SDS Number 123467 Approved/Revised 15-Aug-2003 Version 04
Material GRISOVIN TABLETS
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material GRISOVIN TABLETS
GRISOVIN 125 MG TABLETS * GRISOVIN 500 MG TABLETS *
Synonyms
GRISEOFULVIN, 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
GRISEOFULVIN 69.7-69.8
126-07-8
NON-HAZARDOUS INGREDIENTS 30.2-30.3
Unassigned
3. HAZARDS IDENTIFICATION
This product is expected to be non-combustible.
Fire and Explosion
Health May produce adverse effects on the development of human offspring.
Possible effects of overexposure in the workplace include: nausea;
vomiting; diarrhoea; blurred vision; thirst; dry mouth; dizziness; headache;
fatigue; symptoms of hypersensitivity (such as skin rash, hives, itching, and
difficulty breathing).
Exposure might occur via inhalation; ingestion; skin; eyes.
Handling this product in its final form presents minimal risk from
occupational exposure. 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 123467 Approved/Revised 15-Aug-2003 Version 04
Material GRISOVIN TABLETS
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. Using
appropriate personal protective equipment, move exposed subject to fresh
air. If breathing is difficult or ceases, ensure and maintain ventilation. Give
oxygen as appropriate. The exposed subject should be kept warm and at
rest. Obtain medical attention in cases of known or possible over exposure,
or with symptoms including chest pain, difficulty breathing, loss of
consciousness or other adverse effects, which may be delayed.
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 an antifungal agent
In allergic individuals, exposure to this material may require treatment for
initial or delayed allergic symptoms and signs. This may include immediate
and/or delayed treatment of anaphylactic reactions.
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 Refer to prescribing information for detailed description of medical
conditions caused by or aggravated by overexposure to this product. This
Caused or Aggravated
material is clinically incompatible with oral contraceptives; alcohol;
by Exposure
anticoagulants. Ocular symptoms may be indicative of allergic reaction.
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.
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SDS Number 123467 Approved/Revised 15-Aug-2003 Version 04
Material GRISOVIN TABLETS
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. No
specific decontamination or detoxification procedures have been identified
Procedures
for this product.
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
GRISEOFULVIN
INGREDIENT
2
GSK Occupational
Hazard Category
REPRODUCTIVE HAZARD
GSK Occupational 1000 mcg/m3 (8 HR TWA)
Exposure Limit
MICROCRYSTALLINE CELLULOSE
INGREDIENT
1
GSK Occupational
Hazard Category
MAGNESIUM STEARATE
INGREDIENT
3
GSK Occupational
Hazard Category
POLYVINYLPYRROLIDONE
INGREDIENT
1
GSK Occupational
Hazard Category
DODECYL SODIUM SULFATE
INGREDIENT
3
GSK Occupational
Hazard Category
POLYOXYETHYLENE (20) SORBITAN MONOOLEATE
INGREDIENT
1
GSK Occupational
Hazard Category
POLYETHYLENE GLYCOL 400
INGREDIENT
1
GSK Occupational
Hazard Category
DICHLOROMETHANE
INGREDIENT
2
GSK Occupational
Hazard Category
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.
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Administrative New or expectant mothers might be at greater risk from overexposure. 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. Wash hands and arms
thoroughly after handling.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Off-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 Not expected to be toxic following ingestion. Assessment based upon
effects of individual components.
Skin Effects Irritation might occur following direct contact. Assessment based upon
effects of individual components.
Eye Effects Minor irritation might occur following direct contact with eyes. Assessment
based upon effects of individual components.
Target Organ Effects No specific target organ effects have been identified.
Sensitisation Sensitisation (allergic skin reaction) is not expected. Assessment based
upon effects of individual components. Assessment based upon information
from human exposure.
Genetic Toxicity Known or probable human mutagen. This product contains griseofulvin
which produced evidence of DNA damage in the following assay(s):
mammalian cell mutation assay (L5178Y mouse lymphoma thymidine
kinase locus assay); cultured human lymphocytes. DNA damage occurred
in the following assay(s): mammalian sperm; mammalian eggs. Assessment
based upon information from animal studies. This material was mutagenic
in Chinese hamster cells (chromosomal aberration assay).
Carcinogenicity Griseofulvin, the active substance in this product, produced carcinogenic
effects in a lifetime study in mice; a lifetime study in rats. Not expected to
produce cancer in humans under occupational exposure conditions.
Reproductive Effects This material contains components which have been classified as:
Known or presumed to cause toxicity in developing human offspring.
Possible risk of impaired fertility in humans. Assessment based on studies
using laboratory animals. However, the relevance of these effects to
humans from occupational exposure is not known.
Insufficient information available to classify this material for hazard to milk
production.
Pharmacological Effects This material is an antibiotic; an antifungal agent. Adverse effects of
overexposure might include: symptoms of hypersensitivity (such as skin
rash, hives, itching, and difficulty breathing).
Other Adverse Effects Overexposure in the workplace might have the following effects: headache;
nausea; dizziness; irritation of the gastrointestinal tract; vomiting; diarrhoea;
fatigue; heartburn; blurred vision; thirst.
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Material GRISOVIN TABLETS
12. ECOLOGICAL INFORMATION
Summary No information is available about the potential of this product to produce
adverse environmental effects. This material contains an active
pharmaceutical ingredient that has had limited testing and no adverse
environmental effects were observed in the tests conducted. Local
regulations and procedures should be consulted prior to environmental
release.
ECOTOXICITY
Aquatic
Daphnid This mixture contains an active pharmaceutical ingredient that is not toxic
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.
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
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
None.
US OSHA Standard (29 CFR Part 1910.1200)
Classification This dosage form is exempt from the requirements of the OSHA Hazard
Communication Standard.
Other US Regulations
TSCA Status Exempt
16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 15-Aug-2003 SDS Version Number 4
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SDS Number 123467 Approved/Revised 15-Aug-2003 Version 04
Material GRISOVIN TABLETS
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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