SAFETY DATA SHEET. SECTION 1: Identification of the substance/mixture and of the company/undertaking. Anti-dog IgG conjugate (100x conc.

Transcription

1 SAFETY DATA SHEET SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Trade name or designation Antidog IgG conjugate (100x conc.) of the mixture Registration number Synonyms [Hund Conj IgG 100 x conc] Product code DE Issue date 05March2015 Version number 01 Revision date Supersedes date 1.2. Relevant identified uses of the substance or mixture and uses advised against Identified uses In vitro diagnostics. Uses advised against Use in accordance with supplier's recommendations Details of the supplier of the safety data sheet Manufacturer/Distributor Sekisui Virotech GmbH Address Löwenplatz 5, Rüsselsheim, Germany Telephone number +49 (0) Website Contact person Gayle Brecker Gayle.Brecker@sekisuivirotech.com 1.4. Emergency telephone Europe, Middle East & Africa number Access code SECTION 2: Hazards identification 2.1. Classification of the substance or mixture The mixture has been assessed and/or tested for its physical, health and environmental hazards and the following classification applies. Classification according to Directive 67/548/EEC or 1999/45/EC as amended Classification Xn;R20/21/22, R33 The full text for all Rphrases is displayed in section 16. Classification according to Regulation (EC) No 1272/2008 as amended Health hazards Specific target organ toxicity repeated exposure Category 2 (Central nervous system) H373 May cause damage to organs (Central nervous system) through prolonged or repeated exposure. Hazard summary Physical hazards Not classified for physical hazards. Health hazards Harmful by inhalation, in contact with skin and if swallowed. Danger of cumulative effects. Environmental hazards Not classified for hazards to the environment. Specific hazards Avoid contact with eyes and skin. Do not ingest or inhale. Main symptoms Direct contact with skin and eyes may cause irritation Label elements Label according to Regulation (EC) No. 1272/2008 as amended Hazard pictograms Signal word Warning Antidog IgG conjugate (100x conc.) Version #: 01 Revision date: Issue date: 05March / 7

2 Hazard statements H373 May cause damage to organs (Central nervous system) through prolonged or repeated exposure. Precautionary statements Prevention P260 Do not breathe mist. Response P314 Get medical advice/attention if you feel unwell. Storage None. Disposal P501 Dispose of contents/container in accordance with local/regional/national/international regulations. Supplemental label information Not applicable Other hazards Not a PBT or vpvb substance or mixture. SECTION 3: Composition/information on ingredients 3.2. Mixtures General information Chemical name % CASNo. / EC No. REACH Registration No. INDEX No. Notes Glycerol XXXX Classification: DSD: CLP: Thimerosal (Sodiumethylmercurithiosalicylat) Classification: DSD: T+;R26/27/28, R33, N;R50/53 A,1 CLP: Acute Tox. 2;H300, Acute Tox. 1;H310, Acute Tox. 2;H330, STOT RE 2;H373, Aquatic Acute 1;H400, Aquatic Chronic 1;H410 1,A List of abbreviations and symbols that may be used above DSD: Directive 67/548/EEC. CLP: Regulation No. 1272/2008. Note A: Without prejudice to Article 17(2), the name of the substance must appear on the label in the form of one of the designations given in Part 3. In Part 3, use is sometimes made of a general description such as "... compounds" or "... salts". In this case, the supplier is required to state on the label the correct name, due account being taken of section Note 1: The concentration stated or, in the absence of such concentrations, the generic concentrations of this Regulation (Table 3.1) or the generic concentrations of Directive 1999/45/EC (Table 3.2), are the percentages by weight of the metallic element calculated with reference to the total weight of the mixture. Composition comments SECTION 4: First aid measures All concentrations are in percent by weight unless ingredient is a gas. Gas concentrations are in percent by volume. General information Ensure that medical personnel are aware of the material(s) involved, and take precautions to protect themselves Description of first aid measures Inhalation Move to fresh air. Call a physician if symptoms develop or persist. Skin contact Eye contact Ingestion 4.2. Most important symptoms and effects, both acute and delayed 4.3. Indication of any immediate medical attention and special treatment needed SECTION 5: Firefighting measures General fire hazards For skin contact flush with large amounts of water while removing contaminated clothing. Get medical attention if irritation develops and persists. In case of contact, immediately flush eyes with fresh water for at least 15 minutes while holding the eyelids open. Remove contact lenses if worn. Get medical attention if irritation persists. If material is ingested, immediately contact a physician or poison control centre. Direct contact with skin and eyes may cause irritation. Provide general supportive measures and treat symptomatically. The product is not flammable. Antidog IgG conjugate (100x conc.) Version #: 01 Revision date: Issue date: 05March / 7

3 5.1. Extinguishing media Suitable extinguishing media Unsuitable extinguishing media 5.2. Special hazards arising from the substance or mixture 5.3. Advice for firefighters Special protective equipment for firefighters Special fire fighting procedures Extinguish with water spray, carbon dioxide, dry chemical or material appropriate for the surrounding fire. None known. None known. Selfcontained breathing apparatus and full protective clothing must be worn in case of fire. Use standard firefighting procedures and consider the hazards of other involved materials. SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures For nonemergency Keep unnecessary personnel away. Do not touch damaged containers or spilled material unless personnel wearing appropriate protective clothing. For emergency responders Use personal protection as recommended in section 8 of the SDS Environmental precautions Do not allow to enter drains, sewers or watercourses 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 7.2. Conditions for safe storage, including any incompatibilities 7.3. Specific end use(s) In vitro diagnostics. SECTION 8: Exposure controls/personal protection 8.1. Control parameters Occupational exposure limits UK. EH40 Workplace Exposure Limits (WELs) Components Absorb spill with vermiculite or other inert material. Dispose of waste in accordance with all applicable federal, state, local and provincial environmental regulations, per Section 13. For personal protection, see section 8 of the SDS. For waste disposal, see section 13 of the SDS. Avoid contact with skin and eyes. Wash thoroughly after handling. In case of insufficient ventilation, wear suitable respiratory equipment. Handle and open container with care. Store in a closed container away from incompatible materials. Store at 28 C (3546 F). Type Value Glycerol (CAS 56815) Biological limit values TWA 10 mg/m3 Mist. UK. EH40 Biological Monitoring Guidance Values (BMGVs) Form Components Value Determinant Specimen Thimerosal (Sodiumethylmercurithiosal 20 umol/mol Mercury Creatinine in urine icylat) (CAS 54648) * For sampling details, please see the source document. Recommended monitoring Follow standard monitoring procedures. procedures Derived noeffect level (DNEL) Sampling time * Predicted no effect concentrations (PNECs) Exposure guidelines Follow standard monitoring procedures Exposure controls Appropriate engineering Provide adequate ventilation. Provide easy access to water supply and eye wash facilities. controls Individual protection measures, such as personal protective equipment General information Personal protective equipment should be chosen according to the CEN standards and in discussion with the supplier of the personal protective equipment. Eye/face protection Wear approved safety glasses or goggles. Skin protection Antidog IgG conjugate (100x conc.) Version #: 01 Revision date: Issue date: 05March / 7

4 Hand protection Wear appropriate chemical resistant gloves. Nitrile gloves are recommended. Other Wear lab coat or other protective garments. Remove contaminated clothing promptly. Respiratory protection Under normal conditions, respirator is not normally required. Thermal hazards Wear appropriate thermal protective clothing, when necessary. Hygiene measures Handle in accordance with good industrial hygiene and safety practices. Environmental exposure Inform appropriate managerial or supervisory personnel of all environmental releases. controls SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Appearance Colourless liquid. Physical state Liquid. Form Liquid. Colour Colourless. Odour Odourless. Odour threshold ph Melting point/freezing point Initial boiling point and boiling range Flash point Evaporation rate Flammability (solid, gas) Not applicable. Upper/lower flammability or explosive limits Flammability limit lower (%) Flammability limit upper (%) Vapour pressure Vapour density Relative density Solubility(ies) Partition coefficient (noctanol/water) Autoignition temperature Decomposition temperature Viscosity Explosive properties Not explosive. Oxidizing properties Not oxidizing Other information No relevant additional information available. SECTION 10: Stability and reactivity Reactivity The product is nonreactive under normal conditions of use, storage and transport Chemical stability Material is stable under normal conditions Possibility of hazardous Hazardous polymerisation does not occur. reactions Conditions to avoid Ultraviolet light. Exposure to light Incompatible materials Strong oxidizers, strong acids, and strong bases Hazardous None known. decomposition products SECTION 11: Toxicological information General information Occupational exposure to the substance or mixture may cause adverse effects. Information on likely routes of exposure Inhalation In high concentrations, mists/vapors may irritate throat and respiratory system and cause coughing. Skin contact May cause skin irritation. Antidog IgG conjugate (100x conc.) Version #: 01 Revision date: Issue date: 05March / 7

