SDS Number 110547 Approved/Revised 03-Jul-2008 Version 7
DARAPRIM TABLETS
Material
SAFETY DATA SHEET
* 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
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Material DARAPRIM TABLETS
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DARAPRIM TABLETS 25 MG * DARAPRIM COMPRIMES * DARAPRIM COMPRIMIDOS *
Synonym(s)
DARAPRIM TABLETAS * DARAPRIM TABLETKI * DARAPRIM TABLETTEN * NDC NO
0173-0201-55 * PYRIMETHAMINE, 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.
NON-HAZARDOUS INGREDIENTS Unassigned 82.5
PYRIMETHAMINE 58-14-0 17.5
3. HAZARDS IDENTIFICATION
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Expected to be non-combustible.
Fire and Explosion
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Caution - Pharmaceutical agent.
Health
Exposure might occur via skin; eyes; ingestion.
May produce mutagenic effects in human cells.
May produce adverse effects on the development of human offspring.
May impair the quantity or quality of human milk production.
Health effects information is based on hazards of components.
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Dangerous for the environment. Harmful to aquatic organisms. May cause long-term adverse
Environment
effects in the aquatic environment.
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 110547 Approved/Revised 03-Jul-2008 Version 7
DARAPRIM TABLETS
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
Medical treatment in cases of overexposure should be treated as an overdose of an inhibitor
Medical Treatment
of folic acid metabolism. Treat according to locally accepted protocols. For additional
guidance, refer to the current prescribing information or to the local poison control
information centre.
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None for occupational exposure.
Medical Conditions
Caused or Aggravated by
Exposure
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Pre-placement and periodic health surveillance is not usually indicated. The final
Health Surveillance
determination of the need for health surveillance should be determined by local risk
Procedures
assessment.
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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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Collect and place it in a suitable, properly labelled container for recovery or disposal.
Clean-up Methods
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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
Avoid breaking or crushing tablets.
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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PYRIMETHAMINE
INGREDIENT
4
GSK Occupational Hazard
Category
REPRODUCTIVE HAZARD
GSK Occupational 7 mcg/m3 (8 HR TWA)
Exposure Limit
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ENGINEERING CONTROLS
Open handling may result in overexposure. Consider use of enclosures.
Containment
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SDS Number 110547 Approved/Revised 03-Jul-2008 Version 7
DARAPRIM TABLETS
Material
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Entry to the working area should be controlled. Restrict access to authorised personnel. New
Administrative
or expectant mothers might be at greater risk from overexposure. Risk assessments must
take this into consideration. Female employees anticipating pregnancy or with a confirmed
pregnancy must be encouraged to notify an occupational health professional or their line
manager. This will act as the trigger for individual re-assessment of the employee's work
practices.
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Wear appropriate clothing to avoid skin contact. Wash hands and arms thoroughly after
Other Equipment or
handling.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
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Appearance
Tablet.
Physical Form
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 product contains active ingredient(s) with the following activity: an inhibitor of folic acid
Pharmacological Effects
metabolism.
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Adverse effects might occur in the following organ(s) following overexposure: kidney; bone
Target Organ Effects
marrow and formation of blood cells.
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Routes of Exposure
Adverse effects might occur following ingestion.
Oral Toxicity
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Minor irritation might occur following direct contact.
Skin Effects
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Minor irritation might occur following direct contact with eyes.
Eye Effects
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Potential for inducing allergic reactions via the dermal or respiratory route is not known.
Sensitisation
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Possible human mutagen.
Genetic Toxicity
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No components are listed as carcinogens by GSK, IARC, NTP or US OSHA. Not expected to
Carcinogenicity
produce cancer in humans under occupational exposure conditions.
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Contains components which have been classified as: Possible risk of toxicity in developing
Reproductive Effects
human offspring. Possible risk of affecting the quantity or the quality of breast milk in
humans.
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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 has been tested and which
Summary
may be harmful if released directly to the environment. This material contains an active
pharmaceutical ingredient that may persist in the environment. Consult the MSDS of the
active ingredient for specific information about potential environmental effects. 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.
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: > 3200 mg/l, 3 Hours, Activated sludge,
Nominal
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NOEC: 10 , 3 Hours
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This material contains an active pharmaceutical ingredient that is
Algal
harmful to algae.
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SDS Number 110547 Approved/Revised 03-Jul-2008 Version 7
DARAPRIM TABLETS
Material
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IC50: 20 mg/l, 48 Hours, Chlorella pyrenoidosa, green
algae
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This material contains an active pharmaceutical ingredient that is toxic
Daphnid
to daphnids.
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EC50: 4.8 mg/l, 48 Hours, Daphnia magna, Static test
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This material contains an active pharmaceutical ingredient that is toxic
Fish
to fish.
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Juvenile Oncorhyncus mykiss, rainbow trout
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EC50: 5.9 mg/l, 48 Hours, Static test
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MOBILITY
This material contains an active pharmaceutical ingredient that for environmental fate
Solubility
predictions has limited solubility in water.
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This material contains an active pharmaceutical ingredient that will not readily enter into air
Volatility
from water.
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Henrys Law Constant 1.08E-10 atm m3/mol, Estimated at 25 C
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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 will not 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 stable in water. Hydrolysis is unlikely to be a significant depletion mechanism.
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Half-Life, Neutral: 6 Months, Measured, Deionized Water
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This material contains an active pharmaceutical ingredient that is not readily biodegradable
Biodegradation
(as defined by 1993 OECD Testing Guidelines). It may persist in the environment.
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Aerobic - Inherent
Percent Degradation: 2 %, 28 days, Modified MITI (II) Test., Activated sludge
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. The
recommended method of disposal is incineration.
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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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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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SDS Number 110547 Approved/Revised 03-Jul-2008 Version 7
DARAPRIM TABLETS
Material
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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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7
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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