SDS Number 3139 Approved/Revised 25-Jan-2007 Version 15
ARGATROBAN INJECTION
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material ARGATROBAN INJECTION
ARGATROBAN INJECTION CONCENTRATE 100 MG/ML * SKF-105043,
Synonyms
FORMULATED PRODUCT * NDC NO. 0007-4407-01 * ARGATROBAN,
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
ARGATROBAN, BULK ACTIVE 10
74863-84-6
ETHANOL 38
64-17-5
NON-HAZARDOUS INGREDIENTS 52
Unassigned
3. HAZARDS IDENTIFICATION
This product is classified as flammable.
Fire and Explosion
Health Caution - Pharmaceutical agent.
Exposure might occur via ingestion; skin; eyes.
Eye irritant.
Possible effects of overexposure in the workplace include: reduced blood
coagulation.
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 3139 Approved/Revised 25-Jan-2007 Version 15
ARGATROBAN INJECTION
Material
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 anti-coagulant. Treat according to locally accepted protocols.
For additional guidance, refer to the local poison control information centre.
Medical Conditions None for occupational exposure.
Caused or Aggravated
by Exposure
Health Surveillance Pre-placement and periodic health surveillance is not usually indicated. The
final determination of the need for health surveillance should be determined
Procedures
by local risk assessment.
Antidotes No specific antidotes are recommended.
5. FIRE-FIGHTING MEASURES
Fire and Explosion This product is flammable. Fire and explosions might result if vapours are
allowed to accumulate in the vicinity of a source of ignition.
Hazards
Extinguishing Media Carbon dioxide, dry powder or foam extinguishers are recommended. Do
not use water extinguishers. Water jets may intensify the fire or 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. Move containers from the fire area if
possible without increased personal risk.
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 Stop leak and eliminate all sources of ignition (no smoking, sparks or
flames). Fence or cordon the affected area and do not allow individuals to
touch or walk through the spilled material unless wearing appropriate
protective clothing. Wear protective clothing and equipment consistent with
the degree of hazard. Vapour-suppressing foam or water spray may be
used to control vapours as appropriate.
Environmental Precautions Prevent entry into waterways, sewers, surface drainage systems and poorly
ventilated areas.
Clean-up Methods Spread an inert absorbent on the spill and place in a suitable, properly
labelled container for recovery or disposal. Equipment used for clean-up
should be earthed (grounded) and non-sparking.
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SDS Number 3139 Approved/Revised 25-Jan-2007 Version 15
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Material
Decontamination No specific decontamination or detoxification procedures have been
identified for this product. Detergent solutions can be used for clean-up and
Procedures
decontamination operations.
7. HANDLING AND STORAGE
HANDLING
General Requirements This material contains flammable components. Ensure that any area in
which this material is handled has sufficient ventilation to avoid the build up
of vapour and to control employee potential exposure to volatiles below
National Occupational Exposure Limits.
Ignition Controls Avoid contact with ignition sources. This liquid might ignite in contact with
some types of ignition source.
STORAGE Keep in tightly sealed containers or packages in a well-ventilated area. No
storage requirements necessary for occupational hazards. Follow product
information storage instructions to maintain efficacy. Keep away from
sources of ignition.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
ARGATROBAN, BULK ACTIVE
INGREDIENT
3
GSK Occupational
Hazard Category
GSK Occupational 80 mcg/m3 (8 HR TWA)
Exposure Limit
PERSONAL PROTECTIVE EQUIPMENT
Eye Protection Wear approved safety glasses with side shields or cover goggles if eye
contact is possible.
Other Equipment or An eye wash station should be available. Wear appropriate clothing to avoid
skin contact.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Clear.
Clarity
Colourless/light yellow.
Colour
Liquid.
Physical Form
Vial.
Packaging
27 to 28 掳C (Estimation based on components).
Flash Point
10. STABILITY AND REACTIVITY
Stability This product is expected to be stable.
