CHORULON - Issue 3
MATERIAL SAFETY DATA SHEET
CHORULON庐
July 21st, 2004
Issue Date:
July 21st, 2007
Review Date:
Company Address: Intervet Australia Pty Limited
Box 2800
Bendigo Delivery Centre
VIC 3554
Phone: 03 5440 9888
Fax: 03 5442 3162
Emergency Tel. No.: Veterinary Services Manager
Intervet Australia Pty Limited
03 5440 9888
Poisons Information Centre: 13 11 26
1. IDENTIFICATION
1.10 Product Name: Chorulon Chorionic Gonadotrophin
1.11 Correct Shipping Name: Chorulon Chorionic Gonadotrophin
1.12 Other Names: Human chorionic gonadotrophin
1.13 NRA Number: 37225 ( 5000iu ) and 37226 ( 1500iu )
1.14 Hazchem Code: None Allocated (not listed as a hazardous substance)
1.15 Dangerous Goods Class: None
Sub-risk: None Allocated (not listed as a hazardous substance)
1.16 Poison Schedule: S4
1.17 Manufacturers Product
Code: 21135-6
1.18 Use: Prescription Only drug for animal treatment only 鈥? Source
of luteinizing hormone for gonadogenesis by injection in
horses, cattle, dogs and fish
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CHORULON - Issue 3
1.2 Ingredients
Proportion per vial#
1.20 Chemical Entity CAS No.
Freeze Dried Product
* Human chorionic gonadotrophin 9002-61-3 1500 or 5000 i.u.
Mannitol 69-65-8 +
Disodium hydrogen phosphate 7558-79-4 +
Sodium dihydrogen phosphate 7558-80-7 +
Diluent (per mL)
Disodium hydrogen phosphate 7558-79-4 +
Sodium dihydrogen phosphate 7558-80-7 +
Water for injection 7732-18-5 To 1mL
* Active Constituent
+ Confidential Manufacturing Information
#
A 5% overage is applied
1.21 Chemical Characterisation: Chorionic gonadotrophin freeze dried sterile injection in
1500 i.u. or 5000 i.u. plus vial diluents.
1.3 Physical Description / Properties
Freeze Dried Product Diluent
1.30 Form: White to off-white powder or Clear aqueous
dried plug. solution
1.31 Colour: White to off-white Colourless
1.32 Odour: None None
1.33 Change in Physical State: Not relevant Not relevant
1.34 SG: Not relevant Not available
1.35 Vapour Pressure: Not available Not relevant
1.36 Viscosity: Not relevant Not relevant
1.37 Solubility in Water: Very soluble Miscible
1.38 pH Value: 6.5 鈥? 7 6.5 鈥? 7.2
1.39 Flash Point: Non flammable
1.40 Ignition Temperature: Not relevant
1.41 Explosive Limits: Not relevant
1.5 Other Properties
1.51 Further Information: See Martindale Extra Pharmacopoeia 29th ed., page 1144.
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CHORULON - Issue 3
2. HEALTH HAZARD INFORMATION
2.1 Health Effects:
2.10 Information on Toxicity: HCG given parenterally can profoundly influence human
fertility so care must be taken to avoid accidental self
injection. The effect however is strongly dose dependent.
HCG is a glycoprotein and is inactive if taken orally,
however with glycoproteins there is always the risk of an
anaphylactoid reaction from parenteral use.
In addition, side effects in humans from HCG injection
include headache, tiredness, moods, oedema and pain at
injection site. Caution in humans whom fluid retention may
be a hazard 鈥? asthma, epilepsy, migraine, cardiac and
renal disease.
2.2 First Aid
2.20 First Aid: a. Eye contact - Flush eyes with copious amounts of
water for at least 15 minutes. Seek medical advice.
b. Skin contact - Flush skin for 15 minutes with
copious amounts of cold water . Remove and wash
contaminated clothing before reuse.
c. Self Injection 鈥? Wash and disinfect self injection
injuries. Seek medical advice if irritancy or an
allergic response occurs. Take the vial and this
Material Safety Data Sheet to the doctor.
