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HomeMy WebLinkAboutAlcohol Prep Pads Safety Data Sheet according to Regulation (EC) No. 1907/2006 (REACH) Material Name: WEBCOL/Curity Alcohol Prep Pads SDS ID: COV-001 ____________________________________________________________ Page 1 of 11 Issue date: 2015-04-30 Revision 1.0 Print date: 2015-04-30 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1 Product identifier Material Name WEBCOL/Curity Alcohol Prep Pads Synonyms Isopropyl Alcohol 65-75% Trade Names 5033, 5110, 5750, 6818, 6818-1, 63001, 15033, 16818, 176818, 20339, 681812, 6818-2 , 7MJ46621, 7MJ36339, 7RA58200, 7RA71200, 7RI43405, 7R145719, 7RI45720, 7RI45721, 7RI45722, 7RI82380, 7RI82402, 70Y33230, 985629, MKN42634, 693035, 121-6131, 6818M, GS42634 Chemical Family ISOPROPYL ALCOHOL Substance Registration Number(s) REACH obligation for the substances in this product is under review. 1.2 Relevant identified uses of the substance or mixture and uses advised against Identified uses Skin preparation pads for use in medical applications Uses advised against For use under medical supervision only. 1.3 Details of the supplier of the safety data sheet Covidien, LP 15 Hampshire Street Mansfield, MA 02048 USA Phone: +1-(508) 261-8000 (Monday - Friday 8:00 am to 5:00 pm) Email: customerservice@medtronic.com 1.4 Emergency telephone number CHEMTREC (800) 424-9300 (for US and Canada), 1(703) 527-3887 (Outside US and Canada), Collect calls accepted SECTION 2: Hazards identification 2.1 Classification of the substance or mixture Classification according to Regulation (EC) No. 1272/2008 [CLP] Flammable Liquids - Category 2 Serious Eye Damage/Eye Irritation - Category 2 Safety Data Sheet according to Regulation (EC) No. 1907/2006 (REACH) Material Name: WEBCOL/Curity Alcohol Prep Pads SDS ID: COV-001 ____________________________________________________________ Page 2 of 11 Issue date: 2015-04-30 Revision 1.0 Print date: 2015-04-30 2.2 Label elements Labeling according to Regulation (EC) No. 1272/2008 [CLP] Hazard symbols Signal word Danger Hazard statements H225 Highly flammable liquid and vapor H319 Causes serious eye irritation Precautionary statements Prevention P210 Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking P264 Wash thoroughly after handling Response P370+P378 In case of fire: Use appropriate media to extinguish P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing P337+P313 If eye irritation persists: Get medical advice/attention Storage P402 Store in a dry place Disposal P501 Dispose of contents/container in accordance with local/regional/national/international regulations 2.3 Other hazards No additional information available. SECTION 3: Composition / information on ingredients CAS EC No Registration No Component Name Synonyms 1272/2008 (CLP) Percent (%) 7732-18-5 231-791-2 Not available Water Note(s): No classification 25 - 35 67-63-0 Isopropyl alcohol Flam. Liq. 2 - H225 65 - 75 Safety Data Sheet according to Regulation (EC) No. 1907/2006 (REACH) Material Name: WEBCOL/Curity Alcohol Prep Pads SDS ID: COV-001 ____________________________________________________________ Page 3 of 11 Issue date: 2015-04-30 Revision 1.0 Print date: 2015-04-30 200-661-7 Not available Acute Tox. (Oral) 4 - H302 Eye Dam. 2 - H319 STOT SE 3 - H336 Note(s): Self- classification SECTION 4: First aid measures 4.1 Description of first aid measures Inhalation Not a likely route of exposure. Skin It is unlikely that first aid will be required. If skin irritation occurs: Get medical advice/attention. Eyes Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists, get medical advice/attention. Ingestion If swallowed, get medical attention. 4.2 Most Important Symptoms/Effects Acute Causes serious eye irritation. Delayed No information on significant adverse effects. 