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1 1. Identification of the substance/mixture and of the company/undertaking 1.1 Product identifier Commercial Product Name : Mat.-No./ Genisys-No. : Relevant identified uses of the substance or mixture and uses advised against Recommended restrictions on use : For professional users only. 1.3 Details of the supplier of the safety data sheet Company : Roche Diagnostics NZ Ltd - 15 Rakino Way Mt. Wellington, Auckland address : - Telephone : Telefax : Responsible Department : - In case of emergencies: : Roche Diagnostics NZ Ltd Then Press 2 National Poisons Centre : Dunedin 24 Hour Help Line Hazards identification 2.1 Classification of the substance or mixture Classification (REGULATION (EC) No 1272/2008) Acute toxicity, Category 3 H301: Toxic if swallowed. Classification (67/548/EEC, 1999/45/EC) Toxic R25: Toxic if swallowed. 2.2 Label elements Labelling (REGULATION (EC) No 1272/2008) Hazard pictograms : Signal word : Danger 1 / 16

2 Hazard statements : H301 Toxic if swallowed. Precautionary statements : Prevention: P264 P270 Response: P301 + P310 P330 Storage: P405 Disposal: P501 Wash skin thoroughly after handling. Do not eat, drink or smoke when using this product. IF SWALLOWED: Immediately call a POISON CENTER or doctor/ physician. Rinse mouth. Store locked up. Dispose of contents/ container to an approved waste disposal plant. Hazardous components which must be listed on the label: (1R,2S,3R,6S)-1,2-dimethyl-3,6-epoxycyclohexane-1,2-dicarboxylic anhydride 2.3 Other hazards No information available. 3. Composition/information on ingredients 3.2 Mixtures Hazardous components Chemical Name (1R,2S,3R,6S)-1,2- dimethyl-3,6- epoxycyclohexane-1,2- dicarboxylic anhydride CAS-No. EC-No. Registration number Classification (67/548/EEC) T+; R28- R36/37/38 Okadasäure T; T; R23/24/25 Xi; R38 Classification (REGULATION (EC) No 1272/2008) Acute Tox. 2; H300 Skin Irrit. 2; H315 Eye Irrit. 2; H319 STOT SE 3; H335 Acute Tox. 3; H301 Acute Tox. 3; H331 Acute Tox. 3; H311 Skin Irrit. 2; H315 Concentration [%] >= 1 - < 7 < 3 For the full text of the R-phrases mentioned in this Section, see Section 16. For the full text of the H-Statements mentioned in this Section, see Section / 16

3 4. First aid measures 4.1 Description of first aid measures General advice : Move out of dangerous area. Consult a physician. Show this safety data sheet to the doctor in attendance. Symptoms of poisoning may appear several hours later. Do not leave the victim unattended. If inhaled In case of skin contact In case of eye contact If swallowed : Move to fresh air. If unconscious place in recovery position and seek medical advice. If symptoms persist, call a physician. : If skin irritation persists, call a physician. If on skin, rinse well with water. If on clothes, remove clothes. : Flush eyes with water as a precaution. Remove contact lenses. Protect unharmed eye. Keep eye wide open while rinsing. If eye irritation persists, consult a specialist. : Clean mouth with water and drink afterwards plenty of water. Keep respiratory tract clear. Do not give milk or alcoholic beverages. Never give anything by mouth to an unconscious person. If symptoms persist, call a physician. Take victim immediately to hospital. 4.2 Most important symptoms and effects, both acute and delayed Symptoms : No information available. 4.3 Indication of any immediate medical attention and special treatment needed Treatment : The first aid procedure should be established in consultation with the doctor responsible for industrial medicine. 5. Firefighting measures 5.1 Extinguishing media Suitable extinguishing media : Use extinguishing measures that are appropriate to local circumstances and the surrounding environment. 3 / 16

