pH

Hazard statements (CLP)

H319, H373, H412

Code

Statements

H319

Causes serious eye irritation

2.1 Classification of the substance or mixture

and indication Hazard labelling pursuant to EC Regulation 1272/2008 (CLP) and subsequent amendments and supplements. Evaporation rate AK HUN 5 Not available.

Environmental hazards

Intended use Flammability (solid, gas) - CAS NUMBER: Chemical Abstract Service Number Intended use Specific target organ toxicity - repeated exposure, category 2 Not available. Alginates for dental impressions - ISO 21563:2013 === GMDN 35863 ==== MEDICAL 20 H373 May cause damage to organs through prolonged or repeated 12.1. Toxicity. SECTION 4. First aid measures. Store only in the original container. Store the containers sealed, in a well ventilated place, away from direct sunlight. Keep containers away Lower inflammability limit. MAC NLD 5 Not available. DEVICE DIRECTIVE 93/42/EEC (Class I) - CE50: Effective concentration (required to induce a 50% effect) from any incompatible materials, see section 10 for details. exposure. 4.1. Description of first aid measures. - CE NUMBER: Identifier in ESIS (European archive of existing substances) Upper inflammability limit. Not applicable. Eye irritation, category 2 NDS POL 5 10 H319 Not available. Causes serious eye irritation. Lower explosive limit. ZINC OXIDE Hazardous to the aquatic environment, chronic toxicity, category 3 4 Not available. H412 Identified Uses Upper explosive limit. Identified Uses EYES: Remove contact lenses, if present. Wash immediately with plenty of water for at least 30-60 minutes, opening the eyelids fully. Get - CLP: EC Regulation 1272/2008 MV Harmful to aquatic life with long lasting effects. SVN Not available. Industrial Professional Consumer 7.3. Specific end use(s). LC50 - for Fish. Dental medical device Vapour pressure. Dental medical device MAK SWE 5 Not available. 1,1 mg/l/96h Oncorhynchus mykiss - SU: 10. 14.6. Special precautions for user. medical advice/attention. - DNEL: Derived No Effect Level

2.2 Label elements

Information not available. Vapour density EC50 - for Crustacea. TLV-ACGIH 2 Not available. 1,7 mg/l/48h Daphnia magna 10 ERC: 2, 3. SKIN: Remove contaminated clothing. Rinse skin with a shower immediately. Get medical advice/attention. Relative density. - EmS: Emergency Schedule EC50 - for Algae / Aquatic Plants. Not applicable. 2,300 0,14 mg/l/72h Pseudokirchnerella subcapitata Kg/l Solubility INGESTION: Have the subject drink as much water as possible. Get medical advice/attention. Do not induce vomiting unless explicitly - GHS: Globally Harmonized System of classification and labeling of chemicals Not available. PROC: 1, 3, 5. Hazard labelling pursuant to EC Regulation 1272/2008 (CLP) and subsequent amendments and supplements. Partition coefficient: n-octanol/water Chronic NOEC for Fish. Not available. 0,53 mg/l PC: 32. 14.7. Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code. SECTION 8. Exposure controls/personal protection. authorised by a doctor. Auto-ignition temperature. - IATA DGR: International Air Transport Association Dangerous Goods Regulation Chronic NOEC for Algae / Aquatic Plants. Not available. 0,024 mg/l Decomposition temperature. INHALATION: Get medical advice/attention immediately. Remove victim to fresh air, away from the accident scene. If the subject stops - IC50: Immobilization Concentration 50% DIPOTASSIUM HEXAFLUOROTITANIUM(2-) Not available. - 8.1. Control parameters.

Hazard pictograms

Threshold Limit Value. Viscosity Not available. 12.2. Persistence and degradability. breathing, administer artificial respiration. Take suitable precautions for rescue workers. Information not relevant. - IMDG: International Maritime Code for dangerous goods Explosive properties Not available. 1.3. Details of the supplier of the safety data sheet Oxidising properties - IMO: International Maritime Organization Type Country TWA/8h Not available. STEL/15min mg/m3 ppm mg/m3 Regulatory References: - INDEX NUMBER: Identifier in Annex VI of CLP ppm 4.2. Most important symptoms and effects, both acute and delayed.

