SAFETY DATA SHEET. SECTION 1: Identification of the substance/mixture and of the company/undertaking

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 of the mixture IgG-Conjugate (anti-human) Registration number - Synonyms [CONJ IgG goat] Product code , U Issue date 08-April-2014 Version number 02 Revision date 21-January-2015 Supersedes date 10-September 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 R-phrases 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 Hazard summary Physical hazards Health hazards Environmental hazards Specific hazards Main symptoms Category 2 Category 2 Category 1 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. H315 - Causes skin irritation. H319 - Causes serious eye irritation. H317 - May cause an allergic skin reaction. 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: Mixture of: 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one and magnesium nitrate (ProClin 150) IgG-Conjugate (anti-human) Version #: 02 Revision date: 21-January-2015 Issue date: 08-April / 7

2 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 % CAS-No. / EC No. REACH Registration No. INDEX No. Notes Mixture of: 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one 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 SECTION 4: First aid measures 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 H-phrases is displayed in section 16. 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 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. IgG-Conjugate (anti-human) Version #: 02 Revision date: 21-January-2015 Issue date: 08-April / 7

3 4.2. Most important symptoms and effects, both acute and delayed 4.3. Indication of any immediate medical attention and special treatment needed 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. 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 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 Self-contained 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 non-emergency 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 no-effect 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. IgG-Conjugate (anti-human) Version #: 02 Revision date: 21-January-2015 Issue date: 08-April / 7

4 - 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 Green liquid. Physical state Liquid. Form Liquid. Colour Green. 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 (n-octanol/water) Auto-ignition 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 non-reactive 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 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 eczema-like skin disorders (dermatitis). Eye contact Causes serious eye irritation. IgG-Conjugate (anti-human) Version #: 02 Revision date: 21-January-2015 Issue date: 08-April / 7

5 Ingestion Symptoms Information on toxicological effects May cause discomfort if swallowed. Contact with this material can cause irritation to the skin, eyes and mucous membranes. Headaches, nausea and vomiting. Dermatitis. 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. May cause an allergic skin reaction. 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: 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one 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 n-octanol/water (log Kow) Bioconcentration factor (BCF) Mobility in soil Mobility in general 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 chemical-specific and universal/standard precautions. IgG-Conjugate (anti-human) Version #: 02 Revision date: 21-January-2015 Issue date: 08-April / 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 Other EU regulations Directive 96/82/EC (Seveso II) on the control of major-accident 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 Mixture of: 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one and magnesium nitrate (ProClin 150) (CAS ) Directive 94/33/EC on the protection of young people at work Mixture of: 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one and magnesium nitrate (ProClin 150) (CAS ) IgG-Conjugate (anti-human) Version #: 02 Revision date: 21-January-2015 Issue date: 08-April / 7

7 Other regulations National regulations Chemical safety assessment 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. 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 R-phrases and H-statements under Sections 2 to 15 Training information Disclaimer DNEL: Derived No-Effect Level. PNEC: Predicted No-Effect 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 long-term 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-Conjugate (anti-human) Version #: 02 Revision date: 21-January-2015 Issue date: 08-April / 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 of the mixture IgM-Conjugate (anti-human) Registration number - Synonyms [CONJ IgM goat] Product code , U Issue date 08-April-2014 Version number 02 Revision date 03-March-2015 Supersedes date 21-January 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 R-phrases 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 Hazard summary Physical hazards Health hazards Environmental hazards Specific hazards Main symptoms Category 2 Category 2 Category 1 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. H315 - Causes skin irritation. H319 - Causes serious eye irritation. H317 - May cause an allergic skin reaction. 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: Mixture of: 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one and magnesium nitrate (ProClin 150) IgM-Conjugate (anti-human) Version #: 02 Revision date: 03-March-2015 Issue date: 08-April / 7

9 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 % CAS-No. / EC No. REACH Registration No. INDEX No. Notes Mixture of: 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one 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 SECTION 4: First aid measures 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 H-phrases is displayed in section 16. 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 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. IgM-Conjugate (anti-human) Version #: 02 Revision date: 03-March-2015 Issue date: 08-April / 7

10 4.2. Most important symptoms and effects, both acute and delayed 4.3. Indication of any immediate medical attention and special treatment needed 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. 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 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 Self-contained 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 non-emergency 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 no-effect 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. IgM-Conjugate (anti-human) Version #: 02 Revision date: 03-March-2015 Issue date: 08-April / 7

