Page 1 of 6
Revision date: 05-Jan-2007

MATERIAL SAFETY DATA SHEET
Version: 1.1
1.
IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING




Material Name: Sultamicillin Tosylate Tablets


Trade Name:
UNASYN Tablets

Chemical Family:
Mixture

Intended Use:
Pharmaceutical product used as antibiotic agent

2. COMPOSITION/INFORMATION ON INGREDIENTS

Hazardous
Ingredient
CAS Number
EU EINECS List
%
Sultamicillin Tosylate
83105-70-8
Not listed
70
Corn Starch
9005-25-8
232-679-6
*
Magnesium stearate
557-04-0
209-150-3
*


Ingredient
CAS Number
EU EINECS List
%
Lactose
63-42-3
200-559-2
*
Hydroxypropyl cellulose
9004-64-2
Not listed
*
Sodium starch glycolate
9063-38-1
Not listed
*

Additional Information:
* Proprietary
Ingredient(s) indicated as hazardous have been assessed under standards for workplace
safety.

3. HAZARDS IDENTIFICATION

Appearance:
White tablets
Signal Word:
WARNING

Statement of Hazard:
May cause allergic skin and respiratory reaction
May cause allergic reaction in penicillin-sensitive individuals
Additional Hazard Information:

Short Term:
Not acutely toxic (based on animal data) . Individuals who are allergic to penicillin antibiotics
could have allergic reaction, possibly severe. Accidental ingestion may cause effects similar to
those seen in clinical use.

Long Term:
Repeated inhalation may result in sensitization.
Known Clinical Effects:
May cause effects similar to those generally seen in clinical use of antibiotics including
gastrointestinal irritation, vomiting, transient diarrhea, nausea, and abdominal pain. May cause
mild skin rash. Pseudomembranous colitis (manifested by watery diarrhea, urge to defecate,
abdominal cramps, low-grade fever, bloody stools, and abdominal pain) may also occur.
Pfizer Ltd
Ramsgate Road
Sandwich, Kent
CT13 9NJ
United Kingdom
+00 44 (0)1304 616161
Emergency telephone number:
CHEMTREC (24 hours): 1-800-424-9300
Emergency telephone number:
ChemSafe (24 hours): +44 (0)208 762 8322
Pfizer Inc
Pfizer Pharmaceuticals Group
235 East 42nd Street
New York, New York 10017
1-212-573-2222

MATERIAL SAFETY DATA SHEET

_______________________________________________________________________________________________________

Material Name: Sultamicillin Tosylate Tablets
Revision date: 05-Jan-2007
Page 2 of 6
Version: 1.1
EU Indication of danger:
Harmful
Irritant
EU Hazard Symbols:

EU Risk Phrases:
R42/43 - May cause sensitization by inhalation and skin contact.

Note:
This document has been prepared in accordance with standards for workplace safety, which
require the inclusion of all known hazards of the active substance or its intermediates
regardless of the potential risk. The precautionary statements and warnings included may not
apply in all cases. Your needs may vary depending upon the potential for exposure in your
workplace.


4. FIRST AID MEASURES

Eye Contact:
Rinse thoroughly with plenty of water, also under the eyelids. If irritation occurs or persists, get
medical attention.

Skin Contact:
Wash skin with soap and water. If irritation occurs or persists, get medical attention.

Ingestion:
Get medical attention. Do not induce vomiting unless directed by medical personnel. Never
give anything by mouth to an unconscious person.

Inhalation:
Remove to fresh air. If discomfort persists, get medical attention.

5. FIRE FIGHTING MEASURES

Extinguishing Media:
Water, carbon dioxide, dry chemical or foam

Hazardous Combustion Products:
Emits toxic fumes of carbon monoxide, carbon dioxide, nitrogen oxides, sulfur oxides and other
sulfur-containing compounds.

Fire Fighting Procedures:
During all fire fighting activities, wear appropriate protective equipment, including self-
contained breathing apparatus.

Fire / Explosion Hazards:
Not applicable

6. ACCIDENTAL RELEASE MEASURES

Health and Safety Precautions:
Personnel involved in clean-up should wear appropriate personal protective equipment (see
Section 8). Minimize exposure.

Measures for Cleaning / Collecting: Contain the source of spill if it is safe to do so. Collect spilled material by a method that
controls dust generation. A damp cloth or a filtered vacuum should be used to clean spills of
dry solids. Clean spill area thoroughly.

Measures for Environmental
Protections:
Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to
avoid environmental release.

Additional Consideration for Large
Spills:
Non-essential personnel should be evacuated from affected area. Report emergency
situations immediately. Clean up operations should only be undertaken by trained personnel.


MATERIAL SAFETY DATA SHEET

_______________________________________________________________________________________________________

Material Name: Sultamicillin Tosylate Tablets
Revision date: 05-Jan-2007
Page 3 of 6
Version: 1.1
7. HANDLING AND STORAGE

General Handling:
If tablets or capsules are crushed and/or broken, avoid breathing dust and avoid contact with
eyes, skin, and clothing.

Storage Conditions:
Keep container tightly closed when not in use. Store out of direct sunlight in a well ventilated
area at room temperature.

8. EXPOSURE CONTROLS / PERSONAL PROTECTION

The exposure limit(s) listed for solid components are only relevant if dust may be generated.
The purpose of the Occupational Exposure Band (OEB) classification system is to separate substances into different Hazard categories
when the available data are sufficient to do so, but inadequate to establish an Occupational Exposure Limit (OEL). The OEB given is
based upon an analysis of all currently available data; as such, this value may be subject to revision when new information becomes
available.