4 Unsuitable extinguishing : High volume water jet media 5.2 Special hazards arising from the substance or mixture Specific hazards during firefighting : Do not allow run-off from fire fighting to enter drains or water courses. 5.3 Advice for firefighters Special protective equipment for firefighters Further information : Wear self contained breathing apparatus for fire fighting if necessary. : Collect contaminated fire extinguishing water separately. This must not be discharged into drains. Fire residues and contaminated fire extinguishing water must be disposed of in accordance with local regulations. 6. Accidental release measures 6.1 Personal precautions, protective equipment and emergency procedures Personal precautions : Use personal protective equipment. Avoid dust formation. Avoid breathing dust. 6.2 Environmental precautions Environmental precautions : Prevent product from entering drains. Prevent further leakage or spillage if safe to do so. If the product contaminates rivers and lakes or drains inform respective authorities. 6.3 Methods and materials for containment and cleaning up Methods for cleaning up : Keep in suitable, closed containers for disposal. 6.4 Reference to other sections Treat recovered material as described in the section "Disposal considerations". 7. Handling and storage 7.1 Precautions for safe handling Advice on safe handling : Avoid formation of respirable particles. Do not breathe vapours/dust. Avoid contact with skin and eyes. For personal protection see section 8. Smoking, eating and drinking should be prohibited in the application area. Dispose of rinse water in accordance with local and national 4 / 16

5 regulations. Advice on protection against fire and explosion : Avoid dust formation. Provide appropriate exhaust ventilation at places where dust is formed. 7.2 Conditions for safe storage, including any incompatibilities Requirements for storage areas and containers : Prevent unauthorized access. Keep container tightly closed in a dry and well-ventilated place. Containers which are opened must be carefully resealed and kept upright to prevent leakage. Observe label precautions. Electrical installations / working materials must comply with the technological safety standards. Further information on storage conditions German storage class Other data : See label, package insert or internal guidelines : 6.1C Combustible, acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects : No decomposition if stored and applied as directed. 7.3 Specific end use(s) Specific use(s) : Laboratory chemicals 8. Exposure controls/personal protection 8.1 Control parameters Components CAS-No. Value Control parameters Update Basis Polyethylengl ycol AGW mg/m DE TRGS 900 Further information : DFG: Senate commission for the review of compounds at the work place dangerous for the health (MAK-commission). When there is compliance with the OEL and biological tolerance values, there is no risk of harming the unborn child 8.2 Exposure controls Personal protective equipment 5 / 16

6 Hand protection : Protective gloves : The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 derived from it. This recommendation is only valid for the product mentioned in the safety data sheet and provided by us and for the application specified by us. Please observe the instructions regarding permeability and breakthrough time which are provided by the supplier of the gloves. Also take into consideration the specific local conditions under which the product is used, such as the danger of cuts, abrasion, and the contact time. The suitability for a specific workplace should be discussed with the producers of the protective gloves. Eye protection Skin and body protection Hygiene measures : Eye wash bottle with pure water Tightly fitting safety goggles : Choose body protection according to the amount and concentration of the dangerous substance at the work place. : Avoid contact with skin, eyes and clothing. When using do not eat or drink. When using do not smoke. Wash hands before breaks and immediately after handling the product. Environmental exposure controls General advice : Prevent product from entering drains. Prevent further leakage or spillage if safe to do so. If the product contaminates rivers and lakes or drains inform respective authorities. 9. Physical and chemical properties 9.1 Information on basic physical and chemical properties Appearance : solid Colour Melting point/range Boiling point/boiling range Flash point Flammability (solid, gas) : white : does not flash : Sustains combustion 6 / 16

7 Lower explosion limit Upper explosion limit Vapour pressure Water solubility Partition coefficient: n- octanol/water Ignition temperature Thermal decomposition Viscosity, dynamic Oxidizing properties 9.2 Other information Conductivity Oxidising potential Surface tension : completely soluble : The substance or mixture is not classified as oxidizing. 10. Stability and reactivity 10.1 Reactivity No dangerous reaction known under conditions of normal use Chemical stability Stable under normal conditions Possibility of hazardous reactions Hazardous reactions : No dangerous reaction known under conditions of normal use. : Further information: No decomposition if stored and applied as directed Conditions to avoid Conditions to avoid 10.5 Incompatible materials Materials to avoid : Strong oxidizing agents 10.6 Hazardous decomposition products Hazardous decomposition products 7 / 16