5 Eye contact Ingestion Symptoms May cause eye irritation. May cause discomfort if swallowed. Direct contact with skin and eyes may cause irritation Information on toxicological effects Acute toxicity Components Glycerol (CAS 56815) Acute Oral LD50 Skin corrosion/irritation Serious eye damage/eye irritation Respiratory sensitisation Skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity Specific target organ toxicity single exposure May cause discomfort if swallowed. Species Rat May cause skin irritation. May cause eye irritation. Not classifiable as to carcinogenicity to humans. Test results mg/kg Specific target organ toxicity repeated exposure Aspiration hazard Mixture versus substance information Other information May cause damage to organs (Central Nervous System) through prolonged or repeated exposure. No other specific acute or chronic health impact noted. SECTION 12: Ecological information Toxicity The product is not classified as environmentally hazardous. However, this does not exclude the possibility that large or frequent spills can have a harmful or damaging effect on the environment Persistence and No data is available on the degradability of this product. degradability Bioaccumulative potential Partition coefficient noctanol/water (log Kow) Glycerol (CAS 56815) 1.76 Bioconcentration factor (BCF) Mobility in soil No data available. Mobility in general No data available Results of PBT Not a PBT or vpvb substance or mixture. and vpvb assessment Other adverse effects No data available. SECTION 13: Disposal considerations Waste treatment methods Residual waste Contaminated packaging EU waste code Disposal methods/information Dispose in accordance with all applicable regulations. Empty containers or liners may retain some product residues. This material and its container must be disposed of in a safe manner (see: Disposal instructions). Empty containers should be taken to an approved waste handling site for recycling or disposal. The Waste code should be assigned in discussion between the user, the producer and the waste disposal company. Dispose waste and residues in accordance with applicable federal, state, and local regulations. Contaminated instruments and surfaces should be disinfected in accordance with your employer's chemicalspecific and universal/standard precautions. Antidog IgG conjugate (100x conc.) Version #: 01 Revision date: Issue date: 05March / 7

6 SECTION 14: Transport information ADR RID ADN IATA IMDG Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code Not applicable. SECTION 15: Regulatory information Safety, health and environmental regulations/legislation specific for the substance or mixture EU regulations Regulation (EC) No. 1005/2009 on substances that deplete the ozone layer, Annex I Regulation (EC) No. 1005/2009 on substances that deplete the ozone layer, Annex II Regulation (EC) No. 850/2004 On persistent organic pollutants, Annex I as amended Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 1 as amended Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 2 as amended Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 3 as amended Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex V as amended Regulation (EC) No. 166/2006 Annex II Pollutant Release and Transfer Registry Regulation (EC) No. 1907/2006, REACH Article 59(10) Candidate List as currently published by ECHA Authorisations Regulation (EC) No. 1907/2006, REACH Annex XIV Substances subject to authorisation, as amended Regulation (EC) No. 1907/2006, REACH Annex XVII Substances subject to restriction on marketing and use as amended Restrictions on use Regulation (EC) No. 1907/2006, REACH Annex XVII Substances subject to restriction on marketing and use as amended Directive 2004/37/EC: on the protection of workers from the risks related to exposure to carcinogens and mutagens at work Directive 92/85/EEC: on the safety and health of pregnant workers and workers who have recently given birth or are breastfeeding Thimerosal (Sodiumethylmercurithiosalicylat) (CAS 54648) Other EU regulations Directive 96/82/EC (Seveso II) on the control of majoraccident hazards involving dangerous substances Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work Thimerosal (Sodiumethylmercurithiosalicylat) (CAS 54648) Directive 94/33/EC on the protection of young people at work Thimerosal (Sodiumethylmercurithiosalicylat) (CAS 54648) Antidog IgG conjugate (100x conc.) Version #: 01 Revision date: Issue date: 05March / 7

7 Other regulations National regulations Chemical safety assessment The product is classified and labelled in accordance with Regulation (EC) 1272/2008 (CLP Regulation) as amended and respective national laws implementing EC directives. This Safety Data Sheet complies with the requirements of Regulation (EC) No 1907/2006. In the European Union this product is regulated under the In Vitro Diagnostic Medical Devices Directive (98/79/EC). Follow national regulation for work with chemical agents. No Chemical Safety Assessment has been carried out. SECTION 16: Other information List of abbreviations References Information on evaluation method leading to the classification of mixture Full text of any statements or Rphrases and Hstatements under Sections 2 to 15 Training information Disclaimer DNEL: Derived NoEffect Level. PNEC: Predicted NoEffect Concentration. PBT: Persistent, bioaccumulative and toxic. vpvb: Very Persistent and very Bioaccumulative. The classification for health and environmental hazards is derived by a combination of calculation methods and test data, if available. R20/21/22 Harmful by inhalation, in contact with skin and if swallowed. R26/27/28 Very toxic by inhalation, in contact with skin and if swallowed. R33 Danger of cumulative effects. R50/53 Very toxic to aquatic organisms, may cause longterm adverse effects in the aquatic environment. H300 Fatal if swallowed. H310 Fatal in contact with skin. H330 Fatal if inhaled. H373 May cause damage to organs through prolonged or repeated exposure. H400 Very toxic to aquatic life. H410 Very toxic to aquatic life with long lasting effects. Follow training instructions when handling this material. The information above is provided in good faith. It is believed to be accurate and represents the best information currently available to us. HOWEVER, WE MAKE NO WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR OF ANY OTHER TYPE, EXPRESSED OR IMPLIED, WITH RESPECT TO PRODUCTS DESCRIBED OR DATA OR INFORMATION PROVIDED, AND WE ASSUME NO LIABILITY RESULTING FROM THE USE OF SUCH PRODUCTS, DATA OR INFORMATION. Users should make their own investigations to determine the suitability of the information for their particular purposes, and the user assumes all risk arising from their use of the material. The user is required to comply with all laws and regulations relating to the purchase, use, storage and disposal of the material, and must be familiar with and follow generally accepted safe handling procedures. In no event shall Sekisui Diagnostics be liable for any claims, losses, or damages of any individual or for lost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if Sekisui Diagnostics has been advised of the possibility of such damages. Antidog IgG conjugate (100x conc.) Version #: 01 Revision date: Issue date: 05March / 7

8 SAFETY DATA SHEET SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Trade name or designation Antihorse IgG conjugate (100x conc.) of the mixture Registration number Synonyms [Pferd Conj IgG 100 x conc] Product code DE Issue date 05March2015 Version number 01 Revision date Supersedes date 1.2. Relevant identified uses of the substance or mixture and uses advised against Identified uses In vitro diagnostics. Uses advised against Use in accordance with supplier's recommendations Details of the supplier of the safety data sheet Manufacturer/Distributor Sekisui Virotech GmbH Address Löwenplatz 5, Rüsselsheim, Germany Telephone number +49 (0) Website Contact person Gayle Brecker Gayle.Brecker@sekisuivirotech.com 1.4. Emergency telephone Europe, Middle East & Africa number Access code SECTION 2: Hazards identification 2.1. Classification of the substance or mixture The mixture has been assessed and/or tested for its physical, health and environmental hazards and the following classification applies. Classification according to Directive 67/548/EEC or 1999/45/EC as amended Classification Xn;R20/21/22, R33 The full text for all Rphrases is displayed in section 16. Classification according to Regulation (EC) No 1272/2008 as amended Health hazards Specific target organ toxicity repeated exposure Category 2 (Central nervous system) H373 May cause damage to organs (Central nervous system) through prolonged or repeated exposure. Hazard summary Physical hazards Not classified for physical hazards. Health hazards Harmful by inhalation, in contact with skin and if swallowed. Danger of cumulative effects. Environmental hazards Not classified for hazards to the environment. Specific hazards Avoid contact with eyes and skin. Do not ingest or inhale. Main symptoms Direct contact with skin and eyes may cause irritation Label elements Label according to Regulation (EC) No. 1272/2008 as amended Hazard pictograms Signal word Warning Antihorse IgG conjugate (100x conc.) Version #: 01 Revision date: Issue date: 05March / 7

9 Hazard statements H373 May cause damage to organs (Central nervous system) through prolonged or repeated exposure. Precautionary statements Prevention P260 Do not breathe mist. Response P314 Get medical advice/attention if you feel unwell. Storage None. Disposal P501 Dispose of contents/container in accordance with local/regional/national/international regulations. Supplemental label information Not applicable Other hazards Not a PBT or vpvb substance or mixture. SECTION 3: Composition/information on ingredients 3.2. Mixtures General information Chemical name % CASNo. / EC No. REACH Registration No. INDEX No. Notes Glycerol XXXX Classification: DSD: CLP: Thimerosal (Sodiumethylmercurithiosalicylat) Classification: DSD: T+;R26/27/28, R33, N;R50/53 A,1 CLP: Acute Tox. 2;H300, Acute Tox. 1;H310, Acute Tox. 2;H330, STOT RE 2;H373, Aquatic Acute 1;H400, Aquatic Chronic 1;H410 1,A List of abbreviations and symbols that may be used above DSD: Directive 67/548/EEC. CLP: Regulation No. 1272/2008. Note A: Without prejudice to Article 17(2), the name of the substance must appear on the label in the form of one of the designations given in Part 3. In Part 3, use is sometimes made of a general description such as "... compounds" or "... salts". In this case, the supplier is required to state on the label the correct name, due account being taken of section Note 1: The concentration stated or, in the absence of such concentrations, the generic concentrations of this Regulation (Table 3.1) or the generic concentrations of Directive 1999/45/EC (Table 3.2), are the percentages by weight of the metallic element calculated with reference to the total weight of the mixture. Composition comments SECTION 4: First aid measures All concentrations are in percent by weight unless ingredient is a gas. Gas concentrations are in percent by volume. General information Ensure that medical personnel are aware of the material(s) involved, and take precautions to protect themselves Description of first aid measures Inhalation Move to fresh air. Call a physician if symptoms develop or persist. Skin contact Eye contact Ingestion 4.2. Most important symptoms and effects, both acute and delayed 4.3. Indication of any immediate medical attention and special treatment needed SECTION 5: Firefighting measures General fire hazards For skin contact flush with large amounts of water while removing contaminated clothing. Get medical attention if irritation develops and persists. In case of contact, immediately flush eyes with fresh water for at least 15 minutes while holding the eyelids open. Remove contact lenses if worn. Get medical attention if irritation persists. If material is ingested, immediately contact a physician or poison control centre. Direct contact with skin and eyes may cause irritation. Provide general supportive measures and treat symptomatically. The product is not flammable. Antihorse IgG conjugate (100x conc.) Version #: 01 Revision date: Issue date: 05March / 7

