SAFETY DATA SHEET according to 1907/2006/EC, Article 31

Transcription

1 SAFETY DATA SHEET according to 1907/2006/EC, Article 1 CHLAMYDIA CULTURE CONJUGATE REAGENT SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product name Product code CHLAMYDIA CULTURE CONJUGATE REAGENT 8H019UL 1.2. Relevant identified uses of the substance or mixture and uses advised against Product Use Description 1.. Details of the supplier of the safety data sheet Company Address Web date Page 1/7 2 [SU22] Professional uses: Public domain (administration, education, entertainment, services, craftsmen); [PC21] Laboratory chemicals; [PROC4] Use in batch and other process (synthesis) where opportunity for exposure arises; Chlamydia Culture Conjugate Reagent. Trinity Biotech IDA Business Park Bray Co. Wicklow Ireland Telephone Fax Local Supplier Company Address info@trinitybiotech.com Trinity Biotech USA 282 Girts Rd Jamestown NY USA Telephone Fax Emergency telephone number SECTION 2: Hazards identification 2.1. Classification of the substance or mixture Main hazards No Significant Hazard 2.2. Label elements Risk phrases No Significant Hazard 2.. Other hazards Other hazards Contact your local Emergency Health Provider. Ireland-Technical Support Group USA-Technical Support Group Biohazardous Material.

2 Further information CHLAMYDIA CULTURE CONJUGATE REAGENT date Caution! All components containing biological material must be treated as potentially biohazardous. Handle as if potentially infectious. Page 2/7 2 SECTION : Composition/information on ingredients.2. Mixtures EC 1272/2008 Chemical Name Index No. CAS No. EC No. REACH Registration Number Conc. (%w/w) Classification Sodium azide (Sodium azide (as % Acute Tox. 2: H00; Aquatic NaN)) Acute 1: H400; Aquatic Chronic 1: H410; M-factor. Further information SECTION 4: First aid measures 4.1. Description of first aid measures Inhalation Eye contact Skin contact Ingestion No substance is present at a concentration level, specified by EC Directive, which presents a health or environmental hazard. Move the exposed person to fresh air. Rinse immediately with plenty of water for 15 minutes holding the eyelids open. Wash off immediately with plenty of soap and water. Remove contaminated clothing. DO NOT INDUCE VOMITING Most important symptoms and effects, both acute and delayed Inhalation Eye contact Skin contact Ingestion May cause irritation to mucous membranes. Irritating to eyes. Irritating to skin. Ingestion may cause nausea and vomiting. 4.. Indication of any immediate medical attention and special treatment needed Inhalation Eye contact Skin contact Ingestion SECTION 5: Firefighting measures 5.1. Extinguishing media 5.2. Special hazards arising from the substance or mixture 5.. Advice for firefighters SECTION 6: Accidental release measures If you feel unwell, seek medical advice (show the label where possible). In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. Seek medical attention if irritation or symptoms persist. Seek medical attention if irritation or symptoms persist. Use extinguishing media appropriate to the surrounding fire conditions. Burning produces irritating, toxic and obnoxious fumes. Wear suitable respiratory equipment when necessary. Wear protective clothing Personal precautions, protective equipment and emergency procedures 6.2. Environmental precautions Ensure adequate ventilation of the working area. 6.. Methods and material for containment and cleaning up Do not allow product to enter drains. Prevent further spillage if safe. Absorb with inert, absorbent material. Sweep up. Transfer to suitable, labelled containers for disposal. Clean spillage area thoroughly with plenty of water.

