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    DENTSPLY InternationalDENTSPLY PROSTHETICS

    Safety Data Sheet

    Safety Data Sheet (in compliance with Regulation (EC)

    1907/2006, Regulation (EC) 1272/2008 and Regulation

    (EC) 453/2010)

    Date Issued: 2 July 2008

    Document Number: 430

    Date Revised: 14, January 2014

    Revision Number: 4

    1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE

    COMPANY/UNDERTAKING

    1.1 Product Identifier:

    Trade Name (as labeled): Ceramco3 Modeling Liquid E

    Part/Item Number: 301127

    1.2 Relevant Identified Uses of the Substance or Mixture and Uses Advised Against:

    Recommended Use: Used in fabrication of dental crown, bridges, and

    laminated veneers.

    Restrictions on Use: For Professional Use Only

    1.3Details 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: [email protected]

    1.4Emergency Telephone Number:

    Emergency Contact Telephone Number: 800-424-9300 Chemtrec

    2. HAZARDS IDENTIFICATION

    2.1 Classification of the Substance or Mixture:

    GHS Classification:

    Health Environmental Physical

    Not Hazardous Not Hazardous Aquatic Chronic Category 3

    EU Classification: R52/53

    2.2 Label Elements:

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    Hazard Phrases Precautionary Phrases

    H412 Harmful to aquatic life with long lasting effects. P273 Avoid release to the environment.

    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. # EINECS # Classification WT %

    Non-hazardous Ingredients Proprietary Proprietary Not Applicable 100

    Zinc Chloride 7646-85-7 231-592-0 Xn, C, N R22, R34, R50/53

    Acute Tox. 4 (H302)

    Skin Corr 1B (H315)

    Aquatic Acute 1 (H400)

    Aquatic Chronic 1 (H410)

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    Fire Fighting Procedures: Cool fire exposed containers and structures with water.

    Precautions for Fire

    Fighters:

    Firefighters should wear full emergency equipment and approved positive pressure self-

    contained breathing apparatus.Do not enter fire area without proper protection.

    Recommended Protective Equipment for Fire Fighters:

    EYES/FACE HANDS RESPIRATORY THERMAL

    6. ACCIDENTAL RELEASE MEASURES

    6.1 Personal Precautions, Protective Equipment and Emergency Procedures:

    Wear appropriate protective clothing as described in Section 8.

    Recommended Personal Protective Equipment for Containment and Clean-up:

    EYES/FACE HANDS RESPIRATORY SKIN

    6.2 Environmental Precautions:

    Do not release to the environment. Report releases as required by local and national authorities.

    6.3 Methods and Material for Containment and Cleaning up:

    Collect with an inert absorbent material and place into an appropriate 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 contact with the eyes, skin and clothing. Use with adequate ventilation. Wash thoroughly with soap and water after

    handling.

    7.2 Conditions for Safe Storage, Including Any Incompatibilities: Store in a cool, dry, well-ventilated area away. Protect

    from physical damage.

    7.3 Specific End Use (s): For professional use only.

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    8. EXPOSURE CONTROLS/PERSONAL PROTECTION

    8.1 Control Parameters:

    Occupational Exposure Limits:

    Non-hazardous Ingredients United States None Established

    Germany None Established

    United Kingdom None Established

    European Union None Established

    Zinc Chloride United States 1 mg/m3 TWA OSHA PEL (as fume)

    1 mg/m2 TWA ACGIH TLV (as fume)

    2 mg/m3 STEL ACGIH TLV (as fume)

    Germany 0.1 mg/m3 TWA DFG MAK (respirable)

    2 mg/m3 TWA DFG MAK (inhalable)

    United Kingdom 2 mg/m3 TWA STEL UK WEL

    European Union Belgium: 1 mg/m2 TWA

    2 mg/m3 STEL

    Biological Exposure Limits:None Established

    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 are recommended if splashing may occur

    Specific Skin Protection:Wear impervious gloves such as natural rubber for prolonged contact.

    Specific Respiratory Protection: When grinding, polishing or where exposure levels are excessive, an approved

    respirator with dust/mist cartridges or supplied air respirator appropriate for the form and concentration of the

    contaminants should be used. Selection and use of respiratory equipment must be in accordance with applicable

    regulations and good industrial hygiene practice.

    Specific Thermal Hazards:None required.

