ALAMYCIN AEROSOL TOPICAL SPRAY

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

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Active ingredient:
OXYTETRACYCLINE AS OXYTETRACYCLINE HYDROCHLORIDE
Available from:
NORBROOK LABORATORIES AUSTRALIA PTY LIMITED
INN (International Name):
oxytetracycline as HCl(33mg/g)
Pharmaceutical form:
TOPICAL AEROSOL SPRAY
Composition:
OXYTETRACYCLINE AS OXYTETRACYCLINE HYDROCHLORIDE ANTIBIOTIC Active 33.0 mg/g
Units in package:
140g
Class:
VM - Veterinary Medicine
Therapeutic group:
CATTLE | PIG - ADULT | SHEEP | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | EW
Therapeutic area:
DERMATOLOGICAL PREPS.
Therapeutic indications:
DERMATITIS | FOOT ROT | ORGANISMS SENSITIVE TO OXYTETRACYCLINE | ENTERIC BACTERIAL INFECTION | GANGRENOUS | RESPIRATORY INFECTION | SKIN DISORDER
Product summary:
Poison schedule: 4; Withholding period: WHP: Meat:Nil Milk:Nil Avoid milk co ntamination. Wash thoroughly from teat s and udders prior to milking. ESI: An imals can be slaughtered for export at zero days after the last treatment.; Host/pest details: CATTLE: [DERMATITIS, ORGANISMS SENSITIVE TO OXYTETRACYCLINE]; PIG - ADULT: [ORGANISMS SENSITIVE TO OXYTETRACYCLINE]; SHEEP: [FOOT ROT, ORGANISMS SENSITIVE TO OXYTETRACYCLINE]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [DERMATITIS, ORGANISMS SENSITIVE TO OXYTETRACYCLINE]; PIG - ADULT: [ORGANISMS SENSITIVE TO OXYTETRACYCLINE]; SHEEP: [FOOT ROT, ORGANISMS SENSITIVE TO OXYTETRACYCLINE]; An aid in the treatment of foot rot in sheep, digital dermatitis in cattle and superficial skin infections caused by oxytetracycline sensitive organisms in pigs, sheep & cattle.
Authorization status:
Registered
Authorization number:
47532
Authorization date:
2020-07-01

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Product Name: Alamycin Aerosol Topical Spray

Page: 1 of 5

This revision issued: September, 2009

MATERIAL SAFETY DATA SHEET

Issued by: Norbrook Laboratories Australia Pty Ltd

Freecall: 1800 665 866

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

Section 1 - Identification of Chemical Product and Company

Norbrook Laboratories Australia Pty Ltd

Freecall: 1800 665 866

Unit 7/1 Trade Park Drive

Tullamarine, Vic 3043 AUSTRALIA

Substance:

Methanol/Isopropanol solution of antibiotic; presented as an aerosol.

Trade Name:

Alamycin Aerosol Topical Spray

APVMA Code:

47532

Product Use:

An aid in the treatment of superficial skin infections caused by oxytetracycline-

sensitive organisms in sheep and cattle.

Creation Date:

September, 2009

This version issued:

September, 2009

and is valid for 5 years from this date.

Section 2 - Hazards Identification

Statement of Hazardous Nature

This product is classified as:

Xi, Irritating. T, Toxic. Hazardous according to the criteria of SWA.

Dangerous according to the Australian Dangerous Goods (ADG) Code.

Risk Phrases:

R36, R23/24/25, R39/23/24/25. Irritating to eyes. Toxic by inhalation, in contact with skin, and if

swallowed. Toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed.

Safety Phrases:

S2, S7, S16, S20, S23, S26, S28, S29, S38, S45, S24/25, S36/37/39. Keep out of reach of

children. Keep container tightly closed. Keep away from sources of ignition - No smoking. When using, do not eat or

drink. Do not breathe vapours or mists. In case of contact with eyes, rinse immediately with plenty of water and

contact a doctor or Poisons Information Centre. After contact with skin, wash immediately with plenty of soap and

water. Do not empty into drains. In case of insufficient ventilation, wear suitable respiratory equipment. In case of

accident or if you feel unwell, contact a doctor or Poisons Information Centre immediately (show this MSDS where

possible). Avoid contact with skin and eyes. Wear suitable protective clothing, gloves and eye/face protection.

