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Safety Data Sheet according to the guideline (EC) 1907/2006 Page 1/8 Art. -No., product name: 03537 smartseal® cervi 1 Identification of the substance or preparation and of the company Identification of the substance/the preparation: Light curing protective lacquer for use in dentistry. +49 7243/510-0 Telefax: +49 7243/510-100 This number is only obtainable during office hours (Monday - Thursday 8.00 a.m. - 5.00 p.m., Friday 8.00 a.m. - 4.00 p.m.) Classification (67/548/EEC, 1999/45/EC): May cause sensitization by skin contact. Repeated exposure may cause skin dryness or cracking. Vapours may cause drowsiness and dizziness. Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. May cause sensitization by skin contact. Repeated exposure may cause skin dryness or cracking. Vapours may cause drowsiness and dizziness. Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. Safety Data Sheet according to the guideline (EC) 1907/2006 Page 2/8 Art. -No., product name: 03537 smartseal® cervi Keep container tightly closed and in a well-ventilated place. Keep away from sources of ignition – No smoking. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. This material and its container must be disposed of as hazardous waste. Avoid release to the environment. Refer to special instructions/Safety data sheets. Hazardous ingredients (Labelling according to EC): Contains: Acetone, Triclosan. Composition / information on ingredients Chemical characterisation (preparation): Mixture of acrylic/methacrylic resins with triclosan + auxiliary The identification letters and the R-Phrases are described in In case of accident or if you feel unwell, seek medical advice (if Medical advice is necessary in case of symptoms evidently being due to the contact of this product with skin and eyes, or being due Seek medical advice immediately. Move to fresh air and lay the victim restful down, in case of respiratory distress in a half-sitting position; in case of unconsciousness but with existing respiration in a stable lateral position. If necessary, give breathe donation. Wash with plenty of water and soap. Do not use organic solvents! Avoid direct UV- or sunlight. Seek medical advice. Safety Data Sheet according to the guideline (EC) 1907/2006 Page 3/8 Art. -No., product name: 03537 smartseal® cervi 4.4 Rinse the open eyes immediately with plenty of water for at least 15 minutes, seek immediately medical advice. Seek immediately medical advice. Immediately rinse mouth well with water and drink plenty of water in small portions. Do not induce vomiting. In case of spontaneous vomiting take care of an unhindered flow out of the vomit (danger of suffocation). Take care of a sufficient autoprotection (hand protection, foil mask Water mist, dry powder, carbon dioxide, alcohol-resistant foam. Extinguishing media which must not be used for safety reasons: Water jet. Special exposure hazards arising from the substance or preparation itself, combustion products, Possible formation of acrid acrylic fumes. Do not breathe combu- Special protective equipment for fire fighting: Wear self-contained breathing apparatus. In case of massive release of harmful substances, wear suitable protective clothing. Accomplish decontamination by means of explosion-proofed Collect contaminated extinguishing water separately. Prevent it running into in-shore waters, ground water and earth. Avoid unprotected exposure. Wear suitable protective clothing. Keep away from sewage treatment plants, in-shore waters and Absorb with liquid binding material (mica, diatomaceous earth) and collect it in a suitable container, labelled according to regula- The vapour-air-mixture is explosive. Avoid sources of ignition. Avoid contact with eyes, skin and clothing. Do not allow the liquid to dry on the skin. Do not breathe vapours. Take precautionary measures against static discharges. Keep away from sources of ignition - No smoking. Remove all containers not yet affected by fire. Cool endangered containers with water mist. Forms explosive mixtures with air. Conditions for storage rooms and vessels: Keep only in the original