Material Safety Data Sheet
Material Name: Diphenhydramine Hydrochloride Injection
50mg/mL
* * * Section 1 - Chemical Product and Company Identification * * *
Manufacturer Information
Bioniche Pharma Phone: 888-258-4199
272 E Deerpath Road
Suite 304 Emergency # 888-875-1671
Lake Forest, IL 60045
* * * Section 2 - Hazards Identification * * *
Emergency Overview
May cause eye, skin, gastrointestinal, and/or respiratory tract irritation.
Potential Health Effects: Eyes
May cause irritation.
Potential Health Effects: Skin
May cause irritation.
Potential Health Effects: Ingestion
Not considered a likely route of exposure under normal product use. May casue gastrointestinal irritation if
swallowed.
Potential Health Effects: Inhalation
Not considered a likely route of exposure under normal product use. May cause respiratory tract irritation.
HMIS Ratings: Health: 1 Fire: 0 HMIS Reactivity 0
Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate 3 = Serious 4 = Severe * = Chronic hazard
* * * Section 3 - Composition / Information on Ingredients * * *
CAS # Component
7732-18-5 Water
147-24-0 Diphenhydramine hydrochloride
1310-73-2 Sodium hydroxide
7647-01-0 Hydrogen chloride
121-54-0 Benzethonium chloride
* * * Section 4 - First Aid Measures * * *
First Aid: Eyes
Flush immediately with water for at least 15 minutes. Do not rub eyes.
First Aid: Skin
For skin contact, flush with large amounts of water. If irritation persists, get medical attention.
First Aid: Ingestion
If ingestion of a large amount does occur, seek medical attention.
First Aid: Inhalation
Move person to non-contaminated air. If the affected person is not breathing, apply artificial respiration.
* * * Section 5 - Fire Fighting Measures * * *
General Fire Hazards
See Section 9 for Flammability Properties.
None
Hazardous Combustion Products
Not determined
____________________________________________________________
Page 1 of 5 Issue Date: 08/05/08 Revision: 1.0000 Print Date: 8/13/2008
Material Safety Data Sheet
Material Name: Diphenhydramine Hydrochloride Injection 50mg/mL
Extinguishing Media
Use extinguishing media appropriate for surrounding fire.
Fire Fighting Equipment/Instructions
Firefighters should wear full protective gear.
NFPA Ratings: Health: 1 Fire: 0 Reactivity: 0
Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate 3 = Serious 4 = Severe
* * * Section 6 - Accidental Release Measures * * *
Containment Procedures
Contain the discharged material.
Clean-Up Procedures
Wear appropriate protective equipment and clothing during clean-up. Use sand or perlite or vermiculite as an
absorbent for large spills of this material.
Evacuation Procedures
Isolate area. Keep unnecessary personnel away.
Special Procedures
Avoid contact with skin and eyes.
* * * Section 7 - Handling and Storage * * *
Handling Procedures
Wash hands after handling and before eating.
Storage Procedures
Keep this material in a cool, well-ventilated place.
* * * Section 8 - Exposure Controls / Personal Protection * * *
A: Component Exposure Limits
Hydrogen chloride (7647-01-0)
ACGIH: 2 ppm Ceiling
OSHA: 5 ppm Ceiling; 7 mg/m3 Ceiling
NIOSH: 5 ppm Ceiling; 7 mg/m3 Ceiling
Sodium hydroxide (1310-73-2)
ACGIH: 2 mg/m3 Ceiling
OSHA: 2 mg/m3 Ceiling
NIOSH: 2 mg/m3 Ceiling
Engineering Controls
Use general ventilation and use local exhaust, where possible, in confined or enclosed spaces.
PERSONAL PROTECTIVE EQUIPMENT
Personal Protective Equipment: Eyes/Face
Wear safety glasses; chemical goggles (if splashing is possible).
Personal Protective Equipment: Skin
Use impervious gloves.
Personal Protective Equipment: Respiratory
Not normally needed.
Personal Protective Equipment: General
Eye wash fountain is recommended.
* * * Section 9 - Physical & Chemical Properties * * *
____________________________________________________________
Page 2 of 5 Issue Date: 08/05/08 Revision: 1.0000 Print Date: 8/13/2008
Material Safety Data Sheet
Material Name: Diphenhydramine Hydrochloride Injection 50mg/mL
Appearance: Odor:
Clear None
Physical State: pH:
Liquid ND
Vapor Pressure: Vapor Density:
ND ND
Boiling Point: Melting Point:
ND ND
Solubility (H2O): Specific Gravity:
Slight ND
Evaporation Rate: VOC:
ND ND
Octanol/H2O Coeff.: Flash Point:
ND ND
Flash Point Method: Upper Flammability Limit
ND ND
(UFL):
Lower Flammability Limit Burning Rate:
ND ND
(LFL):
Auto Ignition: ND
* * * Section 10 - Chemical Stability & Reactivity Information * * *
Chemical Stability
This is a stable material.
Chemical Stability: Conditions to Avoid
None
Incompatibility
Not Determined
Hazardous Decomposition
Not Determined
Possibility of Hazardous Reactions
Will not occur.