4.3 Indication of Immediate Medical Attention and Special Treatment Treat symptomatically and supportively. SECTION 5: Firefighting measures 5.1 Extinguishing media Suitable extinguishing media Use dry chemical, carbon dioxide, alcohol-resistant foam or water spray. Unsuitable Extinguishing Media None known. 5.2 Special hazards arising from the substance or mixture Highly flammable liquid and vapor. Combustion Oxides of carbon Fire Fighting Measures Avoid inhalation of material or combustion by-products. Safety Data Sheet according to Regulation (EC) No. 1907/2006 (REACH) Material Name: WEBCOL/Curity Alcohol Prep Pads SDS ID: COV-001 ____________________________________________________________ Page 4 of 11 Issue date: 2015-04-30 Revision 1.0 Print date: 2015-04-30 SECTION 6: Accidental release measures 6.1 Personal precautions, protective equipment and emergency procedures Wear personal protective clothing and equipment. 6.2 Environmental precautions Avoid release to the environment. 6.3 Methods and Materials for Containment and Cleaning Up Clear up spills immediately and dispose of waste safely. 6.4 Reference to other sections Safe handling: see section 7. Personal protection equipment: see section 8. Disposal: see section 13. SECTION 7: Handling and storage 7.1 Precautions for safe handling Keep away from heat/sparks/open flames/hot surfaces. 7.2 Conditions for safe storage, including any incompatibilities Store in a dry place Incompatible Materials Aldehydes, halogenated compounds, halogens, strong acids, strong oxidizing agents 7.3 Specific end use(s) Skin preparation pads for use in medical applications SECTION 8: Exposure controls/personal protection 8.1 Control parameters Component Exposure Limits Isopropyl alcohol 67-63-0 Austria: 200 ppm TWA [TMW] (short time value for large casting); 500 mg/m3 TWA [TMW] (short time value for large casting) 800 ppm STEL [KZW] 4 X 15 min; 2000 mg/m3 STEL [KZW] 4 X 15 min; 800 ppm STEL [KZW] (STEL for large casting valid till 12/31/2013) 4 X 30 min; 2000 mg/m3 STEL [KZW] (STEL for large casting valid till 12/31/2013) 4 X 30 min Belgium: 200 ppm TWA; 500 mg/m3 TWA 400 ppm STEL; 1000 mg/m3 STEL Denmark: 200 ppm TWA; 490 mg/m3 TWA Safety Data Sheet according to Regulation (EC) No. 1907/2006 (REACH) Material Name: WEBCOL/Curity Alcohol Prep Pads SDS ID: COV-001 ____________________________________________________________ Page 5 of 11 Issue date: 2015-04-30 Revision 1.0 Print date: 2015-04-30 Finland: 200 ppm TWA; 500 mg/m3 TWA 250 ppm STEL; 620 mg/m3 STEL France: 400 ppm STEL [VLCT]; 980 mg/m3 STEL [VLCT] Germany (TRGS): 200 ppm TWA AGW (The risk of damage to the embryo or fetus can be excluded when AGW and BGW values are observed) exposure factor 2; 500 mg/m3 TWA AGW (The risk of damage to the embryo or fetus can be excluded when AGW and BGW values are observed) exposure factor 2 Germany (DFG): 200 ppm TWA MAK; 500 mg/m3 TWA MAK 400 ppm Peak; 1000 mg/m3 Peak Greece: 400 ppm TWA; 980 mg/m3 TWA 500 ppm STEL; 1225 mg/m3 STEL Ireland: 200 ppm TWA 400 ppm STEL Potential for cutaneous absorption Portugal: 200 ppm TWA [VLE-MP] 400 ppm STEL [VLE-CD Spain: 200 ppm TWA [VLA-ED] (it is prohibited the partial or complete commercialization or use of this substance as a phytosanitary or biocide compound); 500 mg/m3 TWA [VLA- ED] (it is prohibited the partial or complete commercialization or use of this substance as a phytosanitary or biocide compound) 400 ppm STEL [VLA-EC]; 1000 mg/m3 STEL [VLA-EC] Sweden: 150 ppm LLV; 350 mg/m3 LLV 250 ppm STV; 600 mg/m3 STV United Kingdom: 400 ppm TWA; 999 mg/m3 TWA 500 ppm STEL; 1250 mg/m3 STEL Biological limit value There are no biological limit values for any of this product's components. Derived No Effect Levels (DNELs) No DNELs available. Predicted No Effect Concentrations (PNECs) No PNECs available. Safety