3 6.4. Reference to other sections CHLAMYDIA CULTURE CONJUGATE REAGENT See section 2,, 8 & 1 for further information. date Page /7 2 SECTION 7: Handling and storage 7.1. Precautions for safe handling 7.2. Conditions for safe storage, including any incompatibilities 7.. Specific end use(s) Avoid contact with eyes and skin. Ensure adequate ventilation of the working area. Adopt best Manual Handling considerations when handling, carrying and dispensing. Keep in a cool, dry, well ventilated area. Keep containers tightly closed. Store in correctly labelled containers. Medical diagnostics. SECTION 8: Exposure controls/personal protection 8.1. Control parameters 8.2. Exposure controls Appropriate engineering controls Individual protection measures Eye / face protection Skin protection - Handprotection Ensure adequate ventilation of the working area. Wear chemical protective clothing. Approved safety goggles. Face shield. Chemical resistant gloves (PVC). SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties

4 CHLAMYDIA CULTURE CONJUGATE REAGENT 9.1. Information on basic physical and chemical properties Appearance Solid Colour Blue Odour Odourless Odour threshold No data available Melting point No data available Freezing Point Not applicable. Initial boiling point No data available Flash point Not applicable. Evaporation rate Not applicable. Flammability (solid, gas) No data available Vapour pressure Not applicable. Vapour density Not applicable. Relative density (H2O = 20 C) Fat Solubility No data available Partition coefficient No data available Autoignition temperature Not applicable. Viscosity Not applicable. Explosive properties Not applicable. Oxidising properties Not applicable. Solubility Soluble in water 9.2. Other information Conductivity No data available Surface tension Not applicable. Gas group Not applicable. SECTION 10: Stability and reactivity Reactivity Chemical stability Stable under normal conditions Possibility of hazardous reactions Conditions to avoid Heat, sparks and open flames Incompatible materials Hazardous decomposition products Burning produces obnoxious and irritating fumes. SECTION 11: Toxicological information date Page 4/7 2 SECTION 12: Ecological information Persistence and degradability 12.. Bioaccumulative potential

5 12.. Bioaccumulative potential Partition coefficient Mobility in soil CHLAMYDIA CULTURE CONJUGATE REAGENT CHLAMYDIA CULTURE No data available CONJUGATE REAGENT Results of PBT and vpvb assessment Other adverse effects date Page 5/7 2 SECTION 1: Disposal considerations 1.1. Waste treatment methods General information Disposal methods Disposal of packaging SECTION 14: Transport information ADR/RID IMDG IATA Further information SECTION 15: Regulatory information Disposal should be made in accordance with local and national regulations. Dispose of in compliance with all local and national regulations. Disposal should be made in accordance with existing procedures / protocols currently in place at facility for infectious waste. Do NOT reuse empty containers. Empty containers can be sent for disposal or recycling Safety, health and environmental regulations/legislation specific for the substance or mixture Chemical safety assessment COMMISSION REGULATION (EU) No 45/2010 of 20 May 2010 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 79/9 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 9/67/EEC, 9/105/EC and 2000/21/EC. REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 79/9 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 9/67/EEC, 9/105/EC and 2000/21/EC.

6 15.2. Chemical safety assessment CHLAMYDIA CULTURE CONJUGATE REAGENT No data is available on this product. date Page 6/7 2 SECTION 16: Other information Other information Text of Hazard Statements in Section This document differs from the previous version in the following areas:. 1 - Description. 2 - Other hazards Label elements. 2 - Precautionary Statement: Prevention. 2 - Further information. - Further information. 4 - Skin contact. 4 - Eye contact. 4 - Inhalation. 4 - Ingestion. 4 - Inhalation Indication of any immediate medical attention and special treatment needed. 4 - Inhalation. 4 - Eye contact. 4 - Skin contact. 4 - Ingestion Personal precautions, protective equipment and emergency procedures Reference to other sections Control parameters Information on basic physical and chemical properties (Initial boiling point) Information on basic physical and chemical properties (Melting point) Information on basic physical and chemical properties (Flash point) Information on basic physical and chemical properties (Flammability (solid, gas)) Information on basic physical and chemical properties (Autoignition temperature) Information on basic physical and chemical properties (Explosive properties) Information on basic physical and chemical properties (Oxidising properties) Information on basic physical and chemical properties (Vapour pressure) Information on basic physical and chemical properties (Relative density) Information on basic physical and chemical properties (Viscosity) Information on basic physical and chemical properties (Vapour density) Information on basic physical and chemical properties (Evaporation rate) Information on basic physical and chemical properties (Freezing Point) Information on basic physical and chemical properties (Fat Solubility) Information on basic physical and chemical properties (Solubility) Information on basic physical and chemical properties (Odour threshold) Other information (Conductivity) Other information (Partition coefficient) Other information (Gas group) Other information (Surface tension) Hazardous decomposition products Toxicity. 1 - Disposal methods. 1 - Disposal of packaging Waste treatment methods Risk phrases Safety, health and environmental regulations/legislation specific for the substance or mixture Chemical safety assessment. EUH02 - Contact with acids liberates very toxic gas. Acute Tox. 2: H00 - Fatal if swallowed. Aquatic Acute 1: H400 - Very toxic to aquatic life. Aquatic Chronic 1: H410 - Very toxic to aquatic life with long lasting effects.

