Product Name: Pentamidine Isethionate
Chemical Formula: C19H24N4O2·2C2H6O4S
CAS Number: 140-64-7
Synonyms: Pentamidine 2-hydroxyethanesulfonate
Manufacturer: Multiple pharmaceutical manufacturers globally supply this compound, primarily for clinical and laboratory use.
Recommended Use: Therapeutic agent for protozoal infections, notably Pneumocystis pneumonia and leishmaniasis.
Emergency Contact: Refer to local poison control center or safety officer phone numbers as listed by supplier.
Hazard Classification: Harmful if inhaled, swallowed, or absorbed through the skin; classified as hazardous according to GHS standards.
Signal Word: Warning
Hazard Statements: Suspected of causing genetic defects, causes serious eye irritation, may damage organs through prolonged or repeated exposure.
Precautionary Statements: Avoid breathing dust; wash thoroughly after handling; use only outdoors or in well-ventilated area; wear protective gloves, clothing, and eye protection; in the event of exposure, follow first aid procedures as indicated below.
Main Routes of Exposure: Inhalation, skin and eye contact, ingestion.
Physical Dangers: Not combustible, but dust may form explosive mixtures in air.
Symptoms of Exposure: Headache, nausea, vomiting, respiratory distress, possible kidney effects, hypoglycemia, rashes.
Substance: Pentamidine Isethionate
Concentration: 99% or as labeled by the supplier
Chemical Category: Aromatic diamidine salt
Impurities: Trace manufacturing-related ylide or isomer residues, typically less than 1%
Ingredient Disclosure: No additional ingredients regarded as hazardous above regulatory thresholds
Inhalation: Move affected person to fresh air; keep individual warm and at rest; seek medical advice if breathing becomes difficult.
Skin Contact: Remove contaminated clothing immediately; rinse skin thoroughly with soap and water for at least 15 minutes; monitor for irritation; seek medical help if symptoms persist.
Eye Contact: Rinse cautiously with water for several minutes; remove contact lenses if present and easy to do; continue rinsing; obtain medical attention without delay.
Ingestion: Rinse mouth thoroughly; do not induce vomiting; seek immediate medical attention.
Advice for Physicians: Symptomatic and supportive treatment recommended; monitor renal and hepatic function; consider hospitalization depending on the severity.
Suitable Extinguishing Media: Dry chemical, CO2, water spray, or foam; use fire-fighting measures suitable for surrounding conditions.
Unsuitable Media: Do not use direct water jet on substance.
Specific Hazards: Emits toxic fumes under fire conditions, including carbon oxides, nitrogen oxides, and sulfur oxides.
Special Protective Equipment: Use self-contained breathing apparatus and full protective gear; avoid inhaling combustion products.
Special Firefighting Procedures: Move containers away from fire area if safe; prevent run-off to waterways; avoid inhalation as smoke may contain residues.
Personal Precautions: Evacuate unnecessary personnel; ventilate affected area; avoid dust formation; use recommended personal protective equipment.
Environmental Precautions: Prevent entry into drains, sewers, and watercourses; notify environmental authorities in the event of large spills.
Methods for Containment: Sweep up and shovel spilled material; avoid raising dust; moisten spill area lightly to prevent dispersion.
Clean Up Procedures: Collect spillage into suitable labeled containers for disposal; wash affected surface with detergent and water; ensure area is properly ventilated.
Disposal of Contaminated Materials: Handle as chemical waste according to local or national regulations.
Safe Handling: Use only in well-ventilated settings with local exhaust; minimize exposure to dust and aerosols; avoid contact with skin, eyes, or clothing; wash hands after use.
Storage Requirements: Keep tightly sealed in original container; store in a cool, dry, well-ventilated location away from incompatible substances, direct sunlight, and moisture.
Incompatible Materials: Strong oxidizers, bases, and acids.
Precautions for Safe Transfer: Take precautions against electrostatic discharges; use grounding and bonding where necessary.
Control Parameters: No occupational exposure limits established by OSHA, ACGIH, or NIOSH for Pentamidine Isethionate; minimize exposure through engineering controls.
Respiratory Protection: Use approved respirator for dust or particulate environments if exposure exceeds limits or ventilation is poor.
Hand Protection: Wear chemical-resistant gloves, such as nitrile or neoprene.
Eye Protection: Use safety goggles or face shield.
