Material Safety Data Sheet
Doxycycline Antibiotic Tablets - 50mg & 100mg
Not classified as hazardous according to the criteria of NOHSC
SECTION I Identification of the Material and Supplier
Product Name	Doxycycline Antibiotic Tablets - 50mg & 100mg
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 Doxycycline monohydrate 564-25-0 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	Rinse mouth with water, give water to drink and seek medical advice.
Eye	Irrigate with copious quantities of lukewarm 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	Dry agent, foam, carbon dioxide, water spray or fog for large fires. As appropriate for surrounding material.
Combustion Hazards	May emit toxic fumes under fire conditions including carbon dioxide and nitrogen oxides.
Precautions for Firefighters	Wear self contained breathing apparatus and protective clothing.
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, gloves, goggles and boots). Shovel spillage into clean, dry, labelled containers and dispose after consulting appropriate authorities.
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 or room temperature).
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. Wash hands after handling and prior to touching eye and in particular handling contact lenses.
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	Round, yellow, quarter scored tablets.
Odour	Non specific 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	No specific conditions to avoid other than extreme heat.
Incompatible materials	No data available.
Decomposition products	No known decomposition products.
Hazardous reactions	No data available.
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 eye contact may result in a transient irritation and associated redness and pain.
Skin	Skin contact is not a great risk as this product is a tablet. The data available suggests that skin contact may result in mild discomfort. Sensitisation may occur and results in allergic dermatitis, rashes, itchiness, hives and swelling of the extremities. Tetracyclines can cause yellow discolouration of the skin and a sun induced dermatitis with swelling, redness, itch and warmth.
Inhalation	Inhalation is not a great risk as this product is a tablet. Inhalation of the dust may be discomforting to the upper respiratory tract. Pre-existing respiratory disease may be exacerbated by inhalation of the dusts.
Chronic Health Effects
Ingestion	Chronic ingestion is unlikely however can cause sore throat, hoarseness, black hairy tongue, bulky loose stools, fat in the faeces, inflammation of the oral cavity, difficulty swallowing, damage to the anogenital area and oesophageal ulcers. Vitamin K function and clotting are affected. Tetracyclines will be deposited in bones and can retard the growth in foetuses. Hypersensitivity can cause loss of platelets, white and red blood cells, swelling of the blood vessels and nerves, pericarditis, exacerbation of lupus and anaphylactic shock. Temporary muscle disorders, psychotic reactions and fatal hepatic failure have also been reported. Increased pressure in the head can cause swelling of the optic nerve, headache, vision impairment and bleeding from the retina, especially in children. Pregnant women seem to be the most susceptible to liver damage and the foetus will show retardation of skeletal growth and underdevelopment of the enamel of the teeth.
Eye	The data available suggests that repeated or prolonged exposure may lead to conjunctivitis. Deposits in the eyes (from systemic use) can cause an abnormal pigmentation of the conjunctiva. Hypersensitivity reactions include burning of the eyes and conjunctivitis.
Skin	The data available suggests that repeated or prolonged contact may be discomforting to the skin. Hypersensitivities can produce red rashes, dermatitis with sloughing, hives and swollen cracked lips. Loosening and pigmentation of the nails can also occur.
Inhalation	The data available suggests that repeated or prolonged exposure can induce hypersensitivities with signs as described above.
Advice to Doctor	Treatment for any adverse effects should be symptomatic.
Carcinogenicity	No ingredient in this formulation is known to be carcinogenic.
Compounding effects	Doxycycline will cross the placenta and is secreted in breast milk where it has adverse effects on the foetus or neonate.
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.