Page 1 of 6 SECTION 1: Identification of the substance/mixture and of the company/undertaking Product identifier: Product trade name: CHLORAXID 5,25% GEL Relevant identified uses of the substance or mixture: Root canal irrigant Details of the supplier of the safety data sheet: Distributor: PPH CERKAMED Wojciech Pawłowski 37-450 Stalowa Wola ul. Kwiatkowskiego Tel. 015 / 842 35 85 Emergency telephone number: Toxicology Information (0-22) 618 77 10, National Poison Information Centre (0-42) 631 47 24 Person responsible for SDS: katarzyna.motyka@cerkamed.pl SDS revision date:23.08.2016 SECTION 2: Hazards identification Irritating. Irritating to eyes and skin. GHS classification WARNING Hazard statements (H): H315 Causes skin irritation. H319 Causes serious eye irritation. EUH 031 Contact with acids liberates toxic gas. Precautionary statements (P): P201 Obtain special instructions before use. P270 Do not eat, drink or smoke when using this product. P273 Avoid release to the environment. P281 Use personal protective equipment as required. P302 + P352 IF ON SKIN: Wash with plenty of soap and water. P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Storage: P402 Store in a dry place. P403 Store in a well-ventilated place. P410 Protect from sunlight. P501 Dispose of contents/container in accordance with national laws.
Page 2 of 6 SECTION 3: Composition/information on ingredients Substance name CAS No. EC No. H statements Conc. % (by weight) Sodium hypochlorite 7681-82-9 231-668-3 290,314,335,400 5,25 Sodium hydroxide 1310-73-2 215-185-5 314 >1 For full text of H statements and symbols refer to Section 16 of the SDS. SECTION 4: First aid measures General information: Never give anything by mouth to an unconscious person. Keep at rest in a position comfortable for breathing and call a doctor/physician. Inhalation Provide fresh air. Call a doctor/physician. Eye contact: Rinse immediately with plenty of water for at least 10 minutes. Avoid strong water jet due to the risk of mechanical corneal damage. Consult a doctor/physician immediately. Skin contact: Remove contaminated clothing. Flush skin with plenty of water. In case of irritation seek medical advice. Ingestion: Rinse mouth with water. Give milk to drink. Call a doctor/physician. SECTION 5: Firefighting measures Non-flammable mixture, use extinguishing agents suitable for the surrounding fire Suitable extinguishing media: powders and firefighting foams, carbon dioxide. Unsuitable extinguishing media (for safety reasons) Organic agents Special hazards arising from the substance or mixture Reaction with acids releases chlorine gas. Hazardous decomposition products Chlorine, hydrogen chloride Advice for firefighters: Special protective equipment for fire-fighters: Substances hazardous to health may be formed in case of fire. Wear gas-tight protective clothing and self-contained breathing apparatus (respirator with a face mask). SECTION 6: Accidental release measures Personal precautions, protective equipment and emergency procedures: Avoid contact with eyes and skin. Provide air exchange (ventilation). Follow occupational health and safety practices for handling chemicals. Use individual protection measures as specified in Section 8. Environmental precautions: In case of accident avoid release to the environment. Prevent from entering sewers, ground water, soil. Methods and material for containment and cleaning up: Use adsorbent materials, e.g. cover with sand, carefully collect, and place in appropriate, suitably labelled waste disposal container. Flush contaminated surface with water. SECTION 7: Handling and storage Precautions for safe handling: Handle in accordance with good professional practices and comply with OHS provisions. Do not eat, drink, or smoke, avoid eye and skin contact, and use individual protection measures (as specified in Section 8) when using this product. Spilled product produces a slippery surface. Fire and explosion protection: Non-flammable product.