    Recommended Personal Protective Equipment

    EYES/FACE HANDS RESPIRATORY SKIN

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    9. PHYSICAL AND CHEMICAL PROPERTIES

    9.1 Information on Basic Physical and Chemical Properties:

    Appearance: Clear liquid Explosive limits:

    LEL:Not applicable

    UEL: Not applicable

    Odor: OdorlessVapor pressure

    (mmHg):Not available

    Odor threshold: Not determined Vapor density: Not available

    pH: Not available Relative density: 1.0

    Melting/freezing point: ~0C / ~32F Solubility(ies): Completely soluble in water

    Initial boiling point and

    boiling range:~100C / ~212F

    Partition coefficient: n-

    octanol/water:Not available

    Flash point: Not flammable Auto-ignitiontemperature:

    Not applicable

    Evaporation rate: Not availableDecomposition

    temperature:Not available

    Flammability

    (solid, gas):Not applicable Viscosity: Not applicable

    Explosive Properties: Not explosive Oxidizing Properties: None

    9.2

    Other Information:None available

    10. STABILITY AND REACTIVITY

    10.1 Reactivity:None known.

    10.2 Chemical Stability:Stable.

    10.3 Possibility of Hazardous Reactions:None known.

    10.4 Conditions to Avoid:None known.

    10.5 Incompatible materials:No known incompatible materials.

    10.6Hazardous Decomposition Products:Decomposition may produce carbon and zinc oxide.

    11. TOXICOLOGICAL INFORMATION

    11.1 Information on Toxicological Effects:

    Potential Health Effects:Eyes: May cause mild irritation with redness and tearing.

    Skin: Prolonged contact may cause irritation and defatting of the skin.

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    Ingestion: Large amounts may cause gastric upset

    Inhalation: No adverse expected under normal use. High aerosol concentrations may cause slight irritation of the nose and

    throat.

    Chronic Health Effects:None known.

    Irritation:Zinc chloride is highly irritating to corrosive to rabbit eye and skin.

    Corrosivity:This product is not corrosive.

    Sensitization:Zinc chloride was negative in a Mouse local lymphnode assay. None of the other components are expected

    to cause sensitization on animals or humans.

    Carcinogenicity:None of the components of this product are listed as carcinogens by OSHA, IARC, NTP, ACGIH or the

    EU Directive.

    Mutagenicity:Zinc chloride was negative in an in vitro mammalian chromosome aberration test, mammalian cell gene

    mutation assay and in vivo chromosome aberration assay. None of the other components are expected to cause mutagenic

    activity.

    Medical Conditions Aggravated by Exposure:Individuals with pre-skin disorders may be at increased risk from exposure.

    Acute Toxicity Data:

    Non-hazardous Ingredients: Oral rat LD50 22000 mg/kg; Dermal rabbit 2000 mg/kg

    Zinc Chloride: Oral rat LD50 1100 mg/kg

    Reproductive Toxicity Data:None of the components have been shown to cause reproductive or developmental toxicity.

    Specific Target Organ Toxicity (STOT):

    Single Exposure: No data available.

    Repeated Exposure:No data available.

    12. ECOLOGICAL INFORMATION

    12.1 Toxicity:Non-hazardous ingredients: 96 hr LC50 Oncorhynchus mykiss 40613 mg/L; 48 hr LC50 Ceriodaphnia dubia 18340 mg/L;

    72 hr EC50 Pseudokirchnerella subcapitata 24200 mg/L.

    Zinc Chloride: 96 hr Oncorhynchus kisutch 820 g/L; 48 he LC50 daphnia magna 330 mg/L

    12.2 Persistence and Degradability:Biodegradation is not applicable to inorganic substances such zinc chloride. All the

    other components are readily biodegradable.

    12.3 Bio-accumulative Potential:No data available

    12.4 Mobility in Soil:No data available

    12.5 Results of PBT and vPvB Assessment:Not required

    12.6 Other Adverse Effects:None known

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    13. DISPOSAL CONSIDERATIONS

    13.1 Waste Treatment Methods:

    Regulations:Dispose in accordance with all national and local regulations.

    Properties (Physical/Chemical) Affecting Disposal:Empty containers retain product residues and can be hazardous.

    Follow all SDS precautions when handling empty containers.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

    14.5 Environmental

    Hazards

    DOT Not Regulated None

    ADR/RID Not Regulated None

    IMDG Not Regulated None

    IATA/ICAO Not Regulated 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 - 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 has a ReportableQuantity (RQ) of 100,000 lbs. based on the RQ for Zinc Chloride of 1000 lbs. Releases above the RQ must be reported

    to the National Response Center. 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:

    Immediate Hazard: No Pressure Hazard: No

    Delayed Hazard: No Reactivity Hazard: No

    Fire Hazard: No

    This product contains the following toxic chemical(s) subject to reporting requirements of SARA Section 313

    (40 CFR 372):

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    Components C.A.S. # WT %

    Zinc Chloride 7646-85-7

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    H410 Very toxic to aquatic life with long lasting effects.

    Xn Harmful

    C Corrosive

    N Dangerous for the Environment

    R22 Harmful if swallowed.

    R34 Causes burns.R50/53 Very toxic to aquatic organisms; may cause long-term effects in the aquatic environment.

    Supersedes: 12 December 2013

    Revision Summary: Correct error in section 2.2.

    Data Sources: US NLM ChemID Plus and HSDB, Substance SDS for components, IUCLID Dataset EU Chemical Bureau,

    ESIS, Country websites for occupational exposure limits.