Skin/Body Protection: Wear lab coat or chemical-resistant apron.
Engineering Controls: Ensure adequate ventilation, fume hoods, and eye wash stations in work area.
Hygiene Measures: Remove and wash contaminated clothing; practice good personal hygiene during and after handling.
Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not determined
pH: 5.5–7 (1% solution)
Melting Point: 196-202°C (decomposes)
Boiling Point: Not applicable (decomposes before boiling)
Flash Point: Non-flammable
Flammability: Not readily flammable
Solubility: Soluble in water; insoluble in organic solvents
Vapor Pressure: Not applicable
Relative Density: 1.4–1.6 g/cm³
Partition Coefficient: Not determined
Decomposition Temperature: Above 190°C
Viscosity: Not applicable
Explosive Properties: Not classified as explosive, dust may be combustible.
Oxidizing Properties: Not classified as oxidizing.
Chemical Stability: Stable under specified conditions for storage and use.
Possibility of Hazardous Reactions: No hazardous polymerization observed.
Conditions to Avoid: Exposure to light, excessive heat, and moisture can degrade product.
Incompatible Materials: Strong acids, strong oxidizers, strong bases.
Hazardous Decomposition Products: Thermal decomposition produces toxic gases such as carbon monoxide, nitrogen oxides, and sulfur oxides.
Acute Toxicity: Harmful by ingestion, inhalation, and contact; acute oral and dermal LD50 in rats not fully defined but recognized as toxic.
Chronic Toxicity: Possible chronic organ damage with repeated exposure, particularly affecting liver, kidneys, and pancreas.
Irritation/Sensitization: Causes serious eye irritation and may cause skin sensitization reactions in susceptible individuals.
Germ Cell Mutagenicity: Some evidence of genetic toxicity in animal studies.
Carcinogenicity: No data from IARC, NTP, or OSHA classifies compound as carcinogen.
Reproductive Toxicity: Data not sufficient for full assessment; caution warranted.
Target Organ Effects: Liver, pancreas, kidneys, central nervous system.
Potential Symptoms: Nausea, vomiting, headache, confusion, hypoglycemia, rash, arrhythmia with significant exposure.
Medical Conditions Aggravated: Preexisting liver, renal, or glucose metabolism disorders.
Ecotoxicity: No detailed data available, but pentamidine is both toxic and persistent; avoid environmental release.
Persistence and Degradability: Demonstrates slow degradation in natural waters and soils.
Bioaccumulative Potential: Expected to have low bioaccumulation due to high water solubility.
Mobility in Soil: Likely to move into aquatic environments due to solubility.
Other Adverse Effects: PPE and containment during use and disposal minimize risks to aquatic and terrestrial organisms.
Waste Disposal Methods: Dispose of solid residue as hazardous pharmaceutical waste in line with local laws; incineration or burial in authorized landfill recommended.
Container Disposal: Rinse containers with water, ensure packaging is punctured or crushed before final disposal.
Description of Additional Disposal Practices: Large-volume waste requires coordination with environmental department for destruction; consult regional regulatory agencies for further guidance.
Contaminated Packaging: Dispose of in accordance with national or regional hazardous waste management regulations.
UN Number: Not assigned for product form but may be regulated as hazardous substance in bulk sizes.
Proper Shipping Name: Pharmaceuticals, n.o.s. (pentamidine isethionate)
Transport Hazard Class: Non-hazardous for air, sea, and road transport under typical shipping conditions; consult carrier for bulk transit.
Packing Group: Not regulated (see local or international guidelines for large quantities).
Environmental Hazards: Not classified as environmentally hazardous but avoid spillages; follow regulatory reporting requirements.
Special Precautions: Secure packaging to prevent leakage or dust generation; label shipments clearly.
US Federal Regulations: Not listed on SARA Title III Sections 302, 304, or 313; follow OSHA hazard communication standard.
TSCA Inventory: Not required for pharmaceuticals.
EU Directives: Covered as a hazardous substance in accordance with REACH and CLP regulations.
Other Country Specific Regulation: National registration or pharmaceutical control in place; check local inventory status for import, use, and disposal.
GHS Classification: Acute Tox Cat 4, Eye Irrit. Cat 2A, STOT RE Cat 2.
Labeling Requirements: Appropriate hazard symbols, R-phrases, S-phrases provided by supplier and according to destination country rules.