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MATERIAL SAFETY DATA SHEET

Revision date: 31-Jan-2008
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING

Pfizer Animal Health

Pfizer Ltd,
Pfizer Inc
235 East 42nd Street
New York, NY 10017
United Kingdom
Poison Control Center Phone: 1-866-531-8896
+00 44 (0)1304 616161
Technical Services Phone: 1-800-366-5288

Emergency telephone number:

Emergency telephone number:
CHEMTREC (24 hours): 1-800-424-9300
ChemSafe (24 hours): +44 (0)208 762 8322
Contact E-Mail:

Material Name: Lincomycin Hydrochloride Premix
Trade

Lincomix®; Lincomix® 8.8 premix; Lincomix® 20; Lincomix® 44; Lincomix® 50 Feed Medication; Lincomix® 110 Chemical
Intended
Veterinary product used as antibiotic agent 2. HAZARDS IDENTIFICATION

Appearance:

Signal Word:

Statement of Hazard:

Additional Hazard Information:
Short

May cause eye and skin irritation. Individuals sensitive to this chemical or other materials in its chemical class may develop allergic reactions.
Known Clinical Effects:
The most common adverse effects reported with clinical use were diarrhea, nausea, rash, and vomiting. Effects on blood and blood-forming organs have also occurred. This compound can cross the placenta in pregnant women. Secreted in human breast milk.
EU Indication of danger:
EU Hazard Symbols:

EU Risk Phrases:

R43 - May cause sensitization by skin contact. Australian Hazard Classification
Hazardous Substance. Non-Dangerous Goods.
(NOHSC):
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. _______________________________________________________________________________________________________
MATERIAL SAFETY DATA SHEET

Material Name: Lincomycin Hydrochloride Premix

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Revision date: 31-Jan-2008
Version: 2.4
_______________________________________________________________________________________________________
3. COMPOSITION/INFORMATION ON INGREDIENTS

Hazardous

Ingredient
CAS Number
EU EINECS/ELINCS List
Classification
Ingredient
CAS Number
EU EINECS/ELINCS List
Classification

Additional Information:
* Proprietary Ingredient(s) indicated as hazardous have been assessed under standards for workplace safety.
For the full text of the R phrases mentioned in this Section, see Section 16

4. FIRST AID MEASURES

Eye Contact:

Flush with water while holding eyelids open for at least 15 minutes. Seek medical attention immediately.

Skin Contact:

Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seek medical attention. Delayed effects may occur. For information on potential delayed effects, see Section 2 - Hazards Identification and/or Section 11 - Toxicological Information.

Ingestion:

Never give anything by mouth to an unconscious person. Wash out mouth with water. Do not induce vomiting unless directed by medical personnel. Seek medical attention immediately.

Inhalation:

Remove to fresh air and keep patient at rest. Seek medical attention immediately.

Notes to Physician:

Epinephrine and supportive measures are recommended if the patient presents with anaphylactic symptoms.
5. FIRE FIGHTING MEASURES

Extinguishing Media:

Use carbon dioxide, dry chemical, or water spray.
Hazardous Combustion Products:


Fire Fighting Procedures:

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

Fire / Explosion Hazards:

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.
_______________________________________________________________________________________________________
MATERIAL SAFETY DATA SHEET

Material Name: Lincomycin Hydrochloride Premix

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Revision date: 31-Jan-2008
Version: 2.4
_______________________________________________________________________________________________________

Measures for Environmental

Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to Protections:

Additional Consideration for Large

Non-essential personnel should be evacuated from affected area. Report emergency situations immediately. Clean up operations should only be undertaken by trained personnel.
7. HANDLING AND STORAGE

General Handling:

Minimize dust generation and accumulation. Avoid breathing dust. Avoid contact with eyes, skin and clothing. When handling, use appropriate personal protective equipment (see Section 8). Wash thoroughly after handling. Releases to the environment should be avoided.
Storage Conditions:

Store at room temperature in properly labeled containers. Keep away from heat, sparks and flames.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Lincomycin Hydrochloride

Pfizer OEL TWA-8 Hr:
Mineral oil

ACGIH Threshold Limit Value (TWA)
= 5 mg/m3 TWA sampled by method that does not collect vapor ACGIH Threshold Limit Value (STEL)
ACGIH OELs - Notice of Intended Changes
Australia TWA
Belgium OEL - TWA
Bulgaria OEL - TWA
Czech Republic OEL - TWA
Denmark OEL - TWA
Finland OEL - TWA
Greece OEL - TWA
Ireland OEL - TWAs
Latvia OEL - TWA
OSHA - Final PELS - TWAs:
Poland OEL - TWA
Portugal OEL - TWA
= 5 mg/m3 TWA sampled by a method that does not collect vapor Romania OEL - TWA
Slovakia OEL - TWA
= 1 mg/m3 TWA raw = 5 mg/m3 TWA refined = 5 ppm TWA raw Spain OEL - TWA
Sweden OEL - TWAs
The exposure limit(s) listed for solid components are only relevant if dust may be generated. Refer to available public information for
specific member state Occupational Exposure Limits.