SUSDP Classification:

ADG Classification:

Class 2.2: Non-flammable, non-toxic gases.

UN Number:

1950, AEROSOLS

Emergency Overview

Physical Description & Colour

: Blue suspension, presented as an aerosol.

Odour:

Characteristic smell of isopropyl alcohol/methanol. Do not test for odour.

Major Health Hazards:

toxic by inhalation, in contact with skin and if swallowed, eye irritant. This is an antibiotic

preparation. Any person with a history of allergies to this class of substances should avoid all contact with this product

as it may cause sensitisation. This is a physiologically active product and so contact should be minimised, especially if

the user is taking a form of medication, as interactions can sometimes give unexpected and undesired results.

The following is a summary of methanol toxicity and symptomology

1. A latency usually of 12-18 hours, during which time the only clinical signs are those of a generally mild and

transient state of inebriation as after ethanol.

2. Headache, anorexia, weakness, fatigue, leg cramps, vertigo, restlessness.

3. Nausea, occasionally vomiting and diarrhoea. Violent abdominal pain, back pain, leg pain.

4. Apathy or delirium progressing sometimes rapidly to coma. Rarely excitement, mania, and convulsions.

5. Dimness of vision with dilated pupils, reacting poorly, if at all, to light, followed often by bilateral blindness (transient

or permanent). Eyes are often sensitive to pressure, and eye movements are painful.

6. Breathing is rapid and shallow, not usually deep and laboured as seen in other types of metabolic acidosis.

7. Mild tachycardia is common, but the blood pressure is usually well maintained.

8. Death in coma is due to respiratory failure or rarely to circulatory collapse.

9. Protracted convalescence with asthenia. Blindness is usually permanent. May cause very serious irreversible

effects.

Potential Health Effects

Inhalation:

Short Term Exposure:

Available data shows that this product is toxic, see symptoms above. In addition product

may be mildly irritating, although unlikely to cause anything more than mild transient discomfort. Intentional misuse by

deliberately concentrating and inhaling contents of aerosol containers can be harmful or fatal.

Product Name: Alamycin Aerosol Topical Spray

Page: 2 of 5

This revision issued: September, 2009

MATERIAL SAFETY DATA SHEET

Issued by: Norbrook Laboratories Australia Pty Ltd

Freecall: 1800 665 866

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

Long Term Exposure:

No data for health effects associated with long term inhalation.

Skin Contact:

Short Term Exposure:

Major health effect from this product is misuse of the aerosol function. If sprayed

continuously on skin or in eyes, it can cause frostbite.

Long Term Exposure:

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

Eye Contact:

Short Term Exposure

: If sprayed directly in the eye, this product will irritate. If spraying is prolonged, it may cause

damage through frostbite.

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 toxic, see symptoms above. However, this product is an oral irritant. Symptoms may include burning

sensation and reddening of skin in mouth and throat. Other symptoms may also become evident, but all should

disappear once exposure has ceased.

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:

Isopropanol is Class 3 - unclassifiable as to carcinogenicity to humans.

See the IARC website for further details. A web address has not been provided as addresses frequently change.

Section 3 - Composition/Information on Ingredients

Ingredients

CAS No

Conc,%

TWA (mg/m

3

)

STEL (mg/m

3

)

Oxytetracycline hydrochloride

2058-46-0

<0.5

not set

not set

Methanol

67-56-1

30-60

Isopropanol

67-63-0

30-60

1230

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 with you when you call.

Inhalation:

If inhalation occurs, contact a Poisons Information Centre. Urgent hospital treatment is likely to be

needed. Remove source of contamination or move victim to fresh air. If breathing is difficult, oxygen may be beneficial

if administered by trained personnel, preferably on a doctor's advice. DO NOT allow victim to move about

unnecessarily. Symptoms of pulmonary oedema can be delayed up to 48 hours after exposure.

Skin Contact:

Quickly and gently blot away excess liquid. Flush contaminated area with lukewarm, gently flowing

water for at least 20-30 minutes, by the clock. DO NOT INTERRUPT FLUSHING. If necessary, keep emergency

vehicle waiting (show paramedics this MSDS and take their advice). Under running water, remove contaminated

clothing, shoes and leather goods (eg watchbands and belts). If breathing has stopped, trained personnel should

begin artificial respiration or, if the heart has stopped, cardiopulmonary resuscitation (CPR) immediately.