Data Sheet according to Regulation (EC) No. 1907/2006 (REACH) Material Name: WEBCOL/Curity Alcohol Prep Pads SDS ID: COV-001 ____________________________________________________________ Page 6 of 11 Issue date: 2015-04-30 Revision 1.0 Print date: 2015-04-30 8.2 Exposure Controls Engineering controls Based on available information, additional ventilation is not required. Ensure compliance with applicable exposure limits. Eye/face protection Safety glasses or goggles are recommended when there is a potential for eye contact. Skin Protection Not required. Respiratory Protection No respirator is required under normal conditions of use. Glove Recommendations Hand protection is not required. SECTION 9: Physical and chemical properties 9.1 Information on basic physical and chemical properties Appearance Non-woven cloth saturated with liquid in foil package Physical State Liquid Odor Alcohol Color Colorless Odor Threshold Not available pH Not available Melting Point Not available Boiling Point 82 °C (literature value) Freezing point -89 °C (literature value) Evaporation Rate Not available Boiling Point Range Not available Flammability (solid, gas) Not available Autoignition 399 °C (literature value) Flash Point 12 °C (estimate based on isopropyl alcohol) Lower Explosive Limit 2 % (V) Decomposition Not available Upper Explosive Limit 12 % (V) Vapor Pressure 33 mmHg (@ 20 °C - literature value) Vapor Density (air=1) 2.1 (literature value) Specific Gravity (water=1) 0.7855 (@ 20 °C - literature value) Water Solubility 100% Partition coefficient: n- octanol/water 0.05 (measured value) Viscosity Not available Solubility (Other) Not available Density Not available Safety Data Sheet according to Regulation (EC) No. 1907/2006 (REACH) Material Name: WEBCOL/Curity Alcohol Prep Pads SDS ID: COV-001 ____________________________________________________________ Page 7 of 11 Issue date: 2015-04-30 Revision 1.0 Print date: 2015-04-30 9.2 Other information No additional information available. SECTION 10: Stability and reactivity 10.1 Reactivity Not known to occur. 10.2 Chemical stability Stable under normal conditions of use. 10.3 Possibility of hazardous reactions Hazardous polymerization will not occur. 10.4 Conditions to avoid Avoid direct sunlight. 10.5 Incompatible materials Aldehydes, halogenated compounds, halogens, strong acids, strong oxidizing agents 10.6 Hazardous decomposition products Oxides of carbon SECTION 11: Toxicological information 11.1 Information on toxicological effects Component Analysis - LD50/LC50 The components of this material have been reviewed in various sources and the following selected endpoints are published: Isopropyl alcohol (67-63-0) Oral LD50 Rat 5045 mg/kg (Safety Data Sheet) Dermal LD50 Rabbit 12800 mg/kg (Safety Data Sheet) Inhalation LC50 Rat 1600 ppm 4 h (Safety Data Sheet) Irritation/Corrosivity Data Causes serious eye irritation. Respiratory Sensitization No data available. Dermal Sensitization No data available. Germ Cell Mutagenicity No data available. Safety Data Sheet according to Regulation (EC) No. 1907/2006 (REACH) Material Name: WEBCOL/Curity Alcohol Prep Pads SDS ID: COV-001 ____________________________________________________________ Page 8 of 11 Issue date: 2015-04-30 Revision 1.0 Print date: 2015-04-30 Component Carcinogenicity Isopropyl alcohol 67-63-0 IARC: Monograph 71 [1999]; Supplement 7 [1987]; Monograph 15 [1977] (Group 3 (not classifiable)) Reproductive toxicity No data available. Specific Target Organ Toxicity - Single Exposure No information available. Specific Target Organ Toxicity - Repeated Exposure No information available. Aspiration hazard No data available. SECTION 12: Ecological information 12.1 Toxicity Avoid release to the environment. Component Analysis - Aquatic Toxicity Isopropyl alcohol 67-63-0 Fish: LC50 96 h Pimephales promelas 9640 mg/L [flow-through]; LC50 96 h Pimephales promelas 11130 mg/L [static]; LC50 96 h Lepomis macrochirus >1400000 µg/L Algae: EC50 96 h Desmodesmus subspicatus >1000 mg/L IUCLID; EC50 72 h Desmodesmus subspicatus >1000 mg/L IUCLID Invertebrate: EC50 48 h Daphnia magna 13299 mg/L IUCLID 12.2 Persistence and degradability No information available for the product. 