8 11. Toxicological information 11.1 Information on toxicological effects Product Acute oral toxicity : Acute toxicity estimate: 207,47 mg/kg, Calculation method Acute inhalation toxicity Acute dermal toxicity Acute toxicity (other routes of administration) Skin corrosion/irritation Serious eye damage/eye irritation Aspiration toxicity Further information : Acute toxicity estimate: > 5 mg/l, 4 h, dust/mist, Calculation method : Acute toxicity estimate: > mg/kg, Calculation method : May cause skin irritation and/or dermatitis. : Product dust may be irritating to eyes, skin and respiratory system. Components: (1R,2S,3R,6S)-1,2-dimethyl-3,6-epoxycyclohexane-1,2-dicarboxylic anhydride: Acute oral toxicity : Acute toxicity estimate: > 5 mg/kg, Expert judgement Acute inhalation toxicity Acute dermal toxicity Acute toxicity (other routes of administration) Skin corrosion/irritation Serious eye damage/eye irritation Respiratory or skin sensitisation STOT - single exposure : Result: Irritating to skin., May cause skin irritation in susceptible persons. : Result: Irritating to eyes., May cause irreversible eye damage. : Result : Exposure routes: Inhalation Assessment: May cause respiratory irritation. 8 / 16

9 Aspiration toxicity Further information Okadasäure: Acute oral toxicity Acute inhalation toxicity Acute dermal toxicity Acute toxicity (other routes of administration) Skin corrosion/irritation Serious eye damage/eye irritation Respiratory or skin sensitisation STOT - single exposure : Acute toxicity estimate: 100 mg/kg, Expert judgement : Acute toxicity estimate: > 0,5 mg/l, dust/mist, Expert judgement : Acute toxicity estimate: 300 mg/kg, Expert judgement : Result: Irritating to skin., May cause skin irritation in susceptible persons. : Product dust may be irritating to eyes, skin and respiratory system. : Result : Assessment: The substance or mixture is not classified as specific target organ toxicant, single exposure. Aspiration toxicity Further information 12. Ecological information 12.1 Toxicity Product: Toxicity to fish Toxicity to daphnia and other aquatic invertebrates Toxicity to algae Toxicity to bacteria Ecotoxicology Assessment Toxicity Data on Soil Other organisms relevant to : Not expected to adsorb on soil. 9 / 16

10 the environment Components: (1R,2S,3R,6S)-1,2-dimethyl-3,6-epoxycyclohexane-1,2-dicarboxylic anhydride: Toxicity to fish Toxicity to daphnia and other aquatic invertebrates Toxicity to algae Toxicity to bacteria Ecotoxicology Assessment Toxicity Data on Soil Other organisms relevant to the environment Okadasäure: Toxicity to fish Toxicity to daphnia and other aquatic invertebrates Toxicity to algae Toxicity to bacteria Ecotoxicology Assessment Toxicity Data on Soil : Not expected to adsorb on soil. : Not expected to adsorb on soil. Other organisms relevant to the environment 12.2 Persistence and degradability Product: Biodegradability Components: (1R,2S,3R,6S)-1,2-dimethyl-3,6-epoxycyclohexane-1,2-dicarboxylic anhydride: Biodegradability Okadasäure: Biodegradability 12.3 Bioaccumulative potential 10 / 16

11 Product: Bioaccumulation Components: (1R,2S,3R,6S)-1,2-dimethyl-3,6-epoxycyclohexane-1,2-dicarboxylic anhydride: Bioaccumulation Okadasäure: Bioaccumulation 12.4 Mobility in soil Product: Mobility Distribution among environmental compartments Environmental fate and pathways Physico-chemical removability Components: (1R,2S,3R,6S)-1,2-dimethyl-3,6-epoxycyclohexane-1,2-dicarboxylic anhydride: Mobility Distribution among environmental compartments Environmental fate and pathways Physico-chemical removability Okadasäure: Mobility Distribution among environmental compartments Environmental fate and pathways Physico-chemical removability 12.5 Results of PBT and vpvb assessment 11 / 16

