HomeMy WebLinkAboutGSK Engerix- BSAFETY DATA SHEET
1. Identification
Product identifier ENGERIX-B
Other means of identification
Synonyms ENGERIX B ADULT INJECTION 20 MCG/ML * ENGERIX B PAEDIATRIC INJECTION 10
MCG/0.5 ML * HEPATITIS B SURFACE ANTIGEN VACCINE * HEPATITIS B (RECOMBINANT
DNA) VACCINE (ADSORBED)
Recommended use Medicinal Product
This safety data sheet is written to provide health, safety and environmental information for people
handling this formulated product in the workplace. It is not intended to provide information relevant
to medicinal use of the product. In this instance patients should consult prescribing
information/package insert/product label or consult their pharmacist or physician. For health and
safety information for individual ingredients used during manufacturing, refer to the appropriate
safety data sheet for each ingredient.
Recommended restrictions No other uses are advised.
Manufacturer/Importer/Supplier/Distributor information
Manufacturer
GlaxoSmithKline US
5 Moore Drive
Research Triangle Park, NC 27709 USA
US General Information (normal business hours): +1-888-825-5249
Email Address: msds@gsk.com
Website: www.gsk.com
EMERGENCY PHONE NUMBERS -
TRANSPORT EMERGENCIES::
US / International toll call +1 703 527 3887
available 24 hrs/7 days; multi-language response
2. Hazard(s) identification
Classified hazards
Exempt from requirements - product regulated as a medicinal product, cosmetic product or medical device.
Label elements
Exempt from requirements - product regulated as a medicinal product, cosmetic product or medical device.
Hazard(s) not otherwise classified (HNOC)
Exempt from requirements - product regulated as a medicinal product, cosmetic product or medical device.
3. Composition/information on ingredients
Mixtures
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Material name: ENGERIX-B
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SDS US
CAS number %Chemical name Common name and synonyms
AF 260 * ALCOA 331 * ALCOA C 30BF *
ALUMIGEL * ALUMINA HYDRATED *
ALUMINA TRIHYDRATE *
ALPHA-ALUMINA TRIHYDRATE *
ALUMINIC ACID * ALUMINIUM
HYDROXIDE * ALUMINUM HYDRATE *
ALUMINUM(III) HYDROXIDE * ALUMINUM
HYDROXIDE GEL * ALUMINUM OXIDE
TRIHYDRATE * ALUMINUM TRIHYDRATE *
ALUMINUM TRIHYDROXIDE * ALUSAL *
AMBEROL ST 140F * AMPHOJEL * BACO
AF 260 * BRITISH ALUMINUM AF 260 * C
31 * C 33 * C 31C * C 4D * C 31F * C-31-F *
C.I. 77002 * GHA 331 * GHA 332 * H 46 *
HIGILITE * HIGILITE H 32 * HIGILITE H 42 *
HIGILITE H 31S * HYCHOL 705 * HYDRAL
705 * HYDRAL 710 * HYDRATED ALUMINA
* LIQUIGEL * MARTINAL * P 30BF * PGA *
TRIHYDRATED ALUMINA *
TRIHYDROXYALUMINUM
21645-51-2ALUMINIUM HYDROXIDE 1
DISODIUM HYDROGEN
ORTHOPHOSPHATE * PHOSPHORIC
ACID, DISODIUM SALT * DIBASIC SODIUM
PHOSPHATE * DISODIUM
MONOHYDROGEN PHOSPHATE * DSP *
EXSICCATED SODIUM PHOSPHATE *
SODA PHOSPHATE * DISODIUM
PHOSPHORIC ACID * SODIUM
MONOHYDROGEN PHOSPHATE *
DISODIUM ACID ORTHOPHOSPHATE *
DISODIUM HYDROPHOSPHATE *
HYDROGEN DISODIUM PHOSPHATE *
DISODIUM HYDROGEN PHOSPHATE
ANHYDROUS * SODIUM PHOSPHATE
DIBASIC * DISODIUM PHOSPHATE *
TRISODIUM PHOSPHATE
7558-79-4DISODIUM HYDROGEN
PHOSPHATE
1
UnassignedHEPATITIS B VIRUS SURFACE
ANTIGEN
<1
MERCURATE(1-),
ETHYL(2-MERCAPTOBENZOATE(2-)-O,S)-,
SODIUM * MERCURY, ETHYL(HYDROGEN
O-MERCAPTOBENZOATO)-, SODIUM
SALT * ETHYLMERCURITHIOSALICYLIC
ACID, SODIUM SALT * SODIUM
ETHYLMERCURITHIOSALICYLATE *
MERCUROTHIOLATE * MERTHIOLATE
SODIUM * THIMEROSAL
54-64-8ETHYLMERCURITHIOSALICYLIC
ACID SODIUM SALT
Other components below reportable levels >96
0.1
*Designates that a specific chemical identity and/or percentage of composition has been withheld as a trade secret.
