SAFETY DATA SHEET Potassium hydroxide solution 54% Page 1 / 10 REACHLaw Ltd. (Only Representative) Date 13/04/2015 Previous date: - SECTION 1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/ UNDERTAKING 1.1 1.1.1 Product identifier Commercial Product Name Potassium hydroxide solution 54% 1.1.2 Product code Substance name: Potassium hydroxide CAS-No.: 1310-58-3 EC-No.: 215-181-3 REACH Registration Number 01-2119487136-33-0027 Relevant identified uses of the substance or mixture and uses advised against 1.2 1.2.1 1.3 1.3.1 1.3.3 1.4 1.4.1 Recommended use Industrial, professional and consumer use of potassium hydroxide solution, including use in batteries. Uses advised against: The recommended uses are listed above and in section 7.3. Other uses are not recommended unless a safety assessment is completed prior to commencement of that use, which demonstrates that the possible exposure to the substance will be controlled. Such an additional assessment is the responsibility of the individual user. Details of the supplier of the safety data sheet Supplier REACHLaw Ltd. (Only Representative) Street address Vänrikinkuja 3 JK 21 Postcode and post office 02600 Espoo Finland Telephone +358(0) 9 412 3055 Telefax +358(0) 9 412 3049 Email [email protected], webpage: www.reachlaw.fi Identification of the non-community manufacturer Joint Stock Company "BELARUSKALI" Korzh Str., 5 223710 Soligorsk Belarus Email: [email protected] Emergency telephone number Telephone number, name and address See section 16.6 for the list of telephone numbers of poison centers in the European Economic Area. SECTION 2. HAZARDS IDENTIFICATION 2.1 The substance is classified as hazardous in accordance with the CLP Regulation 1272/2008 and the Directive 67/548/EEC. The skin corrosion and oral toxicity hazard classes are derived based on the harmonized classification entries of the CLP Annex VI. The physical hazard class Corrosive to metals is based on selfclassification of the lead registrant in REACH registration. Classification of the substance or mixture 67/548/EEC (DSD): Xn; R22 C; R35 1272/2008 (CLP) Page 2 / 10 SAFETY DATA SHEET Potassium hydroxide solution 54% REACHLaw Ltd. (Only Representative) Date 13/04/2015 Previous date: Met. Corr. 1, H290 Acute Tox. 4, H302 Skin Corr. 1A, H314 2.2 Label elements 1272/2008 (CLP) GHS07 - GHS05 Signal word Danger Hazard Statements H290 May be corrosive to metals. H302 Harmful if swallowed. H314 Causes severe skin burns and eye damage. Precautionary Statements P260 Do not breathe dust/fume/gas/mist/vapours/spray. P280 Wear protective gloves/protective clothing/eye protection/face protection. P303+P361+P353 IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower. P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310 Immediately call a POISON CENTER or doctor/physician. 2.3 Other hazards The substance is inorganic, therefore, the PBT/vPvB assessment is not applicable. SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS 3.1 Substances Mono-constituent substance. CAS/EC and EINECS Reg.number 1310-58-3 215-181-3 Chemical name of the substance potassium hydroxide Concentration Classification 1310-73-2 sodium hydroxide <0,8 % 215-185-5 54 % Xn; R22;C; R35; Acute Tox. 4, H302; Skin Corr. 1A, H314; Met. Corr. 1, H290 C; R35; Skin Corr. 1A, H314 SECTION 4. FIRST AID MEASURES 4.1 Description of first aid measures Assess the situation quickly. Ensure that medical personnel are aware of the substance(s) involved and take precautions to protect themselves. Seek medical advice immediately; do not wait to see if symptoms subside after administration of first aid measures. 4.1.2 Inhalation Keep patient calm and at rest, remove to fresh air. If difficulty in breathing develops seek medical attention immediately. Continue to monitor the breathing until medical help arrives. If patient is unconscious and breathing, place in the recovery position and keep monitoring the airway and breathing. DO NOT place a pillow under the person’s head if he is lying down (this can close the airway). 4.1.3 Skin contact Remove and isolate contaminated clothing and shoes (USE CAUTION while removing shirts to prevent contamination of the face and eyes). Immediately wash affected area with soap and plenty of water. Consult a doctor. SAFETY DATA SHEET Potassium hydroxide solution 54% Page 3 / 10 REACHLaw Ltd. (Only Representative) Date 13/04/2015 Previous date: 4.1.4 4.1.5 Eye contact Rinse immediately with plenty of water for at least 15 minutes. Do not apply neutralizing agents. Consult a doctor. Ingestion Refer immediately for medical attention. Do NOT induce vomiting. Rinse mouth with water. Never give water to an unconscious person. 4.2 Most important symptoms and effects, both acute and delayed After inhalation: Cough. Sore throat. Burning sensation. Shortness of breath. After contact with skin: Redness. Pain. Serious skin burns. Blisters. After contact with eyes: Redness. Pain. Blurred vision. Severe burns. After ingestion: Abdominal pain. Burns in mouth and throat. Burning sensation in the throat and chest. Nausea. Vomiting. Shock or collapse. 4.3 Indication of immediate medical attention and special treatment needed No data available. SECTION 5. FIREFIGHTING MEASURES 5.1 5.1.1 5.2 5.3 The product is non-combustible. Extinguishing media Suitable extinguishing media Use fire-extinguishing media appropriate for surrounding materials. Unsuitable extinguishing media: water may be ineffective. Special hazards arising from the substance or mixture Corrosive liquid. Not combustible. Reacts violently with water. Gives off hydrogen by reaction with metals. Advice for firefighters Use fire fighting water moderately and contain it. Use water spray to cool tanks/containers exposed to heat / remove them into safety. Wear self contained breathing apparatus in case of fire. Wear corrosionproof suit. SECTION 6. ACCIDENTAL RELEASE MEASURES 6.1 Personal precautions, protective equipment and emergency procedures Isolate the area. Evacuate personnel to safe areas. Approach from upwind. Ventilate the area. Keep away from incompatible products. Wear chemical resistant personal protective equipment. Prevent further leakage or spillage if safe to do so. Abundant running water should be available for emergency use. Refer to protective measures listed in sections handling and storage and exposure controls/personal protection. 