Material Safety Data Sheet: Diphenhydramine Citrate

Identification

Product Name: Diphenhydramine Citrate
Synonyms: Benadryl Citrate, 2-(Diphenylmethoxy)-N,N-dimethylethylamine citrate
CAS Number: 5634-33-7
Use: Antihistamine component in pharmaceutical preparations
Manufacturer Information: Refer to label or supplier details for actual source and emergency contact
Recommended Restrictions: Not intended for veterinary, animal feed, or food use outside controlled pharmaceutical contexts

Hazard Identification

GHS Classification: Acute toxicity (oral, category 4), Skin irritation (category 2), Eye irritation (category 2A), Specific Target Organ Toxicity - Single Exposure (Category 3: Central Nervous System effects)
GHS Label Elements: Signal word: Warning. Pictograms: Exclamation mark
Hazard Statements: Harmful if swallowed. Causes skin and eye irritation. May cause drowsiness or dizziness
Precautionary Statements: Avoid contact with skin, eyes, and clothing. Wear appropriate protective equipment. Use in well ventilated area. Wash thoroughly after handling
Potential Health Effects: Inhalation may cause respiratory tract irritation. Ingestion may lead to symptoms like dry mouth, nausea, confusion, or sedation

Composition / Information on Ingredients

Chemical Name: Diphenhydramine Citrate
Chemical Formula: C17H21NO · C6H8O7
CAS Number: 5634-33-7
Concentration: 100% (for pure substance MSDS), or refer to actual preparation for proprietary blends in pharmaceutical formats
Impurities and Stabilizing Additives: Typically absent, but product quality may vary depending on the manufacturer

First Aid Measures

Inhalation: Move person to fresh air as soon as possible. If breathing problems continue, get medical attention. Remove from exposure area until symptoms subside
Skin Contact: Remove contaminated clothing. Wash skin thoroughly with soap and water. If irritation persists or develops, seek medical attention
Eye Contact: Rinse cautiously with water for several minutes, holding eyelids open. Remove contact lenses if present and easy to do. Continue rinsing, and seek medical advice if discomfort persists
Ingestion: Do not induce vomiting. Rinse mouth with water. Medical advice is necessary due to risk of central nervous system effects

Fire-Fighting Measures

Suitable Extinguishing Media: Dry chemical, CO2, water spray, or alcohol-resistant foam. Do not use water jet directly on solid spills
Hazardous Combustion Products: Oxides of carbon and nitrogen, toxic fumes specific to decomposition under fire conditions
Special Protective Equipment and Precautions for Firefighters: Wear full protective gear including self-contained breathing apparatus. Fight fire from upwind location to avoid chemical exposure
Specific Hazards: May emit hazardous vapors during fire. Dust can form explosive mixtures in air under certain conditions

Accidental Release Measures

Personal Precautions: Avoid breathing dust. Use personal protective equipment, including gloves, goggles, and respiratory mask when necessary
Environmental Precautions: Prevent release into the drainage system, water bodies, or soil. Notify authorities if spillage enters environment
Methods for Containment and Clean Up: Sweep up or vacuum spillage, avoiding contamination of clean areas. Store collected material in closed labeled containers. Dispose according to local regulations

Handling and Storage

Precautions for Safe Handling: Avoid inhalation, ingestion, and contact with skin or eyes. Work in well-ventilated area. Wash hands and face after use
Conditions for Safe Storage: Keep container tightly closed in a dry, cool, and well-ventilated place. Protect against light and moisture. Store separate from incompatible substances like oxidizers or acids
Incompatible Materials: Strong oxidizing agents and acids. Avoid contact with reactive chemicals

Exposure Controls and Personal Protection

Engineering Controls: Local exhaust ventilation, process enclosures, or other engineering controls to keep airborne levels below recommended exposure limits
Personal Protective Equipment: Chemical resistant gloves, safety goggles, lab coat or protective clothing
Respiratory Protection: Use NIOSH-approved respirators if dust or aerosol concentration exceeds recommended limits
Exposure Limits: No established OSHA PEL or ACGIH TLV; recommend minimizing exposure as much as possible due to potential pharmacological effects

Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: No discernible odor
Odor Threshold: Not established
pH: 4–6 (1% in water)
Melting Point/Freezing Point: 140–144°C
Boiling Point/Range: Not available
Flash Point: Not available
Evaporation Rate: Not determined
Flammability: Not easily combustible under normal conditions
Vapor Pressure: Negligible at room temperature
Vapor Density: Not determined
Relative Density: No information available
Solubility: Readily soluble in water and alcohol
Partition Coefficient: Not established
Auto-ignition Temperature: No information available
Decomposition Temperature: No information available
Viscosity: Not applicable for solid powder

Stability and Reactivity

Chemical Stability: Remains stable under normal ambient conditions, out of direct sunlight and humidity
Reactivity: No dangerous reactions under normal handling
Hazardous Reactions: Contact with strong oxidizers or acids may produce hazardous vapors
Incompatible Materials: Oxidizing agents and strong acids lead to hazardous decomposition
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, and other potentially toxic vapors if overheated or exposed to flame

Toxicological Information

Acute Toxicity: LD50 (oral, rat): 520 mg/kg, based on similar diphenhydramine salts
Routes of Exposure: Inhalation, ingestion, dermal and ocular absorption
Symptoms: Drowsiness, dry mouth, blurred vision, sedative effects, confusion, tachycardia
Chronic Effects: Prolonged exposure can lead to tolerance and possible liver or kidney effects at high chronic doses
Cancer Information: Not classified as carcinogenic by IARC, NTP, or OSHA
Reproductive Effects: No direct evidence in humans; animal studies show effects in high doses
Other Information: Abuse potential if misused, especially by vulnerable groups

Ecological Information

Ecotoxicity: Data limited, but active pharmaceutical ingredients can be hazardous to aquatic species in large accidental releases
Persistence and Degradability: Partially biodegradable in aquatic environments, but breakdown may be slow
Bioaccumulative Potential: Low to moderate based on structural similarity to other antihistamines
Mobility in Soil: Moderate mobility. Risk of contamination if large spill occurs near waterway or drain
Other Adverse Effects: Pharmaceuticals in environment contribute to antimicrobial resistance; urge responsible disposal

Disposal Considerations

Waste Treatment Methods: Incinerate in approved chemical waste facilities or hand over to licensed chemical disposal companies
Contaminated Packaging: Dispose of as unused product. Triple rinse containers before discarding according to local guidelines
Special Precautions: Never discharge into environment or normal municipal waste streams. Consult local authorities for pharmaceutical disposal sites

Transport Information

UN Number: Not regulated under most hazardous materials (HAZMAT) guidelines for ground, sea, or air
Transport Hazard Class: Not classified as dangerous for transport
Packing Group: No assignment
Environmental Hazards: None specifically associated with transport, though caution advised to prevent release
Special Precautions: Avoid mixing with foodstuffs and reduce risk of rupture from rough handling

Regulatory Information

U.S. Regulations: Not listed as a controlled substance by DEA. Ingredient regulated under FDA for pharmaceutical application. Not specifically regulated under TSCA for non-industrial use
International Listings: Listed on appropriate chemical inventories in EU, Canada, Australia under pharmaceutical use
Workplace Regulations: General workplace safety applies. No special chemical-specific OSHA or EU workplace exposure limits. Product label or certificate of analysis should contain relevant National and International controls
Other Regulatory Issues: May require prescription status in some regions. Subject to transport and safety data sheet documentation during shipping and handling at industrial scale