Valid on the date of printing 05/10/2001, Apralan Soluble Powder, Page 1 of 7
T M.
MATERIAL SAFETY DATA SHEET
APRALAN SOLUBLE POWDER
AH0635
Revision 3.3, 5 October 2001
STATEMENT OF HAZARDOUS NATURE:
"Hazardous according to criteria of Worksafe Australia"
Irritant; R38 Irritating to skin.
Company Name and Address:
Elanco Animal Health
A Division of Eli Lilly Australia Pty Ltd
A.B.N. 39 000 233 992
112 Wharf Road, West Ryde, N.S.W. 2114, Australia
Contact Numbers:
Tel: (02) 9878 7777
Fax: (02) 9878 7720
Emergency Telephone Numbers:
Elanco Animal Health:
1800 226 324 (Toll free)
OR
Poisons Information Centre:
131126 (Australia-wide)
Section 1 - Identification
AH0635
Product Name: Elanco Apralan Soluble Powder
Other Names: Apramycin sulphate
Manufacturer鈥檚 Product Code: AH0635
UN Number: None allocated
Dangerous Goods Class/Subsidiary Risk: None allocated
Hazchem Code: None allocated
Poisons Schedule Number: S4
Pack Size and Container Type: 400 mL polythene bottle
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Use:
Major Recommended Uses: Apralan Soluble Powder is for treatment as follows:
PIGS: For the treatment of bacterial enteritis caused by susceptible strains of Escherichia coli and other
organisms susceptible to apramycin.
CALVES: For the prophylaxis or treatment of bacterial enteritis in calves caused by Escherichia coli and
Salmonella organisms susceptible to apramycin.
BROILERS: For use in the control and treatment of colisepticaemia (colibacillosis) in broilers caused by
susceptible strains of E. coli.
Major Recommended Method(s) of Application: Powder for oral use
Section 2 - Composition / Information on Ingredients
Ingredient CAS
Apramycin Sulfate 65710-07-8
Contains no hazardous components (one percent or greater) or carcinogens (one-tenth percent or greater)
not listed above.
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Exposure Guidelines: Apramycin - LEG 4 mg/m TWA for 8 or 12 hours.
Section 3 - Hazards Identification
Appearance: Tan to brown free-flowing powder
Physical State: Solid
Odor: Musty
Emergency Overview
Primary Physical and Health Hazards: Irritant (skin).
Caution Statement: Apralan Soluble Powder contains apramycin sulfate and may be irritating to the skin.
Routes of Entry: Inhalation and skin contact.
Potential Signs and Symptoms of Occupational Exposure: Skin irritation has been reported with occupational
exposure to apramycin.
Medical Conditions Aggravated by Exposure: None known.
Carcinogenicity: Apramycin - Not listed by IARC, NTP, ACGIH, or OSHA. Not considered carcinogenic
in animal studies conducted by Lilly Research Laboratories.
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.
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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 Poisons Information Centre. Phone 13 1126
(Australia-wide). 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: Contain dry material by sweeping up or vacuuming. Vacuuming may disperse dust if appropriate
dust collection filter is not part of the vacuum. Be aware of potential for dust explosion when using
electrical equipment. Large spills due to traffic accidents, etc., should be reported immediately to Elanco
Animal Health for assistance. Prevent spilled material from flowing onto adjacent land or into streams,
ponds, or lakes. Wear protective equipment, including eye protection, to avoid exposure (see Section 8
for specific handling precautions).
Section 7 - Handling and Storage
Storage: Store below 30掳C (Room Temperature) in a dry place.
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: Safety glasses.
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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.
Other Handling Precautions: 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
Boiling Point: Not applicable.
Melting Point: Not applicable.
Specific Gravity: No applicable information found.
pH: No applicable information found.
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.).
Hazardous Decomposition: May emit toxic fumes when heated to decomposition.
Hazardous Polymerization: Will not occur.
Section 11 - Toxicological Information
Animal Toxicity Data Single Exposure
Toxicity data for the active ingredient, apramycin sulfate, are reported.
Oral: Apramycin sulfate - Rat, 4160 mg/kg, no deaths.
