SDS Number 127806 Approved/Revised 23-Mar-2007 Version 7
ALTABAX OINTMENT
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material ALTABAX OINTMENT
ALTABAX OINTMENT 1% * ALTABAX OINTMENT 2% * ALTARGO
Synonyms
OINTMENT * SB-275833 OINTMENT * TOPICAL PLEUROMUTILIN * NDC
NO. 0007-5180-05 * NDC NO. 0007-5180-10 * NDC NO. 0007-5180-22 * NDC
NO. 0007-5180-61 * NDC NO. 0007-5180-62 * RETAPAMULIN, 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
SB-275833 1 to 2
224452-66-8
NON-HAZARDOUS INGREDIENTS 98.0 to 99.0
Unassigned
3. HAZARDS IDENTIFICATION
Expected to be non-combustible.
Fire and Explosion
Health Caution - Pharmaceutical agent. Exposure might occur via ingestion; skin;
eyes.
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 127806 Approved/Revised 23-Mar-2007 Version 7
ALTABAX OINTMENT
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 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 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 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, 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 Detergent solutions can be used for clean-up and decontamination
operations. No specific decontamination or detoxification procedures have
Procedures
been identified for this product.
7. HANDLING AND STORAGE
HANDLING
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SDS Number 127806 Approved/Revised 23-Mar-2007 Version 7
ALTABAX OINTMENT
Material
General Requirements No special control measures required for the normal handling of this
product. Normal room ventilation is expected to be adequate for routine
handling of this product.
STORAGE No storage requirements necessary for occupational hazards. Follow
product information storage instructions to maintain efficacy.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
SB-275833
INGREDIENT
2
GSK Occupational
Hazard Category
GSK Occupational 400 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
Ointment.
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 Minor irritation might occur following direct contact with eyes.
Target Organ Effects No specific target organ effects have been identified.
Sensitisation Allergic skin reactions might occur following dermal exposure.
Genetic Toxicity Not expected to be genotoxic under occupational exposure conditions.
Carcinogenicity Not expected to produce cancer in humans under occupational exposure
conditions. 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: an
antibiotic.
Other Adverse Effects None known for occupational exposure.
12. ECOLOGICAL INFORMATION
Summary This product contains an active ingredient that has been tested and which
may be harmful if released directly 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 127806 Approved/Revised 23-Mar-2007 Version 7
ALTABAX OINTMENT
Material
Activated Sludge This material contains an active pharmaceutical ingredient that is harmful to
activated sludge microorganisms.
Respiration
IC50: 5.3 mg/l, 3 Hours, Activated sludge, Nominal
NOEC: 0.1 mg/l, 3 Hours
Microtox Microtox is a general toxicity test which utilizes a sensitive marine photo
bacteria as the test species. This material contains an active
pharmaceutical ingredient that is not toxic to these microorganisms.
EC50: 103.6 mg/l, 15 Minutes
Daphnid This material contains an active pharmaceutical ingredient that is harmful to
daphnids.
EC50: 40 mg/l, 48 Hours, Daphnia magna, Measured
NOEL: 18 mg/l, 48 Hours
MOBILITY
Solubility This material contains an active pharmaceutical ingredient that for
environmental fate predictions has limited solubility in water.
Distribution
Octanol/Water 1.89 at pH 7.4
Distribution Coefficient
(log Dow):
Adsorption This material contains an active pharmaceutical ingredient that is not likely
to adsorb to soil or sediment if released directly to the environment. This
material contains an active pharmaceutical ingredient that is not likely to
adsorb to sludge or biomass if released directly to the environment.
Sludge Biomass 0.57 Measured Measured at pH 6.8
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
Hydrolysis This material contains an active pharmaceutical ingredient that has been
shown to be chemically stable in water.
Biodegradation This mixture 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. This
material is likely to have low removal in a wastewater treatment plant.
Aerobic - Inherent
Percent Degradation: 45 %, 5 days, Batch activated sludge (BAS),
Activated sludge
Percent Degradation: 9 %, 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.
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SDS Number 127806 Approved/Revised 23-Mar-2007 Version 7
ALTABAX OINTMENT
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 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 23-Mar-2007 SDS Version Number 7
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.
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