Universal Buffer

SECTION 2: Hazards identification

Overview

Hazard statements

May be harmful if swallowed, however this is not a normal route of entry. May be harmful if in contact with skin. May be irritating to eyes. None

Precautionary statements

Avoid contact with skin and eyes. Regulation None

2.1 Classification of the substance or mixture

WHMIS Controlled chemical ingredients are present at concentrations lower than specified on the Ingredients Disclosure List GHS Not classified as a dangerous mixture according to the Globally Harmonized Standard OSHA Not classified as hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200) Section 3 - Composition/Information on Ingredients Component CAS No. Composition LD50 LC50 Human serum/plasma* N/A <75% N/A Sucrose 57-50-1 <10% 29 700 mg/kg (oral, rat) N/A Sodium chloride 7647-14-5 <10% 3000 mg/kg (oral, rat) >42 000 mg/m3 (rat) Disodium phosphate 7558-79-4 <5% N/A *The human serum/plasma is non-reactive for Hepatitis B Surface Antigen (HBsAg), Human Immunodeficiency Virus Antibody (anti-HIV), Hepatitis B Core Antibody (anti-HBc), Hepatitis C Virus Antibody (anti-HCV) and Treponema pallidum Antibody (anti-TP). However, as no test method can offer complete assurance as to the absence of infectious agents, this material should be handled as though capable of transmitting infectious disease and disposed of accordingly. Section 4 - First Aid Measures Chemical Contact Instructions Remove contact lenses, if applicable. Flush contaminated eye(s) for at least 15 Eye Contact minutes with running lukewarm water. Take care not to rinse contaminated water in non-affected eye. Always seek medical attention for incidents involving eyes. Skin Contact Immediately flush the skin with lukewarm water for at least 15 minutes. Remove contaminated clothing. Seek medical attention if irritation persists. Inhalation Move to fresh air or well-ventilated area. Seek medical attention if irritation or laboured breathing is observed. Ingestion Wash material from mouth with water provided person is conscious. Seek medical attention. Preparation Date 12/03/15 Section 5 - Fire Fighting Measures Use an extinguisher appropriate to the surrounding area that is Suitable Extinguishing Media burning. Use dry chemical, sand, earth, regular foam, or water to extinguish fire. Unsuitable Extinguishing Media No information available Hazards from Combustion Products Avoid inhalation of the material or combustion by-products. Products of Combustion Not Available Special Remarks on Fire/Explosion Not Available Protective Equipment and As in any fire, wear self-contained breathing apparatus pressure- Precautions for Firefighters demand, MSHA/NIOSH (approved or equivalent) and full protective gear. Section 6 - Accidental Release Measures Personal Precautions Use appropriate personal protective equipment Methods for Containment and Treat releases and spills according to biohazardous waste Clean Up procedures. Section 7 - Handling and Storage Handling Wear gloves, eye protection and laboratory coat when handling test controls. WHMIS Controlled chemical ingredients are present at concentrations lower than specified on the Ingredients Disclosure List GHS Not classified as a dangerous mixture according to the Globally Harmonized Standard OSHA Not classified as hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200) Section 3 - Composition/Information on Ingredients Component CAS No. Composition Human serum/plasma* N/A <75% Sodium tetraborate 1303-96-4 <2% decahydrate (Borate) *The human serum/plasma is reactive for Hepatitis B Virus Core Antibody (anti-HBc), Human Immunodeficiency Virus Antibody (anti-HIV), and Hepatitis C Virus Antibody (anti-HCV). Section 4 - First Aid Measures Chemical Contact Instructions Remove contact lenses, if applicable. Flush contaminated eye(s) for at least 15 Eye Contact minutes with running lukewarm water. Take care not to rinse contaminated water in non-affected eye. Always seek medical attention for incidents involving eyes. Skin Contact Immediately flush the skin with lukewarm water for at least 15 minutes. Remove contaminated clothing. Seek medical attention if irritation persists. Inhalation Move to fresh air or well-ventilated area. Seek medical attention if irritation or laboured breathing is observed. Ingestion Wash material from mouth with water provided person is conscious. Seek medical attention. Preparation Date 02/17/16 Section 5 - Fire Fighting Measures Use an extinguisher appropriate to the surrounding area that is Suitable Extinguishing Media burning. Use dry chemical, sand, earth, regular foam, or water to extinguish fire. Avoid inhalation of the material or combustion by- products. Unsuitable Extinguishing Media No Information available Hazards from Combustion Products Avoid inhalation of the material or combustion by-products Products of Combustion Not Available Protective Equipment and As in any fire, wear self-contained breathing apparatus pressure- Precautions for Firefighters demand, MSHA/NIOSH (approved or equivalent) and full protective gear. Section 6 - Accidental Release Measures Personal Precautions Use appropriate personal protective equipment Methods for Containment and Treat releases and spills according to biohazardous waste Clean Up procedures Section 7 - Handling and Storage Handling Wear gloves, eye protection and laboratory coat when handling test controls.

