: SP6/T7 Transcription Kit

Transcription

1 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1 Product identifier Commercial Product Name : Mat.-No./ Genisys-No. : Substance name : SP6/T7 Transcription Kit 1.2 Relevant identified uses of the substance or mixture and uses advised against Recommended restrictions : For professional users only. on use 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 : Emergency telephone number In case of emergencies: : Roche Diagnostics NZ Ltd Then Press 2 National Poisons Centre : Dunedin 24 Hour Help Line SECTION 2: Hazards identification 2.1 Classification of the substance or mixture Classification (REGULATION (EC) No 1272/2008) Classification (67/548/EEC, 1999/45/EC) Not a hazardous substance or mixture according to EC-directives 67/548/EEC or 1999/45/EC. 2.2 Label elements Labelling (REGULATION (EC) No 1272/2008) Additional Labelling: EUH210 Safety data sheet available on request. EUH208 May produce an allergic reaction. 1 / 39

2 Contains: Nuclease, deoxyribo-, and 2-mercaptoethanol, Other hazards None known. SECTION 3: Composition/information on ingredients pspt18 DNA Classification (REGULATION (EC) No 1272/2008) Classification (67/548/EEC, 1999/45/EC) Remarks : No hazardous ingredients pspt19 DNA Classification (REGULATION (EC) No 1272/2008) Classification (67/548/EEC, 1999/45/EC) Remarks : No hazardous ingredients Control DNA Classification (REGULATION (EC) No 1272/2008) Classification (67/548/EEC, 1999/45/EC) Remarks : No hazardous ingredients ATP Classification (REGULATION (EC) No 1272/2008) 2 / 39

3 Classification (67/548/EEC, 1999/45/EC) Remarks : No hazardous ingredients CTP Classification (REGULATION (EC) No 1272/2008) Classification (67/548/EEC, 1999/45/EC) Remarks : No hazardous ingredients GTP Classification (REGULATION (EC) No 1272/2008) Classification (67/548/EEC, 1999/45/EC) Remarks : No hazardous ingredients UTP Classification (REGULATION (EC) No 1272/2008) Classification (67/548/EEC, 1999/45/EC) Remarks : No hazardous ingredients Transcription buffer (10x conc.) Classification (REGULATION (EC) No 1272/2008) Classification (67/548/EEC, 1999/45/EC) 3 / 39

4 Hazardous components Chemical Name (R*,R*)-1,4- dimercaptobutane- 2,3-diol CAS-No. EC-No. Registration number Classification (67/548/EEC) Xn; R22 Xi; R36/38 Classification (REGULATION (EC) No 1272/2008) Acute Tox.4; H302 Skin Irrit.2; H315 Eye Irrit.2; H319 Aquatic Chronic3; H412 Concentration [%] >= 1 - < 2,5 For explanation of abbreviations see section 16. DNase I, RNase-free Classification (REGULATION (EC) No 1272/2008) Classification (67/548/EEC, 1999/45/EC) Remarks : No hazardous ingredients RNase Inhibitor Classification (REGULATION (EC) No 1272/2008) Classification (67/548/EEC, 1999/45/EC) Remarks : No hazardous ingredients Sp6-RNA - Polymerase Classification (REGULATION (EC) No 1272/2008) Classification (67/548/EEC, 1999/45/EC) Remarks : No hazardous ingredients T7-RNA Polymerase 4 / 39

5 Classification (REGULATION (EC) No 1272/2008) Classification (67/548/EEC, 1999/45/EC) Remarks : No hazardous ingredients SECTION 4: First aid measures 4.1 Description of first aid measures General advice : 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. : Immediately flush eye(s) with plenty of water. Remove contact lenses. Protect unharmed eye. Keep eye wide open while rinsing. If eye irritation persists, consult a specialist. : 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. Rinse mouth with water. 4.2 Most important symptoms and effects, both acute and delayed 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. SECTION 5: Firefighting measures 5.1 Extinguishing media 5 / 39

