Version 13
ApprovedlRevised 26-May-2005
SDS Number 155
Material FNGERIX-B
SAFETYDATA SHEET
Claxo5mithKline
1. IDENTIFICATION THE SUBSTANCE/PREPARATION OF THE
AND
OF
COMPANY/UNDERTAKING
EN鈧珽RIX鈧?
Material
ENGERIX ADULT* ENGERIX PAEDIATRIC HEPATITIS VACCINE, B
B
B "
Synonyms . NDC
- NDCNO.58160-859-01 " NDCNO.58160-859-11
(RECOMBINANT)
*
* NDC NO.58160-859-06NDC NO. 58160-860-01NDC
"
NO. 58160-859-05
* NDCNO,58160-861-05
NO.58160-860-16
Health Safety
&
Corporate Environment,
GlaxoSmithKline,
CompanyName
980 GreatWest Road
TW8 gGS UK
Brentford,
Middlesex
+44-20-8047-500Q
UK Generaflnformation:
+44-1865-407333
(EU)
Emergency
Transport
+1-612-221-3999' 221
Ext
MedicalEmergency
US number,available hours
24
and Advice:
lnformation
response
Multi-language
Health& Safety
Corporate Environment,
GlaxoSmithKline,
Blvd,Suite105
2200Renaissance
King Prussia,PA 19406US
of
+1-888-825-5249
Information:
USGeneral
+1-703-527-3887
(non
Emergency EU)
Transport
available hours
24
US number,
guageresponse
Multi-lan
/ INFORMATION INGREDIENTS
ON
2, COMPOSITION
Percentage
CAS RN
Ingredients
Unassigned
INGREDIENTS
NON-HMARDOUS
Not applicable
ANTIGEN Unassigned
HEPATITIS VIRUSSURFACE
B
3. HAZARDS
IDENTIFICATION
This productis classified non-flammable.
as
Fire and Explosion
Handling product itsfinalformpresents minimal from
risk
in
this
Health
exposure.
occupational
effectsof overexposure the
in
Possible
May produceallergicskin reactions.
(suchas skinrash,hives,
symptoms hypersensitivity
include: of
workplace
Healtheffectsinformation basedon
is
itching,and difficulty
breathing).
hazardsof components.
aboutthe potential this product produce
to
of
No information available
is
Environment
effects,
adverseenvironmental
MEASURES
4. FIRST-AID
Pagel/8
Version 13
Approved/Revised 26-MaY-2005
SDSNumber155
MaterialENGERIX-B
vomiting. notattempt giveany solidor liquid
to
Do
Neverattempt induce
to
Ingestion
Wash
by mouthif the exposedsubjectis unconscious semi-conscious'
or
give
subject fullyconscious,
is
out the mouthwithwater.lf the exposed
attention.
plentyof waterto drink.Obtainmedical
is
exposure negligible
formsuggests riskof inhalation
that
Physical
lnhalation
inated
protective ipment,removecontam
personal equ
Usingappropriate
Skin Contact
areawithlargeamounts water.Obtain
of
and flushexposed
clothing
or
whichmay be immediate
occurs,
attention skinreaction
if
medical
delayed.
for
with cleanand gentlyflowingwater.Continue at least
Wash immediately
Eye Contact
Obtainmedicalattention.
15 minutes.
NOTESTO HEALTHPROFESSIONALS
None.
MedicalTreatment
to
contained thisvaccine generally considered
not
are
in
The components
MedicalConditions
causediseasein humans.
Caused or Aggravated
by Exposure
antidotes recommended.
are
No specific
Antidotes
MEASURES
5. FIRE.FIGHTING
although packaging combustible.
is
Fire and Explosion Hazards Notexpected the product, the
for
packaging.
Water is recommended fires involving
for
Media
Extinguishing
needed'For larger
requirements
For singleunits(packages): special
No
Special Firefighting
packages/pallets) product: or
Sincetoxic,corrosive
amounts(multiple of
Procedures
this productand
vapoursmightbe evolvedfrom fires involving
flammable
and full protective
apparatus
packaging, contained breathing
self
associated
equipment recommended firefighters. possible, containand collect
tf
for
are
waterfor laterdisposal.
firefighting
productsare expected
thermaldecomposition
Toxic,corrosive flammable
Combustion or
Hazardous
productis exposedto fire.
when the
Products
MEASURES
RELEASE
6. ACCIDENTAL
consistent the degreeof
with
Wear protective and
clothing equipment
Personal Precautions
hazard.
Precautions For largespills,take precautions prevententry intowaterways'sewers,or
to
Environmental
surfacedrainagesystems.
or
labelledcontainer recovery
for
properly
Collectand placeit in a suitable,
Methods
Glean-up
disposal.
