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Material Safety Data Sheet: Dydrogesterone

Identification

Product Name: Dydrogesterone
Chemical Name: 6-Dehydro-9β,10α-progesterone
CAS Number: 152-62-5
Use: Pharmaceutical ingredient for hormone replacement and gynecological therapies
Synonyms: Duotine, Dubaston
Manufacturer: Refer to supplier packaging or documentation for details
Emergency Contact: Refer to local poison control and medical emergency services

Hazard Identification

GHS Classification: Not classified as hazardous under GHS criteria
Physical Hazards: No significant explosive or flammable risk
Health Hazards: Reproductive toxicity risk from chronic exposure, may cause hormone disruption, possible mild skin and eye irritation
Environmental Hazards: May cause long-term adverse effects in aquatic environments
Label Elements: Not a controlled product under WHMIS or OSHA; caution with handling due to hormonal effect risk

Composition / Information on Ingredients

Chemical Identity: Dydrogesterone
Concentration: Typically 98–100% pure for pharmaceutical use
Impurities: Related steroids may occur at minor levels, specific details provided by manufacturer
Molecular Formula: C21H28O2
Molecular Weight: 312.45 g/mol

First Aid Measures

Skin Contact: Wash with water and mild soap, remove contaminated clothing, seek medical attention if skin irritation persists
Eye Contact: Rinse gently with water for at least fifteen minutes, remove contact lenses, consult a physician if discomfort continues
Inhalation: Move to fresh air, seek medical attention if symptoms like cough or respiratory difficulty arise
Ingestion: Rinse mouth with water, do not induce vomiting, get medical help immediately
Most Important Effects: Hormonal changes, possible allergic response, prolonged hormonal effects in sensitive individuals

Fire-Fighting Measures

Suitable Extinguishing Media: Use water spray, dry chemical, foam, or carbon dioxide
Special Hazards: Combustion may release carbon oxides and other unidentified toxic fumes
Protective Equipment: Firefighters should wear suitable protective gear, including self-contained breathing apparatus
Explosion Risk: Not explosive under normal storage and handling
Advice: Avoid inhaling smoke, maintain safe distance, prevent water runoff from contaminating surface water or storm drains

Accidental Release Measures

Personal Precautions: Wear gloves, eye protection, dust mask or respirator if dust forms
Spill Cleanup: Sweep up and place in labeled container for chemical waste, avoid raising dust, ventilate area, clean spill site using detergent
Environmental Precautions: Prevent material from entering drains or watercourses, notify authorities if large amounts contaminate the environment
Disposal: Dispose of according to local, regional, and national regulations
Decontamination: Wash area with soap and water after cleanup

Handling and Storage

Handling: Use gloves, lab coats, and respiratory protection when handling powder or tablets
Storage Requirements: Store in a cool, dry, well-ventilated place away from direct sunlight, heat, acids, and oxidizers
Packaging: Keep container tightly closed and labeled; use original packaging
Hygiene Practices: Wash hands and face after handling, avoid eating, drinking, or smoking in handling areas
Special Considerations: Handle under local exhaust or fume hood if available to limit exposure

Exposure Controls and Personal Protection

Exposure Limits: No specific occupational exposure limits; minimize exposure as for hormone-active substances
Engineering Controls: Work in a well-ventilated area, use local exhaust if powder is present
Personal Protective Equipment: Gloves, lab coats, protective eyewear, respiratory protection under dusty conditions
Hygiene Measures: Do not eat, drink, or smoke during handling; wash thoroughly after exposure
Environmental Protection: Use spill trays and secondary containment to prevent leaks or accidental exposure

Physical and Chemical Properties

Appearance: White or almost white crystalline powder
Odor: Odorless
Melting Point: 196–201 °C
Boiling Point: Decomposes before boiling
Solubility: Practically insoluble in water, freely soluble in methanol and ethanol, soluble in acetone
pH: Not applicable (non-aqueous solid)
Density: Not established for pure powder
Partition Coefficient (log Pow): Approximately 2.5–3.2
Vapor Pressure: Negligible

Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions
Reactivity: Not reactive with most substances under normal conditions
Conditions to Avoid: Excessive heat, open flame, direct sunlight, sources of ignition, moisture
Incompatible Materials: Strong oxidizers, acids, bases
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, other toxic vapors on thermal decomposition

Toxicological Information

Acute Toxicity: Expected low acute oral and dermal toxicity based on structure and animal data
Chronic Effects: Can interfere with endogenous hormones, reproductive toxicity, endocrine disruption, possible fetal effects
Routes of Exposure: Inhalation, skin contact, ingestion, eye contact
Symptoms: Nausea, headache, dizziness, menstrual irregularities, possible allergic reactions
Carcinogenicity: Not classified as carcinogenic by IARC, NTP, OSHA
Mutagenicity/Teratogenicity: Animal data suggest potential effects on reproduction at high doses

Ecological Information

Ecotoxicity: Harmful to aquatic organisms at high concentration, risk of hormone disruption in wildlife
Persistence and Degradability: Biodegradation may be slow, especially in aquatic environments
Bioaccumulation Potential: Potential for moderate bioaccumulation due to hydrophobic characteristics
Mobility in Soil: Low mobility, binds strongly to soil and sediment
Other Harmful Effects: May contribute to endocrine disruption effects in surface waters and affected ecosystems

Disposal Considerations

Waste Treatment: Avoid release to environment, collect material in appropriate containers for hazardous waste disposal
Disposal Methods: Incinerate at authorized chemical waste facility, in compliance with local, regional, and national regulations
Contaminated Packaging: Dispose of as hazardous chemical waste, do not reuse containers
Precautions: Do not discard with household waste or pour down drains or watercourses

Transport Information

UN Number: Not regulated as dangerous goods under major transport regulations
Proper Shipping Name: Dydrogesterone, solid, non-hazardous
Transport Hazard Class: Not classified
Packing Group: Not applicable
Marine Pollutant: No specific designation, but prevent large spills from entering waterways
Special Precautions: Move in original, sealed and labeled containers; avoid direct contact and environmental exposure during transit

Regulatory Information

TSCA Status: Listed or exempted for pharmaceutical use
WHMIS Classification: Exempt as a drug product
OSHA Status: Not specifically regulated
GHS Label: Substance not classified as hazardous under current GHS guidelines for end-use pharmaceutical products
Other Legislation: Controlled under various national pharmaceutical regulations; handle and use according to health authority guidelines