6.2 Environmental precautions SAFETY DATA SHEET Potassium hydroxide solution 54% Page 4 / 10 REACHLaw Ltd. (Only Representative) Date 13/04/2015 Previous date: - 6.3 6.4 Should not be released into the environment. Do not flush into surface water or sanitary sewer system. Dam up the liquid spill. Contain leaking substance, pump over in suitable containers. Notify environmental personnel. Methods and materials for containment and cleaning up Take up liquid spill with inert absorbent material. Scoop absorbed substance into closing containers. Carefully collect spill / leftovers. Equipment must be corrosion resistant. Flush contaminated areas with large amounts of water and direct rinsings to chemical sewer or collect for treatment. Reference to other sections See also section 8. SECTION 7. HANDLING AND STORAGE 7.1 Precautions for safe handling Observe strict hygiene - avoid eye and skin contact. Avoid splashing of material. Safety showers should be readily available in handling and storage areas. Eye wash fountains should be located in the work areas and should be immediately accessible for emergency use. Remove contaminated clothing immediately. When diluting, always add the product to water. Never add water to the product. Keep away from incompatible products. 7.2 Conditions for safe storage, including any incompatibilities Store in a well-ventilated area. Store at ambient temperature. Keep container tightly closed. KOH in contact with water or moisture may result in enough heat to ignite combustibles. Keep away from : heat sources, highly flammable materials, incompatible products. 7.3 Suitable packaging material: stainless steel, synthetic material / polyethylene, glass. To avoid: lead, aluminium, copper, tin, zinc, bronze Specific end use(s) The exposure assessment for environment is based on measured data and analogous data from the exposure assessment of the EU RAR for sodium hydroxide (2007). The risk assessment for the environment is only relevant for the aquatic environment, when applicable including STPs/WWTPs, as emissions mainly apply to (waste) water. The exposure assessment for human helath is done qualitatevily except for the inhalation exposure. ECETOC TRA tool is used to estimate workplace exposure for inhalation. See further the information provided in the Annexes to this SDS. The technical conditions and measures at process level and to control dispersion from source towards the workers are also summarized in section 8 of this SDS. List of ES's: ES 1: Industrial use of solid and liquid KOH ES 2: Professional use of solid and liquid KOH (excl. batteries) ES 3: Consumer use of solid and liquid KOH, use in batteries SAFETY DATA SHEET Potassium hydroxide solution 54% Page 5 / 10 REACHLaw Ltd. (Only Representative) Date 13/04/2015 Previous date: - SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION 8.1 Control parameters 8.1.4 DNELs DNELs for workers: Acute exposure - Systemic Not established as KOH is not expected to become systemically available in the body under normal handling and use conditions. Acute exposure - Local dermal: the concentration limit for corrosivity of KOH is considered to be 2%. inhalation: not applicable. Long-term exposure - Systemic Not established as KOH is not expected to become systemically available in the body under normal handling and use conditions. Long-term exposure - Local dermal: not derived. inhalation: 1.0 mg/m³. Based on read-across from DNEL of sodium hydroxide (EU RAR (2007). 8.1.5 8.2 8.2.1 8.2.2 8.2.2.1 8.2.2.2 8.2.2.3 8.2.2.4 8.2.3 DNELs for the general population: Acute - short-term exposure - local effects - dermal: concentration of 2%. Long-term exposure - Local-inhalation: 1.0 mg/m³. Based on read-across from DNEL of sodium hydroxide (EU RAR (2007). PNECs PNEC aqua: not derived. pH and the buffer capacity of natural waters show considerable differences resulting in different pH optima and pH ranges that are tolerated. Based on read-across from EU RAR for sodium hydroxide (2007). PNEC sediment and PNEC soil: not derived. KOH dissociates in water and will not absorb on particulate matter. PNEC STP: no generic PNEC for STP effluent could be calculated. Based on read-across from EU RAR for sodium hydroxide (2007). Exposure controls Appropriate engineering controls Handle in accordance with good industrial hygiene and safety practice. Ensure adequate ventilation. Apply technical measures to comply with the occupational exposure limits. Individual protection measures Respiratory protection In the case of dust or aerosol formation use respirator with an approved filter. Recommended Filter type: P2. Hand protection Handle with impervious gloves. Suitable material: PVC, Neoprene, Natural rubber, Butyl rubber. Unsuitable material: Leather. Eye/face protection Wear chemical resistant goggles. Face shield if risk on splashes. Skin protection Corrosionproof clothing. Suitable material: PVC, Neoprene, Natural rubber, Butyl rubber. Environmental exposure controls Dispose of rinse water in accordance with local and national regulations. SAFETY DATA SHEET Potassium hydroxide solution 54% Page 6 / 10 REACHLaw Ltd. (Only Representative) Date 13/04/2015 Previous date: - SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES 9.1 9.1.1 Important Health Safety and Environmental Information Appearance Form: liquid. Colour: colourless or with a shade of blue, green or grey. Possible crystalline precipitate. 9.1.2 Odour 9.1.5 Melting point/freezing point 9.1.6 Initial boiling point and boiling range 9.1.13 Relative density 9.1.14 9.1.14.1 Solubility(ies) Water solubility 9.1.19 Explosive properties 9.1.20 Oxidising properties 9.2 Other information KOH is a strong alkaline substance that dissociates completely in water into the potassium ion (K+) and hydroxyl ion (OH-). The dissolution/dissociation in water is strongly exothermic, so a vigorous reaction occurs when KOH is added to water. NEVER pour water into this substance; when dissolving or diluting always add it slowly to the water. odourless 406°C (CRC Handbook of Chemistry & Physics (Lide)) 1327°C at 1013 hPa 1,456 g/mL at 25 °C 121g/100g water at 25°C There are no chemical groups associated with explosive properties present in the molecule. Substance does not contain functional groups associated with oxidising properties. SECTION 10. STABILITY AND REACTIVITY 10.1 Reactivity Potential for exothermic hazard May be corrosive to metals. 