Safety Data Sheet. according to Regulation (EC) No 1907/2006. Visalys Core

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Page 1 of 6 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier 1.2. Relevant identified uses of the substance or mixture and uses advised against 1.3. Details of the supplier of the safety data sheet Company name: Street: Place: Im Heerfeld 7 D-35713 Eschenburg Telephone: + 49(0) 2774/705-0 Telefax:+49 (0)2774/705-87 e-mail: info@kettenbach.de Contact person: Regulatory Affairs Manager Telephone: +49 (0)2774/705-0 Internet: Responsible Department: www.kettenbach.de Regulatory Affairs 1.4. Emergency telephone number: +49 (0)30 30686790 (English/German) Further Information For dental use only! SECTION 2: Hazards identification 2.1. Classification of the substance or mixture Indications of danger: Xi - Irritant R phrases: Irritating to eyes and skin. May cause sensitisation by skin contact. GHS classification Hazard categories: Skin corrosion/irritation: Skin Irrit. 2 Serious eye damage/eye irritation: Eye Irrit. 2 Respiratory/skin sensitization: Skin Sens. 1 Specific target organ toxicity - single exposure: STOT SE 3 Hazard Statements: Causes skin irritation. Causes serious eye irritation. May cause respiratory irritation. 2.2. Label elements Hazardous components which must be listed on the label Ytterbium (III) fluoride Aliphatic Dimethacrylate Aliphatic Trimethacrylate Signal word: Pictograms: Warning GHS07

Page 2 of 6 Hazard statements H315 H317 H319 H335 Causes skin irritation. Causes serious eye irritation. May cause respiratory irritation. Precautionary statements P280 Wear protective gloves/protective clothing/eye protection/face protection. SECTION 3: Composition/information on ingredients 3.2. Mixtures Chemical characterization Preparation of multifunctional methacrylates, filler materials and additives Hazardous components EC No CAS No Index No REACH No 13760-80-0 3077-12-1 94-36-0 Chemical name Classification GHS classification Ytterbium (III) fluoride Xi - Irritant R36/37/38 Skin Irrit. 2, Eye Irrit. 2, STOT SE 3; H335 H319 H315 Aliphatic Dimethacrylate Xi - Irritant R36/37/38-43 Skin Irrit. 2, Eye Irrit. 2, Skin Sens. 1, STOT SE 3; H315 H319 H317 H335 Aliphatic Trimethacrylate Xi - Irritant R36/37/38-43 Skin Irrit. 2, Eye Irrit. 2, Skin Sens. 1; H315 H319 H317 p-tolyldiethanolamine Xi - Irritant R36/37/38 Skin Irrit. 2, Eye Irrit. 2A; H319 H315 Dibenzoylperoxide O - Oxidizing, Xi - Irritant R07-36-43 Self-react. C, Skin Sens. 1; H242 H317 Quantity 20 - < 25 % 5 - < 10 % 1 - < 5 % < 1 % < 1 % 2440-22-4 Full text of R and H phrases: see Section 16. 2-(2-Hydroxy-5-methylphenyl)benzotriazole Xi - Irritant R36/37/38 Eye Irrit. 2B, Skin Sens. 1; H320 H317 < 1 % SECTION 4: First aid measures 4.1. Description of first aid measures After contact with skin After contact with skin, wash immediately with: Water and soap. After contact with eyes If product gets into the eye, keep eyelid open and rinse immediately with large quantities of water, for at least 5 minutes. Subsequently consult an ophthalmologist. After ingestion Do not induce vomiting. Rinse mouth immediately and drink large quantities of water. Medical