7 Further information CHLAMYDIA CULTURE CONJUGATE REAGENT date Page 7/7 2 The information supplied in this Safety Data Sheet is designed only as guidance for the safe use, storage and handling of the product. This information is correct to the best of our knowledge and belief at the date of publication however no guarantee is made to its accuracy. This information relates only to the specific material designated and may not be valid for such material used in combination with any other materials or in any other process.

8 SAFETY DATA SHEET according to 1907/2006/EC, Article 1 RECONSTITUTION DILUENT SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product name Product code RECONSTITUTION DILUENT 8H019UL, 8H149UL, 8H219UL, 8H49UL 1.2. Relevant identified uses of the substance or mixture and uses advised against Product Use Description date Page 1/7 [SU22] Professional uses: Public domain (administration, education, entertainment, services, craftsmen); [PC21] Laboratory chemicals; [PROC4] Use in batch and other process (synthesis) where opportunity for exposure arises; Reconstitution Diluent. 1.. Details of the supplier of the safety data sheet Company Address Web Trinity Biotech IDA Business Park Bray Co. Wicklow Ireland Telephone Fax Local Supplier Company Address info@trinitybiotech.com Trinity Biotech USA 282 Girts Rd Jamestown NY USA Telephone Fax Emergency telephone number SECTION 2: Hazards identification 2.1. Classification of the substance or mixture Classification /45/ЕC Main hazards 2.2. Label elements 2.. Other hazards Contact your local Emergency Health Provider. Ireland-Technical Support Group USA-Technical Support Group Xn; R22 Symbols: Xn: Harmful. Harmful if swallowed. In accordance with EC directives, this product does not need to be labelled.

9 Page 2/7 RECONSTITUTION DILUENT date 2.. Other hazards Other hazards SECTION : Composition/information on ingredients.2. Mixtures 67/548/EEC / 1999/45/EC Chemical Name Index No. CAS No. EC No. REACH Registration Number Conc. (%w/w) Classification Sodium azide (Sodium azide (as % T+; R28 R2 N; R50/5 NaN)) M-factor. EC 1272/2008 Chemical Name Index No. CAS No. EC No. REACH Registration Number Conc. (%w/w) Classification Sodium azide (Sodium azide (as % Acute Tox. 2: H00; Aquatic NaN)) Acute 1: H400; Aquatic Chronic 1: H410; M-factor. Further information SECTION 4: First aid measures 4.1. Description of first aid measures Inhalation Eye contact Skin contact Ingestion No substance is present at a concentration level, specified by EC Directive, which presents a health or environmental hazard. Move the exposed person to fresh air. Rinse immediately with plenty of water for 15 minutes holding the eyelids open. Wash off immediately with plenty of soap and water. Remove contaminated clothing. DO NOT INDUCE VOMITING Most important symptoms and effects, both acute and delayed Inhalation Eye contact Skin contact Ingestion May cause irritation to respiratory system. May cause irritation to eyes. May cause irritation to skin. Harmful if swallowed. 4.. Indication of any immediate medical attention and special treatment needed Inhalation Eye contact Skin contact Ingestion SECTION 5: Firefighting measures 5.1. Extinguishing media If exposed or concerned, seek medical attention. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. If exposed or concerned, seek medical attention Special hazards arising from the substance or mixture 5.. Advice for firefighters SECTION 6: Accidental release measures If swallowed, do not induce vomiting: seek medical advice immediately and show this container or label. Use as appropriate: Carbon dioxide (CO2), Dry chemical, Foam. Burning produces irritating, toxic and obnoxious fumes. Self-contained breathing apparatus. Wear protective clothing Personal precautions, protective equipment and emergency procedures 6.2. Environmental precautions Ensure adequate ventilation of the working area. Wear suitable protective equipment. Do not allow product to enter drains. Prevent further spillage if safe.

