SDS Number 129124 Approved/Revised 08-Feb-2007 Version 3
ALLI
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material ALLI
ORLISTAT 60 MG CAPSULES * ORLISTAT OTC CAPSULES * PROJECT
Synonyms
GEMINI * ORLISTAT, 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
ORLISTAT 49.95
96829-58-2
NON-HAZARDOUS INGREDIENTS 50.05
Unassigned
3. HAZARDS IDENTIFICATION
Expected to be non-combustible.
Fire and Explosion
Health Handling this product in its final form presents minimal risk from
occupational exposure.
Health effects information is based on hazards of components.
Environment Dangerous for the environment. Toxic to aquatic organisms. May cause
long-term adverse effects in the aquatic environment.
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.
Page 1 / 5
SDS Number 129124 Approved/Revised 08-Feb-2007 Version 3
ALLI
Material
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 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 is recommended for fires involving packaging.
Special Firefighting For single units (packages): No special requirements needed.
For larger amounts (multiple packages/pallets) of product: Since toxic,
Procedures
corrosive or 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 or corrosive thermal decomposition products are expected when this
material 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 capsules.
STORAGE No storage requirements necessary for occupational hazards. Follow
product information storage instructions to maintain efficacy.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
ORLISTAT
INGREDIENT
1
GSK Occupational
Hazard Category
GSK Occupational 2000 mcg/m3 (8 HR TWA)
Exposure Limit
Page 2 / 5
SDS Number 129124 Approved/Revised 08-Feb-2007 Version 3
ALLI
Material
ENGINEERING CONTROLS
Containment No special engineering controls are required.
Other Equipment or Wash hands and arms thoroughly after handling.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Capsule.
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 No specific target organ effects have been identified.
Sensitisation Potential for inducing allergic reactions via the dermal or respiratory route is
not known.
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 None known for occupational exposure.
12. ECOLOGICAL INFORMATION
Summary This material contains an active pharmaceutical ingredient that has been
tested, and which may be toxic to aquatic organisms if released directly to
the environment. This material contains an active pharmaceutical ingredient
that may persist in 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
Activated Sludge This material contains an active pharmaceutical ingredient that is not toxic
to activated sludge microorganisms.
Respiration
Page 3 / 5
SDS Number 129124 Approved/Revised 08-Feb-2007 Version 3
ALLI
Material
Algal No toxicity to algae 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 the compound.
IC50: > 1.92 mg/l, 10 Days, Selenastrum capricornutum,
green algae
NOEL: 1.92 mg/l, 10 Days, Selenastrum capricornutum,
green algae
Daphnid This material contains an active pharmaceutical ingredient that is toxic to
daphnids.
EC50: 6.92 mg/l, 48 Hours, Daphnia magna
NOEL: 1.95 mg/l, 48 Hours, Daphnia magna
Fish No toxicity to fish was observed for the active pharmaceutical ingredient,
but the upper range of the test was limited by the low water solubility of the
compound.
Adult Oncorhyncus mykiss, rainbow trout
EC50: > 18.5 mg/l, 96 Hours
Adult Oncorhyncus mykiss, rainbow trout
NOEL: 18.5 mg/l, 96 Hours
Terrestrial
Earthworm This mixture contains an active pharmaceutical ingredient that is not toxic
to earthworms.
Lumbricus terrestris, earthworm
EC50: 907 mg/kg, 28 Days,
MOBILITY
Solubility This material contains an active pharmaceutical ingredient that for
environmental fate predictions has very low solubility in water.
Adsorption This material contains an active pharmaceutical ingredient that is likely to
adsorb to soil or sediment. The active pharmaceutical ingredient may
persist in soil or sediment if this mixture is released directly to the
environment.
Soil Sediment Sorption 5.2, Measured
(log Koc):
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
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 - Ready
Percent Degradation: 18 %, 30 days
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 material.
Page 4 / 5
SDS Number 129124 Approved/Revised 08-Feb-2007 Version 3
ALLI
Material
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 Exempt when packaged for sale to consumers in a retail establishment.
Other US Regulations
TSCA Status Exempt
16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 08-Feb-2007 SDS Version Number 3
SDS Sections Updated
Sections Subsections
IDENTIFICATION OF SUBSTANCE / PREPARATION AND
OF COMPANY
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.
Page 5 / 5
|