KERR Material Safety Data Sheet in accordance with Community Regulation 2006/1907/EC (R.E.A.Ch.) Revision Date: 31th August 2009 SECTION 1 Product & Company identification
1.1 Product name TEMPHASE CATALYST
1.2 Uses/Application: Crown&Bridge self curing dental material. 1.3 Company (Name, address and info phone number) Kerr Corporation (DMC) 1717 West Collins Avenue 92867 Orange – CALIFORNIA (U.S.A.) 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: SECTION 2 Hazard identification
2.1 Hazard classification (according to communitarian directives 67/548/EEC & 99/45/EC) None. 2.2 Other hazard Uncured material may be harmful if swallowed in large amounts. SECTION 3 Composition/Information on Ingredients (according to communitarian directives 67/548/EEC, 99/45/EC & 2001/58/EC) 3.1 Hazardous ingredients HAZARDOUS INGREDIENTS
3.2 Other non-hazardous ingredients None.
Material Safety Data Sheet for: TEMPHASE CATALYST SECTION 4 First aid measures
4.1 Treatment for eye contact: Flush with water for 15 minutes including under eyelids. If irritation persists,
4.2 Treatment for skin contact: Wash with soap and water. If irritation persists, consult a physician. 4.3 Treatment for inhalation (breathing): Remove to fresh air. If irritation persists, seek medical attention. 4.4 Treatment for ingestion (swallowing): Contact a physician.
SECTION5 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.
SECTION6 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: Absorb spills with inert material. Prevent spilled material to reach sewers. SECTION7 Handling and Storage (according to article 5 of communitarian directive 98/24/EC) 7.1 Handling Precautions: Handle away from sources of ignition. 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: TEMPHASE CATALYST SECTION8 Exposure controls/personal protection
TWA/TLV (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: Adequate to maintain exposure limits.
Mechanical (General) Ventilation: Should be sufficient.
Use in a well ventilated area. Avoid breathing vapours of uncured material.
Wear impervious gloves to avoid contact with uncured material.
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 to use a lab coat.
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.SECTION9 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 directive 94/9/EC): Material Safety Data Sheet for: TEMPHASE CATALYST SECTION10 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: Carbon oxides.
Hazardous Polymerization Products: Will not occur when using clinical amounts of this material.
Safety significance in case of change in physical appearance: None
Stabilizers: The product is stabilized with non-hazardous polymerization inhibitors.
SECTION11 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 if swallowed in large
Effects for prolonged Exposure: Unknown. Toxic-kinetic effects: Unknown. Effects on metabolism: Unknown. ______________________________________________________________________________ Toxicological data for ingredients:
Material Safety Data Sheet for: TEMPHASE CATALYST SECTION12 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:
EC50 (Bacteria, breathing inhibition of active muds)
SECTION13 Disposal considerations Unpolymerized (uncured) material may be hazardous waste. Dispose of in accordance of local regulations. SECTION14 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. SECTION15 (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: TEMPHASE CATALYST SECTION16 Other information
16.1 Risk phrases of all ingredients
Risk of explosion by shock, friction, fire or other source of ignition
May cause sensitisation by skin contact.
16.1.1 Safety phrases of all ingredients
Keep container tightly closed in a cool place.
Keep away from reducing and oxidizing agents, peroxides and amines.
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 – European chemical Substances Information System (ESIS - A.C.G.I.H. N.I.OS.H. O.S.H.A. U.E. I.A.R.C. N.T.P. 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: TEMPHASE CATALYST 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.
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