, as amended by Regulation (EU) No. 45/2010 SAFETY DATA SHEET SECTION 1 Identification of the substance/mixture and of the company/undertaking Product identifier Product name Other means of identification None. Product type Paste. Relevant identified uses of the substance or mixture and uses advised against Identified uses Dental impression material. Details of the supplier of the safety data sheet National contact Cavex Holland Fustweg 5 201 CJ Haarlem The Netherlands T +1 2 50 7700 E-Mail dental@cavex.nl F +1 2 55 6482 Website www.cavex.nl National advisory body/poison Centre/Emergency telephone number Telephone number +1 2 50 7700 (Office hours) SECTION 2 Hazards identification Classification of the substance or mixture Product definition Preparation Classification according to Regulation (EC) No. 1272/2008 [CLP/GHS] H226 - FLAMMABLE LIQUIDS Category. H17 - Sensitisation Skin Category 1. H19 - Eye irritation Category 2A. H2 - ACUTE TOXICITY INHALATION Category 4. H5 - SPECIFIC TARGET ORGAN TOXICITY (SINGLE EXPOSURE) Category. H7 - SPECIFIC TARGET ORGAN TOXICITY (REPEATED EXPOSURE) Category 2. See Section 16 for the full text of the R phrases or H statements declared above. See Section 11 for more detailed information on health effects and symptoms. Label elements Hazard pictograms Signal word Hazard statements Precautionary statements Danger / Warning H226 - Flammable liquid and vapour. H17 - May cause an allergic skin reaction. H19 - Causes serious eye irritation. H2 - Harmful if inhaled. H5 - May cause respiratory irritation. H7 - May cause damage to organs through prolonged or repeated exposure. Prevention P261 - Avoid breathing dust/fume/gas/mist/vapours/spray. Response Supplemental label elements Other hazards Other hazards which do not result in classification Substance meets the criteria for PBT according to Regulation (EC) No. 1907/2006, Annex X Substance meets the criteria for vpvb according to Regulation (EC) No. 1907/2006, Annex X Date of issue/date of revision 20-4-2015. Date of previous issue 17-06-2010 Version 2 1/6
SECTION Composition/information on ingredients Substance/mixture Preparation Product/ingredient name Europe Identifiers Classification % Regulation (EC) No. 1272/2008 [CLP] Type Tetraethyl orthosilicate 10-20 H226, H19, H2, H5 [1] Dioctyltinoxide 10-25 H7, H41 - Tetramethyl orthosilicate 0.1-1 H226, H02, H18, H0 [1] Type 1 Occupational exposure limits, if available, are listed in Section 8. See Section 16 for the full text of the H statements declared above. SECTION 4 First aid measures Description of first aid measures Eye contact Inhalation Skin contact Ingestion Protection of firstaiders Notes to physician Specific treatments In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Get medical attention if irritation occurs. Supply fresh air, consult a doctor in case of symtoms. Wash contaminated skin with soap and water. S64- If swallowed, rinse mouth with water (only if the person is conscious). Get medical attention immediately. Wash contaminated clothing thoroughly with water before removing it, or wear gloves. Most important symptoms and effects, both acute and delayed Potential acute health effects Eye contact Inhalation Harmful by inhalation. Skin contact Non-irritating (EU). Ingestion Irritating (EU). LD50 Oral Rat dioctyltin oxide (CAS 870-08-6) 4,000 mg/kg. LD50 Oral Rat tetramethyl orthosilicate (CAS 681-84-5) 700 mg/kg. Indication of any immediate medical attention and special treatment needed Extinguishing media Causes eye irritation. Not available. SECTION 5 Firefighting measures Suitable extinguishing media Unsuitable extinguishing media Special hazards arising from the substance or mixture Hazards from the substance or mixture Hazardous thermal decomposition products Advice for firefighters Special protective actions for fire-fighters Special protective equipment for fire-fighters Additional information Use extinguishing media suitable for surrounding materials. None known. Vapours may form explosive mixtures with air. SnO, SnO2 Avoid breathing dusts, vapours or fumes from burning materials. Fire-fighters should wear appropriate protective equipment. No additional remark. Date of issue/date of revision 20-4-2015. Date of previous issue 17-06-2010 Version 2 2/6