2.21 Advice to Doctor: The substance is not toxic parenterally and inactive orally.
See comment re gonadal effects and possibility of
anaphylaxis.
Treat symptomatically any allergic reaction or any local
irritancy.
3. PRECAUTIONS FOR USE
3.1 Exposure Standards / Engineering Control
3.10 Regulations: This product is not subject to the Australian Code for the
Transport of Dangerous Goods by Road and Rail.
This product is a Poison Schedule 4 prescription drug and
may only be possessed and used by those people with
appropriate authorisation.
3.11 Technical Protective
Measures: No special measures are required. Exercise normal care
to prevent accidental ingestion. Store away from food,
drink or animal feeding stuffs. Store at 8oC for freeze dried
product, 2-8掳C after reconstitution. Protect from light.
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CHORULON - Issue 3
3.2 Personal Protective Measures
3.21 Personal Protective
Equipment: None required
3.22 Industrial Hygiene: Avoid contact with the skin and eyes
3.3 Flammability
3.31 Protection Against Fire: The product is water based and not flammable.
4. MEASURES IN CASE OF ACCIDENTS AND FIRES
4.1 Storage and Transport
4.11 Classification under the
Transportation of Dangerous
Goods Code:
Shipping Name: Not Available
Packing Group: None
UN Number: None Allocated
DG Class: None
Sub-risk: None
Hazchem: None
4.12 DG storage/transport in accordance with State and Territory regulations. This product is
not subject to the requirements of the Australian Code for the Transport of Dangerous
Goods by Road and Rail. Product should be stored and handled in accordance with
regulations governing Schedule 4 (prescription) drugs.
4.13 International Transport
Codes: Not relevant
4.2 Spills and Disposals
4.21 Dispose of unused or expired material in an authorised landfill.
4.22 After Spillage/Leakage: Spillage quantities will be minor due to the small volumes
of
product normally transported and stored. Prevent the spill
spreading to contaminate other areas. Do not allow the
product to contact skin or eyes. Wear rubber gloves for
clean-up operations. Do not smoke or eat during clean-up
operations. If contact occurs immediately wash off with
soap and water.
4.23 Disposal of Spillage: Absorb into paper towel, hydrated lime, soil or sand,
depending on quantity involved. Dispose of contaminated
absorbent material in an appropriate manner. Rinse area
of spill with detergent and water.
On completion of clean-up wash all exposed skin areas
and any contaminated protective clothing. Inform the local
water authority if large amounts enter the drainage system.
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CHORULON - Issue 3
4.3 Fire / Exposure Hazards
4.35 Thermal Decomposition: In fire incidents toxic fumes of nitrogen oxides, sulphur
oxides, carbon monoxide may be formed.
4.36 Hazardous Decomposition Do not use expired, pre-used or past date material in
Products: animals.
4.37 Hazardous Reactions: None
4.38 Extinguishing Media: Not relevant
4.39 Further Information: Spillages must be cleared promptly.
5. OTHER INFORMATION
5.10 Information on Ecological There is no data on ecological effects. It is not anticipated
Effects: that this product will enter the environment as a
consequence of normal use.
6. CONTACT POINT (For Non-Emergency Calls)
6.10 Product Safety Coordinator: Veterinary Services Manager
Intervet Australia Pty Limited
03 5440 9888
DISCLAIMER
The Material Safety Data Sheet has been developed according to WORKSAFE Australia / NOHSC guidelines.
The data, information and recommendations herein (鈥渋nformation鈥?) are represented in good faith and believed to be
correct as of the date hereof.
The purpose of this Material Safety Data Sheet is to describe product in terms of their safety requirements.
Intervet Australia Pty Limited makes no representation of merchantability, fitness for a particular purpose or
application, or of any other nature with respect to the information or the product to which the information refers (鈥渢he
product鈥?).
The information is supplied upon the condition that the persons receiving same will make their own determination as
to its suitability for their purposes prior to use of the product.
The physical data shown herein are typical values based on material tested. These values should not be construed
as a guaranteed analysis of any specific lot or as guaranteed specification for the product or specific lots thereof.
Due care should be taken to make sure that the use or disposal of this product is in compliance with relevant Federal,
State and Local Government regulations.
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