxicity in animal models at intended concentrations; intravenous LD50 (rat) exceeds 10 mL/kg
Chronic Toxicity: Repeated dose in renal impairment linked to risk of nephrogenic systemic fibrosis
Skin/Eye Irritation: Possible mild skin and eye irritation after direct contact
Sensitization: Allergic-type reactions (rash, hives, anaphylaxis) possible in sensitive persons
Carcinogenicity: No tumorigenic or mutagenic effects observed in chronic studies to date
Reproductive Effects: No clear evidence in animal testing; use in pregnancy only if essential
Other Data: Prolonged systemic exposure to gadolinium complexes after repeated dosing in patients with poor kidney clearance
Aquatic Toxicity: Gadolinium compounds persist in environment; low acute toxicity to aquatic life
Persistence and Degradability: Not readily biodegradable; can accumulate in sediment and water systems
Bioaccumulation: Potential for gadolinium ion buildup in soils and aquatic organisms over time
Mobility in Soil: Moderate mobility; potential for leaching in groundwater
Environmental Fate: Stable; not likely to hydrolyze or volatilize
Other Hazards: Concerns on increasing gadolinium levels in rivers near hospitals; active research on long-term effects
Product Disposal: Hospital or clinic should collect unused material as hazardous waste; incinerate or manage in accordance with local regulations
Container Disposal: Rinse and discard as medical waste per protocol
Waste Disposal Methods: Follow guidance for pharmaceuticals; avoid disposal to wastewater or regular trash
Special Considerations: Notify local environmental agency for large quantities to prevent gadolinium release
UN Number: Not assigned (not classified as dangerous goods for transport)
Transport Hazard Class: Non-hazardous
Packing Group: Not applicable
Shipping Name: Gadodiamide Solution
Label Requirements: No special labeling required outside standard medical shipment notifications
Bulk Transport: Avoid bulk shipment; handle in regulated medical packaging
Special Precautions: Protect from freezing or overheating in transit
FDA/NDA Status: Approved for prescription use as contrast agent
EU Regulations: Classified as medicinal product; comply with Directive 2001/83/EC
OSHA: Not considered hazardous under OSHA regulations
WHMIS Classification: Not controlled product in Canada
REACH Status: Exempt as medicinal use substance
Labeling Requirements: Prescription product, not for general sale; labeled for professional use
SARA/Title III: Not listed
Other National Inventory Lists: Consult country-specific databases for details
Restriction Notices: Renal impairment warnings on product label by regulatory mandate