10 5.1. Extinguishing media Suitable extinguishing media Unsuitable extinguishing media 5.2. Special hazards arising from the substance or mixture 5.3. Advice for firefighters Special protective equipment for firefighters Special fire fighting procedures Extinguish with water spray, carbon dioxide, dry chemical or material appropriate for the surrounding fire. None known. None known. Selfcontained breathing apparatus and full protective clothing must be worn in case of fire. Use standard firefighting procedures and consider the hazards of other involved materials. SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures For nonemergency Keep unnecessary personnel away. Do not touch damaged containers or spilled material unless personnel wearing appropriate protective clothing. For emergency responders Use personal protection as recommended in section 8 of the SDS Environmental precautions Do not allow to enter drains, sewers or watercourses 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 7.2. Conditions for safe storage, including any incompatibilities 7.3. Specific end use(s) In vitro diagnostics. SECTION 8: Exposure controls/personal protection 8.1. Control parameters Occupational exposure limits UK. EH40 Workplace Exposure Limits (WELs) Components Absorb spill with vermiculite or other inert material. Dispose of waste in accordance with all applicable federal, state, local and provincial environmental regulations, per Section 13. For personal protection, see section 8 of the SDS. For waste disposal, see section 13 of the SDS. Avoid contact with skin and eyes. Wash thoroughly after handling. In case of insufficient ventilation, wear suitable respiratory equipment. Handle and open container with care. Store in a closed container away from incompatible materials. Store at 28 C (3546 F). Type Value Glycerol (CAS 56815) Biological limit values TWA 10 mg/m3 Mist. UK. EH40 Biological Monitoring Guidance Values (BMGVs) Form Components Value Determinant Specimen Thimerosal (Sodiumethylmercurithiosal 20 umol/mol Mercury Creatinine in urine icylat) (CAS 54648) * For sampling details, please see the source document. Recommended monitoring Follow standard monitoring procedures. procedures Derived noeffect level (DNEL) Sampling time * Predicted no effect concentrations (PNECs) Exposure guidelines Follow standard monitoring procedures Exposure controls Appropriate engineering Provide adequate ventilation. Provide easy access to water supply and eye wash facilities. controls Individual protection measures, such as personal protective equipment General information Personal protective equipment should be chosen according to the CEN standards and in discussion with the supplier of the personal protective equipment. Eye/face protection Wear approved safety glasses or goggles. Skin protection Antihorse IgG conjugate (100x conc.) Version #: 01 Revision date: Issue date: 05March / 7

11 Hand protection Wear appropriate chemical resistant gloves. Nitrile gloves are recommended. Other Wear lab coat or other protective garments. Remove contaminated clothing promptly. Respiratory protection Under normal conditions, respirator is not normally required. Thermal hazards Wear appropriate thermal protective clothing, when necessary. Hygiene measures Handle in accordance with good industrial hygiene and safety practices. Environmental exposure Inform appropriate managerial or supervisory personnel of all environmental releases. controls SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Appearance Colourless liquid. Physical state Liquid. Form Liquid. Colour Colourless. Odour Odourless. Odour threshold ph Melting point/freezing point Initial boiling point and boiling range Flash point Evaporation rate Flammability (solid, gas) Not applicable. Upper/lower flammability or explosive limits Flammability limit lower (%) Flammability limit upper (%) Vapour pressure Vapour density Relative density Solubility(ies) Partition coefficient (noctanol/water) Autoignition temperature Decomposition temperature Viscosity Explosive properties Not explosive. Oxidizing properties Not oxidizing Other information No relevant additional information available. SECTION 10: Stability and reactivity Reactivity The product is nonreactive under normal conditions of use, storage and transport Chemical stability Material is stable under normal conditions Possibility of hazardous Hazardous polymerisation does not occur. reactions Conditions to avoid Ultraviolet light. Exposure to light Incompatible materials Strong oxidizers, strong acids, and strong bases Hazardous None known. decomposition products SECTION 11: Toxicological information General information Occupational exposure to the substance or mixture may cause adverse effects. Information on likely routes of exposure Inhalation In high concentrations, mists/vapors may irritate throat and respiratory system and cause coughing. Skin contact May cause skin irritation. Antihorse IgG conjugate (100x conc.) Version #: 01 Revision date: Issue date: 05March / 7

12 Eye contact Ingestion Symptoms May cause eye irritation. May cause discomfort if swallowed. Direct contact with skin and eyes may cause irritation Information on toxicological effects Acute toxicity Components Glycerol (CAS 56815) Acute Oral LD50 Skin corrosion/irritation Serious eye damage/eye irritation Respiratory sensitisation Skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity Specific target organ toxicity single exposure May cause discomfort if swallowed. Species Rat May cause skin irritation. May cause eye irritation. Not classifiable as to carcinogenicity to humans. Test results mg/kg Specific target organ toxicity repeated exposure Aspiration hazard Mixture versus substance information Other information May cause damage to organs (Central Nervous System) through prolonged or repeated exposure. No other specific acute or chronic health impact noted. SECTION 12: Ecological information Toxicity The product is not classified as environmentally hazardous. However, this does not exclude the possibility that large or frequent spills can have a harmful or damaging effect on the environment Persistence and No data is available on the degradability of this product. degradability Bioaccumulative potential Partition coefficient noctanol/water (log Kow) Glycerol (CAS 56815) 1.76 Bioconcentration factor (BCF) Mobility in soil No data available. Mobility in general No data available Results of PBT Not a PBT or vpvb substance or mixture. and vpvb assessment Other adverse effects No data available. SECTION 13: Disposal considerations Waste treatment methods Residual waste Contaminated packaging EU waste code Disposal methods/information Dispose in accordance with all applicable regulations. Empty containers or liners may retain some product residues. This material and its container must be disposed of in a safe manner (see: Disposal instructions). Empty containers should be taken to an approved waste handling site for recycling or disposal. The Waste code should be assigned in discussion between the user, the producer and the waste disposal company. Dispose waste and residues in accordance with applicable federal, state, and local regulations. Contaminated instruments and surfaces should be disinfected in accordance with your employer's chemicalspecific and universal/standard precautions. Antihorse IgG conjugate (100x conc.) Version #: 01 Revision date: Issue date: 05March / 7

13 SECTION 14: Transport information ADR RID ADN IATA IMDG Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code Not applicable. SECTION 15: Regulatory information Safety, health and environmental regulations/legislation specific for the substance or mixture EU regulations Regulation (EC) No. 1005/2009 on substances that deplete the ozone layer, Annex I Regulation (EC) No. 1005/2009 on substances that deplete the ozone layer, Annex II Regulation (EC) No. 850/2004 On persistent organic pollutants, Annex I as amended Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 1 as amended Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 2 as amended Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 3 as amended Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex V as amended Regulation (EC) No. 166/2006 Annex II Pollutant Release and Transfer Registry Regulation (EC) No. 1907/2006, REACH Article 59(10) Candidate List as currently published by ECHA Authorisations Regulation (EC) No. 1907/2006, REACH Annex XIV Substances subject to authorisation, as amended Regulation (EC) No. 1907/2006, REACH Annex XVII Substances subject to restriction on marketing and use as amended Restrictions on use Regulation (EC) No. 1907/2006, REACH Annex XVII Substances subject to restriction on marketing and use as amended Directive 2004/37/EC: on the protection of workers from the risks related to exposure to carcinogens and mutagens at work Directive 92/85/EEC: on the safety and health of pregnant workers and workers who have recently given birth or are breastfeeding Thimerosal (Sodiumethylmercurithiosalicylat) (CAS 54648) Other EU regulations Directive 96/82/EC (Seveso II) on the control of majoraccident hazards involving dangerous substances Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work Thimerosal (Sodiumethylmercurithiosalicylat) (CAS 54648) Directive 94/33/EC on the protection of young people at work Thimerosal (Sodiumethylmercurithiosalicylat) (CAS 54648) Antihorse IgG conjugate (100x conc.) Version #: 01 Revision date: Issue date: 05March / 7

