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KERR Material Safety Data Sheet in accordance with Community Regulation 2006/1907/EC (R.E.A.Ch.) Revision Date: 03rd May 2009 SECTION 1 Product & Company identification 1.1 Product name FORMATRAY POWDER 1.2 Uses/Application: Dental material for customized impression trays. 1.3 Company (Name, address and info phone number) KERR ITALIA S.r.l. Via Passanti, 332 84018 Scafati (SA) - Italy Free Phone: 00-800-41-050-505 1.4 Emergency phone (according to communitarian directive 99/45/EC, article 17) +39.081.8508.325 (08.00-17.00, European time, GMT+1) E-mail address: [email protected] SECTION 2 Hazard identification 2.1 Hazard classification (according to communitarian directives 67/548/EEC & 99/45/EC) None. 2.2 Other hazard None. SECTION 3 Composition/Information on Ingredients (according to communitarian directives 67/548/EEC, 99/45/EC & 2001/58/EC) 3.1 Hazardous ingredients Benzoyl PerOxide (BPO) 3.2 Other non-hazardous ingredients Polymethylmethacrylate (PMMA). Material Safety Data Sheet for: FORMATRAY POWDER SECTION 4 First aid measures 4.1 Treatment for eye contact: Immediately flush with water for at least 15 minutes. Call a physician. 4.2 Treatment for skin contact: Wash with soap and water. If irritation persists, consult a physician 4.3 Treatment for inhalation (breathing): Move to fresh air. If breathing difficulty persists, consult a 4.4 Treatment for ingestion (swallowing): Ingestion of small quantities of this material under normal circumstances would not cause harmful effects. SECTION 5 Fire-fighting Measures 5.1 Suitable extinguishing media: Carbon dioxide, water, dry chemical. 5.2 Forbidden extinguishing media: Unknown. 5.3 Special fire fighting measures: None. 5.4 Unusual fire and explosion hazards: Complete combustion in air gives water and carbon dioxide. 5.5 Special protection equipment: None. SECTION 6 Accidental Release Measures 6.1 Personal Precautions: Adopt precautions listed in section 8. 6.2 Environmental Precautions: None. 6.3 Reclaiming Methods: Sweep up carefully to prevent slippery hazard. Vacuum the material. SECTION 7 Handling and Storage (according to article 5 of communitarian directive 98/24/EC) 7.1 Handling Precautions: Adopt precautions listed in section 8. 7.2 Precautions in case of Fire and Explosion: Not available. 7.3 Storage Conditions: Store in a dry place. Keep containers closed to prevent moisture absorption and 7.4 Suggested container(s): The original containers provided by manufacturer. 7.5 Indication for Combined Storage: Avoid contact with oxidizing agents and strong acids. 7.6 Environmental precautions: Store in a dry place far from sewers and water. 7.7 Other Precautions: Use according to directions and good personal hygiene and safety practices. Material Safety Data Sheet for: FORMATRAY POWDER SECTION 8 Exposure controls/personal protection 8.1 Exposure Limits: TWA/TLV: PMMA: 10 mg/m3 (total dust);4 mg/m3 (respirable fraction); (BPO): 0,5ppm (5 mg/m3) 8.2 Exposure control measures 8.2.1 Precautionary Measures: (according to communitarian directives 89/686/EEC & article 4 of 98/24/EC) Local Exhaust Ventilation: Use the product in a well ventilated area. Special Ventilation: None. Mechanical (General) Ventilation: None. Other Ventilation: None. Respiratory Protection: None required under normal conditions. Hands Protection: Impervious gloves, neoprene type. Eyes Protection: Safety glasses or goggles. Skin Protection: Handle in accordance with good personal hygiene and safety practices. Other Protective Equipments: In case of dust formation in air, wear mask with self-contained breathing Measures listed in this paragraph are to be considered as indications and NOT prescriptions (89/656/EEC) 8.2.2 Environment exposure control measures Not Applicable. SECTION 9 Physical and Chemical Properties 9.1 General information Appearance: White powder. Odour: Odourless. 9.2 Information related to health, safety and environment pH: Not applicable (N/A) Relative density: Not available Boiling point: N/A Specific gravity: N/A Flash point: 305°C Solubility: Insoluble Flammability: Not flammable. Partition coefficient n-octanol/water: N/A Lower Explosivity Limit (L.E.L.): N/A Upper Explosivity Limit (U.E.L.): N/A Vapor density (air = 1): N/A Oxidizing properties: None Evaporation rate (n-butane = 1): N/A Vapour pressure: N/A Melting point: Not established 9.3 Other information (according to communitarian directive 94/9/EC): Miscibility: N/A. Conducibility: N/A Solubility in Lipids: Not available Gases Group: N/A Material Safety Data Sheet for: FORMATRAY POWDER SECTION 10 Stability and Reactivity Stability: Stable. 