container in a cool, dry and well-ventilated place, away from foodstuffs. Keep container always tightly closed. Advice for storage of incompatible materials: Do not store with spontaneously flammable or combustible Safety Data Sheet according to the guideline (EC) 1907/2006 Page 4/8 Art. -No., product name: 03537 smartseal® cervi Keep at temperatures of 2 oC - 25 oC / 36oF - 77 oF. Keep away from all kind of light. An inert gas blanket should not be applied, because the stability of the product depends on the presence of Sealing varnish to protect exposed root dentine; for use by trained Exposure controls and personal protection Associate substances with specific control parameters such as limit values Air limit value according to EC-guideline 2000/39/EG: Air limit value according to TRGS 900 (Germany): Peak limitation: Excursion factor 2; duration 15 min, mean; 4 times Category: I – Substances for which local irritant effects determine the exposure limit value, also respiratory allergens. Limitation and control of the exposition 8.2.1 Limitation and control of the exposition at the place of work: Exposition limit values must be supervised by means of appropriate analytical equipment. General protection and hygiene measures: The usual precautions in handling with chemicals must be respec- ted. When using to not eat, drink or smoke. Take off immediately all contaminated clothing. Do not breathe vapours. Provide for In an emergency (e.g. unintentional release of the product, excee- ding the occupational exposure limit values) respiratory protection must be worn. Respiratory protection: Gas filter A. Consider the Use protective gloves. Check the tightness before wear. Gloves should be well cleaned before being removed, then stored in a Suitable are gloves of the following material (permeation time ≥ 1 hour): Unsuitable are gloves of the following materials: Natural rubber/Natural latex - NR; Polychloroprene – CR; Nitrile rubber/Nitrile latex – NBR; Fluoro carbon rubber – FKM; Polyvinyl Textile or leather gloves are completely unsuitable. The times listed are suggested by measurements taken at 22 oC / oF and constant contact. Temperatures raised by warmed sub- Safety Data Sheet according to the guideline (EC) 1907/2006 Page 5/8 Art. -No., product name: 03537 smartseal® cervi stances, body heat, etc. and a weakening of the effective layer thickness caused by expansion can lead to a significantly shorter In case of doubt contact the gloves’ manufacturer. Wear protective glasses / face protection. 8.2.2 Limitation and control of the environmental exposition: Don’t let the material penetrate into sewage treatment Important information on health and environmental protection and on safety: Ignition temperature .: = > 400 oC / 752 oF DIN Vapour pressure .: = approx. 140 hPa at 20 oC/68 oF y approx. 50 kPa at 50 oC/122 oF Density .: = approx. 0.98 g/cm³ at 20 oC / 68 oF Solubility in water .: = soluble in parts Distribution coefficient octanol / water: Explosion limits .: = lower: approx. 2 vol.-% y upper: approx. 12 vol.-% Higher temperatures advance the formation of explosive vapour- air mixtures, therefore don’t expose the product to increased Ultra-violet light and daylight initiate polymerisation of the product. Therefore keep only in tightly closed containers away from any sources of light. Keep at temperatures of 2 oC-25 oC / 36oF -77 oF. Reacts violently with strong oxidising agents, free-radical produ- No decomposition, if stored and handled in accordance with standard industrial practices. In case of fire, acrid acrylic fumes The product may irritate the skin and the mucous membranes of eyes and respiratory system. Toxicological symptoms depend on the way and period of exposure and may vary: Headache, nausea, vomiting, giddiness, unconsciousness, haemolysis, hepatic and renal lesions. In case of aspiration, pulmonary oede- ma and pneumonia may occur. Sensitisation by skin contact is these data refer to the ingredient acetone. Safety Data Sheet according to the guideline (EC) 1907/2006 Page 6/8 Art. -No., product name: 03537 smartseal® cervi Mutagenicity/Carcinogenicity/Reproductive The available data did not provide indications of any mutagenic No hints of any potential to initiate or promote tumours were obtained from dermal studies on rodents. (This refers to the Remark of the DFG (German Research Community): There is no reason to fear a risk of damage to the developing embryo or foetus when the occupational exposure limit values and the biological ex- 12 Ecological information 12.1 Ecological toxicity: Effects in sewage treatment plants (bacteria toxicity: respiration-/reproduction inhibition): Do not introduce into purification plants. May cause long-term adverse effects in the aquatic environment. 