DENTSPLY International Safety Data Sheet Safety Data Sheet (in compliance with Regulation (EC) 1907/2006, Regulation (EC) 1272/2008 and Regulation (EC) 453/2010), US 29CFR1910.1200, Canada Hazardous Products Regulation Date Issued: 8 May 2015 Document Number: 463 Date Revised: None Revision Number: New SDS 1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 1.1 Product Identifier: Trade Name (as labeled): Ney® Aluminum Oxide Part/Item Number: 9996102, 9996103, 9996120, 9996150 1.2 Relevant Identified Uses of the Substance or Mixture and Uses Advised Against: Recommended Use: Abrasive Cleaning Restrictions on Use: For Professional Use Only 1.3 Details of the Supplier of the Safety Data Sheet: Manufacturer/Supplier Name: DENTSPLY Prosthetics Manufacturer/Supplier Address: 570 West College Ave. York, PA 17401 Manufacturer/Supplier Telephone Number: 717-845-7511 (Product Information) Email address: Prosthetics_MSDS@Dentsply.com 1.4 Emergency Telephone Number: Emergency Contact Telephone Number: 800-424-9300 Chemtrec 2. HAZARDS IDENTIFICATION 2.1 Classification of the Substance or Mixture: GHS Classification: Health Carcinogen Category 2 H351 Environmental Not hazardous Physical Not Hazardous 2.2 Label Elements: Ney® Aluminum Oxide Page 1 of 8 Signal Word: Warning! Contains: Titanium Dioxide Hazard Phrases H351 Suspected of causing cancer. Precautionary Phrases P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. P280 Wear protective gloves and eye protection. P308 + P313 IF exposed or concerned: Get medical attention. P405 Store locked up. P501 Dispose of contents and container in accordance with local and national regulations. 2.3 Other Hazards: None known. 3. COMPOSITION/INFORMATION ON INGREDIENTS 3.2 Mixture: Hazardous Components C.A.S. # Aluminum Oxide 1344-28-1 EINECS # REACH Registration # 215-691-6 Titanium Dioxide 13463-67-7 Silicon Dioxide 7631-86-9 Classification WT % Not Applicable 96.4 236-675-5 Carc. 2 H351 2.7 231-545-4 Not Applicable 0.5 The exact concentration is being withheld as a trade secret. Refer to Section 16 for the full text of the GHS Classifications. 4. FIRST AID MEASURES 4.1 Description of First Aid Measures: Flush eyes thoroughly with large amounts of water, holding eyelids open. If irritation persists, seek Eye medical attention. Skin Inhalation Ingestion Wash skin with soap and water. If irritation or other symptoms develop, seek medical attention. Move to fresh air. If breathing is difficult, have qualified personnel administer oxygen. Seek medical attention if irritation or other symptoms persist Do not induce vomiting. Rinse mouth with water. Seek medical attention if large amount is swallowed or if you feel unwell. 4.2 Most Important Symptoms and Effects, Both Acute and Delayed: Dust may cause eye and respiratory irritation. Prolonged inhalation of high concentration of dust may cause adverse effects on the lungs. May cause cancer based on animal data. Exposure to dust generated from processing the base material or coatings may present additional health hazards 4.3 Indication of Any Immediate Medical Attention and Special Treatment Needed: No immediate medical attention required. Ney® Aluminum Oxide Page 2 of 8 5. FIRE-FIGHTING MEASURES 5.1 Extinguishing Media: Use any media that is suitable for the surrounding fire. 5.2 Special Hazards Arising from the Substance or Mixture: This product is not flammable or combustible; however, consideration must be given to the potential fire/explosion hazards from the base material being processed. Many materials create flammable/explosive dusts when machined or ground. 5.3 Advice for Fire-Fighters: Fire Fighting Procedures/Precautions for Fire Fighters: Firefighters should wear positive pressure self-contained breathing apparatus and full protective clothing for fires involving chemicals. 6. ACCIDENTAL RELEASE MEASURES 6.1 Personal Precautions, Protective Equipment and Emergency Procedures: Wear appropriate respirator and protective clothing as needed to avoid eye contact and inhalation of dust. 6.2 Environmental Precautions: Report spills as required to authorities 6.3 Methods and Material for Containment and Cleaning up: Carefully collect dry material, avoiding the creation of airborne dust. Place in a suitable container for disposal. 6.4 Reference to Other Sections: Refer to Section 8 for Personal Protective Equipment and Section 13 for Disposal information. 