14 Other regulations National regulations Chemical safety assessment The product is classified and labelled in accordance with Regulation (EC) 1272/2008 (CLP Regulation) as amended and respective national laws implementing EC directives. This Safety Data Sheet complies with the requirements of Regulation (EC) No 1907/2006. In the European Union this product is regulated under the In Vitro Diagnostic Medical Devices Directive (98/79/EC). Follow national regulation for work with chemical agents. No Chemical Safety Assessment has been carried out. SECTION 16: Other information List of abbreviations References Information on evaluation method leading to the classification of mixture Full text of any statements or Rphrases and Hstatements under Sections 2 to 15 Training information Disclaimer DNEL: Derived NoEffect Level. PNEC: Predicted NoEffect Concentration. PBT: Persistent, bioaccumulative and toxic. vpvb: Very Persistent and very Bioaccumulative. The classification for health and environmental hazards is derived by a combination of calculation methods and test data, if available. R20/21/22 Harmful by inhalation, in contact with skin and if swallowed. R26/27/28 Very toxic by inhalation, in contact with skin and if swallowed. R33 Danger of cumulative effects. R50/53 Very toxic to aquatic organisms, may cause longterm adverse effects in the aquatic environment. H300 Fatal if swallowed. H310 Fatal in contact with skin. H330 Fatal if inhaled. H373 May cause damage to organs through prolonged or repeated exposure. H400 Very toxic to aquatic life. H410 Very toxic to aquatic life with long lasting effects. Follow training instructions when handling this material. The information above is provided in good faith. It is believed to be accurate and represents the best information currently available to us. HOWEVER, WE MAKE NO WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR OF ANY OTHER TYPE, EXPRESSED OR IMPLIED, WITH RESPECT TO PRODUCTS DESCRIBED OR DATA OR INFORMATION PROVIDED, AND WE ASSUME NO LIABILITY RESULTING FROM THE USE OF SUCH PRODUCTS, DATA OR INFORMATION. Users should make their own investigations to determine the suitability of the information for their particular purposes, and the user assumes all risk arising from their use of the material. The user is required to comply with all laws and regulations relating to the purchase, use, storage and disposal of the material, and must be familiar with and follow generally accepted safe handling procedures. In no event shall Sekisui Diagnostics be liable for any claims, losses, or damages of any individual or for lost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if Sekisui Diagnostics has been advised of the possibility of such damages. Antihorse IgG conjugate (100x conc.) Version #: 01 Revision date: Issue date: 05March / 7

15 SAFETY DATA SHEET SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Trade name or designation of the mixture Registration number Synonyms [NEG, CO, POS, 215Q] IgG / IgM / IgA Control Sera (negative, cut off, positive control), IgGQuantificationSet in buffer ZB200.7 Product code , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , DE226C61, DE226C62, U110101, U110102, U110103, U111804, U111805, U111806, U114001, U114002, U114003, U114004, U114005, U114006, U115010, U115011, U115012, UWE227C60, UWE227C80, UWE227N10, UWE227P60, UWE227P80, UWE228C80, UWE228N10, UWE228P80, UWE228P81, WE102N10, WE102P60, WE102P80, WE116N20, WE116P40, WE116P60, WE130N60, WE130P60, WE150N10, WE150P60, WE150P80, WE214C40, WE214C60, WE214C80, WE214N50, WE214P40, WE214P60, WE214P80, WE222N10, WE222P60, WE222P80, WE223N60, WE223P60, WE224N10, WE224P60, WE224P80, WE225N60, WE225P60, WE242, WE242P40, WE242P60, WE243N20, WE243P40, WE243P60 Issue date 08April2014 Version number 02 Revision date 03March2015 Supersedes date 08April Relevant identified uses of the substance or mixture and uses advised against Identified uses In vitro diagnostics. Uses advised against Use in accordance with supplier's recommendations Details of the supplier of the safety data sheet Manufacturer/Distributor Sekisui Virotech GmbH Address Löwenplatz 5, Rüsselsheim, Germany Telephone number +49 (0) Website Contact person Gayle Brecker Gayle.Brecker@sekisuivirotech.com 1.4. Emergency telephone Europe, Middle East & Africa number Access code SECTION 2: Hazards identification 2.1. Classification of the substance or mixture The mixture has been assessed and/or tested for its physical, health and environmental hazards and the following classification applies. Classification according to Directive 67/548/EEC or 1999/45/EC as amended Classification Xi;R36/38, R43 The full text for all Rphrases is displayed in Section 16. Classification according to Regulation (EC) No 1272/2008 as amended Health hazards Skin corrosion/irritation Serious eye damage/eye irritation Skin sensitisation Category 2 Category 2 Category 1 H315 Causes skin irritation. H319 Causes serious eye irritation. H317 May cause an allergic skin reaction. Hazard summary Physical hazards Health hazards Environmental hazards Specific hazards Not classified for physical hazards. Irritating to eyes and skin. May cause sensitisation by skin contact. Not classified for hazards to the environment. Avoid contact with eyes and skin. Do not ingest or inhale. IgG / IgM / IgA Control Sera (negative, cut off, positive control), IgGQuantificationSet in buffer ZB Version #: 02 Revision date: 03March2015 Issue date: 08April / 7

16 Main symptoms Contact with this material can cause irritation to the skin, eyes and mucous membranes. Headaches, nausea and vomiting. Dermatitis Label elements Label according to Regulation (EC) No. 1272/2008 as amended Contains: 2Methyl2Hisothiazol3one (ProClin 950), Mixture of: 5chloro2methyl4isothiazolin3one and 2methyl4isothiazolin3one and magnesium nitrate (ProClin 150) Hazard pictograms Signal word Warning Hazard statements H315 Causes skin irritation. H319 Causes serious eye irritation. H317 May cause an allergic skin reaction. Precautionary statements Prevention P264 Wash thoroughly after handling. P280 Wear eye/face protection. P261 Avoid breathing dust/fume/gas/mist/vapours/spray. P272 Contaminated work clothing must not be allowed out of the workplace. P280 Wear protective gloves. Response P302 + P352 IF ON SKIN: Wash with plenty of water. P333 + P313 If skin irritation or rash occurs: Get medical advice/attention. P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P337 + P313 If eye irritation persists: Get medical advice/attention. P362 Take off contaminated clothing and wash before reuse. Storage None. Disposal P501 Dispose of contents/container in accordance with local/regional/national/international regulations. Supplemental label information Not applicable Other hazards Not a PBT or vpvb substance or mixture. SECTION 3: Composition/information on ingredients 3.2. Mixtures General information Chemical name % CASNo. / EC No. REACH Registration No. INDEX No. Notes 2Methyl2Hisothiazol3one (ProClin 950) Classification: DSD: CLP: T;R23/24/25, C;R34, R43, N;R50/53 Acute Tox. 3;H301, Acute Tox. 3;H311, Skin Corr. 1B;H314, Skin Sens. 1;H317, Acute Tox. 3;H331, Aquatic Acute 1;H400, Aquatic Chronic 1;H410 Mixture of: 5chloro2methyl4isothiazolin3one and 2methyl4isothiazolin3one and magnesium nitrate (ProClin 150) Classification: DSD: CLP: T;R23/24/25, C;R34, R43, N;R50/53 Acute Tox. 3;H301, Acute Tox. 3;H311, Skin Corr. 1B;H314, Skin Sens. 1;H317, Acute Tox. 3;H331, Aquatic Acute 1;H400, Aquatic Chronic 1;H410 List of abbreviations and symbols that may be used above DSD: Directive 67/548/EEC. CLP: Regulation No. 1272/2008. Composition comments All concentrations are in percent by weight unless ingredient is a gas. Gas concentrations are in percent by volume. The full text for all R and Hphrases is displayed in section 16. IgG / IgM / IgA Control Sera (negative, cut off, positive control), IgGQuantificationSet in buffer ZB Version #: 02 Revision date: 03March2015 Issue date: 08April / 7

17 SECTION 4: First aid measures General information Ensure that medical personnel are aware of the material(s) involved, and take precautions to protect themselves Description of first aid measures Inhalation Move to fresh air. Call a physician if symptoms develop or persist. Skin contact Eye contact Ingestion 4.2. Most important symptoms and effects, both acute and delayed 4.3. Indication of any immediate medical attention and special treatment needed SECTION 5: Firefighting measures General fire hazards 5.1. Extinguishing media Suitable extinguishing media Unsuitable extinguishing media 5.2. Special hazards arising from the substance or mixture 5.3. Advice for firefighters Special protective equipment for firefighters Special fire fighting procedures For skin contact flush with large amounts of water while removing contaminated clothing. If skin rash or an allergic skin reaction develops, get medical attention. In case of contact, immediately flush eyes with fresh water for at least 15 minutes while holding the eyelids open. Remove contact lenses if worn. Get medical attention if irritation persists. If material is ingested, immediately contact a physician or poison control centre. Contact with this material can cause irritation to the skin, eyes and mucous membranes. Headaches, nausea and vomiting. Dermatitis. Provide general supportive measures and treat symptomatically. The product is not flammable. Extinguish with water spray, carbon dioxide, dry chemical or material appropriate for the surrounding fire. None known. None known. SECTION 6: Accidental release measures Selfcontained breathing apparatus and full protective clothing must be worn in case of fire. Use standard firefighting procedures and consider the hazards of other involved materials Personal precautions, protective equipment and emergency procedures For nonemergency Keep unnecessary personnel away. Do not touch damaged containers or spilled material unless personnel wearing appropriate protective clothing. For emergency responders Use personal protection as recommended in section 8 of the SDS Environmental precautions Do not allow to enter drains, sewers or watercourses 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 7.2. Conditions for safe storage, including any incompatibilities 7.3. Specific end use(s) In vitro diagnostics. Absorb spill with vermiculite or other inert material. Dispose of waste in accordance with all applicable federal, state, local and provincial environmental regulations, per Section 13. For personal protection, see section 8 of the SDS. For waste disposal, see section 13 of the SDS. Avoid contact with skin and eyes. Persons susceptible for allergic reactions should not handle this product. Wash thoroughly after handling. In case of insufficient ventilation, wear suitable respiratory equipment. Handle and open container with care. Store in a closed container away from incompatible materials. SECTION 8: Exposure controls/personal protection 8.1. Control parameters Occupational exposure limits Biological limit values Recommended monitoring procedures Derived noeffect level (DNEL) No exposure limits noted for ingredient(s). No biological exposure limits noted for the ingredient(s). Follow standard monitoring procedures. IgG / IgM / IgA Control Sera (negative, cut off, positive control), IgGQuantificationSet in buffer ZB Version #: 02 Revision date: 03March2015 Issue date: 08April / 7