10.2 Chemical stability Stable under recommended storage conditions. Possibility of hazardous reactions Gives of hydrogen by reaction with metals. Exothermic reaction with strong acids. 10.3 10.4 Conditions to avoid Unstable on exposure to air. 10.5 Incompatible materials Keep away from: heat sources, oxidizing agents, acids, highly flammable materials, halogens, organic materials. Keep away from: lead, aluminium, copper, tin, zinc, bronze. Hazardous decomposition products Absorbs the atmospheric CO2. 10.6 Hydrogen : reacts with (some) metals and their compounds: release of highly flammable gas. SECTION 11. TOXICOLOGICAL INFORMATION 11.1 Information on toxicological effects Upon dermal exposure, the uptake of KOH is relatively low. Upon ingestion, the adsorbtion of KOH is effective but it is not expected to be systamically available in the body. 11.1.1 Acute toxicity Oral, rat (Sprague-Dawley), male LD50: 333 mg/kg bw (equivalent or similar to OECD Guideline 425). KOH is classified as an acute toxicant category 4 for the oral route. Not classified as an acute toxicant for inhalation and dermal routes. SAFETY DATA SHEET Potassium hydroxide solution 54% Page 7 / 10 REACHLaw Ltd. (Only Representative) Date 13/04/2015 Previous date: 11.1.2 11.1.3 11.1.4 Irritation and corrosion Skin irritation / corrosion: based on studies on rabbit, guinea pig (Hartley) and in vitro methods (TER, Corrositex, Episkin and Skin²ZK1350): corrosive (OECD Guideline 404). Eye irritation / corrosion, rabbit (Albino): corrosive (OECD Guideline 405). Respiratory irritation, human data: not irritating (self-reporting of symptoms). Potassium hydroxide is classified Skin corrosive, category 1A. The concentration limit for corrosivity to the skin of potassium hydroxide is considered to be 2%. KOH is a strong corrosive substance at a concentration > or = 5%. The concentration range for eye/skin irritation of KOH is 0.5 % ≤ C < 2%. Sensitisation Skin sensitisation, guinea pig (albino) male: not sensitising (Landsteiner and Jacobs method). No classification regarding sensitisation is required. Subacute, subchronic and prolonged toxicity Repeated dose toxicity: Systemic effects of KOH after repeated exposure are not expected to occur under normal handling and use. No classification regarding repeated dose toxicity is required. Mutagenicity: Genetic toxicity: not feasible to perform genotoxicity tests at physiological pH with KOH. No classication regarding genetic toxicity is required. Carcinogenicity: Lack of positive in vitro and in vivo mutagenecity data support no classification for carcinogenicity and support no additional animal testing to assess carcinogenicity. 11.1.5 11.1.6 11.1.7 11.1.8 Reproductive toxicity: KOH is not expected to be systemically available in the body under normal handling and use conditions. No classification regarding reproductive toxicity is required. STOT-single exposure Potassium hydroxide has not been classified for STOT SE. STOT-repeated exposure Potassium hydroxide has not been classified for STOT RE. Aspiration hazard No classification regarding aspiration hazard is required. Other information on acute toxicity No data availalbe. SECTION 12. ECOLOGICAL INFORMATION 12.1 12.1.1 Toxicity Aquatic toxicity Potassium hydroxide is not classified for the environmental compartment based on its dissociation in the environment, lack of bioaccumulation, and lack of adsorption to particulate matter or surfaces. KOH is known to be a strong alkaline substance that dissociates completely in water to K+ and OH- (OECD SIAR potassium hydroxide, 2002). The only posssible effect of KOH would be indirect as a result of the pH effect. pH is expected to remain within environmentally expected ranges. 12.1.2 Toxicity to other organisms Potassium hydroxide is expected to remain in the water phase due to high water solubility and low octanolwater partitioning coefficient. 12.2 12.2.1 Persistence and degradability Biodegradation Not applicable as potassium hydroxide is an inorganic substance. SAFETY DATA SHEET Potassium hydroxide solution 54% Page 8 / 10 REACHLaw Ltd. (Only Representative) Date 13/04/2015 Previous date: 12.2.2 12.3 Chemical degradation Not applicable as potassium hydroxide dissociates completely in water to ions. Bioaccumulative potential Potassium hydroxide is not expected to bioaccumulate in organisms. 12.4 Mobility in soil Potassium hydroxide dissociates in surface water, therefore, sorption to particulate matter and sediment will be negligible. The substance will follow water movements. 12.5 Results of PBT and vPvB assessment The substanve does not fulfill the criteria either for persistent, bioaccumulative and toxic substances (PBTsubstances), nor for very persistent and very bioaccumulative substances (vPvB-substances). 12.6 Other adverse effects Indirect exposure via air is not expected. SECTION 13. DISPOSAL CONSIDERATIONS 13.1 Provisions relating to waste: - Waste material code (91/689/EEC, Council Decision 2001/118/EC, O.J. L47 of 16/2/2001): 06 02 04 (sodium and potassium hydroxide) - Waste material code (Flanders): 302 - Hazardous waste (91/689/EEC) - Waste material code packaging (91/689/EEC, Council Decision 2001/118/EC, O.J. L47 of 16/2/2001): 15 01 10 (packaging containing residues of or contaminated by dangerous substances). Waste treatment methods Discharging to municipal wasterwater should be avoided. Dilution with plenty of water and neutralisation with pH control is recommended. Liquid waste should be reused or neutralized waste is discharged to the industrial wastewater. Waste treatment should be done in accordance with local and national regulations. Contaminated packaging is treated in accordance with local and national regulations. Where possible, recycling is preferred to disposal or incineration. Containers should be cleaned with water. SECTION 14. TRANSPORT INFORMATION 14.1 UN number 14.2 UN proper shipping name 14.3 Transport hazard class(es) 14.4 Packing group 14.5 Environmental hazards ADR/RID: no. IMDG: Marine pollutant: no. IATA: no. 14.6 Special precautions for users ADR/RID labels: DANGER LABEL TANKS : 8. DANGER LABEL PACKAGES : 8. IMDG: EmS number 8-06. Labels: 8 CORROSIVE EMS: F-A, S-B. IATA labels: CORROSIVE PACKING INSTRUCTIONS PASSENGER AIRCRAFT : 809/Y809 PACKING INSTRUCTIONS CARGO AIRCRAFT : 813 Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code No data available. 