Page 3 of 6 Conditions for safe storage, including any incompatibilities: Store in a well-ventilated and dry room, at the temperature 2-8 C. Protect from sunlight. SECTION 8: Exposure controls/personal protection Control parameters: Not determined for the mixture, only for hazardous constituents of the mixture: Substance name NDS (TLV-TWA, Poland) NDSCh (TLV-STEL, Poland) Sodium hydroxide [CAS: 1310-73-2] Sodium hypochlorite [CAS: 7681-82-9] 0.5 mg/m 3 1 mg/m 3 0.7 mg/m 3 1.5 mg/m 3 Legal basis Regulation of the Minister of Labour and Social Policy of 6 June 2014 on the highest permissible concentrations and intensities of agents harmful to health in workplace Determination of airborne concentration at workplace Respiratory protection: Not required if product is properly handled. Eye protection: Necessary - when working with the product wear safety glasses or face protection e.g. protective dental visor. Skin protection: Necessary - when working with the product wear safety gloves and suitable protective clothing apron. Other information: Avoid eye and skin exposure, do not eat, drink and smoke when using this product. SECTION 9: Physical and chemical properties Physical state, colour, odour Boiling point Melting point Vapour pressure Solubility in water Viscosity Flash point ph light-textured, colourless or slightly milky gel very good 4-6 Pa s 11 SECTION 10: Stability and reactivity Chemical stability: Product is stable under normal use and storage conditions. Incompatible materials and conditions to avoid: Acids, amines, ammonium compounds, cellulose
Page 4 of 6 Hazardous decomposition products Hydrogen chloride may be produced at high temperature. SECTION 11: Toxicological information Inhalation: Ingestion (swallowing): May cause irritation of the gastrointestinal mucosa. Skin exposure: Sodium hydroxide (CAS 1310-73-2): LD50 (rabbit): 1350 mg/kg May cause skin irritation: local redness. Eye exposure: Avoid contact with eyes. May cause eye irritation. Other information The product does not contain any components classified as carcinogenic, mutagenic or toxic for reproduction according to the Regulation of the Minister of Health of 24 July 2012 on carcinogenic or mutagenic chemical substances, mixtures, agents or technological processes in working environment (Polish Journal of Laws - Dz.U. 2012 No 0 item 890) SECTION 12: Ecological information Toxicity: Bioaccumulative potential: Persistence and degradability: Biodegradable. Other information: Regulation of the Minister of Environment of 28 January 2009 amending Regulation on the conditions to be met when releasing sewage into the water or soil, and on the substances that are particularly harmful to the aquatic environment free chlorine 0.2 mg Cl2/L, ph: 6.5-9.5 SECTION 13: Disposal considerations Waste product Avoid contamination of surface and ground water. Do not dispose with municipal waste. Transfer waste product to an authorised waste disposal company. (Polish Journal of Laws - Dz.U. 2013 item 888 of 13 June 2013) Waste code: 18 01 06 (Regulation of the Minister of Environment of 9 December 2014 on waste catalogue) Packaging Non-contaminated packaging should be transferred for recycling. Contaminated packaging should be transferred for recycling after emptying and cleaning. Waste code: 15 01 02 (Act of 13 June 2013 on the management of packaging and packaging waste)
Page 5 of 6 SECTION 14: Transport information The product is not subject to regulations on the transport of dangerous goods. Road transport (ADR/RID) not classifiable Sea transport (IMDG) not classifiable Air transport (ICAO/IATA) not classifiable SECTION 15: Regulatory information The product is subject to labelling. H315 Causes skin irritation. H319 Causes serious eye irritation. WARNING Other information: For use by qualified medical personnel only, as specified by the manufacturer. European Community laws: COMMISSION REGULATION (EU) No 453/2010 of 20 May 2010 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 National laws: ACT of 25 February 2011 on chemical substances and mixtures thereof (Polish Journal of Laws - Dz.U. of 2011 No 63 item 322) REGULATION OF THE MINISTER OF HEALTH of 20 April 2012 on labelling the packaging of hazardous substances, hazardous mixtures and certain chemical mixtures (Polish Journal of Laws - Dz.U. of 2012 No 0 item 445 as amended) REGULATION OF THE MINISTER OF HEALTH of 24 July 2012 on carcinogenic or mutagenic chemical substances, mixtures, agents or technological processes in working environment (Polish Journal of Laws - Dz.U. of 2012 No 0 item 890, as amended) Regulation of the Minister of Labour and Social Policy of 6 June 2014 on the highest permissible concentrations and intensities of agents harmful to health in workplace Regulation of the Minister of the Economy of 21 December 2005 on essential requirements for personal protective equipment (Polish Journal of Laws - Dz.U. No 259 item 2173, 2005) Government statement of 26 March 2015 on entry into force of amendments to Appendices A and B of the European Agreement concerning International Carriage of Dangerous Goods by Road (ADR) (Polish Journal of Laws - Dz.U. of 2015 item 882) Regulation of the Minister of Health of 16 January 2003 on preservatives, sweeteners, colourants,
Page 6 of 6 antioxidants which may be added to medicinal products SECTION 16: Other information Explanation of the symbols and statements listed in Section 3: Hazard statements (H): H290 May be corrosive to metals H314 Causes severe skin burns and eye damage. H315 Causes skin irritation. H318 Causes serious eye damage. H33 May cause respiratory irritation H400 Very toxic to aquatic life EUH031 Contact with acids liberates toxic gas Other basic data sources for compilation of SDS: SDSs of the manufacturers of individual components of the product. EINECS computer database, 2005. IUCLID Data Bank ESIS European Chemical Substances Information System These data are based on the present state of our knowledge. The information provided in this SDS describe the product in terms of safety requirements. It is the responsibility of the user to secure conditions for safe use of the product. Moreover, the user accepts responsibility for the consequences of improper use of the product.