SDS Number 110568 Approved/Revised 24-Nov-2004 Version 07
Material MEPRON SUSPENSION
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material MEPRON SUSPENSION
MEPRON SUSPENSION 750MG/5ML * WELLVONE SUSPENSION
Synonyms
750MG/5ML * NDC NO 0173-0547-00 * NDC NO 0173-0665-18 *
ATOVAQUONE, 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
ATOVAQUONE 15
95233-18-4
NON-HAZARDOUS INGREDIENTS 85
Unassigned
3. HAZARDS IDENTIFICATION
Expected to be non-combustible.
Fire and Explosion
Health Handling this product in its final form presents minimal risk from
occupational exposure.
Health effects information is based on hazards of components. Eye irritant.
Possible effects of overexposure in the workplace include: headache;
nausea; insomnia; yellow discolouration of the skin; diarrhoea; rash.
Environment Dangerous for the environment. Toxic to aquatic organisms. May cause
long-term adverse effects in the aquatic environment.
4. FIRST-AID MEASURES
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SDS Number 110568 Approved/Revised 24-Nov-2004 Version 07
Material MEPRON SUSPENSION
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 No special requirements needed.
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 leakage of this material occurs, contain and collect 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 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 No specific decontamination or detoxification procedures have been
identified for this product.
Procedures
7. HANDLING AND STORAGE
HANDLING
General Requirements No special control measures required for the normal handling of this
product. Normal room ventilation is expected to be adequate for routine
handling of this product.
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SDS Number 110568 Approved/Revised 24-Nov-2004 Version 07
Material MEPRON SUSPENSION
STORAGE No storage requirements necessary for occupational hazards. Follow
product information storage instructions to maintain efficacy.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
ATOVAQUONE
INGREDIENT
2
GSK Occupational
Hazard Category
GSK Occupational 200 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 None required for normal handling. Wash hands and arms thoroughly after
handling.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Suspension.
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 Not expected to be toxic following ingestion.
Skin Effects Irritation might occur 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 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.
Pharmacological Effects It is an agent intended for the treatment of parasitic infection. Adverse
effects of overexposure might include: headache; rash; diarrhoea; nausea;
insomnia; vomiting.
Other Adverse Effects Overexposure in the workplace might have the following effects: yellow
discolouration of the skin. The following adverse effects have been noted
with therapeutic use of this material: symptoms of hypersensitivity (such as
skin rash, hives, itching, and/or difficulty breathing).
12. ECOLOGICAL INFORMATION
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SDS Number 110568 Approved/Revised 24-Nov-2004 Version 07
Material MEPRON SUSPENSION
* Summary This material contains an active pharmaceutical ingredient that has been
tested, and which may be very toxic to aquatic organisms if released
directly to the environment. 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.
ECOTOXICITY
Aquatic
* Microbial Growth No toxicity to these microorganisms was observed for the active
pharmaceutical ingredient of this mixture, but the upper range of the test
Inhibition
was limited by the low water solubility of the compound.
Minimum Inhibition > 11 mcg/l, , Aspergillus flavus
Concentration: > 11 mcg/l, , Azotobacter chroococcum
> 11 mcg/l, , Chaetomium globosum
> 11 mcg/l, , Nostoc sp.
> 11 mcg/l, , Pseudomonas acidovorans
* Daphnid This material contains an active pharmaceutical ingredient that is very toxic
to daphids.
EC50: 0.0035 mg/l, 48 Hours, Daphnia magna, Static
test
NOEL: 0.0018 mg/l, 48 Hours, Daphnia magna, Static
test
Terrestrial
* Earthworm This mixture contains an active pharmaceutical ingredient that is not toxic
to earthworms.
Eisenia foetida, manure worm
EC50: > 1000 mg/kg, 14 Days, Nominal
Eisenia foetida, manure worm
NOEL: 1000 mg/kg, 14 Days, Nominal
MOBILITY
* Solubility This material contains an active pharmaceutical ingredient that for
environmental fate predictions has very low solubility in water.
* Adsorption 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.
Soil Sediment Sorption 4.18 to 4.58, Measured
(log Koc):
Sludge Biomass 3.91 to 4.31 Calculated
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 may have the
tendency to distribute into fats.
PERSISTENCE/DEGRADATION
Photolysis This material contains an active pharmaceutical ingredient that has been
shown to be chemically unstable in water when exposed to light. Aqueous
photolysis may be a significant depletion mechanism.
Half-Life, Aqueous: 2.63 Hours, Measured
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SDS Number 110568 Approved/Revised 24-Nov-2004 Version 07
Material MEPRON SUSPENSION
Biodegradation
Aerobic - Soil
Percent Degradation: 75 %, 1 Day, , Soil
* BIOACCUMULATION This material contains an active pharmaceutical ingredient will 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 product is classified as hazardous according to the OSHA Hazard
Communication Standard.
Other US Regulations
TSCA Status Exempt
16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 24-Nov-2004 SDS Version Number 7
SDS Sections Updated
Sections Subsections
COMPOSITION / INFORMATION ON INGREDIENTS
ECOLOGICAL INFORMATION Activated Sludge Respiration
Adsorption
Algal
Algal Degradation
Bioaccumulation
Biodegradation
Daphnid
Distribution
Earthworm
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SDS Number 110568 Approved/Revised 24-Nov-2004 Version 07
Material MEPRON SUSPENSION
SDS Sections Updated
Sections Subsections
ECOLOGICAL INFORMATION 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
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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