DENTSPLY International DENTSPLY PROSTHETICS 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: 11 November 1996 Document Number: 85 Date Revised: 24 June 2015 Revision Number: 6 1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 1.1 Product Identifier: Trade Name (as labeled): Triad VLC Provisional Material Part/Item Number: 89302, 89304-89309, 89311, 89732, 89733 1.2 Relevant Identified Uses of the Substance or Mixture and Uses Advised Against: Recommended Use: Restrictions on Use: 1.3 Details of the Supplier of the Safety Data Sheet: Manufacturer/Supplier Name: Manufacturer/Supplier Address: Manufacturer/Supplier Telephone Number: Email address: 1.4 Emergency Telephone Number: Emergency Contact Telephone Number: 2.1 Classification of the Substance or Mixture: Used in removable dental appliances For Professional Use Only DENTSPLY Prosthetics 570 West College Ave. York, PA 17401 717-845-7511 (Product Information) Prosthetics_MSDS@Dentsply.com 800-424-9300 Chemtrec 2. HAZARDS IDENTIFICATION GHS Classification: Health Environmental Physical Eye Irritant Category 2 (H319) Skin Sensitizer Category 1 (H317) Not hazardous Not hazardous 2.2 Label Elements: Triad VLC Provisional Material Page 1 of 9
Signal Word: Warning Contains: Diurethane Dimethacrylate, Mixture of Isomers, Ethoxylated Trimethylolpropane Triacrylate Esters, Benzoyl peroxide. Hazard Phrases H317 May cause an allergic skin reaction H319 Causes serious eye irritation. Precautionary Phrases P261 Avoid breathing dust or fumes. P264 Wash thoroughly after handling. P272 Contaminated work clothing should not be allowed out of the work place. P280 Wear protective gloves and eye protection. P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P337+P313 If eye irritation persists: Get medical attention. P302+P352 IF ON SKIN: Wash with plenty of water. P333+P313 If skin irritation or rash occurs: Get medical attention. P362+P364 Take of contaminated clothing and wash it before reuse. P501 Dispose of contents and container in accordance with local, regional and national regulations. 2.3 Other Hazards: None known. 3.2 Mixture: 3. COMPOSITION/INFORMATION ON INGREDIENTS Hazardous Components C.A.S. # EINECS # REACH Registration # Classification WT % Diurethane Dimethacrylate, 72869-86-4 276-957-5 Skin Sens 1 (H317) 30-40 Mixture of Isomers Ethoxylated Trimethylolpropane 28961-43-5 500-066-5 Eye Irrit 2 (H319), 5-10 Triacrylate Esters Skin Sens 1 (H317) Urethane Acrylate Oligomer Proprietary Proprietary Skin Irrit 2 (H315), 1-5 3-dimethylaminoneopentyl acrylate Eye Irrit 2 (H319) 20166-73-8 243-553-5 Acute Tox 3 (H301), Skin Corr 1 (H314), STOT SE 3 (H335), Eye Dam 1 (H318), Flam Liq 4 (H227) Benzoyl peroxide 94-36-0 202-327-6 Org Perox Type B (H241), Eye Irrit 2 (H319), Skin Sens 1 (H317) The exact concentration is being withheld as a trade secret. Refer to Section 16 for the full text of the GHS Classifications. <1 <1 Triad VLC Provisional Material Page 2 of 9
4. FIRST AID MEASURES 4.1 Description of First Aid Measures: Eye Skin Inhalation Ingestion Flush eyes with plenty of water for several minutes. Get medical attention if irritation persists. Take off contaminated clothing. Wash skin thoroughly with plenty of soap and water. Seek medical attention if irritation or rash develops or persists. Launder contaminated clothing before re-use. Remove victim to fresh air. Get medical attention if irritation develops. Rinse out mouth with water. Do not induce vomiting. Get medical attention if you feel unwell. 4.2 Most Important Symptoms and Effects, Both Acute and Delayed: May cause serious eye irritation. May cause skin sensitization. Prolonged skin contact may cause mild skin irritation. 4.3 Indication of Any Immediate Medical Attention and Special Treatment Needed: No immediate medical attention is normally required. 5. FIRE-FIGHTING MEASURES 5.1 Extinguishing Media: Water fog, foam, carbon dioxide, water spray or dry chemical. 5.2 Special Hazards Arising from the Substance or Mixture: High temperatures and sunlight may cause a polymerizing reaction to occur. Decomposition may release acrid smoke or fumes, carbon oxides and methylmethacrylate. 5.3 Advice for Fire-Fighters: Fire Fighting Procedures/Precautions for Fire Fighters: Firefighters should wear full emergency equipment and approved positive pressure selfcontained breathing apparatus. Use water spray to cool fire-exposed containers. Use water to cool exposed containers and structures. 6. ACCIDENTAL RELEASE MEASURES 6.1 Personal Precautions, Protective Equipment and Emergency Procedures: Avoid contact with skin, eyes or clothing. Wear appropriate protective clothing as described in Section 8. Avoid breathing dust or fumes. 6.2 Environmental Precautions: Report releases as required by local and national authorities. 6.3 Methods and Material for Containment and Cleaning up: Exposure to sunlight or artificial light will cause the paste to polymerize. Spread the paste to maximize the surface area. Once the material is hard, pick up and place into a container for disposal. 6.4 Reference to Other Sections: Refer to Section 8 for Personal Protective Equipment and Section 13 for Disposal information. Triad VLC Provisional Material Page 3 of 9