14.7 SECTION 15. REGULATORY INFORMATION ADR/RID: ADR/RID: ADR/RID: ADR/RID: 1814 IMDG: 1814 IATA: 1814 POTASSIUM HYDROXIDE SOLUTION 8 IMDG: 8 IATA: 8 II. IMDG: II. IATA: II. SAFETY DATA SHEET Potassium hydroxide solution 54% Page 9 / 10 REACHLaw Ltd. (Only Representative) Date 13/04/2015 Previous date: 15.1 15.2 Safety, health and environmental regulations/legislation specific for the substance or mixture EU Regulation (EC) No. 1907/2006 (REACH) Subject to Authorization (Annex XIV - List of substances subject to authorisation, Substances of very high concern): No. Subject to Restrictions on use (Annex XVII - Restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles): No. Chemical safety assessment In accordance with Regulation (EC) No. 1907/2006 (REACH) Article 14, a Chemical Safety Assessment has been carried out for this substance. SECTION 16. OTHER INFORMATION 16.1 Additions, Deletions, Revisions Version 1.0, all sections aligned with the REACH Chemical Safety Report. This safety data sheet is drawn up to comply with the requirements of Regulation (EC) No. 1907/2006 (REACH), as amended by Annex I to Commission Regulation (EU) No. 453/2010 of 20 May 2010. 16.2 Key or legend to abbreviations and acronyms -CLP - 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 -DNEL - Derived no-effect level -DSD - Council Directive 67/548/EEC (Dangerous Substances Directive) -DPD - Council Directive 1999/45/EC (Dangerous Preparations Directive) -EWC - European Waste Catalogue -GLP - Good Laboratory Practice -LC50 -Concentration of the substance that causes 50 % mortality of the test population -LD50 - Lethal dose of the substance that causes 50 % mortality of the test population -MAK - Maximale Arbeitsplatzkonzentrationen (Germany): maximum concentration of a chemical substance in the workplace, expressed as daily 8-hour time-weighed average values and apply to healthy adults. -NOAEL- No observed adverse effect level -NOEC - No observed effect concentration -NOEL- No observed effect level -OECD - Organisation for Economic Co-operation and Development -OEL - Occupational exposure limit -PBT/vPvB - Persistent, bioaccumulative and toxic/ very persistent and very bioaccumulative -PEL - Permissible exposure limit -PNEC - Predicted no-effect concentration -QSAR - Quantitative structure-activity relationship -REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals -REL - Recommended exposure limit -STEL - Short term exposure limit -STOT RE - Specific Target Organ Toxicity, Repeated Exposure -STOT SE - Specific Target Organ Toxicity, Single Exposure -STP - Sewage treatment plant -TLV - Threshold limit value -TWA - Time weighted average 16.3 Key literature references and sources for data REACH Chemical Safety Report Part B, Potassium hydroxide. All referenced studies within this safety data sheet can be found from the original Chemical Safety Report. Classification procedure This substance has a harmonised classification according to Annex VI to Regulation (EC) No. 1272/2008 (CLP). In addition to harmonised classification, the self-classification is done by the Lead registrant. 16.4 SAFETY DATA SHEET Potassium hydroxide solution 54% Page 10 / 10 REACHLaw Ltd. (Only Representative) Date 13/04/2015 Previous date: 16.6 16.7 Emergency telephone number Europe-wide emergency number: 112 Contact a poison control centre. List of Telephone Numbers : AUSTRIA (Vienna Wien) +43 1 406 43 43; BELGIUM (Brussels Bruxelles) +32 70 245 245; BULGARIA (Sofia) + 359 2 9154 409; CZECH REPUBLIC (Prague Praha) +420 224 919 293; DENMARK (Copenhagen) 82 12 12 12; ESTONIA (Tallinn) 112; FINLAND (Helsinki) +358 9 471 977; FRANCE (Paris) +33 1 40 0548 48; GERMANY (Berlin) +49 30 19240; GREECE (Athens Athinai) +30 10 779 3777; HUNGARY (Budapest) 06 80 20 11 99; ICELAND (Reykjavik) +354 525 111, +354 543 2222; IRELAND (Dublin) +353 1 8379964; ITALY (Rome) +39 06 305 4343; LATVIA (Riga) +371 704 2468; LITHUANIA (Vilnius) +370 5 236 20 52 or +370 687 53378; MALTA (Valletta) 2425 0000; NETHERLANDS (Bilthoven) +31 30 274 88 88; NORWAY (Oslo) 22 591300; POLAND (Gdansk) +48 58301 65 16 or +48 58 349 2831; PORTUGAL (Lisbon Lisboa) 808 250 143; ROMANIA (Bucharest) +40 21 3183606 SLOVAKIA (Bratislava) +421 2 54 77 4166; SLOVENIA (Ljubljana) + 386 41 650 500; SPAIN (Barcelona) +34 93 227 98 33 or +34 93 227 54 00 bleep 190; SWEDEN (Stockholm) 112 or +46 8 33 12 31 (mon-fri 9.00-17.00); UNITED KINGDOM (London) 112 or 0845 4647 (NHS Direct). Recommended restrictions DISCLAIMER OF LIABILITY: The information in this SDS was obtained from recent Chemical Safety Report of this substance from REACH registration 2010. However, the information is provided without any warranty, express or implied, regarding its correctness. The conditions or methods of handling, storage, use or disposal of the product are beyond our control and may be beyond our knowledge. For this and other reasons, we do not assume responsibility and expressly disclaim liability for loss, damage or expense arising out of or in any way connected with the handling, storage, use or disposal of the product. This SDS was prepared and is to be used only for this product. If the product is used as a component in another product, this SDS information may not be applicable. Conforms to Annex II of Regulation (EC) No. 1907/2006 (REACH) ANNEX TO EXTENDED SAFETY DATA SHEET Potassium hydroxide solution th Date: 13 April 2015 Previous date: REACHLaw Ltd. (Only Representative) Page 1 / 9 Version 1.0 Annex to extended Safety Data Sheet Table of Contents SDS-ES Nro CSR-ES Nro Exposure scenario (ES) name 1 ES 3 Industrial and professional use of solid and liquid KOH 2 ES 4 Consumer use of solid and liquid KOH (excl. batteries) 3 ES 5 Consumer use, service life and waste stage of KOH in batteries Page 2 6 8 Conforms to Annex II of Regulation (EC) No. 1907/2006 (REACH) ANNEX TO EXTENDED SAFETY DATA SHEET Potassium hydroxide solution th Date: 13 April 2015 Previous date: Page 2 / 9 Version 1.0 REACHLaw Ltd. (Only Representative) ES 1: Industrial and professional use of solid and liquid KOH 1. Title of Exposure scenario Exposure Scenario 3: Industrial and professional use of solid and liquid KOH Description of process(es) covered in the Exposure Scenario: Environment: ERC2, ERC4, ERC5, ERC6, The exposure assessment is based on measured data and analogous data from the exposure assessment of the EU ERC7, ERC8 RAR for NaOH (2007). Worker contributing scenarios: can be potentially used in all sectors of use (SU 1-23) Use in closed process, no likelihood of exposure PROC 1 Use in closed, continuous process with occasional controlled exposure PROC 2 Use in closed batch process (synthesis or formulation) PROC 3 Use in batch and other process (synthesis) where opportunity for exposure arises PROC 4 Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact) PROC 5 Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities PROC 8a Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC 8b Transfer of substance or preparation into small containers (dedicated filling line, including weighing) PROC 9 Roller application or brushing of adhesive and other coating PROC 10 Spraying outside industrial settings or applications PROC 11 Treatment of articles by dipping and pouring PROC 13 Production of preparations or articles by tabletting, compression, extrusion, pelletisation PROC 14 Use as laboratory reagent PROC 15 Hand-mixing with intimate contact and only PPE available PROC 19 Open processing and transfer operations (with minerals) at elevated temperature PROC 23 High (mechanical) energy work-up of substances bound in materials and/or articles PROC 24 Handling of solid inorganic substances at ambient temperature PROC 26 Description of activities covered in the Exposure Scenario: This exposure scenario covers the industrial and professional use of potassium hydroxide that includes non-dispersive and wide dispersive uses. Non-dispersive uses on industrial level: as an intermediate or as a reactive processing aid in production of potassium carbonate, chemical manufacturing, production of potassium chemicals, production of fertilizers, production of phosphates, production of detergents, production of agricultural chemicals, production of alkaline batteries. Uses on professional level include transfer of KOH by professionals and wide dispersive indoor and outdoor use of KOH-containing formulations: detergents, fertilizers, drain cleaners, paint strippers, cosmetics/personal care. In fertilizers, KOH usually interacts with other ingredients in acid-base reactions and thus practically no free KOH is left in the final product. In some cases, up to 20% of free KOH can still be present in the fertilizer. KOH amount in the end products are limited. The KOH will be diluted and will interact with other ingredients in acidbase reactions and thus practically no free KOH is left in the final product. 2. Conditions of use affecting exposure 2.1 Control of environmental exposure Product characteristics Physical form: Solid/liquid Molecular weight: 56.105 Water Solubility 121g/100g water at 25°C Daily use at a site: 200 days/year Conforms to Annex II of Regulation (EC) No. 1907/2006 (REACH) ANNEX TO EXTENDED SAFETY DATA SHEET Potassium hydroxide solution th Date: 13 April 2015 Previous date: REACHLaw Ltd. (Only Representative) Page 3 / 9 Version 1.0 Environment factors not influenced by risk management Flow rate of receiving surface water: not applicable Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to reduce or limit discharges, air emissions and releases to soil Containment Process losses are reduced to the absolute minimum through the use of closed or covered manufacturing equipment. Technical measures to reduce releases to air Not relevant. Technical measures to reduce releases to water Control of pH (neutralization) of effluents should take place. Technical measures to reduce releases to soil Not applicable. The composition of products and the overall processes are such that there are no discharges of raw materials or products to soil from the manufacturing plant. Organizational measures to prevent/limit release from site Personnel are trained in environment, health and safety issues, i.e. in safe handling of chemicals and good housekeeping. Conditions and measures related to municipal sewage treatment plant Municipal STP: Waste water emission controls are not applicable as direct release to wastewater should be avoided. Discharge rate of effluent Not relevant. Sludge treatment technique Not applicable. Conditions and measures related to external recovery of waste Not relevant. Additional good practise advice beyond the REACH CSA Note: The measures reported in this section have not been taken into account in the exposure estimates related to the exposure scenario above. They are not subject to obligation laid down in Article 37 (4) of REACH, Thus, the downstream user is not obliged to i) carry out an own CSA and ii) to notify the use to the Agency, if he does not implement these measures. Housekeeping: General good hygiene and housekeeping. 2.2 Control of workers exposure Product characteristic Physical form: Solid/liquid Concentration of substance in product (if liquid): >5% Frequency and duration of use/exposure and other operational conditions affecting workers exposure Duration of activity >4 h, no local exhaust ventilation (LEV), no respiratory protection. Technical conditions and measures at process level (source) to prevent release Organisational measures to prevent /limit releases, dispersion and exposure Replacing, where appropriate, manual processes by automated and/or closed processes. This would avoid irritating mists, sprays and subsequent potential splashes: use closed systems or cover open containers (e.g. screens) and transport through pipes, technical barrel filling/emptying of barrel with automatic systems (suction pumps etc.) Use of pliers, grip arms with long handles with manual use to avoid direct contact and exposure by splashes. Technical conditions and measures to control dispersion from source towards