11 - 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 Red liquid. Physical state Liquid. Form Liquid. Colour Red. 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 (n-octanol/water) Auto-ignition 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 non-reactive 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 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 eczema-like skin disorders (dermatitis). Eye contact Causes serious eye irritation. IgM-Conjugate (anti-human) Version #: 02 Revision date: 03-March-2015 Issue date: 08-April / 7

12 Ingestion Symptoms Information on toxicological effects May cause discomfort if swallowed. Contact with this material can cause irritation to the skin, eyes and mucous membranes. Headaches, nausea and vomiting. Dermatitis. 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. May cause an allergic skin reaction. 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: 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one 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 n-octanol/water (log Kow) Bioconcentration factor (BCF) Mobility in soil Mobility in general 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 chemical-specific and universal/standard precautions. IgM-Conjugate (anti-human) Version #: 02 Revision date: 03-March-2015 Issue date: 08-April / 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 Other EU regulations Directive 96/82/EC (Seveso II) on the control of major-accident 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 Mixture of: 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one and magnesium nitrate (ProClin 150) (CAS ) Directive 94/33/EC on the protection of young people at work Mixture of: 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one and magnesium nitrate (ProClin 150) (CAS ) IgM-Conjugate (anti-human) Version #: 02 Revision date: 03-March-2015 Issue date: 08-April / 7

14 Other regulations National regulations Chemical safety assessment 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. 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 R-phrases and H-statements under Sections 2 to 15 Training information Disclaimer DNEL: Derived No-Effect Level. PNEC: Predicted No-Effect 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 long-term 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. IgM-Conjugate (anti-human) Version #: 02 Revision date: 03-March-2015 Issue date: 08-April / 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 IgA-Conjugate (anti-human), IgA 2-Conjugate (anti-human) Registration number - Synonyms [CONJ IgA goat] Product code , U131301; , U Issue date 27-March-2014 Version number 02 Revision date 21-January-2015 Supersedes date 21-January 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 R-phrases 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 Hazard summary Physical hazards Health hazards Environmental hazards Specific hazards Main symptoms Category 2 Category 2 Category 1 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. H315 - Causes skin irritation. H319 - Causes serious eye irritation. H317 - May cause an allergic skin reaction. 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: Mixture of: 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one and magnesium nitrate (ProClin 150) IgA-Conjugate (anti-human), IgA 2-Conjugate (anti-human) Version #: 02 Revision date: 21-January-2015 Issue date: 27-March / 7

16 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 % CAS-No. / EC No. REACH Registration No. INDEX No. Notes Mixture of: 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one 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 SECTION 4: First aid measures 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 H-phrases is displayed in section 16. 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 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. IgA-Conjugate (anti-human), IgA 2-Conjugate (anti-human) Version #: 02 Revision date: 21-January-2015 Issue date: 27-March / 7

17 4.2. Most important symptoms and effects, both acute and delayed 4.3. Indication of any immediate medical attention and special treatment needed 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. 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 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 Self-contained 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 non-emergency 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 no-effect 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. IgA-Conjugate (anti-human), IgA 2-Conjugate (anti-human) Version #: 02 Revision date: 21-January-2015 Issue date: 27-March / 7

18 - 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 Red liquid. Physical state Liquid. Form Liquid. Colour Red. 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 (n-octanol/water) Auto-ignition 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 non-reactive 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 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 eczema-like skin disorders (dermatitis). Eye contact Causes serious eye irritation. IgA-Conjugate (anti-human), IgA 2-Conjugate (anti-human) Version #: 02 Revision date: 21-January-2015 Issue date: 27-March / 7

19 Ingestion Symptoms Information on toxicological effects May cause discomfort if swallowed. Contact with this material can cause irritation to the skin, eyes and mucous membranes. Headaches, nausea and vomiting. Dermatitis. 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. May cause an allergic skin reaction. 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: 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one 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 n-octanol/water (log Kow) Bioconcentration factor (BCF) Mobility in soil Mobility in general 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 chemical-specific and universal/standard precautions. IgA-Conjugate (anti-human), IgA 2-Conjugate (anti-human) Version #: 02 Revision date: 21-January-2015 Issue date: 27-March / 7

20 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 Other EU regulations Directive 96/82/EC (Seveso II) on the control of major-accident 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 Mixture of: 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one and magnesium nitrate (ProClin 150) (CAS ) Directive 94/33/EC on the protection of young people at work Mixture of: 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one and magnesium nitrate (ProClin 150) (CAS ) IgA-Conjugate (anti-human), IgA 2-Conjugate (anti-human) Version #: 02 Revision date: 21-January-2015 Issue date: 27-March / 7