SECTION 6 Accidental release measures Personal precautions, protective equipment and emergency procedures For non-emergency personnel For emergency responders Environmental precautions Methods and materials for containment and cleaning up Small spill Large spill Reference to other sections SECTION 7 Handling and storage Avoid breathing vapour or mist. Avoid breathing vapour or mist. Use appropriate containment to avoid environmental contamination. Do not allow to enter drains or watercourses. Absorb with liquid-binding material (sand, diatomite, universal binders etc.) or use a spill kit. Absorb with liquid-binding material (sand, diatomite, universal binders etc.) or use a spill kit. See Section 1 for emergency contact information. See Section 8 for information on appropriate personal protective equipment. See Section 1 for additional waste treatment information. The information in this section contains generic advice and guidance. The list of Identified Uses in Section 1 should be consulted for any available use-specific information provided in the Exposure Scenario(s). Precautions for safe handling Protective measures Advice on general occupational hygiene Conditions for safe storage, including any incompatibilities Store in a dry place. Store in a dry place. No specific storage is required. SECTION 8 Exposure controls/personal protection The information in this section contains generic advice and guidance. The list of Identified Uses in Section 1 should be consulted for any available use-specific information provided in the Exposure Scenario(s). Control parameters Occupational exposure limits Product/ingredient name Exposure limit values Europe Tetraethyl orthosilicate EU OEL (Europe, 9/2006). TWA 10 mg/m³ Tetramethyl orthosilicate EU OEL (Netherlands, 1/2006). TGG 2 mg/m³, (Vapour) Recommended monitoring procedures DNELs/DMELs Exposure controls Eye/face protection Skin protection Hand protection Respiratory protection The product does not contain any relevant quantities of materials with critical values that have to be monitored at the workplace. Appropriate engineering controls Ventilation is normally required when handling or using this product. Hygiene measures No DNELs/DMELs available. PNECs No PNECs available Individual protection measures Body protection Other skin protection Safety glasses. Nitrile gloves. Lab coat. Wash with soap and water. Ventilation is normally required when handling or using this product. Environmental exposure controls S57- Use appropriate containment to avoid environmental contamination. Date of issue/date of revision 20-4-2015. Date of previous issue 17-06-2010 Version 2 /6
SECTION 9 Physical and chemical properties Information on basic physical and chemical properties Appearance Physical state Colour Odour ph Melting point/freezing point Initial boiling point and boiling range Flash point Relative density Auto-ignition temperature Viscosity Oxidising properties Liquid. [Paste.] Red. Aromatic. 110 C. > 48 C. 1.0 g/cm³. Solubility in water Other information Decomposition temperature SECTION 10 Stability and reactivity Chemical stability Conditions to avoid Hazardous decomposition products 100,000 mpas (20 C.). No additional information. Reactivity No additional information. Possibility of hazardous reactions The product is stable. Incompatible materials SECTION 11 Toxicological information Information on toxicological effects Potential acute health effects Potential chronic health effects Under normal conditions of storage and use, hazardous decomposition products should not be produced. No specific data. Acute toxicity CAS 870-08-6 dioctyl tinoxide ORAL (LD50) > 4,000 mg/kg CAS 681-84-5 tetramethyl orthosilicate ORAL (LD50) > 700 mg/kg Irritation/Corrosion Sensitisation Mutagenicity Carcinogenicity Based on available data, the classification criteria are not met. Reproductive toxicity Based on available data, the classification criteria are not met. Teratogenicity Eye contact Inhalation Harmful by inhalation. Skin contact Non-irritating (EU). Ingestion Irritating to eyes. Irritating (EU). LD50 Oral Rat dioctyltin oxide (CAS 870-08-6) 4,000 mg/kg. LD50 Oral Rat tetramethyl orthosilicate (CAS 681-84-5) 700 mg/kg. No known significant effects or critical hazards. Other information No additional information. Sensitizing effect by skin contact is possible by prolonged exposure. Date of issue/date of revision 20-4-2015. Date of previous issue 17-06-2010 Version 2 4/6
