1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION. Material for temporary filling and rebuilding root canals

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1 Page 1 of 7 1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION Product name: BIO MTA + Application: Manufacturer s name: Material for temporary filling and rebuilding root canals Wojciech Pawłowski Stalowa Wola ul. Kwiatkowskiego 1 Tel. 015 / Toxicological Information (0-22) , National Centre of Toxicological Information (0-42) Person responsible for MSDS compilation: katarzyna.motyka@cerkamed.pl Date of MSDS compilation: 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 3. COMPONENTS Name CAS No WE No H phrases Conc. % (weight) Calcium oxide H315, H319, H318 >50 Bismuth oxide >15 Hydroxyapatite H315, H319, H335 <15 Full text of H-phrases and symbols can be found in the section 16. of MSDS.

2 Page 2 of 7 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 an 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. Firefighting media: Dry powder and foam extinguishers, carbon dioxide. Firefighting media prohibited in safety reasons: Not specified Special risks: Unknown Hazardous decomposition products: Can produce toxic vapour when on fire. 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: Carefully gather the powder and place in an appropriately marked waste container. Rinse the contaminated area with water. 7. HANDLING AND STORAGE Dealing with the preparation: Proceed in accordance with the principles of good practice and comply with health and safety rules. While using the device do not eat, drink or smoke, avoid eye and skin contact with the liquid, use personal protective equipment (as defined in section 8). Protection against the fire and explosion: Non-flammable

3 Page 3 of 7 Storage: Store in a well-ventilated and dry area. Store the container tightly closed at temperature o C. Protect against moisture and air. Special requirements: Do not use metal container. 8. EXPOSURE CONTROLS/INDIVIDUAL PROTECTION Hazardous ingredients, the highest exposure limit values which should be monitored: For calcium oxide dusts NDS: 2 mg/m 3 For calcium oxide dusts NDSCh: 6 mg/m 3 Legal basis Regulation of the Minister of Labour and Social Policy of June 6, 2014, on maximum permissible concentration and intensity of harmful factors in the work environment. Air marking at work stations: Undefined. Legal basis Undefined. Biological monitoring: Not applicable. Respiratory protection: With proper handling the product respiratory protection is not required. Eyes protection: Required - when using the product wear eye or face protection such as protective dental visor. Skin protection: Required - when handling the product, wear gloves and appropriate protective clothing, such as apron. Other information: When applying the product avoid exposure of eyes and skin, do not eat, drink. Don t smoke. 9. PHYSICAL/CHEMICAL PROPERTIES Physical state, odour, colour: colourless liquid Boiling point: Melting point: Vapour pressure: Solubility in water: very good Density: ~1 g/ml Ignition temperature: ph 8

4 Page 4 of STABILITY AND REACTIVITY Stability: The product is stable under normal use and storage conditions. Materials and conditions to avoid: Not specified. Hazardous decomposition products: Not specified. 11. TOXICOLOGICAL INFORMATION Respiratory system Not specified. Ingestion: High toxicity: EDTA (CAS ) LD 50 (rat) 2000 mg/kg Swallowing may cause irritation of oral mucosa, throat, oesophagus Skin contact: Sodium hydroxide (CAS ): LD50 (rabbit): 1350 mg/kg May cause skin irritation: local redness. Eye contact: Avoid contact with eyes. May be irritating to eyes. Other information: None of the ingredients of the product is classified as carcinogenic, mutagenic or hazardous to reproduction in accordance with the regulations and is not placed on the list of carcinogenic or mutagenic substances being an appendix to the Regulation No. 1272/2008 of the European Parliament and of the Council of December 16, 2008 on classification, labelling and packaging of substances and mixtures. 12. ECOLOGICAL INFORMATION Eco toxicity: Harmful for aquatic organism, harmful effect depends on ph level, prevent the product from entering sewers, groundwater, soil. Fish: Cyprinus carpio LC50 = 1070 mg/l for 96 h Bioaccumulation: Not specified Biodegradation: Biodegradable

5 Page 5 of 7 Other information: Prevent the product from entering sewers, groundwater, soil. 13. Disposal: Used product Do not allow contamination of surface water and groundwater. Do not dispose together with municipal waste. Dispose of the product to an authorized waste contractor. (Journal of Laws of 2013, Item 888 dated June 13, 2013). Waste code: , (Regulation of the Minister of the Environment of 12/9/2914 on the waste catalogue) Packaging Non-contaminated packaging should be taken for recycling. After emptying and washing, contaminated packaging should be taken for recycling. Waste code: (Regulation of June 13, 2013 on the management of packaging and packaging waste). 14. Transport information The product is not subject to regulations on transport of hazardous materials. Road transport (ADR/RID) not classified Sea transport (IMDG) not classified Air transport (ICAO/IATA) 8, III 15. REGULATION Product has to be labelled. H315 Irritating to skin. H319 Irritating to eyes. H318 Cause major eye damage H335 May cause irritation to air-passages HAZARDOUS General information: The product intended for use only by qualified medical personnel, as recommended by the manufacturer. COMMISSION REGULATION (EU) No. 453/2010 of May 20, 2010 amending Regulation (EC) No. 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

6 Page 6 of 7 REGULATION (EC) No. 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL No. 1272/2008 of December 16, 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 National regulations: ACT of February 25, 2011 on chemical substances and mixtures (Journal of Laws 2011 No. 63, Item 322) REGULATION OF THE MINISTER OF HEALTH of April 20, 2012 on the labelling of chemical substances and mixtures, and certain mixtures (Journal of Laws 2012 No. 0, Item 445 as amended) REGULATION OF THE MINISTER OF HEALTH of July 24, 2012 on chemical substances and their mixtures, factors or technological processes with carcinogenic or mutagenic effect in the work environment (Journal of Laws 2012 No. 0, Item 890 as amended) Regulation of the Minister of Labour and Social Policy of June 6, 2014, on maximum permissible concentration and intensity of harmful factors in the work environment Regulation of the Minister of Economy of December 21, 2005 on the essential requirements for personal protective equipment (Journal of Laws, No. 259, Item 2173, 2005) Government Statement of March 26, 2015 on the entry into force of amendments to Annexes A and B to the European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) (Journal of Laws of 2015, Item 882) REGULATION OF THE MINISTER OF HEALTH of January 16, 2003 on preservatives or sweeteners, colourants and antioxidants which may be used for medicinal products. 16. OTHER INFORMATION Explanation of the symbols and descriptions in part 3: H315 Irritating to skin. H319 Irritating to eyes. H318 Cause major eye damage Other sources of basic data to compile the data sheet: Computer Database EINECS, IUCLID Data Bank ESIS - European Chemical Substances Information System All data herein is based on our current knowledge. The purpose of the information in MSDS is to describe the product in terms of safety requirements. User is responsible for creating conditions for

7 Page 7 of 7 the safe use of the product and assumes responsibility for the consequences resulting from improper use of this product.

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