Product Name: Hydrocortisone
Chemical Name: 11β,17α,21-Trihydroxypregn-4-ene-3,20-dione
Synonyms: Cortisol, Hydrocortone
CAS Number: 50-23-7
Molecular Formula: C21H30O5
Recommended Use: Pharmaceutical active ingredient, topical and systemic corticosteroid
Restrictions on Use: Not intended for veterinary or household uses unless prescribed
Supplier Identification: Manufacturer and distributor details, emergency contact
Emergency Phone Contact: 24-hour emergency number provided by supplier
Relevant Identified Uses: Anti-inflammatory, immunosuppressive agent in medical settings
GHS Classification: Not classified as hazardous based on current criteria
Health Hazards: Possible dermal, ocular, or inhalation exposure may result in irritation, hormonal effects, and gastrointestinal symptoms if significant exposure occurs
Environmental Hazards: Low bioaccumulation potential, aquatic toxicity not expected at normal pharmaceutical doses but improper disposal might impact aquatic life
Signs and Symptoms of Exposure: Eye and skin irritation, dizziness, headaches, nausea, allergic reactions possible
Label Elements: No signal word, hazard statements include “May cause skin and eye irritation”, “Long-term exposure may disrupt endocrine activity”
Precautionary Statements: Avoid contact with skin and eyes, use only with adequate ventilation, do not breathe dust or vapors
Main Component: Hydrocortisone, CAS No. 50-23-7, concentration 97-100%
Impurities: Trace amounts of other corticosteroids, residual solvents, under 2%
Additives: Generally none unless formulated product—excipients or carriers specified on the finished product label
Batch Information: Purity and content to be verified by certificate of analysis with each batch
Eye Contact: Rinse cautiously with lukewarm water for a minimum of fifteen minutes; hold eyelids apart; seek medical attention if irritation persists
Skin Contact: Remove contaminated clothing, wash affected skin with soap and water; if symptoms develop, consult medical personnel
Inhalation: Move to fresh air, keep person calm and warm; if breathing difficulties arise, treat symptomatically and seek medical help
Ingestion: Rinse mouth out, never give anything by mouth if person is unconscious; consult poison control or medical attention right away
Most Important Symptoms: Allergic reactions, endocrine suppression, gastrointestinal upset; chronic exposure may lead to systemic hormonal effects
Notes to Physician: Treat based on symptoms; hydrocortisone exposure rarely needs advanced intervention, but monitor for delayed effects on blood pressure and glucose
Suitable Extinguishing Media: Water spray, carbon dioxide, dry powder, or foam
Unsuitable Media: High-pressure water streams may spread material
Specific Hazards: Combustion may produce fumes of carbon oxides, possible trace toxic pyrolysis products
Protective Equipment: Firefighters should use self-contained breathing apparatus, full protective gear
Firefighting Procedures: Approach from upwind, avoid generating dust, contain run-off with inert material
Explosion Data: Dust may form explosive mixtures with air in certain conditions, though the risk is considered low for typical use amounts
Personal Precautions: Limit exposure; use gloves, goggles, and dust mask; avoid inhaling powder or vapors
Environmental Precautions: Prevent entry into waterways and drainage systems; notify authorities if large quantities escape
Clean-up Methods: Sweep or vacuum up spill, place in a sealed container for disposal; clean surface with water and detergent, keeping powders damp to minimize dust
Handling of Contaminated Materials: Place all cleanup waste in appropriate chemical waste containers; wash hands thoroughly afterward
Handling: Use only in well-ventilated areas, minimize dust; avoid contact with skin, eyes, and clothing; wash hands before eating, drinking, or toileting
Storage: Store in tightly closed container, in a cool, dry, well-ventilated place; protect from light and moisture
Incompatible Materials: Strong oxidizing agents, acids; extended contact with strong bases may degrade compound
Precautionary Practices: Clearly label storage area, restrict access to authorized personnel, maintain inventory control to track usage and prevent theft or misuse
Occupational Exposure Limit: No specific regulatory limit set, general dust standard applies (e.g., OSHA PEL for nuisance dust)
