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Product Name: Promethazine Hydrochloride
Chemical Name: N,N,α-Trimethylphenothiazine-10-propanamine hydrochloride
Common Use: Antihistamine and antiemetic agent in medicine
Synonyms: Phenergan hydrochloride
CAS Number: 58-33-3
Manufacturer: Identified by pharmaceutical supplier
Emergency Contact: Information available through public poison control centers
Hazard Class: Toxic by ingestion, harmful in contact with skin, can cause eye and respiratory irritation
Signal Word: Warning
Pictograms: Skull and crossbones, exclamation mark
Acute Effects: Drowsiness, confusion, respiratory depression, agitation, hallucinations
Chronic Effects: Prolonged use can impact liver function, hematologic system
Routes of Exposure: Eyes, skin, inhalation, ingestion
Target Organs: Central nervous system, liver, kidneys
Chemical Formula: C17H20N2S·HCl
Concentration: Typically 99% or greater for pure substance
Impurities: Trace organic or inorganic process byproducts possible, unspecified in pharmaceuticals
Active Ingredient: Promethazine hydrochloride, over 99% by weight
Inactive Components: Excipients present in formulated tablets or liquid solutions
Inhalation: Move person to fresh air, monitor for difficulty breathing, seek medical support if symptoms develop
Skin Contact: Remove contaminated clothing, rinse area with plenty of water and mild soap, obtain medical attention for irritation
Eye Contact: Flush eyes with water for 15 minutes, keep eyelids apart and investigate vision changes with a healthcare professional
Ingestion: Do not induce vomiting, rinse mouth with water, call a poison center or physician immediately
Symptoms to Watch: Sedation, confusion, unsteady gait, irregular breathing, hallucinations
Advice for Physicians: Symptomatic treatment, consider activated charcoal, provide supportive care for CNS or respiratory depression
Suitable Extinguishing Media: Use carbon dioxide, dry chemical, or foam; water spray for cooling containers only
Specific Hazards: Emits toxic fumes like hydrochloric acid, nitrogen oxides, and sulfur oxides when combusted
Protective Equipment: Firefighters should wear self-contained breathing apparatus and full protective gear
Additional Information: Avoid breathing smoke or fumes, keep away from flames and ignition sources
Decomposition Products: Harmful gases such as HCl, SOx, NOx can build up in enclosed spaces during fire
Personal Precautions: Ensure proper ventilation, restrict access to spill area, use personal protective equipment such as gloves and goggles
Environmental Precautions: Prevent entry into drains, waterways, groundwater, or soil
Cleaning Methods: Absorb spill with inert material like sand or vermiculite, sweep and shovel into labeled waste container
Disposal: Place collected material in appropriate, tightly sealed disposal containers and label for hazardous waste pickup
Reporting: Alert facilities and local authorities in significant releases due to potential risk to public health
Safe Handling Practices: Avoid breathing dust, vapor, or mist; minimize skin and eye contact using personal protection
Personal Hygiene: Wash hands after handling, before eating or drinking
Storage Conditions: Store in a tightly sealed original container in a dry, well-ventilated, cool area
Temperature Requirements: Keep away from sources of heat and direct sunlight
Incompatible Materials: Strong oxidizing agents, alkalis, acids
Occupational Exposure Limits: Not established specifically for promethazine; general pharmaceutical exposure precautions recommended
Engineering Controls: Use local exhaust ventilation, fume hoods, or equivalent engineering means
Eye Protection: Chemical safety goggles
Skin Protection: Nitrile gloves or equivalent, lab coats or coveralls
Respiratory Protection: Respirators if ventilation is inadequate
Workplace Practices: No food, drink, or smoking in work area; regular equipment maintenance and inspection
Environmental Exposure Controls: Wastewaters and residues managed using pharmaceutical hazardous waste controls
Form: Solid powder or crystalline form
Color: White to yellowish
Odor: Odorless or faint, characteristic odor
pH (1% Solution): 4.0–5.5
Melting Point: 230–232°C (pure)
Water Solubility: Freely soluble
Molecular Weight: 320.88 g/mol
Vapor Pressure: Negligible at room temperature
Partition Coefficient: logP approximately 4 (indicates significant lipophilicity)
Chemical Stability: Stable under recommended storage and handling conditions
Reactivity: No dangerous reactions under normal use, but reacts with acids, strong oxidizers, and bases
Decomposition: Produces hazardous gases (nitrogen oxides, sulfur oxides, HCl) when strongly heated or combusted
Polymerization: Not expected
Corrosivity: Not inherently corrosive but may degrade some materials if exposed for long periods
Acute Toxicity: Oral LD50 in rats approximately 50 mg/kg
Inhalation Effects: May cause respiratory distress if significant dust inhaled
Skin/Eye Effects: Causes mild to moderate irritation; rarely, allergic dermatitis or conjunctivitis
Chronic Effects: Liver dysfunction, agranulocytosis, long-term CNS depression have occurred in repeated poisoning
Carcinogenicity: No reliable evidence for carcinogenic risk in humans
Reproductive Effects: Adverse outcomes possible in late pregnancy or neonatal withdrawal syndrome
Mutagenicity: Animal studies generally unremarkable but regular exposure avoided
Ecotoxicity: No full data but potential for toxicity to aquatic organisms at high concentrations
Persistence/Degradability: Not readily biodegradable, residues can linger in soil or water
Bioaccumulation: Low to moderate based on physicochemical profile
Mobility in Soil: High solubility may drive some leaching potential if released in volume
Aquatic Effects: May inhibit algal growth, disrupt aquatic invertebrates if improperly disposed
Other Hazards: No anticipated effects on ozone or long-range atmospheric transport
Waste Management: Collect all drug residues, packaging, cleaning materials for incineration by licensed hazardous waste contractors
Incineration: High-temperature treatment required for safe destruction, avoid casual disposal in regular trash
Container Rinsing: Do not rinse into municipal sewer systems
Labeling: Ensure all waste is labeled in line with pharmaceutical hazardous waste regulations
Legal Compliance: Keep full disposal records to demonstrate regulatory compliance and good stewardship
UN Number: Classified as pharmaceutical product, not always regulated under transport of dangerous goods
Proper Shipping Name: Promethazine hydrochloride (for bulk hazardous shipments)
Packaging Requirements: Keep in tightly closed, leak-proof containers
Special Handling: Protect against breakage and spills during transport
Transport Labels: Label as “Medicinal Product” or “Pharmaceutical Substance”, hazardous marking where required by law
International Listings: Included in WHMIS, OSHA, REACH, and local pharmaceutical regulations
Federal Status: Prescription-only medication; flagged as dangerous for use or sale without proper authority
SARA Title III: Not specifically listed
TSCA: Not subject to routine control but handled under general pharmaceutical safety
Other Regulations: Subject to GMP standards, Poison scheduling, DEA prescription scheduling for controlled substances
Workplace Regulations: Controlled under hazard communication standards; safety training and written protocols required