Further information

SODIUM PHOSPHATE TRIBASIC ANHYDROUS OEL EU 2,5 SECTION 15. Regulatory information. Name VOC (Directive 2010/75/EC) : Name For symptoms and effects caused by the contained substances, see chap. 11. - LC50: Lethal Concentration 50% 0 MAJOR PRODOTTI DENTARI S.P.A VOC (volatile carbon) : Solubility in water. CZE Česká Republika Nařízení vlády č. 361/2007 Sb. kterým se stanoví podmínky ochrany zdraví při práci Full address - LD50: Lethal dose 50% Full address 0 > 10000 mg/l Via Einaudi, 23 Biodegradability: Information not available. DEU Deutschland MAK-und BAT-Werte-Liste 2012 4.3. Indication of any immediate medical attention and special treatment needed. District and Country - OEL: Occupational Exposure Level 10024 Moncalieri (TO) 15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture. DNK

PBT Substances

Persistent bioaccumulative and toxic as REACH Regulation Danmark Graensevaerdier per stoffer og materialer Italy SECTION 10. Stability and reactivity. Information not available. SODIUM PYROPHOSPHATE ESP - PEC: Predicted environmental Concentration Solubility in water. España Warning INSHT - Límites de exposición profesional para agentes químicos en España 2015 Tel. 58500 mg/l 011 6400211 10.1. Reactivity.

Signal word

Threshold Limit Value. Seveso category. EST Eesti None. Töökeskkonna keemiliste ohutegurite piirnormid 1. Vastu võetud 18.09.2001 nr 293 RT I 2001, 77, 460 - PEL: Predicted exposure level Fax 011 6400222 Biodegradability: Information not available. There are no particular risks of reaction with other substances in normal conditions of use. Type Country TWA/8h - Redaktsiooni jõustumise kp: 01.01.2008 STEL/15min SECTION 5. Firefighting measures. e-mail address of the competent person Restrictions relating to the product or contained substances pursuant to Annex XVII to EC Regulation 1907/2006. - PNEC: Predicted no effect concentration e-mail address of the competent person mg/m3 ppm mg/m3 ppm

Hazard statements

FRA France responsible for the Safety Data Sheet - REACH: EC Regulation 1907/2006 responsible for the Safety Data Sheet None. H373 TLV DNK May cause damage to organs through prolonged or repeated exposure. 5 sds@majordental.com 5.1. Extinguishing media. 10.2. Chemical stability. ZINC OXIDE GRB H319 United Kingdom Causes serious eye irritation. EH40/2005 Workplace exposure limits - RID: Regulation concerning the international transport of dangerous goods by train 5 SUITABLE EXTINGUISHING EQUIPMENT Solubility in water. GRC The product is stable in normal conditions of use and storage. H412 VLEP FRA Ελλάδα Harmful to aquatic life with long lasting effects. ΕΦΗΜΕΡΙΣ ΤΗΣ ΚΥΒΕΡΝΗΣΕΩΣ -ΤΕΥΧΟΣ ΠΡΩΤΟ Αρ. Φύλλου 19 - 9 Φεβρουαρίου 2012 2,9 mg/l Product distribution by Substances in Candidate List (Art. 59 REACH). - TLV: Threshold Limit Value Product distribution by WEL GRB 5 Major Prodotti Dentari S.p.A. The extinguishing equipment should be of the conventional kind: carbon dioxide, foam, powder and water spray. Solubility in water. HRV None. - TLV CEILING: Concentration that should not be exceeded during any time of occupational exposure. Hrvatska NN13/09 - Ministarstvo gospodarstva, rada i poduzetništva mg/l 0,1 - 100