6 Suitable extinguishing media : Use extinguishing measures that are appropriate to local circumstances and the surrounding environment. Unsuitable extinguishing : High volume water jet media 5.2 Special hazards arising from the substance or mixture Specific hazards during : No information available. firefighting 5.3 Advice for firefighters Special protective equipment : Wear self contained breathing apparatus for fire fighting if for firefighters necessary. Further information : Standard procedure for chemical fires. Use extinguishing measures that are appropriate to local circumstances and the surrounding environment. SECTION 6: Accidental release measures 6.1 Personal precautions, protective equipment and emergency procedures Personal precautions : Use personal protective equipment. Refer to protective measures listed in sections 7 and Environmental precautions Environmental precautions : 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 : Wipe up with absorbent material (e.g. cloth, fleece). Keep in suitable, closed containers for disposal. 6.4 Reference to other sections Treat recovered material as described in the section "Disposal considerations". SECTION 7: Handling and storage 7.1 Precautions for safe handling Advice on safe handling Advice on protection against fire and explosion : 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 regulations. : Normal measures for preventive fire protection. 6 / 39

7 Hygiene measures : When using do not eat or drink. When using do not smoke. Wash hands before breaks and at the end of workday. 7.2 Conditions for safe storage, including any incompatibilities Requirements for storage areas and containers : Keep container tightly closed in a dry and well-ventilated place. Electrical installations / working materials must comply with the technological safety standards. Further information on storage conditions Storage class (TRGS 510) Other data : See label, package insert or internal guidelines : 12, Non Combustible Liquids : No decomposition if stored and applied as directed. 7.3 Specific end use(s) Specific use(s) : Laboratory chemicals SECTION 8: Exposure controls/personal protection 8.1 Control parameters pspt18 DNA Contains no substances with occupational exposure limit values. pspt19 DNA Contains no substances with occupational exposure limit values. Control DNA Contains no substances with occupational exposure limit values. ATP Contains no substances with occupational exposure limit values. CTP 7 / 39

8 Contains no substances with occupational exposure limit values. GTP Contains no substances with occupational exposure limit values. UTP Contains no substances with occupational exposure limit values. Transcription buffer (10x conc.) Contains no substances with occupational exposure limit values. DNase I, RNase-free Contains no substances with occupational exposure limit values. RNase Inhibitor Contains no substances with occupational exposure limit values. Sp6-RNA - Polymerase Contains no substances with occupational exposure limit values. T7-RNA Polymerase Contains no substances with occupational exposure limit values. 8.2 Exposure controls Personal protective equipment Eye protection : Eye wash bottle with pure water Tightly fitting safety goggles Hand protection Material : Protective gloves 8 / 39

9 Remarks : 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. Skin and body protection : impervious clothing Choose body protection according to the amount and concentration of the dangerous substance at the work place. Environmental exposure controls General advice : Prevent further leakage or spillage if safe to do so. If the product contaminates rivers and lakes or drains inform respective authorities. SECTION 9: Physical and chemical properties 9.1 Information on basic physical and chemical properties pspt18 DNA Appearance : liquid Colour : colourless Melting point/range : Boiling point/boiling range : Flash point : Remarks: Upper explosion limit Lower explosion limit Solubility(ies) Water solubility Ignition temperature Thermal decomposition Oxidizing properties : : : completely miscible : : : The substance or mixture is not classified as oxidizing. pspt19 DNA 9 / 39

10 Appearance : liquid Colour : colourless Odour : none ph : 7,0 Melting point/range : Boiling point/boiling range : Flash point : Remarks: Upper explosion limit Lower explosion limit Solubility(ies) Water solubility Ignition temperature Thermal decomposition Oxidizing properties : : : completely miscible : : : The substance or mixture is not classified as oxidizing. Control DNA Appearance : liquid Colour : colourless ph : 7,0 Melting point/range : Boiling point/boiling range : Flash point : Remarks: Upper explosion limit Lower explosion limit Solubility(ies) Water solubility Ignition temperature Thermal decomposition Oxidizing properties : : : completely miscible : : : The substance or mixture is not classified as oxidizing. ATP Appearance Colour Odour : liquid : colourless : odourless 10 / 39

