Material Safety Data Sheet
Amoxycillin 200, 400 Broad Spectrum Antibiotic Tablets
Not classified as hazardous according to the criteria of NOHSC

SECTION I Identification of the Material and Supplier

Product Name Amoxycillin 200, 400 Broad Spectrum Antibiotic Tablets
Recommended Use
Supplier Details Apex Laboratories Pty. Ltd.
ACN Number 000 397 240
Street 61 Chivers Road
Suburb Somersby
State NSW
Country Australia
Post Code 2250
Phone +61 2 4372 1661 (Business hours – 8.30am – 5.00pm)
Fax +61 2 4372 1668 (fax)
Website http://www.apexlabs.com.au
Emergency contact As above or Poisons Information Centre 131126 (Australia)

SECTION II Hazard Identification

Classification Not classified as hazardous according to the criteria of NOHSC
Risk Phrases None allocated
Safety Phrases None allocated
ADG Class None allocated
Hazchem Code None allocated
Poisons Schedule S4

SECTION III Composition

Ingredients CAS No Proportion TWA mg/m3 STEL mg/m3
Amoxycillin 61336-70-7 30-60% not set not set
Other non hazardous ingredients NA to 100% NA NA
The 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 over an entire working lifetime. The TWA exposure standard set by Worksafe Australia for dusts not otherwise specified is 10mg/m3. The STEL (Short Term Exposure Limit) is an exposure value that should not be exceeded for more than 15 minutes and should not be repeated for more than 4 times per day. There should be at least 60 minutes between successive exposures at the STEL.

SECTION IV First Aid Measures

This first aid information pertains particularly to the active ingredients and any hazardous ingredients, rather than to the formulated product. As the finished product is a tablet for oral or intrauterine administration to animals, inhalation and ingestion by humans are unlikely to occur or to pose a problem.
Ingestion Generally not required. If concerned rinse mouth with water, give water to drink and seek medical advice.
Eye Generally not required. If irritation does occur irrigate with copies quantities of luke warm water for 10 minutes and seek medical advice.
Skin Generally not required. If concerned wash well with soap and water and seek medical advice.
Inhalation Generally not required. If concerned move to fresh air and seek medical advice.

SECTION V Fire Fighting Measures

Extinguishing Media Foam, dry chemical powder, carbon dioxide, water spray (large fires). As appropriate for surrounding materials.
Combustion Hazards Amoxycillin trihydrate (active ingredient) can emit toxic fumes under fire conditions
Precautions for Firefighters Wear breathing apparatus.
Hazchem Code None allocated

SECTION VI Accidental Release Measures

Emergency Procedures Spillage of formulated product from marketed packaging is unlikely to ever be serious, however, in the event of a major spill, protect drains and water courses from contamination.
Materials and Methods Wear protective clothing (overalls, goggles, gloves and boots) and prevent further spillage. Shovel spillage into labelled containers and dispose after consulting appropriate authorities. All equipment used in clean up process needs to be thoroughly cleaned. Personnel undertaking cleaning need to be informed of contamination.

SECTION VII Handling and Storage

Precautions Always use good occupational work practices and observe recommendations on the label. Keep exposure to this product to a minimum. Prohibit eating, drinking and smoking in storage and handling areas. Wash hands after handling and remove contaminated clothing and any protective equipment before entering eating areas.
Conditions Store product in original containers as per label instruction (below 30oC). Avoid contact with oxidising agents as reactions may occur.

SECTION VIII Exposure Controls and Personal Protection

National Exposure Standards No exposure standard has been allocated for this mixture or any significant ingredient within this mixture.
Biological Limit Values No biological limit has been allocated for this mixture.
Engineering Controls No specific engineering controls are required for this mixture.
Personal Protective Equipment
Eye Eye protection is not normally necessary. If concerned wear protective goggles or glasses.
Skin Skin protection is not normally necessary, however it is good practice to avoid contact with chemicals by wearing suitable gloves when handling.
Respiratory Protection from inhalation is not normally necessary. If ventilation is inadequate or dust is likely to build up then use of a suitable dust mask would be appropriate.

SECTION IX Physical and Chemical Properties

Appearance Green, round quarter scored tablets.
Odour Typical penicillin odour.
pH
Vapour pressure
Boiling point/range No data available.
Freezing/Melting point No data available.
Solubility No data available.
Specific gravity/density No data available.
Flash Points No data available.
Flammable limits (in air) No data available.
Ignition temperature No data available.