12.3 Bioaccumulative potential No information available for the product. 12.4 Mobility in soil No information available for the product. 12.5 Results of PBT and vPvB assessment EU - Interim Strategy for Management of PBT and vPvB Substances No components of this material are listed. 12.6 Other adverse effects No additional information available. Safety Data Sheet according to Regulation (EC) No. 1907/2006 (REACH) Material Name: WEBCOL/Curity Alcohol Prep Pads SDS ID: COV-001 ____________________________________________________________ Page 9 of 11 Issue date: 2015-04-30 Revision 1.0 Print date: 2015-04-30 SECTION 13: Disposal considerations 13.1 Waste treatment methods Dispose in accordance with all applicable regulations. SECTION 14: Transport information Component Marine Pollutants (IMDG) Not regulated as dangerous goods. ADR RID ICAO IATA ADN IMDG 14.1 UN Number Not regulated, as per ADR, Special Provision 216 Not regulated Not regulated Not regulated, as per IATA, Special Provision A46 Not regulated Not regulated, as per IMDG Code, Special Provision 216 14.2 UN Proper Shipping Name Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable 14.3 Transport Hazard Class(es) Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable 14.4 Packing Group Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable 14.5 Environmental Hazards Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable 14.6 Special Precautions For User Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable 14.7 Transport in Bulk According to Annex II or MARPOL 73/78 and the IBC Code Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable Safety Data Sheet according to Regulation (EC) No. 1907/2006 (REACH) Material Name: WEBCOL/Curity Alcohol Prep Pads SDS ID: COV-001 ____________________________________________________________ Page 10 of 11 Issue date: 2015-04-30 Revision 1.0 Print date: 2015-04-30 14.8 Additional information No additional information available No additional information available No additional information available Consult current IATA regulations prior to shipping by air No additional information available No additional information available International Bulk Chemical Code This material does not contain any chemicals required by the IBC Code to be identified as dangerous chemicals in bulk. SECTION 15: Regulatory information 15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture EU - REACH (1907/2006) - Annex XIV List of Substances Subject to Authorization No components of this material are listed. EU - REACH (1907/2006) - Article 59(1) Candidate List of Substances Subject to Authorization No components of this material are listed. EU - REACH (1907/2006) - Annex XVII Restrictions of Certain Dangerous Substances, Mixtures and Articles No components of this material are listed. EU - Biocides (1451/2007) - Existing Active Substance Isopropyl alcohol 67-63-0 Present Germany Regulations Germany Water Classification Isopropyl alcohol (67-63-0) ID Number 135 , hazard class 1 - low hazard to waters Denmark Regulations No components of this material are listed. 