11 ph : 6,8-7,2 Melting point/range : Boiling point/boiling range : Flash point : Remarks: does not flash Upper explosion limit Lower explosion limit Solubility(ies) Water solubility Ignition temperature Thermal decomposition Oxidizing properties : : : completely miscible : : : The substance or mixture is not classified as oxidizing. CTP Appearance : liquid Colour : colourless Odour : odourless ph : 6,8-7,2 Melting point/range : Boiling point/boiling range : Flash point : Remarks: does not flash Upper explosion limit Lower explosion limit Solubility(ies) Water solubility Ignition temperature Thermal decomposition Oxidizing properties : : : completely miscible : : : The substance or mixture is not classified as oxidizing. GTP Appearance : liquid Colour : colourless Odour : odourless ph : 6,8-7,2 Melting point/range : 11 / 39

12 Boiling point/boiling range Flash point Upper explosion limit Lower explosion limit Solubility(ies) Water solubility Ignition temperature Thermal decomposition Oxidizing properties : : Remarks: does not flash : : : completely miscible : : : The substance or mixture is not classified as oxidizing. UTP Appearance : liquid Colour : colourless Odour : odourless ph : 6,8-7,2 Melting point/range : Boiling point/boiling range : Flash point : Remarks: does not flash Upper explosion limit Lower explosion limit Solubility(ies) Water solubility Ignition temperature Thermal decomposition Oxidizing properties : : : completely miscible : : : The substance or mixture is not classified as oxidizing. Transcription buffer (10x conc.) Appearance : liquid Colour : colourless Odour : very faint ph : 8,0 Flash point : Remarks: Upper explosion limit : 12 / 39

13 Lower explosion limit Solubility(ies) Water solubility Ignition temperature Thermal decomposition Oxidizing properties : : completely miscible : : : The substance or mixture is not classified as oxidizing. DNase I, RNase-free Appearance : liquid Colour : light yellow Odour : odourless ph : 7,6 Boiling point/boiling range : Flash point : Remarks: does not flash Upper explosion limit Lower explosion limit Density : : : ca. 1,15 g/cm3 Solubility(ies) Water solubility Ignition temperature Thermal decomposition Oxidizing properties : completely miscible : : : The substance or mixture is not classified as oxidizing. RNase Inhibitor Appearance : liquid Colour : colourless Odour : very faint ph : 7,6 Melting point/range : Boiling point/boiling range : Flash point : Remarks: Upper explosion limit Lower explosion limit Solubility(ies) : : 13 / 39

14 Water solubility Ignition temperature Thermal decomposition Oxidizing properties : completely miscible : : : The substance or mixture is not classified as oxidizing. Sp6-RNA - Polymerase Appearance Colour Odour ph Melting point/range Boiling point/boiling range Flash point Upper explosion limit Lower explosion limit Solubility(ies) Water solubility Ignition temperature Thermal decomposition Oxidizing properties : liquid : colourless : odourless : ca. 7,9, (4 C) : : : Remarks: does not flash : : : completely miscible : : : The substance or mixture is not classified as oxidizing. T7-RNA Polymerase Appearance Colour ph Melting point/range Boiling point/boiling range Flash point Upper explosion limit Lower explosion limit Solubility(ies) Water solubility Ignition temperature Thermal decomposition : liquid : colourless : 7,9, (4 C) : : : Remarks: does not flash : : : completely miscible : : 14 / 39

15 Oxidizing properties : The substance or mixture is not classified as oxidizing. 9.2 Other information pspt18 DNA pspt19 DNA Control DNA ATP CTP GTP UTP Transcription buffer (10x conc.) 15 / 39

