Randlab Butorphanol Injection

Page 1 of 6

This revision issued: August, 2019

SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER

Chemical nature: Injection of butorphanol as butorphanol tartrate

Trade Name: Randlab Butorphanol Injection

APVMA Code: 87965

Product Use: Animal analgesic and sedative for use as described on the product label.

Creation Date: August, 2019

This version issued: August, 2019 and is valid for 5 years from this date.

Poisons Information Centre: Phone 13 1126 from anywhere in Australia

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 Australian Dangerous Goods (ADG) Code, IATA or IMDG/

IMSBC criteria.

SUSMP Classification: S8. Possession without authority is illegal.

ADG Classification: None allocated. Not a Dangerous Good according to Australian Dangerous Goods (ADG) Code,

IATA or IMDG/IMSBC criteria.

UN Number: None allocated

GHS Signal word: NONE. Not hazardous.

PREVENTION

P262: Do not get in eyes, on skin, or on clothing.

P264: Wash contacted areas thoroughly after handling.

P270: Do not eat, drink or smoke when using this product.

P272: Contaminated work clothing should not be allowed out of the workplace.

P281: Use personal protective equipment as required.

RESPONSE

P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.

P370+P378: In case of fire, use carbon dioxide, dry chemical, foam, water fog.

STORAGE

P410: Protect from sunlight.

P402+P404: Store in a dry place. Store in a closed container.

P411+P235: Store at temperatures not exceeding 25°C. Keep cool.

DISPOSAL

P501: Dispose of contents and containers as specified on the registered label.

EMERGENCY OVERVIEW

Physical Description & Colour: Liquid, no data regarding colour

Odour: No data.

Major Health Hazards: no significant risk factors have been found for this product.

Randlab Butorphanol Injection

ISSUED BY: Randlab Australia Pty Ltd

POISONS INFORMATION CENTRE: 13 1126 from anywhere in Australia, (0800 764 766 in New Zealand)

SECTION 3 - COMPOSITION/INFORMATION ON INGREDIENTS

Ingredients CAS No Conc, mg/mL TWA (mg/m3) STEL (mg/m3)

Butorphanol tartrate 58786-99-5 10 not set not set

Other non hazardous ingredients secret to 1 mL 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 SDS 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: Irritation is unlikely. However, if irritation does occur, flush with lukewarm, gently flowing water for 5 minutes or until

chemical is removed.

Eye Contact: 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: The major hazard in fires is usually inhalation of heated and toxic or oxygen deficient (or both), fire

gases. There is no risk of an explosion from this product under normal circumstances if it is involved in a fire.

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

Extinguishing Media: In case of fire, use 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: No data

Upper Flammability Limit: No data.

Lower Flammability Limit: No data.

Autoignition temperature: No data.

Flammability Class: No data.

Page 2 of 6

This revision issued: August, 2019

Randlab Butorphanol Injection

ISSUED BY: Randlab Australia Pty Ltd

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 no specific manufacturer recommendations. Use

impermeable gloves with care. Eye/face protective equipment should comprise, as a minimum, protective glasses and, preferably,

goggles. If there is a significant chance that vapours or mists are likely to build up in the cleanup area, we recommend that

you use a respirator. Usually, no respirator is necessary when using this product. However, if you have any doubts consult the

Australian Standard mentioned below (section 8).

Stop leak if safe to do so, and contain spill. Absorb onto sand, vermiculite or other suitable absorbent material. If spill is too

large or if absorbent material is not available, try to create a dike to stop material spreading or going into drains or waterways.

Sweep up and shovel or collect recoverable product into labelled containers for recycling or salvage, and dispose of promptly.

Recycle containers wherever possible after careful cleaning. Refer to product label for specific instructions. After spills, wash

area preventing runoff from entering drains. If a significant quantity of material enters drains, advise emergency services. Full

details regarding disposal of used containers, spillage and unused material may be found on the label. If there is any conflict

between this SDS and the label, instructions on the label prevail. 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

SDS 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 controlled drug. Possession without authority is illegal. Observe all relevant regulations regarding sale,

transport and storage of this substance. Protect this product from light. Store in the closed original container in a dry, cool, wellventilated

area out of direct sunlight. Store below 25°C. Make sure that the product does not come into contact with substances

listed under “Incompatibilities” in Section 10. Some liquid preparations settle or separate on standing and may require stirring

before use. Check packaging - there may be further storage instructions on the label.

SECTION 8 - EXPOSURE CONTROLS AND PERSONAL PROTECTION

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/m3) STEL (mg/m3)

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

No special equipment is usually needed when occasionally handling small quantities. The following instructions are for bulk

handling or where regular exposure in an occupational setting occurs without proper containment systems.

Ventilation: This product should only be used where there is ventilation that is adequate to keep exposure below the TWA levels. If

necessary, use a fan.