18 Predicted no effect concentrations (PNECs) Exposure guidelines Follow standard monitoring procedures Exposure controls Appropriate engineering Provide adequate ventilation. Provide easy access to water supply and eye wash facilities. controls Individual protection measures, such as personal protective equipment General information Personal protective equipment should be chosen according to the CEN standards and in discussion with the supplier of the personal protective equipment. Eye/face protection Wear approved safety glasses or goggles. Skin protection Hand protection Wear appropriate chemical resistant gloves. Other Wear lab coat or other protective garments. Remove contaminated clothing promptly. Respiratory protection Under normal conditions, respirator is not normally required. Thermal hazards Wear appropriate thermal protective clothing, when necessary. Hygiene measures Handle in accordance with good industrial hygiene and safety practices. Environmental exposure Inform appropriate managerial or supervisory personnel of all environmental releases. controls SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Appearance Colourless liquid. Physical state Liquid. Form Liquid. Colour Colourless. Odour Odourless. Odour threshold ph Melting point/freezing point Initial boiling point and boiling range Flash point Evaporation rate Flammability (solid, gas) Not applicable. Upper/lower flammability or explosive limits Flammability limit lower (%) Flammability limit upper (%) Vapour pressure Vapour density Relative density Solubility(ies) Partition coefficient (noctanol/water) Autoignition temperature Decomposition temperature Viscosity Explosive properties Oxidizing properties 9.2. Other information No relevant additional information available. SECTION 10: Stability and reactivity Reactivity The product is nonreactive under normal conditions of use, storage and transport Chemical stability Material is stable under normal conditions Possibility of hazardous Hazardous polymerisation does not occur. reactions IgG / IgM / IgA Control Sera (negative, cut off, positive control), IgGQuantificationSet in buffer ZB Version #: 02 Revision date: 03March2015 Issue date: 08April / 7

19 10.4. Conditions to avoid No data available Incompatible materials Hazardous None known. decomposition products SECTION 11: Toxicological information General information Occupational exposure to the substance or mixture may cause adverse effects. Information on likely routes of exposure Inhalation Vapours may irritate throat and respiratory system and cause coughing. Skin contact Causes skin irritation. May cause eczemalike skin disorders (dermatitis). Eye contact Causes serious eye irritation. Ingestion May cause discomfort if swallowed. Symptoms Contact with this material can cause irritation to the skin, eyes and mucous membranes. Headaches, nausea and vomiting. Dermatitis Information on toxicological effects Acute toxicity Skin corrosion/irritation Serious eye damage/eye irritation Respiratory sensitisation Skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity Specific target organ toxicity single exposure Specific target organ toxicity repeated exposure Aspiration hazard Mixture versus substance information Other information May cause discomfort if swallowed. Causes skin irritation. Causes severe eye irritation. No data available. May cause an allergic skin reaction. No data available. No data available. No data available. No data available. No data available. No data available. No other specific acute or chronic health impact noted. SECTION 12: Ecological information Toxicity The product is not classified as environmentally hazardous. However, this does not exclude the possibility that large or frequent spills can have a harmful or damaging effect on the environment. Components Species Test results Mixture of: 5chloro2methyl4isothiazolin3one and 2methyl4isothiazolin3one and magnesium nitrate (ProClin 150) (CAS ) Aquatic Acute Algae EC50 Algae 0.06 mg/l, 96 hours Persistence and No data is available on the degradability of this product. degradability Bioaccumulative potential Partition coefficient noctanol/water (log Kow) Bioconcentration factor (BCF) Mobility in soil Mobility in general No data available Results of PBT Not a PBT or vpvb substance or mixture. and vpvb assessment Other adverse effects SECTION 13: Disposal considerations Waste treatment methods IgG / IgM / IgA Control Sera (negative, cut off, positive control), IgGQuantificationSet in buffer ZB Version #: 02 Revision date: 03March2015 Issue date: 08April / 7

20 Residual waste Contaminated packaging EU waste code Disposal methods/information Dispose in accordance with all applicable regulations. Empty containers or liners may retain some product residues. This material and its container must be disposed of in a safe manner (see: Disposal instructions). Empty containers should be taken to an approved waste handling site for recycling or disposal. The Waste code should be assigned in discussion between the user, the producer and the waste disposal company. Dispose waste and residues in accordance with applicable federal, state, and local regulations. Contaminated instruments and surfaces should be disinfected in accordance with your employer's chemicalspecific and universal/standard precautions. SECTION 14: Transport information ADR RID ADN IATA IMDG Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code Not applicable. SECTION 15: Regulatory information Safety, health and environmental regulations/legislation specific for the substance or mixture EU regulations Regulation (EC) No. 1005/2009 on substances that deplete the ozone layer, Annex I Regulation (EC) No. 1005/2009 on substances that deplete the ozone layer, Annex II Regulation (EC) No. 850/2004 On persistent organic pollutants, Annex I as amended Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 1 as amended Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 2 as amended Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 3 as amended Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex V as amended Regulation (EC) No. 166/2006 Annex II Pollutant Release and Transfer Registry Regulation (EC) No. 1907/2006, REACH Article 59(10) Candidate List as currently published by ECHA Authorisations Regulation (EC) No. 1907/2006, REACH Annex XIV Substances subject to authorisation, as amended Regulation (EC) No. 1907/2006, REACH Annex XVII Substances subject to restriction on marketing and use as amended Restrictions on use Regulation (EC) No. 1907/2006, REACH Annex XVII Substances subject to restriction on marketing and use as amended Directive 2004/37/EC: on the protection of workers from the risks related to exposure to carcinogens and mutagens at work Directive 92/85/EEC: on the safety and health of pregnant workers and workers who have recently given birth or are breastfeeding IgG / IgM / IgA Control Sera (negative, cut off, positive control), IgGQuantificationSet in buffer ZB Version #: 02 Revision date: 03March2015 Issue date: 08April / 7

21 Other EU regulations Directive 96/82/EC (Seveso II) on the control of majoraccident hazards involving dangerous substances Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work 2Methyl2Hisothiazol3one (ProClin 950) (CAS ) Mixture of: 5chloro2methyl4isothiazolin3one and 2methyl4isothiazolin3one and magnesium nitrate (ProClin 150) (CAS ) Directive 94/33/EC on the protection of young people at work 2Methyl2Hisothiazol3one (ProClin 950) (CAS ) Mixture of: 5chloro2methyl4isothiazolin3one and 2methyl4isothiazolin3one and magnesium nitrate (ProClin 150) (CAS ) Other regulations The product is classified and labelled in accordance with EC directives or respective national laws. This Safety Data Sheet complies with the requirements of Regulation (EC) No 1907/2006 as amended. In the European Union this product is regulated under the In Vitro Diagnostic Medical Devices Directive (98/79/EC). Young people under 18 years old are not allowed to work with this product according to the EU Directive 94/33/EC on the protection of young people at work. National regulations Follow national regulation for work with chemical agents Chemical safety No Chemical Safety Assessment has been carried out. assessment SECTION 16: Other information List of abbreviations References Information on evaluation method leading to the classification of mixture Full text of any statements or Rphrases and Hstatements under Sections 2 to 15 Training information Disclaimer DNEL: Derived NoEffect Level. PNEC: Predicted NoEffect Concentration. PBT: Persistent, bioaccumulative and toxic. vpvb: Very Persistent and very Bioaccumulative. The classification for health and environmental hazards is derived by a combination of calculation methods and test data, if available. R23/24/25 Toxic by inhalation, in contact with skin and if swallowed. R34 Causes burns. R36/38 Irritating to eyes and skin. R43 May cause sensitisation by skin contact. R50/53 Very toxic to aquatic organisms, may cause longterm adverse effects in the aquatic environment. H301 Toxic if swallowed. H311 Toxic in contact with skin. H314 Causes severe skin burns and eye damage. H317 May cause an allergic skin reaction. H331 Toxic if inhaled. H400 Very toxic to aquatic life. H410 Very toxic to aquatic life with long lasting effects. Follow training instructions when handling this material. The information above is provided in good faith. It is believed to be accurate and represents the best information currently available to us. HOWEVER, WE MAKE NO WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR OF ANY OTHER TYPE, EXPRESSED OR IMPLIED, WITH RESPECT TO PRODUCTS DESCRIBED OR DATA OR INFORMATION PROVIDED, AND WE ASSUME NO LIABILITY RESULTING FROM THE USE OF SUCH PRODUCTS, DATA OR INFORMATION. Users should make their own investigations to determine the suitability of the information for their particular purposes, and the user assumes all risk arising from their use of the material. The user is required to comply with all laws and regulations relating to the purchase, use, storage and disposal of the material, and must be familiar with and follow generally accepted safe handling procedures. In no event shall Sekisui Diagnostics be liable for any claims, losses, or damages of any individual or for lost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if Sekisui Diagnostics has been advised of the possibility of such damages. IgG / IgM / IgA Control Sera (negative, cut off, positive control), IgGQuantificationSet in buffer ZB Version #: 02 Revision date: 03March2015 Issue date: 08April / 7

