SDS Number 110579 Approved/Revised 23-Oct-2007 Version 10
THIOGUANINE TABLETS
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material THIOGUANINE TABLETS
THIOGUANIN GSK TABLETTEN 40 MG * TABLOID BRAND THIOGUANINE
Synonyms
TABLETS 40 MG * TABLOID COMPRIMIDOS * TIOGUANINE TABLET 40 MG
* TIOGUANINA WELLCOME COMPRIMIDOS * LANVIS TABLETS 40 MG *
NDC NO 0173-0880-25 * THIOGUANINE, 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
THIOGUANINE 16.8 to 18
154-42-7
NON-HAZARDOUS INGREDIENTS 82.0 to 83.2
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 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 110579 Approved/Revised 23-Oct-2007 Version 10
THIOGUANINE 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 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.
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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SDS Number 110579 Approved/Revised 23-Oct-2007 Version 10
THIOGUANINE TABLETS
Material
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
THIOGUANINE
INGREDIENT
4
GSK Occupational
Hazard Category
CARCINOGEN, REPRODUCTIVE
GSK Occupational 10 mcg/m3 (8 HR TWA)
HAZARD
Exposure Limit
ENGINEERING CONTROLS
Exposure Controls 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.
Containment Open handling may result in overexposure. Consider segregating
operations, use of enclosures and sealed transfer systems.
Administrative Entry to the working area should be controlled. Restrict access to authorised
personnel.
* Other Equipment or Follow all local regulations if personal protective equipment (PPE) is used
in the workplace. Wear appropriate clothing to avoid skin contact. Wash
Procedures
hands and arms thoroughly after handling.
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
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 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 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; liver.
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SDS Number 110579 Approved/Revised 23-Oct-2007 Version 10
THIOGUANINE TABLETS
Material
Sensitisation Allergic skin reactions might occur following dermal exposure.
Genetic Toxicity Possible human mutagen.
Carcinogenicity Contains a component listed as a carcinogen by: (GSK) Known or probable
human carcinogen. No components are listed as carcinogens by: (IARC);
(NTP); (US OSHA); (EU).
Reproductive Effects Contains components which have been classified as: Possible risk of
toxicity in developing human offspring.
Pharmacological Effects This preparation contains ingredient(s) with the following activity: a
nucleoside analogue.
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.
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
Algal This material contains an active pharmaceutical ingredient that is very toxic
to algae.
IC50: 0.0034 mg/l, 72 Hours, Scenedesmus subspicatus,
green algae, Static test
NOEL: 0.0005 mg/l, 72 Hours, Scenedesmus subspicatus,
green algae, Static test
Daphnid This material contains an active pharmaceutical ingredient that is harmful to
daphnids.
EC50: 16.5 mg/l, 48 Hours, Daphnia magna
MOBILITY
Solubility This material contains an active pharmaceutical ingredient that for
environmental fate predictions has limited solubility in water.
Volatility This material contains an active pharmaceutical ingredient that will not
readily enter into air from water.
Henry's Law Constant 1.42E-14 atm m^3/mol, Calculated at 25 掳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
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SDS Number 110579 Approved/Revised 23-Oct-2007 Version 10
THIOGUANINE TABLETS
Material
Hydrolysis This material contains an active pharmaceutical ingredient that may be
chemically unstable under basic conditions. Hydrolysis may be a significant
depletion mechanism.
Half-Life, Neutral: 62 Days, Measured, Deionized Water
Biodegradation This material contains an active pharmaceutical ingredient that is not
readily biodegradable but is inherently biodegradable (as defined by 1993
OECD Testing Guidelines) and is not expected to persist in the
environment.
Aerobic - Inherent
Percent Degradation: 0 %, 28 days, Modified MITI (II) Test., Activated
sludge
Percent Degradation: 68 %, 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. 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.
Other US Regulations
TSCA Status Exempt
16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 23-Oct-2007 SDS Version Number 10
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SDS Number 110579 Approved/Revised 23-Oct-2007 Version 10
THIOGUANINE TABLETS
Material
SDS Sections Updated
Sections Subsections
EXPOSURE CONTROLS / PERSONAL PROTECTION Other Equipment or Procedures
HAZARDS IDENTIFICATION Conditions Aggravated by Exposure
Environment
Eye Contact
Health
Ingestion
Inhalation
Overview
Skin Contact
Summary
IDENTIFICATION OF SUBSTANCE / PREPARATION AND
OF COMPANY
TOXICOLOGY INFORMATION Carcinogenicity
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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