Material Safety Data Sheet for Dydrogesterone

1. Identification

Product Name: Dydrogesterone
Chemical Name: 9β,10α-Pregna-4,6-diene-3,20-dione
CAS Number: 152-62-5
Synonyms: 6-Dehydro-9β,10α-progesterone
Recommended Use: Pharmaceutical intermediate, hormonal agent
Supplier Details: Pharmaceutical manufacturers or suppliers
Emergency Contact: Refer to packaging or local emergency contact point

2. Hazard Identification

Hazard Classification: Not classified as hazardous according to GHS for workplace exposure, but may be hazardous to human health on repeated or high-level exposure
Signal Word: Warning
Hazard Statements: May cause reproductive or developmental toxicity, may induce changes to endocrine function, dust may irritate eyes, skin, or respiratory tract
Precautionary Statements: Avoid breathing dust, avoid contact with skin or eyes, use only in well-ventilated areas, wash hands after handling
Label Elements: Pharmaceutical product, handle with care, use personal protection

3. Composition / Information on Ingredients

Chemical: Dydrogesterone
CAS Number: 152-62-5
Percent Composition: 98-100% (pharmaceutical grade)
Impurities/Additives: Trace synthetic by-products or carriers rarely present

4. First Aid Measures

Eye Contact: Rinse affected eye briefly under running water, remove contact lenses if safe, continue rinsing, get medical attention if irritation continues
Skin Contact: Wash with plenty of soap and water, remove contaminated clothing and rinse, seek medical advice if symptoms develop
Inhalation: Move person to fresh air, monitor for respiratory irritation, get medical attention if any discomfort or symptoms occur
Ingestion: Rinse mouth with water, do not induce vomiting, seek medical advice or contact Poison Control immediately
Physician Notes: Symptomatic treatment and supportive measures; monitor endocrine and reproductive status as indicated

5. Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, foam, dry chemical powder, carbon dioxide
Unsuitable Extinguishing Media: Avoid high-pressure water jet due to possible spread of dust
Hazards from Combustion: May produce toxic fumes, including carbon monoxide, carbon dioxide, and nitrogen oxides
Protective Equipment for Firefighters: Self-contained breathing apparatus, full protective gear
Firefighting Instructions: Avoid inhalation of smoke, keep containers cool by spraying with water if exposed to fire, remove material if safe

6. Accidental Release Measures

Personal Precautions: Wear protective gloves, eyewear, and dust mask to avoid contact
Environmental Precautions: Prevent further spillage, avoid entry into waterways or soil
Containment Methods: Collect spillage using inert absorbent material, sweep or vacuum in a manner that minimizes dust scatter
Clean-up Procedures: Dispose in appropriate labelled container for disposal, ventilate area, wash floors and contamination sites after collection

7. Handling and Storage

Safe Handling: Use in a fume hood or well-ventilated area, avoid skin or eye contact, avoid generation of dust, wear recommended PPE
Storage Conditions: Store in tightly sealed container in a cool, dry place away from incompatible substances including oxidizers and acids, keep out of reach of unauthorized people, protect from light and moisture
Incompatible Materials: Strong oxidizing agents, acids, bases
Specific End Uses: Pharmaceutical manufacturing, research laboratories under controlled conditions

8. Exposure Controls and Personal Protection

Engineering Controls: Work under local exhaust ventilation or fume hood, maintain good room ventilation
Personal Protective Equipment: Safety goggles, lab coat, gloves (nitrile recommended), dust mask or respirator if high dust risk
Exposure Limits: Occupational exposure limit not established for dydrogesterone
Other Protective Measures: Wash hands after handling, do not eat or drink in work area, dispose of single-use PPE appropriately

9. Physical and Chemical Properties

Appearance: White or off-white crystalline powder
Odor: Odorless
Molecular Formula: C21H28O2
Molecular Weight: 312.45 g/mol
Melting Point: 196–201°C
Solubility: Poorly soluble in water, soluble in organic solvents (ethanol, acetone, chloroform)
pH: Not applicable
Boiling Point: Not applicable (decomposes)
Flash Point: Not determined
Partition Coefficient (log Pow): 2.54
Vapor Pressure: Not applicable (solid under ambient conditions)

10. Stability and Reactivity

Chemical Stability: Chemically stable under standard conditions if unopened and stored properly
Conditions to Avoid: Exposure to light, moisture, heat, open air can degrade product
Materials to Avoid: Strong oxidizers, acids, bases
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, other noxious gases
Hazardous Polymerization: Does not occur under normal handling
Reactivity: Minimal reactivity under normal temperature and pressure in storage

11. Toxicological Information

Acute Toxicity: Not acutely toxic by oral, dermal, or inhalation routes at typical exposure levels for laboratory or pharmaceutical workers
Skin and Eye Irritation: Dust can cause local irritation to mucous membranes, eyes, or skin
Chronic Effects: May disrupt hormone cycles, prolonged or repeated exposure may impact reproductive organs or functions
Sensitization: Rare reports of allergic contact dermatitis or respiratory sensitization
Carcinogenicity: Not listed as carcinogen by IARC, NTP, or OSHA
Target Organs: Endocrine and reproductive systems
Other Information: Use precautions to avoid unnecessary medical exposure, risk highest with inappropriate or occupational misuse

12. Ecological Information

Ecotoxicity: Limited data for dydrogesterone; compounds of this class may affect aquatic organisms at high concentrations
Persistence and Degradability: Not rapidly biodegradable, stable in natural conditions
Bioaccumulation Potential: Possible bioaccumulation in aquatic environments
Mobility in Soil: Expected to have low mobility due to low water solubility
Other Adverse Effects: Disposal into water systems may disrupt aquatic hormone balance, avoid uncontrolled release into environment

13. Disposal Considerations

Waste Treatment Methods: Collect solid waste and contaminated packaging in labelled containers, incinerate under controlled conditions or dispose of according to local hazardous waste procedures
Disposal of Product: Do not discharge into drains, surface water, or soil
Contaminated Packaging: Dispose containers after triple rinse or as hazardous waste
Residue Precautions: Handle residue and remains as pharmaceutical active, use dedicated waste streams

14. Transport Information

UN Number: Not regulated under ADR, IMDG, ICAO for transport
Proper Shipping Name: Pharmaceuticals, not otherwise specified
Transport Hazard Class: Not regulated as hazardous for ground, air, or sea transport
Packing Group: Not assigned
Environmental Hazards: None specifically identified for commercial forms
Special Precautions: Avoid releasing dust during handling; transport in tightly closed packaging to avoid contamination and accidental exposure

15. Regulatory Information

Inventory Status: Listed in national pharmaceutical registries and chemical inventories where applicable
Regulatory Classification: Prescription drug in many jurisdictions; occupational use regulated under workplace safety rules
Labelling Requirements: Comply with local pharmaceutical labelling obligations, include hazard warnings if intended for laboratory use
Chemical Safety Assessment: Not required for finished pharmaceutical products, recommended for bulk chemical handling
Other Standards: Subject to medical and pharmaceutical regulatory frameworks including Good Manufacturing Practice, controlled substances regulation in some regions