SDS Number 124461 Approved/Revised 21-Jan-2005 Version 04
Material MALOPRIM TABLETS
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material MALOPRIM TABLETS
MALOPRIM TABLETS 12.5 MG * PYRIMETHAMINE 12.5 MG AND DAPSONE
Synonyms
100 MG TABLETS * PYRIMETHAMINE AND DAPSONE, FORMULATED
PRODUCT
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
DAPSONE 34.5
80-08-0
PYRIMETHAMINE 4.3
58-14-0
NON-HAZARDOUS INGREDIENTS 61.2
Unassigned
3. HAZARDS IDENTIFICATION
Expected to be non-combustible.
Fire and Explosion
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SDS Number 124461 Approved/Revised 21-Jan-2005 Version 04
Material MALOPRIM TABLETS
Health Caution - Pharmaceutical agent. May produce mutagenic effects in human
cells. May produce adverse effects on human fertility. May produce adverse
effects on the development of human offspring. Possible effects of
overexposure in the workplace include: symptoms of hypersensitivity (such
as skin rash, hives, itching, and difficulty breathing); irregular heartbeat;
anorexia; vomiting; temporary decrease in platelet count; temporary
decrease in white blood cell count; anaemia; nervousness; muscle
weakness; convulsions.
Exposure might occur via ingestion; skin; eyes
Health effects information is based on hazards of components.
Handling this product in its final form presents minimal risk from
occupational exposure.
Environment Dangerous for the environment. Harmful to aquatic organisms. May cause
long-term adverse effects in the aquatic environment.
4. FIRST-AID MEASURES
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 Conditions Refer to prescribing information for detailed description of medical
conditions caused by or aggravated by overexposure to this product.
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, dry powder or foam extinguishers are recommended. Carbon
dioxide extinguishers may be ineffective.
Special Firefighting For single units (packages): No special requirements needed. For larger
amounts (multiple packages/pallets) of product: Since toxic, corrosive or
Procedures
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
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SDS Number 124461 Approved/Revised 21-Jan-2005 Version 04
Material MALOPRIM TABLETS
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 Water can be used for clean-up and decontamination operations. No
specific decontamination or detoxification procedures have been identified
Procedures
for this product.
7. HANDLING AND STORAGE
HANDLING
General Requirements Avoid breaking or crushing tablets.
STORAGE No storage requirements necessary for occupational hazards. Follow
product information storage instructions to maintain efficacy.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
DAPSONE
INGREDIENT
2
GSK Occupational
Hazard Category
PYRIMETHAMINE
INGREDIENT
4
GSK Occupational
Hazard Category
REPRODUCTIVE HAZARD
GSK Occupational 7 mcg/m3 (8 HR TWA)
Exposure Limit
ENGINEERING CONTROLS
Exposure Controls An Exposure Control Approach (ECA) is established for operations
involving this material based upon the OEL/Occupational Hazard Category
and the outcome of a site- or operation-specific risk assessment. Refer to
the Exposure Control Matrix for more information about how ECA's are
assigned and how to interpret them.
Administrative New 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.
PERSONAL PROTECTIVE EQUIPMENT
Eye Protection Wear approved safety glasses with side shields if eye contact is possible.
Respirators If respiratory protective equipment (RPE) is used, the type of RPE will
depend upon air concentrations present, required protection factor as well
as hazards, physical properties and warning properties of substances
present. Follow local regulations for respirator use in the workplace.
Other Equipment or Wash hands and arms thoroughly after handling. An eye wash station
should be available.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
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Material MALOPRIM TABLETS
Appearance
White.
Colour
Tablet.
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.
* Skin Effects Minor irritation might occur following direct contact.
* 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: kidney; bone marrow and formation of blood cells.
* Sensitisation Potential for inducing allergic reactions via the dermal or respiratory route is
not known.
* Genetic Toxicity Possible human mutagen.
* Carcinogenicity No components are listed as carcinogens by GSK, IARC, NTP or US
OSHA. Not expected to produce cancer in humans under occupational
exposure conditions.
* Reproductive Effects Contains components which have been classified as: Possible risk of
toxicity in developing human offspring. Possible risk of affecting the
quantity or the quality of breast milk in humans.
* Pharmacological Effects This product contains active ingredient(s) with the following activity: an
inhibitor of folic acid metabolism.
* Other Adverse Effects None known for occupational exposure.
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: > 3200 mg/l, 3 Hours, Activated sludge, Nominal
NOEC: 10 , 3 Hours
* Algal This material contains an active pharmaceutical ingredient that is harmful to
algae.
IC50: 20 mg/l, 48 Hours, Chlorella pyrenoidosa, green
algae
* Daphnid This material contains an active pharmaceutical ingredient that is toxic to
daphids.
EC50: 4.8 mg/l, 48 Hours, Daphnia magna, Static test
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Material MALOPRIM TABLETS
* Fish This material contains an active pharmaceutical ingredient that is toxic to
fish.
Juvenile Oncorhyncus mykiss, rainbow trout
EC50: 5.9 mg/l, 48 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 1.08E-10 atm m^3/mol, Estimated at 25 C
* 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
* Hydrolysis This material contains an active pharmaceutical ingredient that has been
shown to be chemically stable in water. Hydrolysis is unlikely to be a
significant depletion mechanism.
Half-Life, Neutral: 6 Months, Measured, Deionized Water
* Biodegradation This material contains an active pharmaceutical ingredient that is not
readily biodegradable (as defined by 1993 OECD Testing Guidelines). It
may persist in the environment.
Aerobic - Inherent
Percent Degradation: 2 %, 28 days, Modified MITI (II) Test., Activated
sludge
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.
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SDS Number 124461 Approved/Revised 21-Jan-2005 Version 04
Material MALOPRIM TABLETS
Other US Regulations
TSCA Status Exempt
16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 21-Jan-2005 SDS Version Number 4
SDS Sections Updated
Sections Subsections
COMPOSITION / INFORMATION ON INGREDIENTS
ECOLOGICAL INFORMATION Activated Sludge Respiration
Adsorption
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
REGULATORY INFORMATION European Union Classification and Labelling
Requirements
TOXICOLOGY INFORMATION Carcinogenicity
Eye Effects
Genetic Toxicity
Inhalation Toxicity
Oral Toxicity
Other Adverse Effects
Pharmacological Effects
Reproductive Effects
Sensitisation
Skin Toxicity
Target Organ Effects
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SDS Number 124461 Approved/Revised 21-Jan-2005 Version 04
Material MALOPRIM TABLETS
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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