Safety Data Sheet Compudose 400 / AH0343 /A4902/HSR2272
Compudose 400
Effective Date: 1-July-2007
1. New Zealand (ERMANZ) information
2. Global Material Safety Data Sheet
Elanco Animal Health
Identification of the Substance and Supplier
New Zealand Company details: NEW ZEALAND EMERGENCY PHONE:
Elanco Animal Health
(Div. Eli Lilly & Co (NZ) Ltd.) National Poisons Centre
0800 POISON (0800 764 766)
Level 1, 123 Ormiston Road
Botany Junction, Auckland 2016
Telephone (weekdays): 09 523 9320 CHEMCALL:
0800 ELANCO (0800 352 626) 0800 CHEMCALL (0800 243 622)
Common Name: Compudose 100, Compudose 200, Compudose 400
Indications: Growth promotant implants for steers and non breeding heifers.
Hazards Identification
Hazard classifications (ERMANZ): 6.7A (Carcinogen), 6.8A (Reproductive toxin),
6.9B (Target organ toxin).
Priority identifiers:
None required
Secondary identifiers:
Veterinary medicines that are implants are not required to be labelled with information on
the chronic toxic hazards (variation to I16: Regulation 25 is deleted).
Handling and Storage
Storage Conditions: Store in closed containers at room temperature (below
30oC). Product should not be used after the date printed on the container. This product
must be kept secured when not in use.
Handling practices: Handle with care. Under normal use and handling conditions, no
protective equipment is required. Wash hands thoroughly with soap and water after
handling. Do not eat, drink or smoke while using.
Approved handlers: Not required.
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Safety Data Sheet Compudose 400 / AH0343 /A4902/HSR2272
Regulatory requirements: This substance is subject to a requirement for an
Emergency Response Plan whenever it is held in quantities of 1000 kg or more.
Packaging: The packaging for this substance must conform to the conditions of Packing
Group III (PG3) for all packs containing 3 kg or more. Smaller packs must meet
Packaging Schedule 4.
NZ Transport Information
UN Number: Not assigned
Dangerous Goods Class: Not assigned
Proper Shipping Name: Not assigned
Hazchem code: Not assigned
Carriage on public transport is not restricted.
Regulatory Information
Compudose is approved pursuant to the ACVM Act 1997 (A4363, A7298 & A4902).
See www.nzfsa.govt.nz/acvm/ for registration conditions.
Compudose is approved pursuant to the HSNO Act 1996, No HSR002272. The ERMA
website www.ermanz.govt.nz should be consulted for the full list of triggered controls
and cited regulations.
SDS Sections Revised: This SDS is effective as of 1 July 2007.
Due for revision within 5 years.
SDS must be provided when 0.5 kg or more of Compudose is sold or supplied.
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Compudose
Effective Date: 18-Nov-2003
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: Compudose
Chemical Name: Estra-1,3,5(10)-triene-3,17-diol (17beta)-
Synonym(s): Shur-Gain; 033636 Formulation; Controlled Release Implant; Estradiol Implants
Trademarks(s): Compudose 100; Encore; Compudose 400; Compudose 200
Lilly Item Code(s): AH0320; AH0323; AH0327; AH0340; AH0343; AH0347; AH0351; AH0370;
AH0373; AH0918; AH0919; QA330A; SI6480; UC5190; UC5199
See attached glossary for abbreviations.
Section 2 - Composition / Information on Ingredients
Ingredient CAS Concentration %
Estradiol 50-28-2 4-8
Oxytetracycline Hydrochloride 2058-46-0 0 - 0.25
Sodium Bicarbonate 144-55-8 0 - 0.25
Silicone Rubber 63394-02-5 92 - 96
Dimethicone 9006-65-9 Trace
Implant may be dusted with sodium bicarbonate or tetracycline.
Contains no hazardous components (one percent or greater) or carcinogens (one-tenth percent or
greater) not listed above.
Exposure Guidelines:
Estradiol - LEG 0.01 micrograms/m3 TWA for 12 hours.
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Bristol-Myers Squibb Exposure Guideline 0.1 micrograms/m3 TWA.
