SYNOVEX H HEIFER GROWTH AND FINISHING IMPLANTS

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Active ingredient:
TESTOSTERONE PROPIONATE; OESTRADIOL BENZOATE; DETECTABLE MARKER
Available from:
ZOETIS AUSTRALIA PTY LTD
INN (International Name):
oestradiol benzoate(20mg/Im)+testosterone propionate(200mg/Im)
Pharmaceutical form:
PARENTERAL IMPLANT, DEVICE
Composition:
TESTOSTERONE PROPIONATE STEROID-ANABOLIC Active 200.0 mg/Im; OESTRADIOL BENZOATE STEROID-ESTROGEN Active 20.0 mg/Im; DETECTABLE MARKER MISCELLANEOUS Other 0.0 P
Units in package:
100 Impls
Class:
VM - Veterinary Medicine
Manufactured by:
ZOETIS AUSTRALIA
Therapeutic group:
HEIFER (YOUNG FEMALE CATTLE) | BOVINE | COW YOUNG
Therapeutic area:
NUTRITION & METABOLISM
Therapeutic indications:
PROMOTE ANIMAL GROWTH | FEED CONVERSION | FINISHING | GROWTH PROMOTION | GROWTH RATE | LIVEWEIGHT GAIN
Product summary:
Poison schedule: 6; Withholding period: WHP: Meat: Nil. Milk: Do not use in he ifers which are producing or may in the future produce milk or milk products f or human consumption. TRADE ADVICE: E XPORT SLAUGHTER INTERVAL (ESI): Zero (0 ) Days.; Host/pest details: HEIFER (YOUNG FEMALE CATTLE): [PROMOTE ANIMAL GROWTH]; For improved weight gain in heifers.For use only in heifers. DO NOT USE in any other species of animals. Must only be supplied in accordance with Div.2 part 4 of the Agvet Regulations (Supply of Hormonal Growth Promotants). See RESTRAINTS/PRECAUTIONS on label also.
Authorization status:
Registered
Authorization number:
49955
Authorization date:
2020-07-01

Info

pest

Verified

Product Name: Synovex® H Heifer Growth and Finishing Implants

Page: 1 of 5

This revision issued: July, 2012

SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: 1800 814 883

Poisons Information Centre: 13 1126 from anywhere in Australia, (0800 764 766 in New Zealand)

Section 1 - Identification of The Material and Supplier

Pfizer Australia Pty Ltd

38-42 Wharf Road

West Ryde NSW 2114

Tel: 1800 814 883

Fax: (02) 9850 3399

____________________________________

Pfizer Australia Pty Ltd

A.B.N. 50 008 422 348

Chemical nature:

Active ingredients include a mixture of esters of naturally occurring hormones.

Trade Name:

Synovex

®

H Heifer Growth and Finishing Implants

Other names:

None

APVMA code:

49955

Product Use:

Growth regulator preparation for calves.

Creation Date:

July, 2012

This version issued:

July, 2012

and is valid for 5 years from this date.

SECTION 2 - HAZARDS IDENTIFICATION

Statement of Hazardous Nature

This product is classified as:

Not classified as hazardous according to the criteria of SWA.

Not a Dangerous Good according to the Australian Dangerous Goods (ADG) Code.

Risk Phrases:

Not Hazardous - No criteria found.

Safety Phrases:

S24, S36. Avoid contact with skin. Wear suitable protective clothing.

SUSMP Classification:

ADG Classification:

None allocated. Not a Dangerous Good under the ADG Code.

UN Number:

None allocated

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Physical Description & colour

: Implant pellets applied beneath skin in ear by special gun.

Odour:

No data.

Major Health Hazards:

no significant risk factors have been found for this product.

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Note: different Hazard Assessment Criteria of SWA and TGA may result in seeming inconsistencies between

MSDS and label. Effects described in this MSDS relate to short term emergency situations, such as accidents

and spills with the potential for gross overexposure, and to long term industrial and manufacturing exposure.

See product label for assessment of Health Effects of exposure during normal on-farm usage.

In men, overexposure may lead to gynecomastia (breast tenderness, breast nodules or enlarged breasts),

galactorrhoea (secretion of milk), decreased libido and damage to the testes resulting in atrophy and infertility. In

women, overexposure may cause menstrual irregularities (breakthrough bleeding, changes in menstrual flow,

spotting, amenorrhoea), temporary infertility, breast changes (tenderness, enlargement, and secretion), hirsutism

(excessive hair growth) and fluid retention. The IARC has determined that there is sufficient evidence that

testosterone and oestradiol benzoate are carcinogenic in experimental animals. However, data are inadequate to

evaluate the carcinogenicity in humans. No specific data is available for the product for chronic exposure symptoms.

