BECONASE AQ NASAL SPRAY
110536
Approved/Revised 23-Mar-2007
Material
SDS Number
Version 10
GlaxoSmithKline, Corporate Environment, Health & Safety
Company Name
980 Great West Road
+44-20-8047-5000
UK General Information:
+44-1865-407333
Transport Emergency (EU)
+1-612-221-3999, Ext 221
Medical Emergency
US number, available 24 hours
Information and Advice:
Multi-language response
Brentford, Middlesex TW8 9GS UK
+1-888-825-5249
US General Information:
+1-703-527-3887
Transport Emergency (non EU)
US number, available 24 hours
Multi-language response
One Franklin Plaza, 200 N 16th Street
GlaxoSmithKline, Corporate Environment, Health & Safety
Philadelphia, PA 19102-1225 US
Percentage
CAS RN
Ingredients
0.04 to 0.05
5534-09-8
BECLOMETHASONE DIPROPIONATE
99.95 to 99.96
Unassigned
NON-HAZARDOUS INGREDIENTS
Fire and Explosion
This product is classified as non-flammable.
Health
Caution - Potent pharmaceutical agent.
Health effects information is based on hazards of components.
May cause steroid withdrawal rash.
Environment
No information is available about the potential of this product to produce
adverse environmental effects.
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
2. COMPOSITION / INFORMATION ON INGREDIENTS
3. HAZARDS IDENTIFICATION
4. FIRST-AID MEASURES
Synonyms
BECONASE HAY FEVER (UK) * BECONASE AQUEOUS NASAL SPRAY 42
MCG * 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
Material
BECONASE AQ NASAL SPRAY
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BECONASE AQ NASAL SPRAY
110536
Approved/Revised 23-Mar-2007
Material
SDS Number
Version 10
Ingestion
Never attempt to induce vomiting. Do not attempt to give any solid or liquid
by mouth if the 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.
Inhalation
Physical form suggests that risk of inhalation exposure is negligible.
Skin Contact
Using appropriate personal protective equipment, remove contaminated
clothing and flush exposed area with large amounts of water. Obtain
medical attention if skin reaction occurs, which may be immediate or
delayed.
Eye Contact
Wash immediately with clean and gently flowing water. Continue for at least
15 minutes. Obtain medical attention.
NOTES TO HEALTH PROFESSIONALS
Medical Treatment
Treat according to locally accepted protocols. For additional guidance, refer
to the current prescribing information or to the local poison control
information centre. Medical treatment in cases of overexposure should be
treated as an overdose of glucocorticosteroid.
Medical Conditions
Caused or Aggravated
by Exposure
Refer to prescribing information for detailed description of medical
conditions caused by or aggravated by overexposure to this product.
Antidotes
No specific antidotes are recommended.
Fire and Explosion
Hazards
Not expected for the product, although the packaging is combustible.
Extinguishing Media
Water, dry powder or foam extinguishers are recommended. Carbon
dioxide extinguishers may be ineffective.
Special Firefighting
Procedures
For single units (packages): No special requirements needed. For larger
amounts (multiple packages/pallets) of product: Since toxic, corrosive or
flammable vapours might be evolved 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.
Hazardous Combustion
Products
Toxic, corrosive or flammable thermal decomposition products are
expected when the product is exposed to fire.
Personal Precautions
Wear protective clothing and equipment consistent with the degree of
hazard.
Environmental Precautions Prevent entry into waterways, sewers, surface drainage systems and poorly
ventilated areas.
Clean-up Methods
Spread an inert absorbent on the spill and place in a suitable, properly
labelled container for recovery or disposal.
Decontamination
Procedures
No specific decontamination or detoxification procedures have been
identified for this product.
HANDLING
General Requirements
Normal room ventilation is expected to be adequate for routine handling of
this product.
STORAGE
No storage requirements necessary for occupational hazards. Follow
product information storage instructions to maintain efficacy.
5. FIRE-FIGHTING MEASURES
6. ACCIDENTAL RELEASE MEASURES
7. HANDLING AND STORAGE
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BECONASE AQ NASAL SPRAY
110536
Approved/Revised 23-Mar-2007
Material
SDS Number
Version 10
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
INGREDIENT
BECLOMETHASONE DIPROPIONATE
GSK Occupational
Hazard Category
4
GSK Occupational
Exposure Limit
6 mcg/m3 (8 HR TWA)
SKIN
PERSONAL PROTECTIVE EQUIPMENT
Eye Protection
Wear approved safety glasses with side shields if eye contact is possible.
Other Equipment or
Procedures
Follow all local regulations if personal protective equipment (PPE) is used
in the workplace. Wear appropriate clothing to avoid skin contact. Wash
hands and arms thoroughly after handling.
Appearance
Physical Form
Aqueous solution.
9. PHYSICAL AND CHEMICAL PROPERTIES
6 to 6.8
pH of Aqueous Solutions
Stability
This product is expected to be stable.
Conditions to Avoid
None for normal handling of this product.
11. TOXICOLOGICAL INFORMATION
Oral Toxicity
Not expected to be toxic following ingestion.
Skin Effects
Irritation is not expected following direct contact. Pharmacological effects
may occur following skin absorption.
Eye Effects
Minor irritation might occur following direct contact with eyes.
Target Organ Effects
Adverse effects might occur in the following organ(s) following
overexposure: adrenal glands; immune system.