Section 3 - Hazards Identification
Appearance: Light yellow cylindrical silicone rubber implant coated with dimethicone
Physical State: Solid
Odor: Odorless
Emergency Overview
Special
C = Carcinogen
P = Potent
R = Reproductive
Emergency Overview Effective Date: 07-Jul-2001
Lilly Laboratory Labeling Codes:
Health 1 Fire 1 Reactivity 0 Special C, P, R
Primary Physical and Health Hazards: Not hazardous if intact. Skin Permeable. Carcinogen.
Highly Potent. Reproductive and Hormonal Effects.
Caution Statement: The intact silicon rubber implant is not considered to be a health hazard.
Compudose contains estradiol which may enter the body through the skin, causes cancer, and is
highly potent. Effects of exposure to the contents of Compudose may include fetal changes,
decreased fertility, reproductive tissue changes, menstrual disorders, and changes in hormone levels.
Routes of Entry: Inhalation and skin absorption.
Effects of Overexposure: The physical nature and packaging of Compudose implants make exposure to
significant quantities of the active ingredient, estradiol, highly unlikely. There have been no reports of
ill effects from the handling of this device. Although no significant Elanco occupational exposures to
estradiol have been reported, increased breast size and other feminizing effects have been produced in
males occupationally exposed to estrogens. Breast enlargement and menstrual disorders have been
reported in estrogen-exposed women. Even intermittent absorption of small amounts of estrogen
through the skin may result in accumulation of relatively high systemic levels. Increased breast size in
boys and pseudoprecocious puberty in girls have been observed in children born to occupationally
exposed women. An accelerated skeletal maturation, strong pigmentation of the sexual organs and a
feminizing syndrome in boys has also been noted in children whose parents work in estrogen
production. Other effects of exposure may include headache, nausea, vomiting, abnormal blood
clotting, and increased incidence of cancer. The estradiol is highly potent based on hormonal effects.
Tetracycline is present on the surface of certain implants in such small quanities that the chemical does
not merit general toxicological consideration. The possibility of a local sensitization reaction is
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discussed in Section 4, First Aid, Skin.
Medical Conditions Aggravated by Exposure: This material may aggravate pre-existing estrogen-
dependent neoplasias including malignancies of the female reproductive organs and breast,
thromboembolic diseases, impaired liver or kidney function, and pregnancy.
Carcinogenicity:
Estradiol - IARC Group 1 (sufficient evidence of carcinogenicity in humans). NTP - Known Human
Carcinogen. Not listed by ACGIH or OSHA.
Remaining ingredients - No carcinogenicity data found. Not listed by IARC, NTP, ACGIH, or OSHA.
Section 4 - First Aid Measures
Eyes: The physical nature of Compudose implants and their packaging make injury to the eye, except
by accidental mechanical means, extremely unlikely. If by remote circumstances the eyes are exposed
and irritation develops, flush eyes with water and contact a physician.
Skin: Estradiol, the active ingredient in Compudose implants, is well absorbed through the skin, as is
tetracycline, the local antibacterial agent. The physical nature of Compudose implants and their
packaging eliminate exposure if proper handling instructions are followed. However, certain
Compudose implants are coated with approximately 1.5 mg of tetracycline. In allergic or sensitive
individuals, a skin or systemic reaction may develop if the packaging is broken and the dose is
handled. 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: Compudose implants present negligible human hazard through inhalation because of their
physical nature and packaging. Because of the size of the implant it may cause mechanical obstruction
of the airway if accidentally inhaled by a small child. If this should occur, immediately contact a
physician.
Ingestion: Because of the physical nature of Compudose implants, it is difficult to conceive of their
presenting an acute oral hazard. If a dose is accidentally swallowed, it is estimated that 2 mg of
estradiol may be absorbed before excretion. If an adverse reaction should occur, contact 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: None known.
Hazardous Combustion Products: May emit toxic fumes when exposed to heat or fire.
Section 6 - Accidental Release Measures
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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. If the silicon rubber implant remains
intact, scoop or scrape up material into containers for disposal. If the silicon rubber implant is broken
and the contents are released, contain dry material by lightly misting with water, followed 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.
Section 7 - Handling and Storage
Storage Conditions: Store in closed containers at room temperature. Product should not be used after
the date printed on the container. A dating of 36 months is noted on the container.
Section 8 - Exposure Controls / Personal Protection
See Section 2 for Exposure Guideline information.
Under normal use and handling conditions, no protective equipment is required. The following is
recommended for a production setting:
Respiratory Protection: Use an approved HEPA-filtered or supplied-air respirator.