10 6.. Methods and material for containment and cleaning up 6.4. Reference to other sections SECTION 7: Handling and storage 7.1. Precautions for safe handling RECONSTITUTION DILUENT date Page /7 Absorb with inert, absorbent material. Transfer to suitable, labelled containers for disposal. Clean spillage area thoroughly with plenty of water. See section 2,, 8 & 1 for further information Conditions for safe storage, including any incompatibilities Suitable packaging 7.. Specific end use(s) Avoid contact with eyes and skin. Ensure adequate ventilation of the working area. Adopt best Manual Handling considerations when handling, carrying and dispensing. Keep containers tightly closed. Store at temperatures between 2 C and 8 C. Store in original container. Medical diagnostics. SECTION 8: Exposure controls/personal protection 8.1. Control parameters Exposure Limit Values Sodium azide (Sodium azide (as NaN)) WEL 8-hr limit ppm: - WEL 8-hr limit mg/m: 0.1 WEL 15 min limit ppm: - WEL 15 min limit mg/m: 0. WEL 8-hr limit mg/m total - WEL 15 min limit mg/m total - inhalable dust: inhalable dust: WEL 8-hr limit mg/m total - WEL 15 min limit mg/m total - respirable dust: respirable dust: 8.2. Exposure controls Appropriate engineering controls Individual protection measures Eye / face protection Skin protection - Handprotection Respiratory protection Ensure adequate ventilation of the working area. Wear chemical protective clothing. Approved safety goggles. Chemical resistant gloves (PVC). Self-contained breathing apparatus. Wear protective clothing. SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties

11 9.1. Information on basic physical and chemical properties Appearance Liquid Colour Clear Odour Odourless Odour threshold Not applicable. ph No data available Melting point Not applicable. Freezing Point Not applicable. Initial boiling point Not applicable. Flash point No data available Evaporation rate Not applicable. Flammability (solid, gas) No data available Vapour pressure Not applicable. Vapour density Not applicable. Relative density (H2O = 20 C) Fat Solubility No data available Partition coefficient No data available Autoignition temperature No data available 9.2. Other information Viscosity No data available Explosive properties No data available Oxidising properties Not applicable. Solubility Soluble in water Conductivity No data available Surface tension No data available Gas group Not applicable. Benzene Content Not applicable. Lead content Not applicable. VOC (Volatile organic compounds) Not applicable. SECTION 10: Stability and reactivity Reactivity Chemical stability 10.. Possibility of hazardous reactions Conditions to avoid Incompatible materials Hazardous decomposition products RECONSTITUTION DILUENT Stable under normal conditions. SECTION 11: Toxicological information Information on toxicological effects Toxicological Information Burning produces obnoxious and irritating fumes. Acute Tox. 4: H02 - Harmful if swallowed. date Page 4/7