10.1 Conditions to avoid: Temperatures above 300°C. 10.2 Materials to avoid (incompatibility): Strong acids and oxidizing agents. 10.3 Hazardous decomposition products: Carbon monoxide and methyl methacrylate monomer, depending on conditions of heating or burning. Other precautions: Hazardous Polymerization Products: Will not occur Safety significance in case of change in physical appearance: None known Stabilizers: Product is not required to be stabilized. SECTION 11 Toxicological Information CMR effects (Carcinogenicity, Mutagenicity and toxicity for reproduction): None. _ Effects and hazards of eye contact: Nuisance particulates may cause irritation. Effects and hazards of skin contact: Nuisance particulates may cause irritation. Effects and hazards of Inhalation (Breathing): May cause irritation to the respiratory tract. Effects and hazards of Ingestion (Swallowing): Ingestion of small quantities of this material under normal circumstances would not cause harmful effects. Effects for prolonged Exposure: Unknown. Toxic-kinetic effects: Unknown. Effects on metabolism: Unknown. Toxicological data for ingredients: LC50 (inhalation rat/4hrs) Material Safety Data Sheet for: FORMATRAY POWDER SECTION 12 Ecological Information This product has not known ecological hazardous effects. 12.1 Eco-toxicity: Not available 12.2 Mobility: Not available 12.3 Persistence and degradability: Not available 12.4 Bioaccumulative potential: Not available 12.5 Results of PBT (Persistent Bio-Toxicity) assessment: Not available 12.6 Other adverse effects: Not available Aquatic toxicity data for ingredients: LC50 (Fishes, acute toxicity) 2,0 mg/l (96 hours) 2,91 mg/l (48 hours) EC50 (Bacteria, breathing inhibition of active muds) SECTION 13 Disposal considerations Dispose of in accordance of local regulations. SECTION 14 Transport information 14.1 Sea transportation (IMDG) The product is not regulated. 14.2 Air transportation (ICAO/IATA) The product is not regulated. 14.3 Transportation by Road/Railway (RID/ADR) The product is not regulated. SECTION 15 (Classification according to communitarian directives 67/548/EEC & 99/45/EC) Regulatory information Hazard labelling not required. This product is an exempted medical device (directive 1999/45/EC, article 1, paragraph 5g). Material Safety Data Sheet for: FORMATRAY POWDER SECTION 16 Other information 16.1 Risk phrases of all ingredients 3 Extreme risk of explosion by shock, friction, fire or other sources of ignition Irritating to eyes. May cause sensitisation by skin. 16.1.1 Safety phrases of all ingredients 1/2 Keep locked up and out of the reach of children. Keep container tightly closed in a cool place. Keep away from . (incompatible materials to be indicated by the manufacturer). 36/37/39 Wear suitable protective clothing, gloves and eye/face protection. 16.2 Sources of key data used to compile the Safety Data Sheet: European Chemicals Bureau (ECB – www.ecb.jrc.it) European chemical Substances Information System (ESIS - www.ecb.jrc.it/esis) A.C.G.I.H. (www.acgih.org) N.I.OS.H. (www.cdc.gov/niosh/) O.S.H.A. (www.osha.gov/) U.E. (www.europa.eu/index_it.htm) I.A.R.C. (www.iarc.fr/) N.T.P. (www.ntp.niehs.nih.gov) European Community Directives: Classification, packaging and labelling of dangerous substances. Directive concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations. Second amendment of directive 91/155/EEC for the definition of a detailed arrangement of specific information relating to dangerous preparations (art. 14 of 99/45/EC) and substances (art. 27 of 67/548/EEC). Directive on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace (third individual directive within the meaning of Article 16 (1) of Directive 89/391/EEC). Approximation of the laws of the Member States relating to personal protective equipment. Approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres Protection of the health and safety of workers from the risks related to chemical agents at work. Document modification history: First version in compliance of Community Regulation 2006/1907/EC Material Safety Data Sheet for: FORMATRAY POWDER CAUTION: PRODUCT FOR PROFESSIONAL USE The information on this Safety Sheet is based on presently available data and to our best knowledge for the correct handling of the product under normal conditions. Any use of this product in any way not indicated on this Sheet or the use of this product together with any other process/procedure will be exclusively under the user's responsibility. This document does not constitute explicit or implicit warranty of product quality or fitness for a particular purpose.

Source: http://tr.kerrdental.eu/media/Products/ProductFamily/371/en-US/Documents/54645/MSDS_Formatray_Powder.pdf