Download Material Safety Data Sheet for Benadryl® (Diphenhydramine hydrochloride) Injection and more Study notes Toxicology in PDF only on Docsity!
Revision date: 05-Jan-2007 Page 1 of 6 Version: 2.
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING
Material Name: Benadryl ® (Diphenhydramine hydrochloride) for Injection
Trade Name: Benadryl (R) Chemical Family: Mixture Intended Use: Pharmaceutical product used as antihistamine sedative
2. COMPOSITION/INFORMATION ON INGREDIENTS
Hazardous Ingredient CAS Number EU EINECS List % Diphenhydramine hydrochloride 147-24-0 205-687-2 5 Hydrogen chloride 7647-01-0 231-595-7 ** Sodium hydroxide 1310-73-2 215-185-5 **
Ingredient CAS Number EU EINECS List % Water for injection 7732-18-5 231-791-2 *
Additional Information: ** to adjust pH Ingredient(s) indicated as hazardous have been assessed under standards for workplace safety.
3. HAZARDS IDENTIFICATION
Appearance: Colorless, odorless solution Signal Word: WARNING
Statement of Hazard: Harmful if swallowed.
Additional Hazard Information: Short Term: Not an eye irritant , Not a skin irritant , Not a skin sensitizer (based on components). May cause central nervous system effects. Known Clinical Effects: The most common adverse effects seen with the therapeutic use of diphenhydramine HCl include drowsiness, sleepiness, dizziness, sedation, and gastrointestinal disturbance. Higher doses may cause CNS stimulation and/or depression, and impairment of motor and cognitive skills. EU Indication of danger: Not classified
Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York 10017 1-212-573-
Pfizer Ltd Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom +00 44 (0)1304 616161
Emergency telephone number: CHEMTREC (24 hours): 1-800-424-
Emergency telephone number: ChemSafe (24 hours): +44 (0)208 762 8322
_______________________________________________________________________________________________________
Material Name: Benadryl ® (Diphenhydramine hydrochloride) for Injection
Revision date: 05-Jan-
Page 2 of 6
Version: 2.
Note: This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the product or its ingredients regardless of the potential risk. The precautionary statements and warnings included may not apply in all cases. Your needs may vary depending upon the potential for exposure in your workplace.
4. FIRST AID MEASURES
Eye Contact: Immediately flush eyes with water for at least 15 minutes. If irritation occurs or persists, get medical attention.
Skin Contact: Remove contaminated clothing and shoes. Wash skin with soap and water. If irritation occurs or persists, get medical attention.
Ingestion: Never give anything by mouth to an unconscious person. Wash out mouth with water. Do not induce vomiting unless directed by medical personnel. Seek medical attention immediately.
Inhalation: Remove to fresh air and keep patient at rest. Seek medical attention immediately.
5. FIRE FIGHTING MEASURES
Extinguishing Media: Use carbon dioxide, dry chemical, or water spray.
Hazardous Combustion Products: May emit toxic fumes of nitrogen oxides and hydrogen chloride.
Fire Fighting Procedures: During all fire fighting activities, wear appropriate protective equipment, including self- contained breathing apparatus.
Fire / Explosion Hazards: Not applicable
6. ACCIDENTAL RELEASE MEASURES
Health and Safety Precautions: Personnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize exposure.
Measures for Cleaning / Collecting: Contain the source of spill if it is safe to do so. Collect spill with absorbent material. Clean spill area thoroughly.
Measures for Environmental Protections:
Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental release.
Additional Consideration for Large Spills:
Non-essential personnel should be evacuated from affected area. Report emergency situations immediately. Clean up operations should only be undertaken by trained personnel.
7. HANDLING AND STORAGE
General Handling: Use appropriate ventilation. Avoid breathing vapor or mist. Avoid contact with skin and clothing.
