SDS Number 2925 Approved/Revised 25-Nov-2004 Version 11
DYAZIDE CAPSULES, REFORMULATED
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material DYAZIDE CAPSULES, REFORMULATED
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, FORMULATED PRODUCT
Synonyms
GlaxoSmithKline, Corporate Environment, Health & Safety
Company Name
980 Great West Road
Brentford, Middlesex TW8 9GS UK
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
GlaxoSmithKline, Corporate Environment, Health & Safety
2200 Renaissance Blvd, Suite 105
King of Prussia, PA 19406 US
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
Percentage
Ingredients CAS RN
TRIAMTERENE 24
396-01-0
HYDROCHLOROTHIAZIDE 16
58-93-5
NON-HAZARDOUS INGREDIENTS 60
Unassigned
3. HAZARDS IDENTIFICATION
Expected to be non-combustible.
Fire and Explosion
* Health Caution - Pharmaceutical agent.
Eye irritant.
Exposure might occur via inhalation; ingestion; skin; eyes.
Health effects information is based on hazards of components.
Environment No information is available about the potential of this product to produce
adverse environmental effects.
4. FIRST-AID MEASURES
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SDS Number 2925 Approved/Revised 25-Nov-2004 Version 11
DYAZIDE CAPSULES, REFORMULATED
Material
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 Medical treatment in cases of overexposure should be treated as an
overdose of a thiazide diuretic. Treat according to locally accepted
protocols. For additional guidance, refer to the current prescribing
information or to the local poison control information centre.
* Medical Conditions None for occupational exposure.
Caused or Aggravated
by Exposure
Health Surveillance Pre-placement and periodic health surveillance is not usually indicated. The
final determination of the need for health surveillance should be determined
Procedures
by local risk assessment.
Antidotes No specific antidotes are recommended.
5. FIRE-FIGHTING MEASURES
Fire and Explosion Not expected for the product, although the packaging is combustible.
Hazards
Extinguishing Media Water or foam extinguishers are recommended.
Carbon dioxide or dry powder extinguishers may be ineffective.
Special Firefighting For single units (packages): No special requirements needed.
For larger amounts (multiple packages/pallets) of product: Since toxic,
Procedures
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 Toxic, corrosive or flammable thermal decomposition products are
expected when the product is exposed to fire.
Products
6. ACCIDENTAL RELEASE MEASURES
Personal Precautions Wear protective clothing and equipment consistent with the degree of
hazard.
Environmental Precautions For large spills, take precautions to prevent entry into waterways, sewers, or
surface drainage systems.
Clean-up Methods Collect and place it in a suitable, properly labelled container for recovery or
disposal.
Decontamination No specific decontamination or detoxification procedures have been
identified for this product.
Procedures
7. HANDLING AND STORAGE
HANDLING
General Requirements Avoid breaking or crushing capsules.
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SDS Number 2925 Approved/Revised 25-Nov-2004 Version 11
DYAZIDE CAPSULES, REFORMULATED
Material
STORAGE No storage requirements necessary for occupational hazards. Follow
product information storage instructions to maintain efficacy.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
TRIAMTERENE
INGREDIENT
1
GSK Occupational
Hazard Category
GSK Occupational 1000 MCG/M3 (8 HR TWA)
Exposure Limit
HYDROCHLOROTHIAZIDE
INGREDIENT
2
GSK Occupational
Hazard Category
GSK Occupational 500 MCG/M3 (8 HR TWA)
Exposure Limit
PERSONAL PROTECTIVE EQUIPMENT
* Eye Protection Wear approved safety glasses with side shields if eye contact is possible.
* Other Equipment or Wash hands and arms thoroughly after handling.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Opaque.
Clarity
Red/white.
Colour
Capsule.
Physical Form
10. STABILITY AND REACTIVITY
Stability This product is expected to be stable.
Conditions to Avoid None for normal handling of this product.
11. TOXICOLOGICAL INFORMATION
Oral Toxicity Adverse effects might occur following ingestion.
* Inhalation Toxicity No studies have been conducted.
Skin Effects Irritation is not expected following direct contact.
Eye Effects Irritation might occur following direct contact with eyes.
Target Organ Effects No specific target organ effects have been identified.
Sensitisation Sensitisation (allergic skin reaction) is not expected.
Genetic Toxicity Not expected to be genotoxic under occupational exposure conditions.
* Carcinogenicity Contains a material classified as a carcinogen by external agencies. (NTP)
Not expected to produce cancer in humans under occupational exposure
conditions.
* Reproductive Effects Not expected to produce adverse effects on fertility or development under
occupational exposure conditions. Insufficient information available to
classify this material for hazard to milk production.
* Pharmacological Effects This product contains active ingredient(s) with the following activity: diuretic
that can affect the function of the kidneys.
* Other Adverse Effects None known for occupational exposure.
