Type: Title: Syphilis EIA II Total Antibody 480 (Bio-Rad) Syphilis EIA II Total Antibody 480 (Bio-Rad)

Transcription

1 DATE OF ISSUE: December 2013 ISSUED TO MEET THE REQUIREMENTS OF REGULATION (EC) 1907/2006: ARTICLE 31, 3 (a) and 3 (c). SECTION 1: Identification of the mixture and of the company/undertaking 1.1. Product identification: SYPHILIS EIA TEST KITS Kit Code Kit Name Syphilis EIA 96 Tests (Lab21) Syphilis EIA 480 Tests (Lab21) Syphilis EIA II Total Antibody 96 (Bio-Rad) 72518SP Syphilis EIA II Total Antibody 96 (Bio-Rad) Syphilis EIA II Total Antibody 480 (Bio-Rad) 72519SP Syphilis EIA II Total Antibody 480 (Bio-Rad) 1.2. Use of the product: Medical in vitro diagnostic device for professional use 1.3. Manufacturer: Name: Trinity Biotech UK Address: Lanwades Business Park, Kentford, Suffolk, CB8 7PN, United Kingdom Telephone: + 44 (0) productsupport@trinitybiotech.com 1.4. Emergency telephone Number: + 44 (0) Available times: (GMT) SECTION 2: Hazards identification 2.1. Classification of the product (Regulation (EC) No. 1907/2006, Article 31): This product does not meet the criteria for classification as a dangerous mixture Adverse effects and symptoms: Physicochemical: May cause corrosion Health: May cause irritation to eyes, skin, and respiratory and digestive systems. Environmental: None known 2.3. Other hazards: None known Page 1 of 8

2 SECTION 3: Composition/information on ingredients 3.1. General description: Kit containing the following components Syphilis EIA Plate: Polystyrene plate with reagent-coated U-wells in a foil laminate pouch. (See NOTE 1) Syphilis EIA Positive Control: Aqueous solution containing buffer salts, dye, antimicrobial agent, and human serum. (See NOTE 2). Syphilis EIA Negative Control: Aqueous solution containing buffer salts, dye, antimicrobial agent, and human serum. (See NOTE 2). Syphilis EIA Conjugate: Aqueous solution of buffer salts, dye, antimicrobial agent, detergent, bovine serum, and recombinant antigen conjugated to horseradish peroxide enzyme. (See NOTE 1) Syphilis EIA Substrate: Aqueous buffered, dyed solution of tetramethylbenzidine (TMB) and hydrogen peroxide. Syphilis EIA Wash Solution Concentrate: Aqueous solution containing sodium chloride, detergent and antimicrobial agent Syphilis EIA Stop Solution: Aqueous acidic saline solution. NOTE 1: This product contains materials of biological origin. As no method of preparation or testing of such materials can guarantee complete absence of such materials, it is recommended that the product is handled as potentially infectious. NOTE 2: Each human blood donor unit in this product has been tested and found negative for HBsAg, antibodies to HIV 1 and 2, and antibodies to HCV. All sera used have been subsequently heat treated (56 C) for 30 minutes. However, as no method of testing or treatment of material can guarantee the absence of infectious agents, it is recommended that this product is handled as potentially infectious Substances present Ingredients specified in Regulation (EC) 1907/2006, Article 31, (3): a. Presenting a hazard to health or environment, with individual concentrations 1% w/w: Substance: Tris (hydroxymethyl) aminomethane Hazard Classification: Irritant Symbol letters: Xi R-phrases: R36/37/38 CAS number: Concentration in product: 1.25% in Syphilis EIA Conjugate Substance: Citric acid Hazard Classification: Irritant Symbol letters: Xi R-phrases: R36 CAS number: Concentration in mixture: < 5% in Syphilis EIA Substrate Page 2 of 8