12 Toxicological Information RECONSTITUTION DILUENT date Page 5/7 Sodium azide Oral Rat LD50: 10mg/kg Dermal Rabbit LD50: 20mg/kg SECTION 12: Ecological information Toxicity Harmful if swallowed. Sodium azide Daphnia EC50/48h: mg/l No data is available on this product Persistence and degradability 12.. Bioaccumulative potential Partition coefficient RECONSTITUTION DILUENT No data available Sodium azide No data available Mobility in soil Results of PBT and vpvb assessment Other adverse effects SECTION 1: Disposal considerations 1.1. Waste treatment methods General information Disposal methods Disposal of packaging SECTION 14: Transport information ADR/RID IMDG IATA Further information SECTION 15: Regulatory information Disposal should be made in accordance with local and national regulations. Dispose of in compliance with all local and national regulations. Contact a licensed waste disposal company. For disposal within the EC, the appropriate code according to the European Waste Catalogue (EWC) should be used. Do NOT reuse empty containers. Empty containers can be sent for disposal or recycling Safety, health and environmental regulations/legislation specific for the substance or mixture COMMISSION REGULATION (EU) No 45/2010 of 20 May 2010 amending Regulation (EC) No

13 RECONSTITUTION DILUENT Safety, health and environmental regulations/legislation specific for the substance or mixture Chemical safety assessment SECTION 16: Other information Other information date Page 6/7 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 79/9 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 9/67/EEC, 9/105/EC and 2000/21/EC. REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 79/9 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 9/67/EEC, 9/105/EC and 2000/21/EC. No data is available for this product. This document differs from the previous version in the following areas:. 1 - Description. 1 - Product Use. 2 - Other hazards Classification of the substance or mixture Label elements. - Further information. 4 - Skin contact. 4 - Eye contact. 4 - Inhalation. 4 - Ingestion. 4 - Inhalation. 4 - Skin contact. 4 - Ingestion. 4 - Inhalation. 4 - Eye contact. 4 - Skin contact. 4 - Ingestion Reference to other sections. 7 - Suitable packaging Control parameters Information on basic physical and chemical properties (PH) Information on basic physical and chemical properties (Initial boiling point) Information on basic physical and chemical properties (Melting point) Information on basic physical and chemical properties (Flash point) Information on basic physical and chemical properties (Flammability (solid, gas)) Information on basic physical and chemical properties (Autoignition temperature) Information on basic physical and chemical properties (Explosive properties) Information on basic physical and chemical properties (Oxidising properties) Information on basic physical and chemical properties (Vapour pressure) Information on basic physical and chemical properties (Relative density) Information on basic physical and chemical properties (Viscosity) Information on basic physical and chemical properties (Vapour density) Information on basic physical and chemical properties (Evaporation rate) Information on basic physical and chemical properties (Freezing Point) Information on basic physical and chemical properties (Fat Solubility) Information on basic physical and chemical properties (Solubility) Information on basic physical and chemical properties (Odour threshold) Other information (Conductivity).

14 Other information Text of risk phrases in Section Text of Hazard Statements in Section Further information RECONSTITUTION DILUENT date Page 7/ Other information (Partition coefficient) Other information (Gas group) Other information (Surface tension) Other information (Benzene Content) Other information (Product Subcategory) Other information (Lead content) Hazardous decomposition products Toxicological Information Information on toxicological effects Toxicity Waste treatment methods Labelling Symbols Risk phrases Safety, health and environmental regulations/legislation specific for the substance or mixture Chemical safety assessment Maximum content of VOC. R28 - Very toxic if swallowed. R2 - Contact with acids liberates very toxic gas. R50/5 - Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. EUH02 - Contact with acids liberates very toxic gas. Acute Tox. 2: H00 - Fatal if swallowed. Aquatic Acute 1: H400 - Very toxic to aquatic life. Aquatic Chronic 1: H410 - Very toxic to aquatic life with long lasting effects. The information supplied in this Safety Data Sheet is designed only as guidance for the safe use, storage and handling of the product. This information is correct to the best of our knowledge and belief at the date of publication however no guarantee is made to its accuracy. This information relates only to the specific material designated and may not be valid for such material used in combination with any other materials or in any other process.