MATERIAL SAFETY DAT'A SHEET
SECTION 1- CHEMICAL PRODUCT & COMPANY IDENTIFICATION
Pfizer Inc Emergencytelephone +1-212-573-2222
Pfizer Pharmaceuticals Group 24 hours
Hours of operation
235 E 42nd Street
New York, NY f 0017
Productname Benadryl@ (Diphenhydramine hydrochloride) 50 mg/ml solution f'r
Injection
Therapeuticuse Antihistamine agent
Description Colorless,
odorlesssolution
SECTION 2 - COMPOSITION/INI'ORMATION ON INGREDIENTS
Insredient CAS Number Amount
*
Diphenhydraminehydrochloride r41-24-0 5.0%
Sodium hydroxide
NF* l3r0-'73-2 to adjustpH
or
Hydrochloric
acid,NF* 7647-01-0 to adjustpH
*Flazardous
Note: Ingredient(s)indicatedas hazardoushave been assessed
under standards
for workplace safetv.
SECTION3 - HAZARDS IDENTIFICATION
Signal word CAUTION!
Statements of hazard MAY BE HARMFUL IF SWALLOWED
MAY CAUSENERVOUSSYSTEMEFFECTS
Eye effects Active ingredient not an irritant(based animaldata).
is on
Skin effects May cause skin irritation.Active ingredient not a skin sensitizer
is (based
on animaldata).
Inhalation effects An occupational Exposure Limit has been establishedfor one or more
of
the ingredients(seeSection8).
Ingestion effects May be harmful if swallowed.see'statementsof hazard','Krown clinical
effects', andlor'Other potential health effects' in this section.
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( hy 5 Solution or Iniection
f Pfizer Inc.
R e v i s i o n a t e :0 2 l 1 0 1 0 3 , e r s i o n :2 . 0 . 0
d V
Page I of6
SECTION 3 - HAZARDS IDENTIFICATION ... continued
Known clinical effects The most common adverseeffects seenwith the therapeuticusc of
diphenhydramineHCI include drowsiness,sleepiness, dizziness,sedation,
and gastrointestinaldisturbance,Higher dosesmay cause cNS stimulation
and/or depression,and irnpairment of motor and cognitive .skills.
Other potentialhealth Individuals sensitiveto this material or other materials in its chemical class
effects may develop allergic reactions.
Additional data For a more detailed discussionof potential health hazards and toxicitv see
Section11.
NOTD: This docurnent has been prepared in accordancewith standardsfor
workplace safefy, which require the inclusion of all known hazards
of the
product or its ingredientsregardlessofthe potential risk. The
precautionary statementsand wamings included may not apply
in all
cases.Your needsmay vary depending upon the potentiar for exposure
in
your workplace.
SECTION 4 - FIRST AID MEASURES
Eyes Imrnediately flush eyes with water for at least 15 minutes until no
evidence
of product remains.If initation occursor persists,get medicarattention.
Skin Remove contaminatedclothing and shoes.wash skin with soap
and water.
This material may not be completely removed by conventional
laundering.
consult professional laundry service. Do not home launder. If irritation
occurs or persists,get medicai attention.
Inhalation Remove to fresh air. If not breathing,give artificial rcspiration.
If
discomfort persists,get mcdical attention.
Ingestion Get medical attention. Do not induce vomiting unless directed
by medical
personnel.Never give anything by mouth to an unconscious
person.
SECTION 5 - F'IRE FIGHTING MEASURES
Fire fi ghting instructions wear approved positivepressure,
self-contained
breathingapparatus
and
full protective
tum out gear.
Extinguishing
media Usecarbondioxide,dry chemical, waterspray.
or
Hazardouscombustion None known or expected.
products
Flashpoint >61"C(>141.9.F)
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( e 50 m g i m l S o l u t i o nf o r I n i e c t i o n
Pfizer Inc.
R e v i s i o n a t e :0 2 l l 0 / 0 3 ,V e r s i o n : . 0 . 0
d 2
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SECTION 6 - ACCIDENTAL RELEASD MEASURES
General Review Sections3, 8 and 12 beforeproceedingwith clean up.
Small spill Use non-combustiblematerial to absorb spill; then place in a suitable,
labeled recovery container. Clean spill area thoroughly.
Large spill collect spill with a non-combustibleabsorbentmaterial. Transfer all waste
to a labeled container and move it to a secureholdine area.
SECTION T, HANDLING AND STORAGE
General
handling use appropriate
ventilation.
Avoid breathing
vaporor mist. Avoid contact
with skinandclothing.
Storageconditions Storeat controlledroom temperature.
Protectfrom freezingand light.
Temperature range l5-30"c (59-86"F)
for storage
SECTION 8 - EXPOSURE CONTROLS/PERSONAL PROTECTION
Exposurelimits
Compound Issuer Twe OEL
Diphenhydramine
hydrochloride Pfruer TWA-8 Hr 0.15rng/m3 freebase)
(as
Diphenhydramine:
Analytical method SAM# 190.0(contact
Pfizerfor additional
details)
Engineering
Ventilation conholsshouldbe usedastheprimarymeans control
to
exposures.
Local andgeneral ventilationshouldbe usedasnecessary,
when handling material bulk.For laboratory
this in use,handlein a lab
hood.