7. HANDLING AND STORAGE 7.1 Precautions for Safe Handing: Avoid contact with the eyes, skin and clothing. Avoid breathing dust or fumes. Wear protective clothing and equipment as described in Section 8. Use only with adequate ventilation. Wash thoroughly with soap and water after handling. Keep containers closed when not in use. Empty containers retain product residues and can be hazardous. Follow all SDS precautions when handling empty containers. 7.2 Conditions for Safe Storage, Including Any Incompatibilities: Store in a tightly closed container in a cool, well ventilated location away from incompatible materials. Do not store near high temperatures or ignition sources. Prevent contact with moisture. Refrigeration prolongs shelf life. Store away from food or beverages. 7.3 Specific End Use (s): For professional use only. 8.1 Control Parameters: Occupational Exposure Limits: "7,7,9-(resp.7,9,9-)trimethyl-4,13- dioxo-3,14-dioxa-5,12- diazahexadecane-1,16-dioldimethacrylate" Ethoxylated Triacrylate Esters Urethane Acrylate Oligomer 3-dimethylaminoneopentyl acrylate Benzoyl peroxide 8. EXPOSURE CONTROLS/PERSONAL PROTECTION None Established Trimethylolpropane None Established Biological Exposure Limits: None Established None Established None Established 5 mg/m 3 TWA ACGIH TLV 5 mg/m 3 TWA OSHA PEL 5 mg/m 3 TWA DFG MAK (inhalable aerosol), 5 mg/m 3 STEL (inhalable aerosol) 5 mg/m 3 TWA UK WEL Belgium: 5 mg/m 3 TWA 8.2 Exposure Controls: Appropriate Engineering Controls: Use with adequate local exhaust ventilation to maintain exposures below the occupational exposure limits. Individual Protection Measures (PPE): Specific Eye/face Protection: Chemical safety glasses or chemical splash goggles recommended. Specific Skin Protection: Wear impervious gloves such as rubber to prevent skin contact. Recommended glove: Rubber. Consult glove supplier for thickness and breakthrough times. Specific Respiratory Protection: None under normal use conditions. If the product is heated and ventilation is inadequate, wear an approved respirator appropriate for the exposure conditions. Triad VLC Provisional Material Page 4 of 9
Specific Thermal Hazards: None required. 9. PHYSICAL AND CHEMICAL PROPERTIES 9.1 Information on Basic Physical and Chemical Properties: Appearance: Odor: Off-white doughy paste in the uncured state. Tooth-colored hard plastic when cured Not determined Explosive limits: Vapor pressure (mmhg): LEL: Not applicable UEL: Not applicable <1 Odor threshold: Not determined Vapor density: >1 ph: Not applicable Relative density: 1.2 Melting/freezing point: <-40 C(<-40 F) Solubility: Negligible in water Initial boiling point and range: Not applicable (polymerizes) Partition coefficient: n- octanol/water: Not available Flash point: Not applicable Auto-ignition temperature: Not applicable Evaporation rate: Not determined Decomposition temperature: Not determined Flammability: Not Flammable Viscosity: Not determined Explosive Properties: Not determined Oxidizing Properties: None 9.2 Other Information: None available 10. STABILITY AND REACTIVITY 10.1 Reactivity: Polymerization can occur. 10.2 Chemical Stability: Stable under normal storage and handling conditions. 10.3 Possibility of Hazardous Reactions: Material will cause thermal burns if exposed to direct sunlight or high temperatures. 10.4 Conditions to Avoid: Avoid excessive heat, flames, ignition sources and direct sunlight. Polymerizes to form a hard plastic in 6 hours at 60 C (140 F) with low exotherm. 10.5 Incompatible materials: Oxidizing agents, reducing agents, tertiary amines, heavy metals, peroxides, and free radical initiators. 10.6 Hazardous Decomposition Products: Decomposition may release acrid smoke or fumes, carbon oxides and methylmethacrylate. Triad VLC Provisional Material Page 5 of 9
11.1 Information on Toxicological Effects: 11. TOXICOLOGICAL INFORMATION Potential Health Effects: Eyes: Direct contact may cause serious eye irritation. Skin: May cause mild skin irritation with prolonged contact. May cause an allergic reaction. Ingestion: No adverse effects expected. Swallowing large amounts may cause gastrointestinal irritation and nausea. Inhalation: No adverse expected under normal use. Chronic Health Effects: None expected under normal use. Irritation: This product is classified as an eye irritant. Corrosivity: No data available. This product is not expected to be corrosive. Sensitization: This product is classified as a skin sensitizer. Carcinogenicity: None of the components of this product are listed as carcinogens by OSHA, IARC, NTP, ACGIH or the EU Substances Directive. Mutagenicity: No data available. This product is not expected to cause mutagenic activity. Acute Toxicity Data: Diurethane Dimethacrylate, Mixture of Isomers: Oral rat LD50 > 5000 mg/kg Ethoxylated Trimethylolpropane Triacrylate Esters: Oral rat LD50 > 2000 mg/kg,dermal rabbit LD50 > 13200 mg/kg Urethane Acrylate Oligomer: No data available. 