Trillium Lyse Concentrate Material Safety Data Sheet TRILLIUM DIAGNOSTICS Revision Number: 1 Revised Date: 29 Jan, 2014 1. Identification of the substance/mixture and of the company 1.1 Product Identifier Product Name: Trillium Lyse Concentrate Product Number: LYS-30 1.2 Relevant identified uses of the substance or mixture and uses advised against Trillium Lyse Concentrate is a 10X concentrate when diluted 1:10 with reagent grade water, is intended for use for the lysis of red blood cells for the purpose of antibody labeling of white blood cells in whole blood. Trillium Lyse Concentrate is also suitable for use in any laboratory application in which removal of red blood cells from whole blood is necessary. This product is intended for use as a General Laboratory Reagent. Not for in vivo use. 1.3 Details of the supplier of the safety data sheet Manufacturer: Trillium Diagnostics, LLC Street/PO: PO BOX 67 City, State, Postal Code, Brewer, Maine, 04412, USA Contact for Technical Inquiries: Bruce H. Davis, info@trilliumdx.com Phone, Fax, E-mail: (207) 945-0900, (207) 942-0346, info@trilliumdx.com 1.4 Emergency telephone numbers ITALY: +39 06 305 4343 (Centro Antiveleni, Roma) FRANCE: +33 1 40 05 48 48 (Centres antipoison et de toxicovigilance, Paris) GERMANY: +49 551 19240 (Giftinformationszentrum-Nord, Göttingen) NETHERLANDS: +31 88 755 85 61 (National Poisons Information Centre, Utrecht) SPAIN: +34 91 562 04 20 (Servicio de Información Toxicológica, Instituto Nacional de Toxicología, Madrid) UNITED KINGDOM: +44 (0)20 7188 0100 (Guy’s & St. Thomas’ Poisons Unit, Medical Toxicology Services, London) UNITED STATES OF AMERICA: +1 800 222 1222 (All US poison centers can be reached at this number) See www.who.int/ipcs/poisons/centre/en/ for a worldwide directory of poison control centers. Phone: 207-945-0900 Fax: 207-942-0346 info@trilliumdx.com www.trilliumdx.com Page 1 of 8 Trillium Lyse Concentrate MATERIAL SAFETY DATA SHEET 2. Hazards identification TRILLIUM DIAGNOSTICS 2.1 Classification of the substance or mixture The product is not classified as hazardous according to Directive 1999/45/EC and Directive 67/548/EEC. 2.2 Label elements The product composition does not contain dangerous substances in amounts that need to be hazard labeled according to EC Directive 88/379/EEC. R-Phrases: None apply. S- Phrases S13 Keep away from food, drink, and animal feedstuffs. S18 Handle and open container with care. S20 /21 When using do not eat, drink or smoke. S24 /25 Avoid contact with skin and eyes. S26 In case of contact with eyes, rinse S27/28 After contact with skin, wash with soap and water. S35 This material and its container must be disposed of in a safe way S36/37/39 Wear suitable protective clothing, gloves and eye/face protection. 2.3 Other Hazards There are no reported health hazards for the product in the current formulation and applications. The statements below refer to the hazard information known about the substances in their pure forms. The product composition does not contain dangerous substances in amounts that need to be hazard labeled according to EC Directive 88/379/EEC. No toxic effects are to be expected when the product is handled appropriately. Potential Health Effects Ammonium Chloride (H4ClN)-Ammonium chloride may be harmful if ingested, inhaled, or absorbed through the skin. It can cause serious irritation to the skin, respiratory tract and especially the eyes. Use gloves when handling and avoid skin contact. Handle in accordance with good laboratory practices using appropriate precautions. Avoid skin or eye contact. Do not inhale or ingest. EDTA (Ethylenediaminetetraacetic acid) – EDTA may be harmful if ingested, inhaled, or absorbed through the skin. Use gloves when handling and avoid skin contact. Handle in accordance with good laboratory practices using appropriate precautions. Avoid skin or eye contact. Do not inhale or ingest. Pottassium Phosphate (H2KO4P) – Potassium Phosphate may be harmful if ingested, inhaled, or absorbed through the skin. It can cause serious irritation to the skin, respiratory tract