SDS Number 4371 Approved/Revised 25-Jan-2005 Version 16
Material STELAZINE TABLETS
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material STELAZINE TABLETS
ESKAZINE TABLETS * STELAZINE TABLETS 1 MG * STELAZINE TABLETS
Synonyms
2 MG * STELAZINE TABLETS 5 MG * STELAZINE TABLETS 10 MG * NDC
NO. 0108-4903-20 * NDC NO. 0108-4904-20 * NDC NO. 0108-4906-20 * NDC
NO. 0108-4907-20 * TRIFLUOPERAZINE DIHYDROCHLORIDE,
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
TRIFLUOPERAZINE DIHYDROCHLORIDE 1 to 3
440-17-5
NON-HAZARDOUS INGREDIENTS 97 to 99
Unassigned
3. HAZARDS IDENTIFICATION
Expected to be non-combustible.
Fire and Explosion
Health Exposure might occur via eyes; skin; ingestion.
Caution - Pharmaceutical agent. Possible effects of overexposure in the
workplace include: seizures; decrease in blood pressure; muscle cramps;
menstrual irregularities; blurred vision; drowsiness; dizziness; restlessness;
incoordination.
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 4371 Approved/Revised 25-Jan-2005 Version 16
Material STELAZINE 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.
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 stelazine . 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
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.
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.
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SDS Number 4371 Approved/Revised 25-Jan-2005 Version 16
Material STELAZINE TABLETS
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
TRIFLUOPERAZINE DIHYDROCHLORIDE
INGREDIENT
4
GSK Occupational
Hazard Category
GSK Occupational 3 mcg/m3 (8 HR TWA)
Exposure Limit
Other Equipment or None required for normal handling. Wash hands and arms thoroughly after
handling.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Blue.
Colour
Film-coated 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 Adverse effects might occur following inhalation.
Skin Effects Irritation is not expected following direct contact.
Eye Effects Irritation is not expected following direct contact with eyes.
Target Organ Effects No specific target organ effects have been identified.
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.
Other Adverse Effects This material can produce central nervous system depression or affect
muscular movements or coordination.
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 material 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
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SDS Number 4371 Approved/Revised 25-Jan-2005 Version 16
Material STELAZINE TABLETS
* Activated Sludge This material contains an active pharmaceutical ingredient that is harmful to
activated sludge microorganisms.
Respiration
IC50: 66 mg/l, 3 Hours, Activated sludge, Nominal
NOEC: 10 mg/l
* Algal This material contains an active pharmaceutical ingredient that is very toxic
to algae.
IC50: 0.31 mg/l, 72 Hours, Selenastrum capricornutum,
green algae, Nominal
NOEL: 0.13 mg/l
* Daphnid This material contains an active pharmaceutical ingredient that is toxic to
daphids.
EC50: 2.6 mg/l, 48 Hours, Daphnia magna, Nominal
NOEL: 0.63 mg/l, 48
* Fish This material contains an active pharmaceutical ingredient that is toxic to
fish.
Juvenile Oncorhyncus mykiss, rainbow trout
EC50: 1.4 mg/l, 96 Hours, Nominal
NOEL: 0.5 mg/l
MOBILITY
* Solubility This material contains an active pharmaceutical ingredient that for
environmental fate predictions has solubility in water.
* Adsorption This material contains an active pharmaceutical ingredient that is likely to
adsorb to sludges and other biomass. This material contains an active
pharmaceutical ingredient that is likely to adsorb to soil or sediment.
Sludge Biomass 3.16 Measured Measured at pH 7
Distribution Coefficient
(log Kd):
* 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 may have the
tendency to distribute into fats.
PERSISTENCE/DEGRADATION
* Photolysis This material contains an active pharmaceutical ingredient that has been
shown to be chemically unstable in water when exposed to light. Aqueous
photolysis may be a significant depletion mechanism.
Half-Life, Aqueous: 50 %, < 1 day, Measured, Deionized Water
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.
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SDS Number 4371 Approved/Revised 25-Jan-2005 Version 16
Material STELAZINE TABLETS
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 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 25-Jan-2005 SDS Version Number 16
SDS Sections Updated
Sections Subsections
COMPOSITION / INFORMATION ON INGREDIENTS
ECOLOGICAL INFORMATION Activated Sludge Respiration
Adsorption
Algal
Algal Degradation
Bioaccumulation
Biodegradation
Daphnid
Distribution
Earthworm
Ecotoxicity
Fish
Hydrolysis
Microbial Growth Inhibition
Microtox
Mobility
Other Adverse Effects
Other Species - Aquatic
Other Species - Terrestrial
Partitioning
Persistence/Degradation
Photolysis
Solubility
Summary
Volatility
REGULATORY INFORMATION European Union Classification and Labelling
Requirements
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SDS Number 4371 Approved/Revised 25-Jan-2005 Version 16
Material STELAZINE 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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