22 SAFETY DATA SHEET SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Trade name or designation of the mixture Registration number Synonyms IgG / IgM / IgA Control Sera (negative, cut off, positive control), CSF Standards, AIControl, IgG Standards, Validation Control (containing IgG), Pipetting control in buffer ZB200.3 [NEG, CO, POS, CSF STD, CSF AI, STD,VAL, 250 P] Product code , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,110838, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , DC122C61, DC122C62, DC122C81, DC122N61, DC122N62, DC122P61, U110104, U110105, U110106, U110501, U110502, U110503, U110504, U110505, U110506, U110601, U110602, U110603, U110604, U110605, U110606, U110701, U110702, U110703, U110704, U110705, U110706, U111101, U111102, U111103, U111801, U111802, U111803, U111901, U111902, U111903, U111904, U111905, U111906, U112101, U112102, U112103, U112104, U112105, U112106, U114301, U114302, U114303, U114304, U114305, U114306, U114307, U114308, U114309, U114801, U114802, U114803, U120201, U120202, U120203, U120201, U120202, U120203, U120304, U120305, U120306, U120401, U120402, U120403, U120501, U120502, U Issue date 16February2015 Version number 02 Revision date 03March2015 Supersedes date 16February Relevant identified uses of the substance or mixture and uses advised against Identified uses In vitro diagnostics. Uses advised against Use in accordance with supplier's recommendations Details of the supplier of the safety data sheet Manufacturer/Distributor Sekisui Virotech GmbH Address Löwenplatz 5, Rüsselsheim, Germany Telephone number +49 (0) Website Contact person Gayle Brecker Gayle.Brecker@sekisuivirotech.com 1.4. Emergency telephone Europe, Middle East & Africa number Access code IgG / IgM / IgA Control Sera (negative, cut off, positive control), CSF Standards, AIControl, IgG Standards, Validation Cont Version #: 02 Revision date: 03March2015 Issue date: 16February / 7

23 SECTION 2: Hazards identification 2.1. Classification of the substance or mixture The mixture has been assessed and/or tested for its physical, health and environmental hazards and the following classification applies. Classification according to Directive 67/548/EEC or 1999/45/EC as amended This preparation is not classified as dangerous according to Directive 1999/45/EC and its amendments. Classification according to Regulation (EC) No 1272/2008 as amended This mixture does not meet the criteria for classification according to Regulation (EC) 1272/2008 as amended. Hazard summary Physical hazards Not classified for physical hazards. Health hazards Not classified for health hazards. Environmental hazards Not classified for hazards to the environment. Specific hazards Avoid contact with eyes and skin. Do not ingest or inhale. Main symptoms Direct contact with skin and eyes may cause irritation Label elements Label according to Regulation (EC) No. 1272/2008 as amended Hazard pictograms None. Signal word None. Hazard statements None. Precautionary statements Prevention None. Response None. Storage None. Disposal None. Supplemental label information Not applicable Other hazards Not a PBT or vpvb substance or mixture. SECTION 3: Composition/information on ingredients 3.2. Mixtures The components are not hazardous or are below required disclosure limits. SECTION 4: First aid measures General information Ensure that medical personnel are aware of the material(s) involved, and take precautions to protect themselves Description of first aid measures Inhalation Move to fresh air. Call a physician if symptoms develop or persist. Skin contact Eye contact Ingestion 4.2. Most important symptoms and effects, both acute and delayed 4.3. Indication of any immediate medical attention and special treatment needed SECTION 5: Firefighting measures General fire hazards 5.1. Extinguishing media Suitable extinguishing media Unsuitable extinguishing media 5.2. Special hazards arising from the substance or mixture For skin contact flush with large amounts of water while removing contaminated clothing. Get medical attention if irritation develops and persists. In case of contact, immediately flush eyes with fresh water for at least 15 minutes while holding the eyelids open. Remove contact lenses if worn. Get medical attention if irritation persists. If material is ingested, immediately contact a physician or poison control centre. Direct contact with skin and eyes may cause irritation. Provide general supportive measures and treat symptomatically. The product is not flammable. Extinguish with water spray, carbon dioxide, dry chemical or material appropriate for the surrounding fire. None known. None known. IgG / IgM / IgA Control Sera (negative, cut off, positive control), CSF Standards, AIControl, IgG Standards, Validation Cont Version #: 02 Revision date: 03March2015 Issue date: 16February / 7

24 5.3. Advice for firefighters Special protective equipment for firefighters Special fire fighting procedures Selfcontained breathing apparatus and full protective clothing must be worn in case of fire. Use standard firefighting procedures and consider the hazards of other involved materials. SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures For nonemergency Keep unnecessary personnel away. Do not touch damaged containers or spilled material unless personnel wearing appropriate protective clothing. For emergency responders Use personal protection as recommended in section 8 of the SDS Environmental precautions Do not allow to enter drains, sewers or watercourses 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 7.2. Conditions for safe storage, including any incompatibilities 7.3. Specific end use(s) In vitro diagnostics. Absorb spill with vermiculite or other inert material. Dispose of waste in accordance with all applicable federal, state, local and provincial environmental regulations, per Section 13. For personal protection, see section 8 of the SDS. For waste disposal, see section 13 of the SDS. Avoid contact with skin and eyes. Wash thoroughly after handling. In case of insufficient ventilation, wear suitable respiratory equipment. Handle and open container with care. Store in a closed container away from incompatible materials. SECTION 8: Exposure controls/personal protection 8.1. Control parameters Occupational exposure limits Biological limit values Recommended monitoring procedures Derived noeffect level (DNEL) No exposure limits noted for ingredient(s). No biological exposure limits noted for the ingredient(s). Follow standard monitoring procedures. Predicted no effect concentrations (PNECs) Exposure guidelines Follow standard monitoring procedures Exposure controls Appropriate engineering Provide adequate ventilation. Provide easy access to water supply and eye wash facilities. controls Individual protection measures, such as personal protective equipment General information Personal protective equipment should be chosen according to the CEN standards and in discussion with the supplier of the personal protective equipment. Eye/face protection Wear approved safety glasses or goggles. Skin protection Hand protection Wear appropriate chemical resistant gloves. Other Wear lab coat or other protective garments. Remove contaminated clothing promptly. Respiratory protection Under normal conditions, respirator is not normally required. Thermal hazards Wear appropriate thermal protective clothing, when necessary. Hygiene measures Handle in accordance with good industrial hygiene and safety practices. Environmental exposure Inform appropriate managerial or supervisory personnel of all environmental releases. controls SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Appearance Colourless liquid. Physical state Liquid. Form Liquid. Colour Colourless. Odour Odourless. Odour threshold IgG / IgM / IgA Control Sera (negative, cut off, positive control), CSF Standards, AIControl, IgG Standards, Validation Cont Version #: 02 Revision date: 03March2015 Issue date: 16February / 7

25 ph Melting point/freezing point Initial boiling point and boiling range Flash point Evaporation rate Flammability (solid, gas) Not applicable. Upper/lower flammability or explosive limits Flammability limit lower (%) Flammability limit upper (%) Vapour pressure Vapour density Relative density Solubility(ies) Partition coefficient (noctanol/water) Autoignition temperature Decomposition temperature Viscosity Explosive properties Oxidizing properties 9.2. Other information No relevant additional information available. SECTION 10: Stability and reactivity Reactivity The product is nonreactive under normal conditions of use, storage and transport Chemical stability Material is stable under normal conditions Possibility of hazardous Hazardous polymerisation does not occur. reactions Conditions to avoid No data available Incompatible materials Hazardous None known. decomposition products SECTION 11: Toxicological information General information Occupational exposure to the substance or mixture may cause adverse effects. Information on likely routes of exposure Inhalation Vapours may irritate throat and respiratory system and cause coughing. Skin contact May cause skin irritation. Eye contact May cause eye irritation. Ingestion May cause discomfort if swallowed. Symptoms Direct contact with skin and eyes may cause irritation Information on toxicological effects Acute toxicity Skin corrosion/irritation Serious eye damage/eye irritation Respiratory sensitisation Skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity Specific target organ toxicity single exposure May cause discomfort if swallowed. May cause skin irritation. May cause eye irritation. Not classifiable as to carcinogenicity to humans. IgG / IgM / IgA Control Sera (negative, cut off, positive control), CSF Standards, AIControl, IgG Standards, Validation Cont Version #: 02 Revision date: 03March2015 Issue date: 16February / 7

