SDS Number 110566 Approved/Revised 14-Jul-2008 Version 13
LEUKERAN TABLETS
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
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Material LEUKERAN TABLETS
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LEUKERAN TABLETS 2 MG * GR64465X * NDC NO 0173-0635-35 * CHLORAMBUCIL,
Synonym(s)
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.
CHLORAMBUCIL 305-03-3 2.1
NON-HAZARDOUS INGREDIENTS Unassigned 97.9
3. HAZARDS IDENTIFICATION
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Expected to be non-combustible.
Fire and Explosion
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Caution - Potent pharmaceutical agent.
Health
May cause cancer.
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).
Health effects information is based on hazards of components.
Exposure might occur via ingestion; skin; eyes.
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No information is available about the potential of this product to produce adverse
Environment
environmental effects.
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SDS Number 110566 Approved/Revised 14-Jul-2008 Version 13
LEUKERAN TABLETS
Material
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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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 a cytotoxic
Medical Treatment
agent. 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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The need for pre-placement and periodic health surveillance must be determined by risk
Health Surveillance
assessment. Following assessment, if the risk of exposure is considered significant then
Procedures
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).
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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. For all spills,
Personal Precautions
isolate the spill area, restrict access, post the area for a carcinogen and immediately
implement emergency procedures for cleanup and control of occupational carcinogens.
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For large spills, take precautions to prevent entry into waterways, sewers, or surface drainage
Environmental Precautions
systems.
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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.
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SDS Number 110566 Approved/Revised 14-Jul-2008 Version 13
LEUKERAN TABLETS
Material
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
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CHLORAMBUCIL
INGREDIENT
5
GSK Occupational Hazard
Category
CARCINOGEN, REPRODUCTIVE
GSK Occupational 0.5 mcg/m3 (8 HR TWA)
HAZARD, SKIN SENSITISER
Exposure Limit
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ENGINEERING CONTROLS
The active ingredient was formerly assigned to OHC 4 with the Highly Potent notation. An
Exposure Controls
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. Special considerations apply in the planning, design,
review and implementation of controls - seek specialist assistance from local occupational
hygienist or safety department.
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Open handling may result in overexposure. It is strongly advised that dedicated areas and
Containment
containment, such as glove boxes, isolators, and enclosed material transfer systems be used
to prevent personnel exposure and spread of contamination.
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Local exhaust ventilation (LEV) is not appropriate at this level, since total containment should
Ventilation
usually be used.
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Strict control of access to the working area is essential. Only trained personnel should enter
Administrative
the area during operations. Adopt procedures to prevent contamination of working materials
and adjacent areas.
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PERSONAL PROTECTIVE EQUIPMENT
When isolation is not possible, chemical splash goggles or equivalent eye protection must be
Eye Protection
used with other applicable protective equipment.
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Care must be exercised if insufficient data are available and further guidance should be
Gloves
sought from your local EHS department. Glove selection must take into account any solvents
and other hazards present. The selection of gloves for a specific activity must be based on
the material's properties and on possible permeation and degradation that may occur under
the circumstances of use. Potential allergic reactions can occur with certain glove materials
(e.g. Latex) and therefore these should be avoided.
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When isolation is not possible, respiratory protective equipment (RPE) should be combined
Respirators
with applicable protective equipment.
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Follow all local regulations if personal protective equipment (PPE) is used in the workplace.
Other Equipment or
When isolation is not possible in production areas, applicable protective equipment must be
Procedures
used. Consider additional control procedures for maintenance, cleaning and emergencies.
This product is listed by US NIOSH as a hazardous drug when handled in health care
settings. For additional information about the NIOSH hazardous drugs programme and
recommendations for preventing exposure see US NIOSH publication No. 2004-165,
"Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health
Care Settings."
9. PHYSICAL AND CHEMICAL PROPERTIES
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Appearance
Brown.
Colour
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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: a cytotoxic agent.
Pharmacological Effects
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LEUKERAN TABLETS
Material
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Adverse effects might occur in the following organ(s) following overexposure: bone marrow
Target Organ Effects
and formation of blood cells; gastro-intestinal tract; liver.
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Routes of Exposure
Adverse effects might occur following ingestion.
Oral Toxicity
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No studies have been conducted.
Inhalation Toxicity
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No studies have been conducted.
Skin Effects
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No studies have been conducted.
Eye Effects
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Allergic skin reactions might occur following dermal exposure. Assessment based upon
Sensitisation
effects of structurally similar substances.
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Known or probable human mutagen.
Genetic Toxicity
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Contains a material classified as a carcinogen by external agencies. Classification by
Carcinogenicity
external agencies: Human carcinogen; (IARC); (NTP).
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Contains components which have been classified as: Known or presumed to impair fertility
Reproductive Effects
in humans. Known or presumed to cause toxicity in developing human offspring.
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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. It should not be released into the
environment without dilution, detoxification or other applicable pre-treatment. Local
regulations and procedures should be consulted prior to environmental release.
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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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This mixture contains an active pharmaceutical ingredient that is
Daphnid
harmful to daphnids.
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MOBILITY
This mixture 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 the
Volatility
air from hard surfaces or from a container of the pure substance. This material contains an
active pharmaceutical ingredient that will not readily enter into air from water.
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This material contains an active pharmaceutical ingredient that is not likely to adsorb to, or
Adsorption
persist in, soil or sediment if released directly to the environment.
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This mixture 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 unstable in water. Hydrolysis may be a significant depletion mechanism.
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This material contains an active pharmaceutical ingredient that has been shown to be
Photolysis
chemically unstable in the atmosphere. Atmospheric photolysis may be a significant
depletion mechanism.
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. 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.
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Observe all local and national regulations when disposing of this product.
Regulatory Requirements
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SDS Number 110566 Approved/Revised 14-Jul-2008 Version 13
LEUKERAN TABLETS
Material
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 product is classified as hazardous according to the OSHA Hazard Communication
Classification
Standard. However, products that are subject to the labelling requirements of the Food and
Drug Administration are exempt from the labelling provisions of the standard.
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May cause adverse effects on bone marrow; gastrointestinal tract; liver.
Target Organ Statement
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Other US Regulations
Exempt
TSCA Status
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This product is classified as hazardous according to the NOHSC Approved Criteria for
Australian Classification
Classifying Hazardous Substances.
according to Hazardous
Substance and Dangerous
Goods Regulatory Framework
16. OTHER INFORMATION
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GSK Hazard Determination
References
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13
SDS Version Number
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SDS Sections Updated
Sections Subsections
COMPOSITION / INFORMATION ON INGREDIENTS
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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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