3 Substance: Sulphuric acid Hazard Classification: Corrosive Symbol letters: C R-phrases: R35 CAS number: Concentration in mixture: < 5 % in Syphilis EIA Stop Solution b. Classified as persistent, bioaccumulative or toxic (EC 1907/2006 Annex XIII) and with individual concentrations 0.1 % w/w: None c. Having EC workplace exposure limits: Substance: Sulphuric acid Hazard Classification: Corrosive Symbol letters: C R-phrases: R35 CAS number: Concentration in mixture: < 5 % in Syphilis EIA Stop Solution SECTION 4: First aid measures 4.1. Inhalation (Unlikely in normal use, but possible if aerosols are raised from liquid components) Immediate symptoms and effects: Possible irritation Delayed symptoms and effects: Possible irritation First aid actions: Remove to fresh air Seek medical advice as soon as possible 4.2. Skin contact Immediate symptoms and effects: Possible irritation Delayed symptoms and effects: Possible irritation First aid actions: Wash affected area with soap and running water. Remove contaminated clothing Seek medical advice if irritation appears or persists. Show this data sheet Eye contact Immediate symptoms and effects: Possible irritation Delayed symptoms and effects: Possible irritation First aid actions: Wash open eye in running water for at least 15 minutes. Seek medical advice as soon as possible. Show this data sheet Ingestion (Unlikely in normal use) Immediate symptoms and effects: Possible irritation Delayed symptoms and effects: Possible irritation First aid actions: Rinse mouth with water. Seek medical advice as soon as possible. Show this data sheet Equipment to be available at the workplace for specific and immediate treatment Supply of clean running water Page 3 of 8

4 SECTION 5: Fire-fighting measures 5.1. Suitable extinguishing media: According to surrounding materials and environment 5.2. Unsuitable extinguishing media: According to surrounding materials and environment 5.3. Special hazards arising from the product or its combustion: The liquid components are aqueous and unlikely to combust. However, the containers may burst in fire conditions and eject sharp fragments and hot liquids. Toxic fumes may be evolved in fire conditions Special protective equipment for fire-fighters: Eye, skin and respiratory protection. SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures: Wear protective clothing as in 8. Avoid direct contact with the plate micro-well interiors or the vial contents Environmental precautions: Avoid uncontrolled release to the environment Methods and material for containment and cleaning up: Plates: Pick up gently and hold in a closed container pending disposal. Controls: Take up in inert absorbent material. Hold in closed plastic containers pending disposal. Wash cleared area with combined virucidal / bactericidal disinfectant. Conjugate, Substrate and Wash Solutions: Take up in inert absorbent material. Hold in closed plastic containers pending disposal. Wash cleared area with water. Stop Solution: Take up in sodium carbonate or inert absorbent material. Hold in closed plastic containers pending disposal. Wash cleared area with water Measures to avoid: Abrasion (plates). Splashing or raising mist or spray (liquids). Use of metal tools Refer to sections 8 and 13. SECTION 7: Handling and storage 7.1. Handling: Recommended procedures and equipment: Standard laboratory precautions if handled according to supplied instructions for use. Handle gently. Keep containers closed when not in use. Procedures and equipment to avoid: Plates: Abrasion, excessive force, touching micro-well interiors. Liquids: Splashing or raising mist or spray. Page 4 of 8

5 7.2. Storage: Recommended conditions: As stated on the label and instructions for use. Conditions to avoid: Heat and light.7.3. Specific use: As an in vitro diagnostic medical device according to the instructions supplied with the kit. SECTION 8: Exposure controls/personal protection 8.1. Exposure limit values: Stop Solution: Long-term time-weighted average for sulphuric acid (8-hour reference period): 0.05 mg.m -3. Airborne dispersal on this scale is unlikely in the normal use of this product 8.2. Exposure controls: Occupational a. Respiratory protection: None required in normal use b. Hand protection: Impermeable gloves c. Eye protection: Safety spectacles d. Skin protection: Laboratory coat or overall Environmental: Clear spillages promptly. Avoid uncontrolled release to the environment SECTION 9: Physical and chemical properties 9.1. General information: Appearance Syphilis EIA Plate: Clear solid indented plate. Syphilis EIA Positive Control: Red/orange coloured liquid. Syphilis EIA Negative Control: Yellow coloured liquid. Syphilis EIA Conjugate: Blue coloured liquid Syphilis EIA Substrate: Pink to red-brown coloured liquid Syphilis EIA Wash Solution Concentrate: Colourless liquid Syphilis EIA Stop Solution: Colourless liquid 9.2. Health, safety and environmental information All liquid components are miscible with water. Syphilis EIA Positive Control: ph 7 Syphilis EIA Negative Control: ph 7 Syphilis EIA Conjugate: ph 7 Syphilis EIA Substrate: ph Syphilis EIA Wash Solution Concentrate: ph Syphilis EIA Stop Solution: ph < 1 SECTION 10: Stability and Reactivity Conditions to avoid Heat and light. Page 5 of 8

