SDS Number 110531 Approved/Revised 15-Jul-2004 Version 19
Material ALKERAN INJECTION
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material ALKERAN INJECTION
ALKERAN INJECTION 50 MG * ALKERAN IV INJECTION 50 MG * ALKERAN
Synonyms
INJECTION 50 MG/10 ML * NDC NO 0173-0130-93 * MELPHALAN
HYDROCHLORIDE, 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
MELPHALAN 71.4
148-82-3
NON-HAZARDOUS INGREDIENTS 28.6
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.
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.
Environment No information is available about the potential of this product to produce
adverse environmental effects.
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SDS Number 110531 Approved/Revised 15-Jul-2004 Version 19
Material ALKERAN INJECTION
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 a cytotoxic agent. 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 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 110531 Approved/Revised 15-Jul-2004 Version 19
Material ALKERAN INJECTION
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 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.
STORAGE No storage requirements necessary for occupational hazards. Follow
product information storage instructions to maintain efficacy.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
MELPHALAN
INGREDIENT
4
GSK Occupational
Hazard Category
CARCINOGEN, REPRODUCTIVE
GSK Occupational 1 mcg/m3 (8 HR TWA)
HAZARD, SKIN SENSITISER
Exposure Limit
ENGINEERING CONTROLS
Containment Open handling may result in overexposure. Consider use of enclosures.
Administrative Entry to the working area should be controlled. New or expectant mothers
are at greater risk if exposed to the active ingredient which is readily
absorbed through the skin. They should not handle unpackaged product.
Risk assessments must take this into consideration. Female employees
anticipating pregnancy or with a confirmed pregnancy must be encouraged
to notify an occupational health professional or their line manager. This will
act as the trigger for individual re-assessment of the employee鈥? work
s
practices.
Other Equipment or Wear appropriate clothing to avoid skin contact. When isolation is not
possible in production areas, appropriate personal protective equipment
Procedures
must be used. Consider additional control procedures for maintenance,
cleaning and emergencies.
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
White/off-white.
Colour
Freeze dried powder.
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.
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SDS Number 110531 Approved/Revised 15-Jul-2004 Version 19
Material ALKERAN INJECTION
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 which may be harmful if released directly to the environment.
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.
ECOTOXICITY
Aquatic
Activated Sludge This material contains an active pharmaceutical ingredient that is not toxic
to activated sludge microorganisms.
Respiration
Daphnid This mixture contains an active pharmaceutical ingredient that is harmful to
daphnids.
MOBILITY
Partitioning This mixture 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.
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.
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SDS Number 110531 Approved/Revised 15-Jul-2004 Version 19
Material ALKERAN INJECTION
UN Classification and Labelling
Medicine, solid, toxic, nos
Proper Shipping Name
(MELPHALAN HYDROCHLORIDE, FORMULATED PRODUCT)
UN 3249
UN Number
6.1
Class/Division
II
Packing Group
Class 6.1 Toxic
Risk Label(s)
International Air Transport (IATA Requirements)
As UN Classification and Labelling above
Classification and
Labelling
Quantities equal to or less than 1 kg per inner packaging are not subject to
Limited Quantities
the full packaging and labelling requirements, although the appropriate
shipping papers will be required.
International Maritime Transport (IMDG Requirements)
As UN Classification and Labelling above
Classification and
Labelling
Marine Pollutant Status Not listed
Quantities equal to or less than 0.5 kg per inner packaging are not subject
Limited Quantities
to the full packaging and labelling requirements, although the appropriate
shipping papers will be required.
US Domestic Transport (DOT Requirements)
As UN Classification and Labelling above
Classification and
Labelling
US Emergency Response 151
Guide Number
Quantities equal to or less than 5 kg per inner packaging are not subject to
Quantity Limitations
the full packaging and labelling requirements, although the appropriate
shipping papers will be required.
European Ground Transport (ADR/RID Requirements)
As UN Classification and Labelling above
Classification and
Labelling
61GT8-I-L
TREMCARD Number
60
Hazard Identification
Number
Emergency Action Code 2X
(UK only)
Quantities equal to or less than 1 kg per inner packaging and 4 kg per
Limited Quantities
package are not subject to the full packaging and labelling requirements,
although the appropriate shipping papers will be required.
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.
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SDS Number 110531 Approved/Revised 15-Jul-2004 Version 19
Material ALKERAN INJECTION
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 bone marrow; gastrointestinal tract; liver.
Statement
Other US Regulations
TSCA Status Exempt
16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 15-Jul-2004 SDS Version Number 19
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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