26 Specific target organ toxicity repeated exposure Aspiration hazard Mixture versus substance information Other information No other specific acute or chronic health impact noted. SECTION 12: Ecological information Toxicity The product is not classified as environmentally hazardous. However, this does not exclude the possibility that large or frequent spills can have a harmful or damaging effect on the environment Persistence and No data is available on the degradability of this product. degradability Bioaccumulative potential Partition coefficient noctanol/water (log Kow) Bioconcentration factor (BCF) Mobility in soil Mobility in general No data available Results of PBT Not a PBT or vpvb substance or mixture. and vpvb assessment Other adverse effects SECTION 13: Disposal considerations Waste treatment methods Residual waste Contaminated packaging EU waste code Disposal methods/information Dispose in accordance with all applicable regulations. Empty containers or liners may retain some product residues. This material and its container must be disposed of in a safe manner (see: Disposal instructions). Empty containers should be taken to an approved waste handling site for recycling or disposal. The Waste code should be assigned in discussion between the user, the producer and the waste disposal company. Dispose waste and residues in accordance with applicable federal, state, and local regulations. Contaminated instruments and surfaces should be disinfected in accordance with your employer's chemicalspecific and universal/standard precautions. SECTION 14: Transport information ADR RID ADN IATA IMDG Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code Not applicable. SECTION 15: Regulatory information Safety, health and environmental regulations/legislation specific for the substance or mixture EU regulations Regulation (EC) No. 1005/2009 on substances that deplete the ozone layer, Annex I Regulation (EC) No. 1005/2009 on substances that deplete the ozone layer, Annex II Regulation (EC) No. 850/2004 On persistent organic pollutants, Annex I as amended IgG / IgM / IgA Control Sera (negative, cut off, positive control), CSF Standards, AIControl, IgG Standards, Validation Cont Version #: 02 Revision date: 03March2015 Issue date: 16February / 7

27 Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 1 as amended Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 2 as amended Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 3 as amended Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex V as amended Regulation (EC) No. 166/2006 Annex II Pollutant Release and Transfer Registry Regulation (EC) No. 1907/2006, REACH Article 59(10) Candidate List as currently published by ECHA Authorisations Regulation (EC) No. 1907/2006, REACH Annex XIV Substances subject to authorisation, as amended Regulation (EC) No. 1907/2006, REACH Annex XVII Substances subject to restriction on marketing and use as amended Restrictions on use Regulation (EC) No. 1907/2006, REACH Annex XVII Substances subject to restriction on marketing and use as amended Directive 2004/37/EC: on the protection of workers from the risks related to exposure to carcinogens and mutagens at work Directive 92/85/EEC: on the safety and health of pregnant workers and workers who have recently given birth or are breastfeeding Other EU regulations Directive 96/82/EC (Seveso II) on the control of majoraccident hazards involving dangerous substances Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work Directive 94/33/EC on the protection of young people at work Other regulations This product does not meet the criteria for classification according to Regulation (EC) 1272/2008 (CLP Regulation) and Directive 1999/45/EC and their amendments respectively. This Safety Data Sheet complies with the requirements of Regulation (EC) No 1907/2006. In the European Union this product is regulated under the In Vitro Diagnostic Medical Devices Directive (98/79/EC). National regulations The product has not been classified as dangerous according to the legislation in force Chemical safety No Chemical Safety Assessment has been carried out. assessment SECTION 16: Other information List of abbreviations References Information on evaluation method leading to the classification of mixture Full text of any statements or Rphrases and Hstatements under Sections 2 to 15 Training information DNEL: Derived NoEffect Level. PNEC: Predicted NoEffect Concentration. PBT: Persistent, bioaccumulative and toxic. vpvb: Very Persistent and very Bioaccumulative. The classification for health and environmental hazards is derived by a combination of calculation methods and test data, if available. None. Follow training instructions when handling this material. IgG / IgM / IgA Control Sera (negative, cut off, positive control), CSF Standards, AIControl, IgG Standards, Validation Cont Version #: 02 Revision date: 03March2015 Issue date: 16February / 7

28 Disclaimer The information above is provided in good faith. It is believed to be accurate and represents the best information currently available to us. HOWEVER, WE MAKE NO WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR OF ANY OTHER TYPE, EXPRESSED OR IMPLIED, WITH RESPECT TO PRODUCTS DESCRIBED OR DATA OR INFORMATION PROVIDED, AND WE ASSUME NO LIABILITY RESULTING FROM THE USE OF SUCH PRODUCTS, DATA OR INFORMATION. Users should make their own investigations to determine the suitability of the information for their particular purposes, and the user assumes all risk arising from their use of the material. The user is required to comply with all laws and regulations relating to the purchase, use, storage and disposal of the material, and must be familiar with and follow generally accepted safe handling procedures. In no event shall Sekisui Diagnostics be liable for any claims, losses, or damages of any individual or for lost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if Sekisui Diagnostics has been advised of the possibility of such damages. IgG / IgM / IgA Control Sera (negative, cut off, positive control), CSF Standards, AIControl, IgG Standards, Validation Cont Version #: 02 Revision date: 03March2015 Issue date: 16February / 7

29 SAFETY DATA SHEET SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Trade name or designation of the mixture Registration number Synonyms Product code IgG / IgM / IgA Cut off Control (human serum, prediluted) in buffer ZWB12205 [CO] WE102C60, WE102C80, WE116C40, WE116C60, WE130C60, WE150C60, WE150C80, WE222C60, WE222C80, WE223C60, WE224C60, WE224C80, WE225C60, WE242C40, WE242C60, WE243C40, WE243C60 Issue date 05March2015 Version number 01 Revision date Supersedes date 1.2. Relevant identified uses of the substance or mixture and uses advised against Identified uses In vitro diagnostics. Uses advised against Use in accordance with supplier's recommendations Details of the supplier of the safety data sheet Manufacturer/Distributor Sekisui Virotech GmbH Address Löwenplatz 5, Rüsselsheim, Germany Telephone number +49 (0) Website Contact person Gayle Brecker Gayle.Brecker@sekisuivirotech.com 1.4. Emergency telephone Europe, Middle East & Africa number Access code SECTION 2: Hazards identification 2.1. Classification of the substance or mixture The mixture has been assessed and/or tested for its physical, health and environmental hazards and the following classification applies. Classification according to Directive 67/548/EEC or 1999/45/EC as amended This preparation is not classified as dangerous according to Directive 1999/45/EC and its amendments. Classification according to Regulation (EC) No 1272/2008 as amended This mixture does not meet the criteria for classification according to Regulation (EC) 1272/2008 as amended. Hazard summary Physical hazards Not classified for physical hazards. Health hazards Not classified for health hazards. Environmental hazards Not classified for hazards to the environment. Specific hazards Avoid contact with eyes and skin. Do not ingest or inhale. Main symptoms Direct contact with skin and eyes may cause irritation Label elements Label according to Regulation (EC) No. 1272/2008 as amended Hazard pictograms None. Signal word None. Hazard statements None. Precautionary statements Prevention None. Response None. Storage None. Disposal None. IgG / IgM / IgA Cut off Control (human serum, prediluted) in buffer ZWB Version #: 01 Revision date: Issue date: 05March / 6

30 Supplemental label information Not applicable Other hazards Not a PBT or vpvb substance or mixture. SECTION 3: Composition/information on ingredients 3.2. Mixtures General information Chemical name % CASNo. / EC No. REACH Registration No. INDEX No. Notes Glycerol Classification: DSD: 15% XXXX CLP: SECTION 4: First aid measures General information Ensure that medical personnel are aware of the material(s) involved, and take precautions to protect themselves Description of first aid measures Inhalation Move to fresh air. Call a physician if symptoms develop or persist. Skin contact Eye contact Ingestion 4.2. Most important symptoms and effects, both acute and delayed 4.3. Indication of any immediate medical attention and special treatment needed SECTION 5: Firefighting measures General fire hazards 5.1. Extinguishing media Suitable extinguishing media Unsuitable extinguishing media 5.2. Special hazards arising from the substance or mixture 5.3. Advice for firefighters Special protective equipment for firefighters Special fire fighting procedures For skin contact flush with large amounts of water while removing contaminated clothing. Get medical attention if irritation develops and persists. In case of contact, immediately flush eyes with fresh water for at least 15 minutes while holding the eyelids open. Remove contact lenses if worn. Get medical attention if irritation persists. If material is ingested, immediately contact a physician or poison control centre. Direct contact with skin and eyes may cause irritation. Provide general supportive measures and treat symptomatically. The product is not flammable. Extinguish with water spray, carbon dioxide, dry chemical or material appropriate for the surrounding fire. None known. None known. SECTION 6: Accidental release measures Selfcontained breathing apparatus and full protective clothing must be worn in case of fire. Use standard firefighting procedures and consider the hazards of other involved materials Personal precautions, protective equipment and emergency procedures For nonemergency Keep unnecessary personnel away. Do not touch damaged containers or spilled material unless personnel wearing appropriate protective clothing. For emergency responders Use personal protection as recommended in section 8 of the SDS Environmental precautions Do not allow to enter drains, sewers or watercourses 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 Absorb spill with vermiculite or other inert material. Dispose of waste in accordance with all applicable federal, state, local and provincial environmental regulations, per Section 13. For personal protection, see section 8 of the SDS. For waste disposal, see section 13 of the SDS. Avoid contact with skin and eyes. Wash thoroughly after handling. In case of insufficient ventilation, wear suitable respiratory equipment. Handle and open container with care. IgG / IgM / IgA Cut off Control (human serum, prediluted) in buffer ZWB Version #: 01 Revision date: Issue date: 05March / 6