and especially the eyes. Use gloves when handling and avoid skin contact. Handle in accordance with good laboratory practices using appropriate precautions. Avoid skin or eye contact. Do not inhale or ingest. Phone: 207-945-0900 Fax: 207-942-0346 info@trilliumdx.com www.trilliumdx.com LYS MSDS LTR v1 2014 Page 2 of 8 Trillium Lyse Concentrate MATERIAL SAFETY DATA SHEET Potential Chronic Health Effects: Carcinogenic Effects: None of the component substances are known to be carcinogenic. Mutagenic Effects: None of the component substances are known to be mutagenic.. TRILLIUM DIAGNOSTICS 3. Composition/information on ingredients 3.1 Substances There are no reported or expected further health hazards for the product in the current formulations and applications. The components of this product contain substances that may be hazardous when available in significant amounts and should be treated as potentially biohazardous. 3.2 Mixtures Components: Trillium Lyse Concentrate Ammonium Chloride EDTA Potassium Phosphate CAS-No. EC-No. Annex I Index-No 12125-02-9 60-00-4 7778-77-0 235-186-4 017-014-00-8 200-449-4 607-429-00-8 231-913-4 None 4. First aid measures 4.1 Description of first aid measures After skin contact: Wash with plenty of water for 15 minutes. Remove contaminated clothing. Seek medical advice if irritation develops. After eye contact: Check for and remove contact lenses. Flush eye with plenty of water for 15 minutes and seek medical advice. After Ingestion: Rinse mouth with water for 15 minutes and seek medical advice. Do NOT induce vomiting unless directed to do so by medical personnel. After Inhalation: Expose to fresh air. If breathing problems persist seek medical advice. 4.2 Most important symptoms and effects, both acute and delayed Not available 4.3 Indication of any immediate medical attention and special treatment needed See above under section 4.1 5. Firefighting measures 5.1 Extinguishing media Carbon dioxide or dry chemical extinguishers or water are appropriate. Small Fire: Use DRY chemical powder. Large Fire: Use water spray, fog or foam. Do not use water jet. Suitable extinguishing media include carbon dioxide, dry chemical extinguishers, or water. 5.2 Special hazards arising from the substance or mixture Phone: 207-945-0900 Fax: 207-942-0346 info@trilliumdx.com www.trilliumdx.com LYS MSDS LTR v1 2014 Page 3 of 8 TRILLIUM DIAGNOSTICS Trillium Lyse Concentrate MATERIAL SAFETY DATA SHEET Hazardous decomposition products formed under fire conditions – Oxides of phosphorous, potassium oxides, carbon oxides, nitrogen oxides, and hydrogen chloride gas The product itself is not combustible. 5.3 Advice for firefighters This product does not cause special protective equipment to be required. In the event of a large laboratory fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full-face piece operated in the pressure demand or other positive pressure mode. Water spray may be used to keep fire-exposed containers cool. Poisonous gases may be produced in fires. 6. Accidental release measure 6.1 Personal precautions, protective equipment and emergency procedures Use universal precautions, appropriate personal protective equipment and standard safe laboratory practices to clean up spilled substance promptly. Absorb spill onto an appropriate material. Consult local, state or federal regulations for more information regarding proper disposal. 6.2 Environmental precautions Do not let product enter drains. Avoid discharge into the environment. 6.3 Methods and material for containment and cleaning up Soak up spills with an appropriate absorbent material. Consult local, state, or federal regulations for proper disposal. 6.4 Reference to other sections See Section 2.3, 7 and 8 for follow protective measures. 