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70288-86-7 57-55-6 5464-28-8

File Name: 70288-86-7_57-55-6_5464-28.asp

                                         SAFETY DATA SHEET
Page 1 of 5
Product Name: IVOMEC Injection for Cattle, Sheep and Pigs Reviewed on: 25 September 2007


SECTION 1: IDENTIFICATION OF THE SUBSTANCE AND
SUPPLIER
Product name: IVOMEC Injection for Cattle, Sheep & Pigs

Product code: A7392

Recommended use: For the treatment and control of internal and external parasites of cattle,
sheep and pigs.

Company details: Merial Ancare

Address: Level 3, Merial Building
Osterley Way
Manukau City
New Zealand

Telephone number: Phone: +64 9 980 1600 Fax: +64 9 980 1601

Emergency telephone Merial Ancare Freephone: 0800 800 822
number:
National Poisons Centre: 0800 764 766 (0800 POISON)
Fire Service, Ambulance: Dial 111

Date of preparation: 25 September 2007



SECTION 2: COMPOSITION/INFORMATION ON INGREDIENTS
Multicomponent Liquid / Avermectin
Chemical characterization:

Product components:

Name CAS Proportion
Ivermectin Comp. B1a 70288-86-7
Comp. B1b
(mixture)
Propylene Glycol 57-55-6
Glycerol Formal 5464-28-8



SECTION 3: HAZARDS IDENTIFICATION
Hazard classifications: 6.1D, 6.8B, 6.8C, 6.9B, 9.1A, 9.2C, 9.3C, 9.4A

Priority and secondary Harmful ?keep out of reach of children
identifiers:
Ecotoxic

Risk and safety phrases: Harmful ?may be harmful if swallowed, inhaled or absorbed through the
skin. Do not eat, drink or smoke while using. Wear protective clothing such
as impervious gloves, waterproof hat, coat and trousers when using.
Remove protective clothing and wash hands and face thoroughly before
meals and after work.
Harmful ?may cause reproductive / development damage from repeated
oral exposure. Keep out of reach of children. Do not handle until all safety
precautions have been read and understood.
May cause reproductive/development damage from repeated oral exposure.
Harmful ?May cause organ damage from repeated oral exposure at high
Page 2 of 5
Product Name: IVOMEC Injection for Cattle, Sheep and Pigs Reviewed on: 25 September 2007




doses
Ecotoxic ?Very toxic to aquatic organisms. Avoid contamination of any
water supply with product or empty container.
Harmful to the soil environment. Apply only as directed.
Harmful to terrestrial vertebrates. Apply only as directed. Avoid contact with
skin.
Very toxic to terrestrial invertebrates. Apply only as directed.



SECTION 4: FIRST AID MEASURES
Necessary first aid measures: For advice, contact the National Poisons Centre: 0800 POISON
(0800 764766) or a doctor immediately.
Eye Contact: Flush thoroughly with plenty of water for at least 15 minutes.
Get medical attention if irritation occurs or persists.
Skin Contact: Flush thoroughly with plenty of water and wash contact area
with soap and water. Remove contaminated clothing and wash before
reuse. If irritation occurs or persists, get medical attention.
Inhalation: In case of accidental overexposure, get to fresh air. If irritation
occurs or persists, get medical attention.
Ingestion: Do NOT induce vomiting. Contact the National Poisons Centre.

Workplace facilities: N/A

Required instructions: N/A

Notes for medical personnel: N/A



SECTION 5: FIRE FIGHTING MEASURES
Type of hazard: N/A

Fire hazard properties: Toxic gases including carbon monoxide and carbon dioxide may be
generated.

Regulatory requirements: N/A

Extinguishing media and Extinguish fires with foam, dry chemical or carbon dioxide. Cool sealed
methods: drums with water to prevent rupture due to thermal expansion. Contain
run-off. Keep non-involved persons away.

Hazchem code: 2X

Recommended protective Wear PVC protective clothing and breathing apparatus.
clothing:



SECTION 6: ACCIDENTAL RELEASE MEASURES
In case of spillage wear appropriate protective clothing and prevent material
Emergency procedures:
from entering waterways. Absorb spills with inert material and place in
waste containers. Sweep up solids without creating dust. Wash area with
water and absorb with further inert material. Dispose of waste safely in
accordance with local authorities.



SECTION 7: HANDLING AND STORAGE
Precautions for safe handling: No special protection required under normal conditions of use
Page 3 of 5
Product Name: IVOMEC Injection for Cattle, Sheep and Pigs Reviewed on: 25 September 2007




Regulatory requirements: N/A

Handling practices: N/A

Approved handlers: Not required.

Conditions for safe storage: Keep container closed when not in use.
Keep this and all drugs out of the reach of children.
Store bottle in carton to protect contents from light.

Store site requirements: Stores containing equal to or more than 100L of IVOMEC Injection for
Cattle, Sheep & Pigs require bunding and are subject to signage. See the
Hazardous Substances Emergency Management Regulations 35-41,
Identification Regulations 34 & 35 and NZS 8409 for further information.

