Nanjing Finechem Holding Co.,Limited
Knowledge


Material Safety Data Sheet – Elacestrant

Identification

Product Name: Elacestrant
Chemical Name: N-(4-((3aS,4R,7aR)-2,2-dimethyl-4,7,7a,8-tetrahydro-3aH-benzo[d][1,3]dioxol-4-yl)phenyl)-3-(2-(2-fluoroethoxy)ethoxy)propanamide
Product Code: Varies by supplier
Intended Use: Pharmaceutical active for clinical and research applications
Manufacturer: Refer to purchasing source or package insert
Emergency Phone Number: Listed on packaging or supplier website

Hazard Identification

Hazard Class: Not classified as hazardous under GHS for most laboratory uses; if handled in manufacturing volumes, risk for skin, eye, or respiratory irritation
Signal Word: Warning
Hazard Statements: May cause mild skin and eye irritation; may cause respiratory tract discomfort after significant exposure
Precautionary Statements: Avoid direct contact with skin or eyes; use local exhaust ventilation; use recommended PPE
Potential Health Effects: Laboratory animal studies demonstrate possible changes to liver and reproductive organs after chronic high-dose exposure; occupational exposure risk remains limited

Composition / Information on Ingredients

Component: Elacestrant
Chemical Formula: C26H30FNO5
CAS Number: 1374639-75-4
Concentration: 100% or as supplied
Impurities: Trace synthetic by-products possible, exact identity and abundance specified on Certificate of Analysis from supplier

First Aid Measures

Inhalation: Move exposed individual to fresh air; seek medical advice if cough, breathing difficulty, or throat discomfort appear
Skin Contact: Remove contaminated clothing and wash affected area thoroughly with soap and water; persistence of irritation warrants medical assessment
Eye Contact: Rinse flushed eyes gently with water for 15 minutes; consult medical provider if redness, pain, or impaired vision persist
Ingestion: Rinse mouth; never induce vomiting unless directed by a physician; seek medical attention for larger doses or if symptoms develop

Fire-Fighting Measures

Suitable Extinguishing Media: Dry powder, carbon dioxide, or foam
Unsuitable Media: Water streams may spread powder and intensify chemical run-off
Fire Hazards: Combustible dust may accumulate if powder form disperses in air; can trigger flash fires under rare conditions
Protective Equipment: Use self-contained breathing apparatus and flame-resistant gear
Hazardous Combustion Products: Fumes may contain unidentified toxic byproducts including oxides of carbon, nitrogen, and fluorine

Accidental Release Measures

Personal Protection: Wear gloves, lab coat, goggles, and NIOSH-approved respirator in poorly ventilated places
Environmental Precautions: Prevent chemical from entering drains, soil, or watercourses
Spill Response: Cover powder gently with damp towel or absorbent; scoop up and transfer into approved waste container; ventilate area; wash surface with mild soap and water
Disposal: Dispose according to Section 13 instructions, following local or institutional hazardous waste protocols

Handling and Storage

Handling: Avoid generation of airborne dust or vapors; work inside fume hood if possible; avoid eating, drinking, or smoking near the material
Storage: Keep tightly sealed in an original, labeled container; place in temperature-controlled, dry cabinet away from direct light, strong acids, or oxidizers
Incompatibilities: Strong oxidizers and mineral acids may provoke decomposition or unfavorable reactions

Exposure Controls and Personal Protection

Control Parameters: No established OSHA or ACGIH exposure limits; handle as pharmaceutical agent with limited threshold
Engineering Controls: Use local mechanical exhaust, HEPA-filtered enclosures for weighing or transferring powder
Personal Protective Equipment: Gloves (nitrile preferred), safety glasses, laboratory coat; in large-scale settings, use respiratory protection such as P100 filters or positive-pressure respirators
Hygiene Measures: Wash hands thoroughly after handling, remove contaminated clothing promptly, avoid skin, hair, and mucous membrane contact during handling

Physical and Chemical Properties

Appearance: White to off-white fine powder
Odor: No detectable odor
pH: Not applicable (insoluble in water)
Melting Point: 204-208°C (literature values with batch variation possible)
Boiling Point: Not volatile at atmospheric pressure
Solubility: Negligible in water, measurable solubility in DMSO and ethanol
Vapor Pressure: Not significant under standard conditions
Density: Not well characterized; estimate near 1.2 g/cm³
Partition Coefficient: logP estimated > 2.5, lipophilic
Decomposition: May decompose under sustained heat, light, or humidity

Stability and Reactivity

Chemical Stability: Stable in original packaging under recommended storage; prolonged moisture, light, or air reduces potency
Hazardous Reactions: No self-reactivity under normal laboratory use; strong acids, oxidizers, or bases may trigger breakdown
Conditions to Avoid: Heat above 40°C, direct sunlight, humid environments, contact with incompatible substances
Decomposition Products: Production of carbon oxides, nitrogen oxides, fluorinated gases possible during fire or high-temperature breakdown

Toxicological Information

Acute Toxicity: Minimal oral toxicity observed in animal studies, but human data limited; eye or skin irritation possible with direct contact
Chronic Toxicity: High doses in laboratory animals show potential hepatotoxicity and altered reproductive organ weights over several weeks; mutagenicity or carcinogenicity not confirmed
Sensitization: Not established, low frequency anticipated
Target Organs: Liver, reproductive system at doses well above therapeutic range
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Symptoms: Headache, mild dizziness, or upset stomach in rare accidental ingestion; persistent irritation requires medical follow up

Ecological Information

Ecotoxicity: No aquatic toxicity data available for native compound; expected low hazard from accidental small lab spills
Persistence and Degradability: Structurally persistent due to ether and aromatic groups; slow biodegradation predicted
Bioaccumulation: Possible due to lipophilic structure (high logP); evidence still limited
Mobility in Soil: Limited mobility, binds to soils and sediments
Other Adverse Effects: Unknown chronic environmental effects from long-term release or bioaccumulation

Disposal Considerations

Disposal Method: Place all solid waste in properly labeled, sealed, hazardous waste containers
Incineration: Preferred for large scale residue; use commercial chemical incineration conforming to local, regional, or national guidelines
Waste Code: Not regulated under US RCRA for small volume research use; hazardous pharmaceutical classification likely in bulk disposal settings
Precautions: Prevent substance from entering municipal sewage or surface water; consult environmental health and safety officer for detailed protocols

Transport Information

UN Number: Not classified as dangerous goods by most regulatory authorities in typical laboratory packaging
Proper Shipping Name: Not regulated; ship as packed pharmaceutical substance or organic solid
Packing Group: No special requirements for research quantities
Transportation Hazards: Avoid moisture and extreme temperature during transit for product integrity
Label Requirements: Use standard medicinal compound or research chemical labeling, no hazardous warning necessary for small packed units

Regulatory Information

Regulatory Status: US FDA-approved drug; not listed under US TSCA or CERCLA; not specifically regulated under EU REACH or CLP for research uses
Labeling Requirements: Standard GHS signal word and hazard statements for workplace use
SARA Title III (313): Not subject to reporting
California Proposition 65: Not listed
Other Regulations: Handle in compliance with all institutional, local, and federal regulations for chemicals with potential pharmaceutical effects