the worker Local exhaust ventilation is not required but good practice. General ventilation is a good practice unless local exhaust ventilation is present. Conditions and measures related to personal protection, hygiene and health evaluation Respiratory Protection Workers Eye/face protection: Dermal protection Respiratory protection Chemical resistant goggles Impervious chemical resistant protective with approved filter must be worn. If splashes gloves. (P2). are likely to occur, wear tightly fitting safety goggles, face –shield. Conforms to Annex II of Regulation (EC) No. 1907/2006 (REACH) ANNEX TO EXTENDED SAFETY DATA SHEET Potassium hydroxide solution th Date: 13 April 2015 Previous date: Professionals REACHLaw Ltd. (Only Representative) Respiratory protection with approved filter (P2). If splashes are likely to occur, wear tightly fitting chemical resistant safety goggles, face –shield. Page 4 / 9 Version 1.0 Impervious chemical resistant protective gloves. If splashes are likely to occur, wear suitable protective clothing, aprons, shield and suits, rubber or plastic boots. Additional good practise advice beyond the REACH CSA Note: The measures reported in this section have not been taken into account in the exposure estimates related to the exposure scenario above. They are not subject to obligation laid down in Article 37 (4) of REACH, Thus, the downstream user is not obliged to i) carry out an own CSA and ii) to notify the use to the Agency, if he does not implement these measures. General good hygiene and housekeeping. Workers in the risky process/areas identified should be trained a) to avoid to work without respiratory protection and b) to understand the corrosive properties and, especially, the respiratory inhalation effects of potassium hydroxide and c) to follow the safer procedures instructed by the employer (EU RRS, 2008). The employer should ascertain that the required PPE is available and used according to instructions. 3. Exposure estimation and reference to its source Environment Local exposure estimation and risk characterisation The risk assessment for the environment is only relevant for the aquatic environment, when applicable including STPs/WWTPs, as emissions mainly apply to (waste) water. The aquatic effect and risk assessment only dealt with the effect on organisms/ecosystems due to possible pH + changes related to OH discharges, as the toxicity of the K ion is expected to be insignificant compared to the (potential) pH effect. Only the local scale is addressed, including sewage treatment plants (STPs) or waste water treatment plants (WWTPs) when applicable, both for production and industrial use. Furthermore, the high water solubility and very low vapour pressure indicate that KOH will be found predominantly in water. Significant emissions or exposure to air are not expected due to the very low vapour pressure of KOH. Significant emissions or exposure to the terrestrial environment are not expected either. The sludge application route is not relevant for the emission to agricultural soil, as sorption of KOH to particulate matter will not occur in STPs/WWTPs. Risk characterisation for man via the environment Indirect exposure to humans, for example through the uptake of drinking water, is not relevant for KOH. Any potential for exposure to KOH due to environmental releases will only have relevance at the local scale. Any pH effect of local releases will be neutralized by the buffer capacity of the receiving water and therefore no pH impacts at the regional scale related to KOH releases should be expected. Therefore indirect exposure of humans via the environment (oral) is not relevant in the case of KOH. Worker exposure Qualitative assessment Only qualitative assessment has been done for dermal exposure estimations because a DNEL for dermal exposure is not applicable. KOH products with a concentration > 2% are corrosive, therefore, effective control measures are expected to be in place to prevent dermal exposure. Protective clothing and gloves are considered to be used consistently when handling corrosive substances. Repeated daily dermal exposure to the pure substance is, therefore, considered negligible. Inhalation exposure is estimated with ECETOC TRA v3. Several exposure assessment methods were considered: measured data, analogous measured data (based on NaOH) and modelled estimates. Reasonable worst-case values used for risk characterisation are: 3 0.56 mg/m for PROCs 1-10,13,20 3 0.6 mg/m for PROCs 11-12 and PROCs 14-19 Route ES 3- exposure Leading toxic end DNEL Risk characterisation ratio (RCR) concentrations point / Critical (EC) effect Dermal- local Acute Not relevant Skin/eye irritation/ Qualitative (case KOH concentrations ≥ 2%): Workers can be corrosion Long term Not relevant Skin/eye irritation/ corrosion exposed to corrosive concentrations. However, dermal exposure to KOH is considered to occur only accidentally if the required protection is strictly adhered to. Therefore, a conclusion on adequately controlled risks is justifiable for scenarios in which corrosive concentrations of KOH are handled. Qualitative (case KOH concentrations < 2% and > 0.5%): When existing controls and recommended RMMs are applied, safe use can be concluded. Qualitative (case KOH concentrations < 0.5%): Safe use can be Conforms to Annex II of Regulation (EC) No. 1907/2006 (REACH) ANNEX TO EXTENDED SAFETY DATA SHEET Potassium hydroxide solution th Date: 13 April 2015 Previous date: REACHLaw Ltd. (Only Representative) Page 5 / 9 Version 1.0 concluded because no health effects are observed. Inhalationlocal Acute/Long term 3 0.6 mg/m Respiratory tract irritation 1 mg/m 3 0.6 4. Guidance to DU to evaluate whether he works inside the boundaries set by the ES On the basis of the assumptions made in the exposure assessment and this risk characterisation, it can be concluded that processes associated with the use of potassium hydroxide are unlikely to pose an unacceptable health risk to industrial workers when the exposures are controlled using appropriate operational conditions (e.g. task duration, use of ventilation) and risk management measures (e.g. PPE). Since the exposure assessment and risk characterization has been conducted qualitatively, scaling