15.2 Chemical Safety Assessment No chemical safety assessment has been carried out for the substance/mixture. SECTION 16: Other information 16.1 Indication of changes New SDS: April 30, 2015 Safety Data Sheet according to Regulation (EC) No. 1907/2006 (REACH) Material Name: WEBCOL/Curity Alcohol Prep Pads SDS ID: COV-001 ____________________________________________________________ Page 11 of 11 Issue date: 2015-04-30 Revision 1.0 Print date: 2015-04-30 16.2 Key / Legend ACGIH - American Conference of Governmental Industrial Hygienists; ADR - European Road Transport; AU - Australia; BOD - Biochemical Oxygen Demand; C - Celsius; CA - Canada; CAS - Chemical Abstracts Service; CERCLA - Comprehensive Environmental Response, Compensation, and Liability Act; CLP - Classification, Labelling, and Packaging; CN - China; CPR - Controlled Products Regulations; DFG - Deutsche Forschungsgemeinschaft; DOT - Department of Transportation; DSD - Dangerous Substance Directive; DSL - Domestic Substances List; EEC - European Economic Community; EINECS - European Inventory of Existing Commercial Chemical Substances; EPA - Environmental Protection Agency; EU - European Union; F - Fahrenheit; IARC - International Agency for Research on Cancer; IATA - International Air Transport Association; ICAO - International Civil Aviation Organization; IDL - Ingredient Disclosure List; IDLH - Immediately Dangerous to Life and Health; IMDG - International Maritime Dangerous Goods; JP - Japan; Kow - Octanol/water partition coefficient; KR - Korea; LEL - Lower Explosive Limit; LLV - Level Limit Value; LOLI - List Of LIsts™ - ChemADVISOR’s Regulatory Database; MAK - Maximum Concentration Value in the Workplace; MEL - Maximum Exposure Limits; NFPA - National Fire Protection Agency; NIOSH - National Institute for Occupational Safety and Health; NJTSR - New Jersey Trade Secret Registry; NTP - National Toxicology Program; NZ - New Zealand; OSHA - Occupational Safety and Health Administration; PH - Philippines; RCRA - Resource Conservation and Recovery Act; REACH- Registration, Evaluation, Authorisation, and restriction of Chemicals; RID - European Rail Transport; SARA - Superfund Amendments and Reauthorization Act; STEL - Short-term Exposure Limit; TDG - Transportation of Dangerous Goods; TSCA - Toxic Substances Control Act; TWA - Time Weighted Average; UEL - Upper Explosive Limit; US - United States; WHMIS - Workplace Hazardous Materials Information System 16.3 Key literature references and sources for data Available upon request. 16.4 Methods Used for Classification of Mixture According to Regulation (EC) No 1272/2008 Available upon request. 16.5 Relevant R-, H- and EUH-phrases (Number and full text) H302 Harmful if swallowed H319 Causes serious eye irritation H336 May cause drowsiness or dizziness H225 Highly flammable liquid and vapor 16.6 Training advice Read the Safety Data Sheet before handling product. 16.7 Further Information Disclaimer: The information and recommendations in this safety data sheet are based on sources believed to be accurate as of the date of issue. The information given is designed only as a guidance for safe handling, use, processing, storage, transportation, disposal and release and is not to be considered a warranty or quality specification. Covidien LP makes NO WARRANTY OF MERCHANTABILITY OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED and usage of this safety data sheet shall not establish a legal, contractual relationship. It is the responsibility of the user to determine applicability of this information and the suitability of the material or product for any particular purpose. Covidien LP assumes no responsibility for injury to vendee or third party person proximately caused by the material if reasonable safety procedures are not adhered to as stipulated in the data sheet. Furthermore, Covidien LP assumes no responsibility for injury caused by abnormal use of this material even if reasonable safety procedures are followed. Users should ensure that any use or disposal of the material is in accordance with applicable national, country, federal, state, and local laws, directives, orders and regulations.