Precautionary statements

UNSUITABLE EXTINGUISHING EQUIPMENT Biodegradability: Information not available. GVI HRV 5 Substances subject to authorisarion (Annex XIV REACH). 1.4. Emergency telephone number 10.3. Possibility of hazardous reactions. 1.4. Emergency telephone number HUN - TWA STEL: Short-term exposure limit P260 Magyarország Do not breathe dust / fume / gas / mist / vapours / spray. 50/2011. (XII. 22.) NGM rendelet a munkahelyek kémiai biztonságáról NOT rapidly biodegradable. None in particular. NLD No hazardous reactions are foreseeable in normal conditions of use and storage. None. Nederland Databank of the social and Economic Concil of Netherlands (SER) Values, AF 2011:18 - TWA: Time-weighted average exposure limit P280 Legend: Substances subject to exportation reporting pursuant to (EC) Reg. 649/2012: Wear eye protection / face protection. For urgent inquiries refer to POL For urgent inquiries refer to P305+P351+P338 Polska IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. ROZPORZĄDZENIE MINISTRA PRACY I POLITYKI SPOŁECZNEJ z dnia 16 grudnia 2011r Austria(+43) 1 406 43 43 12.3. Bioaccumulative potential. (C) = CEILING ; INHAL = Inhalable Fraction ; RESP = Respirable Fraction ; THORA = Thoracic Fraction. - VOC: Volatile organic Compounds None. 5.2. Special hazards arising from the substance or mixture. 10.4. Conditions to avoid. SVN VND = hazard identified but no DNEL/PNEC available ; NEA = no exposure expected ; NPI = no hazard identified.

vPvB Substances

Very Persistent and very Bioaccumulative as for REACH Regulation Slovenija Uradni list Republike Slovenije 15. 6. 2007 Belgium(+32) 070 245 245 HAZARDS CAUSED BY EXPOSURE IN THE EVENT OF FIRE

Contains

DIATOMACEOUS EARTH, SODA ASH FLUX CALCINATED SWE None in particular. However the usual precautions used for chemical products should be respected. Substances subject to the Rotterdam Convention: - WGK: Water hazard classes (German). ZINC OXIDE Sverige Occupational Exposure Limit Values, AF 2011:18 Bulgaria (+359) 2 9154 233 Do not breathe combustion products. The product is combustible and, when the powder is released into the air in sufficient concentrations and EU OEL EU Directive 2009/161/EU; Directive 2006/15/EC; Directive 2004/37/EC; Directive 2000/39/EC. During the risk assessment process, it is essential to take into consideration the ACGIH occupational exposure levels for inert particulate BCF. None. Croazia(+385) 1 23-48-342 > 175

2.3 Other hazards

10.5. Incompatible materials. in the presence of a source of ignition, it can create explosive mixtures with air. Fires may start or get worse by leakage of the solid product TLV-ACGIH ACGIH 2014 otherwise classified (PNOC respirable fraction 3 mg/m3; PNOC inhalable fraction 10 mg/m3). For values above these limits, use a P type Czech Republik(+420) 224 919 293, 224 915 402 from the container, when it reaches high temperatures or through contact with sources of ignition. Information not available. Substances subject to the Stockholm Convention: GENERAL BIBLIOGRAPHY Denmark(+.45) 82 12 12 12 12.4. Mobility in soil. filter, whose class (1, 2 or 3) must be chosen according to the outcome of risk assessment. On the basis of available data, the product does not contain any PBT or vPvB in percentage greater than 0,1%. None. 1. Regulation (EU) 1907/2006 (REACH) of the European Parliament DIATOMACEOUS EARTH, SODA ASH FLUX CALCINATED EstoniaLocal 16662 Internat. (+372) 626 93 90 5.3. Advice for firefighters. 10.6. Hazardous decomposition products. Health - Derived no-effect level - DNEL / DMEL 2. Regulation (EU) 1272/2008 (CLP) of the European Parliament Finland(+358) (09) 471 977 (direct) or (09) 4711 (exchange) 8.2. Exposure controls. GENERAL INFORMATION SODIUM PYROPHOSPHATE Healthcare controls.