SAFETY DATA SHEET according to Regulation (EC) No. 453/2010 Dental Use

Transcription

1 Page 1 of 6 SECTION 1 : Identification of the substance/preparation and of the company/undertaking 1.1. Product identifier Product code : Product name Product description : : Powder for mixture with Endo - Eze MTA 1.2. Relevant identified uses of the substance or mixture and uses advised against Relevant identified uses 1.3. Details of the supplier of the safety data sheet : Professional Dental Powder Used For Mixing With MTA Flow Gel Manufacturer Distributor Ultradent Products, Inc. Ultradent Products GmbH 505 W S. Am Westhover Berg 30 South Jordan, UT Cologne Germany infode@ultradent.com Emergency Phone : +49(0) Emergency telephone number CHEMTREC (NORTH AMERICA) :(800) (INTERNATIONAL) :+1(703) SECTION 2: Hazards identification 2.1. Classification of the substance or mixture Classification according to Regulation(EC) No 1272/2008 [CLP] Health : Skin Irritation, Category 2 Eye Damage, Category Label elements Classification according to Regulation(EC) No 1272/2008 [CLP] Hazard pictogram(s) : : The mixture has been assessed and/or tested for its physical, health and environmental hazards and the following classification applies. Signal Word Hazard statement(s) Precautionary statement(s) Prevention Response Exclamation mark : DANGER : H319: Causes serious eye irritation. H315: Causes skin irritation. : P280: Wear protective gloves/protective clothing/eye protection/face protection. : P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes.

2 Page 2 of 6 Storage Remove contact lenses, if present and easy to do. Continue rinsing. P313: Get medical advice/attention. P302+P352: IF ON SKIN: Wash with plenty of soap and water. P362: Take off contaminated clothing. P301: IF SWALLOWED: P330: Rinse mouth. P331: Do NOT induce vomiting. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. : P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P402+P404: Store in a dry place. Store in a closed container. Disposal : P501: Dispose of in compliance with governmental regulations (EC 1975L /11/2003) Other hazards Immediate concerns : None SECTION 3: Composition / information on ingredients 3.1. Substances Not Applicable 3.2. Mixtures Chemical Name CAS EINECS No. Wt.% Classification according to Regulation(EC) No 1272/2008 [CLP] Tricalcium Silicate < 50 Skin Irr.,Cat. 2; EYE DMG.,Cat. 1; H315; H318 Tungsten Flam. Sol.,Cat. 1; Self-Heat,Cat. 2; H228; H252 For full text of H-statements: see SECTION 16. SECTION 4: First aid measures 4.1. Description of first aid measures Following eyes Following skin Following ingestion Following inhalation 4.2. Most important symptoms and effects, both acute and delayed Eyes : Immediately flush with plenty of water. After initial flushing, remove any contact lenses and continue flushing for at least 15 minutes. Have eyes examined and tested by medical personnel. : Immediately flush skin with plenty of water. Remove clothing. Get medical attention immediately. Wash clothing separately before reuse. : If swallowed, Do NOT Induce Vomiting. Give victim a glass of water or milk. Call a physician or poison control center immediately. Never give anything by mouth to an unconscious person. : If inhaled, remove to fresh air. If not breathing give artifical respiration. If breathing is difficult, give oxygen. : May cause irritation.

3 Page 3 of 6 Skin Ingestion Inhalation : May cause mild skin irritation. : May be harmful if swallowed in large quantities. : May cause irritation Indication of any immediate medical attention and special treatment needed Notes to physician SECTION 5: Fire fighting measures 5.1. Extinguishing media : Not Applicable Extinguishing media : Please see Fire Fighting Equipment under Section Special hazards arising from the substance or mixture Explosion hazards 5.3. Advice for firefighters Fire fighting procedures Fire fighting equipment SECTION 6: Accidental release measures : Irritating fumes by be released by thermal decomposition.fumes of silicon dioxide may be evolved from dried material in a fire. : Avoid inhalation of smoke. Use a respirator and protective suit. : Water spray, fog, or mist, foam, dry chemical, carbon dioxide Personal precautions, protective equipment and emergency procedures General procedures 6.2. Environmental precautions Water spill : Refer to Section 8 for Personal Protective Equipment. : Not Applicable 6.3. Methods and material for containment and cleaning up Large spill 6.4. Reference to other sections Reference to other sections SECTION 7: Handling and storage 7.1. Precautions for safe handling General procedures Handling Storage : Sweep up and place in a container for disposal. Avoid raising dust. Ventilate area and wash spill site after material pickup is complete. : Not Applicable : Avoid prolonged inhalation and contact with eyes and skin. : Use suitable protective equipment. : See product labeling Conditions for safe storage, including any incompatibilities Shelf life 7.3. Specific end use(s) Specific end use(s) : See product labeling SECTION 8: Exposure controls / personal protection 8.1. Control parameters : Professional Dental Powder to Mix with MTA Flow Gel