SECTION 12 Ecological information Toxicity Based on available data, the classification criteria are not met. Persistence and degradability No additional remark. Bioaccumulative potential Mobility in soil No additional remark. Results of PBT and vpvb assessment PBT vpvb Other adverse effects No known significant effects or critical hazards. SECTION 1 Disposal considerations Waste treatment methods Product Methods of disposal Hazardous waste Packaging Methods of disposal Special precautions Absorb with an inert material and place in an appropriate waste disposal container. Absorb with an inert material and place in an appropriate waste disposal container. None. SECTION 14 Transport information ADR/RID ADN IMDG IATA UN number 199 199 199 199 UN proper shipping name Tetramethyl orthosilicate) Tetramethyl orthosilicate) Tetramethylorthosilicate) Tetramethylorthosilicate) Transport hazard class (es) Packing group Environmental hazards - - - - Additional information Hazard identification number 0 Remarks Special provisions 274 601 640H - - Passenger and Cargo AircraftQuantity limitation 60 L Packaging instructions 09 Cargo Aircraft Only Quantity limitation 220 L Packaging instructions 10 Special precautions for user Transport in bulk according to Annex II of MARPOL 7/78 and the IBC Code No special measures are required. Not available. SECTION 15 Regulatory information Safety, health and environmental regulations/legislation specific for the substance or mixture EU Regulation (EC) No. 1907/2006 (REACH) Annex XIV - List of substances subject to authorisation Substances of very high concern None of the components are listed. National regulations Date of issue/date of revision 20-4-2015. Date of previous issue 17-06-2010 Version 2 5/6
SECTION 15 Regulatory information Chemical Safety Assessment No Chemical Safety Assessment has been carried out. SECTION 16 Other information Indicates information that has changed from previously issued version. Abbreviations and acronyms ATE = Acute Toxicity Estimate CLP = Classification, Labelling and Packaging Regulation [Regulation (EC) No. 1272/2008] DMEL = Derived Minimal Effect Level DNEL = Derived No Effect Level EUH statement = CLP-specific Hazard statement PBT = Persistent, Bioaccumulative and Toxic PNEC = Predicted No Effect Concentration RRN = REACH Registration Number vpvb = Very Persistent and Very Bioaccumulative Procedure used to derive the classification according to Regulation (EC) No. 1272/2008 [CLP/GHS] Classification Justification H226 - FLAMMABLE LIQUIDS Category. H17 - Sensitisation Skin Category 1. H19 - Eye irritation Category 2A. H2 - ACUTE TOXICITY INHALATION Category 4. H5 - SPECIFIC TARGET ORGAN TOXICITY (SINGLE EXPOSURE) Category. H7 - SPECIFIC TARGET ORGAN TOXICITY (REPEATED EXPOSURE) Category 2. Europe Full text of abbreviated H statements Full text of classifications [CLP/GHS] Date of printing Date of issue/ Date of revision Date of previous issue Version Notice to reader H226 - Flammable liquid and vapour. H02 - Harmful if swallowed. H17 - May cause an allergic skin reaction. H18 - Causes serious eye damage. H19 - Causes serious eye irritation. H2 - Harmful if inhaled. H5 - May cause respiratory irritation. H7 - May cause damage to organs through prolonged or repeated exposure. H41 - May cause long lasting harmful effects to aquatic life. H226 - FLAMMABLE LIQUIDS Category. H02 - ACUTE TOXICITY ORAL Category 4. H17 - Sensitisation skin Category 1. H18 - Eye irritation Category 1. H19 - Eye Irritant Category 1. H0 - ACUTE TOXICITY INHALATION Category 1. H2 - ACUTE TOXICITY INHALATION Category 4. H5 - SPECIFIC TARGET ORGAN TOXICITY (SINGLE EXPOSURE) Category. H7 - SPECIFIC TARGET ORGAN TOXICITY (REPEATED EXPOSURE) Category 2. H41 - Hazardous to aquatic environment - Chronic Category 4. 20-4-2015. 20-4-2015. 17-06-2010 2 To the best of our knowledge, the information contained herein is accurate. However, neither the above-named supplier, nor any of its subsidiaries, assumes any liability whatsoever for the accuracy or completeness of the information contained herein. Final determination of suitability of any material is the sole responsibility of the user. All materials may present unknown hazards and should be used with caution. Although certain hazards are described herein, we cannot guarantee that these are the only hazards that exist. Date of issue/date of revision 20-4-2015. Date of previous issue 17-06-2010 Version 2 6/6