C. F. P. M. Conception, Fabrication de Produits Médicaux et paramédicaux - PDF

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MATERIAL SAFETY DATA SHEET According to 1907/2006 CLINICEM TEMP II (CLINIX) PRODUCT: Version: 22/09/ IDENTIFICATION OF THE SUBSTANCE / PREPARATION AND THE COMPANY Identification of the substance

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MATERIAL SAFETY DATA SHEET According to 1907/2006 CLINICEM TEMP II (CLINIX) PRODUCT: Version: 22/09/ IDENTIFICATION OF THE SUBSTANCE / PREPARATION AND THE COMPANY Identification of the substance or the preparation: Product name: CLINICEM TEMP II (CLINIX) Identification of the supplier: C. F. P. M. 2 bis, chemin du Loup TREMBLAY-EN-FRANCE FRANCE Telephone: Fax: HAZARDS IDENTIFICATION R-Phrases 50/53 Very toxic to aquatic organisms; may cause long-term adverse effects in the aquatic environment. 3 COMPOSITION / INFORMATIONS ON INGREDIENTS Chemical characterization (preparation) Description: Dental temporary filling cement. Hazardous ingredients: Name: Zinc oxide Zinc sulphate CAS-No.: EG-No.: Index-No.: Concentration: 20-40% 10% Identification letter: N Xn N EC/R: 50/ /53 The identification letters and the R-phrases are described in section FIRST AID MEASURES 4.1 General information: In case of persistent complaints, seek medical advice (if possible, show the label or this MSDS). Take off all contaminated clothing. 4.2 After inhalation: Move to fresh air. In case of persistent irritation, seek medical advice. 4.3 After contact with the skin: Remove the product mechanically by means of a cloth or paper. Wash with plenty of water and soap. ln case of visible skin reactions or complaints, seek medical advice (if possible, show the label or this MSDS). 4.4 After contact with the eyes: Rinse the open eyes immediately with plenty of water for at least 15 minutes, seek immediately medical advice. 4.5 After swallowing: Immediately rinse mouth well with water and drink plenty of water. If you feel unwell, seek medical advice. 4.6 Autoprotection of the first assistant Take care of a sufficient autoprotection (hand protection, foil mask). Page 1 sur 5 5 FIRE-FIGHTING MEASURES 5.1 Suitable extinguishing media: The product itself is not combustible. Extinguishing media depend on environmental fire. 5.2 Extinguishing media which must not be used for safety reasons: Depending on the combustible materials in the surrounding area. 5.3 Special exposure hazards arising from the substance or preparation itself, combustion, products, resulting gases: zno-fumes and sulphur oxides may occur. Do not breathe combustion gases. 5.4 Special protective equipment for fire fighting: Use respiratory protection independent of recirculated air. 5.5 Further information: Collect contaminated extinguishing water separately. Prevent it running into in-shore waters, ground water and earth. 6 ACCIDENTAL RELEASE MEASURES 6.1 Personal precautions: If material is accidentally spilled, refer to the possible danger of skidding. Do not pass through the spilled material. 6.2 Environmental precautions: Keep away from sewage treatment plants, in-shore waters and earth. Observe local byelaws. 6.3 Methods for cleaning up: Pick up the product mechanically by means of a cloth or paper and collect in a suitable container, labelled according to the regulations (for disposal see section 13). 7 - HANDLING AND STORAGE 7.1 Handling: Precautions for safe handling: The usual precautions in handling with chemicals are to be observed. When using, not to eat drink or smoke. Avoid contact with eyes. Precautions against fire and explosion: 7.2 Storage: Conditions for storage rooms and vessels: Advice for storage of incompatible materials: Further information for storage: Remove all containers not yet affected by fire. Cool endangered containers with water mist or cover them with foam. Keep the product in the original container in a cool and dry place, away from foodstuffs. Keep away from acids and lyes. Keep at temperature not exceeding 25 C / 77 F. Keep away from humidity. 7.3 Definite use Dental provisional filling cement for use by trained specialist staff. 8 EXPOSURE CONTROL AND PERSONAL PROTECTION 8.1 Exposition limit values: Associate substances with specific control parameters such as limit values. Recommendations of the MAK-Commission: Zinc oxide fume 1 mg/mᶟ Page 2 sur 5 8.2 Limitation and control of the exposition. With reference to the alveolar fraction. Peak limitation: Excursion factor 1; duration 15 min, mean; 4 times per shift; interval 1 hour 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 respected. When using not to eat, drink or smoke. Take off all contaminated clothing. Personal protection equipment: Respiratory protection: Hand protection: Eye protection: Body protection: Under the usual working conditions not necessary. Protective gloves are recommended (eg such as gloves of nitrile rubber). To avoid mechanical injuring of the eyes, wear protective glasses Wear working clothing Limitation and control of the environmental exposition: Prevent the material getting into in-shores waters, ground water and earth. 