Engineering Controls: Use process enclosures, exhaust ventilation, or other engineering controls to minimize airborne exposures
Personal Protective Equipment: Nitrile gloves, chemical safety goggles, lab coat; N95 respirator recommended where dust generation is likely
Hygiene Measures: Wash thoroughly after handling material, before breaks and at end of shift; do not eat, drink, or smoke in handling area
Environmental Controls: Do not allow material to contaminate ground or surface water
Physical State: Crystalline powder
Color: White to almost white
Odor: Slight, characteristic
Odor Threshold: Not available
pH: Not determined (insoluble in water)
Melting Point: 215-220°C
Boiling Point: Decomposes before boiling
Flash Point: Not applicable (not flammable at working temperatures)
Evaporation Rate: Not relevant for solid material
Flammability: Not considered highly flammable
Vapor Pressure: Negligible at room temperature
Solubility in Water: Slightly soluble; soluble in alcohol, chloroform, and acetone
Partition Coefficient (n-octanol/water): Log Kow 1.61
Auto-ignition Temperature: No data available
Decomposition Temperature: Above 215°C (melting with decomposition)
Chemical Stability: Stable under recommended storage conditions
Reactivity: No hazardous reactivity under normal circumstances
Hazardous Polymerization: Not expected
Conditions to Avoid: Heat, moisture, light, contact with strong oxidizing agents
Incompatible Materials: Strong acids and bases, oxidizing agents
Decomposition Products: Carbon monoxide, carbon dioxide, possibly minor toxic fumes depending on conditions
Acute Toxicity: Very low toxicity by oral, dermal, or inhalation exposure in comparison to therapeutic doses; LD50 in rodents above 4,000 mg/kg
Chronic Toxicity: Long-term or high-dose exposure may impact adrenal function, suppress immune response, increase infection risk
Irritation: Possible skin and eye irritant; inhalation of dust may provoke respiratory irritation
Sensitization: Rare cases of allergic skin reactions
Carcinogenicity: Not listed as a known or suspected human carcinogen by IARC, NTP, or OSHA
Mutagenicity: Animal studies have not demonstrated genetic toxicity at therapeutic exposures
Reproductive Toxicity: Low risk at normal handling; possible impact on fetal growth with high or chronic exposure
Target Organ Effects: Adrenal glands, immune system, skin, eyes
Ecotoxicity: Low toxicity to aquatic organisms at pharmaceutical-use levels; chronically high concentrations might affect fish and aquatic invertebrates
Persistence and Degradability: Moderate persistence in the environment, susceptible to microbial degradation
Bioaccumulative Potential: No significant bioaccumulation expected in aquatic or terrestrial species
Mobility in Soil: Tends to adsorb to soils, limited leaching to groundwater
Other Adverse Effects: Endocrine-disrupting effects reported in aquatic environments after improper disposal of pharmaceuticals
Waste Treatment Methods: Collect and place in sealed, labeled containers; incinerate at approved facilities
Unused Material Disposal: Dispose of per local, state, federal, and international regulations for pharmaceutical waste
Disposal of Contaminated Packaging: Rinse and discard as hazardous waste; containers must not be reused
Environmental Precautions: Do not flush to sewer or allow to enter surface or groundwater; follow best practices in hazardous pharmaceutical disposal programs
UN Number: Not regulated as a dangerous good
Proper Shipping Name: Hydrocortisone
Transport Hazard Class: Not classified
Packing Group: Not assigned
Marine Pollutant: Not identified as marine pollutant
Special Precautions: Store during transport to prevent accidental spills or exposure; consult specific shipping agency requirements for bulk movement
US TSCA Status: Listed for research and clinical use
FDA: Approved active ingredient in prescription and over-the-counter drug products
EU Regulation: Compliant with REACH requirements, not classified as a hazardous substance for CLP
OSHA: Not listed as hazardous
WHMIS (Canada): D2B—Toxic material causing other toxic effects
SARA Title III: Not listed in any section
Other Regulatory Listings: Review local or national inventory status for updates on regional control standards and occupational exposure guidelines
Labeling Requirements: Product and hazard details must appear clearly on all containers as per pharmaceutical safety rules
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