21 Other regulations National regulations Chemical safety assessment 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. 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 R-phrases and H-statements under Sections 2 to 15 Training information Disclaimer DNEL: Derived No-Effect Level. PNEC: Predicted No-Effect 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 long-term 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. IgA-Conjugate (anti-human), IgA 2-Conjugate (anti-human) Version #: 02 Revision date: 21-January-2015 Issue date: 27-March / 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 IgA+M conjugate (anti-human IgA+IgM mixture) of the mixture Registration number - Synonyms [CONJ IgA+M goat] Product code Issue date 05-March-2015 Version number 01 Revision date - Supersedes date 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 R-phrases 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 Not classified for physical hazards. Health hazards Irritating to eyes and skin. May cause sensitisation by skin contact. Environmental hazards Not classified for hazards to the environment. Specific hazards Avoid contact with eyes and skin. Do not ingest or inhale. 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: 2-Methyl-2H-isothiazol-3-one (ProClin 950), Mixture of: 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one and magnesium nitrate (ProClin 150) IgA+M conjugate (anti-human IgA+IgM mixture) Version #: 01 Revision date: - Issue date: 05-March / 7

23 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 % CAS-No. / EC No. REACH Registration No. INDEX No. Notes 2-Methyl-2H-isothiazol-3-one (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: 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one 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 SECTION 4: First aid measures 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 H-phrases is displayed in section 16. 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. IgA+M conjugate (anti-human IgA+IgM mixture) Version #: 01 Revision date: - Issue date: 05-March / 7

24 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 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. 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 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 Self-contained 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 non-emergency 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 no-effect 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 8.2. Exposure controls Appropriate engineering controls Follow standard monitoring procedures. Provide adequate ventilation. Provide easy access to water supply and eye wash facilities. IgA+M conjugate (anti-human IgA+IgM mixture) Version #: 01 Revision date: - Issue date: 05-March / 7

25 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 Green liquid. Physical state Liquid. Form Liquid. Colour Green. 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 (n-octanol/water) Auto-ignition 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 non-reactive 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 Incompatible materials Hazardous None known. decomposition products IgA+M conjugate (anti-human IgA+IgM mixture) Version #: 01 Revision date: - Issue date: 05-March / 7

26 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 eczema-like 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. May cause an allergic skin reaction. 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: 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one 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 n-octanol/water (log Kow) Bioconcentration factor (BCF) Mobility in soil Mobility in general 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 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. IgA+M conjugate (anti-human IgA+IgM mixture) Version #: 01 Revision date: - Issue date: 05-March / 7

27 EU waste code Disposal methods/information 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 chemical-specific 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 Other EU regulations Directive 96/82/EC (Seveso II) on the control of major-accident hazards involving dangerous substances IgA+M conjugate (anti-human IgA+IgM mixture) Version #: 01 Revision date: - Issue date: 05-March / 7

28 Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work 2-Methyl-2H-isothiazol-3-one (ProClin 950) (CAS ) Mixture of: 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one and magnesium nitrate (ProClin 150) (CAS ) Directive 94/33/EC on the protection of young people at work 2-Methyl-2H-isothiazol-3-one (ProClin 950) (CAS ) Mixture of: 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one 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 R-phrases and H-statements under Sections 2 to 15 Training information Disclaimer DNEL: Derived No-Effect Level. PNEC: Predicted No-Effect 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 long-term 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. IgA+M conjugate (anti-human IgA+IgM mixture) Version #: 01 Revision date: - Issue date: 05-March / 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 Citrate-Stopping Solution of the mixture Registration number - Synonyms [STOP] Product code ; U Issue date 27-March-2014 Version number 02 Revision date 20-January-2015 Supersedes date 20-January 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 C;R34 The full text for all R-phrases is displayed in section 16. Classification according to Regulation (EC) No 1272/2008 as amended Health hazards Skin corrosion/irritation Hazard summary Physical hazards Health hazards Environmental hazards Specific hazards Main symptoms 2.2. Label elements Category 1 H314 - Causes severe skin burns and eye damage. Not classified for physical hazards. Causes burns. Occupational exposure to the substance or mixture may cause adverse health effects. Not classified for hazards to the environment. Hydrochloric acid solutions can readily release high concentrations of hydrogen chloride gas, which is very toxic and corrosive and poses a serious inhalation hazard. In high concentrations, mists/vapors may irritate throat and respiratory system and cause coughing. May cause burns in mucous membranes, throat, oesophagus and stomach. Label according to Regulation (EC) No. 1272/2008 as amended Contains: Hydrochloric acid 1-2%, Sulfuric acid 1-2% Hazard pictograms Citrate-Stopping Solution Version #: 02 Revision date: 20-January-2015 Issue date: 27-March / 9