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Bromhexine Hydrochloride: Material Safety Data Sheet (MSDS)

Identification

Product Name: Bromhexine Hydrochloride
Chemical Formula: C14H20Br2N2·HCl
Synonyms: 2-amino-3,5-dibromo-N-cyclohexyl-N-methylbenzylamine hydrochloride
CAS Number: 611-75-6
Use: Expectorant in pharmaceutical preparations
Manufacturer Information: Obtain from supplier label or regulatory documentation
Emergency Contact: Refer to local regulatory requirements and supplier emergency number

Hazard Identification

Classification: Harmful if swallowed, irritant to eyes and respiratory tract
Label Elements: Skull and crossbones pictogram, exclamation mark
Risk Phrases: Harmful if inhaled or ingested, irritating to skin and mucous membranes
Precautionary Statements: Wear appropriate gloves and goggles, avoid breathing dust, handle in well-ventilated areas
Routes of Exposure: Inhalation, ingestion, contact with skin and eyes
Potential Health Effects: Respiratory discomfort, eye redness, nausea, skin irritation, acute toxicity with large doses; target organs include liver and kidneys

Composition / Information on Ingredients

Chemical Name: Bromhexine Hydrochloride
Concentration: 100% active ingredient in pure form
Impurities: Trace solvents from synthesis process, potential for residual organic compounds
Hazardous Components: None apart from the main active ingredient
Molecular Weight: Approximately 412.6 g/mol

First Aid Measures

Inhalation: Remove to fresh air, support breathing as needed, seek medical attention for persistent symptoms
Eye Contact: Flush with plenty of lukewarm water for at least 15 minutes, remove contact lenses if present, consult an ophthalmologist if irritation persists
Skin Contact: Remove contaminated clothing, wash exposed area with soap and water, seek medical assistance if irritation continues
Ingestion: Rinse mouth with water, never induce vomiting except under medical direction, obtain urgent medical care
General Advice: Provide safety data sheet to physician, monitor vital signs closely in acute exposures, symptomatic treatment as required

Fire-Fighting Measures

Suitable Extinguishing Media: Foam, dry chemical powder, CO2, and water spray can be effective
Hazardous Combustion Products: Emits toxic fumes such as nitrogen oxides, hydrogen chloride, bromine compounds on decomposition
Protective Equipment: Firefighters should wear self-contained breathing apparatus and full protective gear
Special Hazards: Dust can form explosive mixtures in air; chemical may decompose under heat producing hazardous gases
Firefighting Instructions: Ventilate area after extinguishing, avoid contact with runoff water, prevent discharge to sewers

Accidental Release Measures

Personal Precautions: Use personal protective equipment including gloves, mask, and safety goggles
Environmental Precautions: Prevent product from entering drains or waterways, contain spillage with absorbent materials
Cleanup Methods: Scoop up spilled substance carefully, avoid creating dust, place in sealed container for disposal
Decontamination: Wash area with plenty of water and detergent, ventilate area adequately after cleanup
Reporting Procedures: Report large releases to local authorities as specified by regulations

Handling and Storage

Safe Handling: Work in a well-ventilated environment, minimize dust generation, avoid inhalation and skin contact, do not eat or drink near the product
Storage Requirements: Keep container tightly closed, store in a cool, dry place protected from light and moisture, segregate from incompatible chemicals such as strong oxidizing agents
Additional Protection: Use sealed transfer systems where possible, label all storage containers clearly, implement spill control procedures
Hygiene Measures: Thoroughly wash hands and face before leaving work area, do not reuse containers that have held the product

Exposure Controls and Personal Protection

Occupational Exposure Limits: No established TLV or OSHA PEL for Bromhexine Hydrochloride
Engineering Controls: Use laboratory fume hood or local exhaust to limit airborne dust
Respiratory Protection: Approved particulate respirators for dusty operations
Eye Protection: Chemical splash goggles or safety glasses
Skin Protection: Chemical-resistant gloves, long-sleeved lab coat or coveralls
Workplace Hygiene: Remove contaminated clothes immediately, dispose of or launder before reuse

Physical and Chemical Properties

Appearance: White to slightly yellow crystalline powder
Odor: Odorless
Melting Point: Approximately 248°C
Boiling Point: Data not available due to decomposition prior to boiling
Solubility: Freely soluble in water, soluble in alcohol
pH (solution): Near neutral in water
Partition Coefficient: Data not established
Vapor Pressure: Not volatile at room temperature
Density: Approximately 1.56 g/cm³
Other Properties: Non-flammable in solid form, forms dust in air

Stability and Reactivity

Chemical Stability: Stable under standard temperature and pressure, avoids rapid decomposition under normal storage
Reactivity Profile: Reacts with strong oxidizers, releases hazardous vapors at elevated temperatures or on contact with acids
Decomposition Products: Toxic nitrogen oxides, hydrochloric acid, and bromine-containing vapors
Hazardous Polymerization: Not expected
Specific Conditions to Avoid: Excessive heat, moisture, and direct sunlight

Toxicological Information

Acute Toxicity: LD50 (oral, rat): approx. 300 mg/kg; low to moderate toxicity level
Routes of Exposure: Inhalation, ingestion, dermal and ocular contact
Chronic Effects: Prolonged exposure may result in liver and kidney effects; hypersensitivity reactions in some individuals
Carcinogenicity: No evidence from animal studies or human reports
Other Health Effects: Can lead to gastrointestinal upset, headache, dizziness, and allergic dermatitis in sensitive people
Mutagenicity / Reproductive Toxicity: No clear reports of mutagenic or reproductive risks; ongoing monitoring recommended

Ecological Information

Behavior and Fate: Expected to be biologically degradable over time, soluble in aqueous environments
Aquatic Toxicity: Harmful to aquatic organisms at moderate concentrations, possible effects on fish and invertebrates
Mobility: Moves freely in water, persistence considered moderate
Bioaccumulation: Low reported tendency to bioaccumulate
Other Concerns: Avoid large scale discharge to environment, treat effluent before disposal

Disposal Considerations

Hazardous Waste Status: Dispose as pharmaceutical or laboratory waste according to local, state, and national regulations
Methods: Incineration in an approved facility preferred, chemical waste landfill as an alternative depending on local regulations
Contaminated Packaging: Rinse empty containers with water, dispose as hazardous material, do not reuse
Precautions: Prevent exposure to landfill leachate; detailed record-keeping for all disposal actions

Transport Information

UN Number: Not regulated under international transportation guidelines (IMDG, IATA, ADR) for standard quantities
Transport Hazard Class: Not classified as hazardous for transport at the package level
Packing Group: Not assigned
Shipping Label Requirements: Maintain identification and emergency contact details, use strong packaging to prevent rupture
Special Transport Precautions: Prevent breakage, avoid contact with incompatible chemicals, control dust release during bulk shipment

Regulatory Information

Labelling: Products must carry proper identification labels and hazard warnings as per GHS requirements
TSCA Status: Not listed as a regulated substance for the Toxic Substances Control Act (US)
REACH Status: Inclusion in candidate or authorized lists depends on manufacturer region
Other Applicable Regulations: Regular review required for updates to chemical safety, environmental, and workplace safety legislation
Workplace Controls: Must comply with OSHA chemical hygiene standards, EU workplace directives, or comparable frameworks elsewhere
Medical Requirements: Provide safety training and emergency procedures to users handling the product regularly