SDS Number 123443 Approved/Revised 26-Jun-2006 Version 11
IMURAN TABLETS
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material IMURAN TABLETS
IMURAN 25 MG TABLETS * IMURAN 50 MG TABLETS * IMUREK
Synonyms
FILMTABLETTEN * IMUREL TABLETS * AZATHIOPRINE, 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
AZATHIOPRINE 31.4 to 31.8
446-86-6
NON-HAZARDOUS INGREDIENTS 68.2 to 68.6
Unassigned
3. HAZARDS IDENTIFICATION
Expected to be non-combustible.
Fire and Explosion
Health Caution - Potent pharmaceutical agent.
Exposure might occur via ingestion; skin; eyes.
May cause cancer.
May produce adverse effects on human fertility.
May produce adverse effects on the development of human offspring.
May impair the quantity or quality of human milk production.
May produce allergic skin reactions.
Possible effects of overexposure in the workplace include: symptoms of
hypersensitivity (such as skin rash, hives, itching, and difficulty breathing).
Health effects information is based on hazards of components.
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SDS Number 123443 Approved/Revised 26-Jun-2006 Version 11
IMURAN TABLETS
Material
Environment No information is available about the potential of this product to produce
adverse environmental effects.
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 Medical treatment in cases of overexposure should be treated as an
overdose of immunosupressive agent. Treat according to locally accepted
protocols. For additional guidance, refer to the current prescribing
information or to the local poison control information centre. In allergic
individuals, exposure to this material may require treatment for initial or
delayed allergic symptoms and signs. This may include immediate and/or
delayed treatment of anaphylactic reactions.
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 The need for pre-placement and periodic health surveillance must be
determined by risk assessment. Following assessment, if the risk of
Procedures
exposure is considered significant then exposed individuals should undergo
appropriate health surveillance that may include symptom enquiry, clinical
examination and monitoring of lead organ effects (e.g. full blood counts).
In the event of overexposure, individuals should receive post exposure
health surveillance focused on the most likely health effects (e.g. full blood
counts).
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
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SDS Number 123443 Approved/Revised 26-Jun-2006 Version 11
IMURAN TABLETS
Material
Personal Precautions Wear protective clothing and equipment consistent with the degree of
hazard. For all spills, isolate the spill area, restrict access, post the area for
a carcinogen and immediately implement emergency procedures for
cleanup and control of occupational carcinogens.
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. Neutralize
with caustic soda or soda ash.
Procedures
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
AZATHIOPRINE
INGREDIENT
4
GSK Occupational
Hazard Category
CARCINOGEN, REPRODUCTIVE
GSK Occupational 3 mcg/m3 (8 HR TWA)
HAZARD, SKIN SENSITISER
Exposure Limit
ENGINEERING CONTROLS
Containment Open handling may result in overexposure. Consider use of enclosures.
Administrative Strict control of access to the working area is essential. Restrict access to
authorised personnel.
* Other Equipment or Follow all local regulations if personal protective equipment (PPE) is used
in the workplace. Wear appropriate clothing to avoid skin contact. When
Procedures
isolation is not possible in production areas, appropriate personal protective
equipment must be used. Consider additional control procedures for
maintenance, cleaning and emergencies.
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
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.
Inhalation Toxicity No studies have been conducted.
Skin Effects Irritation is not expected following direct contact.
Eye Effects Irritation is not expected following direct contact with eyes.
Target Organ Effects Adverse effects might occur in the following organ(s) following
overexposure: immune system; bone marrow and formation of blood cells.
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SDS Number 123443 Approved/Revised 26-Jun-2006 Version 11
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Material
Sensitisation Allergic skin reactions might occur following dermal exposure.
Genetic Toxicity Known or probable human mutagen.
Carcinogenicity Contains a material classified as a carcinogen by external agencies. Human
carcinogen (IARC); (NTP).
Reproductive Effects Contains components which have been classified as: Known or presumed
to cause toxicity in developing human offspring. Known or presumed to
affect the quantity and quality of breast milk in humans. Possible risk of
impaired fertility in humans.
Pharmacological Effects This product contains active ingredient(s) with the following activity: an
immunosupressive agent.
Other Adverse Effects None known for occupational exposure.
12. ECOLOGICAL INFORMATION
Summary This material contains an active pharmaceutical ingredient that has been
tested, and no environmental effects have been identified. 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 This material contains an active pharmaceutical ingredient that is not toxic
to activated sludge microorganisms.
Respiration
IC50: > 1000 mg/l, 3 Hours, Activated sludge
Algal This material contains an active pharmaceutical ingredient that is not toxic
to algae.
IC50: > 100 mg/l, 72 Hours, Scenedesmus subspicatus,
green algae, Static test
NOEL: 100 mg/l, 72 Hours, Scenedesmus subspicatus,
green algae, Static test
* Daphnid This material contains an active pharmaceutical ingredient that is not toxic
to daphnids.
EC50: > 100 mg/l, 48 Hours, Daphnia magna, Static test
NOEL: > 100 mg/l, 48 Hours, Daphnia magna, 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 8.10E-15 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
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Material
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 - Ready
Percent Degradation: 11 %, 28 days, Modified Sturm test.
Aerobic - Inherent
Percent Degradation: 4 %, 28 days, Modified Zahn-Wellens, DOC
removal., Activated sludge
Percent Degradation: 4 %, 28 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. Wherever possible, disposal should be in an on-site licenced
chemical incinerator, if allowed by the incinerator licence or permit. If no
on-site incinerator is available, dispose of material in a licenced commercial
chemical incinerator.
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.
Target Organ May cause adverse effects on immune system; bone marrow.
Statement
Other US Regulations
TSCA Status Exempt
16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 26-Jun-2006 SDS Version Number 11
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SDS Number 123443 Approved/Revised 26-Jun-2006 Version 11
IMURAN TABLETS
Material
SDS Sections Updated
Sections Subsections
EXPOSURE CONTROLS / PERSONAL PROTECTION Other Equipment or Procedures
IDENTIFICATION OF SUBSTANCE / PREPARATION AND
OF COMPANY
REGULATORY INFORMATION US Environmental (EPA) 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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