SECTION 1 IDENTIFICATION OF THE MATERIAL AND SUPPLIER Product Product Name LEUKOSAN SKINLINK Other Names - Manufacturer s Product Code 72542-00, 72543-00 Use Intended for use as a skin closure device in the treatment of cuts, lacerations and surgical incisions. Supplier Company Smith & Nephew Pty. Limited Address 315 Ferntree Gully Road, Mount Waverley, Victoria 3149 Telephone No. Customer Service: (03) 8540 6777 Toll Free (Australia): 13 13 60 Toll Free (New Zealand): 0800 807 663 Emergency Tel. Nos. (03) 8540 6777 (business hours) SECTION 2 HAZARDS IDENTIFICATION Hazard Classification Hazards Overview Risk Phrases Safety Phrases NON-HAZARDOUS SUBSTANCE. NON-DANGEROUS GOODS. For external use only. Do not use on patients with known sensitivity to cyanoacrylate or formaldehyde. SECTION 3 COMPOSITION / INFORMATION ON INGREDIENTS A sterile kit containing two components: 1. Skin closure strips available in two sizes ( 7mm x 60mm, 12mm x 76mm) a. Substrate: Tan-coloured non-woven, embossed polyester fabric b. Covering film: Polyethylene - terephthalate film coated with medical grade adhesive c. Adhesive: Non-sensitizing acrylic adhesive protected with a release liner 2. Topical skin adhesive: Constituent: N-butyl-2-cyanoacrylate Chemical Name CAS No. N-butyl-2-cyanoacrylate 6606-65-1 Date of Issue: 24 April 2013 Page 1 of 5
SECTION 4 FIRST AID MEASURES Swallowed Eye Skin Inhaled First-Aid Facilities Advice to Doctor In the unlikely event of ingestion, seek immediate medical attention. Apply ophthalmic ointment/lotion. If unintended bonding of intact skin occurs, gently loosen the bond with petroleum jelly, ointment, acetone or adhesive solvents. Do not pull the skin apart. Move individual to fresh air. Seek medical attention if effects persist. Restore and/or support breathing as required. Eye wash plus normal washroom facilities nearby. Treat symptomatically. SECTION 5 FIRE FIGHTING MEASURES Hazards From Combustion Products Suitable Extinguishing Media Fire-fighting Procedures Hazchem Code Acrid smoke and irritating fumes (oxides of carbon, oxides of nitrogen) occur in fire conditions. Water spray, CO 2, Foam, Dry Chemical. Wear full protective equipment including self-contained breathing apparatus. Water may spread fire. Product floats on water when cured. SECTION 6 ACCIDENTAL RELEASE MEASURES Spill / Leak Procedures This product is not a hazardous waste. Dispose of in an approved landfill in accordance with local authority regulations SECTION 7 HANDLING AND STORAGE Handling Advice Storage Advice Refer to instructions for use provided with product. Do not apply adhesive to eyes, mucosa or open wounds. Store between 5 C - 25 C. Date of Issue: 24 April 2013 Page 2 of 5
SECTION 8 EXPOSURE CONTROLS / PERSONAL PROTECTION Exposure Standards Engineering Controls Personal Protection No exposure standards available for the components of this product. No special controls required. No special requirements. SECTION 9 PHYSICAL AND CHEMICAL PROPERTIES Appearance and Odour Melting Point / Boiling Point Vapour Pressure Vapour Density (Air=1) Specific Gravity Flashpoint Flammability Limits (FL) (%) Autoignition Temperature Solubility in Water (g/l) Percent volatile by volume Skin Closure Strips: see Components below. Adhesive: Colourless liquid, slightly pungent odour. BP: >150 C (topical skin adhesive) 1.03 (topical skin adhesive) 85 C (topical skin adhesive) Negligible. 0 at 21 C (topical skin adhesive) SECTION 10 STABILITY AND REACTIVITY Stability Conditions to Avoid Incompatible Materials Hazardous Decomposition Products Hazardous Polymerisation Stable at room temperature. Avoid excessive heat or humidity. No data available. Acrid smoke and irritating fumes (oxides of carbon, oxides of nitrogen) occur in fire conditions. No data available. SECTION 11 - TOXICOLOGICAL INFORMATION Acute Effects Swallowed Eye Skin Inhalation Unlikely route of exposure due to polymerisation. Bonds to oral tissue in seconds. Saliva will lift adhesive in one to two days. May cause severe eye irritation. During period of eye contamination double vision may occur, weeping will occur until clearance is achieved. Bonds in seconds. May cause irritation, may cause allergic skin reaction. May cause sensitisation and upper respiratory tract irritation. Date of Issue: 24 April 2013 Page 3 of 5
Chronic Effects SECTION 12 ECOLOGICAL INFORMATION Environmental Issues Persistence & Degradability Mobility No environmental issues expected. SECTION 13 DISPOSAL CONSIDERATIONS Method of Disposal Dispose of in an approved landfill in accordance with local authority regulations. SECTION 14 TRANSPORT INFORMATION Classification UN No. Class Subsidiary Risk(s) Packing Group Hazchem Code Shipping Name Other Not classified as a Dangerous Good according to the Australian Code for Transport of Dangerous Goods by Road and Rail. SECTION 15 REGULATORY INFORMATION Poison Schedule Not a Scheduled Poison. Date of Issue: 24 April 2013 Page 4 of 5
SECTION 16 OTHER INFORMATION CONTACT POINT : CUSTOMER SERVICE Telephone: (03) 8540 6777 Date of Issue: 24 April 2013 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 should read this MSDS and consider the information in the context of how the product will be handled and used in the workplace including in conjunction with other products. If clarification or further information is needed to ensure that an appropriate risk assessment can be made, the user should contact this company. 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. END OF DOCUMENT Date of Issue: 24 April 2013 Page 5 of 5