Storage

Store at 2 - 30°C. Keep dry and out of direct sunlight. Section 8 - Exposure Controls/Personal Protection Engineering Controls Access to safety shower and eye wash station. Ventilation not required for safe handling. Skin Protection Wear protective gloves and laboratory coat. Eye protection Wear appropriate eye protection. Section 9 - Physical and Chemical Properties Physical State Solid Appearance White to pale yellow solid pellet/cake. Clear to pale yellow solution when reconstituted. Odor Odorless Odour Threshold Not Applicable pH Data not available Melting Point Data not available Freezing Point Not Applicable Boiling Point Not Applicable Flash Point Not Applicable Flammability Not Flammable Lower/Upper Flammable Limits Not Available Vapour Density Not Applicable Vapour Pressure Data not available Volatile Organic Compounds Data not available Solubility Soluble in water Specific Gravity Not Applicable Coefficient of water: oil distribution Data not available Auto-Ignition Temperature Not Applicable Preparation Date 12/03/15 Section 10 - Stability and Reactivity Stability Stable Conditions to avoid High heat. High humidity Chemical Incompatibilities Protect from moisture, strong acids, strong bases, strong oxidizing agents, organic materials, metals Hazardous decomposition products Potassium oxides, hydrogen chloride gas Hazardous polymerization Will not occur Store at 2 - 30°C. Keep dry and out of direct sunlight. Chemical Protect from moisture, strong acids, strong bases, strong oxidizing agents, organic Incompatibilities materials, metals Section 8 - Exposure Controls/Personal Protection Engineering Controls Access to safety shower and eye wash station. Ventilation not required for safe handling Skin Protection Wear protective gloves and laboratory coat. Eye protection Wear appropriate eye protection. Exposure Limits No data available Component Composition LD50 LC50 Human serum/plasma* <75% Data not available Sodium tetraborate < 2% 2 gm/kg (oral, mouse) Data not available decahydrate (Borate) 2660 mg/kg (oral, rat) *The human serum/plasma is reactive for Hepatitis B Virus Core Antibody (anti-HBc), Human Immunodeficiency Virus Antibody (anti-HIV), and Hepatitis C Virus Antibody (anti-HCV). The serum/plasma was inactivated using established heat treatment methods. However, as no test method can offer complete assurance as to the absence of infectious agents, this material should be handled as though capable of transmitting infectious disease and disposed of accordingly. Section 9 - Physical and Chemical Properties Appearance White to pale yellow solid pellet/cake. Clear to pale yellow solution when reconstituted. Odor Odorless Odour Threshold Not applicable pH Not Available Melting Point Not Available Freezing Point Not Applicable Boiling Point Not Applicable Preparation Date 02/17/16 Flash Point Not Applicable Evaporation Rate Not Available Flammability Not Flammable Upper/Lower Flammable Limits Not Available Vapour Pressure Not Available Vapour Density Not Applicable Relative Density Not Applicable Solubility Soluble in water Coefficient of water: oil Not Available distribution Auto-Ignition Temperature Not Applicable Decomposition Temperature Not Available Viscosity Not Available Section 10 - Stability and Reactivity Stability Stable under proper storage conditions Conditions to avoid High heat. High humidity Hazardous decomposition products Potassium oxides, hydrogen chloride gas Hazardous polymerization Will not occur

TOXICOLOGICAL INFORMATION

Potential Routes of Entry Ingestion, inhalation, contact with skin and eyes Acute/Chronic Exposure Effects Data not available Exposure Limits Data not available Irritancy Data not available LD50/LC50 Data not available Carcinogenicity Data not available Potential Routes of Entry Ingestion, inhalation, contact with skin and eyes Acute/Chronic Exposure Effects Data not available Exposure Limits Data not available Irritancy Data not available LD50/LC50 Data not available Carcinogenicity Data not available

Teratogenic Effects

Data not available Reproductive Effects Data not available Neurotoxicity Data not available Mutagenicity Data not available Toxicologically synergistic products Data not available Data not available Reproductive Effects Data not available Neurotoxicity Data not available Mutagenicity Data not available Toxicologically synergistic products Data not available

ECOLOGICAL INFORMATION

Handle and dispose according to biohazardous waste requirements. Handle and dispose according to biohazardous waste requirements.

Disposal

Considerations Waste Disposal Dispose according to biohazardous waste requirements. Methods Section 14 - Transport Information Transport Information Test controls are not hazardous for transport. Section 15 - Regulatory Information Regulatory Information This product has been classified according to the hazard criteria of the CPR and the SDS contains all of the information required by the CPR. Considerations Waste Disposal Dispose according to biohazardous waste requirements. Methods Section 14 - Transport Information Transport Information Test controls are not hazardous for transport. Section 15 - Regulatory Information Regulatory Information This product has been classified according to the hazard criteria of the CPR and the SDS contains all of the information required by the CPR. Preparation Date 02/17/16

Further information

Preparation Date December 3, 2015 Last Revision September 23, 2015 Prepared by Quality Unit, MedMira Laboratories Inc. Contact Person support@medmira.com or 1 877 MEDMIRA The statements contained herein are offered for informational purposes only and are based upon technical data that MedMira Laboratories Inc. believes to be accurate. Since conditions and manner of use are outside our control, we make no WARRANTY, EXPRESS OR IMPLIED, OF MERCHANTABILITY, FITNESS OR OTHERWISE Preparation Date 02/17/16 Preparation Date February 17, 2016 Section 1 - Identification Product Name HBc/HIV/HCV Positive Test Control Recommended Use Accessory to MedMira Rapid Tests Restrictions on Use Intended for use only by persons having the necessary technical skill and at their own discretion and risk. MedMira Laboratories Inc. Manufacturer Contact 155 Chain Lake Drive, Suite 1 Information Halifax, NS, Canada, B3S 1B3 Tel: 1 902 450 1588 Fax: 1 902 450 1580 Overview Preparation Date February 17, 2016 Last Revision February 17, 2016 Prepared by Quality Unit, MedMira Laboratories Inc. Contact Person support@medmira.com or 1 877 MEDMIRA The statements contained herein are offered for informational purposes only and are based upon technical data that MedMira Laboratories Inc. believes to be accurate. Since conditions and manner of use are outside our control, we make no WARRANTY,

Signal word

None

Hazard pictograms

None

2.3 Other hazards

None Regulation