Eye Contact:

Immediately flush the contaminated eye(s) with lukewarm, gently flowing water for 20 minutes or until

the product is removed, while holding the eyelid(s) open. Take care not to rinse contaminated water into the

unaffected eye or onto the face. Obtain medical attention immediately. Take special care if exposed person is wearing

contact lenses.

Ingestion:

If swallowed, do NOT induce vomiting; rinse mouth thoroughly with water and contact a Poisons

Information Centre, or call a doctor at once. Give activated charcoal if instructed.

Product Name: Alamycin Aerosol Topical Spray

Page: 3 of 5

This revision issued: September, 2009

MATERIAL SAFETY DATA SHEET

Issued by: Norbrook Laboratories Australia Pty Ltd

Freecall: 1800 665 866

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

Section 5 - Fire Fighting Measures

Fire and Explosion Hazards

: This product is classified as flammable. There is a moderate risk of an explosion

from this product if commercial quantities are involved in a fire. Firefighters should take care and appropriate

precautions. Vapours from this product are heavier than air and may accumulate in sumps, pits and other low-lying

spaces, forming potentially explosive mixtures. They may also flash back considerable distances.

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

Extinguishing Media

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

or fine spray is the preferred medium for large fires. Try to contain spills, minimise spillage entering drains or water

courses.

Fire Fighting

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

violent reaction or explosion if significant quantities of this product are involved in a fire. Recommended personal

protective equipment is full fire kit and breathing apparatus.

Flash point

:

12°C, Closed cup

Upper Flammability Limit:

No data.

Lower Flammability Limit:

No data.

Autoignition temperature:

No data.

Flammability Class:

Flammable

Section 6 - Accidental Release Measures

Accidental release

: This product is sold in small packages, and the accidental release from one of these is not

usually a cause for concern. For minor spills, clean up, rinsing to sewer and put empty container in garbage. Although

no special protective clothing is normally necessary because of occasional minor contact with this product, it is good

practice to wear impermeable gloves when handling chemical products. In the event of a major spill, prevent spillage

from entering drains or water courses and call emergency services.

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 a cool, well ventilated area. Check containers and valves periodically for leaks.

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, Industrial Clothing: AS2919, Industrial Eye

Protection: AS1336 and AS/NZS 1337, Occupational Protective Footwear: AS/NZS2210.

SWA Exposure Limits

TWA (mg/m

3

)

STEL (mg/m

3

)

Methanol

Isopropanol

1230

The ADI for Oxytetracycline is set at 0.003mg/kg/day. ADI means Acceptable Daily Intake. Taken from Australian ADI

List, Dec 2008.

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 in a well ventilated area. If natural ventilation is inadequate, use of a

fan is suggested.

Eye Protection:

Protective glasses or goggles should be worn when this product is being used. Failure to protect

your eyes may cause them harm. Emergency eye wash facilities are also recommended in an area close to where

this product is being used.

Skin Protection:

It is essential that all skin areas are adequately covered by impermeable gloves, overalls, hair

covering, apron and face shield. See below for suitable material types.

Protective Material Types:

We suggest that protective clothing be made from the following materials: Viton,

nitrile, butyl rubber, Teflon, PE/EVAL, Responder.

Respirator:

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

the Australian Standard mentioned above. Otherwise, not normally necessary.

Product Name: Alamycin Aerosol Topical Spray

Page: 4 of 5

This revision issued: September, 2009

MATERIAL SAFETY DATA SHEET

Issued by: Norbrook Laboratories Australia Pty Ltd

Freecall: 1800 665 866

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

Eyebaths or eyewash stations and safety deluge showers should be provided near to where product is being used.

Section 9 - Physical and Chemical Properties:

Physical Description & colour

Blue suspension, presented as an aerosol.

Odour:

Characteristic smell of isopropyl alcohol/methanol. Do not test for odour.

Boiling Point:

Not available.

Freezing/Melting Point:

No specific data. Liquid at normal temperatures.

Volatiles:

>90%

Vapour Pressure:

No data.

Vapour Density:

No data.

