SDS Number 110536 Approved/Revised 23-Jun-2008 Version 13
BECONASE HAYFEVER ALLERGY SPRAY
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
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Material BECONASE HAYFEVER ALLERGY SPRAY
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BECONASE AQ NASAL SPRAY * BECONASE AQUEOUS NASAL SPRAY 42 MCG *
Synonym(s)
BECONASE AQUEOUS NASAL SPRAY 50 MCG * BECONASE AQ NASAL SPRAY 0.042%
* BECONASE ALLERGY AQUEOUS NASAL SPRAY * BECOTIDE AQUEOUS NASAL
SPRAY * BECLOSOL AQ NASAL * NDC NO 0173-0388-79 * BECLOMETHASONE
DIPROPIONATE, FORMULATED PRODUCT
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GlaxoSmithKline, Corporate Environment, Health & Safety
Company Name
980 Great West Road
Brentford, Middlesex TW8 9GS UK
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UK General Information: +44-20-8047-5000
Transport Emergency (EU) +44-1865-407333
Medical Emergency +1-612-221-3999, Ext 221
Information and Advice: US number, available 24 hours
Multi-language response
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GlaxoSmithKline, Corporate Environment, Health & Safety
One Franklin Plaza, 200 N 16th Street
Philadelphia, PA 19102-1225 US
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US General Information: +1-888-825-5249
Transport Emergency (non EU) +1-703-527-3887
US number, available 24 hours
Multi-language response
.
2. COMPOSITION / INFORMATION ON INGREDIENTS
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Ingredients CAS # Percent EC-No.
BECLOMETHASONE DIPROPIONATE 5534-09-8 0.04 to 0.05 226-886-0
NON-HAZARDOUS INGREDIENTS Unassigned 99.95 to
99.96
3. HAZARDS IDENTIFICATION
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This product is classified as non-flammable.
Fire and Explosion
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Caution - Potent pharmaceutical agent.
Health
Health effects information is based on hazards of components.
May cause steroid withdrawal rash.
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No information is available about the potential of this product to produce adverse
Environment
environmental effects.
4. FIRST-AID MEASURES
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Never attempt to induce vomiting. Do not attempt to give any solid or liquid by mouth if the
Ingestion
exposed subject is unconscious or semi-conscious. Wash out the mouth with water. If the
exposed subject is fully conscious, give plenty of water to drink. Obtain medical attention.
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SDS Number 110536 Approved/Revised 23-Jun-2008 Version 13
BECONASE HAYFEVER ALLERGY SPRAY
Material
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Physical form suggests that risk of inhalation exposure is negligible.
Inhalation
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Using appropriate personal protective equipment, remove contaminated clothing and flush
Skin Contact
exposed area with large amounts of water. Obtain medical attention if skin reaction occurs,
which may be immediate or delayed.
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Wash immediately with clean and gently flowing water. Continue for at least 15 minutes.
Eye Contact
Obtain medical attention.
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NOTES TO HEALTH PROFESSIONALS
Treat according to locally accepted protocols. For additional guidance, refer to the current
Medical Treatment
prescribing information or to the local poison control information centre. Medical treatment in
cases of overexposure should be treated as an overdose of glucocorticosteroid.
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Refer to prescribing information for detailed description of medical conditions caused by or
Medical Conditions
aggravated by overexposure to this product.
Caused or Aggravated by
Exposure
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No specific antidotes are recommended.
Antidotes
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5. FIRE-FIGHTING MEASURES
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Not expected for the product, although the packaging is combustible.
Fire and Explosion Hazards
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Water, dry powder or foam extinguishers are recommended. Carbon dioxide extinguishers
Extinguishing Media
may be ineffective.
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For single units (packages): No special requirements needed. For larger amounts (multiple
Special Firefighting
packages/pallets) of product: Since toxic, corrosive or flammable vapours might be evolved
Procedures
from fires involving this product and associated packaging, self contained breathing
apparatus and full protective equipment are recommended for firefighters. If possible, contain
and collect firefighting water for later disposal.
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Toxic, corrosive or flammable thermal decomposition products are expected when the
Hazardous Combustion
product is exposed to fire.