9 PHYSICAL AND CHEMICAL PROPERTIES 9.1 Appearance: Form: Colour: Odour: paste white almost odourless 9.2 Safety parameters: Method (67 / 548 / EC) ph-value... : n.a Boiling point... : n.a DIN Flash point... : n.a DIN Ignition temperature... : n.a DIN Vapour pressure... : n.a Density... : = approx. 2.44g/cm 3 at 20 C/68 F DIN Solubility in water... : = virtually insoluble Distribution coefficient octanol / water: not available Viscosity, dynamic... : = 15 Mio. mpa.s at 23 C/73 F Brookfield Explosion limits... : not available 9.3 Further information: Thermal decomposition... : 10 STABILITY AND REACTIVITY not tested 10.1 Conditions to avoid: Moisture uptake causes a quality defect of the paste Materials to avoid: Reacts with acids and lyes forming the corresponding salts, -complexes Hazardous decomposition products: No decomposition, if stored and handled in accordance with standard industrial practices. In case of fire, ZnO-fumes and sulphur oxides may occur TOXICOLOGICAL INFORMATION 11.0 General information: According to present experience, the material shows no health risks if handled appropriately, observing the usual hygiene at place of work. Page 3 sur 5 11.1 Toxicological tests Acute toxicity: Acute oral toxicity (LD50): Acute inhalative toxicity (LD50): species rat mg/kg Origin: literature These data refer to the ingredient zinc oxide. species rat 5.7 mg/l 4 hours Origin: literature These data refer to the ingredient zinc oxide. 12 ECOLOGICAL INFORMATION 12.1 Ecological toxicity: Effects in sewage treatment plants (bacteria toxicity: respiration -/reproduction inhibition)/ Do not introduce into purification plants Mobility: No data available Persistence and degradability biodegradation/further information: May cause long-term adverse effects in the aquatic environment Potential of biological accumulation: No data available Other harmful effects: Very toxic to aquatic organisms Further ecotoxicological information: Avoid escape into water, drainage, sewer, or the ground. Do not dispose of to a public disposal site. 13 DISPOSAL CONSIDERATIONS 13.1 Waste management (product): Recommendation: Dispose of according to regulations by handing over to a special waste disposal company. Observe the local byelaws. European Waste catalogue Ref; No.: Please ask your local waste disposal company about the correct Ref.No. according to the European Waste Catalogue Contaminated packaging: Recommendation: Fully empty containers (scraped carefully). Containers may be recycled or re-used. Uncleaned containers must be disposed of as hazardous waste. Observe local/national byelaws. 14 TRANSPORT INFORMATION 14.1 Land transportation ADR/RDI and GGVS/GGVE: GGVS/GGVE-class: 9 cl.-code M7 ADR/RID-class : 9 cl.-code M7 Transportation emergency card number: 9 Warning board - Hazard No.: 90 Substance No.: 3077 PG: III Nomenclature: Environmentally hazardous substance, solid, n.o.s. Further information: Contains zinc oxide Limited Quantities: LQ27 (6 kg / 30 kg) 14.2 Inland navigation ADN/ADNR: Further information: No data available Transportation by sea IMDG/GGVsea: IMDG/GGVsea-class: 9 Label 9 UN-No.: 3077 PG: III EmS-No... : F-A, S-F- Page 4 sur 5 Marine pollutant... : P Proper shipping name... : Environmentally hazardous substance, solid, n.o.s. Technical name... : Contains zinc oxide LTD. QTY... : 5kg/30 kg 14.4 Air transportation ICAO-TI and IATA-DGR transportation by air: ICAO/IATA-class : 9 Label 9 UN-No.: 3077 PG: III Page: 281 (49 edition) Proper shipping narre : Environmentally hazardous substance, solid, n.o.s. Technical narre : Contains zinc oxide Packing regulations : PAC: 911 Max. net.: 400 kg CAO: 911 Max. net.: 400 kg Excepted Quantities : 30 g / 1 kg LTD.QTY : 30 kg gross weight (Y911) 15 REGULATORY INFORMATION 15.1 EC regulations Identification according to EC directives: Identification letters and hazard indications Identification letter: N Hazard indication: Environmentally hazardous Hazardous components for labelling Contains: Zinc oxide. R-phrases: 50/53 Very toxic to aquatic organisms; may cause long-term adverse effects in the aquatic environment. S-phrases: 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 OTHER INFORMATION 16.1 Wording of the R-phrases under section 3: R-Phrases and identification letters R-Phrases: R22 Harmful if swallowed R41 Risk of serious damage to eyes R 50/53 Very toxic to aquatic organisms, may cause longterm adverse effects in the aquatic environment. Identification letters: N Environmentally hazardous Xn Harmful 16.2 Further information Explanation of the abbreviations: n.a. = not applicable n.s. = not subject to 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 Iegal warranty regulations. Page 5 sur 5
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