Eye protection Safetyglasses goggles
or
Skin protection Useprotectiveclothing(lab coats,
disposable
coveralls,
etc.)in both
productionand laboratoryareas.
Hand protection Wearprotectivegloves
Respiratoryprotection If the applicableoccupational
Exposure Limits (oELs) is exceeded, wear
an appropriaterespirator
with a protectionfactor sufficientto control
exposures belowtheOEL.
to
SICTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Physicalform Sterile solution
Color Colorless
Odor Odorless
P D O l 6- B e n a d r y l @D i p h e n h y d r a m i nh y d r o c h r o r i d e5 0 m g / m l S o r u t i o n
( e ) for Iniection
R e v i s i o n a t e :0 2 l 1 0 / 0 3 V e r s i o n :2 . 0 . 0
d ,
SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES ... continued
pH 5.0-6.0
100.c
Boiling point
Melting point Not applicable
Density 1.05g/cm3
Vapor pressure 2 3 h P aa t 2 0 " C
Water solubility Soluble
Solventsolubility No data available
SECTION 10 - STABII,ITY AND REACTIVITY
Reactivity Stable under normal conditions of use.
Conditions avoid
to Avoid direct sunlight, conditions that might generateheat, anrl sources
of
ignition.
Hazardous None known
decomposition
products
Hazardous Will not occur
polymerization
SECTION II - TOXICOLOGY INFORMATION
Toxicology
summary The information included in this section describesthe potential
hazardsof
the active ingredient.
Acute toxicity
Cornnound Tvp" Route Species Result
Diphenhydram hydrochl
ine oride LDso Oral Rat 500 mglkg
Irritation Ocular Rabbit Negative
Eye See Acute toxicity table.
Skin Skin irritation has been repofied in clinical use.
Inhalation No data available
Ingestion See Acute toxicity table.
Mutagenicity No evidence of mutagenic activity in bacterial or mammalian
cels in vttro,
or clastogenicactivity in vitro. Diphenhydramine hydrochloride
was
positive in the cHo assayin rhe absenceof metaboiic
activation oniy.
Sensitization Negative in the Buehler test. Negative in the rnouse Locar
Lyrnph Node
Assay (LLNA).
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f
P f i z e rI n c .
R e v i s i o nd a t e : 2 1 0 / 0 3 , e r s i o n :2 . 0 . 0
01 V
Page of 6
4
SECTION 11 - TOXICOLOGY INFORMATION ... continued
Subchroniceffects In a l3-week oral study, dose-relatediiver toxicity was seen in rats at
doses of >13 mg/kg/day in males and > l5 mgkg/day in females. The
NOAEL in this study was -6.5 mgkg/clay (males) andT mg/kg/day
(females). There were no compound-related historogical effecrs obseryed
in mice.
Chronic effects/ Liver toxicity was seenin a two-year oral study in rats treated with
carcinogenicity diphenhydramine. No-observed-Adverse-Effect-Level (NoAEL) of l5
A
mg/kglday was obtained for female animals. There was equivocal
evidence of carcinogenic activity in male and female rats. No evidence of
carcinogenic activity was observedin male or female mice.
Carcinogen
status None of the componentsof this formulation are listed as a carcinosen bv
IARC, NTP or OSHA.
Reproductiveeffects No evidence of impaired fertility was seenin studies performed in rats and
rabbits at dosesup to 5 times the hunan dose of diphenhydramine
hydrochloride.
Teratogenicity No evidence of harm to the fetus was seen in studies performed in rats and
rabbits at dosesup to 5 times the human dose of diphenhydramine
hydrochloride.
SECTION 12 - ECOLOGICAL INFORMATION
Environmentaloverview The environmental
characteristics this materiar
of havenot beenfully
evaluated.Releases theenvironment
to should avoided.
be
SECTION 13 - DISPOSAL INFORMATION
Disposal procedure Incineration is the recommendedmethod of disposal for this material.
observe all locai and national regulationswhen clisposingof this material.
SECTION I4 . TRANSPORTATION INF'ORMATION
Generalshipping Not regulated transport
for underUSDOT,EUADR, IATA, or IMDG
instructions regulations.
SECTION T5 - REGULATORY INFORMATION
EU Classification Not classified
EU Labelling Nonerequircd
PDOl6 ' BenadrylrD (Diphenhydrarnine hydrochroride)50 mg/mt Solution for Injection
R e v i s i o n , a t eO 2 / 1 0 / 0 3V e r s i o n :2 . 0 . 0
d : ,
SECTION 15 - RECULATORV INFORMATION ... continued
WHMIS Classification This producthasbeenclassified accordance
in with the hazard.criteria
of
the cPR andthe MSDScontains of the informationrequired the
all by
CPR.
SECTION16. OTHER
Disclaimer The information contained in this Material Safety Data sheet is
believed to be accurate, and while it is provided in good faith, it is
without a warranty of any kind, expresJ or implied.
P D O l 6 ' B o n a d r y l @D i p h e n h y < l r a m i n e d r o c h l o r i d e5 0 m g / m rS o r u t i o n
( hy ) for Injection
Revision dile: 021 03, Version: 2.0,0
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