* * * Section 11 - Toxicological Information * * *
Acute Dose Effects
A: General Product Information
No information available for the product.
B: Component Analysis - LD50/LC50
Water (7732-18-5)
Oral LD50 Rat: >90 mL/kg
Diphenhydramine hydrochloride (147-24-0)
Oral LD50 Rat: 500 mg/kg
Hydrogen chloride (7647-01-0)
Inhalation LC50 Rat: 3124 ppm/1H; Oral LD50 Rat:700 mg/kg; Dermal LD50 Rabbit:>5010 mg/kg
Sodium hydroxide (1310-73-2)
Dermal LD50 Rabbit: 1350 mg/kg
Benzethonium chloride (121-54-0)
Oral LD50 Rat: 368 mg/kg
Carcinogenicity
A: General Product Information
No information available for the product.
B: Component Carcinogenicity
Hydrogen chloride (7647-01-0)
ACGIH: A4 - Not Classifiable as a Human Carcinogen
IARC: Monograph 54 [1992] (Group 3 (not classifiable))
____________________________________________________________
Page 3 of 5 Issue Date: 08/05/08 Revision: 1.0000 Print Date: 8/13/2008
Material Safety Data Sheet
Material Name: Diphenhydramine Hydrochloride Injection 50mg/mL
* * * Section 12 - Ecological Information * * *
Ecotoxicity
A: General Product Information
No information available for the product.
B: Component Analysis - Ecotoxicity - Aquatic Toxicity
Hydrogen chloride (7647-01-0)
Test & Species Conditions
48 Hr LC50 Lepomis macrochirus 3.6 mg/L
96 Hr LC50 Gambusia affinis 282 mg/L
Sodium hydroxide (1310-73-2)
Test & Species Conditions
96 Hr LC50 Oncorhynchus mykiss 45.4 mg/L [static]
* * * Section 13 - Disposal Considerations * * *
US EPA Waste Number & Descriptions
Component Waste Numbers
No EPA Waste Numbers are applicable for this product's components.
Disposal Instructions
All wastes must be handled in accordance with local, state and federal regulations.
See Section 7 for Handling Procedures. See Section 8 for Personal Protective Equipment recommendations.
* * * Section 14 - Transportation Information * * *
US DOT Information
Shipping Name: Not Regulated
* * * Section 15 - Regulatory Information * * *
US Federal Regulations
Component Analysis
This material contains one or more of the following chemicals required to be identified under SARA Section 302
(40 CFR 355 Appendix A), SARA Section 313 (40 CFR 372.65) and/or CERCLA (40 CFR 302.4).
Hydrogen chloride (7647-01-0)
SARA 302: 500 lb TPQ (gas only)
SARA 313: 1.0 % de minimis concentration (acid aerosols including mists, vapors, gas, fog, and other
airborne forms of any particle size)
CERCLA: 5000 lb final RQ; 2270 kg final RQ
Sodium hydroxide (1310-73-2)
CERCLA: 1000 lb final RQ; 454 kg final RQ
State Regulations
Component Analysis - State
The following components appear on one or more of the following state hazardous substances lists:
Component CAS CA MA MN NJ PA RI
Hydrogen chloride 7647-01-0 Yes Yes Yes Yes Yes Yes
Sodium hydroxide 1310-73-2 Yes Yes Yes Yes Yes Yes
____________________________________________________________
Page 4 of 5 Issue Date: 08/05/08 Revision: 1.0000 Print Date: 8/13/2008
Material Safety Data Sheet
Material Name: Diphenhydramine Hydrochloride Injection 50mg/mL
Component Analysis - WHMIS IDL
The following components are identified under the Canadian Hazardous Products Act Ingredient Disclosure List:
CAS # Minimum Concentration
Component
Hydrogen chloride 7647-01-0 1%
Sodium hydroxide 1310-73-2 1%
Additional Regulatory Information
Component Analysis - Inventory
Component CAS # TSCA CAN EEC
Water 7732-18-5 Yes DSL EINECS
Diphenhydramine hydrochloride 147-24-0 No DSL EINECS
Hydrogen chloride 7647-01-0 Yes DSL EINECS
Sodium hydroxide 1310-73-2 Yes DSL EINECS
Benzethonium chloride 121-54-0 Yes DSL EINECS
* * * Section 16 - Other Information * * *
Other Information
The information herein is presented in good faith and believed to be accurate as of the effective date given.
However, no warranty, expressed or implied, is given. It is the buyer's responsibility to ensure that its activities
comply with Federal, State or provincial, and local laws.
Key/Legend
EPA = Environmental Protection Agency; TSCA = Toxic Substance Control Act; ACGIH = American Conference
of Governmental Industrial Hygienists; IARC = International Agency for Research on Cancer; NIOSH = National
Institute for Occupational Safety and Health; NTP = National Toxicology Program; OSHA = Occupational Safety
and Health Administration., NJTSR = New Jersey Trade Secret Registry.
____________________________________________________________
Page 5 of 5 Issue Date: 08/05/08 Revision: 1.0000 Print Date: 8/13/2008
|