31 7.2. Conditions for safe storage, including any incompatibilities 7.3. Specific end use(s) In vitro diagnostics. Store in a closed container away from incompatible materials. SECTION 8: Exposure controls/personal protection 8.1. Control parameters Occupational exposure limits UK. EH40 Workplace Exposure Limits (WELs) Components Glycerol (CAS 56815) Biological limit values Recommended monitoring procedures Derived noeffect level (DNEL) Predicted no effect concentrations (PNECs) Type Value Form TWA 10 mg/m3 Mist. No biological exposure limits noted for the ingredient(s). Follow standard monitoring procedures. Exposure guidelines Follow standard monitoring procedures Exposure controls Appropriate engineering Provide adequate ventilation. Provide easy access to water supply and eye wash facilities. controls Individual protection measures, such as personal protective equipment General information Personal protective equipment should be chosen according to the CEN standards and in discussion with the supplier of the personal protective equipment. Eye/face protection Wear approved safety glasses or goggles. Skin protection Hand protection Wear appropriate chemical resistant gloves. Other Wear lab coat or other protective garments. Remove contaminated clothing promptly. Respiratory protection Under normal conditions, respirator is not normally required. Thermal hazards Wear appropriate thermal protective clothing, when necessary. Hygiene measures Handle in accordance with good industrial hygiene and safety practices. Environmental exposure Inform appropriate managerial or supervisory personnel of all environmental releases. controls SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Appearance Colourless liquid. Physical state Liquid. Form Liquid. Colour Colourless. Odour Odourless. Odour threshold ph Melting point/freezing point Initial boiling point and boiling range Flash point Evaporation rate Flammability (solid, gas) Not applicable. Upper/lower flammability or explosive limits Flammability limit lower (%) Flammability limit upper (%) Vapour pressure Vapour density IgG / IgM / IgA Cut off Control (human serum, prediluted) in buffer ZWB Version #: 01 Revision date: Issue date: 05March / 6

32 Relative density Solubility(ies) Partition coefficient (noctanol/water) Autoignition temperature Decomposition temperature Viscosity Explosive properties Not explosive. Oxidizing properties Not oxidizing Other information No relevant additional information available. SECTION 10: Stability and reactivity Reactivity The product is nonreactive under normal conditions of use, storage and transport Chemical stability Material is stable under normal conditions Possibility of hazardous Hazardous polymerisation does not occur. reactions Conditions to avoid Contact with incompatible materials Incompatible materials Strong oxidising agents Hazardous None known. decomposition products SECTION 11: Toxicological information General information Occupational exposure to the substance or mixture may cause adverse effects. Information on likely routes of exposure Inhalation Vapours may irritate throat and respiratory system and cause coughing. Skin contact May cause skin irritation. Eye contact May cause eye irritation. Ingestion May cause discomfort if swallowed. Symptoms Direct contact with skin and eyes may cause irritation Information on toxicological effects Acute toxicity Skin corrosion/irritation Serious eye damage/eye irritation Respiratory sensitisation Skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity Specific target organ toxicity single exposure Specific target organ toxicity repeated exposure Aspiration hazard Mixture versus substance information Other information May cause discomfort if swallowed. May cause skin irritation. May cause eye irritation. Not classifiable as to carcinogenicity to humans. No other specific acute or chronic health impact noted. SECTION 12: Ecological information Toxicity The product is not classified as environmentally hazardous. However, this does not exclude the possibility that large or frequent spills can have a harmful or damaging effect on the environment Persistence and No data is available on the degradability of this product. degradability Bioaccumulative potential Partition coefficient noctanol/water (log Kow) Bioconcentration factor (BCF) IgG / IgM / IgA Cut off Control (human serum, prediluted) in buffer ZWB Version #: 01 Revision date: Issue date: 05March / 6

33 12.4. Mobility in soil Mobility in general No data available Results of PBT Not a PBT or vpvb substance or mixture. and vpvb assessment Other adverse effects SECTION 13: Disposal considerations Waste treatment methods Residual waste Contaminated packaging EU waste code Disposal methods/information Dispose in accordance with all applicable regulations. Empty containers or liners may retain some product residues. This material and its container must be disposed of in a safe manner (see: Disposal instructions). Empty containers should be taken to an approved waste handling site for recycling or disposal. The Waste code should be assigned in discussion between the user, the producer and the waste disposal company. Dispose waste and residues in accordance with applicable federal, state, and local regulations. Contaminated instruments and surfaces should be disinfected in accordance with your employer's chemicalspecific and universal/standard precautions. SECTION 14: Transport information ADR RID ADN IATA IMDG Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code Not applicable. SECTION 15: Regulatory information Safety, health and environmental regulations/legislation specific for the substance or mixture EU regulations Regulation (EC) No. 1005/2009 on substances that deplete the ozone layer, Annex I Regulation (EC) No. 1005/2009 on substances that deplete the ozone layer, Annex II Regulation (EC) No. 850/2004 On persistent organic pollutants, Annex I as amended Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 1 as amended Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 2 as amended Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 3 as amended Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex V as amended Regulation (EC) No. 166/2006 Annex II Pollutant Release and Transfer Registry Regulation (EC) No. 1907/2006, REACH Article 59(10) Candidate List as currently published by ECHA Authorisations Regulation (EC) No. 1907/2006, REACH Annex XIV Substances subject to authorisation, as amended Regulation (EC) No. 1907/2006, REACH Annex XVII Substances subject to restriction on marketing and use as amended IgG / IgM / IgA Cut off Control (human serum, prediluted) in buffer ZWB Version #: 01 Revision date: Issue date: 05March / 6

34 Restrictions on use Regulation (EC) No. 1907/2006, REACH Annex XVII Substances subject to restriction on marketing and use as amended Directive 2004/37/EC: on the protection of workers from the risks related to exposure to carcinogens and mutagens at work Directive 92/85/EEC: on the safety and health of pregnant workers and workers who have recently given birth or are breastfeeding Other EU regulations Directive 96/82/EC (Seveso II) on the control of majoraccident hazards involving dangerous substances Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work Directive 94/33/EC on the protection of young people at work Other regulations This product does not meet the criteria for classification according to Regulation (EC) 1272/2008 (CLP Regulation) and Directive 1999/45/EC and their amendments respectively. This Safety Data Sheet complies with the requirements of Regulation (EC) No 1907/2006. In the European Union this product is regulated under the In Vitro Diagnostic Medical Devices Directive (98/79/EC). National regulations The product has not been classified as dangerous according to the legislation in force Chemical safety No Chemical Safety Assessment has been carried out. assessment SECTION 16: Other information List of abbreviations References Information on evaluation method leading to the classification of mixture Full text of any statements or Rphrases and Hstatements under Sections 2 to 15 Training information Disclaimer DNEL: Derived NoEffect Level. PNEC: Predicted NoEffect Concentration. PBT: Persistent, bioaccumulative and toxic. vpvb: Very Persistent and very Bioaccumulative. The classification for health and environmental hazards is derived by a combination of calculation methods and test data, if available. None. Follow training instructions when handling this material. The information above is provided in good faith. It is believed to be accurate and represents the best information currently available to us. HOWEVER, WE MAKE NO WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR OF ANY OTHER TYPE, EXPRESSED OR IMPLIED, WITH RESPECT TO PRODUCTS DESCRIBED OR DATA OR INFORMATION PROVIDED, AND WE ASSUME NO LIABILITY RESULTING FROM THE USE OF SUCH PRODUCTS, DATA OR INFORMATION. Users should make their own investigations to determine the suitability of the information for their particular purposes, and the user assumes all risk arising from their use of the material. The user is required to comply with all laws and regulations relating to the purchase, use, storage and disposal of the material, and must be familiar with and follow generally accepted safe handling procedures. In no event shall Sekisui Diagnostics be liable for any claims, losses, or damages of any individual or for lost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if Sekisui Diagnostics has been advised of the possibility of such damages. IgG / IgM / IgA Cut off Control (human serum, prediluted) in buffer ZWB Version #: 01 Revision date: Issue date: 05March / 6

35 SAFETY DATA SHEET SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Trade name or designation of the mixture Nitrocellulose test strips with sprayed anitgen, (solid strips stabilised on a plastic foil) Registration number Synonyms [NC] Product code WExxxGxx; WExxxAxx, WExxxMxx, UWExxxGxx, UWExxxMxx Issue date 20January2015 Version number 02 Revision date 11March2015 Supersedes date 20January Relevant identified uses of the substance or mixture and uses advised against Identified uses In vitro diagnostics. Uses advised against Use in accordance with supplier's recommendations Details of the supplier of the safety data sheet Manufacturer/Distributor Sekisui Virotech GmbH Address Löwenplatz 5, Rüsselsheim, Germany Telephone number +49 (0) Website Contact person Gayle Brecker Gayle.Brecker@sekisuivirotech.com 1.4. Emergency telephone Europe, Middle East & Africa number Access code SECTION 2: Hazards identification 2.1. Classification of the substance or mixture The mixture has been assessed and/or tested for its physical, health and environmental hazards and the following classification applies. Classification according to Directive 67/548/EEC or 1999/45/EC as amended Classification F;R11 The full text for all Rphrases is displayed in section 16. Classification according to Regulation (EC) No 1272/2008 as amended Physical hazards Flammable solids Category 1 Hazard summary Physical hazards Highly flammable. Health hazards Not classified for health hazards. Environmental hazards Not classified for hazards to the environment. Specific hazards Ingestion may cause dizziness, nausea and vomiting. Main symptoms Ingestion may cause irritation and malaise Label elements Label according to Regulation (EC) No. 1272/2008 as amended Hazard pictograms H228 Flammable solid. Signal word Hazard statements H228 Danger Flammable solid. Nitrocellulose test strips with sprayed anitgen, (solid strips stabilised on a plastic foil) Version #: 02 Revision date: 11March2015 Issue date: 20January / 7