Eye Protection: Eye protection such as protective glasses or goggles is recommended when this product is being used.

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 lengthy skin contact is likely.

Protective Material Types: There is no data that enables us to recommend any type except that it should be impermeable.

Respirator: Usually, no respirator is necessary when using this product. However, if you have any doubts consult the Australian

Standard mentioned above.

Page 3 of 6

This revision issued: August, 2019

Randlab Butorphanol Injection

ISSUED BY: Randlab Australia Pty Ltd

POISONS INFORMATION CENTRE: 13 1126 from anywhere in Australia, (0800 764 766 in New Zealand)

SECTION 9 - PHYSICAL AND CHEMICAL PROPERTIES:

Physical Description & colour: Liquid, no data regarding colour

Odour: No data.

Boiling Point: Not available.

Freezing/Melting Point: No specific data. Liquid at normal temperatures.

Volatiles: No data.

Vapour Pressure: No data.

Vapour Density: No data.

Specific Gravity: No data.

Water Solubility: No data.

pH: No data.

Volatility: No data.

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: Protect this product from light. Store in the closed original container in a dry, cool, well-ventilated area out of

direct sunlight.

Incompatibilities: strong acids, strong bases, strong oxidising agents.

Fire Decomposition: Combustion forms carbon dioxide, and if incomplete, carbon monoxide and possibly smoke. Water is

also formed. May form nitrogen and its compounds, and under some circumstances, oxides of nitrogen. Occasionally hydrogen

cyanide gas in reducing atmospheres. 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.

CLASSIFICATION OF HAZARDOUS INGREDIENTS

Ingredient Risk Phrases

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

Page 4 of 6

This revision issued: August, 2019

Randlab Butorphanol Injection

ISSUED BY: Randlab Australia Pty Ltd

POISONS INFORMATION CENTRE: 13 1126 from anywhere in Australia, (0800 764 766 in New Zealand)

POTENTIAL HEALTH EFFECTS

Inhalation

Short Term Exposure: 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.

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 irritating to eyes, but is unlikely to cause anything more than mild transient discomfort.

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. Available data shows that this product is not harmful.

This product is unlikely to cause any irritation problems in the short or long term.

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 12 - ECOLOGICAL INFORMATION

Insufficient data to be sure of status.

SECTION 13 - DISPOSAL CONSIDERATIONS

Disposal: You should not attempt to reclaim or recycle this product. We suggest that, subject to the regulations in your area, this

product should be disposed by controlled incineration, or in landfill.

SECTION 14 - TRANSPORT INFORMATION

UN Number: This product is not classified as a Dangerous Good by ADG, IATA or IMDG/IMSBC criteria. 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 ingredient: Butorphanol, is mentioned in the SUSMP.

Page 5 of 6

This revision issued: August, 2019

Randlab Butorphanol Injection

ISSUED BY: Randlab Australia Pty Ltd

7/85 Alfred Rd Chipping Norton, NSW 2170, AUSTRALIA Phone: +612 9728 3505 Fax: +612 9728 4352

POISONS INFORMATION CENTRE: 13 1126 from anywhere in Australia, (0800 764 766 in New Zealand)

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 (7th edition)

AICS Australian Inventory of Chemical Substances

SWA Safe Work Australia, formerly ASCC and NOHSC

CAS number Chemical Abstracts Service Registry Number

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)

SUSMP Standard for the Uniform Scheduling of Medicines & Poisons

UN Number United Nations Number

THIS MSDS SUMMARISES OUR BEST KNOWLEDGE OF THE HEALTH AND SAFETY HAZARD INFORMATION OF THE PRODUCT AND HOW TO SAFELY

HANDLE AND USE THE PRODUCT IN THE WORKPLACE. EACH USER MUST REVIEW THIS MSDS IN THE CONTEXT OF HOW THE PRODUCT WILL BE

HANDLED AND USED IN THE WORKPLACE.

IF CLARIFICATION OR FURTHER INFORMATION IS NEEDED TO ENSURE THAT AN APPROPRIATE RISK ASSESSMENT CAN BE MADE, THE USER

SHOULD CONTACT THIS COMPANY SO WE CAN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION FROM OUR SUPPLIERS OUR RESPONSIBILITY

FOR PRODUCTS SOLD IS SUBJECT TO OUR STANDARD TERMS AND CONDITIONS, A COPY OF WHICH IS SENT TO OUR CUSTOMERS AND IS ALSO

AVAILABLE ON REQUEST.

Please read all labels carefully before using product.

This MSDS is prepared in accord with the SWA document “Preparation of Safety Data Sheets for Hazardous Chemicals - Code of

Practice” (Feb 2016)

Copyright © Kilford & Kilford Pty Ltd, August, 2019.

http://www.kilford.com.au/ Phone (02)8321 8866