Page 3 of 6 treatment necessary. SECTION 5: Firefighting measures 5.1. Extinguishing media Suitable extinguishing media Water spray. Extinguishing powder. Sand. Foam. Carbon dioxide (CO2). 5.3. Advice for firefighters No special technical protective measures are necessary. Additional information Extinguishing materials should be selected according to the surrounding area. SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures avoid contact with skin Following eye contact: Consult an ophthalmologist. 6.3. Methods and material for containment and cleaning up Collect mechanically. Absorb with liquid-binding material (e.g. sand, diatomaceous earth, acid- or universal binding agents). SECTION 7: Handling and storage 7.1. Precautions for safe handling Advice on safe handling Store cartridge at ambient temperatures.. Avoid heat sources and direct sunlight. Further information on handling The usual precautions when handling chemicals have to be obtained. When using do not eat or drink. 7.2. Conditions for safe storage, including any incompatibilities SECTION 8: Exposure controls/personal protection 8.1. Control parameters Exposure limits (EH40) CAS No Substance ppm mg/m³ fibres/ml Category Origin 94-36-0 Dibenzoyl peroxide - 5 TWA (8 h) WEL 8.2. Exposure controls Protective and hygiene measures The usual precautions when handling chemicals have to be obtained. Eye/face protection Safety glasses. Hand protection Protective gloves. - - STEL (15 min) WEL Suitable material: Butyl rubber.,nr (Natural rubber (Caoutchouc), Natural latex).,pvc (Polyvinyl chloride). Unsuitable materials: NBR (Nitrile rubber).

Page 4 of 6 Skin protection Protective clothing. Respiratory protection Not required. Environmental exposure controls Not required. SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Physical state: Colour: Odour: Changes in the physical state Flash point: Density (at 23 C): Water solubility: Viscosity / dynamic: (at 23 C) SECTION 10: Stability and reactivity 10.4. Conditions to avoid None by intended use. 10.5. Incompatible materials Radical former. Reducing agents. 10.6. Hazardous decomposition products None by intended use. SECTION 11: Toxicological information 11.1. Information on toxicological effects Acute toxicity Toxicological data are not available. Paste white, light beige nearly odourless Irritation and corrosivity Irritant effect on the skin: Irritant effect on the eye: Sensitising effects Sensitization trough skin contact possible. Carcinogenic/mutagenic/toxic effects for reproduction No experimental indications of mutagenicity in-vitro exist. Practical experience Observations relevant to classification No data available Further information SECTION 12: Ecological information 12.1. Toxicity > 100 C ca. 1,75 g/cm³ practically insoluble ca. 12000 mpa s Test method

Page 5 of 6 Do not allow uncontrolled leakage of product into the environment. SECTION 13: Disposal considerations 13.1. Waste treatment methods Advice on disposal Can be burnt together with household waste in compliance with official regulations in contact with approved waste disposal companies and with authorities in charge. Carry out a burning of harzardous waste according to official regulations. Waste disposal number of waste from residues/unused products 070799 WASTES FROM ORGANIC CHEMICAL PROCESSES; wastes from the MFSU of fine chemicals and chemical products not otherwise specified; wastes not otherwise specified Waste disposal number of used product 200301 MUNICIPAL WASTES (HOUSEHOLD WASTE AND SIMILAR COMMERCIAL, INDUSTRIAL AND INSTITUTIONAL WASTES) INCLUDING SEPARATELY COLLECTED FRACTIONS; other municipal wastes; mixed municipal waste Waste disposal number of contaminated packaging 200301 MUNICIPAL WASTES (HOUSEHOLD WASTE AND SIMILAR COMMERCIAL, INDUSTRIAL AND INSTITUTIONAL WASTES) INCLUDING SEPARATELY COLLECTED FRACTIONS; other municipal wastes; mixed municipal waste SECTION 14: Transport information Land transport (ADR/RID) Inland waterways transport (ADN) Marine transport (IMDG) Air transport (ICAO) Other applicable information SECTION 15: Regulatory information 15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture National regulatory information Water contaminating class (D): 1 - slightly water contaminating SECTION 16: Other information Full text of R phrases referred to under Sections 2 and 3 07 May cause fire. 36 Irritating to eyes. 36/37/38 Irritating to eyes, respiratory system and skin. 36/38 Irritating to eyes and skin. 43 May cause sensitisation by skin contact. Full text of H statements referred to under Sections 2 and 3 H242 Heating may cause a fire. H315 Causes skin irritation.

Page 6 of 6 H317 H319 H320 H335 Causes serious eye irritation. Causes eye irritaion. May cause respiratory irritation. (The data for the hazardous ingredients were taken respectively from the last version of the sub-contractor's safety data sheet.)