MSDS for Brimonidine D-Tartrate

Identification

Product Name: Brimonidine D-Tartrate
Chemical Name: 5-Bromo-6-(2-imidazolidinylideneamino)quinoxaline tartrate
CAS Number: 70359-46-5
Recommended Use: Pharmaceutical ingredient, primarily in ophthalmic formulations for glaucoma
Supplier: Contact information of manufacturer, address, phone number, emergency telephone
Synonyms: Alphagan tartrate, Brimonidine ditartrate

Hazard Identification

GHS Classification: Acute toxicity (oral and dermal, category 4), Eye irritation (category 2A), Environmental hazard (category 3, chronic)
Hazard Symbols: Exclamation mark, Environment
Signal Word: Warning
Hazard Statements: Harmful if swallowed or in contact with skin. Causes serious eye irritation. Harmful to aquatic life with long lasting effects.
Precautionary Statements: Wear protective gloves and eye protection. Avoid release to the environment. Wash thoroughly after handling.

Composition / Information on Ingredients

Chemical Identity: Brimonidine D-Tartrate
CAS Number: 70359-46-5
Concentration: >98% (by HPLC)
Impurities: Less than 2%, proprietary or trace synthesis byproducts

First Aid Measures

Inhalation: Move to fresh air. Seek medical attention for symptoms including dizziness, headache, or respiratory distress.
Eye Contact: Rinse cautiously with water for at least 15 minutes. Remove contact lenses if present and easy to do. Seek medical care for ongoing irritation.
Skin Contact: Wash immediately with plenty of water. Remove contaminated clothing. Seek medical advice if irritation occurs.
Ingestion: Rinse mouth. Never induce vomiting unless directed by medical personnel. Seek immediate medical attention.
Important Symptoms: May cause drowsiness, headache, eye redness, skin irritation.

Fire-Fighting Measures

Suitable Extinguishing Media: Use water spray, foam, carbon dioxide, or dry chemical.
Unsuitable Media: Direct high-pressure water may cause material spread.
Specific Hazards: May emit toxic fumes such as nitrogen oxides and carbon oxides.
Protective Gear: Firefighters require self-contained breathing apparatus and full protective clothing.
Other Instructions: Prevent runoff from entering water sources. Cool containers exposed to heat with water spray.

Accidental Release Measures

Personal Precautions: Avoid dust formation and inhalation. Use appropriate PPE including gloves, eye protection, and respiratory protection.
Environmental Precautions: Prevent further leakage or spillage. Prevent entry into drains, water courses, or soil.
Cleanup Methods: Sweep up and place in a suitable, labeled waste container for disposal. Clean spill area with water and suitable detergent.

Handling and Storage

Handling: Handle in a well-ventilated area. Avoid skin, eye, or clothing contact. Do not breathe dust or aerosol particles. Keep away from incompatible substances such as strong oxidizers.
Storage: Store locked up, in tightly closed containers at room temperature, away from direct light and humidity. Maintain storage below 25°C.
Special Provisions: Keep out of reach of children and unauthorized personnel.

Exposure Controls and Personal Protection

Engineering Controls: Use local exhaust ventilation and process enclosures when possible.
Personal Protection: Eye/face protection with safety goggles; gloves resistant to chemicals; protective clothing; adequate respiratory protection for dust or aerosol exposure.
Exposure Limits: No occupational exposure limits established for this compound.

Hygiene Measures: Wash hands thoroughly after handling. Do not eat, drink, or smoke in handling areas. Remove contaminated clothing promptly.

Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless or faint chemical odor
pH: 2.9-3.5 (1% solution in water)
Melting Point: 203-206°C
Boiling Point: Not applicable (decomposes)
Water Solubility: Freely soluble
Molecular Formula: C11H10BrN5·C4H6O6
Molecular Weight: 442.24 g/mol
Flash Point: Not determined
Vapor Pressure: Negligible
Density: 1.46 g/cm³ (approximate)
Partition Coefficient: logP < 2.0

Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions.
Possibility of Hazardous Reactions: No dangerous reactions known under normal use.
Conditions to Avoid: Exposure to heat, moisture, direct sunlight, strong oxidizers.
Incompatible Materials: Avoid contact with strong acids, bases, and oxidizing agents.
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, hydrogen bromide may form on combustion or decomposition.

Toxicological Information

Acute Toxicity: Oral LD50 (rat): 50-300 mg/kg. Skin and eye irritation observed at higher doses.
Routes of Exposure: Inhalation, ingestion, skin and eye contact.
Chronic Effects: Repeated or prolonged exposure may result in nervous system effects, eye redness, headache, drowsiness.
Carcinogenicity, Mutagenicity, Reproductive Toxicity: Not classified as carcinogenic or mutagenic by major agencies; toxicological studies in animals suggest possible effects at high doses.
Sensitization: Not known to cause skin sensitization.
Other Effects: May affect blood pressure and heart rate when absorbed in significant amounts.

Ecological Information

Ecotoxicity: Harmful to aquatic organisms, toxicity to fish and invertebrates at low levels.
Mobility in Soil: Potential for water mobility. Binds moderately to soil.
Persistence and Degradability: Expected to be slowly biodegradable under normal conditions.
Bioaccumulation Potential: Low bioaccumulation observed based on logP and persistence data.
Other Environmental Info: Avoid uncontrolled release to the environment.

Disposal Considerations

Waste Disposal Methods: Dispose in accordance with local, regional, and national regulations. Place residues in a sealed container designated for pharmaceutical waste.
Contaminated Packaging: Triple rinse, then dispose of as hazardous waste.
Precautions: Do not flush to sewer, do not recycle containers for other uses.

Transport Information

UN Number: Not classified as a dangerous good for transport.
Proper Shipping Name: Brimonidine D-Tartrate
Transport Hazard Class: Non-hazardous for air, sea, or land transport under UN, IMDG, IATA, DOT
Packing Group: Not applicable
Special Precautions: Ensure packaging prevents leakage and is properly labeled per local guidelines.
Environmental Hazards: Not considered a marine pollutant but take precautions against large releases.

Regulatory Information

TSCA Status: Not listed
EINECS/ELINCS: Not listed
REACH Registration: Exempt as pharmaceutical active substance
OSHA Hazards: Irritant, harmful by ingestion and skin contact
WHMIS Classification: D2B (Toxic material causing other toxic effects)
SARA 313: Contains no chemicals subject to reporting
Other Information: Product intended for professional and industrial use under regulated conditions. Users need training for safe handling and disposal.