4. First-aid measures
Inhalation If not breathing, give artificial respiration. If breathing is difficult, trained personnel should give
oxygen. Get medical attention immediately.
Skin contact Immediately flush with plenty of water for at least 15 minutes while removing contaminated clothing
and shoes. Get medical attention if symptoms occur.
Eye contact In the case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
Get medical attention if irritation develops and persists.
Ingestion Rinse mouth thoroughly. Call a physician or poison control center immediately. Only induce
vomiting at the instruction of medical personnel. Never give anything by mouth to an unconscious
person.
Most important
symptoms/effects, acute and
delayed
None known.
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Indication of immediate
medical attention and special
treatment needed
Provide general supportive measures and treat symptomatically. Keep victim under observation.
Symptoms may be delayed.
General information Ensure that medical personnel are aware of the material(s) involved, and take precautions to
protect themselves. IF exposed or concerned: Get medical advice/attention.
5. Fire-fighting measures
Suitable extinguishing media Water fog. Foam. Dry chemical powder. Carbon dioxide (CO2).
Unsuitable extinguishing
media
None known.
Specific hazards arising from
the chemical
During fire, gases hazardous to health may be formed.
Special protective equipment
and precautions for firefighters
Self-contained breathing apparatus and full protective clothing must be worn in case of fire.
Fire-fighting
equipment/instructions
Move containers from fire area if you can do so without risk.
General fire hazards This product is expected to be non-combustible.
6. Accidental release measures
Personal precautions,
protective equipment and
emergency procedures
Keep unnecessary personnel away. Keep people away from and upwind of spill/leak. Wear
appropriate protective equipment and clothing during clean-up. Do not touch damaged containers
or spilled material unless wearing appropriate protective clothing. Ventilate closed spaces before
entering them. For personal protection, see section 8 of the SDS.
Methods and materials for
containment and cleaning up
Large Spills: Stop the flow of material, if this is without risk. Dike the spilled material, where this is
possible. Cover with plastic sheet to prevent spreading. Absorb in vermiculite, dry sand or earth
and place into containers. Following product recovery, flush area with water.
Small Spills: Wipe up with absorbent material (e.g. cloth, fleece). Clean surface thoroughly to
remove residual contamination.
Never return spills in original containers for re-use. For waste disposal, see section 13 of the SDS.
Environmental precautions Avoid discharge into drains, water courses or onto the ground.
7. Handling and storage
Precautions for safe handling Avoid prolonged exposure. Observe good industrial hygiene practices.
Conditions for safe storage,
including any incompatibilities
Store in original tightly closed container. Store away from incompatible materials (see Section 10
of the SDS).