3-dimethylaminoneopentyl acrylate: No data available. Benzoyl peroxide: Oral rat LD50 > 5000 mg/kg, inhalation rat LC0: 24.3 mg/l Reproductive Toxicity Data: data available. This product is not expected to cause adverse reproductive effects. Specific Target Organ Toxicity Single Exposure (STOT-SE): No data available. Specific Target Organ Toxicity Repeated Exposure (STOT-RE): No data available. 12. ECOLOGICAL INFORMATION 12.1 Toxicity: Diurethane Dimethacrylate, Mixture of Isomers: Daphnia magna EC50 > 1.2 mg/l/48hr Ethoxylated Trimethylolpropane Triacrylate Esters: Danio rerio LC50: 1.95 mg/l/96hr Benzoyl peroxide: Oncorhynchus mykiss LC50: 0.0602 mg/l/96hr 12.2 Persistence and Degradability: Urethane Dimethacrylate is not readily biodegradable. Dibenzoyl peroxide 68% in 28 days. 12.3 Bio-accumulative Potential: No data is currently available 12.4 Mobility in Soil: No data is currently available Triad VLC Provisional Material Page 6 of 9
12.5 Results of PBT and vpvb Assessment: Not required 12.6 Other Adverse Effects: None known. 13.1 Waste Treatment Methods: 13. DISPOSAL CONSIDERATIONS Waste Treatment Recommendations: Treat in accordance with national and local regulations. 14. TRANSPORT INFORMATION 14.1 UN Number 14.2 UN Proper Shipping Name 14.3 Hazard Class(s) 14.4 Packing Group DOT None Not Regulated None None None ADR/RID None Not Regulated None None None IMDG None Not Regulated None None None IATA/ICAO None Not Regulated None None None 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. 14.5 Environmental Hazards 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. Many states have more stringent release reporting requirements. Report spills required under federal, state and local regulations. Toxic Substances Control Act (TSCA): This product is a medical device and not subject to chemical notification. 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: Acute Health This product contains the following toxic chemical(s) subject to reporting requirements of SARA Section 313 (40 CFR 372): Benzoyl Peroxide, <1% State Regulations California: This product contains substances known to the state of California to cause cancer and/or reproductive toxicity. International Regulations Canadian Environmental Protection Act: This product is a medical device and not subject to chemical Triad VLC Provisional Material Page 7 of 9
notification requirements. This SDS has been prepared according to the criteria of the Controlled Products Regulation (CPR) and the SDS contains all of the information required by the CPR. European Inventory of Existing Chemicals (EINECS): This product is a medical device and not subject to chemical notification requirements. EU REACH: All components requiring registration have been pre-registered. Australian Inventory of Chemical Substances: This product is a medical device and not subject to chemical notification requirements. China Inventory of Existing Chemicals and Chemical Substances: This product is a medical device and not subject to chemical notification requirements. Japanese Existing and New Chemical Substances: notification requirements. This product is a medical device and not subject to chemical Korean Existing Chemicals List: This product is a medical device and not subject to chemical notification requirements. Philippine Inventory of Chemicals and Chemical Substances: This product is a medical device and not subject to chemical notification requirements. 15.2 Chemical Safety Assessment: None required. 16. OTHER INFORMATION HMIS Hazard Rating: Health: 2 Flammability: 1 Physical Hazard: 1 Full Text of Hazard Statements and Abbreviations used In Section 3: Eye Dam 1 Eye Damage Category 1 Eye Irrit 2 Eye Irritation Category 2 Acute Tox 3 Acute Toxicity Category 3 Skin Corr 1 Skin Corrosion Category 1 Skin Irrit 2 Skin Irritation Category 2 Skin Sens 1 Skin Sensitization Category 1 STOT SE 3 Specific Target Organ Toxicity Single Exposure Category 3 Flam Liq 4 Flammable Liquid Category 4 Org Perox Type B Organic Peroxide Type B H227 Combustible liquid H241 Heating may cause a fire or explosion H301 Toxic if swallowed H314 Causes severe skin burns and eye damage H315 Causes skin irritation H317 May cause an allergic skin reaction H318 Causes serious eye damage H319 Causes serious eye irritation H335 May cause respiratory irritation Supersedes: 24 May 2013 Date Updated: 24 June 2015 Revision Summary: Converted MSDS to Reach SDS. Updated all sections. Triad VLC Provisional Material Page 8 of 9
Data Sources: US NLM ChemID Plus and HSDB, Substance SDS for components, ECHA Registered Substances, C&L Inventory, Country websites for occupational exposure limits. Triad VLC Provisional Material Page 9 of 9