is not applicable except for inhalation exposure of workers. The assessment indicates safe use when the recommended operational conditions and risk management measures are in use. Compliance can be verified by monitoring, and by comparing the monitored level with the DNEL value. The use is considered safe if the measured emissions divided by the DNEL–value is resulting in a risk characterisation ratio (RCR) less than 1. Taking into account the recommended risk management measures for environment, the existing EU Directives for pH control for surface water, the data of many Member States on (additional) national regulations to control the pH of waste waters (STP influents) and surface waters, it is concluded that STPs and surface waters are sufficiently protected with regard to pH changes. Therefore, environment exposure is under adequate control. Conforms to Annex II of Regulation (EC) No. 1907/2006 (REACH) ANNEX TO EXTENDED SAFETY DATA SHEET Potassium hydroxide solution th Date: 13 April 2015 Previous date: Page 6 / 9 Version 1.0 REACHLaw Ltd. (Only Representative) ES 2: Consumer use of solid and liquid KOH (excl. batteries) 1. Title of Exposure scenario Exposure scenario 4: Consumer use of solid and liquid KOH (excl. batteries) Market sector: Coatings and paints, fillers, putties, thinners, fertilizers, products such as pH-regulators, flocculants, precipitants, neutralization agents, other perfumes, fragrances, washing and cleaning products (including solvent based products), cosmetics. PC 9, PC12, PC20, PC28, PC35, PC39 Description of process(es) covered in the Exposure Scenario: Environment: The estimation takes into account the amount of consumer products used. They are expected to interact with other ingredients in acid-base reactions with no KOH left in the final consumer product. However, some products may contain from 0.25-0.45% to up to 1.1% of KOH in the final formulation. Worker contributing scenarios: PROC not applicable for this ES. Sector of use is private households. SU21 Description of activities covered in the Exposure Scenario: This exposure scenario covers the consumer wide dispersive uses of consumer products, such as paint and varnish removers, drain cleaners, degreasing agents and dairy pipeline cleaners. 2. Conditions of use affecting exposure 2.1 Control of environmental exposure Product characteristics Physical form: liquid Molecular weight: 56.105 Water Solubility 121g/100g water at 25°C Conditions of use affecting environmental exposure There are no specific risk management measures related to environment. Conditions and measures related to disposal Wasted material and its containers must be disposed of in a safe way (e.g. by returning to a public recycling facility). If container is empty, trash as regular municipal waste. 2.2 Control of workers exposure Product characteristic Physical form: liquid Molecular weight: 56.105 Water Solubility 121g/100g water at 25°C Measures to prevent /limit releases, dispersion and exposure to the design of the product It is required to use resistant labelling-package to avoid its auto-damage and loss of the label integrity, under normal use and storage of the product. The lack of quality of the package provokes the physical loss of information on hazards and use instructions. It is required that household chemicals, containing potassium hydroxide for more than 2%, which may be accessible to children should be provided with a child-resistant fastening (currently applied) and a tactile warning of danger (Adaptation to Technical Progress of the Directive 1999/45/EC, annex IV, Part A and Article 15(2) of Directive 67/548 in the case of, respectively, dangerous preparations and substances intended for domestic use). This would prevent accidents by children and other sensitive groups of society. It is required that appropriate use instructions, and product information should always be provided to consumers. This clearly can reduce the risk of misuse. For reducing the number of accidents, it is advisable to use these products in the absence of children or other sensitive groups. Conforms to Annex II of Regulation (EC) No. 1907/2006 (REACH) ANNEX TO EXTENDED SAFETY DATA SHEET Potassium hydroxide solution th Date: 13 April 2015 Previous date: REACHLaw Ltd. (Only Representative) Page 7 / 9 Version 1.0 To prevent improper use of potassium hydroxide, instructions for use should contain a warning against dangerous mixtures. It is advisable to deliver only in very viscous preparations. It is advisable to deliver only in small amounts. Conditions and measures related to personal protection, hygiene and health evaluation Keep out of reach of children. Do not apply product into ventilator openings or slots. 3. Exposure estimation and reference to its source Environment exposure Consumer uses relate to already diluted products which will be quickly neutralized in the sewer and therefore will not reach a WWTP or surface water. Consumer exposure Qualitative assessment for consumer exposure is presented in the table below. The consumer exposure through inhalation is not quantitatively assessed as it is not expected to be higher compared to inhalation exposures in ES1. An accidental exposure is not further assessed as it is excluded from an EU chemical safety assessment and accidental exposure is considered in the OECD SIAR of KOH. The potassium uptake due to the use of KOH containing products is negligible compared to the daily dietary intake of potassium ions (the recommended amount is 2.4 g). Route Dermallocal Leading toxic end point / Critical effect DNEL Acute ES 4- exposure concentrations (EC) Not relevant Risk characterisation ratio Skin/eye irritation/ corrosion Long term Not relevant Skin/eye irritation/ corrosion Qualitative (case KOH concentrations ≥ 2%): Consumers can be exposed to corrosive concentrations. However, dermal exposure to KOH is considered to occur only accidentally if the required protection is strictly adhered to. Therefore, a conclusion on adequately controlled risks is justifiable for scenarios in which corrosive and irritating concentrations of KOH are handled. Qualitative (case KOH concentrations < 2% and > 0.5%): When existing controls and recommended RMMs are applied, safe use can