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					ABBOTT Laboratories Abbott Diagnostics Division (ADD) 100 Abbott Park Road Abbott Park, IL 60064 Release Date: 2/20/06

ADD List Number Product Name 9797-69 Components: 9797P 9797S 9797T 9518-06 9518-05 9527-40 9797-30 9797-32
9797-33
3 This

TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Reagents with Accessories

TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Pretreatment Solution TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Antibody (mouse monoclonal) Solution TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Fluorescein Tracer Solution Cuvettes3 Sample Cartridges3 TDx/TDxFLx Centrifuge Tubes3 TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Solubilization Reagent X-SYSTEMS Cyclosporine Monoclonal Whole Blood Precipitation Reagent / Probe Wash

product is considered an article. Per OSHA 29 CFR 1910.1200, Material Safety Data Sheets are not required for articles. An Article is a manufactured item which is formed to a specific shape or design during manufacture, has end use function(s) dependent in whole or in part upon its shape or design during end use, and under normal conditions of use does not release more than very small quantities, that is, minute or trace amounts of a hazardous chemical, and does not pose a physical hazard or health risk to employees.

Scroll down to display the MSDS as applicable.
Abbott Customers: For additional information, please contact your Abbott Customer Support Center Representative by calling 1-800-527-1869, 1-800-323-9100, or 1-800-235-5396. Abbott employees: For additional information relative to the content of the MSDSs, please contact your local Safety Representative.

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Material Safety Data Sheet
Release date 02/20/2006 Last alteration on 02/20/2006

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1 Identification of Substance · Product name: TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Pretreatment Solution · ADD List number: 9797P · Manufacturer / Supplier: ABBOTT Laboratories Abbott Diagnostics Division (ADD) 100 Abbott Park Road Abbott Park, IL 60064 · Department issuing MSDS: Abbott Diagnostics Division Safety, Health and Environmental Assurance 2 Composition / Information on Ingredients · Chemical characterization: Mixture of chemical and/or biological substances for diagnostic use. · Hazardous ingredients per OSHA criteria: 77-86-1 Tris Hydroxymethyl Aminomethane

*

1.28%

*

3 Hazards Identification / Emergency Overview · Routes of Exposure: None anticipated, when used as directed. · Classification system: The classification was made according to OSHA 29 CFR 1910.1200 and 1910.1030 and applicable European Community Directives, and is expanded upon from company and/or literature data. · National Fire Protection Association (NFPA) ratings (scale 0-4) Health = 0 Fire = 0 Reactivity = 0 · Hazard Overview · Health: Minimal risk if used as directed · Fire: Noncombustible · Reactivity: Minimal Risk · Special Hazards: None · Carcinogenicity information · OSHA (Occupational Safety and Health Administration) None of the ingredients is listed. · NTP (National Toxicology Program) None of the ingredients is listed. · IARC (International Agency for Research on Cancer) None of the ingredients is listed. 4 First Aid Measures · After inhalation: Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention. · After skin contact: Wash effected area with soap and water. If irritation or signs of toxicity occur, seek medical attention. · After eye contact: Flush with copious amounts of water. If irritation or signs of toxicity occur, seek medical attention. · After swallowing: If irritation or signs of toxicity occur, seek medical attention. · Information for medical personnel: · The following symptoms may occur: Kidney effects · Medical conditions aggravated by exposure: Pre-existing renal ailments Pre-existing gastrointestinal tract ailments 5 Fire Fighting Measures · Suitable extinguishing agents: Dry Chemical, CO2, water spray or regular foam. Fight larger fires with water spray, fog or regular foam.
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Material Safety Data Sheet
Release date 02/20/2006 Last alteration on 02/20/2006

Product name: TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Pretreatment Solution

· Protective equipment: For large fires, wear appropriate heat and flame resistant personal protective equipment and a NIOSH/MSHA approved positive pressure, self contained breathing apparatus. * 6 Accidental Release Measures · Safe work practices: If material is released or spilled, minimize exposure by using appropriate personal protective equipment as listed in section 8. If possible, stop leak. Keep unprotected persons away. · Measures for environmental protection: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil. · Measures for cleaning / collecting: Absorb with liquid-binding materials such as sand, diatomite, acid binders, or sawdust. Wash spill area with appropriate cleaning materials. Dispose of spilled and contaminated material in accordance with Federal, State and Local regulations. 7 Handling and Storage · Information for safe handling: Avoid direct contact with material and wash after handling. Practice general safety precautions. · Information about protection against explosions and fires: No special measures required. · Requirements to be met by storerooms and receptacles: Refer to the package insert or product label for additional information on storage conditions. · Information about storage in one common storage facility: Store in original packaging. · Further information about storage conditions: Protect from heat and direct sunlight. * 8 Exposure Controls and Personal Protection · Components with Occupational Exposure Limits 26628-22-8 sodium azide (0.10%) REL STEL/C: C 0.3** mg/m³, C 0.1* ppm *as HN3 vapor; **as NaN3 TLV STEL/C: C 0.29** mg/m³, C 0.11* ppm *as HN3 vapor; **as NaN3 · General protective and hygienic measures: Always maintain good housekeeping. Do not eat, drink or store food and beverages in areas where chemicals are used. Wash hands before breaks and at the end of the workshift. · Breathing equipment: Not necessary if room is well-ventilated. Use appropriate NIOSH/MSHA air purifying respirator if airborne chemical concentrations exceed the exposure limit (if any) listed above. · Hand protection: Wear impervious gloves if hand contact with the material is anticipated. · Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles. · Body protection: Wear laboratory coat or appropriate protective clothing when working with material. 9 Physical and Chemical Properties Liquid · Form: Colorless · Color: Odorless · Odor: · Boiling point/Boiling range: Not determined Not applicable · Flash point: Product is not self-igniting. · Auto igniting: Product does not present an explosion hazard. · Danger of explosion: 1.02 g/cm³ · Density at 20°C (68°F): · Solubility in / Miscibility with Fully miscible Water: 7.5 · pH-value at 20°C (68°F):
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Material Safety Data Sheet
Release date 02/20/2006 Last alteration on 02/20/2006