12 Product: Assessment : This substance is not considered to be persistent, bioaccumulating nor toxic (PBT)., This substance is not considered to be very persistent nor very bioaccumulating (vpvb). Components: (1R,2S,3R,6S)-1,2-dimethyl-3,6-epoxycyclohexane-1,2-dicarboxylic anhydride: Assessment Okadasäure: Assessment 12.6 Other adverse effects Product: Biochemical Oxygen Demand (BOD) Dissolved organic carbon (DOC) Chemical Oxygen Demand (COD) Adsorbed organic bound halogens (AOX) Additional ecological information : This substance is not considered to be persistent, bioaccumulating nor toxic (PBT)., This substance is not considered to be very persistent nor very bioaccumulating (vpvb). : This substance is not considered to be persistent, bioaccumulating nor toxic (PBT)., This substance is not considered to be very persistent nor very bioaccumulating (vpvb). Components: (1R,2S,3R,6S)-1,2-dimethyl-3,6-epoxycyclohexane-1,2-dicarboxylic anhydride: Biochemical Oxygen Demand (BOD) Dissolved organic carbon (DOC) Chemical Oxygen Demand (COD) 12 / 16

13 Adsorbed organic bound halogens (AOX) Okadasäure: Biochemical Oxygen Demand (BOD) Dissolved organic carbon (DOC) Chemical Oxygen Demand (COD) Adsorbed organic bound halogens (AOX) Additional ecological information 13. Disposal considerations 13.1 Waste treatment methods Product Contaminated packaging : Do not contaminate ponds, waterways or ditches with chemical or used container. Send to a licensed waste management company. : Empty remaining contents. Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. 14. Transport information 14.1 UN number ADR IMDG IATA 13 / 16

14 14.2 Proper shipping name ADR IMDG IATA 14.3 Transport hazard class ADR IMDG IATA 14.4 Packing group ADR IMDG IATA_C IATA_P 14 / 16

15 14.5 Environmental hazards ADR IMDG IATA 14.6 Special precautions for user in the meaning of ADR/RID, ADNR, IMDG-Code, ICAO/IATA-DGR 14.7 Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code Remarks : not applicable 15. Regulatory information 15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture Major Accident Hazard Legislation : 96/82/EC Update: 2003 Toxic 2 Quantity 1: 50 t Quantity 2: 200 t Water contaminating class (Germany) : WGK 2 water endangering VWVWS A4 TA Luft List (Germany) : Total dust: not applicable Inorganic substances in powdered form: not applicable Inorganic substances in vapour or gaseous form: not applicable Organic Substances: not applicable Carcinogenic substances: not applicable Mutagenic: not applicable Toxic to reproduction: not applicable 15.2 Chemical Safety Assessment 15 / 16

16 A Chemical Safety Assessment is not required for this substance when it is used in the specified applications. 16. Other information Full text of R-phrases referred to under sections 2 and 3 R23/24/25 R25 R28 R36/37/38 R38 Also toxic by inhalation, in contact with skin and if swallowed. Toxic if swallowed. Very toxic if swallowed. Irritating to eyes, respiratory system and skin. Irritating to skin. Full text of H-Statements referred to under sections 2 and 3. H300 H301 H311 H315 H319 H331 H335 Further information Fatal if swallowed. Toxic if swallowed. Toxic in contact with skin. Causes skin irritation. Causes serious eye irritation. Toxic if inhaled. May cause respiratory irritation. The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information given is designed only as a guidance for safe handling, use, processing, storage, transportation, disposal and release and is not to be considered a warranty or quality specification. The information relates only to the specific material designated and may not be valid for such material used in combination with any other materials or in any process, unless specified in the text. 16 / 16