7. HANDLING AND STORAGE 7.1 Precautions for Safe Handing: Avoid breathing dust. Use with adequate ventilation. Avoid contact with the eyes, skin and clothing. Wear suitable gloves, eye protection and appropriate protective clothing according to the operation. Wash thoroughly after handling. Consider potential exposure to components of the materials or coatings being processed. 7.2 Conditions for Safe Storage, Including Any Incompatibilities: No special storage required. 7.3 Specific End Use (s): Abrasive cleaning Ney® Aluminum Oxide Page 3 of 8 8. EXPOSURE CONTROLS/PERSONAL PROTECTION 8.1 Control Parameters: Occupational Exposure Limits: 5 mg/m3 TWA (respirable), 15 mg/m3 TWA (total dust) OSHA PEL 1 mg/m3 TWA (respirable) ACGIH TLV (aluminum insoluble compounds) 1.5 mg/m3 TWA (respirable), 4 mg/m3 TWA (inhalable) DFG Aluminum Oxide 4 mg/m3 TWA (respirable dust) 10 mg/m3 TWA (inhalable dust) UK WEL 1 mg/m3 TWA (respirable) Belgium (aluminum insoluble compounds) 5 mg/m3 TWA (respirable), 15 mg/m3 TWA (total dust) OSHA PEL 4 mg/m3 TWA DFG (inhalable aerosol) 2.4 mg/m3 TWA (respirable dust) 6 mg/m3 TWA (inhalable dust) UK WEL Silicon 10 mg/m3 TWA Belgium OEL 10 mg/m3 TWA ACGIH TLV 15 mg/m3 TWA (total dust) OSHA PEL 4 mg/m3 TWA (respirable dust) 10 mg/m3 TWA (inhalable dust) UK WEL Titanium Dioxide 10 mg/m3 TWA Belgium OEL Biological Exposure Limits: None Established 8.2 Exposure Controls Appropriate Engineering Controls: Use with adequate general or local exhaust ventilation to maintain exposure levels below the occupational exposure limits. Individual Protection Measures (PPE): Specific Eye/face Protection: Use safety glasses with side shields or goggles. Specific Skin Protection: Protective gloves recommended to avoid skin abrasions. Specific Respiratory Protection: If the exposure limits are exceeded, an approved respirator should be worn. Respirator selection and use should be based on contaminant type, form and concentration. Follow applicable regulations and good Industrial Hygiene practice. Specific Thermal Hazards: 9. PHYSICAL AND CHEMICAL PROPERTIES 9.1 Information on Basic Physical and Chemical Properties: Appearance: White powder Explosive limits: Odor: No odor. Vapor pressure (mmHg): Odor threshold: Not applicable Vapor density: pH: Ney® Aluminum Oxide 9.4-10.1 @ 20°C Relative density: LEL: Not applicable UEL: Not applicable 1 mmHg @ 2158°C Not applicable 4 g/cm3 Page 4 of 8 Melting/freezing point: 2040 °C (3704°F) Solubility(ies): Insoluble Initial boiling point and boiling range: 2980 °C (5396°F) Partition coefficient: noctanol/water: Not applicable Flash point: Not applicable Auto-ignition temperature: Not applicable Evaporation rate: Not applicable Decomposition temperature: Not applicable Flammability (solid, gas): Not applicable Viscosity: Not applicable Explosive Properties: Not applicable Oxidizing Properties: Not applicable 9.2 Other Information: 10. STABILITY AND REACTIVITY 10.1 Reactivity: Not reactive under normal conditions of use and storage. 10.2 Chemical Stability: Stable. 10.3 Possibility of Hazardous Reactions: A slight rise in temperature may result from contact with water. 10.4 Conditions to Avoid: None known 10.5 Incompatible materials: Avoid exposure to moisture. Avoid strong acids, strong bases, chlorine trifluoride, ethylene oxide, halogenated hydrocarbon, oxygen difluoride, sodium nitrate and vinyl compounds. 10.6 Hazardous Decomposition Products: None known. Dust from abrasive processing could contain potentially hazardous components of the base material being processed or coatings applied to the base material 11. TOXICOLOGICAL INFORMATION 11.1 Information on Toxicological Effects: Potential Health Effects: Eye Contact: May cause abrasive irritation and injury. Skin Contact: May cause abrasive skin irritation. Inhalation: Breathing dust may cause irritation to the nose, throat and upper respiratory tract. Ingestion: Not toxic. Swallowing may cause gastrointestinal disturbances. Chronic Health Effects: Prolonged inhalation of respirable dust may cause adverse lung effects. Irritation: This product may cause abrasive eye and skin irritation. Corrosivity: This is not a corrosive product. Sensitization: None of the components have been shown to cause sensitization on animals or humans. Carcinogenicity: Titanium dioxide is listed by IARC as a group 2B carcinogen (possible human carcinogen). None of the other components are listed as a carcinogen or potential carcinogen by IARC, NTP, OSHA or the EU CLP. Ney® Aluminum Oxide Page 5 of 8 Mutagenicity: None of the components have been shown to cause mutagenic activity. Acute Toxicity Data: Aluminum Oxide: