Product Name: Fluphenazine Decanoate
Chemical Name: 4-[3-(2-Trifluoromethylphenothiazin-10-yl)propyl]-1-piperazineethanol decanoate ester
Synonyms: Fluphenazine undecanoate, Modecate
CAS Number: 33125-97-2
Intended Use: Antipsychotic medication for intramuscular injection
Manufacturer: Refer to specific supplier’s documentation
Emergency Contact: Local health authority or poison control
Risk Phrases: May cause respiratory irritation and skin sensitization; toxic if ingested or absorbed through skin; can cause CNS depression or severe psychiatric reactions
Hazard Class: Acute toxicity, Reproductive toxicity, Target organ effects
GHS Classification: Skin irritant (Category 2), Eye irritant (Category 2A), Acute toxicity (oral and dermal, Category 3)
Signal Word: Danger
Route of Exposure: Inhalation, ingestion, skin and eye contact
Symptoms: May cause dizziness, drowsiness, tremors, hypotension, nausea, allergic reactions, difficulty in breathing, muscular rigidity
NFPA Ratings: Health: 3; Flammability: 1; Reactivity: 0
Active Substance: Fluphenazine Decanoate 100% (active pharmaceutical ingredient)
Impurities: Trace solvents and decanoic acid
Excipient Information: Often supplied in sesame oil or another vehicle for injection; refer to product insert for complete profile
Chemical Formula: C32H44F3N3O2S
Molecular Weight: 609.8 g/mol
Inhalation: Move person to fresh air immediately. If breathing troubles begin, seek medical attention and provide oxygen if available.
Skin Contact: Remove contaminated clothing, wash skin thoroughly under running water using soap, monitor for irritation or allergic response, obtain medical advice as needed.
Eye Contact: Flush eyes using lukewarm water for 15 minutes, keep lids apart, consult an ophthalmologist if discomfort persists.
Ingestion: Rinse mouth with water, avoid inducing vomiting, call poison control center or medical professional for further guidance.
Note for Physicians: Symptomatic treatment, monitor cardiovascular and neurological status, observe for skin or mucous irritation.
Suitable Extinguishing Media: Use water spray, foam, dry chemical, or carbon dioxide. Avoid direct water jets near containers.
Fire Hazards: Gives off toxic or irritating fumes including carbon monoxide, nitrogen oxides, and sulfur oxides on combustion.
Protective Equipment for Firefighters: Wear self-contained breathing apparatus and full protective clothing.
Advice: Avoid inhalation of smoke, move product containers from fire zone only if safe, cool exposed containers with water.
Personal Protection: Wear gloves, chemical splash goggles, lab coat; avoid inhaling vapors and contact with skin.
Spill Handling: Absorb spill using inert material such as vermiculite; collect in sealed container, label for hazardous waste.
Ventilation: Work in well-ventilated area; evacuate others not involved in cleanup.
Environmental Precautions: Prevent from entering drains or water courses; use barriers to stop spread.
Decontamination: Wash area with water and mild detergent after material pick-up.
Handling: Use only in safety equipment provided laboratory or healthcare setting; minimize formation of aerosol, keep containers tightly closed, handle with chemical-resistant gloves, avoid all direct contact.
Storage Conditions: Keep containers in a cool, dry place away from sunlight; do not freeze; avoid heat, flame or incompatible substances (oxidizers, strong acids or bases).
Container Materials: Use original container or compatible, clearly labeled packaging.
Special Precautions: Limit access to authorized personnel, maintain record of use, keep out of reach of children and unauthorized persons.
Occupational Exposure Limit: Not established for Fluphenazine Decanoate; handle as hazardous pharmaceutical agent.
Engineering Controls: Use chemical fume hood, closed transfer systems, local exhaust ventilation.
Personal Protective Equipment: Wear nitrile gloves, laboratory coat, chemical safety goggles, possibly face shield; use respiratory protection if dust or mist occurs.
Hygiene Measures: Avoid eating/drinking/smoking during use, wash hands after working, regularly clean all work surfaces and equipment.
Physical State: Oily, viscous liquid or clear solution in pharmaceutical preparations
Color: Pale yellow to amber
Odor: Slight, medicinal
pH: Not applicable (non-aqueous)
Melting Point: Not relevant for oil-based solution
Boiling Point: Decomposes before boiling
Water Solubility: Practically insoluble
Solubility in Other Solvents: Soluble in ethanol, organic solvents, and fixed oils
Vapor Pressure: Low
Partition Coefficient (log Kow): High, due to lipophilic structure
Flash Point: >150°C (estimate for medicinal oil)
Chemical Stability: Stable when stored as directed in sealed original packaging, protected from light
Reactivity: Not reactive under recommended conditions of use
Hazardous Reactions: Can degrade under high temperature, strong acids or bases
Incompatible Materials: Avoid oxidizing agents, strong acids, alkalis
Decomposition Products: Toxic gases including CO, CO2, NOx, SOx, fluorinated compounds
Acute Effects: Toxic by ingestion, inhalation, skin absorption; can cause CNS depression, respiratory difficulties, extrapyramidal symptoms (muscle stiffness, tremors), anticholinergic effects (dry mouth, blurred vision)
Chronic Effects: Potential for liver and kidney effects, movement disorders, long-term neurological changes; suspected reproductive toxicity
Sensitization: May sensitize skin in susceptible individuals
Carcinogenicity: Not classified as carcinogen by IARC, but limited research on long-term effects
Mutagenicity: Not reported in animal studies, handle cautiously
Routes of Exposure: Oral, dermal, inhalation, parenteral injection (medical use)
Target Organs: Brain, nervous system, liver, kidneys
Symptoms: Somnolence, muscle rigidity, fever, jaundice, confusion, seizures (in severe exposures)
Persistence and Degradability: Biodegradation in environment expected to be slow; pharmaceutical residues detected in effluent
Bioaccumulation: High potential in aquatic life due to lipophilicity
Ecotoxicity: Harmful to aquatic organisms at low concentrations; can disrupt algae and invertebrate populations
Mobility in Soil: Tends to bind with organic matter; low mobility
Other Harmful Effects: Unknown long-term effects on food chains; standard wastewater treatments may not fully remove
Product Disposal: Treat as hazardous medical waste; incinerate or dispose of through licensed chemical waste contractor; never introduce into sewer system
Container Disposal: Decontaminate container prior to recycling or dispose as regulated waste
Local Regulations: Follow national and regional pharmaceutical and hazardous waste disposal rules
Precautions: Avoid uncontrolled release into environment; keep detailed waste transfer records
UN Number: Not assigned for finished dosage forms; for bulk or raw chemical use UN 2811 (Toxic solid, organic, n.o.s.)
Hazard Class: Class 6.1 (Toxic substances) for bulk transport
Packing Group: III (for low toxicity solids; varies with concentration)
Transport Labels: Toxic, Keep Away from Heat
Special Precautions: Secure upright, avoid impacts, maintain temperature control, restrict access to trained personnel
Other Regulations: Subject to drug control laws and pharmaceutical transport restrictions
Regulatory Status: Prescription drug, controlled under health and pharmaceutical acts
OSHA: Not specifically listed, but hazardous substance guidelines apply
SARA Title III: Not subject to reporting, but storage and use records required
WHMIS Classification (Canada): D2A (very toxic material causing other toxic effects)
EU Classification: T (Toxic), Xi (Irritant), R22 (harmful if swallowed), R36/38 (irritating to eyes and skin)
Other Label Information: See country-specific pharmacovigilance and workplace safety regulations