Warning:

Chronic overexposure may cause reproductive system disorders. Avoid ingestion, inhalation, skin

contact, and eye contact. Read and understand this Material Safety Data Sheet and information in the product label

and leaflet before working with this product.

Inhalation:

Short term exposure:

Long term inhalation of high amounts of any nuisance dust may overload lung clearance

mechanism. Available data indicates that this product is not harmful. In addition product is unlikely to cause any

discomfort or irritation.

Long Term exposure:

No data for health effects associated with long term inhalation.

Product Name: Synovex® H Heifer Growth and Finishing Implants

Page: 2 of 5

This revision issued: July, 2012

SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: 1800 814 883

Poisons Information Centre: 13 1126 from anywhere in Australia, (0800 764 766 in New Zealand)

Skin Contact:

Short term exposure:

Available data indicates that this product is not harmful. It should present no hazards in

normal use. In addition product is unlikely to cause any discomfort in normal use.

Long Term exposure:

No data for health effects associated with long term skin exposure.

Eye Contact:

Short term exposure

: This product may be mildly irritating to eyes, but is unlikely to cause anything more than

mild discomfort which should disappear once product is removed.

Long Term exposure

: No data for health effects associated with long term eye exposure.

Ingestion:

Short term exposure

: Significant oral exposure is considered to be unlikely. However, this product may be mildly

irritating to mucous membranes but is unlikely to cause anything more than mild transient discomfort.

Long Term exposure

: No data for health effects associated with long term ingestion.

Carcinogen Status:

SWA:

No significant ingredient is classified as carcinogenic by SWA.

NTP:

No significant ingredient is classified as carcinogenic by NTP.

IARC:

No significant ingredient is classified as carcinogenic by IARC.

SECTION 3 - COMPOSITION/INFORMATION ON INGREDIENTS

Ingredients

CAS No

Conc, /Im

TWA (mg/m

3

)

STEL (mg/m

3

)

Testosterone propionate

57-85-2

200mg

not set

not set

Oestradiol benzoate

50-50-0

20mg

not set

not set

Other non hazardous ingredients

secret

to 100%

not set

not set

This is a commercial product whose exact ratio of components may vary slightly. Minor quantities of other non

hazardous ingredients are also possible.

The SWA TWA exposure value is the average airborne concentration of a particular substance when calculated over a normal 8 hour working day

for a 5 day working week. The STEL (Short Term Exposure Limit) is an exposure value that may be equalled (but should not be exceeded) for no

longer than 15 minutes and should not be repeated more than 4 times per day. There should be at least 60 minutes between successive exposures

at the STEL. The term "peak "is used when the TWA limit, because of the rapid action of the substance, should never be exceeded, even briefly.

SECTION 4 - FIRST AID MEASURES

General Information:

You should call The Poisons Information Centre if you feel that you may have been poisoned, burned or irritated by

this product. The number is 13 1126 from anywhere in Australia (0800 764 766 in New Zealand) and is available at all

times. Have this MSDS or product label with you when you call.

Inhalation:

First aid is not generally required. If in doubt, contact a Poisons Information Centre or a doctor.

Skin Contact:

Gently brush away excess solids. Irritation is unlikely. However, if irritation does occur, flush with

lukewarm, gently flowing water for 5 minutes or until chemical is removed.

Eye Contact:

Quickly and gently brush particles from eyes. No effects expected. If irritation does occur, flush

contaminated eye(s) with lukewarm, gently flowing water for 5 minutes or until the product is removed. Obtain medical

advice if irritation becomes painful or lasts more than a few minutes. Take special care if exposed person is wearing

contact lenses.

Ingestion:

If product is swallowed or gets in mouth, do NOT induce vomiting; wash mouth with water and give some

water to drink. If symptoms develop, or if in doubt contact a Poisons Information Centre or a doctor.

SECTION 5 - FIRE FIGHTING MEASURES

Fire and Explosion Hazards

: There is no risk of an explosion from this product under normal circumstances if it is

involved in a fire. Violent steam generation or eruption may occur upon application of direct water stream on hot

liquids.

Fire decomposition products from this product may be toxic if inhaled. Take appropriate protective measures.

Extinguishing Media

: Preferred extinguishing media are carbon dioxide, dry chemical, foam, water fog.