8. Exposure controls/personal protection
Occupational exposure limits
GSK
ValueComponents Type
8 HR TWA 5000 mcg/m3DISODIUM HYDROGEN
PHOSPHATE (CAS
7558-79-4)
OHC 1
US. OSHA Table Z-2 (29 CFR 1910.1000)
ValueComponents Type
Ceiling 0.04 mg/m3ETHYLMERCURITHIOSALI
CYLIC ACID SODIUM SALT
(CAS 54-64-8)
TWA 0.01 mg/m3
US. ACGIH Threshold Limit Values
ValueComponents FormType
TWA 1 mg/m3 Respirable fraction.ALUMINIUM HYDROXIDE
(CAS 21645-51-2)
STEL 0.03 mg/m3ETHYLMERCURITHIOSALI
CYLIC ACID SODIUM SALT
(CAS 54-64-8)
TWA 0.01 mg/m3
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Material name: ENGERIX-B
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US. NIOSH: Pocket Guide to Chemical Hazards
ValueComponents Type
STEL 0.03 mg/m3ETHYLMERCURITHIOSALI
CYLIC ACID SODIUM SALT
(CAS 54-64-8)
TWA 0.01 mg/m3
Biological limit values
ACGIH Biological Exposure Indices
ValueComponents Determinant Specimen Sampling Time
20 µg/g Total inorganic
mercury
Creatinine in
urine
*ETHYLMERCURITHIOSALI
CYLIC ACID SODIUM SALT
(CAS 54-64-8)
* - For sampling details, please see the source document.
Exposure guidelines
US - California OELs: Skin designation
ETHYLMERCURITHIOSALICYLIC ACID SODIUM SALT
(CAS 54-64-8)
Can be absorbed through the skin.
US - Tennesse OELs: Skin designation
ETHYLMERCURITHIOSALICYLIC ACID SODIUM SALT
(CAS 54-64-8)
Can be absorbed through the skin.
US ACGIH Threshold Limit Values: Skin designation
ETHYLMERCURITHIOSALICYLIC ACID SODIUM SALT
(CAS 54-64-8)
Can be absorbed through the skin.
US NIOSH Pocket Guide to Chemical Hazards: Skin designation
ETHYLMERCURITHIOSALICYLIC ACID SODIUM SALT
(CAS 54-64-8)
Can be absorbed through the skin.
Appropriate engineering
controls
No special ventilation requirements.
Individual protection measures, such as personal protective equipment
Eye/face protection Wear safety glasses with side shields.
Hand protection Not normally needed.
Other No special protective equipment required.
Respiratory protection No personal respiratory protective equipment normally required.
Thermal hazards Not available.
General hygiene
considerations
Wash hands before breaks and immediately after handling the product.
9. Physical and chemical properties
Appearance
Physical state Liquid.
Form Vaccine.
Color Not available.
Odor Not available.
Odor threshold Not available.
pH Not available.
Melting point/freezing point Not available.
Initial boiling point and boiling
range
Not available.
Flash point Not available.
Evaporation rate Not available.
Flammability (solid, gas)Not available.
Upper/lower flammability or explosive limits
Flammability limit - lower
(%)
Not available.
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Material name: ENGERIX-B
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Flammability limit - upper
(%)
Not available.
Explosive limit - lower (%)Not available.
Explosive limit - upper (%)Not available.
Vapor pressure Not available.
Vapor density Not available.
Relative density Not available.
Solubility(ies)
Solubility (water)Not available.
Partition coefficient
(n-octanol/water)
Not available.
Auto-ignition temperature Not available.
Decomposition temperature Not available.
Viscosity Not available.
10. Stability and reactivity
Reactivity Not available.
Chemical stability Material is stable under normal conditions.
Possibility of hazardous
reactions
No dangerous reaction known under conditions of normal use.
Conditions to avoid Contact with incompatible materials.
Incompatible materials Strong oxidizing agents.
Hazardous decomposition
products
Irritating and/or toxic fumes and gases may be emitted upon the products decomposition.
11. Toxicological information
Information on likely routes of exposure
Ingestion Not established. Expected to be a low ingestion hazard.
Inhalation Not established.
Skin contact Not established.
Eye contact Not established. Direct contact with eyes may cause temporary irritation.
Symptoms related to the
physical, chemical and
toxicological characteristics
None known.
Information on toxicological effects
Acute toxicity Due to lack of data the classification is not possible. Health injuries are not known or expected
under normal use.