Engineering Controls:

Engineering controls should be used as the primary means to control exposures. General room ventilation is adequate unless the process generates dust, mist or fumes. Keep airborne contamination levels below the exposure limits listed above in this section.
Personal Protective Equipment:
Hands:

Impervious gloves are recommended if skin contact with drug product is possible and for bulk processing operations.
Wear safety glasses or goggles if eye contact is possible. _______________________________________________________________________________________________________
MATERIAL SAFETY DATA SHEET

Material Name: Lincomycin Hydrochloride Premix

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Revision date: 31-Jan-2008
Version: 2.4
_______________________________________________________________________________________________________
Impervious protective clothing is recommended if skin contact with drug product is possible and for bulk processing operations.
Respiratory
protection:
If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriate respirator with a protection factor sufficient to control exposures to below the OEL. 9. PHYSICAL AND CHEMICAL PROPERTIES:

Physical State:

Molecular Formula:
Molecular Weight:
10. STABILITY AND REACTIVITY

Stability:

Conditions to Avoid:
Incompatible Materials:
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)

Lincomycin Hydrochloride
Rat Oral LD 50 > 4000 mg/kg
Rat Intravenous LD 50 342 mg/kg
Mouse Intravenous LD 50 214 mg/kg
Rat Subcutaneous LD 50 9778 mg/kg
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.
Irritation / Sensitization: (Study Type, Species, Severity)
Mineral oil
Eye Irritation Rabbit Moderate
Skin Irritation Rabbit Mild
Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ)
Lincomycin Hydrochloride
30 Day(s) Rat Oral 300 mg/kg/day NOAEL No effects at maximum dose
30 Day(s) Rat Subcutaneous 60 mg/kg/day NOAEL None identified
3 Month(s) Rat Oral 300 mg/kg/day NOAEL None identified
3 Month(s) Dog Oral 400 mg/kg/day LOAEL None identified
6 Month(s) Dog Oral 100 mg/kg/day NOAEL Immune system
Reproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s))
_______________________________________________________________________________________________________
MATERIAL SAFETY DATA SHEET

Material Name: Lincomycin Hydrochloride Premix

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Revision date: 31-Jan-2008
Version: 2.4
_______________________________________________________________________________________________________
Lincomycin Hydrochloride
2 Generation Reproductive Toxicity Rat Oral 100 mg/kg LOAEL Fetotoxicity
Prenatal & Postnatal Development Rat Oral 100 mg/kg NOEL Not Teratogenic
Fertility and Embryonic Development Rat Subcutaneous 75 mg/kg/day NOAEL No effects at maximum dose
Embryo / Fetal Development Rat Subcutaneous 300 mg/kg/day NOAEL Not Teratogenic
Peri-/Postnatal Development Rat Subcutaneous 30 mg/kg/day NOAEL No effects at maximum dose
Genetic Toxicity: (Study Type, Cell Type/Organism, Result)
Lincomycin Hydrochloride
Bacterial Mutagenicity (Ames) Salmonella Negative
Mammalian Cell Mutagenicity Mouse Lymphoma Negative
In Vivo Micronucleus Rat Negative
Direct DNA Interaction Human Lymphocytes Negative

Carcinogen Status:

None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA. See below Mineral oil
IARC:

12. ECOLOGICAL INFORMATION

Environmental Overview:

Environmental properties of the formulation have not been thoroughly investigated. Releases to the environment should be avoided. See aquatic toxicity data for individual components below: Aquatic Toxicity: (Species, Method, End Point, Duration, Result)
Lincomycin Hydrochloride
Lepomis macrochirus (Bluegill Sunfish) ASTM LC50 96 Hours >980 mg/L
Daphnia magna (Water Flea) ASTM EC50 48 Hours >900 mg/L
Anabaena flos-aquae(Cyanobacteria) OECD EC50 72 Hours 30.5 ug/L
Salmo gairdneri (Trout) ASTM LC50 96 Hours >980 mg/L

Aquatic Toxicity Comments:

A greater than symbol (>) indicates that aquatic toxicity was not observed at the maximum dose tested. 13. DISPOSAL CONSIDERATIONS

Disposal Procedures:

Dispose of waste in accordance with all applicable laws and regulations. Member State specific and Community specific provisions must be considered.
14. TRANSPORT INFORMATION
Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations. _______________________________________________________________________________________________________
MATERIAL SAFETY DATA SHEET

Material Name: Lincomycin Hydrochloride Premix

Page 6 of 7
Revision date: 31-Jan-2008
Version: 2.4
_______________________________________________________________________________________________________
15. REGULATORY INFORMATION

EU Symbol:

EU Indication of danger:
EU Risk Phrases:
R43 - May cause sensitization by skin contact.
EU Safety Phrases:

S22 - Do not breathe dust. S24 - Avoid contact with skin. S37 - Wear suitable gloves.
OSHA Label:

WARNING
May cause allergic skin reaction.

Canada - WHMIS: Classifications
WHMIS hazard class:
Class D, Division 2, Subdivision B
Lincomycin Hydrochloride
Australia

EU EINECS/ELINCS List
Mineral oil

Inventory - United States TSCA - Sect. 8(b)
Australia
EU EINECS/ELINCS List
16. OTHER INFORMATION

Text of R phrases mentioned in Section 3
R43 - May cause sensitization by skin contact.
Data Sources:
Safety data sheets for individual ingredients. Publicly available toxicity information.

Reasons for Revision:

Updated Section 3 - Composition / Information on Ingredients. Updated Section 4 - First Aid Measures. Updated Section 7 - Handling and Storage. Updated Section 8 - Exposure Controls / Personal Protection. Updated Section 12 - Ecological Information.
_______________________________________________________________________________________________________
MATERIAL SAFETY DATA SHEET

Material Name: Lincomycin Hydrochloride Premix

Page 7 of 7
Revision date: 31-Jan-2008
Version: 2.4
_______________________________________________________________________________________________________

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 warranty of any kind, expressed or implied. If data for a hazard are not included in this document there is no known
information at this time.
End of Safety Data Sheet
_______________________________________________________________________________________________________

Source: http://www.linco.info/PAHimages/msds_us/LM.pdf

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