Tylan Sulfa-G Premix Page 1 of 8
Tylan Sulfa-G Premix
Effective Date: 16-Dec-2004
Elanco Animal Health
Material Safety Data Sheet
Section 1 - Chemical Product and Company
Manufacturer:
Manufacturer's Emergency Phone:
Elanco Animal Health
1-800-428-4441
Division of Eli Lilly and Company
CHEMTREC:
2001 West Main St
1-800-424-9300 (North America)
PO Box 708
1-703-527-3887 (International)
Greenfield, IN 46140
Common Name: Tylan Sulfa-G Premix
Chemical Name: Tylosin, phosphate (salt)
Chemical Name 2: Benzenesulfonamide, 4-amino-N-(4,6-dimethyl-2-pyrimidinyl)-
Synonym(s): Tylosin Phosphate Formulation; Sulfamethazine Formulation; Sulphadimidine
Formulation
Trademarks(s): Tylasul Premix; Tylan Plus Sulfa Premix
Lilly Item Code(s): AF0901; AF0902; AF0903; AF0904; AF0905; AF0909; AF0912; AF0928;
MS8271
See attached glossary for abbreviations.
Section 2 - Composition / Information on Ingredients
Ingredient CAS Concentration %
Tylosin Phosphate 1405-53-4 1.8 - 12
Sulfamethazine 57-68-1 1.8 - 12
Excipients NA 72 - 85
Anti-dusting Oil NAIF 0-3
Excipients may include soybean feed, soybean mill run, starch, rice hulls, or limestone.
Exposure Guidelines: Tylosin phosphate - LEG <100 micrograms/m3 TWA for 12 hours.
Sulfamethazine - LEG <100 micrograms/m3 TWA for 12 hours.
Grain dust - PEL 10 mg/m3 TWA. TLV 4 mg/m3 TWA for 8 or 12 hours (total). Lilly preferred
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exposure limit is TLV.
UK - Maximum Exposure Limit 10 mg/m3 TWA (total) (Sens).
Ireland - Occupational Exposure Limit 10 mg/m3 TWA (Sens).
Limestone dust - PEL 5 mg/m3 TWA (respirable) and 15 mg/m3 TWA (total). TLV 10 mg/m3 TWA.
UK - Exposure Standard 4 mg/m3 TWA (respirable) and 10 mg/m3 TWA (total).
Ireland - Occupational Exposure Limit 4 mg/m3 TWA (respirable) and 10 mg/m3 TWA (total).
France - Occupational Exposure Limit 10 mg/m3 (VME) TWA.
The anti-dusting oil reduces potential exposure under normal conditions of use.
Section 3 - Hazards Identification
Appearance: Light tan to straw-colored meal
Physical State: Solid
Odor: Musty
Emergency Overview
Special
A = Allergen
Emergency Overview Effective Date: 27-Nov-2001
Lilly Laboratory Labeling Codes:
Health 2 Fire 1 Reactivity 0 Special A
Primary Physical and Health Hazards: Irritant (eyes). Severe Allergen.
Caution Statement: Tylan Sulfa-G Premix contains tylosin phosphate and sulfamethazine, may be
irritating to the eyes, and is classified as a severe allergen because repeated unprotected exposures are
likely to cause allergic reactions.
Routes of Entry: Inhalation and skin contact.
Effects of Overexposure: Allergic reactions to tylosin and sulfamethezine in a manufacturing setting
have been reported. Allergy symptoms may include skin rash, itching, hives, watery eyes, shortness of
breath, nasal congestion, coughing, and wheezing. Based on animal data for mixture of both materials,
may be irritating to the eyes.
Excipients - Prolonged exposure to high concentrations of grain dust may cause irritation of the
respiratory tract and mucous membranes.
Medical Conditions Aggravated by Exposure: Hypersensitivity to tylosin or sulfonamides.
Carcinogenicity: Tylosin base - Not listed by IARC, NTP, ACGIH, or OSHA. Not considered
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carcinogenic in animal studies conducted by Lilly Research Laboratories.
Sulfamethazine - IARC Group 3 (not classifiable as to human carcinogenicity). Not listed by NTP,
ACGIH, or OSHA.
Section 4 - First Aid Measures
Eyes: Hold eyelids open and flush with a steady, gentle stream of water for 15 minutes. See an
ophthalmologist (eye doctor) or other physician immediately.
Skin: Remove contaminated clothing and clean before reuse. Wash all exposed areas of skin with
plenty of soap and water. Get medical attention if irritation develops.
Inhalation: Move individual to fresh air. Get medical attention if breathing difficulty occurs. If not
breathing, provide artificial respiration assistance (mouth-to-mouth) and call a physician immediately.
Ingestion: Do not induce vomiting. Call a physician or poison control center. If available, administer
activated charcoal (6-8 heaping teaspoons) with two to three glasses of water. Do not give anything by
mouth to an unconscious person. Immediately transport to a medical care facility and see a physician.