Skin: Apramycin sulfate - Rabbit, 1040 mg/kg, no deaths or toxicity.
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Inhalation: Apramycin sulfate - Rat, 211 mg/m for 1 hour, no deaths or toxicity.
Skin Contact: Apramycin sulfate - Rabbit, slight irritant.
Eye Contact: Apramycin sulfate - Rabbit, slight irritant.
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Animal Toxicity Data Repeat Exposure
No data are available for Apralan Soluble Powder. Toxicity data for the active ingredient, apramycin
sulfate, are reported.
Target Organ Effects: Apramycin sulfate - No effects identified in animal studies.
Other Effects: Apramycin sulfate - Decreased body weight, vomiting, dark coloured faeces.
Reproduction: Apramycin sulfate - Decreased offspring survival and decreased foetal weight at doses toxic
to the mother.
Sensitization: Apramycin sulfate - Guinea pig, not a contact sensitizer.
Mutagenicity: Apramycin sulfate - Not mutgenic in bacterial or mammalian cells.
Section 12 - Ecological Information
No data are available for this product. Environmental data for apramycin, the active ingredient, are
presented.
Ecotoxicity Data: Apramycin
Rainbow trout 96-hour median lethal concentration: > 300 ppm
Bluegill 96-hour median lethal concentration: > 300 ppm
Daphnia magna 48-hour median effective concentration: 101.6 ppm
Bobwhite 14-day oral median lethal dose: 1669 mg/kg
Bobwhite 5-day dietary median lethal concentration: > 5000 ppm
Mallard 5-day dietary median lethal concentration: > 5000 ppm
Earthworm 14-day median lethal concentration: > 100 ppm
Microorganisms:
N-fixing bacteria (Azotobacter chroococcum) inhibition at 0.1 ppm
N-fixing algae (Anabaena flos aquae) inhibition at 0.1 ppm
N-fixing bacteria (R. leguminosarum) inhibition at 0.1 ppm
N-fixing bacteria (R. japonicum) inhibition between 1 and 10 ppm
Green algae (S. capricornutum) 72-hour median effective concentration average specific growth rate:
818 micrograms/L
Soil microflora respiration and nitrification inhibition: >20 ppm
Environmental Fate: Apramycin
Dissociation constant (pKa): 5.4 to 8.5
Solubility (g/L): > 300
Log octanol-water partition coefficient (Kow): -3.3
Field soil decline:
Bioconcentration factor: 0.022
Greenhouse soil decline in manure: < 25% after 1 year
Greenhouse soil decline: approximately 33% after 1 year
Soil adsorption coefficient (Koc) range in 3 soils: 341,900 - 659,609
Soil desorption (Koc) range in 3 soils: 763,633 - 1,887,467
Environmental summary: Apramycin - Practically non-toxic to fish, earthworms, daphnids, and birds. Not
toxic to soil microflora at highest concentration tested. Moderately to highly toxic to nitrogen-fixing
microorganisms. Highly toxic to green algae. Low potential to bioconcentrate in aquatic organisms.
Persistent in the soil environment. Extensive soil adsorption with minimal soil desorption.
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Lilly Aquatic Exposure Guideline (LAEG): Apramycin
LAEG for Drinking Water: 240 micrograms/L
LAEG for Chronic Exposure of Aquatic Organisms: 130 micrograms/L
LAEG for Acute Exposure of Aquatic Organisms: 820 micrograms/L
Section 13 - Disposal Considerations
Disposal: Dispose of empty container by wrapping with paper and putting in garbage.
Section 14 - Transport Information
No special transport requirements necessary.
Section 15 - Other Information
Sections revised: Company details and Section 4.
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.
CONTACT POINT:
Elanco Animal Health, West Ryde, N.S.W. (refer contact numbers on page 1 of this document)
GLOSSARY
(Abbreviations Used in Material Safety Data Sheets)
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)
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
IEG = Lilly Interim Exposure Guideline
IMO = International Maritime Organization
LEG = Lilly Exposure Guideline
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LEL = Lower Explosive Limit
MSDS = Material Safety Data Sheet
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)
Last Edited by: Zuzanna Rajczyk/AP/LLY
On: 05/10/2001 17:34:18
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