SDS Number 110531 Approved/Revised 03-Aug-2006 Version 21
ALKERAN INJECTION
Material
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 * 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
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
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.
May produce allergic skin reactions.
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.
4. FIRST-AID MEASURES
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SDS Number 110531 Approved/Revised 03-Aug-2006 Version 21
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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 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.
Clean-up Methods Collect and place it in a suitable, properly labelled container for recovery or
disposal.
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Material
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
5
GSK Occupational
Hazard Category
CARCINOGEN, REPRODUCTIVE
GSK Occupational 1 mcg/m3 (8 HR TWA)
HAZARD, SKIN SENSITISER
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.
* 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.
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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 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: bone marrow and formation of blood cells; toxicity to rapidly
dividing cells.
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 impair fertility in human females. 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 had
limited testing and no adverse environmental effects were observed in the
tests conducted. There is insufficient information to determine the scope of
the environmental effects this material may cause. Until there is additional
testing to determine other potential adverse effects on the environment,
appropriate precautions should be taken to limit release of this compound 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
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
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Material
Solubility This material contains an active pharmaceutical ingredient that for
environmental fate predictions has very low solubility in water.
Volatility This material contains an active pharmaceutical ingredient that will not
readily enter into air from water.
Henry's Law Constant 4.20E-13 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
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: 4.9 Hours, , pH 7 Buffer Solution
Half-Life, Acidic: 4.9 Hours, , pH 5 Buffer Solution
Half-Life, Basic: 3.9 Hours
BIOACCUMULATION This material contains an active pharmaceutical ingredient that will not have
a tendency to bioaccumulate in the food chain.
Bioconcentration Factor: 1 Estimated
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
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)
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Material
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
Limited Quantities
the full packaging and labelling requirements, although the appropriate
shipping papers will be required.
European Ground Transport (ADR/RID Requirements)
Not subject to ADR, see SP 601.
Classification and
Labelling
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
Other US Regulations
TSCA Status Exempt
* Australian This product is classified as hazardous according to the NOHSC Approved
Classification according Criteria for Classifying Hazardous Substances.
to Hazardous Substance
and Dangerous Goods
Regulatory Framework
16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 03-Aug-2006 SDS Version Number 21
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SDS Number 110531 Approved/Revised 03-Aug-2006 Version 21
ALKERAN INJECTION
Material
SDS Sections Updated
Sections Subsections
COMPOSITION / INFORMATION ON INGREDIENTS
EXPOSURE CONTROLS / PERSONAL PROTECTION Administrative
Containment
Exposure Controls
Eye Protection
Gloves
Occupational Hygiene Air Monitoring Methods
Occupational Hygiene Surface Monitoring Method
Other Equipment or Procedures
Other Exposure Limits
Other Information
Other Protective Equipment
Respirators
Surface Exposure Target
Ventilation
IDENTIFICATION OF SUBSTANCE / PREPARATION AND
OF COMPANY
REGULATORY INFORMATION Australian Classification according to Hazardous
Substance and Dangerous Goods Regulatory
Framework
US Environmental (EPA) Requirements
US OSHA Standard (29 CFR Part 1910.1200) -
Classification
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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