Sensitisation
Allergic skin reactions might occur following dermal exposure. Assessment
based upon information from human exposure.
Genetic Toxicity
Not expected to be genotoxic under occupational exposure conditions.
Carcinogenicity
Not expected to produce cancer in humans under occupational exposure
conditions. No components are listed as carcinogens by GSK, IARC, NTP
or US OSHA.
Reproductive Effects
Not expected to produce adverse effects on fertility or development under
occupational exposure conditions.
Pharmacological Effects
This material is a selective glucocorticoid receptor agonist.
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.
Other Adverse Effects
None known for occupational exposure.
10. STABILITY AND REACTIVITY
12. ECOLOGICAL INFORMATION
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BECONASE AQ NASAL SPRAY
110536
Approved/Revised 23-Mar-2007
Material
SDS Number
Version 10
Summary
This material contains an active pharmaceutical ingredient that may
bioaccumulate in the 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.
ECOTOXICITY
Aquatic
Activated Sludge
Respiration
IC50:
> 97.2 mg/l, 3 Hours, Activated sludge
This material contains an active pharmaceutical ingredient that is not toxic
to activated sludge microorganisms.
Daphnid
NOEL:
3.74 mcg/l, 48 Hours, Daphnia magna, Static test
No toxicity to daphnids was observed for the active pharmaceutical
ingredient in this mixture, but the upper range of the test was limited by the
low water solubility of this compound.
Other Species
No toxicity to these organisms was observed for the active pharmaceutical
ingredient, but the upper range of the test was limited by the low water
solubility of the compound.
LC50:
Measured
EC50:
> 500 mg/kg, 28 Days, Measured
NOEL:
500 mg/kg, 28 Days
Terrestrial
Earthworm
Eisenia foetida, manure worm
EC50:
> 750 mg/kg, 28 Days, Static test
This mixture contains an active pharmaceutical ingredient that is not toxic
to earthworms.
MOBILITY
Solubility
This material contains an active pharmaceutical ingredient that for
environmental fate predictions has very low solubility in water.
Volatility
This material contains an active pharmaceutical ingredient that will not
readily enter into the 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.
Henry's Law Constant
8.00E-07 atm m^3/mol, Calculated at 20 C
Adsorption
1.88 to 4, Measured
Soil Sediment Sorption
(log Koc):
1.61 to 3.73 Estimated
Sludge Biomass
Distribution Coefficient
(log Kd):
This material contains an active pharmaceutical ingredient that is likely to
adsorb to soil or sediment. This material contains an active pharmaceutical
ingredient that is likely to adsorb to sludges and other biomass.
Partitioning
This material contains an active pharmaceutical ingredient with
octanol/water partition coefficient data that suggests that for environmental
fate predictions the active pharmaceutical ingredient may have the
tendency to distribute into fats.
PERSISTENCE/DEGRADATION
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BECONASE AQ NASAL SPRAY
110536
Approved/Revised 23-Mar-2007
Material
SDS Number
Version 10
Photolysis
This material contains an active pharmaceutical ingredient that is unlikely to
undergo photodegradation.
UV/Visible Spectrum:
240
Biodegradation
This material contains an active pharmaceutical ingredient that is not
readily biodegradable (as defined by 1993 OECD Testing Guidelines).
Percent Degradation:
3 %, 28 days, Modified Sturm test., Activated
sludge
Aerobic - Ready
Aerobic - Soil
Percent Degradation:
21.9 to 61.5 %, 64 days
BIOACCUMULATION
This material contains an active pharmaceutical ingredient that will have a
tendency to bioaccumulate in the food chain.
1806 Calculated
Bioconcentration Factor:
Hydrolysis
This material contains an active pharmaceutical ingredient that has been
shown to be chemically unstable in water. Hydrolysis may be a significant
depletion mechanism.
Half-Life, Neutral:
166 Hours, Measured
Half-Life, Basic:
2.9 Hours, Measured
Half-Life, Acidic:
> 1 Years, Measured
16. OTHER INFORMATION
References
GSK Hazard Determination
Disposal
Recommendations
Collect for recycling or recovery if possible. The disposal method for
rejected products/returned goods must ensure that they cannot be re-sold or
re-used.
Regulatory Requirements
Observe all local and national regulations when disposing of this product.
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.
14. TRANSPORT INFORMATION
13. DISPOSAL CONSIDERATIONS
UN Classification and Labelling
Transport Information
Transportation and shipping of this product is not restricted. It has no known,
significant hazards requiring special packaging or labelling for air, maritime, US
or European ground transport purposes.
15. REGULATORY INFORMATION
EU Classification and Labelling
Exempt from requirements of EU Dangerous Preparations directive - product regulated as a medicinal
product, cosmetic product or medical device.
US OSHA Standard (29 CFR Part 1910.1200)
Classification
This dosage form is exempt from the requirements of the OSHA Hazard
Communication Standard.
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.
Other US Regulations
TSCA Status
Exempt
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BECONASE AQ NASAL SPRAY
110536
Approved/Revised 23-Mar-2007
Material
SDS Number
Version 10
23-Mar-2007
Date Approved/Revised
10
SDS Version Number
SDS Sections Updated
Sections
Subsections
IDENTIFICATION OF SUBSTANCE / PREPARATION AND
OF COMPANY
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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