Conditions to Avoid Avoid direct sunlight, conditions that might generate heat and sources of
ignition.
11. TOXICOLOGICAL INFORMATION
Oral Toxicity Not expected to be toxic following ingestion.
Inhalation Toxicity No studies have been conducted.
Skin Effects Irritation is not expected following direct contact.
Eye Effects Irritation might occur following direct contact with eyes.
Target Organ Effects No specific target organ effects have been identified.
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SDS Number 3139 Approved/Revised 25-Jan-2007 Version 15
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Material
Sensitisation Sensitisation (allergic skin reaction) is not expected.
Genetic Toxicity Not expected to be genotoxic under occupational exposure conditions.
Carcinogenicity No components are listed as carcinogens by GSK, IARC, NTP or US
OSHA.
Reproductive Effects Not expected to produce adverse effects on fertility or development under
occupational exposure conditions.
Pharmacological Effects This preparation contains ingredient(s) with the following activity: a thrombin
inhibitor.
Other Adverse Effects Overexposure in the workplace might have the following effects: impaired
blood coagulation.
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.
Consult the MSDS of the active ingredient for specific information about
potential environmental effects. 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.
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, Nominal
NOEC: 1000 mg/l, 3 Hours
Algal This material contains an active pharmaceutical ingredient that is not toxic
to algae.
IC50: > 100 mg/l, 72 Hours, Scenedesmus subspicatus,
green algae, Measured
NOEL: 100 mg/l, 72 Hours
* Daphnid This material contains an active pharmaceutical ingredient that is harmful to
daphnids.
EC50: 52 mg/l, 48 Hours, Daphnia magna, Measured
NOEL: 5.6 mg/l, 48 Hours
Fish This material contains an active pharmaceutical ingredient that is not toxic
to fish.
Juvenile Oncorhyncus mykiss, rainbow trout
EC50: > 100 mg/l, 96 Hours, Measured
NOEL: 100 mg/l, 96 Hours
MOBILITY
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 - Inherent
Percent Degradation: 10 %, 28 days, Modified Zahn-Wellens, DOC
removal., Activated sludge
Percent Degradation: 8 %, 28 days, Modified Zahn-Wellens, primary
biodegradation, loss of parent., Activated sludge
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.
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
ARGATROBAN INJECTION
Technical Name
Ethanol Solution
Proper Shipping Name
UN 1170
UN Number
3
Class/Division
III
Packing Group
Class 3 Flammable Liquid
Risk Label(s)
International Air Transport (IATA Requirements)
As UN Classification and Labelling above
Classification and
Labelling
International Maritime Transport (IMDG Requirements)
As UN Classification and Labelling above
Classification and
Labelling
US Domestic Transport (DOT Requirements)
This product is exempt from US DOT requirements under exemption
Classification and
DOT-E9275. Reference to this exemption should be included on the
Labelling
packaging and shipping papers for transportation in the US. In case of loss
of contents the carrier must immediately notify GlaxoSmithKline using the
telephone numbers in Section 1 of the MSDS.
European Ground Transport (ADR/RID Requirements)
Not subject to ADR, see SP 601.
Classification and
Labelling
15. REGULATORY INFORMATION
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SDS Number 3139 Approved/Revised 25-Jan-2007 Version 15
ARGATROBAN INJECTION
Material
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.
For waste disposal purpose, this product should be classified in line with the European Waste Catalogue
criteria.
US OSHA Standard (29 CFR Part 1910.1200)
Classification This product is classified as hazardous according to the OSHA Hazard
Communication Standard.
Other US Regulations
TSCA Status Exempt
16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 25-Jan-2007 SDS Version Number 15
SDS Sections Updated
Sections Subsections
IDENTIFICATION OF SUBSTANCE / PREPARATION AND
OF COMPANY
REGULATORY INFORMATION US Environmental (EPA) Requirements
TRANSPORT INFORMATION
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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