4 Page 4 of 6 Control parameters 8.2. Exposure controls Eye/face protection Skin protection Respiratory protection SECTION 9: Physical and chemical properties : Wear eye protection : Latex or Nitrile gloves : Dust mask or respirator 9.1. Information on basic physical and chemical properties Physical state Appearance : Solid ph : ~ 12 Notes Solubility in water : 0.1 to 1% 9.2. Other information Percent volatile SECTION 10: Stability and reactivity Reactivity Reactivity Chemical stability Chemical stability Possibility of hazardous reactions Hazardous polymerization Conditions to avoid Conditions to avoid Incompatible materials Incompatible materials Hazardous decomposition products Hazardous decomposition products SECTION 11: Toxicological information Information on toxicological effects Acute Notes SECTION 12: Ecological information Toxicity : Fine, yellowish powder : The powder's ph is ~ 12 mixed with water : Not Volatile : Stable : Moisture will degrade the powder. : None : Heat, flames, and ignition sources : Moisture : None known. : Device is biocompatible when used as directed by dental professionals per ISO

5 Page 5 of 6 Aquatic toxicity (acute) 96-hour LC hour EC hour EC Persistence and degradability Persistence and degradability Bioaccumulative potential Bioaccumulative potential Mobility in soil Mobility in soil Results of PBT and vpvb assessment Results of PBT and vpvb assessment Other adverse effects Environmental data SECTION 13: Disposal considerations Waste treatment methods : Not hazardous Disposal method : Dispose of in compliance with governmental regulation.(ec 1975L /11/2003) SECTION 14: Transport information UN number UN number UN proper shipping name UN proper shipping name Transport hazard class(es) Hazard classification Packing group Packing group Environmental hazards Marine pollutant # Special precautions for user ADR - road RID - rail IMDG - sea IATA - air Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Transport in bulk

6 Page 6 of 6 SECTION 15: Regulatory information Safety, health and environmental regulations/legislation specific for the substance or mixture RoHS Chemical safety assessment Chemical safety assessment : See Section 11 Additional information SECTION 16: Other information Relevant H-statements (number and full text) Prepared by Revision summary General statements : Please refer to Medical Devices Directive 93/42/EEC : This product is not considered dangerous for transportation : EYE DMG., Cat. 1: Eye Damage, Category 1 Flam. Sol., Cat. 1: Flammable Solids, Category 1 Self-Heat, Cat. 2: Self-Heating Substances, Category 2 Skin Irr., Cat. 2: Skin Irritation, Category 2 H228: Flammable solid. H252: Self-heating in large quantities; may catch fire. H315: Causes skin irritation. H318: Causes serious eye damage. : Anu Kattoju : This SDS replaces the 05/21/2015 SDS. Revised: Section 1: MSDS No. Section 4: INGESTION, INHALATION, SIGNS AND SYMPTOMS OF OVEREXPOSURE ( INHALATION ). Section 5: FIRE EXPLOSION, SENSITIVE TO STATIC DISCHARGE, SENSITIVITY TO IMPACT. Section 9: BOILING POINT, FREEZING POINT, MELTING POINT, PERCENT VOLATILE. Section 15: COMMENTS. Section 16: Revision Summary. = Not Applicable Additional SDS information : Revision #:1 Manufacturer disclaimer : FOR DENTAL USE ONLY: Use as directed. The information and recommendations are taken from sources (raw material SDS(s) and manufacturer's knowledge) believed to be accurate; however,the manufacturer, makes no warranty with respect to the accuracy of the information or the suitability of the recommendation and assumes no liability to any user thereof. Each user should review these recommendations in the specific context of the intended use and determine whether they are appropriate.