EU Safety Data Sheet. Vival NF. Vival NF



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Page 1 of 5 Company Ivoclar Vivadent AG, Bendererstrasse 2, FL - 9494 Schaan Principality of Liechtenstein 1 1.1 Commercial product name and supplier Commercial product name / Designation 1.2 1.3 1.4 1.5 Application / Use Producer Supplier TOX emergency number Dental alginate imperssion material Ivoclar Vivadent AG, Bendererstrasse 2, FL - 9494 Schaan Fürstentum Liechtenstein Emergency-Call: +423 / 235 35 35 or 373 40 40 Ivoclar Vivadent AG, FL-9494 Schaan, Liechtenstein 2 2.1 2.2 2.3 Composition Chemical characterization Hazardous components CAS No. 16919-27-0 Mixture of diatomaceous earth, sodium alginate, calcium sulphate, magnesium oxide, inorganic accelerator and retarder, dyes and flavour < 3 % Potassium fluoro titanate T: Toxic. R25: Toxic if swallowed. R20/21: Harmful by inhalation and in contact with skin. 3 Hazards identification Dust generation 4 4.1 4.2 4.3 4.4 4.5 First aid measures Eye contact Skin contact Ingestion Inhalation Flush eyes with plenty of water (10-15 min.). Call a physician if irritation persists. Wash thoroughly with soap and water. Give large amounts of water. If you feel unwell, seek medical advice (show this safety data sheet). Induce vomiting. Take into fresh air. 5 5.1 5.2 Fire-fighting measures Suitable extinguishing media Extinguishing media to avoid Not required since not combustible.

Page 2 of 5 5.3 6 Accidental release measures Clean up mechanically. Avoid breathing dust. Wash the area with soap and water. Dispose of according to local and national regulations. 7 7.1 7.2 7.3 7.4 7.5 Handling and storage Handling Industrial hygiene Storage Place of storage Fire- and explosion-protection Avoid dust build-up. Keep out of reach of children. Only adequately trained personnel should handle this product. Avoid breathing dust. Usual hygienic measures for dental practice. When using, do not eat, drink or smoke. Store in a cool, dry place away from direct sunlight. Store at 5-28 C / 41-82 F. Store in a cool, dry place. No specific requirements. 8 Exposure controls / Personal protection 8.1 8.2 8.3 8.3.1 8.3.2 8.3.3 8.3.4 Technical measures Control of threshold limits Personal protective equipment Respiratory protection Hand protection Eye protection Other During mixing it is recommended to apply local exhaust ventilation. Producer Industry recommends an exposure limit of 4 mg/m3. In dusty atmospheres, use an approved dust respirator. Avoid breathing dust. Gloves. Safety goggles. 9 9.1 9.2 Physical and chemical properties Appearance Colour powder blue 9.3 Odour like Peppermint 9.4 Change of physical state Test method: 9.5 Density not determined

Page 3 of 5 9.6 9.7 9.8 Vapour pressure Viscosity Solubility Solubility in Gel formation 9.9 ph 9-10 suspension 9.10 9.11 9.12 Flash point Ignition temperature Explosion limits 9.13 not flammable Lower: Upper: 10 10.1 Stability and reactivity Thermal decomposition > 200 C 10.2 Hazardous decomposition products None, if used in accordance to instructions. 10.3 10.4 Hazardous reactions none known 11 11.1 11.2 Toxicological information Acute toxicity Subacute / Chronic toxicity No adverse effects anticipated by this route of exposure incidental to proper industrial handling. possess no cytotoxic potential (tested in a 1:2 ratio as well as in normal use) 11.3 Diatomaceous earth contains crystalline silica. Repeated excessive exposure to dust may cause lung effects. Potassium fluoride: Harmful by inhalation and in contact with skin. Toxic if swallowed. 12 Ecological information No ecological problems to be anticipated if properly handled and used.

Page 4 of 5 13 Disposal considerations Take to an approved landfill or a waste incineration plant, under conditions approved by the local authority. 13.1 EU waste key 20 03 01 14 Transport information 14.1 Transport at land ADR RID UN Number Proper shipping name Kemler Number 14.2 Transport at sea ADNR IMDG UN Number EMS MFAG Proper shipping name 14.3 Air transport ICAO / IATA-DGR UN Number Proper shipping name Passenger airplane Cargo Airplane Subsidiary Risk Labels Packing Instructions max. Packing Instructions max. 14.4 Product is not classified for any mode of transportation. 15 15.1 15.2 Regulatory information UN number National regulations The product is a medical device according to the EC-directive 93/42. This product does not require classification according to the criteria of the EC. 15.3 15.4 15.5 EU number Hazard symbols Hazard designation

Page 5 of 5 15.6 Risk phrases 15.7 Safety phrases 15.8 MAK value ml/m³ (ppm) 15.9 BVD classification (CH) 15.10 VbF (D) 15.11 16 Other information Version: 3 Changes: 13.1 The above mentioned data correspond to our present state of knowledge and experience. The safety data sheet serves as description of the products in regard to necessary safety measures. The indications do not have the meaning of guarantees on properties. This safety data sheet has been generated with the safety database 'ChemManager', ASSiST Applied Software Solutions in Science and Technology AG, Weiherweg 3, CH-4104 Oberwil, Switzerland 91/155/EEC