SDS Number 2444 Approved/Revised 26-Jun-2007 Version 12
ALBENZA TABLETS
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material ALBENZA TABLETS
ALBENZA 200 MG TABLETS * ESKAZOLE TABLETS 200 MG * ZENTEL
Synonyms
TABLETS 200 MG * NDC NO. 0007-5500-40 * ALBENDAZOLE,
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
One Franklin Plaza, 200 N 16th Street
Philadelphia, PA 19102-1225 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
ALBENDAZOLE 30
54965-21-8
NON-HAZARDOUS INGREDIENTS 70
Unassigned
3. HAZARDS IDENTIFICATION
Expected to be non-combustible.
Fire and Explosion
* Health Exposure might occur via inhalation; ingestion; skin; eyes.
May produce adverse effects on the development of human offspring. May
impair the quantity or quality of human milk production. Possible effects of
overexposure in the workplace include: nausea; vomiting; abdominal pain;
headache.
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. Very toxic to aquatic organisms.
4. FIRST-AID MEASURES
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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 New or expectant mothers might be at greater risk from overexposure. Risk
assessments must take this into consideration. Female employees
Caused or Aggravated
anticipating pregnancy or with a confirmed pregnancy must be encouraged
by Exposure
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.
* 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
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
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ALBENZA TABLETS
Material
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
ALBENDAZOLE
INGREDIENT
3
GSK Occupational
Hazard Category
REPRODUCTIVE HAZARD
GSK Occupational 100 MCG/M3 (8 HR TWA)
Exposure Limit
Occupational Hygiene Air For advice on suitable monitoring methods, seek guidance from a qualified
environment, health and safety professional.
Monitoring Methods
Other Equipment or None required for normal handling. Wash hands and arms thoroughly after
handling.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Film-coated 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 Not expected to be toxic following ingestion. Assessment based upon
effects of individual components.
Acute: Rat
LD50: > 2000 mg/kg
Inhalation Toxicity No studies have been conducted.
* Skin Effects Irritation is not expected following direct contact. Assessment based upon
effects of individual components.
* Eye Effects Irritation is not expected following direct contact with eyes. Assessment
based upon effects of individual components.
Target Organ Effects No specific target organ effects have been identified.
* Sensitisation Sensitisation (allergic skin reaction) is not expected. Assessment based
upon effects of individual components.
* Genetic Toxicity Not expected to be genotoxic under occupational exposure conditions.
Assessment based upon effects of individual components.
* Carcinogenicity No components are listed as carcinogens by GSK, IARC, NTP or US
OSHA.
* Reproductive Effects This material contains components which have been classified as:
Known or presumed to cause toxicity in developing human offspring.
Possible risk of affecting the quantity or the quality of breast milk in
humans.
* Pharmacological Effects This preparation contains ingredient(s) with the following activity: a
microtubule synthesis inhibitor. It is an agent intended for the treatment of
parasitic infection. Adverse effects of overexposure might include: nausea;
vomiting; headache; abdominal pain.
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* Other Adverse Effects None known for this material in humans.
12. ECOLOGICAL INFORMATION
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. Consult the MSDS of the active ingredient for
specific information about potential environmental effects. Appropriate
precautions should be taken to limit release of this mixture 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 No toxicity to sludge microorganisms was observed for the active
pharmaceutical ingredient in this mixture, but the upper range of the test
Respiration
was limited by the low water solubility of the compound.
IC50: > 0.27 mg/L, 3 Hours, Residential sludge
Microtox Microtox is a general toxicity test which utilizes a sensitive marine photo
bacteria as the test species. This material contains an active
pharmaceutical ingredient that is toxic to these microorganisms.
EC50: 0.36 mg/L, 15 Minutes
Algal No toxicity to algae 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 the compound.
IC50: > 50 mg/L, 72 Hours, Selenastrum capricornutum,
green algae
Daphnid This material contains an active pharmaceutical ingredient that is very toxic
to daphnids.
EC50: 0.024 mg/L, 48 Hours, Daphnia magna, Static test
NOEL: 0.017 mg/L, 48 Hours, Daphnia magna, Static test
Terrestrial
Earthworm This mixture contains an active pharmaceutical ingredient that is not toxic
to earthworms.
Lumbricus rubellus, redworm
EC50: 15 mg/kg, 60 Days, agricultural soil
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. It may persist in soil or sediment if released
directly to the environment.
Soil Sediment Sorption 3.89 to 4.44, Measured
(log Koc):
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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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: 0.1 to 1.65 Days, Measured
UV/Visible Spectrum: 295 nm at pH 7
BIOACCUMULATION This material contains an active pharmaceutical ingredient that will not have
a tendency to bioaccumulate in the food chain.
Bioconcentration Factor: 1.16 Measured, Lepomis macrochirus, bluegill
sunfish
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 26-Jun-2007 SDS Version Number 12
SDS Sections Updated
Sections Subsections
FIRST-AID MEASURES Antidotes
Eye Contact
Health Surveillance Procedures
Ingestion
Inhalation
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SDS Number 2444 Approved/Revised 26-Jun-2007 Version 12
ALBENZA TABLETS
Material
SDS Sections Updated
Sections Subsections
FIRST-AID MEASURES Medical Conditions Caused or Aggravated by
Exposure
Medical Treatment
Skin Contact
HAZARDS IDENTIFICATION Health
TOXICOLOGY INFORMATION
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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