SAFETY DATA SHEET - Cardinal Health

1 SAFETY data SHEET According to Regulation (EC) No. 1907/2006 (REACH), Annex II Version: SDS Page: 1/6 Date: 29/11//2011 TESTPACK + plus hCG Combo with OBC, Test device 1. SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING Product identifier Trade name Alere TESTPACK + plus hCG Combo with OBC, Test devic e Reference No. 505805J (ROW ) Relevant identified uses of the substance or mixture and uses advised against Identified use(s) In vitro diagnostic reagent. For professional use only. Details of the supplier of the SAFETY data SHEET Company Identification Alere Medical Co.

2 , Ltd. 357 Matsuhidai, Matsudo-shi, Chiba 270-2214, Japan Telephone +81 47 311 5750 E-Mail (competent person) Europe & Middle East: Asia Pacific: Africa, Russia & CIS: Latin Americ a: Canada: Emergency telephone number Emergency Phone No. Europe & Middle East: +44 (0) 161 483 9032 Asia Pacific: + (61) 7 3363 7711 Africa, Russia & CIS: + (972) 8 9429 683 Latin Americ a: + (57) 01800 094 9393 Canada: +1 800 818 8335 2.

3 SECTION 2: HAZARDS IDENTIFICATION Classification of the substance or mixture Directive 67/548/EEC & Directive 1999/45/EC Not classified as dangerous for supply/use. Label elements No measures required. Other hazards None anticipated. 3. SECTION 3: COMPOSITION/INFORMATION ON INGREDIENTS Mixtures Description: In vitro diagnostic reagent test device. Preparation. Laminated test strip consisting of solid support materials impregnated with dried chemical / biochemical reagents. Dangerous components: Hazardous ingredient(s) %W/ W EC No. REACH Registration No. EC Classification and Risk Phrases Tris (hydroxymethyl) aminomethane 1 - 2 201-064-4 Not available Xi; R36/37/38 Tris (hydroxymethyl) aminomethane hydrochloride 1 2 214-684-5 Not available Xi; R36/37/38 Additional Information For full text of R phrases see section 16.

4 SAFETY data SHEET According to Regulation (EC) No. 1907/2006 (REACH), Annex II Version: SDS Page: 2/6 Date: 29/11//2011 TESTPACK + plus hCG Combo with OBC, Test device 4. SECTION 4: FIRST AID MEASURES Description of first aid measures General information The following first aid measures are only relevant in the event of serious misuse, whereby the device is disassembled and there is exposure to the chemicals in the test strip. Inhalation Supply fresh air; consult doctor in case of complaint. Skin Contact W ash skin with soap and water. Eye Contact Rinse cautiously with water for several minutes.

5 Consult doctor in case of complaint. Ingestion W ash out mouth with water. Consult a doctor. Most important symptoms and effects, both acute and delayed None. Indication of the immediate medical attention and special treatment needed None. 5. SECTION 5: FIRE-FIGHTING MEASURES Extinguishing media Suitable Extinguishing Media CO2, powder or water spray. Fight larger fires with water spray or alcohol resistant foam. Special hazards arising from the substance or mixture In case of fire, the following can be released: Hazardous fumes and vapours. Advice for fire-fighters Use fire-extinguishing methods suitable to surrounding conditions.

6 W ear full protective suit and self-contained breathing aparatus (SCBA) when extinguishing fires. 6. SECTION 6: ACCIDENTAL RELEASE MEASURES Personal precautions, protective equipment and emergency procedures Refer to Section 8 for protective measures when handling the spillage. Environmental precautions Avoid release to the environment. Methods and material for containment and cleaning up Collect material and dispose of as waste according to Section 13 Reference to other sections 8, 13 7. SECTION 7: HANDLING AND STORAGE Precautions for safe handling Avoid contact with the eyes, skin and mucous membranes.

7 Keep out of reach of children. Specimens should be handled as potentially infectious materials. Refer to Directive 2000/54/EC for information on handling biohazardous materials. W ash hands before breaks and after work. Clean work areas with hypochlorite or other disinfecting agent. Conditions for safe storage, including any incompatibilities Store in original container at 2 to 30 C. SAFETY data SHEET According to Regulation (EC) No. 1907/2006 (REACH), Annex II Version: SDS Page: 3/6 Date: 29/11//2011 TESTPACK + plus hCG Combo with OBC, Test device Specific end use(s) Use as per instructions for use.

8 8. SECTION 8: EXPOSURE CONTROLS/PERSONAL PROTECTION Control parameters . Occupational Exposure Limits The product does not contain any relevant quantities of materials with critical values that have to be monitored at the workplace. Exposure controls Appropriate engineering controls Not relevant for this material. Personal protection equipment Eye/face protection Saf ety glass es rec ommended. (EN166) Hand protection Disposable gloves. (EN374). Material of gloves: Latex / natural rubber Penetration time of glove material: Gloves resistance is not critical when the product is handled according to the instructions for use.

9 Body protection Laboratory coat. Respiratory protection Not normally required. Environmental Exposure Controls No special measures are required. 9. SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES Information on basic physical and chemical properties Appearance Laminated test strip consisting of solid support materials impregnated with dried chemical / biochemical reagents. Colour White. Odour No odour. Odour Threshold (ppm) Not applicable pH (Value) Not determined Melting Point ( C) / Freezing Point ( C) Not determined Boiling point/boiling range ( C): Not determined Flash Point ( C) Not applicable Evaporation rate (BA = 1) Not applicable Flammability (solid, gas) Not determined Explosive limit ranges Not applicable Vapour Pressure (mm Hg) Not applicable Vapour Density (Air=1) Not applicable Density (g/ml) Not determined Solubility (Water) Not determined Solubility (Other) Not determined Partition Coefficient (n-Octanol/water) Not determined Auto Ignition Temperature ( C) Not determined Decomposition Temperature ( C) Not determined Viscosity ( ) Not determined Explosive properties Not explosive.

10 Oxidising properties Not oxidising Other information Not available SAFETY data SHEET According to Regulation (EC) No. 1907/2006 (REACH), Annex II Version: SDS Page: 4/6 Date: 29/11//2011 TESTPACK + plus hCG Combo with OBC, Test device 10. SECTION 10: STABILITY AND REACTIVITY Reactivity None known. Chemical stability The product is stable in accordance with the recommended storage conditions. Possibility of hazardous reactions None known. Hazardous polymerisation will not occur. Conditions to avoid None Incompatible materials None known. Hazardous Decomposition Product(s) None known.