PPH CERKAMED Material Safety Data Sheet MTA +

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1 Strona 1 of 5 MSDS is prepared in accordance with THE REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), Regulation (UE) No 453/2010 of THE EUROPEAN COMMISSION of 20 May REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, COMMISSION REGULATION (EU) No 618/2012 of 10 July 2012 amending, for the purposes of its adaptation to technical and scientific progress. 1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION Product name: MTA + Application: Manufacturer s name: Material for temporary filling and rebuilding root canals PPH CERKAMED Wojciech Pawłowski Stalowa Wola ul. Kwiatkowskiego 1 Tel. 015 / Toxicology information (0-22) National Toxicology Information Center (0-42) Person responsible for material safety data sheet: malgorzatak@cerkamed.pl Date of Issue: Last update: HAZARDS IDENTIFICATION Irritant preparation. Risk of major eye damage. Classification according to GHS HAZARDOUS Hazardous: Prevention: Storage: H315 Irritating to skin H319 Irritating to eyes H318 Cause major eye damage P305 + P351 + P338 IN CASE OF SKIN CONTACT : wash with soap and water immediately. IN CASE OF EYE CONTACT: Flush water carefully for few minutes. If applicant and possible, take out contact lenses. Continue flushing. Consult/ call a doctor. P402 Store in a dry place P403 Store in a well-ventilated place P233 Store tightly closed.

2 Strona 2 of 5 3. COMPONENTS Name CAS No WE No Classification R-phrases Conc. % (weight) Calcium oxide Bismuth oxide C, Xi - R34, R41 - >50 >15 Full text of R-phrases and symbols can be found in the section 16. of MSDS. 4. EMERGENCY FIRST AID PROCEDURES General information: Do not give anything oral to an unconscious person. After inhalation: Fresh air must be provided. Call a doctor. After eye contact: Rinse eye immediately with plenty of water, at least 10 minutes. Avoid strong stream of water due to the risk of mechanical damage to the cornea. Immediately call a eye specialist. After skin contact: Take off contaminated clothing. Rinse skin with plenty of water. In case of irritation consult a physician. After ingestion: Do not induce vomit. Give water to drink. Call a doctor. 5. FIRE FIGHTING MEASURES Non-flammable. Fire fighting media: Dry powder and foam extinguishers, carbon dioxide. Fire fighting media prohibited in safety reasons: Not specified Special risks: Unknown Hazardous decomposition products: Can produce toxic vapor. Special protective equipment for fire-fighters: Fire can produce harmful substances for human health. Apply a gas-tight protective clothing and breathing apparatus (breathing apparatus complete with mask). 6. ACCIDENTAL RELEASE MEASURES Individual precautions: Avoid contact with skin and eyes. Provide air exchange (ventilation). Follow the rules of safety and health at work with chemical substances. Use personal protective equipment as indicated in Section 8. Environmental precautions: In case of failure do not allow the release to the environment. Prevent product from entering sewers, groundwater, soil. Cleaning methods: Use non-flammable absorber for example cover with sand and clean carefully then place in marked container. Contaminated area rinse by water.

3 Strona 3 of 5 7. HANDLING AND STORAGE Dealing with preparation: Proceed in accordance with the principles of good practice and to comply with health and safety. While using of the device do not eat, drink or smoke, avoid eye and skin contact with the liquid, personal protective equipment (as defined in section 8). Protection against the fire and explosion: Non-flammable Storage: Store in a well-ventilated, dry area. Store container tightly closed at temperature C. Protect against moisture and air. Special requirements: Do not use metal container. 8. EXPOSURE CONTROLS/INDIVIDUAL PROTECTION Biological monitoring: Not applicant. Respiratory protection: With normal use non protective mask must be worn Eyes protection: Required - when using the product wear eye or face protection such as protective dental visor. Skin protection: Required - when using the product wear protective gloves and suitable protective clothing - apron. Other information: When applying the product to avoid exposure of eyes and skin, do not eat, drink and smoke. 9. PHYSICAL/CHEMICAL PROPERTIES Physical state, odor, color: white or light grey powder, odorless Boiling point: Melting point: Vapor pressure: Solubility: insoluble Solubility in organic solvents: Density: 3,2 g/cm 3 Ignition temperature: ph 13,5 10. STABILITY AND REACTIVITY Stability: The product is stable under normal use and storage conditions. Absorbs carbon dioxide from air. Materials and conditions to avoid: Moisture, strong acids. Hazardous decomposition products:

4 Strona 4 of 5 Not specified. 11. TOXICOLOGICAL INFORMATION Air passages: Not specified. Ingestion: High toxicity: Calcium oxide LD50 (rat, per os): mg/kg b.m. May cause irritation to digestive system. Skin contact: May cause irritation to skin. Eye contact: Rabbit 10 mg: High eye irritation effect. Risk of cornea turbidity and loss of sight. Other information None of the ingredients of the product is classified as carcinogenic, mutagenic or reprotoxic. 12. ECOLOGICAL INFORMATION Ecotoxicity: Harmful for aquatic organism, harmful depends on ph level, prevent product from entering sewers, groundwater, soil. Fish: Cyprinus carpio LC50 = 1070 mg/l for 96 h Bioaccumulation: Not specified Biodegradation: Biodegradable Other information: Prevent product from entering sewers, groundwater, soil. 13.DISPOSAL CONSIDERATIONS Dispose of according to local, state and federal regulations or return to the producer. 14. TRANSPORT INFORMATION Product is the subject to regulations for transportation of hazardous materials. Road transport (ADR/RID) - 9, III Maritime transport (IMDG) - NA Air transport (ICAO/IATA) NA 15. REGULATION Product has to be labeled.

5 Strona 5 of 5 H315 Irritating to skin. H319 Irritating to eyes. H318 Cause major eye damage HAZARDOUS General information: The product intended for use only by qualified medical personnel, as recommended by the manufacturer. NOTE: The regulatory information given above only indicates the principal regulations specifically applicable to the product described in the material safety data sheet. The user s attention is drawn to the possible existence of additional provisions which complete these regulations. Refer to all applicable national, international and local regulations or provisions. 16. OTHER INFORMATION Explanation of the symbols and descriptions in part 3: C Xi R43 R 41 Corrosive substance Irritant substance Cause burns Risk of serious damage to eyes Other sources of basic data to compile the data sheet: MSDS of the individual ingredients of this product Computer Database EINECS, IUCLID Data Bank ESIS - European Chemical Substances Information System You will be responsible for creating the conditions for the safe use of the product and bear responsibility for any consequences resulting from misuse of this product.

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