Nanjing Finechem Holding Co.,Limited
Knowledge


Material Safety Data Sheet for 19-Norethindrone Acetate

Identification

Substance Name: 19-Norethindrone Acetate
Chemical Formula: C22H28O3
Synonyms: Norethindrone 17-acetate, Noracetate
CAS Number: 51-98-9
Molecular Weight: 340.46 g/mol
Recommended Use: Pharmaceutical ingredient, hormone therapy
Manufacturer: Refer to product packaging or supplier
Contact Information: Manufacturer emergency phone number or safety contact can be found on the label or vendor website
Emergency Number: Local poison control center or health department contacts are an option for exposure cases

Hazard Identification

Classification: Reproductive toxicity (Category 1B), Carcinogenicity (Category 2), Skin sensitization possible
Label Elements: Signal word: Danger. Pictograms: Exclamation mark, Health hazard
Hazard Statements: May damage fertility or an unborn child. Suspected of causing cancer. May cause an allergic skin reaction.
Precautionary Statements: Avoid unnecessary contact, handle with gloves, avoid inhalation, keep away from drinking water sources
Other Hazards: Dust generation may cause irritation of the respiratory system in a poorly ventilated area, long-term contact triggers hormonal effects

Composition / Information on Ingredients

Chemical Name: 19-Norethindrone Acetate
Concentration: 98-100%
Impurities: Less than 1% related substances, including possible trace solvents used in synthesis
Additives: None known
Formulation: Pure or mixed with pharmaceutical excipients depending on application, otherwise as active ingredient alone

First Aid Measures

Eye Contact: Rinse immediately with clean water for at least 15 minutes, keep eyes wide open, seek medical advice
Skin Contact: Wash thoroughly with soap and water, remove contaminated clothes, seek medical attention if irritation, rash, or symptoms of hormone exposure appear
Inhalation: Move individual to fresh air, monitor breathing, consult a doctor if effects or discomfort persists, artificial respiration may be used if needed
Ingestion: Rinse mouth with water, do not induce vomiting, immediate medical attention recommended, show product label or MSDS to healthcare provider
Important Symptoms: May include delayed effects on menstrual cycle, headache, dizziness, nausea

Fire-Fighting Measures

Suitable Extinguishing Media: Dry chemical, CO2, foam or water spray (use water spray only to cool containers, not directly on fire)
Specific Hazards: Toxic and irritating fumes (carbon oxides, unidentified organic compounds) may emerge during combustion
Protective Equipment: Wear self-contained breathing apparatus, full chemical protective suit for fire situations
Special Precautions: Contain run-off to prevent environmental contamination, remove containers from fire zone if possible

Accidental Release Measures

Personal Precautions: Wear gloves, goggles, lab coat or disposable suit, avoid dust formation and breathing vapors
Environmental Precautions: Keep product away from drains and soil, notify authorities if it enters waterways or large land surfaces
Methods for Cleanup: Sweep or vacuum without generating dust, collect in designated waste container, ventilate affected zone, wash spill site thoroughly, dispose of as hazardous waste
Decontamination: Mop or wipe area with damp cloth, avoid dry dusting, dispose of cleaning materials as contaminated waste

Handling and Storage

Handling: Handle in well-ventilated area, avoid ingestion, inhalation, and contact with skin or eyes, use proper medical gloves, clean hands after use, minimize airborne dust
Storage: Store in tightly sealed original container, keep at 15–30°C, protect from light and moisture, secure in chemical storage cabinet away from food and incompatible substances
Incompatible Materials: Strong acids, bases, oxidizers, extreme humidity
Other Advice: Limit access to trained personnel, monitor for degradation, rotate stock to use oldest containers first if possible

Exposure Controls and Personal Protection

Occupational Exposure Limits: No published occupational limit, minimize all exposure
Engineering Controls: Work in chemical hood or fume cupboard, local exhaust or HEPA filtration preferred where possible
Personal Protective Equipment: Chemical-resistant gloves, eye shields, lab coat, closed footwear, NIOSH-approved respirator for dust or aerosols
Environmental Controls: Filter and control air emissions, avoid direct release to environment

Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless
Melting Point: 205–210°C
Boiling Point: Not determined (decomposes before boiling)
Solubility: Insoluble in water, soluble in ethanol and methanol
Density: 1.18–1.23 g/cm³
pH: Not applicable (non-aqueous)
Flash Point: Not available
Partition Coefficient (log Kow): Approx. 3–4
Other Properties: Stable in dry, cool, protected conditions, may yellow on extended exposure to light or heat

Stability and Reactivity

Chemical Stability: Stable under regular laboratory and storage conditions
Possible Reactions: May react with strong acids and oxidizing agents, avoid prolonged contact with strong bases
Conditions to Avoid: Heat, light, moisture, open air exposure for long periods
Hazardous Decomposition: On combustion, releases carbon oxides, possibly irritating organic fragments
Polymerization: Not known to polymerize

Toxicological Information

Acute Toxicity Data: Limited animal toxicity studies, LD50 not precisely defined, known hormone disruptor
Chronic Exposure: May cause reproductive and developmental toxicity, long-term low doses can alter hormonal balance, probable carcinogen classification by global health authorities
Routes of Exposure: Eye, skin, inhalation, oral
Symptoms: Menstrual irregularity, headache, dizziness, mood change, possible liver enzyme alterations with extended exposure
Additional Risks: Increased thrombosis and cardiovascular risk with significant overexposure due to hormone activity

Ecological Information

Toxicity: Harmful to aquatic organisms due to hormonal activity
Persistence and Degradability: Biodegradation is slow, persists in soil and water, possible hormone disruption effects on wildlife
Bioaccumulative Potential: Potential exists for bioaccumulation due to high log Kow
Mobility: Binds to organic matter in soil, not very mobile in water
Other Information: Environmental exposure should be minimized, treated as pharmaceutical hazardous waste

Disposal Considerations

Waste Treatment: Dispose of as hazardous pharmaceutical waste, never discharge down the drain or into regular trash
Disposal Containers: Use clearly labeled, sealed chemical waste containers
Disposal Method: Deliver to certified chemical waste handler for incineration or secured landfill as directed by regional environmental authority
Decontamination: Any cloths, PPE, or materials exposed must go in hazardous waste stream
Regulatory Compliance: Adhere to local and national hazardous waste disposal regulations, do not attempt to treat or neutralize on site

Transport Information

UN Number: Not classified under typical transport regulations, may need to be managed as dangerous goods for bulk or concentrated forms
Proper Shipping Name: Hormone, solid, n.o.s. (19-Norethindrone Acetate)
Transport Hazard Class: No formal class, but treat as Class 6.1 toxic if shipping significant quantities
Packing Group: III for precautionary measures
Special Precautions: Secure packaging, avoid breaks, keep away from handlers without PPE
Other Information: Check specific air, road, and maritime regulations by country, transport with documentation

Regulatory Information

EU Legislation: Subject to REACH and CLP regulations due to hormone and reproductive toxicity classification
US Regulations: OSHA hazardous substance, not registered under TSCA but handled as pharmaceutical active ingredient
Labeling Requirements: Clear hazard symbols and reproductive risk warning needed
Scheduled Substance: Controlled under specific schedules in many countries for clinical use, subject to prescription and handling regulations
Other Guidelines: Comply with workplace exposure, environmental release, and controlled drug handling rules globally