16 DNase I, RNase-free RNase Inhibitor Sp6-RNA - Polymerase T7-RNA Polymerase SECTION 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. No decomposition if stored and applied as directed Conditions to avoid Conditions to avoid : 10.5 Incompatible materials 16 / 39

17 Materials to avoid : 10.6 Hazardous decomposition products Hazardous decomposition : products SECTION 11: Toxicological information 11.1 Information on toxicological effects pspt18 DNA Acute toxicity Skin corrosion/irritation Serious eye damage/eye irritation Respiratory or skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity STOT - single exposure STOT - repeated exposure 17 / 39

18 Repeated dose toxicity Aspiration toxicity pspt19 DNA Acute toxicity Skin corrosion/irritation Serious eye damage/eye irritation Respiratory or skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity STOT - single exposure STOT - repeated exposure 18 / 39

19 Repeated dose toxicity Aspiration toxicity Control DNA Acute toxicity Skin corrosion/irritation Serious eye damage/eye irritation Respiratory or skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity STOT - single exposure STOT - repeated exposure Repeated dose toxicity 19 / 39

20 Aspiration toxicity ATP Acute toxicity Skin corrosion/irritation Serious eye damage/eye irritation Respiratory or skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity STOT - single exposure STOT - repeated exposure Repeated dose toxicity 20 / 39

21 Aspiration toxicity CTP Acute toxicity Skin corrosion/irritation Serious eye damage/eye irritation Respiratory or skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity STOT - single exposure STOT - repeated exposure Repeated dose toxicity Aspiration toxicity 21 / 39

22 GTP Acute toxicity Skin corrosion/irritation Serious eye damage/eye irritation Respiratory or skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity STOT - single exposure STOT - repeated exposure Repeated dose toxicity Aspiration toxicity 22 / 39

23 UTP Acute toxicity Skin corrosion/irritation Serious eye damage/eye irritation Respiratory or skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity STOT - single exposure STOT - repeated exposure Repeated dose toxicity Aspiration toxicity 23 / 39

24 Transcription buffer (10x conc.) Acute toxicity Components: (R*,R*)-1,4-dimercaptobutane-2,3-diol: Acute oral toxicity : LD50 Oral rat: 400 mg/kg Acute toxicity (other routes of administration) : Symptoms: May cause cardiac arrhythmia., Convulsions, Vomiting Skin corrosion/irritation Components: (R*,R*)-1,4-dimercaptobutane-2,3-diol: Result: Irritating to skin. Serious eye damage/eye irritation Components: (R*,R*)-1,4-dimercaptobutane-2,3-diol: Result: Irritating to eyes. Respiratory or skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity STOT - single exposure STOT - repeated exposure 24 / 39

25 Repeated dose toxicity Aspiration toxicity DNase I, RNase-free Acute toxicity Skin corrosion/irritation Serious eye damage/eye irritation Respiratory or skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity STOT - single exposure STOT - repeated exposure 25 / 39

26 Repeated dose toxicity Aspiration toxicity RNase Inhibitor Acute toxicity Skin corrosion/irritation Serious eye damage/eye irritation Respiratory or skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity STOT - single exposure STOT - repeated exposure Repeated dose toxicity 26 / 39

27 Aspiration toxicity Sp6-RNA - Polymerase Acute toxicity Skin corrosion/irritation Serious eye damage/eye irritation Respiratory or skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity STOT - single exposure STOT - repeated exposure Repeated dose toxicity 27 / 39

28 Aspiration toxicity T7-RNA Polymerase Acute toxicity Skin corrosion/irritation Serious eye damage/eye irritation Respiratory or skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity STOT - single exposure STOT - repeated exposure Repeated dose toxicity Aspiration toxicity 28 / 39