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SDS Number 2925 Approved/Revised 25-Nov-2004 Version 11
DYAZIDE CAPSULES, REFORMULATED
Material
12. ECOLOGICAL INFORMATION
* Summary This material contains two or more active pharmaceutical ingredients that
have been tested, one of which may be harmful if released directly to the
environment. Specific information on that active pharmaceutical ingredient
is provided below. Appropriate precautions should be taken to limit release
of this material to the environment. Local regulations and procedures should
be consulted prior to environmental release.
ECOTOXICITY
Aquatic
* Activated Sludge This material contains an active pharmaceutical ingredient that is not toxic
to activated sludge microorganisms.
Respiration
IC50: > 100 mg/l, 3 Hours, Activated sludge, Nominal
NOEC: 100 mg/l, 3 Hours, Activated sludge, Static test
* Algal This material contains an active pharmaceutical ingredient that is harmful to
algae.
IC50: 14 mg/l, 72 Hours, Selenastrum capricornutum,
green algae, Measured
NOEL: 5 mg/l, 72 Hours, Selenastrum capricornutum,
green algae, Static test
* Daphnid 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.
EC50: > 10 mg/l, 48 Hours, Daphnia magna, Measured
NOEL: 10 mg/l, 48 Hours, Daphnia magna, Static test
* Fish No toxicity to fish was observed for the active pharmaceutical ingredient,
but the upper range of the test was limited by the low water solubility of the
compound.
Adult Oncorhyncus mykiss, rainbow trout
EC50: > 13 mg/l, 96 Hours, Measured
Adult Oncorhyncus mykiss, rainbow trout
NOEL: 13 mg/l, 96 Hours, Static test
MOBILITY
* Solubility This material contains an active pharmaceutical ingredient that for
environmental fate predictions has limited solubility in water.
* Volatility This material contains an active pharmaceutical ingredient that will not
readily enter into air from water.
Henry's Law Constant < 1.90E-15 atm m^3/mol, Estimated at 25 C
* Adsorption This material contains an active pharmaceutical ingredient that is not likely
to adsorb to soil or sediment if released directly to the environment. This
material contains an active pharmaceutical ingredient that is not likely to
adsorb to sludge or biomass if released directly to the environment.
Sludge Biomass 1.95 Measured Measured at pH 7
Distribution Coefficient
(log Kd):
* 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 will not have the
tendency to distribute into fats.
PERSISTENCE/DEGRADATION
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SDS Number 2925 Approved/Revised 25-Nov-2004 Version 11
DYAZIDE CAPSULES, REFORMULATED
Material
* Photolysis This material contains an active pharmaceutical ingredient that is likely to
undergo photodegradation.
UV/Visible Spectrum: 356 nm , Measured
* Biodegradation This material contains an active pharmaceutical ingredient that is not
readily biodegradable but is inherently biodegradable (as defined by 1993
OECD Testing Guidelines) and is not expected to persist in the
environment.
Aerobic - Inherent
Percent Degradation: 50 %, 14 days, Modified Zahn-Wellens, primary
biodegradation, loss of parent., Activated sludge
* BIOACCUMULATION This material contains an active pharmaceutical ingredient that will not have
a tendency to bioaccumulate in the food chain.
13. DISPOSAL CONSIDERATIONS
Disposal Collect for recycling or recovery if possible. The disposal method for
rejected products/returned goods must ensure that they cannot be re-sold or
Recommendations
re-used.
Regulatory Requirements Observe all local and national regulations when disposing of this product.
14. TRANSPORT INFORMATION
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.
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
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.
* 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.
Other US Regulations
TSCA Status Exempt
16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 25-Nov-2004 SDS Version Number 11
SDS Sections Updated
Sections Subsections
COMPOSITION / INFORMATION ON INGREDIENTS
ECOLOGICAL INFORMATION
Activated Sludge Respiration
Adsorption
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SDS Number 2925 Approved/Revised 25-Nov-2004 Version 11
DYAZIDE CAPSULES, REFORMULATED
Material
SDS Sections Updated
Sections Subsections
ECOLOGICAL INFORMATION Algal
Algal Degradation
Bioaccumulation
Biodegradation
Daphnid
Distribution
Earthworm
Ecotoxicity
Fish
Hydrolysis
Microbial Growth Inhibition
Microtox
Mobility
Other Adverse Effects
Other Species - Aquatic
Other Species - Terrestrial
Partitioning
Persistence/Degradation
Photolysis
Solubility
Summary
Volatility
EXPOSURE CONTROLS / PERSONAL PROTECTION Exposure Controls
Eye Protection
Other Equipment or Procedures
FIRST-AID MEASURES Medical Conditions Caused or Aggravated by
Exposure
Medical Treatment
HAZARDS IDENTIFICATION Environment
Health
IDENTIFICATION OF SUBSTANCE / PREPARATION AND
OF COMPANY
REGULATORY INFORMATION European Union Classification and Labelling
Requirements
TOXICOLOGY INFORMATION Carcinogenicity
Inhalation Toxicity
Other Adverse Effects
Pharmacological Effects
Reproductive Effects
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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