SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 1.1 Product identifier Trade name Pro Advantage HCG Pregnacy Tests Reference No. P080063, P080023, P080021 1.2 Relevant identified uses of the substance or mixture and uses advised against Identified use(s) In vitro diagnostic reagent. For professional use only. 1.3 Details of the supplier of the safety data sheet Company Identification NDC, Inc. 407 New Sanford Road LaVergne, TN 37086, USA Telephone 615-366-3230 1.4 Emergency telephone number Emergency Phone No. ChemTel Inc. International access: + (0)1-813-248-0585 ChemTel Inc. Free phone (North America only): SECTION 2: HAZARDS IDENTIFICATION 2.1 Classification of the substance or mixture Regulation (EC) No. 1272/2008 (CLP) Eye Irrit. 2 Hazard statement(s) H319: Causes serious eye irritation. Directive 67/548/EEC & Directive 1999/45/EC Not classified as dangerous for supply/use. OSHA Hazard Communication Standard 29 CFR 1910.1200 (HazCom 2012) / GHS Eye Irrit. 2 Hazard statement(s) Causes serious eye irritation. 2.2 Label elements No measures required. The product is placed on the market in the form of an article, which contains insignificant quantities of hazardous chemicals that are not intended to be released from the device. 2.3 Other hazards None anticipated. SECTION 3: COMPOSITION/INFORMATION ON INGREDIENTS 3.2 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: EC Classification No. 1272/2008 / GHS EC Classification No. 67/548/EEC
SECTION 8: EXPOSURE CONTROLS/PERSONAL PROTECTION 8.1 Control parameters 8.1.1 Occupational Exposure Limits EU IOELV / UK WEL / Irl OELV Sk - Can be absorbed through skin. 8.2 Exposure controls 8.2.1 Appropriate engineering controls Not relevant for this material. 8.2.2 Personal protection equipment Eye/face protection Safety glasses recommended. (EN166) Hand protection Disposable gloves. (EN374). Material of gloves: Latex / natural rubber, Nitrile rubber. Penetration time of material: Gloves resistance is not critical when the product is handled according to the instructions for use. Body protection Laboratory coat. Respiratory protection Not normally required. 8.2.3 Environmental Exposure Controls No special measures are required. SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES 9.1 Information on basic physical and chemical properties Appearance Laminated test strip, which may be housed in a plastic holder. Colour Variable depending on product. Odour No Threshold (ppm) Not applicable. pH (Value) Not determined. Melting Point (°C) / Freezing Point (°C) Not determined. Boiling range (°C): Not determined. 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 applicable. 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 (mPa.s) Not applicable. Explosive properties Not explosive. Oxidising properties Not oxidising 9.2 Other information Not available. SECTION 10: STABILITY AND REACTIVITY 10.1 Reactivity None known. 10.2 Chemical stability The product is stable in accordance with the recommended storage conditions. 10.3 Possibility of hazardous reactions Contact with acids may liberate trace amounts of toxic gas (hydrazoic acid). Hazardous polymerisation will not occur. 10.4 Conditions to None. 10.5 Incompatible materials None. 10.6 Hazardous Decomposition Product(s) None known.