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Product Name: Aminophylline
Chemical Formula: C16H24N10O4
Synonyms: 1,3-Dimethylxanthine, Ethylenediamine salt; Theophylline ethylenediamine complex
CAS Number: 317-34-0
Recommended Use: Pharmaceutical, bronchodilator
Supplier: Pharmaceutical distributors and compounders
Emergency Contact: Local poison control center or medical responder
UN Number: UN2811 for solid material
Product Description: White to slightly yellowish powder, often supplied in tablets or injectable solutions
Classification: Acute toxicity, Category 4 (oral, inhalation, dermal); Eye irritation, Category 2; Skin irritation, Category 2
Signal Word: Warning
Hazard Statements: May be harmful if swallowed, inhaled, or absorbed through skin; causes skin and eye irritation; may cause allergic reaction in sensitized individuals
Symptoms of Exposure: Nausea, vomiting, headache, restlessness, rapid heart rate, tremor, skin redness, respiratory distress
Target Organs: Central nervous system, cardiovascular system
Precautionary Statements: Avoid breathing dust or mist; avoid skin and eye contact; use only with adequate ventilation; wear appropriate protective equipment
Main Ingredients:
Aminophylline (as theophylline and ethylenediamine complex): 100%
Impurities: May include trace amounts of theophylline or related methylxanthines
Other Components: None declared
Inhalation: Move individual to fresh air. Seek medical attention if symptoms persist. If not breathing, provide artificial respiration.
Skin Contact: Remove contaminated clothing. Wash skin thoroughly with soap and water for at least 15 minutes. Get medical help for irritation or allergic responses.
Eye Contact: Flush eyes with plenty of water for at least 15 minutes, lifting upper and lower eyelids occasionally. Seek medical attention if pain, redness, or vision changes persist.
Ingestion: Do not induce vomiting. Rinse mouth with water. Give water to drink if conscious. Obtain immediate medical care.
Important Symptoms and Effects: Seizures, cardiac arrhythmia, nausea, hypotension.
Notes to Physician: Treat symptomatically; monitor cardiac and respiratory status; activated charcoal may be considered for significant ingestion.
Extinguishing Media: Use water spray, dry chemical, foam, or carbon dioxide.
Specific Hazards: Decomposition releases toxic fumes including nitrogen oxides and carbon monoxide.
Protective Equipment: Firefighters wear self-contained breathing apparatus and full protective gear.
Explosion Sensitivity: No data suggests high explosivity, but dust in sufficient concentration can combust.
Firefighting Instructions: Move containers from fire area if it can be done safely; cool exposed containers with water spray.
Personal Precautions: Evacuate unnecessary personnel; wear gloves, goggles, and suitable respirator if dust or aerosols are generated.
Environmental Precautions: Prevent large spills from entering water sources or drains.
Containment: Sweep up and place in suitable sealed containers for disposal; avoid creating dust.
Cleanup Methods: Use non-sparking tools and wet methods to reduce dust; ventilate area after clean-up.
Notification: Notify relevant authorities if spill enters environment or involves large quantity.
Handling: Wear appropriate personal protective equipment; avoid inhalation of dust and contact with skin or eyes; wash hands thoroughly after handling; do not eat, drink, or smoke when using this material.
Storage: Store tightly closed in a cool, dry, well-ventilated area away from incompatible substances like strong acids or alkalis and oxidizing agents; keep container tightly sealed when not in use.
Storage Class: Designated pharmaceutical chemical or hazardous material section.
Specific Practices: Ensure containers are properly labeled and shelved above liquids to avoid leaks contaminating the lower containers.
Exposure Limits: No Occupational Exposure Limits (OELs) specifically set for aminophylline, but handle as hazardous pharmaceutical.
Engineering Controls: Use adequate ventilation, process enclosures, local exhaust, or other engineering controls to keep airborne levels low.
Personal Protective Equipment:
- Eye/Face: Safety goggles or face shield.
- Skin: Lab coat, gloves (nitrile or other chemical-resistant material).