Section 5 - Fire Fighting Measures
Flash Point: No applicable information found
UEL: No applicable information found
LEL: No applicable information found
Extinguishing Media: Use water, carbon dioxide, dry chemical, foam, or Halon.
Unusual Fire and Explosion Hazards: As a finely divided material, may form dust mixtures in air
which could explode if subjected to an ignition source.
Hazardous Combustion Products: May emit toxic fumes when exposed to heat or fire.
Section 6 - Accidental Release Measures
Spills: Wear protective equipment, including eye protection, to avoid exposure (see Section 8 for
specific handling precautions). Large spills due to traffic accidents, etc., should be reported immediately
to CHEMTREC and Elanco Animal Health for assistance. Prevent spilled material from flowing onto
adjacent land or into streams, ponds, or lakes. Vacuum material with appropriate dust collection filter
in place. Be aware of potential for dust explosion when using electrical equipment. If vacuum is not
available, lightly mist material and remove by sweeping or wet wiping.
Section 7 - Handling and Storage
Storage Conditions: Store in a cool, dry place. Protect from moisture and heat. Product should not be
used after the date printed on the container.
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Section 8 - Exposure Controls / Personal Protection
See Section 2 for Exposure Guideline information.
When mixing and handling, use protective clothing, impervious gloves, and dust respirator. Operators
should wash thoroughly with soap and water after handling. If accidental eye contact occurs,
immediately rinse with plenty of water.
Respiratory Protection: Use an approved respirator.
Eye Protection: Chemical goggles and/or face shield.
Ventilation: Laboratory fume hood or local exhaust ventilation.
Other Protective Equipment: In a manufacturing setting, wear chemical-resistant gloves and body
covering to minimize skin contact. If handled in a ventilated enclosure, as in a laboratory setting,
respirator and goggles or face shield may not be required. Safety glasses are always required.
Additional Exposure Precautions: In production settings, airline-supplied, hood-type respirators are
preferred. Shower and change clothing if skin contact occurs. Under normal use and handling
conditions, wear goggles to protect eyes and wear impermeable gloves and protective equipment to
avoid direct contact with skin. Wash thoroughly with soap and water after handling.
Section 9 - Physical and Chemical Properties
Appearance: Light tan to straw-colored meal
Odor: Musty
Boiling Point: No applicable information found
Melting Point: No applicable information found
Specific Gravity: No applicable information found
pH: No applicable information found
Evaporation Rate: No applicable information found
Water Solubility: Insoluble
Vapor Density: No applicable information found
Vapor Pressure: No applicable information found
Section 10 - Stability and Reactivity
Stability: Stable at normal temperatures and pressures.
Incompatibility: May react with strong oxidizing agents (e.g., peroxides, permanganates, nitric acid,
etc.).
Hazardous Decomposition: May emit toxic fumes when heated to decomposition.
Hazardous Polymerization: Will not occur.
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Section 11 - Toxicological Information
Acute Exposure
No data are available for Tylan Sulfa-G Premix. Toxicity data for a tylosin-sulfamethazine mixture are
presented.
Oral: Tylosin-sulfamethazine mixture - Rat, 500 mg/kg, no deaths or toxicity.
Skin: Tylosin-sulfamethazine mixture - Rabbit, 2000 mg/kg, no deaths.
Inhalation: Tylosin-sulfamethazine mixture - Rat, 1000 mg/m3 for 1 hour, no deaths.
Skin Contact: Tylosin-sulfamethazine mixture - Rabbit, slight irritant
Eye Contact: Tylosin-sulfamethazine mixture - Rabbit, irritant
Chronic Exposure
Target Organ Effects: Tylosin base - No effects identified in animal studies.
Sulfamethazine - Thyroid effects (goiter, tissue changes).
Other Effects: Tylosin base - Salivation, diarrhea, and vomiting after repeated large oral doses.
Reproduction: Tylosin base - No effects identified in animal studies.
Sulfamethazine - Decreased offspring survival and fetal changes at doses toxic to the mother. A
continuous breeding study reported reduced fertility in mice, but no changes in sperm parameters
Sensitization: Tylosin base - Guinea pig, positive contact sensitizer.
Mutagenicity: Tylosin base - Mutagenic in one mammalian test system. Not mutagenic in bacterial cell
tests and other mammalian cell tests. Unlikely to pose a genotoxic hazard to man.
Sulfamethazine - Not mutagenic in bacterial or mammalian cells.
Section 12 - Ecological Information
No environmental data for the mixture or formulation. The environmental information for ingredient(s)
or related material(s) are presented.
Environmental Summary: Tylosin base - Practically nontoxic to fish, birds, earthworms, and aquatic
invertebrates. Highly toxic to algae. No volatility expected. Not expected to bioconcentrate in aquatic
organisms. Low mobility in soil. Not persistent in the environment due to degradation and possible
photolysis.