Packaging: Packing Group III



SECTION 8: EXPOSURE CONTROL/PERSONAL PROTECTION
Workplace exposure N/A
standards:

Application in the workplace: N/A

Exposure standards outside N/A
the workplace:

Engineering controls: N/A

Personal protection: No special protection required under normal conditions of use.

References: N/A



SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES
Specify product data: Appearance: Clean, clear, pale straw-coloured sterile liquid.

Required specifications: N/A

Further specifications: N/A

Specific advice: N/A



SECTION 10: STABILITY AND REACTIVITY
Stability of the substance: Stable, protected from light

Conditions to avoid: Avoid direct sunlight.

Material to avoid: N/A

Hazardous decomposition N/A
products:

Hazardous polymerization: Will not occur

Specific data: N/A



SECTION 11: TOXICOLOGICAL INFORMATION
Page 4 of 5
Product Name: IVOMEC Injection for Cattle, Sheep and Pigs Reviewed on: 25 September 2007




Data and interpretation: N/A

Summaries data: N/A

Effects of Acute Exposure: Eye Contact: Under normal conditions of use, no eye contact with the
solution is expected. Direct contact of the solution with eyes can cause
irritation.
Skin Contact: Ivermectin is non-irritating in animal studies. Although skin
absorption of this formulation of Ivermectin is not established, it has been
shown that less than 1% of the closely related compound abamectin is
absorbed through the skin of rhesus monkeys when it is applied as
emulsifiable concentrate or suspended in alcohol. Glycerol formula may be
absorbed through the skin.
Inhalation: Not an expected route of exposure for this formulation.
Ingestion: Pure Ivermectin is considered highly toxic in acute animal
studies. The acute oral toxicity studies of Ivermectin have shown clear
differences among species in sensitivity to Ivermectin toxicity. Rodents are
uniquely sensitive compared to the other species in which the compound
has been tested. It is therefore inappropriate to base human risk
assessment on the response in mice. Ivermectin is used at a therapeutic
dose of 200 mcg/kg in a variety of species, including human. Ivermectin
can be excreted in milk.


If overexposed to Ivermectin, symptoms may include decreased activity,
slow rate of breathing, dilation of the pupils, muscle tremors, and
incoordination. Glycerol formula is practically non-toxic in animal studies.

Effect of Chronic Exposure: Unknown for product mixture. When this product is used according to the
directions, prolonged exposure of man is not expected. Ivermectin has
tested negative in several mutagenicity studies. Ivermectin was
administered to dogs daily for 3 months and to monkeys daily for 2 weeks.
In dogs there was no effect up to 500 mcg/kg/day and in adult rhesus
monkeys there was no effect at the maximum dosage used 1.2 mg/kg/day.
At higher doses in dogs there was dilation of the pupils, and at still higher
doses tremor and anorexia were noted. Ivermectin can be given during
gestation in horses, cattle, pigs and sheep.


Glycerol formula was well tolerated in chronic toxicity studies in rabbits, rats
and dogs up to very high doses (288 mg/kg/day). However, in fetotoxicity
studies in rodents the no effect level was set at 10 mg/kg/day. The
equivalent figure in teratogenicity studies was 75 mg/kd/day.



SECTION 12: ENVIRONMENTAL INFORMATION
Ivermectin: LC50 (Daphnia Magna) = 36 ppt (parts per trillion).
Potential environmental
interactions: Ivermectin is very toxic to certain aquatic species. Avoid contact of spilled
materials and runoff with soil and surface waterways.

Data organisation : N/A

Environmental risk and safety Environmentally hazardous substance, Liquid, N.O.S. (ivermectin)
phrases:
Marine pollutant



SECTION 13: DISPOSAL CONSIDERATIONS
Disposal information : Dispose of this product only by using in accordance with the label or at an
approved landfill. Do NOT reuse container for any other purpose. Ensure
Page 5 of 5
Product Name: IVOMEC Injection for Cattle, Sheep and Pigs Reviewed on: 25 September 2007




container is completely empty. Recycle or burn if circumstances, especially
wind direction and local authority bylaws permit. Otherwise bury in a
suitable landfill.



SECTION 14: TRANSPORT INFORMATION
Maximum Transport Quantity: 250 L
Relevant information:
DG Class 9
UN 3082
Tracking not required.

Other requirements: N/A



SECTION 15: REGULATORY INFORMATION
Registered pursuant to the ACVM Act 1997, No.A7392
Regulatory status:
See www.nzfsa.govt.nz/acvm for registration conditions
Approved pursuant to the HSNO Act 1996,
Approval Code HSR002396.
See www.ermanz.govt.nz for approval conditions

HSNO and ACVM controls: Refer to Section 3

List exposure limits: N/A



SECTION 16: OTHER INFORMATION
For product information visit the Merial website www.merial.co.nz
Additional information:


While the information set forth is believed to be accurate as of the date
hereof, MERIAL NZ LTD. makes no warranty with respect hereto and
disclaims all liability from reliance thereon.

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