Oral rat LD50 >10000 mg/kg; LC50 Inhalation rat >2.3 mg/L/4 hr Titanium Dioxide: Oral rat LD50 >5000 mg/kg, Inhalation rat LC50 >6.82 mg/L/4 hr Silicon: Oral rat LD50 3160 mg/kg Reproductive Toxicity Data: This product is not expected to present a risk of adverse reproductive or developmental toxicity. Specific Target Organ Toxicity Single Exposure (STOT-SE): No data available. Specific Target Organ Toxicity Repeated Exposure (STOT-RE): Recent studies of alumina refinery employees indicate that current exposures to aluminum compounds are not associated with significant adverse respiratory effects. The small changes in pulmonary functions parameters and respiratory symptoms observed were likely due to exposure to irritants and were not considered clinically significant. 12. ECOLOGICAL INFORMATION 12.1 Toxicity: Aluminum oxide: NOEC 96 hr Salmo trutta >100 mg/L; NOEC 48 hr daphnia magna >100 mg/L; NOEC 72 hr Selenastrum capricornutum >100 mg/L Titanium Dioxide: 96 hr LC50 Pimephales promelas >1000 mg/L, 48 hr EC50 daphnia magna >1000 mg/L, 72 hr EC50 Pseudokirchneriella subcapitata 61 mg/L Silicon: No data available 12.2 Persistence and Degradability: Biodegradation is not applicable to inorganic substances. 12.3 Bio-accumulative Potential: Not expected to be bioaccumulative. 12.4 Mobility in Soil: No data available. 12.5 Results of PBT and vPvB Assessment: Not applicable 12.6 Other Adverse Effects: None known. 13. DISPOSAL CONSIDERATIONS 13.1 Waste Treatment Methods: Waste Treatment Recommendations: Dispose in accordance with all local, state and federal regulations. 14. TRANSPORT INFORMATION 14.1 UN Number DOT Ney® Aluminum Oxide 14.2 UN Proper Shipping Name 14.3 Hazard Class(s) 14.4 Packing Group 14.5 Environmental Hazards Not Regulated Page 6 of 8 ADR/RID IMDG IATA/ICAO Not Regulated Not Regulated Not Regulated 14.6 Special Precautions for User: Not applicable 14.7 Transport in Bulk According to Annex II of MARPOL 73/78 and the IBC Code: Not applicable – product is transported only in packaged form. 15. REGULATORY INFORMATION 15.1 Safety, Health and Environmental Regulations/Legislation Specific for the Substance or Mixture: U.S. Federal Regulations Comprehensive Environmental Response and Liability Act of 1980 (CERCLA): This product is not subject to CERCLA reporting requirements as it is sold. Many states have more stringent release reporting requirements. Report spills required under federal, state and local regulations. Toxic Substances Control Act (TSCA): All of the components of this product are listed on the TSCA inventory. . Clean Water Act (CWA): This material is not regulated under the Clean Water Act. Clean Air Act (CAA): This material is not regulated under the Clean Air Act. Superfund Amendments and Reauthorization Act (SARA) Title III Information: SARA Section 311/312 (40 CFR 370) Hazard Categories: Chronic Health This product contains the following toxic chemical(s) subject to reporting requirements of SARA Section 313 (40 CFR 372): None State Regulations California: This product contains the following chemicals that are known to the State of California to cause cancer, birth defects or other reproductive harm: Titanium Dioxide 2.7% International Regulations Canadian Environmental Protection Act: European Inventory of Existing Chemicals (EINECS): EU REACH: Australian Inventory of Chemical Substances: All of the components in this product are listed on the AICS for Australia. China Inventory of Existing Chemicals and Chemical Substances: All of the components in this product are listed on the IECSC for China. Japanese Existing and New Chemical Substances: All of the components in this product are listed on the Japanese ENCS list. Korean Existing Chemicals List: All of the components in this product are listed on the KECL for Korea Philippine Inventory of Chemicals and Chemical Substances: All of the components in this product are listed on the PICCS. Ney® Aluminum Oxide Page 7 of 8 15.2 Chemical Safety Assessment: None required. 16. OTHER INFORMATION HMIS Hazard Rating: Health: 0* Flammability: 0 *Chronic Health Hazard Physical Hazard: 0 Full Text of Hazard Statements and Abbreviations used In Section 3: Carc 2 Carcinogen Category 2 H351 Suspected of causing cancer. Supersedes: None Date Updated: 8 May 2015 Revision Summary: New SDS Data Sources: Data Sources: US NLM ChemID Plus and HSDB, Substance SDS for components, ECHA Registered Substances, C&L Inventory, Country websites for occupational exposure limits. 15 Ney® Aluminum Oxide Page 8 of 8