Nanjing Finechem Holding Co.,Limited
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Material Safety Data Sheet for Estracyt (Estramustine Phosphate Sodium)

Identification

Product Name: Estracyt
Chemical Name: Estramustine Phosphate Sodium
Synonyms: Estracyt, Estramustine Sodium, Emcyt
CAS Number: 26582-44-9
Manufacturer: Pfizer Inc. or authorized laboratory
Intended Use: Pharmaceutical—treatment of prostate cancer
Recommended Contact: Emergency response line or on-site safety officer with medication experience
Molecular Formula: C23H31N2NaO5P
Emergency Phone: Displayed on manufacturer packaging

Hazard Identification

Hazard Classification: Causes eye, skin, and respiratory irritation; possible carcinogen; toxic to reproductive system
Routes of Entry: Inhalation, ingestion, skin absorption, eye contact
Signal Word: Danger
GHS Labels: Health hazard, irritating to skin and eyes, reproductive toxicity
Pictograms: Exclamation mark, Health hazard symbol
Acute Effects: Nausea, vomiting, contact dermatitis, eye redness, coughing
Long-Term Effects: Hormonal disruption, risk of cancer, fertility impact
Target Organs: Eyes, skin, respiratory tract, reproductive organs

Composition / Information on Ingredients

Active Ingredient: Estramustine Phosphate Sodium, 100% by weight in pure form
Impurities: May contain less than 1% disodium phosphate and sodium chloride from formulation
Excipients (Finished Tablets or Capsules): Microcrystalline cellulose, magnesium stearate, gelatin capsule shell, coloring agents
CAS Numbers: Estramustine 26582-44-9

First Aid Measures

Eye Contact: Rinse gently with water for 15 minutes, keep eyelids open, remove contact lenses, get medical attention
Skin Contact: Wash with soap and water, remove contaminated clothing, seek help if irritation stays
Inhalation: Move to fresh air, monitor breathing, doctor visit may be needed for symptoms
Ingestion: Rinse mouth, avoid vomiting unless told by medical staff, go to emergency care for accidental swallowing
Note to Doctors: Treat symptomatically, monitor hormone levels, supportive care for toxic effects

Fire-Fighting Measures

Flash Point: Not tested for pharmaceuticals, flammability may be low
Extinguishing Media: Water spray, dry chemical, foam, carbon dioxide
Protective Equipment: Self-contained breathing apparatus, chemical-resistant clothing, keep run-off out of drains
Hazardous Combustion: May produce carbon oxides, nitrogen oxides, phosphorus oxides, and toxic fumes
Firefighting Instructions: Approach fire from upwind, avoid smoke inhalation, secure area, ventilate after fire

Accidental Release Measures

Personal Precautions: Wear gloves, lab coat, eye protection, and NIOSH-approved respirator if powder airborne
Environmental Precautions: Block drains, prevent waterway contamination, report significant spills
Cleanup Methods: Scoop solid into secure container, clean surface with damp cloth, use absorbent for liquid form, discard cloths and PPE as hazardous waste
Decontamination: Soap and water for skin, ventilate area, avoid vacuum or dry sweeping
Waste Handling: Designated hazardous bin, follow local pharmaceutical disposal guidelines

Handling and Storage

Handling: Gloves, eye shield, avoid breathing dust and skin contact, do not eat or drink in handling area, no smoking
Storage: Room temperature, dry area, tightly closed original container, away from incompatible materials (strong acids, oxidizers)
Incompatibilities: Strong acids, bases, oxidizers
Special Precautions: Access restricted to trained staff, label clearly, monitor expiry dates, keep out of reach of the public

Exposure Controls and Personal Protection

Engineering Controls: Ventilated enclosure, biosafety cabinet for powder handling, eye wash and safety shower nearby
Personal Protection: Nitrile gloves, long-sleeve coat, safety goggles or face shield, fitted mask or respirator if dust present
Hygiene Measures: Wash hands after use, change clothes if contaminated, avoid touching face during handling
Exposure Limits: No exposure limit set for estramustine, minimize all direct contact by standard operating procedures
Environmental Controls: Contain liquid/solid waste, avoid release into environment, monitor air quality in work area

Physical and Chemical Properties

Appearance: Off-white or pale yellow powder (raw form); capsule containing powder or granules (pharmaceutical)
Odor: Odorless or slight medicinal smell
pH: Not available for solid; aqueous solution near neutral
Melting Point: Decomposes above 180°C (approximate data)
Solubility: Water soluble, low in organic solvents
Density: Not established specifically, estimated 1.3–1.5 g/cm³ for powder
Boiling Point: Not applicable, decomposes before boiling
Vapor Pressure: Not volatile at room temperature
Partition Coefficient (Log Kow): Negligible hydrophobicity due to phosphate salt form

Stability and Reactivity

Chemical Stability: Stable under recommended storage, sensitive to moisture and light
Reactivity: No data on violent reactivity, incompatible with strong oxidizers or acids
Hazardous Reactions: Polymerization does not occur, toxic fumes if heated or burned
Decomposition Products: Nitrogen oxides, phosphorus oxides, carbon oxides
Conditions to Avoid: High humidity, heat, direct light, and improper mixing with other chemicals

Toxicological Information

Acute Toxicity: Data limited in humans; nausea, vomiting, diarrhea common
LD50 (Oral, Rat): Not reported specifically for estramustine, related cytotoxicity expected
Chronic Toxicity: Endocrine disruption, impaired fertility, possible carcinogen
Sensitization: Allergic reactions possible, especially after repeated exposure
Mutagenic and Carcinogenic Effects: Mutagenic in vitro; increased cancer risk with long-term exposure
Reproductive Toxicity: Documented in both humans and animals; avoid handling during pregnancy
Other Effects: Altered hormone balance, increased thromboembolic risk

Ecological Information

Ecotoxicity: Harmful to aquatic life, especially in concentrated form
Persistence and Degradability: Slow breakdown in soil and water, risk of bioaccumulation negligible but present because of potency
Mobility: Water soluble, migrates through soil with run-off
Bioaccumulation: Unlikely for general population, risk in specialized settings
Other Environmental Hazard: Even low concentrations can disrupt small aquatic organisms

Disposal Considerations

Disposal Methods: Treat as hazardous pharmaceutical waste, incinerate in licensed facility
Do Not: Flush into drains, discard with household garbage, allow aerosolization during handling
Container Handling: Triple rinse before recycling if possible, or dispose with hazardous waste
Environmental Caution: Prevent spillage or contaminated rinse waters from entering waterways
Regulatory Compliance: Follow national and local hazardous waste rules strictly

Transport Information

UN Number: Not assigned specifically to estramustine
Proper Shipping Name: Pharmaceutical product, store locked
Hazard Class: Not a recognized class under international regulations; may be assigned as toxic, prescription-restricted
Packing Group: Not listed, use strong, sealed packaging
Labeling: Hazard symbol for toxic and hormone-disrupting drugs
Special Precautions: Trained handlers, control temperature, avoid direct exposure during transport

Regulatory Information

OSHA: Not classified, use prudent handling outlined in lab safety rules for hormonal agents
TSCA Status: Not listed for unrestricted commercial sale
EU Classification: Prescription-only, classified as hazardous by risk of reproductive toxicity
WHMIS (Canada): D2A (very toxic, reproductive toxin)
Inventory Status: Controlled under pharmaceutical and hazardous substances regulations
Other Requirements: Comply with DEA, FDA, EMA, or local health ministry standards for procurement, possession, and disposal