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Material Safety Data Sheet (MSDS) – Cyclosporin A

1. Identification

Product Name: Cyclosporin A
Synonyms: Ciclosporin, Cyclosporine
CAS Number: 59865-13-3
Molecular Formula: C62H111N11O12
Molecular Weight: 1202.61 g/mol
Recommended Use: Research, pharmaceutical ingredient, immunosuppressive agent
Supplier: Information varies by region; always consult specific vendor documentation
Contact for Emergency: Refer to national poison center, supplier’s emergency line, or local health authority

2. Hazard Identification

Classification: Toxic if swallowed, may irritate skin, eyes, and respiratory tract; possible reproductive toxin; harmful to aquatic organisms
Routes of Exposure: Inhalation, ingestion, skin absorption, eye contact
Acute Effects: Nausea, vomiting, headache, dizziness, allergy like skin reactions; significant risk with accidental injection or prolonged inhalation
Chronic Effects: Kidney and liver damage, increased risk of infection, possible cancer risk with long-term repeated exposure in some studies
Label Elements: Signal word DANGER; skull and crossbones symbol; exclamation mark for skin/eye irritation
GHS Hazard Statements: H301: Toxic if swallowed; H315: Causes skin irritation; H319: Causes serious eye irritation; H335: May cause respiratory irritation
Precautionary Statements: Avoid breathing dust; wash thoroughly after handling; use personal protective equipment; avoid release to environment

3. Composition / Information on Ingredients

Substance: Cyclosporin A
CAS Number: 59865-13-3
Purity: Typically ≥98% (varies by supplier)
Other Components: No additives or impurities of toxicological significance expected in pharmaceutical grade material; technical or laboratory grade may contain small residual solvents or water

4. First Aid Measures

General Advice: Seek immediate medical attention for all exposures
Inhalation: Remove person to fresh air, provide oxygen if breathing becomes difficult, obtain medical aid
Skin Contact: Remove contaminated clothing, wash skin with soap and water for at least 15 minutes; do not scrub abrasively
Eye Contact: Flush eyes with water for at least 15 minutes, lift eyelids occasionally, seek medical assistance
Ingestion: Rinse mouth with water, do not induce vomiting unless instructed by physician, seek urgent treatment
Symptoms to Watch For: Nausea, rash, breathing difficulty, altered mental status
Special Instructions for Physicians: Treat symptomatically, pay close attention to kidney, liver, and immune function

5. Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, foam, dry powder, carbon dioxide
Specific Hazards: Thermal decomposition releases toxic fumes of nitrogen oxides, carbon monoxide, carbon dioxide; smoke may carry irritant or allergenic compounds
Protective Equipment for Firefighters: Self-contained breathing apparatus, full protective gear
Precautions: Isolate hazard area, prevent firefighting runoff from contaminating soil and water
Special Firefighting Procedures: Use water spray to cool containers, avoid inhalation of combustion products

6. Accidental Release Measures

Personal Precautions: Use personal protective equipment including gloves, goggles, laboratory coat, and suitable respirator for large spills
Evacuation: Evacuate unnecessary personnel and ventilate the area
Spill Cleanup Methods: Avoid dust generation, dampen solid material, collect with non-sparking tools, place in sealed containers
Decontamination: Wash spill site thoroughly with water and detergent after material removal
Environmental Precautions: Prevent release to drains, surface water, or soil—Cyclosporin A is toxic to aquatic life

7. Handling and Storage

Safe Handling: Wear protective clothing, avoid skin and eye contact, operate in fume hood or well-ventilated area, minimize airborne dust
Storage Requirements: Store in tightly closed containers, keep in a cool, dry, well-ventilated area
Temperature Range: Refrigerate or store at 2–8°C for prolonged shelf life; protect from direct sunlight and moisture
Special Storage Notes: Label containers clearly; limit access to trained personnel