Storage Conditions: Store as directed by product packaging.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Pfizer OEL TWA-8 Hr: 0.15 mg/m³, (as free base)
Diphenhydramine hydrochloride
_______________________________________________________________________________________________________
Material Name: Benadryl ® (Diphenhydramine hydrochloride) for Injection
Revision date: 05-Jan-
Page 4 of 6
Version: 2.
Acute Toxicity: (Species, Route, End Point, Dose)
Irritation / Sensitization: (Study Type, Species, Severity)
Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ)
Reproduction & Development Toxicity: (Duration, Species, Route, Dose, End Point, Effect(s))
Liver Central nervous system
Genetic Toxicity: (Study Type, Cell Type/Organism, Result)
Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s))
13 Week(s) Rat Oral 310 mg/kg/day LOAEL Liver
Guinea Pig Oral LD50 284 mg/kg
Mouse Oral LD50 900 mg/kg
2 Year(s) Rat Oral 15 mg/kg/day NOAEL Liver
Hydrogen chloride
2 Year(s) Mouse Oral 21 mg/kg/day NOAEL Liver
Human Oral LDmin. 10.1 mg/kg
Sodium hydroxide
Sodium hydroxide
Diphenhydramine hydrochloride Embryo / Fetal Development Rat Oral 100 mg/kg/day NOAEL Not teratogenic, Maternal toxicity, Fetotoxicity
Eye Irritation Rabbit Severe
Embryo / Fetal Development Mouse Oral 80 mg/kg/day NOAEL Not Teratogenic, Maternal Toxicity, Fetotoxicity
Mouse IP LD50 40 mg/kg
Embryo / Fetal Development Rat Oral 50 mg/kg/day NOAEL Not Teratogenic, Maternal Toxicity, Fetotoxicity
Rat Inhalation LC50 1H 3,124 ppm
Skin Irritation Rabbit Severe
Diphenhydramine hydrochloride
Diphenhydramine hydrochloride
Bacterial Mutagenicity (Ames) Salmonella Negative
Diphenhydramine hydrochloride
In Vitro Mammalian Cell Mutagenicity Mouse Lymphoma Negative
Eye Irritation Rabbit Non-irritating
In Vitro Chromosome Aberration Chinese Hamster Ovary (CHO) cells Positive without activation Negative with activation
In Vitro Sister Chromatid Exchange Chinese Hamster Ovary (CHO) cells Negative
Skin Sensitization - Beuhler Guinea Pig Negative
In Vitro Unscheduled DNA Synthesis Rat Hepatocyte Negative
Rat Oral LD50 500 mg/kg
Mouse Inhalation LC50 1H 1,108 ppm
Skin Sensitization - LLNA Mouse Negative
Diphenhydramine hydrochloride
2 Year(s) Rat Oral 15 mg/kg/day NOAEL Not carcinogenic
Mouse Oral LD50 114 mg/kg
Diphenhydramine hydrochloride
_______________________________________________________________________________________________________
Material Name: Benadryl ® (Diphenhydramine hydrochloride) for Injection
Revision date: 05-Jan-
Page 5 of 6
Version: 2.
Carcinogen Status: None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA. See below
12. ECOLOGICAL INFORMATION
Environmental Overview: The environmental characteristics of this material have not been fully evaluated. Releases to the environment should be avoided.
13. DISPOSAL CONSIDERATIONS
Disposal Procedures: Dispose of waste in accordance with all applicable laws and regulations.
14. TRANSPORT INFORMATION
Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations.
15. REGULATORY INFORMATION
EU Indication of danger: Not classified
OSHA Label: WARNING Harmful if swallowed.
Canada - WHMIS: Classifications
WHMIS hazard class: None required This product has been classified in accordance with the hazard criteria of the CPR and the MSDS contains all of the information required by the CPR.
2 Year(s) Mouse Oral 46 mg/kg/day NOAEL Not carcinogenic
Hydrogen chloride
Diphenhydramine hydrochloride
IARC:
Australia (AICS): Present
Group 3
