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Tylan Injection
Effective Date: 24-Mar-2005
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 Injection
Chemical Name: Tylosin
Synonym(s): Tylosin; Tylosin Base; 027892 Formulation
Trademarks(s): Tylan 200 Injection; Tylan 50 Injection; Tylan
Lilly Item Code(s): AF1400; AF1401; AF7200; AF7202; AH0137; AH0205; AH0206; UC5071;
UC5072; UC5080; UC5104; UC5113; UC5114; UC5119; UC5120; UC5121; UC5122; UC5124;
UC5125; UC5201; UC5202; UC5203; UC5204; UC5205; UC5206; UC5211; UC5212; UC5213;
UC5214; UC5215; UC5216; UC5217; UC5218; UC5219; UC5220; UC5221; UC5222; UC5223;
UC5224; UC5225; UC5226; UC5228; UC5229; UC5230; UC5231; UC5232; UC5233; UC5234;
UC5235; UC5236; UC5237; UC5238; UC5239; UC5240; UC5241; UC5247; UC5248; UC5249;
UC5250; UC5251; UC5252; UC5253; UC5254; UC5255; UC5256; UC5257; UC5258; UC5259;
UC5260; UC5261; UC5262; UC5263; UC5264; UC5265; UC5266; UC5267; UC5268; UC5269;
UC5271; UC5273; UC5276; UC5277; UC5278; UC5280; UC5283; UC5284; UC5285; UC5286;
UC5287; UC5288; UC5289; UC5298
See attached glossary for abbreviations.
Section 2 - Composition / Information on Ingredients
Ingredient CAS Concentration %
Tylosin Base 1401-69-0 5 - 20
Propylene Glycol 57-55-6 40 - 52
Benzyl Alcohol 100-51-6 2-5
Water 7732-18-5 25 - 37
Contains no hazardous components (one percent or greater) or carcinogens (one-tenth percent or greater)
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not listed above.
Exposure Guidelines: Tylosin base - LEG <100 micrograms/m3 TWA for 12 hours.
Propylene glycol - WEEL 50 ppm TWA (total vapor and aerosol), 10 mg/m3 (aerosol only) TWA for 8
hours.
UK - Exposure Standard 10 mg/m3 TWA (particulates), 150 ppm (474 mg/m3) TWA (vapor and
particulates).
Ireland - Occupational Exposure Limit 10 mg/m3 TWA (particulates) 150 ppm (470 mg/m3) TWA
(total vapor and particulates).
Benzyl alcohol - WEEL 10 ppm (44.2 mg/m3) TWA.
Section 3 - Hazards Identification
Appearance: Yellow viscous solution
Physical State: Liquid
Odor: Faint musty
Emergency Overview
Special
A = Allergen
Emergency Overview Effective Date: 19-Jan-2000
Lilly Laboratory Labeling Codes:
Health 1 Fire 1 Reactivity 0 Special A
Primary Physical and Health Hazards: Severe Allergen.
Caution Statement: Tylan Injection contains tylosin base 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 in a manufacturing setting have been
reported. Allergy symptoms may include skin rash, watery eyes, shortness of breath, nasal congestion,
coughing, and wheezing. Based on animal data, may be irritating to the eyes. Accidental injection may
cause pain and swelling at the site accompanied by anxiety. No lasting ill effects have been
reported. May be slightly irritating to the eyes and skin.
Medical Conditions Aggravated by Exposure: Hypersensitivity to tylosin.
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.
Benzyl alcohol - Not listed by IARC, NTP, ACGIH, or OSHA. Two-year carcinogenicity studies
conducted by NTP demonstrated no evidence of carcinogenicity in mice and rats.
Propylene glycol - Not listed by IARC, NTP, ACGIH, or OSHA. Multiple long term dietary, inhalation,
and dermal studies demonstrated no evidence of carcinogenicity in mice, rabbits, or rats.
Section 4 - First Aid Measures
Eyes: Flush eyes with plenty of water. Get medical attention.
