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Product Name: Norethindrone Acetate
Chemical Name: 17α-acetoxy-19-nor-17β-pregn-4-en-20-yn-3-one
CAS Number: 51-98-9
Synonyms: Norlutin Acetate, Norlutate, Aygestin
Recommended Use: Pharmaceutical synthesis, contraceptive hormone, hormone replacement therapy
Manufacturer: Pharmaceutical manufacturing facilities, specialty chemical companies
Contact Information: Emergency response contacts and poison control phone numbers listed on bottle label and shipping paperwork
Classification: May cause reproductive toxicity, suspected of causing cancer, could cause organ damage through prolonged or repeated exposure
GHS Label: Health hazard pictogram, exclamation mark for acute toxicity
Signal Word: Danger
Hazard Statements: Harmful if swallowed or inhaled; May be absorbed through skin; Risk of adverse reproductive effects
Precautionary Statements: Avoid breathing dust; Use personal protective equipment; Wash thoroughly after handling; Do not eat, drink, or smoke when using this product
Chemical Identity: Norethindrone Acetate
Concentration: ≥ 98% pure active ingredient for pharmaceutical-grade material
Molecular Formula: C22H28O3
Impurities: Small amounts of related steroidal compounds, potential traces of residual solvents like methanol or ethanol
Additives: None reported for bulk powder; possible excipients listed for formulated tablets (consult package insert)
Inhalation: Move person to fresh air; support breathing as needed; seek medical advice if cough, dizziness, or shortness of breath develop
Skin Contact: Remove contaminated clothing; wash affected area thoroughly with soap and plenty of water; medical evaluation recommended with irritation or suspected intoxication
Eye Contact: Rinse with plenty of water, lifting eyelids occasionally; continue for minimum 15 minutes; see a doctor if redness or pain persists
Ingestion: Rinse mouth with water (only if conscious); avoid inducing vomiting unless directed by a toxicologist; contact medical professional or poison control right away
Suitable Extinguishing Media: Dry chemical, carbon dioxide, foam, or water spray
Specific Hazards: Powder can form explosive dust/aerosol mixtures in air; thermal decomposition produces toxic gases like carbon oxides
Firefighter Protection: Wear self-contained breathing apparatus and full protective gear; keep containers cool by spraying with water
Hazardous Combustion Products: Carbon monoxide, carbon dioxide, possibly traces of noxious organic fumes
Personal Precautions: Use respiratory protection and gloves; prevent contact with skin, eyes, or clothing
Environmental Precautions: Avoid discharge into drains, surface water, or soil; collect waste for safe disposal
Cleanup Methods: Sweep up carefully to avoid dust formation; dampen with water to control dust; transfer to labeled, closable container for disposal
Handling: Use appropriate exhaust ventilation; handle in accordance with pharmaceutical hygiene protocols; do not breathe dust or handle near open flames or food
Storage: Keep in tightly closed original container; store away from light, moisture, and incompatible chemicals; recommended temperature: 2–8°C (refrigerated storage); segregate from acids and oxidizing agents
Engineering Controls: Chemical fume hood, local exhaust, closed transfer systems
Personal Protective Equipment: Gloves (nitrile or latex), safety goggles, lab coat or chemical-resistant coveralls; for large spills or pharmaceutical compounding, use NIOSH-approved respirator
Occupational Exposure Limits: No established OSHA PEL; company-determined exposure limit often below 0.1 mg/m³ due to potency
Hygiene Measures: Wash hands and exposed skin thoroughly before eating, drinking, or leaving work area
Physical State: Solid (white to off-white powder)
Odor: Odorless or faint steroid-like smell
Melting Point: Approx. 205–210°C
Boiling Point: Decomposes before boiling
Solubility: Practically insoluble in water; soluble in ethanol, methanol, acetone, and chloroform
pH: Not applicable (no significant solubility in water)
Partition Coefficient (log Pow): Estimated 2.5–3.5
Molecular Weight: 340.46 g/mol
Chemical Stability: Stable at recommended storage conditions; sensitive to light and moisture
Incompatible Materials: Strong acids, strong oxidizers, alkali metals
Hazardous Reactions: None expected under normal storage and usage
Hazardous Decomposition: Burning or excessive heat may produce carbon monoxide, carbon dioxide, and steroidal fragments
Acute Toxicity: Based on related steroidal hormones, may cause effects at very low doses; oral LD50 (rat) exceeds 4000 mg/kg
Chronic Toxicity: Prolonged exposure can disrupt endocrine and reproductive function, especially in women of childbearing age
Carcinogenicity: Some evidence for increased tumor risk from long-term, high-dose exposure
Mutagenicity: Data limited; structurally related compounds may cause chromosomal changes in high-dose animal studies
Reproductive Effects: Documented risk to fertility and fetal development; medical grade product carries warning for teratogenic effects
Routes of Exposure: Inhalation, oral, dermal, ocular
Aquatic Toxicity: Low solubility limits acute impacts but persistence in sediments; potential risk to aquatic organisms, especially hormone-sensitive species
Persistence and Degradability: Slowly biodegradable, potential for soil and water contamination
Bioaccumulative Potential: Moderate, with risk of buildup in food chain based on lipophilicity
Mobility in Soil: Limited; binds strongly to organics in soil, little mobility in groundwater
Other Effects: Risk of endocrine disruption in fish and amphibians observed in related hormones
Waste Disposal Methods: Treat waste as hazardous pharmaceutical; incinerate with chemical waste in certified facility
Container Handling: Triple rinse and dispose of containers via approved waste company
Extra Precautions: Do not dispose of product down the drain; avoid landfilling bulk material due to long degradation time and risk of groundwater impact
UN Number: Not regulated under standard hazardous material codes for small quantities and research transport
Proper Shipping Name: Norethindrone Acetate or laboratory reagent, non-hazardous for air/land
Packaging: Double-sealed, shatterproof containers, shipped frozen or at controlled room temperature for stability
Transport Precautions: Shield from light, moisture, and mechanical impact; attach MSDS to shipping paperwork; declare on air waybills and customs documents for bulk shipments
US Federal: Not listed as a controlled substance; designated hazardous under OSHA Guidance for pharmaceutical actives
EU: Included on REACH candidate list as a substance of very high concern; subject to workplace exposure directive
Other Country Regulations: Schedules assigned under prescription drug laws in Canada, Australia, and Japan; restrictions on environmental discharge
Safety and Health Codes: Risk phrases include R46 (may cause heritable genetic damage), R60/61 (may impair fertility/harm unborn child); safety phrases include S22 (do not breathe dust), S24/25 (avoid contact with skin/eyes)