6 10.2. Materials to avoid Oxidising agents, organic solvents, metals, combustible substances Hazardous decomposition products None known in normal use. Stop Solution may release oxides of sulphur in fire conditions or in contact with incompatible materials Special considerations This product is essentially stable when used and stored according to the supplied instructions for use. SECTION 11: Toxicological Information Effects of exposure to the preparation Possible irritation Exposure routes Respiratory tract (unlikely in normal use), digestive tract (unlikely in normal use), skin and eyes Exposure symptoms Possible irritation Effects of specific substances in the preparations Controls: Contact with dyes and antimicrobials may cause skin or eye irritation. Conjugate: The buffer ingredient is known to cause irritation of the skin, eyes, respiratory tract and mucous membranes. It may be harmful by inhalation, ingestion and absorption through the skin. Substrate: Citric acid is known to cause irritation of the eyes. Washing Solution: Contact with saline solutions, detergents and antimicrobials may cause skin or eye irritation. Stop Solution: The sulphuric acid ingredient is corrosive. It causes severe burns on contact with skin, and corneal damage in contact with the eyes. Ingestion causes pain, nausea, vomiting and diarrhoea, with the possibilities of perforation and pyloric stenosis. Inhalation of aerosols causes damage to mucous membranes. SECTION 12: Ecological Information Avoid uncontrolled release into the environment. Substrate: The TMB ingredient is known to be toxic to aquatic organisms and is not predicted to be readily biodegradable. Stop Solution: The sulphuric acid ingredient is known to be toxic to aquatic organisms. SECTION 13: Disposal Considerations Disposal methods: Segregate product for disposal as healthcare waste through a specialist contractor. Waste from testing of specimens should be treated as potentially infectious. Page 6 of 8

7 13.2. Regulatory considerations: Follow local and national regulations for disposal of healthcare waste. European waste codes: Syphilis EIA Plate, Conjugate, Substrate, Wash Solution, Stop Solution: Unused product , used product Syphilis EIA Positive Control, Negative Control: SECTION 14: Transport Information Follow the regulations for biological and chemical materials relevant to the modes of transport, geographical areas and authorities involved. SECTION 15: Regulatory Information Labelling information required by Directives 67/548/EEC or 1999/45/EC: None applicable Other regulatory information: None applicable SECTION 16: Other Information Meanings of R-phrases used in sections 2 and 3: R36/37/38 Irritating to eyes, respiratory system, and skin R36 Irritating to eyes R35 Causes severe burns Training advice For professional use by persons trained in the handling and use of biological and chemical materials Recommended restrictions on use For professional in vitro medical diagnostic use according to the instructions supplied with the kits listed in Sources of information used to compile this sheet Regulation (EC) No. 1907/2006 of the European Parliament and of the Council concerning the registration, evaluation, authorisation and restriction of chemicals (REACH): Article 31: Requirements for safety data sheets, and Annex II: Guide to the compilation of safety data sheets, OJL, 136, , pp and pp Regulation (EC) No. 1272/2008 of the European Parliament and of the Council 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. Commission Decision 2000/532/EC establishing a list of wastes pursuant to Article 1 (a) of Directive 75/442/EEC on Waste and Article 1 (4) of Directive 91/689/EEC on Hazardous Waste. CONSLEG: 2000D /01/2002, Office for Official Publications of the European Communities. Page 7 of 8

8 List of approved workplace exposure limits, Table 1 of EH40/2005, United Kingdom Health and Safety Commission, 2 ND edition published 2011, implementing the European Commission s Indicative Occupational Exposure Limit Values Directive 2009/161/EU. Information from materials suppliers to Trinity Biotech Changes from previous version All sections rewritten for alignment with Regulation (EC) No. 1907/2006 and Regulation (EC) No. 1272/2008. The information in this safety data sheet is considered by Trinity Biotech UK to be proportionate for a product that does not meet the criteria for classification as dangerous according to Regulation (EC) No. 1907/2006, Article 31. The information is believed to be correct at the time of compilation. However, because the properties of many materials have not been fully evaluated, this sheet is for guidance only and is not claimed to be fully comprehensive. No information in this sheet is intended to supersede legislation or other rules applicable to the site of use of the product. It is not intended to replace any assessment of workplace risk that may be required of the product user. Page 8 of 8