Products
6. ACCIDENTAL RELEASE MEASURES
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Wear protective clothing and equipment consistent with the degree of hazard.
Personal Precautions
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Prevent entry into waterways, sewers, surface drainage systems and poorly ventilated areas.
Environmental Precautions
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Spread an inert absorbent on the spill and place in a suitable, properly labelled container for
Clean-up Methods
recovery or disposal.
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No specific decontamination or detoxification procedures have been identified for this
Decontamination Procedures
product.
7. HANDLING AND STORAGE
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HANDLING
Normal room ventilation is expected to be adequate for routine handling of this product.
General Requirements
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No storage requirements necessary for occupational hazards. Follow product information
STORAGE
storage instructions to maintain efficacy.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
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BECLOMETHASONE DIPROPIONATE
INGREDIENT
4
GSK Occupational Hazard
Category
SKIN
GSK Occupational 6 mcg/m3 (8 HR TWA)
Exposure Limit
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PERSONAL PROTECTIVE EQUIPMENT
Wear approved safety glasses with side shields if eye contact is possible.
Eye Protection
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Follow all local regulations if personal protective equipment (PPE) is used in the workplace.
Other Equipment or
Wear appropriate clothing to avoid skin contact. Wash hands and arms thoroughly after
Procedures
handling.
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SDS Number 110536 Approved/Revised 23-Jun-2008 Version 13
BECONASE HAYFEVER ALLERGY SPRAY
Material
9. PHYSICAL AND CHEMICAL PROPERTIES
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Appearance
Aqueous solution.
Physical Form
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6 to 6.8
pH of Aqueous Solutions
10. STABILITY AND REACTIVITY
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This product is expected to be stable.
Stability
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None for normal handling of this product.
Conditions to Avoid
11. TOXICOLOGY INFORMATION
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This material is a selective glucocorticoid receptor agonist.
Pharmacological Effects
Adverse effects of overexposure might include: suppression of adrenal glands; temporary
decrease in white blood cell counts; symptoms of hypersensitivity (such as skin rash, hives,
itching, and difficulty breathing); increased susceptibility to infection.
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Adverse effects might occur in the following organ(s) following overexposure: adrenal glands;
Target Organ Effects
immune system.
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Routes of Exposure
Not expected to be toxic following ingestion.
Oral Toxicity
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Irritation is not expected following direct contact. Pharmacological effects may occur
Skin Effects
following skin absorption.
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Minor irritation might occur following direct contact with eyes.
Eye Effects
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Allergic skin reactions might occur following dermal exposure. Assessment based upon
Sensitisation
information from human exposure.
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Not expected to be genotoxic under occupational exposure conditions.
Genetic Toxicity
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Not expected to produce cancer in humans under occupational exposure conditions. No
Carcinogenicity
components are listed as carcinogens by GSK, IARC, NTP or US OSHA.
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Not expected to produce adverse effects on fertility or development under occupational
Reproductive Effects
exposure conditions.
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None known for occupational exposure.
Other Adverse Effects
12. ECOLOGICAL INFORMATION
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This material contains an active pharmaceutical ingredient that may bioaccumulate in the
Summary
environment. There is insufficient information to determine the scope of the environmental
effects this material may cause. Until there is additional testing to determine other potential
adverse effects on the environment, appropriate precautions should be taken to limit release
of this compound to the environment. Local regulations and procedures should be consulted
prior to environmental release.
Specific information on the active pharmaceutical ingredient is provided below.
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ECOTOXICITY
Aquatic
This material contains an active pharmaceutical ingredient that is not
Activated Sludge
toxic to activated sludge microorganisms.
Respiration
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IC50: > 97.2 mg/l, 3 Hours, Activated sludge
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No toxicity to daphnids was observed for the active pharmaceutical
Daphnid
ingredient in this mixture, but the upper range of the test was limited
by the low water solubility of this compound.
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NOEC: 3.74 mcg/l, 48 Hours, Daphnia magna, Static
test
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No toxicity to these organisms was observed for the active
Other Species - Aquatic
pharmaceutical ingredient, but the upper range of the test was limited
by the low water solubility of the compound.
