SECTION 1 IDENTIFICATION OF THE MATERIAL AND SUPPLIER
Auracol Ear & Skin Suspension For Dogs, Cats & Horses
For the treatment of otitis externa and skin infections caused by
fungi, yeasts, Gram-negative and Gram-positive bacteria in dogs,
SECTION 2 HAZARDS IDENTIFICATION
This product is not classified as dangerous goods under the Australian Dangerous Goods (ADG) Code, but is classified as hazardous according to the classification criteria of NOHSC:1008(2004), Approved Criteria For Classifying Hazardous Substances and the National Code of Practice for the Preparation of Material Safety Data Sheets 2nd Edition [NOHSC:2011(2003)] Health Hazard Information Although this product contains active constituents and excipients that can be both harmful and toxic, only the concentrations of miconazole nitrate and the suspending medium present are above those listed for harmful and toxic substances in the above document. The product may cause allergic or sensitivity reaction for individuals sensitive to one or more of the components Primary Route(s) of Entry:
Signs and Symptoms of Exposure Overexposure Effects:
May cause irritation, vomiting, diarrhoea, convulsions, heart rhythm
None expected under normal conditions of use.
May cause vomiting, diarrhea, convulsions, heart rhythm disorders.
Medical conditions potentially aggravated:
Hypersensitivity to any of the ingredients.
May cause sensitization by skin contact.
S36/37 Wear suitable protective clothing and gloves.
SECTION 3 COMPOSITION/INFORMATION ON INGREDIENTS SECTION 4 FIRST AID MEASURES
The following First Aid directions have been set by the Office of Chemical Safety (OCS) of the Commonwealth Department of Health and Aging: If poisoning occurs, contact a doctor or Poisons Information Centre. Telephone 131126. (FAISD Handbook, Handbook of First Aid Instructions, Safety Directions, Warning Statements, and General Safety Precautions for, Agricultural and Veterinary Chemicals) However, the following additional information is provided for assistance in emergency circumstances while implementing the first aid directions above. Eye and Mucous Membrane Contact:
Remove contact lens if worn. Flush with water for 15 minutes.
Should skin irritation, allergic reaction or rash occur, physically
remove as much of the product as possible and thoroughly flush
Do not induce vomiting as aspiration of the product might occur.
Not expected under normal usage conditions. However the
following actions can be taken if necessary. Remove to fresh air.
If breathing is difficult, give oxygen. If breathing has stopped, give
SECTION 5 FIRE FIGHTING MEASURES
Alcohol foam, dry chemical, carbon dioxide and water spray.
Special protective precautions and equipment for fire fighters:
Use precautions and equipment suitable for the surrounding fire.
SECTION 6 ACCIDENTAL RELEASE MEASURES
Emergency procedures: Slippery when wet. Contain spill using inert absorbent material. Collect and seal contained, absorbed material in chemical waste containers for disposal. Methods and materials for containment and clean up Use absorbent material such as soil, sand or vermiculite. Wash area down with detergent and excess water. Do not allow wash water to enter sewers drains or waterways. Contain wash water as for spilled material.
SECTION 7 HANDLING AND STORAGE
Precautions for safe handling Wash thoroughly after handling. Use normal hygiene to protect hands, eyes and skin. Conditions for safe storage, including any incompatibilities: Store below 25°C (Air Conditioning) away from heat, light, oxidants and bases. Keep container closed when not in use.
SECTION 8 EXPOSURE CONTROLS/PERSONAL PROTECTION
This material is supplied to end users in 30mL squeeze bottles with application nozzles, so exposure will be limited by quantity for these users. Where larger quantities are kept by wholesaler / retailers, the total amounts will be less than 5L. National exposure standards:
SECTION 9 PHYSICAL AND CHEMICAL PROPERTIES
White, slightly viscous liquid suspension
SECTION 10 STABILITY AND REACTIVITY
Keep away fromheat, flame and incompatibles.
Oxides of nitrogen, carbon dioxide and carbon monoxide
SECTION 11 TOXICOLOGICAL INFORMATION
Health effects from the likely routes of exposure. Information on individual hazardous ingredients has been provided below where available Miconazole nitrate: Oral (LD50) (Rat):
There are no reports of miconazole being absorbed from intact skin.