12.4 Potential of biological accumulation: Very toxic to aquatic organisms. A hazard for drinking water sources is possible when larger quantities get into the ground Avoid escape into water, drainage, sewer, or the ground. Do not 13 Disposal considerations 13.1 Waste management (product): Recommendation: Dispose of according to regulations by handing over to a special waste disposal company. Please ask your local waste disposal company about the correct Ref.No. according to the European Waste Catalogue. Recommendation: Fully empty containers (scraped carefully). Uncleaned containers must be disposed of as hazardous waste. 14 Transportation information 14.1 Land transportation ADR/RDI and GGVS/GGVE: Warning board - Hazard No.: 33 Substance No.: 1866 (Vapour pressure at 50 oC/122 oF not more than 110 kPa) Safety Data Sheet according to the guideline (EC) 1907/2006 Page 7/8 Art. -No., product name: 03537 smartseal® cervi 14.3 Transportation by sea IMDG/GGVsea: 14.4 Air transportation ICAO-TI and IATA-DGR transportation by air: 15 Regulatory information 15.1 National regulations (Germany): Information for labelling is given in section 2 of this document. Observe the restrictions on juvenile employment as defined in the Observe the restrictions on the employment of expectant and nur- sing mothers as defined in the „Mutterschutzverordnung”. Classification of possible adverse effects in the aquatic environment (Wassergefährdungsklasse): Class 2 (adverse effects in the aquatic environment). Classification according to VbF (repealed): B 16 Other information 16.1 Wording of the R-phrases under section 3: Irritating to eyes, respiratory system and skin Repeated exposure may cause skin dryness or cracking. Vapours may cause drowsiness and dizziness. Very toxic to aquatic organisms, may cause long-term adverse May cause long-term adverse effects in the aquatic environment Richtlinie 1999/45/EG für die Einstufung, Verpackung und Kennzeichnung gefährlicher Zubereitungen Richtlinie 67/548/EWG für die Einstufung, Verpackung und Kennzeichnung gefährlicher Stoffe, Anhang I Safety Data Sheet according to the guideline (EC) 1907/2006 Page 8/8 Art. -No., product name: 03537 smartseal® cervi Neue Datenblätter für gefährliche Arbeitsstoffe nach der Gefahrstoffverordnung, WEKA-Verlag, Lose- blattsammlung mit Ergänzungslieferungen Sicherheitstechnische Kenndaten chemischer Stoffe, ecomed-Verlag, Loseblattsammlung mit Ergän- Handbuch der Abfallentsorgung, ecomed-Verlag, Loseblattsammlung mit Ergänzungslieferungen Erste Allgemeine Verwaltungsvorschrift zum Bundes-Immissionsschutzgesetz (Technische Anleitung zur VCI: Leitfaden für die Zusammenlagerung von Chemikalien DFG Deutsche Forschungsgemeinschaft: MAK- und BAT-Werte – Liste 2007 Allgemeine Verwaltungsvorschrift zur Änderung der Verwaltungsvorschrift wassergefährdender Stoffe - Safety data sheets and further information from manufacturers / distributors BGIA GESTIS-Stoffdatenbank, Online research IMDG-Code 2011, Amendment 35-10, Verkehrsverlag Fischer Düsseldorf IATA Gefahrgutvorschriften, 54. Ausgabe, International Air Transport Association Montreal The given information describes exclusively the safety requirements of the product(s) and is based on our present-day knowledge. It does not represent a guarantee for the properties of the product(s) described in terms of the legal warranty regulations. This Safety Data Sheet has been adjusted to the Directive (EC) 453/2010.

Source: http://www.detax.de/share/sicherheits_db_dental_englisch/SDB_smartseal-cervi.pdf