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LC50: Measured
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SDS Number 110536 Approved/Revised 23-Jun-2008 Version 13
BECONASE HAYFEVER ALLERGY SPRAY
Material
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EC50: > 500 mg/kg, 28 Days, Measured
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NOEC: 500 mg/kg, 28 Days
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Terrestrial
This mixture contains an active pharmaceutical ingredient that is not
Earthworm
toxic to earthworms.
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EC50: > 750 mg/kg, 28 Days, Eisenia foetida, manure
worm, Static test
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MOBILITY
This material contains an active pharmaceutical ingredient that for environmental fate
Solubility
predictions has very low solubility in water.
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This material contains an active pharmaceutical ingredient that will not readily enter into the
Volatility
air from hard surfaces or from a container of the pure substance. This material contains an
active pharmaceutical ingredient that will not readily enter into air from water.
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Henrys Law Constant 8.00E-07 atm m3/mol, Calculated at 20 C
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This material contains an active pharmaceutical ingredient that is likely to adsorb to soil or
Adsorption
sediment. This material contains an active pharmaceutical ingredient that is likely to adsorb
to sludges and other biomass.
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Soil Sediment Sorption 1.88 to 4, Measured
(log Koc):
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Sludge Biomass 1.61 to 3.73 Estimated
Distribution Coefficient
(log Kd):
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This material contains an active pharmaceutical ingredient with octanol/water partition
Partitioning
coefficient data that suggests that for environmental fate predictions the active
pharmaceutical ingredient may have the tendency to distribute into fats.
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PERSISTENCE/DEGRADATION
This material contains an active pharmaceutical ingredient that has been shown to be
Hydrolysis
chemically unstable in water. Hydrolysis may be a significant depletion mechanism.
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Half-Life, Neutral: 166 Hours, Measured
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Half-Life, Acidic: > 1 Years, Measured
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Half-Life, Basic: 2.9 Hours, Measured
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This material contains an active pharmaceutical ingredient that is unlikely to undergo
Photolysis
photodegradation.
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UV/Visible Spectrum: 240
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This material contains an active pharmaceutical ingredient that is not readily biodegradable
Biodegradation
(as defined by 1993 OECD Testing Guidelines).
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Aerobic - Ready
Percent Degradation: 3 %, 28 days, Modified Sturm test., Activated sludge
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Aerobic - Soil
Percent Degradation: 21.9 to 61.5 %, 64 days
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This material contains an active pharmaceutical ingredient that will have a tendency to
Bioaccumulation
bioaccumulate in the food chain.
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Bioconcentration Factor: 1806 Calculated
13. DISPOSAL CONSIDERATIONS
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Collect for recycling or recovery if possible. The disposal method for rejected
Disposal Recommendations
products/returned goods must ensure that they cannot be re-sold or re-used.
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Observe all local and national regulations when disposing of this product.
Regulatory Requirements
14. TRANSPORT INFORMATION
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The SDS should accompany all shipments for reference in the event of spillage or accidental release. Only authorised persons
trained and competent in accordance with appropriate national and international regulatory requirements may prepare dangerous
goods for transport.
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SDS Number 110536 Approved/Revised 23-Jun-2008 Version 13
BECONASE HAYFEVER ALLERGY SPRAY
Material
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UN Classification and Labelling
Transportation and shipping of this product is not restricted. It has no known,
Transport Information
significant hazards requiring special packaging or labelling for air, maritime, US or
European ground transport purposes.
15. REGULATORY INFORMATION
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The information included below is an overview of the major regulatory requirements. It should not be considered to be an
exhaustive summary. Local regulations should be consulted for additional requirements.
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EU Classification and Labelling
Exempt from requirements of EU Dangerous Preparations directive - product regulated as a medicinal product,
cosmetic product or medical device.
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US OSHA Standard (29 CFR Part 1910.1200)
This dosage form is exempt from the requirements of the OSHA Hazard Communication
Classification
Standard.
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Other US Regulations
Exempt
TSCA Status
16. OTHER INFORMATION
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GSK Hazard Determination
References
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13
SDS Version Number
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SDS Sections Updated
Sections Subsections
COMPOSITION / INFORMATION ON INGREDIENTS
IDENTIFICATION OF SUBSTANCE / PREPARATION AND OF
COMPANY
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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.
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