Microsoft word - herculite_xrv_ultra.doc

KERR Material Safety Data Sheet in accordance with Community Regulation 2006/1907/EC (R.E.A.C.H.) Revision Date: 07th April 2008 SECTION 1 Product & Company identification 1.1 Product name HERCULITE XRV ULTRA 1.2 Uses/Application: Dental restorative material. 1.3 Company (Name, address and info phone number) KERR ITALIA S.r.l. Socio Unico Via Passanti, 332 84018 Scafati (SA) - Italy +39-081-850-8311 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 (Enamel & Dentin shades); Sensitizing (Incisal shade only). 2.2 Other hazard Uncured material may be harmful if swallowed. SECTION 3 Composition/Information on Ingredients (according to communitarian directives 67/548/EEC, 99/45/EC & 2001/58/EC) 3.1 Hazardous ingredients * Contained only in Enamel & Dentin shades; 3.2 Other non-hazardous ingredients Uncured Methacrylate Ester Monomers, Titanium Dioxide (TiO2) and pigments. Material Safety Data Sheet for: HERCULITE XRV ULTRA SECTION 4 First aid measures 4.1 Treatment for eye contact: Flush with water for 15 minutes including under eyelids. 4.2 Treatment for skin contact: Wash thoroughly with soap and water. 4.3 Treatment for inhalation (breathing): Remove to fresh air - get medical attention if discomfort persists. 4.4 Treatment for ingestion (swallowing): Rinse mouth out with water - do not induce vomiting. Seek SECTION 5 Fire-fighting Measures 5.1 Suitable extinguishing media: Chemical foam, CO2, dry chemical. 5.2 Forbidden extinguishing media: Unknown. 5.3 Special fire fighting measures: None. Wear a self contained breathing apparatus. 5.4 Unusual fire and explosion hazards: Heat can cause polymerization with rapid release of energy. 5.5 Special protection equipment: Sealed overall against liquids and gases. SECTION 6 Accidental Release Measures 6.1 Personal Precautions: Follow recommended precautions listed in other sections. 6.2 Environmental Precautions: Material should not be allowed to drain into sewers. 6.3 Reclaiming Methods: Waste resulting from the use of this product must be disposed in accordance with SECTION 7 Handling and Storage (according to article 5 of communitarian directive 98/24/EC) 7.1 Handling Precautions: Avoid exposure to excessive heat. 7.2 Precautions in case of Fire and Explosion: Extinguish all ignition sources. 7.3 Storage Conditions: Store in a cool, dry place away from heat, light and ignition sources. 7.4 Suggested container(s): Original sealed containers provided by manufacturer. 7.5 Indication for Combined Storage: Avoid the contact with reducing and oxidizing agents, peroxides and 7.6 Environmental precautions: Do not allow product to reach sewers and rivers. 7.7 Other Precautions: Use according to directions. Material Safety Data Sheet for: HERCULITE XRV ULTRA SECTION 8 Exposure controls/personal protection PEL/TLV (TiO2 contained only in dentin shades): 3,1ppm (10mg/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: Good general ventilation should be sufficient to control airborne levels of vapors released by Special Ventilation: None. Mechanical (General) Ventilation: Good general ventilation recommended. Other Ventilation: Not applicable. Avoid prolonged or excessive breathing of vapors of uncured material Impervious rubber gloves recommended when contacting uncured material Not required if used as directed. May be used safety glasses. Handle in accordance with good personal hygiene and safety practices. These practices include avoiding unnecessary exposure to uncured material. Other Protective Equipments: It would be better use a lab coat. Measures listed in this paragraph are to be consider as indications and NOT as prescriptions (89/656/EEC) 8.2.2 Environment exposure control measures Not Applicable. SECTION 9 Physical and Chemical Properties 9.2 Information related to health, safety and environment Partition coefficient n-octanol/water: N/D Vapour density (air = 1): Not determined Evaporation rate (n-butane = 1): Not determined 9.3 Other information (according to communitarian directives 94/9/EC & 1882/2003/EC): Material Safety Data Sheet for: HERCULITE XRV ULTRA SECTION 10 Stability and Reactivity Stability: Stable if stored as directed. 10.1 Conditions to avoid: Heat, light, aging and contamination. 10.2 Materials to avoid (incompatibility): Reducing and oxidizing agents, peroxides and amines. 10.3 Hazardous decomposition products: Oxides of Carbon. Hazardous Polymerization Products: May occur Safety significance in case of change in physical appearance: None Stabilizers: The product is stabilized with MEHQ (see section 3.1) SECTION 11 Toxicological Information CMR effects (Carcinogenicity, Mutagenicity and toxicity for reproduction): No _____________________________________________________________________________ Effects and hazards of eye contact: May cause irritation and damage if not removed promptly. Effects and hazards of skin contact: Prolonged or repeated exposure to uncured material may cause irritation or skin rash especially in sensitive individuals. Effects and hazards of Inhalation (Breathing): Prolonged or excessive inhalation may cause respiratory tract Effects and hazards of Ingestion (Swallowing): Uncured material may be harmful or fatal if swallowed. Effects for prolonged Exposure: Unknown. Toxic-kinetic effects: Unknown. Effects on metabolism: Unknown. ______________________________________________________________________________ Toxicological data for ingredients: Material Safety Data Sheet for: HERCULITE XRV ULTRA 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: 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: HERCULITE XRV ULTRA SECTION 16 Other information 16.1 Risk phrases of all ingredients 2 Risk of explosion by shock, friction, fire or other source of ignition. 22 Harmful if swallowed. 36/38 Irritating to eyes and skin. 43 May cause sensitisation by skin contact. 16.1.1 Safety phrases of all ingredients 2 Keep out of the reach of children 7 Keep container tightly closed 24/25 Avoid contact with eyes 26 In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. 37/39 Wear suitable 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. Regulation of EU Parliament adapting to Council Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its implementing powers. Material Safety Data Sheet for: HERCULITE XRV ULTRA Document modification history: First version in compliance of Community Regulation 2006/1907/EC 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.

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