Product Name: Dienogest
Chemical Formula: C20H25NO2
Synonyms: 17α-cyanomethyl-17β-hydroxyestra-4,9-dien-3-one
CAS Number: 65928-58-7
Recommended Use: Pharmaceutical ingredient, often sold as an oral tablet for gynecological or hormonal therapies
Supplier: Pharmaceutical manufacturers, chemical distributors, research organizations
Emergency Contact: Local poison control center or healthcare provider
Classification: Substance not classified as hazardous by the GHS; nonetheless, healthcare risks require caution
Possible Hazards: Endocrine disruption, reproductive risks, skin and eye irritation, potential for environmental contamination
Hazard Statements: Prolonged exposure may interfere with hormonal balance; dust or powder may cause respiratory sensitization
Pictograms: Not mandatory under GHS, but recommended: Health Hazard
Precautionary Statements: Avoid inhaling dust, wash exposed areas after handling, do not eat, drink, or smoke during handling
Target Organs: Reproductive system, liver, skin, mucous membranes
Main Ingredient: Dienogest (purity typically >98%)
Impurities: Trace synthesis byproducts, residual solvents depending on manufacturing conditions
Other Ingredients: May contain excipients if supplied as a finished dosage form such as cellulose derivatives or coloring agents
Inhalation: Move affected person to fresh air; if difficulty breathing, seek immediate medical attention
Skin Contact: Wash with soap and water; remove contaminated clothing; medical evaluation for persistent irritation or allergic reaction
Eye Contact: Rinse immediately with plenty of water for at least 15 minutes; seek medical advice if irritation continues
Ingestion: Rinse mouth thoroughly, drink water; obtain medical consultation for ingestion of any appreciable amount, especially by children or pregnant individuals
General Advice: Show this data sheet to the physician providing treatment
Suitable Extinguishing Media: Dry chemical, foam, carbon dioxide, water spray
Unsuitable Extinguishing Media: High-pressure water streams might disperse powders
Special Hazards: Burning may produce toxic gases including nitrogen oxides, carbon monoxide, hydrogen cyanide
Protective Equipment for Fire-Fighters: Self-contained breathing apparatus, full protective clothing to prevent contact with skin and eyes
Specific Procedures: Prevent firewater runoff contamination; ventilate area after fire is extinguished
Personal Precautions: Use personal protective equipment such as gloves, goggles, respirator for dust
Environmental Precautions: Prevent residue from entering water systems or drains, contain spill using absorbent material
Clean-up Methods: Avoid raising dust; collect spilled material with suitable tools and place in closed containers for disposal; clean affected area with detergent and water
Handling: Work in well-ventilated areas; avoid inhalation, ingestion, and contact with skin or eyes; use protective gear and facilities for eye washing
Storage: Store in tightly sealed original containers, in a cool, dry place away from light, moisture, oxidizers, and incompatible chemicals
Special Requirements: Product should remain inaccessible to unauthorized personnel, children, or animals
Control Parameters: No occupational exposure limits established specifically for dienogest; attention to good laboratory practices
Engineering Controls: Use fume hoods, local exhaust ventilation
Personal Protective Equipment (PPE): Gloves (nitrile or equivalent), safety goggles, disposable lab coats, and N95 masks for dust situations; emergency showers and eyewash stations recommended
Hygiene Measures: Wash hands and exposed skin before breaks and after handling; remove contaminated clothing promptly
Appearance: White to off-white crystalline powder
Odor: Odorless or faint characteristic odor
Melting Point: 210–215 °C
Boiling Point: Not applicable (decomposes before boiling)
Solubility: Slightly soluble in water, more soluble in ethanol and other organic solvents
pH: Not applicable (insoluble in water)
Partition Coefficient (log Pow): Approximately 3.6
Vapor Pressure: Negligible at room temperature
Density: About 1.18 g/cm³
Chemical Stability: Stable under recommended storage and handling conditions
Reactivity: Not reactive under normal conditions
Possible Hazardous Reactions: Strong oxidizers may degrade product, releasing toxic gases
Conditions to Avoid: Excess moisture, direct sunlight, extreme heat
Incompatible Materials: Oxidizing agents, acids, bases
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, hydrogen cyanide upon combustion
Routes of Exposure: Inhalation, ingestion, skin, and eye contact
Acute Toxicity: Low acute oral and dermal toxicity in animal studies; LD50 in rats exceeds 2000 mg/kg
Chronic Exposure: Endocrine modulation, menstrual abnormalities, reduced fertility in animal systems
Symptoms: Nausea, headache, fatigue, changes in menstrual cycle, possible allergic reactions on skin
Carcinogenicity: Not classified as carcinogenic by major agencies
Reproductive Effects: May affect hormonal pathways, not advised for handling by pregnant or breastfeeding staff without stringent protection
Ecotoxicity: Environmental exposure to dienogest may disrupt aquatic life due to endocrine activity
Persistence and Degradability: Not rapidly biodegradable; can persist in soil or water for extended periods
Bioaccumulative Potential: Moderately bioaccumulative (log Pow >3)
Mobility in Soil: Tends to adsorb to soil particles, limiting groundwater contamination but possible buildup in sediments
Further Information: Release in large quantities into waterways may cause long-term environmental effects
Residue Disposal: Collect in closed, labelled containers for incineration or disposal under professional chemical waste regulations
Contaminated Packaging: Decontaminate containers, then treat as hazardous waste
Waste Codes: Follow regional and national guidelines for disposal; do not flush into sewers or discard with regular household trash
UN Number: Not assigned for this compound under international guidelines
Proper Shipping Name: No designation as hazardous material for transport
Transport Hazard Class: Not classified as hazardous
Packing Group: Not required
Special Precautions: Transport in secure, labelled containers, protect from moisture, heat, and direct sunlight; avoid shipment near food or animal feed
Safety, Health, and Environmental Regulations: Subject to pharmaceutical and workplace safety laws in most countries
OSHA Status: Not regulated as a hazardous chemical in the United States, but must observe good laboratory practices for active pharmaceutical ingredients
TSCA Status: Not listed as a chemical substance with manufacturing restrictions
Other Regulation: Must follow controlled substance and prescription drug handling rules in many jurisdictions. Consult GHS and local sources for site-specific procedures
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