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.
Additional Information: Accidental Injection: For accidental injection no specific treatment is needed
other than symptomatic. Treat wound if necessary and consider need for tetanus immunization.
Section 5 - Fire Fighting Measures
Auto Ignition: 412 C (774 F)
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: None known.
Hazardous Combustion Products: May emit toxic fumes when exposed to heat or fire.
Section 6 - Accidental Release Measures
Spills: Do not contaminate any body of water. Clean up spill using suitable absorbent material. Place it
and damaged unusable containers in landfill in accordance with applicable regulations. 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.
Section 7 - Handling and Storage
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Material Handling Precautions: Do not mix with other injectable solutions as this may cause
precipitation of the active ingredients. Do not administer to horses or other equines. Injection of tylosin
in equines has been fatal.
Storage Conditions: Store at 22 C (72 F) or below. Product should not be used after the date printed on
the container.
Section 8 - Exposure Controls / Personal Protection
See Section 2 for Exposure Guideline information.
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: Yellow viscous solution
Odor: Faint musty
Boiling Point: No applicable information found
Melting Point: Not applicable
Specific Gravity: 1.09
pH: 8-10
Evaporation Rate: No applicable information found
Water Solubility: Soluble
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.).
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Hazardous Decomposition: May emit toxic fumes when heated to decomposition.
Hazardous Polymerization: Will not occur.
Section 11 - Toxicological Information
Acute Exposure
Toxicity data for a 20% tylosin base formulation with propylene glycol and benzyl alcohol are
presented.
Oral: 20% Tylosin base mixture - Rat, 535 mg/kg, no deaths or toxicity.
Skin: 20% Tylosin base mixture - Rabbit, 2140 mg/kg, no deaths or toxicity.
Inhalation: 20% Tylosin base mixture - Rat, 1050 mg/m3 for 1 hour, no deaths.
Skin Contact: 20% Tylosin base mixture - Rabbit, slight irritant
Eye Contact: 20% Tylosin base mixture - Rabbit, slight irritant
Chronic Exposure
Toxicity data for tylosin base are presented.
Target Organ Effects: Tylosin base - No effects identified in animal studies.
Propylene glycol - No significant adverse effects were reported in monkeys exposed to saturated vapor
for 18 months or dogs administered 2000 mg/kg for 2 years.
Other Effects: Tylosin base - Salivation, diarrhea, vomiting.
Reproduction: Tylosin base - No effects identified in animal studies.
Propylene glycol - In animal studies, has been shown not to interfere with reproduction.
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 risk to man.
Propylene glycol - In vitro mutagenicity studies were negative. Animal mutagenicity studies were
negative.
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
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photolysis.
Propylene glycol - Practically non-toxic to aquatic organisms. Material is not expected to bioconcentrate
in aquatic organisms. Material may leach from soil into groundwater. Material is expected to be
degraded by microorganisms. Biodegraation is expected to be achievable in secondary waste water
treatment plant. Material is not expected to readily evaporate; however, once in the atmosphere it is
expected to rapidly degrade (within minutes to hours).
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: No special package disposal required.
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
TSCA - No
CERCLA - Not on this list.
SARA 302 - Not on this list.
SARA 313 - Not on this list.
OSHA Substance Specific - No
NADA No. 12-965
Remaining Ingredients
TSCA - Yes
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CERCLA - Not on this list
SARA 302 - Not on this list
SARA 313 - Not on this list
OSHA Substance Specific - No
EU Regulations
EC Classification
Xn (Harmful)
Risk Phrases
R 42/43 - May cause sensitization by inhalation and skin contact.
Safety Phrases
S 36/37/39 - Wear suitable protective clothing, gloves and eye/face protection.
Section 16 - Other Information
MSDS Sections Revised: Sections 1, 2, and 7
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)
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IARC = International Agency for Research on Cancer
ICAO/IATA = International Civil Aviation Organization/International Air Transport Association
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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