be concluded. Qualitative (case KOH concentrations < 0.5%): Safe use can be concluded because no health effects are observed. Inhalation - local Acute Not relevant Respiratory tract irritation Long term Not relevant Respiratory tract irritation Qualitative: KOH will be rapidly neutralised as a result of its reaction with CO2 (or other acids). Since the KOH concentration and amount handled are smaller compared to professional use and since the DNEL and RMMs are similar, safe use can be concluded for consumer use. Man via environment Indirect exposure to humans, for example through the uptake of drinking water, is not relevant for KOH. Any potential for exposure to KOH due to environmental releases will only have relevance at the local scale. Any pH effect of local releases will be neutralized by the buffer capacity of the receiving water and therefore no pH impacts at the regional scale related to KOH releases should be expected. Therefore indirect exposure of humans via the environment (oral) is not relevant in the case of KOH. This conclusion is similar to OECD SIAR (2002). 4. Guidance to DU to evaluate whether he works inside the boundaries set by the ES The assessment indicates safe use for consumers when the recommended risk management measures are in use. Conforms to Annex II of Regulation (EC) No. 1907/2006 (REACH) ANNEX TO EXTENDED SAFETY DATA SHEET Potassium hydroxide solution th Date: 13 April 2015 Previous date: Page 8 / 9 Version 1.0 REACHLaw Ltd. (Only Representative) ES 3: Consumer use, service life and waste stage of KOH in batteries 1. Title of Exposure scenario Exposure scenario 5: Consumer use, service life and waste stage of KOH in batteries Sector of use: Consumer uses (Private households) SU21 Product categories: not applicable. Article category: Electrical batteries and accumulators. AC 3 Description of activities covered in the Exposure Scenario: This exposure scenario covers the consumer use of batteries with aqueous potassium hydroxide as electrolyte in alkaline batteries based on nickel-cadmium and manganese dioxide-zinc. Potassium hydroxide is preferred over sodium hydroxide because its solutions are more conductive. KOH is still present in alkaline batteries, but the substance is strictly confined in the battery containers and is not in direct contact with consumers. The industrial and professional uses of KOH in batteries (incl. recycling operations) are covered under ES 1. This ES focuses on the consumer use, the service life and the end-of-life stage of KOH in batteries. Batteries are sealed articles and during normal use its contents, including KOH, will not be directly released and emission from KOH in these life-cycle stages should be minimal. 2. Conditions of use affecting exposure 2.1 Control of environmental exposure The environmental release from the consumer use and the service life are negligible because batteries are sealed articles with a long service life. After use, batteries should be recycled as much as possible but in case of disposal as municipal waste, KOH is not expected to cause a significant (pH) effect to the environment when incinerated or landfilled. Therefore, the use of KOH in alkaline batteries is adequately under control for the environment. Conditions and measures related to disposal Batteries should be recycled as much as possible (e.g. by returning to a public recycling facility). Recovery of KOH from alkaline batteries includes removing the electrolyte, collection and neutralization with sulphuric acid and carbon dioxide. The occupational exposure related to these steps is considered in the exposure scenario on industrial and professional use of KOH. 2.2 Control of workers exposure Conditions and measures related to personal protection, hygiene and health evaluation No consumer exposure is expected because batteries are sealed articles with a long service life maintenance. Therefore, consumer use of KOH in batteries is adequately under control. Additional good practise advice beyond the REACH CSA Note: The measures reported in this section have not been taken into account in the exposure estimates related to the exposure scenario above. They are not subject to obligation laid down in Article 37 (4) of REACH, Thus, the downstream user is not obliged to i) carry out an own CSA and ii) to notify the use to the Agency, if he does not implement these measures. Housekeeping: General good hygiene and housekeeping. 3. Exposure estimation and reference to its source Environment: The environmental release from the consumer use and the service life are negligible because batteries are sealed articles with a long service life. After use, batteries should be recycled as much as possible but in case of disposal as municipal waste, KOH is not expected to cause a significant (pH) effect to the environment when incinerated or landfilled. Therefore, the use of KOH in alkaline batteries is adequately under control for the environment. Consumers: No consumer exposure is expected because batteries are sealed articles with long service life maintenance. Therefore, consumer use of KOH in batteries is adequately under control. Risk characterization man via environment Indirect exposure to humans, for example through the uptake of drinking water, is not relevant for KOH. Any potential for exposure to KOH due to environmental releases will only have relevance at the local scale. Any pH effect of local releases will be neutralized by the buffer capacity of the receiving water and therefore no pH impacts at the regional scale related to KOH releases should be expected. Therefore indirect exposure Conforms to Annex II of Regulation (EC) No. 1907/2006 (REACH) ANNEX TO EXTENDED SAFETY DATA SHEET Potassium hydroxide solution th Date: 13 April 2015 Previous date: REACHLaw Ltd. (Only Representative) Page 9 / 9 Version 1.0 of humans via the environment (oral) is not relevant in the case of KOH. This conclusion is similar to OECD SIAR (2002). 4. Guidance to DU to evaluate whether he works inside the boundaries set by the ES Based on the assumptions made in this exposure scenario, it is concluded that potassium hydroxide is of no concern for consumers with regard to use in batteries.
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