Sulfamethazine - Practically non-toxic to aquatic organisms. If released into air, material is expected to
exist primarily in the particulate-phase and may be removed by wet or dry deposition processes. Vapor-
phase material is expected to rapidly degrade in the atmosphere. Material may covalently bond with
humic materials in soil and water. Material not covalently bonded may leach into
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groundwater. Volatilization is not expected to occur. Material is not expected to bioconcentrate in
aquatic organisms.
Lilly Aquatic Exposure Guideline (LAEG): Tylosin base
LAEG for Drinking Water: 36 micrograms/L
LAEG for Chronic Exposure of Aquatic Organisms: 99 micrograms/L
LAEG for Acute Exposure of Aquatic Organisms: 220 micrograms/L
Section 13 - Disposal Considerations
Waste Disposal: Dispose of any cleanup materials and waste residue according to all applicable laws
and regulations.
Container Disposal: Packages may be burned or buried in accordance with environmental standards.
Section 14 - Transport Information
Regulatory Organizations:
DOT: Not Regulated
ICAO/IATA: Not Regulated
IMO: Not Regulated
Section 15 - Regulatory Information
Below is selected regulatory information chosen primarily for possible Elanco Animal Health
usage. This section is not a complete analysis or reference to all applicable regulatory
information. Please consider all applicable laws and regulations for your country/state.
U.S. Regulations
Tylosin phosphate
TSCA - No
CERCLA - Not on this list
SARA 302 - Not on this list
SARA 313 - Not on this list
OSHA Substance Specific - No
Sulfamethazine
TSCA - Yes
CERCLA - Not on this list
SARA 302 - Not on this list
SARA 313 - Not on this list
OSHA Substance Specific - No
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EU Regulations
EC Classification
Xn (Harmful)
Xi (Irritant)
Risk Phrases
R 36 - Irritating to eyes.
R 42/43 - May cause sensitization by inhalation and skin contact.
Safety Phrases
S 26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
S 36/37/39 - Wear suitable protective clothing, gloves and eye/face protection.
Section 16 - Other Information
MSDS Sections Revised: Section 12.
As of the date of issuance, we are providing available information relevant to the handling of this
material in the workplace. All information contained herein is offered with the good faith belief that it is
accurate. THIS MATERIAL SAFETY DATA SHEET SHALL NOT BE DEEMED TO CREATE ANY
WARRANTY OF ANY KIND (INCLUDING WARRANTY OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE). In the event of an adverse incident associated with this material,
this safety data sheet is not intended to be a substitute for consultation with appropriately trained
personnel. Nor is this safety data sheet intended to be a substitute for product literature which may
accompany the finished product.
For additional information contact:
ELANCO Animal Health
1-800-428-4441
1-317-276-2000
GLOSSARY:
ACGIH = American Conference of Governmental Industrial Hygienists
AIHA = American Industrial Hygiene Association
BEI = Biological Exposure Index
CAS Number = Chemical Abstract Service Registry Number
CERCLA = Comprehensive Environmental Response Compensation and Liability Act (of 1980)
CHAN = Chemical Hazard Alert Notice
CHEMTREC = Chemical Transportation Emergency Center
DOT = Department of Transportation
EC = European Community
EINECS = European Inventory of Existing Chemical Substances
ELINCS = European List of New Chemical Substances
EPA = Environmental Protection Agency
HEPA = High Efficiency Particulate Air (Filter)
IARC = International Agency for Research on Cancer
ICAO/IATA = International Civil Aviation Organization/International Air Transport Association
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IEG = Lilly Interim Exposure Guideline
IMO = International Maritime Organization
Kow = Octanol/Water Partition Coefficient
LEG = Lilly Exposure Guideline
LEL = Lower Explosive Limit
MSDS = Material Safety Data Sheet
MSHA = Mine Safety and Health Administration
NA = Not Applicable, except in Section 14 where NA = North America
NADA = New Animal Drug Application
NAIF = No Applicable Information Found
NCI = National Cancer Institute
NIOSH = National Institute for Occupational Safety and Health
NOS = Not Otherwise Specified
NTP = National Toxicology Program
OSHA = Occupational Safety and Health Administration
PEL = Permissible Exposure Limit (OSHA)
RCRA = Resource Conservation and Recovery Act
RQ = Reportable Quantity
RTECS = Registry of Toxic Effects of Chemical Substances
SARA = Superfund Amendments and Reauthorization Act
STEG = Lilly Short Term Exposure Guideline
STEL = Short Term Exposure Limit
TLV = Threshold Limit Value (ACGIH)
TPQ = Threshold Planning Quantity
TSCA = Toxic Substances Control Act
TWA = Time Weighted Average/8 Hours Unless Otherwise Noted
UEL = Upper Explosive Limit
UN = United Nations
WEEL = Workplace Environmental Exposure Level (AIHA)
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