1. PRODUCT IDENTIFICATION. Product Identifier (Part/Item Number): Gutta Core (GC020-GC090 depending on taper and size)

Transcription

1 Safety Data Sheet Date Issued: Document Number: MSDSGC9/11B Date Revised: Revision Number: PRODUCT IDENTIFICATION Trade Name (as labeled): Gutta Core Obturators Chemical Name/Classification: Polyisoprene Compound Product Identifier (Part/Item Number): Gutta Core (GC020-GC090 depending on taper and size) U.N. Number: Not Applicable U.N. Dangerous Goods Classification: Not Applicable Recommended Use: Obturating root canals Restrictions on Use: Allergy to dry natural rubber Manufacturer/Supplier Name: DENTSPLY Tulsa Dental Specialties Manufacturer/Supplier Address: 608 Rolling Hills Drive, Johnson City, TN, Manufacturer/Supplier Telephone Number: (Product Information) Emergency Contact Telephone Number: address: 2. HAZARD(s) IDENTIFICATION Hazard/Danger Classification: Health Environmental Physical Associated Hazards: Hazard Statements Gutta Core is a medical product according to Directive 93/42/EC and no hazardous substance or preparation according to Regulation 1272/2008 EC. Include as applicable Precautionary Statements Page 1 of 8 Rev. 00 (8/10)

2 EU Classification: EU Risk (R) and Safety (S) Phrases: Refer to Section 16 for the full text of the EU Classifications and R Phrases. 3. COMPOSITION AND INFORMATION ON INGREDIENTS Hazardous Components C.A.S. # EC# IUPAC Name Substance Classification Tungsten Tungsten Inorganic 36.4% Zinc Oxide Oxozinc Inorganic <1% 1-Octadeanamine n-octadecylamine Organic <1% Paraffinic Petroleum Oil Olefin Inorganic <1% Stearic Acid n-octadecanoic acid Organic <1% Zinc Stearate Octadecanoic acid zinc salt Inorganic <1% Refer to Section 16 for the full text of the GHS and H phrases and EU Classifications and R Phrases. WT % 4. FIRST-AID MEASURES Routes of Exposure Eye Skin Inhalation First Aid Instructions Ingestion Most important symptoms of exposure Other Small amount ingestion is generally considered non-hazardous. Consult a doctor in case of complaints. Note to Physicians (Treatment, Testing, and Monitoring) 5. FIRE-FIGHTING MEASURES Suitable Extinguishing Media: Fire Fighting Procedures: Specific Hazards Arising from the Water, ABC, dry chemical or Protein type air foams. General: Evacuate all personnel; use protective equipment for fire-fighting. Use self-contained breathing apparatus when the product is involved in fire Page 2 of 8 Rev. 00 (8/10)

3 Chemical: Precautions for Fire Fighters: Page 3 of 8 Rev. 00 (8/10)

4 Recommended Protective Equipment for Fire Fighters: EYES/FACE SKIN RESPIRATORY THERMAL 6. ACCIDENTAL RELEASE MEASURES Personal Precautions, PPE and Emergency Procedures: Environmental Precautions: Methods and Materials for Containment and Clean-up: Take up mechanical. Forward for disposal. Clean up affected area. Recommended Personal Protective Equipment for Containment and Clean-up: EYES/FACE SKIN RESPIRATORY THERMAL 7. HANDLING AND STORAGE Precautions for Safe Handing: Conditions for Safe Storage: 8. EXPOSURE CONTROLS/PERSONAL PROTECTION Occupational Exposure Limits: Biological Exposure Limits: Page 4 of 8 Rev. 00 (8/10)

5 Appropriate Engineering Controls: Individual Protection Measures (PPE) Specific Eye/face Protection: Specific Skin Protection: Specific Respiratory Protection: Specific Thermal Hazards: Recommended Personal Protective Equipment EYES/FACE SKIN RESPIRATORY THERMAL Environmental Exposure Controls: General Hygiene Considerations and Work Practices: Protective Measures During Repair and Maintenance of Contaminated Equipment: 9. PHYSICAL AND CHEMICAL PROPERTIES Appearance: Pink coating on Gray carrier Explosive limits: Odor: Mild Vapor pressure: Odor threshold: Vapor density: ph: Neutral Relative density: 2g/cc Melting/freezing point: 50 C Solubility: Initial boiling point and range: Partition coefficient: n-octanol/water: Flash point: Auto-ignition temperature: Evaporation rate: Decomposition temperature: 300 C Flammability: Viscosity: Page 5 of 8 Rev. 00 (8/10)

6 Explosive Properties: Oxidizing Properties: 10. STABILITY AND REACTIVITY Reactivity: Chemical Stability: Stable Possibility of Hazardous Reactions: Conditions to Avoid: Incompatible materials: Hazardous Decomposition Products: Smoke, fume, incomplete combustion products, oxides of carbon, flammable hydrocarbons, oxides of nitrogen, metallic oxides, hydrogen cyanide, ammonia 11. TOXICOLOGICAL INFORMATION Signs and Symptoms of Overexposure: Emergency Overview: Likely Routes of Exposure Signs and Symptoms Single, Repeated, or Lifetime Exposure Severity (Mild, Moderate, Severe) Acute and Chronic Health Effect(s) Target Organ(s) LD50 Testing Data (as applicable) Eye: Skin: Inhalation: Ingestion: Discomfort Single Mild Other: Medical Conditions Aggravated by Exposure: Carcinogenicity: LC50 Testing Data (as applicable) 12. ECOLOGICAL INFORMATION Toxicity: No hazards none. Persistence and Degradability: Bio-accumulative Potential: Page 6 of 8 Rev. 00 (8/10)

7 Mobility in Soil: Other Adverse Effects: Results of PBT/vPvB Assessment: 13. DISPOSAL CONSIDERATIONS Regulations: Waste resulting from this product as supplied is not known to be classified as a hazardous waste. It is the user s responsibility to determine, per the regulations of state, local or other governmental agency, the proper disposal technique. Properties (Physical/Chemical) Affecting Disposal: Waste Treatment Recommendations: 14. TRANSPORT INFORMATION UN Identification Number: UN Proper Shipping Name: Transport hazard class(es): Packing Group: Special precautions for user: 15. REGULATORY INFORMATION U.S. Federal Regulations Comprehensive Environmental Response and Liability Act of 1980 (CERCLA): Toxic Substances Control Act (TSCA): Clean Water Act (CWA): Clean Air Act (CAA): Superfund Amendments and Reauthorization Act (SARA) Title III Information: SARA Section 311/312 (40 CFR 370) Hazard Categories: Page 7 of 8 Rev. 00 (8/10)

8 Immediate Hazard: Pressure Hazard: Delayed Hazard: Reactivity Hazard: Fire Hazard: This product contains the following toxic chemical(s) subject to reporting requirements of SARA Section 313 (40 CFR 372): Components C.A.S. # WT % State Regulations California: This product does not contain any chemicals that are known to the State of California to cause cancer, birth defects or any other reproductive harm. International Regulations Canadian Environmental Protection Act: Canadian Workplace Hazardous Materials Information System (WHMIS): European Inventory of Existing Chemicals (EINECS): 16. OTHER INFORMATION Full text of Classification abbreviations used in Section 2 and 3: Date of SDS Preparation/Revision: 9/27/11 Data Sources: Page 8 of 8 Rev. 00 (8/10)