8. Exposure Controls and Personal Protection

Occupational Exposure Limits: No established thresholds specific for Cyclosporin A; minimize exposure as much as possible
Engineering Controls: Local exhaust ventilation, chemical fume hood
Personal Protective Equipment: Nitrile gloves, chemical splash goggles, lab coat, shoe covers, appropriate respiratory protection for powder handling
Hygiene Practices: Wash hands, remove and clean contaminated clothing before reuse, no eating or drinking in work areas

9. Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless or faint odor
pH (solution): Not applicable
Melting Point: 148–151°C
Boiling Point: Decomposes before boiling
Solubility: Slightly soluble in water, soluble in methanol, ethanol, and chloroform
Vapor Pressure: Not measurable at ambient conditions
Density: Approximately 1.27 g/cm³
Partition Coefficient (log Kow): 3.4
Flash Point: Not applicable—solid
Decomposition Products: Toxic fumes under fire conditions

10. Stability and Reactivity

Chemical Stability: Stable under recommended storage and handling conditions
Incompatible Materials: Strong oxidizers, acids, bases
Hazardous Reactions: Decomposes on exposure to heat, flames, or incompatible materials
Hazardous Decomposition Products: Nitrogen oxides, carbon monoxide, carbon dioxide
Polymerization: Will not occur under normal conditions

11. Toxicological Information

Routes of Exposure: Ingestion, inhalation, skin, and eye contact
Acute Toxicity: Oral LD50 (rat): ~ 27 mg/kg; skin absorption and inhalation data limited; potent effects at low doses
Effects from Short-Term Exposure: Irritation of mucous membranes, nausea, vomiting, allergic skin reactions
Effects from Long-Term Exposure: Chronic immunosuppression, nephrotoxicity (kidney damage), hepatotoxicity (liver injury), possible tumor promotion in animal models
Sensitization: Known to cause allergic responses in sensitive individuals
Carcinogenicity/Mutagenicity: No clear human data; animal studies show tumor-promoting effects in context of long-term immunosuppression
Reproductive Toxicity: Possible fetal toxicity based on animal studies, birth defects observed
Other Data: Close medical monitoring required during therapeutic applications

12. Ecological Information

Aquatic Toxicity: Highly toxic to aquatic organisms, may cause long-term adverse effects in aquatic environments
Persistence and Degradability: Slow to biodegrade in soil and water; persistent bioactive residues
Bioaccumulation Potential: Moderate; detected in aquatic food webs downstream from hospitals
Mobility in Soil: Low to moderate; may bind to organic material
Other Adverse Effects: Breaks down to bioactive metabolites that remain hazardous to water quality and wildlife

13. Disposal Considerations

Waste Disposal Methods: Treat as hazardous pharmaceutical waste; incinerate in authorized facility; do not flush or dispose with general waste
Container Disposal: Rinse with suitable solvent, dispose of rinsate as hazardous waste; puncture and recycle or landfill containers in accordance with local regulations
Regulatory Considerations: Must follow local, state, and national requirements for hazardous chemical waste

14. Transport Information

UN Number: Not assigned for standard Cyclosporin A powder
Proper Shipping Name: Cyclosporin A, bulk pharmaceutical chemical
Hazard Class: Not regulated under standard UN dangerous goods protocols, but subject to regional requirements for toxic or pharmaceutical agents
Packing Group: Consult local regulations
Environmental Hazards: Marine pollutant by effect, handle to prevent release
Special Transport Precautions: Double containment, dedicated shipping containers, accompanying MSDS documentation
Labeling Requirements: Toxic substance, handle with care, restricted to trained personnel

15. Regulatory Information

TSCA (US): Not listed as a bulk chemical; research and pharmaceutical use regulated
OSHA (US): No established exposure limit, use provisions for toxic substances
REACH (EU): Controlled under REACH for pharmaceutical and research use
WHMIS (Canada): Not classified; falls under general toxic chemical rules
Other International Regulations: Subject to national drug and chemical management legislation
Restrictions on Use: Only for use by qualified personnel in approved facilities
Additional Labelling: Hazard pictograms, risk and safety phrases, lot and batch tracking required