Fire Fighting

: If a significant quantity of this product is involved in a fire, call the fire brigade.

Flash point

:

Combustible solid.

Upper Flammability Limit:

No data.

Lower Flammability Limit:

No data.

Autoignition temperature:

No data.

Flammability Class:

Combustible solid.

Product Name: Synovex® H Heifer Growth and Finishing Implants

Page: 3 of 5

This revision issued: July, 2012

SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: 1800 814 883

Poisons Information Centre: 13 1126 from anywhere in Australia, (0800 764 766 in New Zealand)

SECTION 6 - ACCIDENTAL RELEASE MEASURES

Accidental release

: In the event of a major spill, prevent spillage from entering drains or water courses. As a

minimum, wear overalls, goggles and gloves. Suitable materials for protective clothing include rubber, PVC. If there is

a significant chance that dusts are likely to build up in cleanup area, we recommend that you use a suitable Dust

Mask.

Stop leak if safe to do so, and contain spill. Sweep up and shovel or collect recoverable product into labelled

containers for recycling or salvage, and dispose of promptly. Consider vacuuming if appropriate. Recycle containers

wherever possible after careful cleaning. After spills, wash area preventing runoff from entering drains. If a significant

quantity of material enters drains, advise emergency services. This material may be suitable for approved landfill.

Ensure legality of disposal by consulting regulations prior to disposal. Thoroughly launder protective clothing before

storage or re-use. Advise laundry of nature of contamination when sending contaminated clothing to laundry.

SECTION 7 - HANDLING AND STORAGE

Handling

: Keep exposure to this product to a minimum, and minimise the quantities kept in work areas. Check

Section 8 of this MSDS for details of personal protective measures, and make sure that those measures are followed.

The measures detailed below under "Storage" should be followed during handling in order to minimise risks to

persons using the product in the workplace. Also, avoid contact or contamination of product with incompatible

materials listed in Section 10.

Storage

: This product is a Scheduled Poison. Observe all relevant regulations regarding sale, transport and storage

of this schedule of poison. Store in the closed original container in a dry, cool, well-ventilated area out of direct

sunlight. Make sure that the product does not come into contact with substances listed under "Incompatibilities" in

Section 10. Check packaging - there may be further storage instructions on the label.

SECTION 8 - EXPOSURE CONTROLS AND PERSONAL PROTECTION

This MSDS describes personal protective measures relating to long term industrial and manufacturing

exposure, and emergency situations, such as accidents and spills.

See product label for personal protective measures during normal on farm usage .

The following Australian Standards will provide general advice regarding safety clothing and equipment:

Respiratory equipment: AS/NZS 1715, Protective Gloves: AS 2161, Occupational Protective Clothing: AS/NZS 4501

set 2008, Industrial Eye Protection: AS1336 and AS/NZS 1337, Occupational Protective Footwear: AS/NZS2210.

SWA Exposure Limits

TWA (mg/m

3

)

STEL (mg/m

3

)

Exposure limits have not been established by SWA for any of the significant ingredients in this product.

Ventilation:

No special ventilation requirements are normally necessary for this product. However make sure that

the work environment remains clean and that dusts are minimised.

Eye Protection:

Eye protection is not normally necessary when this product is being used. However, if in doubt,

wear suitable protective glasses or goggles.

Skin Protection:

The information at hand indicates that this product is not harmful and that normally no special skin

protection is necessary. However, we suggest that you routinely avoid contact with all chemical products and that you

wear suitable gloves (preferably elbow-length) when skin contact is likely.

Protective Material Types:

There is no specific recommendation for any particular protective material type.

Respirator:

If there is a significant chance that dusts are likely to build up in the area where this product is being

used, we recommend that you use a suitable Dust Mask.

Safety deluge showers should, if practical, be provided near to where this product is being used.

Other: Workers in operations with direct exposure to bulk active should shower after their shifts are complete or

whenever they change to street clothes. Workers should not take any work clothing home, including work shoes,

socks, lab coats, etc. All workers should wash their hands, face, and any other exposed skin surfaces after working

with this product and especially before eating, drinking or smoking. When practicable, hand transfer of granulations

and pellets should be replaced with closed-system mechanical transfer techniques. If portable vacuum cleaners are

used for cleanup they must be equipped with high efficiency particulate (HEPA) filters. Skin contact with solvents can

facilitate absorption of steroids and must be avoided during cleanup activities.