Sodium
operations'
and
Watercan be usedfor clean-up decontaminalion
Decontamination
oxidizers be usedin clean-up
can
(bleach) otherstrong
or
hypochlorite
Procedures
surfacesshouldbe washedwith
Contaminated
operations,
decontamination
followedby anotherwater
water,then bleachor otheroxidizingsolution,
wash.
AND STORAGE
7. HANDLING
HANDLING
handling this
of
required thenormal
for
measures
control
No special
GeneralRequirements
for
ventilation expected be adequate routine
to
product. is
room
Normal
handling thisproduct.
of
- STORAGE Dispose properly frozen.
if
of
DONOTFREEZE.
PROTECTION
8. EXPOSURE
CONTROLS/PERSONAL
Page2/8
Version 13
Approved/Revised 26-MaY-2005
SDSNumber155
MaterialENGERIX-B
after
Washhandsand armsthoroughly
handling.
Nonerequired normal
for
Other Equipmentor
handling.
Procedures
Appearance
Liquidsuspension.
PhysicalForm
-
DO NOT FREEZE dispose properly frozen.
if
of
Stability
handling thisproduct'
of
Nonefor normal
Conditions to Avoid
ingestion.
Not expected be toxicfollowing
to
OralToxicity
No studieshave beenconducted.
InhalationToxicity
directcontact.
following
lrritation not expected
is
Skin Effects
directcontactwith eyes.
following
lrritation not expected
is
Eye Effects
Assessment
dermalexposure.
mightoccurfollowing
skinreactions
Allergic
Sensitisation
Respiratory
similarsubstances.
basedupon effectsof structurally
exposure.
mightoccurfollowing
(allergic)
reactions
sensitisation
conditions.
exposure
Notexpected be genotoxic underoccupational
to
GeneticToxicity
exposure
cancerin humansunderoccupational
Notexpected produce
to
Carcinogenicity
conditions. components listed carcinogens GSK,IARC,NTPor
by
as
are
No
US OSHA.
under
Not expected produceadverseeffectson fertilityor development
to
ReproductiveEffects
itions.
cond
exposure
occupational
* Other Adverse Effects exposure.
Noneknownfor occupational
aboutthe potential this productto produce
of
No information available
is
Summary
and proced res shou be
ld
u
effects.Localregulations
adverseenvironmental
priorto environmental release.
consulted
goods mustensurethat
products/returned
The disposalmethodfor rejected
Disposal
they cannotbe re-soldor re-used.
Recommendations
whendisposing thisproduct.
of
regulations
Observe localand national
all
RegulatoryRequirements
INFORMATION
14. TRANSPORT
Only
release'
accompany shipments reference the eventof spillage accidental
or
in
for
all
The SDS should
and international
national
in accordance appropriate
with
personstrainedand competent
authorised
goodsfor transport.
requirements prepare dangerous
may
regulatory
and Labelling
UN Glassification
Transportation shipping this productis not restri_cled,has no known,
lt
of
and
Transport Information
US
packaging labelling air,maritime,
for
or
special
hazards requiring
significant
purposes.
ground transport
or European
INFORMATION
15. REGULATORY
requirements. shouldnot be
lt
belowis an overviewof the majorregulatory
included
The information
requirements.
for
shouldbe consulted additional
Localregulations
considered be an exhaustivesummary.
to
Page3/8
Version 13
SDSNumber155 Approved/Revised 26-May-2005
MaterialENGERIX-B
* EU Classificatiori
and Labelling
-
directive product
regulated a medicinal
as
Preparations
fromrequirements EU Dangerous
of
Exempt
product medical
product, device.
or
cosmetic
US OSHAStandard(29 CFR Part 1910.1200)
This productis exemptfrom the requirements the OSHA Hazard
of
Classification
Comm unication Standard.