Eye Protection: Chemical goggles and/or face shield.
Ventilation: Extensive local exhaust or enclosed process equipment.
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: CAUTION! The estradiol is a potent drug. Avoid skin contact and
inhalation. Overexposure can cause tender enlargement of the breasts and breast nodule formation in
both males and females, loss of sex drive in males, and menstrual disorders in females. It has been
identified as a confirmed animal carcinogen and a suspect reproductive hazard. 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 yellow cylindrical silicone rubber implant coated with dimethicone
Odor: Odorless
Boiling Point: Not applicable
Melting Point: Not applicable
Specific Gravity: Not applicable
pH: Not applicable
Evaporation Rate: No applicable information found
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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.
Section 11 - Toxicological Information
Acute Exposure
Data for Compudose 400 and estradiol, the active ingredient, are reported as indicated.
Oral:
Estradiol - Rat, 500 mg/kg, no deaths.
Skin:
Compudose 400 - Rabbit, 5 implants taped to skin, no deaths or toxicity.
Estradiol - Rabbit, 100 mg/kg, no deaths or toxicity.
Inhalation: No applicable information found.
Skin Contact:
Estradiol - Rabbit, nonirritant
Eye Contact:
Estradiol - Rabbit, slight irritant
Chronic Exposure
No data available for mixture or formulation. Data for ingredient(s) or related material(s) are presented.
Target Organ Effects:
Estradiol - Mammary, pituitary, uterine, cervical, vaginal, testicular, and lymphoid tissue changes
reported in a number of chronic and subchronic subcutaneous injection studies. Effects reported with
doses as low as 2.5 micrograms.
Reproduction:
Estradiol - Reproductive tissue changes, decreased fertility, menstrual irregularities, fetal changes, and
developmental changes in offspring.
Oxytetracycline hydrochloride - Rats exposed to 1200, 1350, or 1500 mg/kg/day on gestation days 6
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through 15 showed no evidence of teratogenicity at doses which produced maternal and fetal toxicity.
Sensitization: No applicable information found.
Mutagenicity:
Estradiol - Negative in bacterial cells. Induced micronuclei but not chromosomal aberrations,
aneuploidy, or sister chromatid exchanges in in-vitro human cell assays. It induced aneuploidy and
unscheduled DNA synthesis but did not induce DNA strand breaks or sister chromatid exchanges in in-
vitro rodent cell assays. Did not induce chromosomal aberrations in bone marrow cells of mice treated
in-vivo.
Oxytetracycline hydrochloride - Negative in Ames, Drosophila, and in in vitro chromosome aberrations
and sister chromatid exchange assays. Positive in mouse lymphoma assay.
Section 12 - Ecological Information
No environmental data for the mixture or formulation. The environmental information for ingredient(s)
or related material(s) are presented.
Ecotoxicity Data: No applicable information found.
Environmental Fate:
Estradiol
10-day abiotic degradation in drinking water (measured): 39%
Environmental Summary:
Estradiol - Material is almost insoluble in water and is not expected to leach significantly from soil into
groundwater. Estrogens, as a class of compounds, are relatively persistent in the
environment. However, they are naturally occurring organic molecules and so some degradation is
expected.
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
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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
Estradiol
TSCA - No
CERCLA - Not on this list
SARA 302 - Not on this list
SARA 313 - Not on this list
OSHA Substance Specific - No
California Proposition 65 (Cancer/Reproductive) - Name on carcinogen list is estradiol-17beta.
Oxytetracycline hydrochloride
TSCA - Yes
CERCLA - Not on this list
SARA 302 - Not on this list
SARA 313 - Not on this list
OSHA Substance Specific - No
California Proposition 65 (Cancer/Reproductive) - Name on developmental toxin list is oxytetracycline
hydrochloride (with internal use)
Remaining Ingredients
TSCA - No
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
Compudose is not expected to be hazardous if intact. The EC Classification below pertains to the
components.
T (Toxic)
Carcinogen Category 1
Reproductive Category 1
Risk Phrases
R 45 - May cause cancer.
R 60 - May impair fertility.
R 61 - May cause harm to the unborn child.
Safety Phrases
S 36/37/39 - Wear suitable protective clothing, gloves and eye/face protection.
S 53 - Avoid exposure -- obtain special instructions before use.
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Section 16 - Other Information
MSDS Sections Revised: Sections 1 and 16.
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
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
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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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