- Respiratory: NIOSH-approved respirator if dust or aerosols are generated.
- Hygiene: Wash hands and exposed skin before breaks or leaving work area.
Appearance: White or off-white crystalline powder
Odor: Odorless
Odor Threshold: Not applicable
pH: Approximately 6.8-7.8 (5% solution)
Melting Point: 210–220°C (dec.)
Boiling Point: Not applicable (decomposes)
Solubility: Freely soluble in water; practically insoluble in chloroform, alcohol, and ether.
Partition Coefficient (octanol/water): Not established
Vapor Density: Not applicable
Vapor Pressure: Not applicable
Evaporation Rate: Not available
Density: 1.52 g/cm³
Flash Point: Not determined
Auto-ignition Temperature: Not determined.
Chemical Stability: Stable under normal storage and handling conditions.
Reactive With: Strong oxidizing agents, acids, bases.
Hazardous Decomposition Products: Nitrogen oxides (NOx), carbon monoxide, carbon dioxide
Polymerization: Does not polymerize.
Conditions to Avoid: Excessive heat, moisture, incompatibles.
Incompatibilities: Strong oxidizing agents, strong acids and bases.
Routes of Entry: Inhalation, skin contact, eye contact, ingestion.
Immediate Effects: Can cause irritation, CNS stimulation, gastrointestinal upset, restlessness, rapid or irregular heartbeat.
Delayed Effects: Repeated or prolonged exposure may cause sensitization or more serious toxic effects such as seizures or cardiotoxicity.
LD50 (Oral, Rat): About 900 mg/kg
Acute Toxicity: Nausea, vomiting, diarrhea, tremor, headache, insomnia, seizures.
Chronic Toxicity: Potential for cardiac arrhythmias and central nervous system effects with repeated significant exposure.
Carcinogenic Status: Not classified as carcinogenic by IARC, NTP, or OSHA.
Reproductive Toxicity: No clear evidence in humans, animal data limited; medical supervision recommended if exposure occurs during pregnancy or lactation.
Mutagenicity: Not known to cause genetic damage in standard tests.
Ecotoxicity: Potentially toxic to aquatic organisms in large quantities; limited persistence expected due to rapid hydrolysis and biodegradation.
Mobility in Soil: High water solubility suggests potential to move through soil and reach groundwater.
Bioaccumulation: Not expected to bioaccumulate due to water solubility and metabolism by organisms.
Degradability: Microbial decomposition under environmental conditions.
Aquatic Toxicity: May be harmful to aquatic life with long-lasting effects if released in significant amounts.
Special Precautions: Avoid uncontrolled release into surface water and sewage systems.
Waste Treatment Methods: Place material in sealed container for proper disposal through licensed chemical waste contractor.
Incineration: Permitted under controlled conditions.
Hazardous Waste Classification: May meet criteria for pharmaceutical hazardous waste (consult local regulations).
Pollution Prevention: Prevent waste generation by minimizing spills and maximizing utilization.
Packing Waste: Contaminated packaging should be treated as chemical waste and disposed of accordingly.
UN Number: UN2811 (Toxic solid, organic, n.o.s. [Aminophylline])
Regulatory Class: 6.1 (Toxic substances)
Packing Group: III
Label: Toxic
Special Provisions: Ensure packaging is secure, clearly labeled, and accompanied by safety documentation during transport.
Environmental Hazards: Not considered marine pollutant in small pharmaceutical quantities.
Additional Requirements: Check all relevant national and international transport regulations.
Inventory Status: Listed on the U.S. TSCA Inventory for research and pharmaceutical use.
OSHA Hazard Category: Acute health hazard
SARA Title III: Not listed as a reportable substance under Sections 302, 304, 313
WHMIS Classification: D2B (Toxic material causing other toxic effects in Canada)
EU Regulation: Classified as hazardous under EU CLP Regulation (EC) No 1272/2008
Other Restrictions: Subject to prescription-only status and monitoring by national authorities for medicinal use.
Label Requirements: Product must be labeled with hazards, storage instructions, and handling precautions.