SECTION 9 - PHYSICAL AND CHEMICAL PROPERTIES:

Physical Description & colour

Implant pellets applied beneath skin in ear by special gun.

Odour:

No data.

Boiling Point:

No specific data. Expected to decompose before boiling.

Freezing/Melting Point:

Not known. Melting point for testosterone propionate is 118-122°C, and for

oestradiol benzoate is 191-196°C.

Volatiles:

No data.

Product Name: Synovex® H Heifer Growth and Finishing Implants

Page: 4 of 5

This revision issued: July, 2012

SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: 1800 814 883

Poisons Information Centre: 13 1126 from anywhere in Australia, (0800 764 766 in New Zealand)

Vapour Pressure:

Negligible at normal ambient temperatures.

Vapour Density:

No data.

Specific Gravity:

No data.

Water Solubility:

No data. Expected to be slowly soluble.

pH:

No data.

Volatility:

Negligible at normal ambient temperatures.

Odour Threshold:

No data.

Evaporation Rate:

No data.

Coeff Oil/water distribution

No data

Autoignition temp:

No data.

SECTION 10 - STABILITY AND REACTIVITY

Reactivity:

This product is unlikely to react or decompose under normal storage conditions. However, if you have

any doubts, contact the supplier for advice on shelf life properties.

Conditions to Avoid:

Store in the closed original container in a dry, cool, well-ventilated area out of direct sunlight.

Incompatibilities:

No particular Incompatibilities.

Fire Decomposition:

Carbon dioxide, and if combustion is incomplete, carbon monoxide and smoke. Water.

Carbon monoxide poisoning produces headache, weakness, nausea, dizziness, confusion, dimness of vision,

disturbance of judgment, and unconsciousness followed by coma and death.

Polymerisation:

This product will not undergo polymerisation reactions.

SECTION 11 - TOXICOLOGICAL INFORMATION

Local Effects:

Target Organs:

There is no data to hand indicating any particular target organs.

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Ingredient

Risk Phrases

No ingredient mentioned in the HSIS Database is present in this product at hazardous concentrations.

SECTION 12 - ECOLOGICAL INFORMATION

This product is biodegradable. It will not accumulate in the soil or water or cause long term problems.

SECTION 13 - DISPOSAL CONSIDERATIONS

Disposal: All Synovex residues should be contained and stored separately from other facility waste discharges.

Dispose of any waste residues according to prescribed federal, state, and local guidelines, e.g. secured chemical

landfill disposal, approved chemical wastes incineration or approved aqueous discharge of rinse waters resulting from

spill cleanups to municipal or on-site waste water treatment facilities. Full details regarding disposal of used

containers, spillage and unused material may be found on the label. If there is any conflict between this MSDS and

the label, instructions on the label prevail.

SECTION 14 - TRANSPORT INFORMATION

ADG Code:

This product is not classified as a Dangerous Good. No special transport conditions are necessary

unless required by other regulations.

SECTION 15 - REGULATORY INFORMATION

AICS:

All of the significant ingredients in this formulation are compliant with NICNAS regulations.

The following ingredients: Testosterone, Oestradiol are mentioned in the SUSMP.

Section 16 - Other Information

This MSDS contains only safety-related information. For other data see product literature.

Acronyms:

ADG Code

Australian Code for the Transport of Dangerous Goods by Road and Rail (7

edition)

AICS

Australian Inventory of Chemical Substances

SWA

Safe Work Australia, formerly ASCC and NOHSC

CAS number

Chemical Abstracts Service Registry Number

Product Name: Synovex® H Heifer Growth and Finishing Implants

Page: 5 of 5

This revision issued: July, 2012

SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: 1800 814 883

Poisons Information Centre: 13 1126 from anywhere in Australia, (0800 764 766 in New Zealand)

Hazchem Code

Emergency action code of numbers and letters that provide information to emergency

services especially firefighters

IARC

International Agency for Research on Cancer

NOS

Not otherwise specified

NTP

National Toxicology Program (USA)

R-Phrase

Risk Phrase

SUSMP

Standard for the Uniform Scheduling of Medicines & Poisons

UN Number

United Nations Number

Contact Points:

Pfizer

1800 814 883

Police and Fire Brigade:

Dial 000

If ineffective:

Dial Poisons Information Centre

(

13 1126 from anywhere in Australia)

Please read all labels carefully before using product.

This MSDS copyright © Kilford & Kilford Pty Ltd, July, 2012.

http://www.kilford.com.au/ Phone (02)9251 4532

MSDS64-VERSION1

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