SDS: Safety Data Sheet 1. Identification Product description: PCR Master Mix MGB Alert 2x PCR Master Mix (vial product codes M400254 and M400559). Product Use: In vitro diagnostic medical device component. For professional use only. Company identification: ELITechGroup Inc. Molecular Diagnostics 21720 23rd Dr SE, Suite 150 Bothell, WA 98021 Telephone number: 1-800-453-2725 Emergency Telephone: InfoTrac Emergency Response Calls within USA: 1-800-535-5053 Calls outside USA: +1-352-323-3500 (call collect) Customer ID # 90104 (Note: this number is required when a customer calls into either phone number) 2. Hazard(s) Identification Classification: Per OSHA 29CFR1910.1200 and (EC) 1272/2008, not a hazardous substance or mixture at supplied concentrations. Potential Health Effects Inhalation: No information available Ingestion: May be harmful if swallowed. Skin Contact: Moderate skin irritation. Components of the product may be absorbed into the body through the skin. Eye Contact: Mild eye irritation. Chronic Exposure: No information available. Aggravation of Pre-existing Conditions: No information available. Hazards not otherwise classified: No information available. SDS: M500929 Revision 0 Effective Date: (04/2016) Page 1 of 5
3. Composition/Information on Ingredients Hazardous/Non-hazardous Components Ingredient CAS No Percent Hazardous --------------------------------------- ------------ ------------ ------------- Glycerol 56-81-5 1-5% No Dimethylsulfoxide 67-68-5 1-5% No 4. First Aid Measures Inhalation: Move to fresh air Ingestion: Never give anything by mouth to an unconscious person Skin Contact: Wash off immediately with plenty of water Eye Contact: Rinse thoroughly with plenty of water, also under the eyelids. Most important symptoms/effects, acute and delayed: No information available. Immediate medical or special attention needed: No information available. 5. Fire Fighting Measures Fire Extinguishing Media: Dry chemical. Specific Hazards: No information available. Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full facepiece operated in the pressure demand or other positive pressure mode. 6. Accidental Release Measures Personal precautions: Use personal protective equipment Methods for cleaning up: Soak up with inert absorbent material. 7. Handling and Storage Precautions for safe handling: No special handling advice required. Conditions for safe storage: Keep in properly labeled containers. 8. Exposure Controls/Personal Protection Exposure Limits: No information available Engineering Controls: Ensure adequate ventilation, especially in confined areas. Personal protective equipment Respiratory protection: In case of insufficient ventilation wear suitable respiratory equipment Hand protection: Protective gloves. Eye protection: Safety glasses with side-shields Skin and body protection: Lightweight protective clothing. Hygiene measures: Handle in accordance with good industrial hygiene and safety practice Environmental exposure: Prevent product from entering drains SDS: M500929 Revision 0 Effective Date: (04/2016) Page 2 of 5
9. Physical and Chemical Properties Appearance (physical state, color, etc.): Liquid Odor: No data available Odor threshold: No data available ph: No data available Melting point/freezing point: No data available Initial boiling point and boiling range: No data available Flash point: No data available Evaporation rate: No data available Flammability (solid, gas): No data available Upper/lower flammability or explosive limits: No data available Vapor pressure: No data available Vapor density: No data available Relative density: No data available Solubility(ies): No data available Partition coefficient: n-octanol/water: No data available Auto-ignition temperature: No data available Decomposition temperature: No data available Viscosity: No data available 10. Stability and Reactivity Reactivity: No information available Chemical Stability: Stable under ordinary conditions of use and storage. Possibility of hazardous reactions: Hazardous polymerization does not occur Conditions to Avoid: No information found. Incompatible materials: No information available Hazardous Decomposition Products: No information available 11. Toxicological Information Likely Routes of Exposure: Eyes: Mild eye irritation. Skin: moderate skin irritation. Components of the product may be absorbed into the body through the skin. Inhalation: No information available Ingestion: May be harmful if swallowed Symptoms related to physical, chemical and toxicological characteristics: No information available Delayed and immediate effects / chronic effects from short and long term exposure: No information available Numerical measure of toxicity: Hazardous Ingredients (specific) CAS Number LD 50 (oral, rat/ mouse) LD 50 (dermal, rat/ rabbit) LD 50 (inhalation, rat/ mouse) Glycerol 56-81-5 12600 mg/kg (Rat) 10g/kg (rabbit) 570 mg/m3 (Rat) Dimethylsulfoxide 67-68-5 14500 mg/kg (Rat) No data available No data available SDS: M500929 Revision 0 Effective Date: (04/2016) Page 3 of 5
12. Ecological Information Ecotoxicity effects: No information available. Persistence and degradability: No information available. Bioaccumulation: Does not bioaccumulate. Mobility in soil: No information available. Other adverse effects: No information available. 13. Disposal Considerations Product: Used devices and other contaminated materials should be disposed of as potentially biohazardous waste. To ensure compliance with anti-pollution and other laws of the country concerned, we recommend that you contact the relevant (local) authorities and/or an approved waste-disposal company for information. European waste catalogue: 18 01 03 wastes whose collection and disposal is subject requirements in order to prevent infection. Packaging: Disposal must be made in accordance with local waste management regulations. Non-contaminated packaging materials may be recycled. Contact your local service providers for further information. 14. Transport Information UN-No.: None UN Proper shipping name: None Transport Hazard Class: Not regulated for transport. Packing group None Environmental Hazards: None Transport in bulk: Not applicable Special precautions to be aware of: None 15. Regulatory International Inventories: Chemical Name TSCA PICCS ENCS DSL NDSL AICS Glycerol Listed Listed Listed Listed - Listed Dimethylsulfoxide Listed Listed Listed Listed - Listed Clean Air Act, Section 112 Hazardous Air Pollutants (HAPs) Not Applicable US Hazard warnings according to 16 CFR 1600 and ANSI Standard Z129.1 Not required U. S. State Regulations: Chemical Name MA RTK NJ RTK PA RTK IL RTK RI RTK Glycerol Listed - Listed - Listed dimethylsulfoxide Listed - - - - California Proposition 65: This product does not contain chemicals listed under Proposition 65. WHMIS hazard class Non-controlled SARA Title III Section 313 Not regulated. This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations (CPR) and the MSDS contains all of the information required by CPR. SDS: M500929 Revision 0 Effective Date: (04/2016) Page 4 of 5
16. Other Information Date of last revision: 05/2015 This material is sold for research and development purposes. It is also for clinical diagnostic use. It is not intended for food, drug, household, agricultural, or cosmetic use. An individual technically qualified to handle potentially hazardous chemicals must supervise the use of this material. The above information was acquired by diligent search and/or investigation and the recommendations are based on prudent application of professional judgment. The information shall not be taken as being all inclusive and is to be used only as a guide. All materials and mixtures may be present unknown hazards and should be used with caution. Since ELITechGroup Inc. Molecular Diagnostics, a division of ELITechGroup Inc., a member of the ELITech Group cannot control the actual methods, volumes, or conditions of use, the Company shall not be held liable for any damages or losses resulting from the handling or from contact with the product as described herein. THE INFORMATION IN THIS SDS DOES NOT CONSTITUTE A WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE. End of Safety Data Sheet SDS: M500929 Revision 0 Effective Date: (04/2016) Page 5 of 5