Specific Gravity:

0.9 approx

Water Solubility:

Soluble.

pH:

8.4-8.8

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:

This product should be kept in a cool place, preferably below 30°C. Keep containers and

surrounding areas well ventilated.

Incompatibilities:

strong acids, strong bases, strong oxidising agents.

Fire Decomposition:

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

chloride gas, other compounds of chlorine. 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.

Toxicity of methanol:

The following figures suggest that methanol is neither toxic nor even harmful. However, it

causes severe health problems and even death in ways not adequately measured by quick LD

measurements.

Oral (rat) LD

: 5628 mg/kg.

Oral (mouse) LD

: 7300 mg/kg.

Oral (monkey) LD

: 7000 mg/kg.

Skin (rabbit) LD

:15,800 mg/kg.

Inhalation (rat) LC

: 64,000 ppm, 4-hr exposure.

Skin Irritation (rabbit): Moderate, 20 mg, 24-hr exposure

Eye Irritation (rabbit): Moderate, 100 mg, 24-hr exposure

In human methanol poisoning, the transformation of methanol to formaldehyde and formic acid can cause metabolic

acidosis and ocular injury. Repeated exposure to airborne concentrations in the range of 200 to 375 ppm have been

associated with headaches, and at 1200 to 8300 ppm with damaged vision. Repeated skin contact can cause

defatting dermatitis with dryness and cracking.

Repeated inhalation exposures to rats caused CNS and behavioural effects, and changes to the spleen. Repeated

oral exposures to rats caused liver toxicity, CNS effects and behavioural changes.

Inhalation exposure of pregnant rats to very high concentrations of methanol in air, 7 hr/day on gestation days 1-19,

produced foetotoxic effects (10,000 ppm) and birth defects (20,000 ppm), as well as maternal toxicity. No adverse

effects were seen at 5,000 ppm. Pregnant rats administered methanol orally at very high dose levels (20-35 g/kg) on

gestation day 10 produced foetotoxic effects, as well as maternal toxicity.

Classification of Hazardous Ingredients

Ingredient

Risk Phrases

Methanol

Conc>=20%: T; R23/24/25; R39/23/24/25

Isopropanol

Conc>=20%: Xi; R36

Section 12 - Ecological Information

Insufficient data to be sure of status.

Product Name: Alamycin Aerosol Topical Spray

Page: 5 of 5

This revision issued: September, 2009

MATERIAL SAFETY DATA SHEET

Issued by: Norbrook Laboratories Australia Pty Ltd

Freecall: 1800 665 866

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

Section 13 - Disposal Considerations

Disposal:

Dispose of small quantities and empty containers by wrapping with paper and putting in garbage. For

larger quantities, if recycling or reclaiming is not possible, use a commercial waste disposal service.

Section 14 - Transport Information

ADG Code:

1950, AEROSOLS

Hazchem Code:

Special Provisions:

63, 190, 277

Limited quantities:

ADG 7 specifies a Limited Quantity value of 120mL for this class of product.

Dangerous Goods Class:

Class 2.2: Non-flammable, non-toxic gases.

Packaging Group:

Not set

Packaging Method:

P003

Class 2.2 Non-Flammable, Non-Toxic gases shall not be loaded in the same vehicle or packed in the same freight

container with Classes 1 (Explosives), 4.2 (Spontaneously Combustible Substances), and 5.2 (Organic Peroxides).

They may however be loaded in the same vehicle or packed in the same freight container with Classes 2.1

(Flammable Gases), 2.3 (Toxic Gases), 3 (Flammable Liquids), 4.1 (Flammable Solids), 4.3 (Dangerous When Wet

Substances), 5.1 (Oxidising Agents), 6 (Toxic Substances), 7 (Radioactive Substances), 8 (Corrosive Substances) 9

(Miscellaneous Dangerous Goods), Foodstuffs and foodstuff empties.

Section 15 - Regulatory Information

AICS:

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

The following ingredients: Oxytetracycline, Methanol, are mentioned in the SUSDP.

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

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

SUSDP

Standard for the Uniform Scheduling of Drugs & 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 “National Code of Practice for the Preparation of

Material Safety Data Sheets” 2nd Edition [NOHSC:2011(2003)]

Copyright © Kilford & Kilford Pty Ltd, September, 2009.

http://www.kilford.com.au/

Phone (02)9251 4532

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