7. Handling and storage 7.1 Precautions for safe handling Universal precautions should be followed when using this product. Avoid inhaling, ingesting and contact with eyes and skin. Wash hands after handling. Wear appropriate personal protective equipment and follow safe laboratory practices. No eating, drinking, or smoking in work areas Wear appropriate personal protective equipment Wash hands after use Remove contaminated clothing and protective equipment before leaving work area Avoid inhaling, ingesting, and contact with eyes and skin 7.2 Conditions for safe storage, including any incompatibilities Store Trillium Lyse Concentrate vials upright, tightly capped at 2-8C when not in use. Avoid unnecessary cycles of warming and cooling. Protect product from freezing, temperatures above 30C, or prolonged exposure to light. After dilution of the Trillium Lyse Concentrate, the diluted working solutions of the buffer should be refrigerated (2-8C). Phone: 207-945-0900 Fax: 207-942-0346 info@trilliumdx.com www.trilliumdx.com LYS MSDS LTR v1 2014 Page 4 of 8 Trillium Lyse Concentrate MATERIAL SAFETY DATA SHEET TRILLIUM DIAGNOSTICS 7.3 Specific end use(s) Trillium Lyse Concentrate is intended for use for lysing red blood cells in preparations of whole blood. Trillium Lyse concentrate can be used for removal of red blood cells prior to white blood cell antibody labeling, or for other laboratory assays in which red blood cell removal from whole blood is necessary. Universal precautions should be used. 8. Exposure controls/personal protection 8.1 Control parameters The product does not contain any materials that need to be monitored at the workplace in accordance with Directive 98/24/EC. Universal precautions should be followed when using this product. 8.2 Exposure controls Universal precautions should be used. Under normal conditions, the use of this product should not require respiratory protection. Wear appropriate personal protective equipment and follow safe laboratory practices. Body protection: None required Eye protection: Safety glasses according to EN 374 Skin protection: Gloves according to EN 166 Respiratory protection: None required when product is used as recommended 9. Physical and chemical properties 9.1 Information on basic physical and chemical properties Trillium Lyse Concentrate Appearance: Clear, colorless liquid Odor: None Odor Threshold: Not Applicable pH: Neutral Initial boiling Point: Not Applicable Melting point / freezing point: Not available Flash point: Not Applicable Evaporation Rate: Not available Flammability: Not Applicable Upper / Lower Flammability Limits: Not Applicable Vapor Pressure: Not Applicable Vapor Density: Not Applicable Relative Density: Not available Solubility: Fully miscible in water Partition coefficient: Not available Auto-ignition temperature: Product is not self-igniting Decomposition Temperature: Not Applicable Viscosity: Not available Explosive properties: Product is not explosive Oxidizing properties: Product is not oxidizing Phone: 207-945-0900 Fax: 207-942-0346 info@trilliumdx.com www.trilliumdx.com LYS MSDS LTR v1 2014 Page 5 of 8 Trillium Lyse Concentrate MATERIAL SAFETY DATA SHEET 9.2 Other information No other information available. TRILLIUM DIAGNOSTICS 10. Stability and reactivity 10.1 Reactivity Stable under normal temperatures and pressures. 10.2 Chemical stability The product components in their final concentrations and volumes are stable and nonhazardous when properly handled. 10.3 Possibility of hazardous reactions No hazardous incompatibilities identified 10.4 Conditions to avoid None identified. 10.5 Incompatible materials No hazardous incompatibilities identified. 10.6 Hazardous decomposition products No hazardous decomposition products are known to be formed by this product. 11. Toxicological information 11.1 Information on toxicological effects The complete toxicological effects of the product components in their final concentrations and volumes have not been fully investigated and are expected to be non-hazardous when properly handled. However, the product contains substances that may cause serious problems when available in significant amounts. The product should be handled using universal precautions and considered to be potentially infectious. Acute Toxicity: Skin Corrosion/Irritation: Serious Eye Damage/Irritation: Respiratory or Skin Sensitization: Toxicity on Repeated Exposure: Carcinogenity: Mutagenicity: Toxicity for Reproduction: No toxic effect known. No irritant effect known. No irritant effect known. No sensitizing effect known. No toxic effect known. No effect known. No effect known. No toxic effect known. 