Animal studies in rats and rabbits involving the oral route of
administration of miconazole, have revealed evidence of reproductive
Acute miconazole toxicity studies in dogs, guinea pigs, mice and rats, via
the oral, subcutaneous, intraperitoneal and intravenous routes of
administration demonstrated evidence of ataxia and stomach ulceration
Prednisolone acetate: Oral (LD50) (Mouse):
Polymyxin B Sulphate: Oral (LD50) (Mouse):
SECTION 12 ECOLOGICAL INFORMATION
No ecological information available. As a precaution, prevent from entering sewers, drains, streams or other waterways.
SECTION 13 DISPOSAL CONSIDERATIONS
Disposal methods and containers: The following disposal directions for containers have been approved by the APVMA:
Dispose of empty container by wrapping with paper and
In addition, do not burn empty containers or unused product. Unused product may be disposed of in local municipal landfill. Special precautions for landfill or incineration: Seek advice from local government authority before disposing of unused product in municipal landfill.
SECTION 14 TRANSPORT INFORMATION
Not defined as Dangerous Goods by the Australian Code for the Transport of Dangerous Goods by Road and Rail.
SECTION 15 REGULATORY INFORMATION
This product has been registered by the Australian Pesticides and Veterinary Medicines Authority (APVMA). In granting registration to any product, the APVMA has exercised its legislative responsibility to ensure that the product is suitably formulated and properly labelled and, when used according to instructions is:
safe to the host, the user, consumers and the environment;
efficacious (that is, the product does the job it claims it shall do); and
The APVMA uses the services of a number of Australian and State government agencies as advisers to help with some of these evaluations of applications for registration of agricultural and veterinary chemical products. These include: PHARMACHEM
the Office of Chemical Safety (OCS) of the Commonwealth Department of Health and Ageing which:
evaluates and reports on toxicology and metabolism studies; proposes first aid and safety directions; determines poison schedule classifications; and establishes acceptable daily intakes (ADIs) and acute reference doses (ARfD); and
evaluates the occupational health and safety aspects of an application and recommends safety directions and occupational controls on use and advises on a Material Safety Data Sheet (MSDS);
the Commonwealth Department of the Environment and Heritage (DEH) which evaluates environmental data and recommends appropriate use controls and instructions for the product that will protect the environment; and
State and Territory departments responsible for agricultural and primary industries which evaluate and reports on efficacy and target crop or animal safety data for new agricultural chemicals and new uses of registered products. In some cases the APVMA contracts this work out to other agencies such as universities, the CSIRO or to other experts.
Although all ingredients appear in the Australian Inventory of Chemical Substances (AICS), they have not been assessed by NICNAS (National Industrial Chemicals Notification and Assessment Scheme)
SECTION 16 OTHER INFORMATION CONTACT POINT
B/Hrs Phone (07) 3868 0333 A/Hrs (07) 3630 1654
References: 1. FAISD Handbook, Handbook of First Aid Instructions, Safety Directions, Warning Statements, and General Safety Precautions for, Agricultural and Veterinary Chemicals, December 2009 2. Approved Criteria For Classifying Hazardous Substances, NOHSC:1008 (2004) 3. National Code of Practice for the Preparation of Material Safety Data Sheets 2nd Edition [NOHSC:2011 (2003)] 4. AICS (Australian Inventory of Chemical Substances), Safework Australia 5. APVMA Manual of Requirements and Guidelines for Agricultural Chemicals, Version 4.1, March 2008 Revision 6. ADI [Acceptable Daily Intake] List, Commonwealth Department of Health & Aged Care, TGA, March 2010 7. The Australian Code for the Transport of Dangerous Goods by Road and Rail (ADG Code) 7th Edition 8. Standard for the Uniform Scheduling of Drugs and Poisons, National Drugs and Poisons Schedule Committee 9. Hazardous Substances Information System, Last Updated – April 2009, Safework Australia
All information contained in this Material Safety Data Sheet is as accurate and up to date as possible. Since Pharmachem cannot anticipate or control the conditions under which this information may be used, each user should review the information in the specific context of the intended application. Pharmachem will not be responsible for damages of any nature resulting from use of or reliance upon the information. No expressed or implied warranties are given other than those implied as mandatory by Commonwealth State or Territory legislation.
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