Other US Regulations
TSCA Status Exempt
16. OTHER NFORMATION
I
GSK HazardDetermination
References
SDSVersionNumber 13
26-May-2005
DateApproved/Revised
SDS SectionsUpdated
Sections Subsections
Clean-up Methods
RELEASE
MEASURES
ACCIDENTAL
Procedures
Decontamination
Precautions
Environmental
Precautions
Personal
Spills
Disposal Recommendations
DISPOSAL
CONSIDERATIONS
and Guidance
GSK Standards
Requirements
Reg ulatory
SludgeRespiration
Activated
INFORMATION
ECOLOGICAL
Adsorption
Algal
AlgalDegradation
Bioaccumulation
Biodegradation
Daphnid
Distribution
Earthworm
Ecotoxicity
Fish
Hydrolysis
Growthlnhibition
Microbial
Microtox
Mobility
OtherAdverseEffects
-
OtherSpecies Aquatic
OtherSpecies- Terrestrial
Partitioning
Persistence/Deg radation
Photolysis
Solubility
Summary
Volatility
PROTECTION
EXPOSURE / PERSONAL
CONTROLS Administrative
Page4/8
13
Version
26-May-2005
Approved/Revised
SDS Number 155
Material ENGERIX-B
SDS SectionsUpdated
Subsections
Sections
Containment
PROTECTION
CONTROLS PERSONAL
/
EXPOSURE
Exposure Controls
Eye Protection
Gloves
Methods
Hygiene Monitoring
Air
Occupational
Metho,
Monitoring
Hygiene Surface
Occupational
OtherEquipment Procedures
or
Limits
OtherExposure
Otherlnformation
Equipment
OtherProtective
Respirators
Target
SurfaceExposure
Ventilation
Media
Extinguishing
MEASURES
FIRE-FIGHTING
Hazards
Fireand Explosion
Products
Hazardous Combustion
htingProcedures
SpecialFirefig
Combustibility
Sustained
Antidotes
FIRST-AID
MEASURES
Eye Contact
Procedures
Surveillance
Health
lngestion
lnhalation
by
Causedor Aggravated
Conditions
Medical
Exposure
Treatment
Medical
SkinContact
Requirements
General
AND STORAGE
HANDLING
Handling
Controls
lgnition
Systems
Protective
Storage
Aggravated Exposure
by
Conditions
HMARDS IDENTIFICATION
Environment
Eye Contact
Health
lngestion
Inhalation
Overview
SkinContact
Summary
Classification
OTHERINFORMATION
SafetyData Sheet
Disclaimer
DisclaimerSafetySummary
Technical Sheet
Disclaimer
Information HazardLabel
on
Natureof/Reason Amendment
for
Page5/8
SDSNumber155 Approved/Revised 26-May-2005 Version 13
MaterialENGERIX-B
SDS SectionsUpdated
Sections Subsections
Otherlnformation
OTHERINFORMATION
References
Riskand SafetyPhrases
SB Classification
TargetOrgan
Temperature
Autoignition
AND CHEMICAL
PROPERTIES
PHYSICAL
BoilingPoint
Clarity
Colour
Conductivity
Dissociation Constant
Properties
Dust Electrostatic
DustExplosion
Rate
Evaporation
Explosive Properties
Flammability
FlashPoint
Freezing Point
Gas Group/T-Rating
General
LowerExplosive Limit
Melting Point
Coefficient
OctanolWater Distribution
Odour
Properties
Oxidising
OxygenBalance
Packaging
Size
Particle
pH of Aqueous Solutions
PhysicalForm
lndex
Refractive
Density
Relative
(Other)
Solubility
Tension
Surface
TrainFire
Limit
UpperExplosive
VapourDensity
VapourPressure
Viscosity
VolatileComponents
WaterSolubility
UnionClassification Labelling
and
European
INFORMATION
REGULATORY
Requirements
OtherRegulations
- 65
Proposition
OtherUS Regulations California
- TSCAStatus
OtherUS Regulations
StateRegulations
Page6/8
SDSNumber155 Version 13
ApprovedlRevised 26-May-2005
MaterialENGERIX-B
SDS SectionsUpdated
Subsections
Sections
Summary
REGULATORY FORMATION
IN
(EPA)Requirements
US Environmental
-
(29
US OSHAStandard CFR Part1910.1200)
Classification
-
(29
US OSHAStandard CFR Part1910.1200)
TargetOrganStat
Conditions Avoid
to
ANDREACTIVITY
STABILITY
Corrosivity
Prod
Decomposition ucts
Hazardous
Polymerisation
Hazardous
Materials Avoid
to
Stability
Thermal Stability
Carcinogenicity
INFORMATION
TOXICOLOGY
Eye Effects
GeneticToxicity
Toxicity
Inhalation
OralToxicity
OtherAdverseEffects
Effects
Pharmacological
Effects
Reproductive
Sensitisation
SkinToxicity
TargetOrganEffects
Class/Division
INFORMATION
TRANSPORT
ActionCode
Emergency
GuideNumber
Response
Emergency
Number
EMS
Transport
Ground
European
Exceptions
Number
Hazard ldentification
Item
Marginal
MarinePollutant
MFAGNumber
NA Number
Group
Packing
Instructions
Packing
Name
Shipping
Proper
(RQ)
Reportable Quantity
SpecialPrecautions Transport
for
Risk
Subsidiary
Summary
Name
Technical
Category
Transport
Classification Labelling
and
Transport
Label(s)
Transport
Number
Tremcard
PageT/8
13
Version
Approved/Revised 26-MaY-2005
SDS Number 155
Material ENGERIX-B
SDS SectionsUpdated
Subsections
Sections
UN Number
INFORMATION
TRANSPORT
accurate
The information recommendations this safetydatasheetare,to the best of our knowledge,
in
and
implied' is the
lt
express,or
anywarranty,
shallbe deemed create
to
herein
as of the dateof issue.Nothing
or
of the userto delermine applicability this information the suitability the material
of
and
of
the
responsibility
purpose.
product any particular
for
PageS/8
|