12. Ecological information 12.1 Toxicity Undetermined. Phone: 207-945-0900 Fax: 207-942-0346 info@trilliumdx.com www.trilliumdx.com LYS MSDS LTR v1 2014 Page 6 of 8 Trillium Lyse Concentrate MATERIAL SAFETY DATA SHEET 12.2 Persistence and degradability Undetermined. TRILLIUM DIAGNOSTICS 12.3 Bioaccummulative potential Undetermined. 12.4 Mobility in soil Undetermined. 12.5 Results of PBT and vPvB assessment Undetermined. 12.6 Other adverse effects. The complete ecological properties of the product components in their final concentrations and volumes have not been investigated and are expected to be non-hazardous when properly handled. However, the product contains substances that may cause serious problems when available in significant amounts. No ecological problems are to be expected when the product is handled and used with due care and attention. 13. Disposal considerations 13.1 Waste treatment methods There are no uniform EC regulations for the disposal of chemicals or biohazardous waste. Country, State, and local regulations are varied and change frequently, we recommend that you contact either the authorities in charge or appropriate waste disposal companies which will advise you on how to dispose of potentially infectious biological product waste. Dispose contaminated packaging in compliance with local, state and federal regulations. Handle contaminated packaging in the same manner as the substance itself. 14. Transport information 14.1 UN Number Not applicable. 14.2 UN proper shipping name Not determined. 14.3 Transport hazard class Not classified as hazardous under RID/ADR regulations (Ref. UN TRANS/WP.15/AC.1/94 Add.2 Sec.2.2.62.1.6 and 2.2.62.1.7) 14.4 Packing group Not applicable. 14.5 Environmental hazards Not applicable. Phone: 207-945-0900 Fax: 207-942-0346 info@trilliumdx.com www.trilliumdx.com LYS MSDS LTR v1 2014 Page 7 of 8 Trillium Lyse Concentrate MATERIAL SAFETY DATA SHEET 14.6 Special precautions for users See subsections 6-8. TRILLIUM DIAGNOSTICS 14.7 Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Not classified. 15. Regulatory Information 15.1 Safety, health and environmental regulations specific for the substance or mixture Product is not classified. To the best of our knowledge, safety, health, and environmental regulations according to VO (EC) 1907/2006 are not applicable. 15.2 Chemical safety assessment No chemical safety assessment has been carried out. 16. Other Information Literature References 1. “Biosafety in Microbial and Biomedical Laboratories”, 2nd ed.,1988. HHS Publication No. 88-8395, Centers for Disease Control. 2. EC Directives 1999/45/EC, 67/548/EEC, 89/686/EE and 88/379/EEC 3. 29.CFR1910.1030, Occupational Exposure to Bloodborne Pathogens 4. CEN Standards, in accordance with EC Directive 98/24/EC Notes The information presented in this Material Safety Data Sheet is based on the present state of our knowledge. The product should be used according to the instructions provided by the manufacturer, see “Instructions for use” as presented in the package insert accompanying every product. We make no warranty, express or implied, with respect to such information, and we assume no liability resulting from its use. Users should make their own investigations to determine the suitability of the information for their particular purposes. The product should be used according to the instructions provided by the manufacturer, see “instructions for use” as presented in the Package Insert accompanying every product. Trillium Diagnostics, LLC and distributors thereof shall not be held liable for any claims, losses, or damages resulting from handling or from contact with the product. For additional information, see our website, www.trilliumdx.com. Phone: 207-945-0900 Fax: 207-942-0346 info@trilliumdx.com www.trilliumdx.com LYS MSDS LTR v1 2014 Page 8 of 8