Test ResultsComponents Species
DISODIUM HYDROGEN PHOSPHATE (CAS 7558-79-4)
LD50 Rat
Oral
Acute
17 g/kg
* Estimates for product may be based on additional component data not shown.
Skin corrosion/irritation Due to lack of data the classification is not possible. Health injuries are not known or expected
under normal use.
Serious eye damage/eye
irritation
Due to lack of data the classification is not possible. Health injuries are not known or expected
under normal use.
Respiratory or skin sensitization
Respiratory sensitization Due to lack of data the classification is not possible.
Skin sensitization Due to lack of data the classification is not possible.
Germ cell mutagenicity Due to lack of data the classification is not possible. No data available to indicate product or any
components present at greater than 0.1% are mutagenic or genotoxic.
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Material name: ENGERIX-B
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Carcinogenicity Due to lack of data the classification is not possible. This product is not considered to be a
carcinogen by IARC, ACGIH, NTP, or OSHA.
OSHA Specifically Regulated Substances (29 CFR 1910.1001-1050)
Not listed.
Reproductive toxicity Due to lack of data the classification is not possible.
Specific target organ toxicity -
single exposure
Due to lack of data the classification is not possible.
Specific target organ toxicity -
repeated exposure
Due to lack of data the classification is not possible.
Aspiration hazard Not available.
12. Ecological information
Ecotoxicity Contains a substance which causes risk of hazardous effects to the environment.
Components Test ResultsSpecies
ALUMINIUM HYDROXIDE (CAS 21645-51-2)
Aquatic
Acute
NOECAlgae > 100 mg/l, 72 hoursGreen algae (Selenastrum
capricornutum)
NOECCrustacea > 100 mg/l, 48 hoursWater flea (Daphnia magna)
NOECFish > 100 mg/l, 96 hours Static renewal testBrown trout (Adult Salmo trutta)
* Estimates for product may be based on additional component data not shown.
DISODIUM HYDROGEN PHOSPHATE (CAS 7558-79-4)
Aquatic
Acute
EC50Crustacea 252 mg/lWater flea (Daphnia magna)
Persistence and degradability No data is available on the degradability of this product.
Bioaccumulative potential No data available.
Mobility in soil No data available.
Other adverse effects Not available.
13. Disposal considerations
Disposal instructions Collect and reclaim or dispose in sealed containers at licensed waste disposal site.
Local disposal regulations Dispose in accordance with all applicable regulations.
Hazardous waste code The waste code should be assigned in discussion between the user, the producer and the waste
disposal company.
Waste from residues / unused
products
Dispose of in accordance with local regulations. Empty containers or liners may retain some
product residues. This material and its container must be disposed of in a safe manner (see:
Disposal instructions).
Contaminated packaging Empty containers should be taken to an approved waste handling site for recycling or disposal.
Since emptied containers may retain product residue, follow label warnings even after container is
emptied.
14. Transport information
DOT
Not regulated as a dangerous good.
IATA
Not regulated as dangerous goods.
IMDG
Not regulated as dangerous goods.
MARPOL Annex II applies to liquids used in a ship's operation that pose a threat to the marine
environment. These materials may not be transported in bulk.
Transport in bulk according to
Annex II of MARPOL 73/78 and
the IBC Code
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Material name: ENGERIX-B
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SDS US
15. Regulatory information
US federal regulations
TSCA Section 12(b) Export Notification (40 CFR 707, Subpt. D)
Not regulated.
CERCLA Hazardous Substance List (40 CFR 302.4)
DISODIUM HYDROGEN PHOSPHATE (CAS 7558-79-4) Listed.
SARA 304 Emergency release notification
Not regulated.
OSHA Specifically Regulated Substances (29 CFR 1910.1001-1050)
Not listed.
Superfund Amendments and Reauthorization Act of 1986 (SARA)
Hazard categories Immediate Hazard - No
Delayed Hazard - No
Fire Hazard - No
Pressure Hazard - No
Reactivity Hazard - No
SARA 302 Extremely hazardous substance
Not listed.
