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MSDS Material Safety Data Sheet
CAS

44-20-8
55-98-1

File Name: msds-gsk_com---1105690d.asp
SDS Number 110569            Approved/Revised 23-Oct-2007                                       Version 13
MYLERAN TABLETS
Material



SAFETY DATA SHEET




1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material MYLERAN TABLETS
MYLERAN TABLETS 2 MG * GW274383X TABLETS * NDC NO 0173-0713-25
Synonyms
* BUSULPHAN, 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
BUSULPHAN 0.56 to 2
55-98-1
NON-HAZARDOUS INGREDIENTS 98 to 99.4
Unassigned

3. HAZARDS IDENTIFICATION
Expected to be non-combustible.
Fire and Explosion
* Health Caution - Potent pharmaceutical agent.
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.
Environment No information is available about the potential of this product to produce
adverse environmental effects.


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SDS Number 110569 Approved/Revised 23-Oct-2007 Version 13
MYLERAN TABLETS
Material



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 treatment in cases of overexposure should be
treated as an overdose of a cytotoxic agent.
Medical Conditions None for occupational exposure.
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
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.


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SDS Number 110569 Approved/Revised 23-Oct-2007 Version 13
MYLERAN TABLETS
Material


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
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
BUSULPHAN
INGREDIENT
5
GSK Occupational
Hazard Category
CARCINOGEN, REPRODUCTIVE
GSK Occupational 1 mcg/m3 (8 HR TWA)
HAZARD
Exposure Limit
ENGINEERING CONTROLS
Exposure Controls The active ingredient was formerly assigned to OHC 4 with the Highly
Potent notation. 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. Special considerations apply in the
planning, design, review and implementation of controls - seek specialist
assistance from local occupational hygienist or safety department.
Containment Open handling may result in overexposure. It is strongly advised that
dedicated areas and containment, such as glove boxes, isolators, and
enclosed material transfer systems be used to prevent personnel exposure
and spread of contamination.
Ventilation Local exhaust ventilation (LEV) is not appropriate at this level, since total
containment should usually be used.
Administrative Strict control of access to the working area is essential. Only trained
personnel should enter the area during operations. Adopt procedures to
prevent contamination of working materials and adjacent areas.
PERSONAL PROTECTIVE EQUIPMENT
Eye Protection When isolation is not possible, chemical splash goggles or equivalent eye
protection must be used with other applicable protective equipment.
Gloves Care must be exercised if insufficient data are available and further
guidance should be 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.
Respirators When isolation is not possible, respiratory protective equipment (RPE)
should be combined with applicable protective equipment.




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SDS Number 110569 Approved/Revised 23-Oct-2007 Version 13
MYLERAN TABLETS
Material


* Other Equipment or Follow all local regulations if personal protective equipment (PPE) is used
in the workplace. When isolation is not possible in production areas,
Procedures
applicable protective equipment must be 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
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.
Inhalation Toxicity No studies have been conducted.
Skin Effects No studies have been conducted.
Eye Effects No studies have been conducted.
Target Organ Effects Adverse effects might occur in the following organ(s) following
overexposure: bone marrow and formation of blood cells; gastro-intestinal
tract; liver.
Sensitisation Allergic skin reactions might occur following dermal exposure. Assessment
based upon effects of structurally similar substances.
Genetic Toxicity Known or probable human mutagen.
Carcinogenicity Contains a material classified as a carcinogen by external agencies.
Classification by external agencies: Human carcinogen; (IARC); (NTP).
Reproductive Effects Contains components which have been classified as: Known or presumed
to impair fertility in humans. Known or presumed to cause toxicity in
developing human offspring.
Pharmacological Effects This product contains active ingredient(s) with the following activity: a
cytotoxic 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




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SDS Number 110569 Approved/Revised 23-Oct-2007 Version 13
MYLERAN TABLETS
Material


Activated Sludge This material contains an active pharmaceutical ingredient that is not toxic
to activated sludge microorganisms.
Respiration
IC50: > 100 mg/l, 3 Hours, Activated sludge
Daphnid No toxicity to daphnids 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 this compound.
EC50: > 10 mg/l, 48 Hours, Daphnia magna
MOBILITY
Solubility This material contains an active pharmaceutical ingredient that for
environmental fate predictions has solubility in water.
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 unstable in water. Hydrolysis may be a significant
depletion mechanism.
Half-Life, Neutral: < 24 Hours, Measured
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. However, products that are subject to the
labelling requirements of the Food and Drug Administration are exempt
from the labelling provisions of the standard.
Target Organ May cause adverse effects on bone marrow; gastrointestinal tract; liver.
Statement
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SDS Number 110569 Approved/Revised 23-Oct-2007 Version 13
MYLERAN TABLETS
Material


Other US Regulations
TSCA Status Exempt
Australian Classification This product is classified as hazardous according to the NOHSC Approved
according to Hazardous Criteria for Classifying Hazardous Substances.
Substance and
Dangerous Goods
Regulatory Framework

16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 23-Oct-2007 SDS Version Number 13


SDS Sections Updated
Sections Subsections
EXPOSURE CONTROLS / PERSONAL PROTECTION Other Equipment or Procedures
HAZARDS IDENTIFICATION Health
IDENTIFICATION OF SUBSTANCE / PREPARATION AND
OF COMPANY
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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