SECTION X Stability and Reactivity

Chemical stability This mixture is stable under normal ambient and anticipated storage and handling conditions of temperature and pressure.
Conditions to avoid This product should be kept under 30oC.
Incompatible materials Oxidising agents.
Decomposition products Amoxycillin trihydrate (active ingredient) can emit toxic fumes under fire conditions.
Hazardous reactions Hazardous polymerisation will not occur with amoxycillin.

SECTION XI Toxicological Information

Handling of the formulated product is not expected to cause any adverse affects. The following data pertains particularly to the active and any hazardous ingredients in the formulation, rather than this specific formulation.
Acute Health Effects  
Ingestion
Eye Eye contact is not a great risk as this product is a tablet. The data available suggests that this product may cause a transient irritation that is unlikely to be anything more than mildly uncomfortable. This effect should disappear when the product is removed.
Skin Skin contact is not a great risk as this product is a tablet. The data available suggests that this product is not harmful. Allergic skin reactions may develop in sensitive individuals.
Inhalation Inhalation is not a great risk as this product is a tablet. The data available suggests that this product will not harm the respiratory system if inhaled. Allergic reactions can result in sensitive individuals following inhalation.
Chronic Health Effects  
Ingestion The data available suggests that repeated ingestion of penicillin products may cause vomiting and or nausea, diarrhoea, sore and dry throat, sore and black hairy tongue. Some bacterial may develop resistance to this antibiotic with chronic exposure and there is a risk of superinfection due to overgrowth of non-susceptible organisms.
Eye There is no data available on the long term effects of eye contamination with this product.
Skin There is no data available on the long term effects of skin contact with this product.
Inhalation There is no data available on the long term effects of inhalation of this product.
Advice to Doctor Treatment for any adverse effects should be symptomatic. Amoxycillin is widely distributed in body fluids and tissues including pleural, pericardial, peritoneal and synovial fluid. It also crosses the placenta. The blood brain barrier is only significantly crossed in the presence of inflammation. Skin reactions usually spontaneously resolve within a few days of withdrawal of amoxycillin. Antihistamines with or without corticosteroids may alleviate symptoms. If serious analphylactoid reactions occur, treatment including adrenalin, oxygen, intravenous corticosteroids and endotracheal intubation may be required.
Carcinogenicity No ingredient in this formulation is known to be carcinogenic.
Compounding effects Amoxycillin is secreted in breast milk.

SECTION XII Ecological Information

Ecotoxicity No data available.
Persistence and Degradability No data available.
Mobility No data available.

SECTION XIII Disposal Considerations

Disposal Methods Empty containers may be recycled or sent to a commercial waste disposal site. Unused product should be suitable for landfill however contact the relevant local Waste Disposal Authority.
Special Precautions

SECTION XIV Transport Information

UN Number
UN Shipping Name None allocated.
ADG Class None allocated
Packing Group None allocated.
Special Precautions None allocated.
Hazchem Code None allocated

SECTION XV Regulatory Information

Poisons Schedule S4

SECTION XVI Other Information

Date This MSDS has been reviewed and updated as required in May 2009.
   
Key to Abbreviations  
NOHSC: National Occupational Health and Safety Commission
ADG Class: Australian Dangerous Goods Class
CAS Number: Chemical Abstracts Service Number
TWA: Time Weighted Average
STEL: Short Term Exposure Limit
UN: United Nations
 
Disclaimer
This Material Safety Data Sheet has been developed according to WORKSAFE Australia, NOHSC Guidelines. Hazard Classifications have been determined in consultation with the Approved Criteria for Classifying Hazardous Substances [NOHSC:1008(1999)]. However, to the best of our knowledge, the finished product is unlikely to cause harm to humans handling, administering and dispensing as per label instructions. The data, information and recommendations herein are represented in good faith and are believed to be correct as of the date hereof. The purpose of this Material Safety Data Sheet is to describe products in terms of their safety requirements. Apex Laboratories Pty Ltd make 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 ("the product"). The information is supplied upon the condition that the persons receiving same will make their own determination as to its suitability 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 guaranteed analysis of any specific lot or as guaranteed specification for the product or specific lots hereof. Due care should be taken to make sure that the use or disposal of this product and/or its packaging is in compliance with relevant Federal, State and Local Government Regulations.