SARA 311/312 Hazardous
chemical
No
SARA 313 (TRI reporting)
Not regulated.
Other federal regulations
Clean Air Act (CAA) Section 112 Hazardous Air Pollutants (HAPs) List
ETHYLMERCURITHIOSALICYLIC ACID SODIUM SALT (CAS 54-64-8)
Clean Air Act (CAA) Section 112(r) Accidental Release Prevention (40 CFR 68.130)
Not regulated.
Safe Drinking Water Act
(SDWA)
Not regulated.
US state regulations
US. Massachusetts RTK - Substance List
DISODIUM HYDROGEN PHOSPHATE (CAS 7558-79-4)
ETHYLMERCURITHIOSALICYLIC ACID SODIUM SALT (CAS 54-64-8)
US. New Jersey Worker and Community Right-to-Know Act
DISODIUM HYDROGEN PHOSPHATE (CAS 7558-79-4)
ETHYLMERCURITHIOSALICYLIC ACID SODIUM SALT (CAS 54-64-8)
US. Pennsylvania Worker and Community Right-to-Know Law
DISODIUM HYDROGEN PHOSPHATE (CAS 7558-79-4)
ETHYLMERCURITHIOSALICYLIC ACID SODIUM SALT (CAS 54-64-8)
US. Rhode Island RTK
DISODIUM HYDROGEN PHOSPHATE (CAS 7558-79-4)
ETHYLMERCURITHIOSALICYLIC ACID SODIUM SALT (CAS 54-64-8)
US. California Proposition 65
WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive
harm.
US - California Proposition 65 - CRT: Listed date/Developmental toxin
ETHYLMERCURITHIOSALICYLIC ACID SODIUM
SALT (CAS 54-64-8)
Listed: July 1, 1990
International Inventories
Country(s) or region Inventory name On inventory (yes/no)*
NoAustralia Australian Inventory of Chemical Substances (AICS)
NoCanada Domestic Substances List (DSL)
NoCanada Non-Domestic Substances List (NDSL)
NoChina Inventory of Existing Chemical Substances in China (IECSC)
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Material name: ENGERIX-B
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SDS US
Country(s) or region Inventory name On inventory (yes/no)*
NoEurope European Inventory of Existing Commercial Chemical
Substances (EINECS)
NoEurope European List of Notified Chemical Substances (ELINCS)
NoJapan Inventory of Existing and New Chemical Substances (ENCS)
NoKorea Existing Chemicals List (ECL)
NoNew Zealand New Zealand Inventory
NoPhilippines Philippine Inventory of Chemicals and Chemical Substances
(PICCS)
NoUnited States & Puerto Rico Toxic Substances Control Act (TSCA) Inventory
*A "Yes" indicates that all components of this product comply with the inventory requirements administered by the governing country(s)
A "No" indicates that one or more components of the product are not listed or exempt from listing on the inventory administered by the governing
country(s).
16. Other information, including date of preparation or last revision
Issue date 08-08-2014
Revision date 08-08-2014
Version #17
Further information HMIS® is a registered trade and service mark of the NPCA.
HMIS® ratings Health: 1
Flammability: 0
Physical hazard: 0
NFPA ratings Health: 1
Flammability: 0
Instability: 0
References GSK Hazard Determination
Disclaimer The information and recommendations in this safety data sheet are, to the best of our knowledge,
accurate as of the date of issue. Nothing herein shall be deemed to create any warranty, express
or implied. It is the responsibility of the user to determine the applicability of this information and
the suitability of the material or product for any particular purpose.
Revision Information Composition / Information on Ingredients: Ingredients
First-aid measures: Most important symptoms/effects, acute and delayed
Fire-fighting measures: Unsuitable extinguishing media
Fire-fighting measures: Specific methods
Physical & Chemical Properties: Multiple Properties
Physical and chemical properties: <INDENT>Form
Regulatory Information: United States
Other information, including date of preparation or last revision: References
Other information, including date of preparation or last revision: Further information
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Material name: ENGERIX-B
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SDS US