Analytical Method:
Analytical method available for sultamicillin. Contact Pfizer Inc for further information.

Engineering Controls:
Engineering controls should be used as the primary means to control exposures. Use process
containment, local exhaust ventilation, or other engineering controls to maintain airborne levels
within the OEB range.

Personal Protective Equipment:


Hands:
Not required for the normal use of this product. Wear protective gloves when working with
large quantities.

Eyes:
Not required under normal conditions of use. Wear safety glasses or goggles if eye contact is
possible.

Skin:
Not required for the normal use of this product. Wear protective clothing when working with
large quantities.

Respiratory protection:
Not required for the normal use of this product. If airborne exposures are within or exceed the
Occupational Exposure Band (OEB) range, wear an appropriate respirator with a protection
factor sufficient to control exposures to the bottom of the OEB range.


9. PHYSICAL AND CHEMICAL PROPERTIES:




ACGIH Threshold Limit Value (TWA)
= 10 mg/m3 TWA
Sultamicillin Tosylate

Pfizer Occupational Exposure
Band (OEB):
OEB 2 - Sensitizer (control exposure to the range of >100ug/m3 to < 1000ug/m3, provide
additional precautions to protect from skin contact)

Australia TWA
= 10 mg/m3 TWA
Corn Starch
Physical State:
Tablet
Magnesium stearate
Color:
White
Molecular Formula:
Mixture
Molecular Weight:
Mixture

ACGIH Threshold Limit Value (TWA)
= 10 mg/m3 TWA except stearates of toxic metals

OSHA - Final PELS - TWAs:
= 15 mg/m3 TWA total
= 5 mg/m3 TWA

Australia TWA
= 10 mg/m3 TWA

MATERIAL SAFETY DATA SHEET

_______________________________________________________________________________________________________

Material Name: Sultamicillin Tosylate Tablets
Revision date: 05-Jan-2007
Page 4 of 6
Version: 1.1

10. STABILITY AND REACTIVITY

Stability:
Stable
Conditions to Avoid:
None known
Incompatible Materials:
As a precautionary measure, keep away from strong oxidizers.

11. TOXICOLOGICAL INFORMATION

General Information:
The information included in this section describes the potential hazards of the individual
ingredients.

Acute Toxicity: (Species, Route, End Point, Dose)
Acute Toxicity Comments:
A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievable
at the highest dose used in the test.

Carcinogen Status:
None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA.



12. ECOLOGICAL INFORMATION

Environmental Overview:
Environmental properties have not been investigated. Releases to the environment should be
avoided.





13. DISPOSAL CONSIDERATIONS

Disposal Procedures:
Dispose of waste in accordance with all applicable laws and regulations.

14. TRANSPORT INFORMATION
Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations.



Mouse Oral LD 50 > 10 g/kg
Lactose
Sultamicillin Tosylate
Rat Oral LD50 > 10 g/kg
Magnesium stearate
Rat Oral LD 50 > 10 g/kg
Rat Oral LD50 > 2000 mg/kg
Rat Inhalation LC50 > 2000 mg/m3

MATERIAL SAFETY DATA SHEET

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Material Name: Sultamicillin Tosylate Tablets
Revision date: 05-Jan-2007
Page 5 of 6
Version: 1.1
15. REGULATORY INFORMATION

EU Symbol:
Xn
EU Indication of danger:
Harmful
Irritant
EU Risk Phrases:
R42/43 - May cause sensitization by inhalation and skin contact.

EU Safety Phrases:
S22 - Do not breathe dust.
S24 - Avoid contact with skin.
S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection.



OSHA Label:
WARNING
May cause allergic skin and respiratory reaction
May cause allergic reaction in penicillin-sensitive individuals

Canada - WHMIS: Classifications

WHMIS hazard class:
Class D, Division 2, Subdivision A





Inventory - United States TSCA - Sect. 8(b)
XU
Australia (AICS):
Present

Australia (AICS):
Present

EU EINECS List
232-679-6

EU EINECS List
Sodium starch glycolate
200-559-2
Lactose

Inventory - United States TSCA - Sect. 8(b)
XU

Australia (AICS):
Present
Hydroxypropyl cellulose
Magnesium stearate

Inventory - United States TSCA - Sect. 8(b)
Present

Inventory - United States TSCA - Sect. 8(b)
XU

Australia (AICS):
Present

Inventory - United States TSCA - Sect. 8(b)

EU EINECS List
209-150-3
Present

Australia (AICS):
Present
Corn Starch

MATERIAL SAFETY DATA SHEET

_______________________________________________________________________________________________________

Material Name: Sultamicillin Tosylate Tablets
Revision date: 05-Jan-2007
Page 6 of 6
Version: 1.1
16. OTHER INFORMATION

Reasons for Revision:
Updated Section 3 - Hazard Identification. Updated Section 5 - Fire Fighting Measures.
Updated Section 6 - Accidental Release Measures. Updated Section 7 - Handling and Storage.
Updated Section 8 - Exposure Controls / Personal Protection. Updated Section 10 - Stability
and Reactivity. Updated Section 13 - Disposal Considerations.

Prepared by:
Toxicology and Hazard Communication
Pfizer Global Environment, Health, and Safety

Pfizer Inc believes that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, it
is without a warranty of any kind, expressed or implied.

End of Safety Data Sheet