29 SECTION 12: Ecological information 12.1 Toxicity pspt18 DNA pspt19 DNA Control DNA ATP CTP GTP UTP Transcription buffer (10x conc.) 29 / 39

30 Components: (R*,R*)-1,4-dimercaptobutane-2,3-diol : Toxicity to daphnia and other aquatic invertebrates Ecotoxicology Assessment : EC50 (Daphnia magna (Water flea)): 27 mg/l Exposure time: 48 h Toxicity Data on Soil Other organisms relevant to the environment : Not expected to adsorb on soil. : DNase I, RNase-free RNase Inhibitor Sp6-RNA - Polymerase T7-RNA Polymerase 12.2 Persistence and degradability pspt18 DNA pspt19 DNA Control DNA ATP CTP 30 / 39

31 GTP UTP Transcription buffer (10x conc.) DNase I, RNase-free RNase Inhibitor Sp6-RNA - Polymerase T7-RNA Polymerase 12.3 Bioaccumulative potential pspt18 DNA pspt19 DNA Control DNA ATP CTP 31 / 39

32 GTP UTP Transcription buffer (10x conc.) Components: (R*,R*)-1,4-dimercaptobutane-2,3-diol : Partition coefficient: n- : log Pow: ca. -0,48 octanol/water DNase I, RNase-free RNase Inhibitor Sp6-RNA - Polymerase T7-RNA Polymerase 12.4 Mobility in soil pspt18 DNA pspt19 DNA Control DNA ATP 32 / 39

33 CTP GTP UTP Transcription buffer (10x conc.) DNase I, RNase-free RNase Inhibitor Sp6-RNA - Polymerase T7-RNA Polymerase 12.5 Results of PBT and vpvb assessment pspt18 DNA pspt19 DNA Control DNA ATP CTP 33 / 39

34 GTP UTP Transcription buffer (10x conc.) DNase I, RNase-free RNase Inhibitor Sp6-RNA - Polymerase T7-RNA Polymerase 12.6 Other adverse effects pspt18 DNA pspt19 DNA Control DNA ATP 34 / 39

35 CTP GTP UTP Transcription buffer (10x conc.) DNase I, RNase-free RNase Inhibitor Sp6-RNA - Polymerase T7-RNA Polymerase 35 / 39

36 SECTION 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. SECTION 14: Transport information 14.1 UN number ADR Not dangerous goods IMDG Not dangerous goods IATA Not dangerous goods 14.2 Proper shipping name ADR Not dangerous goods IMDG Not dangerous goods IATA Not dangerous goods 14.3 Transport hazard class ADR 36 / 39

37 Not dangerous goods IMDG Not dangerous goods IATA Not dangerous goods 14.4 Packing group ADR Not dangerous goods IMDG Not dangerous goods IATA_C Not dangerous goods IATA_P Not dangerous goods 14.5 Environmental hazards ADR Not dangerous goods IMDG Not dangerous goods IATA Not dangerous goods 14.6 Special precautions for user Not dangerous goods 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 37 / 39

38 SECTION 15: Regulatory information 15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture Seveso II - Directive 2003/105/EC amending Council Directive 96/82/EC on the control of majoraccident hazards involving dangerous substances not applicable Water contaminating class (Germany) : WGK 2 water endangering 15.2 Chemical Safety Assessment A Chemical Safety Assessment is not required for this substance when it is used in the specified applications. SECTION 16: Other information Full text of R-Phrases R22 Harmful if swallowed. R36/38 Irritating to eyes and skin. Full text of H-Statements H302 Harmful if swallowed. H315 Causes skin irritation. H319 Causes serious eye irritation. H412 Harmful to aquatic life with long lasting effects. Full text of other abbreviations Acute Tox. Acute toxicity Aquatic Chronic Chronic aquatic toxicity Eye Irrit. Eye irritation Skin Irrit. Skin irritation Further information 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. 38 / 39

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