Product name: TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Pretreatment Solution

· Water:

87.4 %

10 Stability and Reactivity · Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications. · Dangerous reactions: Reactions with heavy metals may form explosive substances. Contact with acids may release toxic gas (i.e. hydrazoic acid HN3). · Dangerous products of decomposition: No dangerous decomposition products known. * 11 Toxicological Information · LD50/LC50 values for hazardous ingredients per OSHA criteria: · Ingredients (100% pure substance/s) 77-86-1 Tris Hydroxymethyl Aminomethane Oral LD50 590-1780 mg/kg (rat) LDLo 1000 mg/kg (rabbit) · Primary toxicological effects of the final product: · Skin irritation: No irritant effect. · Eye irritation: No irritant effect. · Sensitization: No sensitizing effects known. · Additional toxicological information: None · Target organs/systems: Kidneys 12 Ecological Information · Ecotoxicological effects: Copper Sulphate: Fish Toxicity: 140 ug/L 96 hours L50 (Mortality) Australian Redtail Rainbowfish (Melanotaenia nigrans) Invertebrate Toxicity: 17.3 ug/L 48 hours EC50 (Immobilization) Water flea (Daphnia magna) Other Toxicity: 39 ug/L 96 hours L50 (Mortality) Frog (Rana hexadactyla) · General notes: Do not allow product to reach ground water, water course, or sewage system. 13 Disposal Considerations · Recommendation for disposal of unused product: Dispose in accordance with Federal, State and Local regulations. · Recommendation for disposal of packaging: Dispose in accordance with Federal, State and Local regulations. · Recommended cleansing agent: Water, if necessary with cleansing agents. 14 Transport Information · Road: DOT class Not restricted for transportation. · Remarks: · Sea: IMDG Class No · Marine pollutant: Not restricted for transportation. · Remarks: · Air: ICAO/IATA Class Not restricted for transportation. · Remarks: * 15 National and International Regulations · SARA (Superfund Amendments and Reauthorization Act of 1986 - USA): · Section 302/304 (40CFR355.30 / 40CFR355.40): 26628-22-8 sodium azide · Section 313 (40CFR372.65): 26628-22-8 sodium azide
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Page 4/4

Material Safety Data Sheet
Release date 02/20/2006 Last alteration on 02/20/2006

Product name: TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Pretreatment Solution

· California Proposition 65 (USA): · Chemicals known to cause cancer: The product does not contain listed substances. · Chemicals known to cause reproductive toxicity: The product does not contain listed substances. · Markings according to European guidelines: The product has been classified and labeled in accordance with applicable European Community (EC) Directives. · Hazard determining substance/s of labeling: copper sulphate · Risk phrases: 52/53 Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment · Safety phrases: 35 This material and its container must be disposed of in a safe way. 61 Avoid release to the environment. Refer to special instructions/Safety data sheets 16 Other Information This information is based on our present knowledge. However, this shall not constitute a guarantee for any specific product features and shall not establish a legally valid contractual relationship. · Contact: - general information: ABBOTT Laboratories Diagnostics Division Safety, Health and Environmental Assurance Department 3A4 100 Abbott Park Road Abbott Park, IL 60064 Phone: 847-937-3386 - 24 hour EMERGENCY PHONE: 847-937-7970 · * Sections marked with an asterisk (*) have been altered since the previous version.
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Page 1/4

Material Safety Data Sheet
Release date 02/20/2006 Last alteration on 02/20/2006

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1 Identification of Substance · Product name: TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Antibody (mouse monoclonal) Solution · ADD List number: 9797S · Manufacturer / Supplier: ABBOTT Laboratories Abbott Diagnostics Division (ADD) 100 Abbott Park Road Abbott Park, IL 60064 · Department issuing MSDS: Abbott Diagnostics Division Safety, Health and Environmental Assurance 2 Composition / Information on Ingredients · Chemical characterization: Mixture of chemical and/or biological substances for diagnostic use. · Hazardous ingredients per OSHA criteria: 107-21-1 ethylene glycol

*

2.00%

*

3 Hazards Identification / Emergency Overview · Routes of Exposure: None anticipated, when used as directed. · Classification system: The classification was made according to OSHA 29 CFR 1910.1200 and 1910.1030 and applicable European Community Directives, and is expanded upon from company and/or literature data. · National Fire Protection Association (NFPA) ratings (scale 0-4) Health = 0 Fire = 0 Reactivity = 0 · Hazard Overview · Health: Minimal risk if used as directed · Fire: Noncombustible · Reactivity: Minimal Risk · Special Hazards: None · Carcinogenicity information · OSHA (Occupational Safety and Health Administration) None of the ingredients is listed. · NTP (National Toxicology Program) None of the ingredients is listed. · IARC (International Agency for Research on Cancer) None of the ingredients is listed. 4 First Aid Measures · After inhalation: Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention. · After skin contact: Wash effected area with soap and water. If irritation or signs of toxicity occur, seek medical attention. · After eye contact: Flush with copious amounts of water. If irritation or signs of toxicity occur, seek medical attention. · After swallowing: If irritation or signs of toxicity occur, seek medical attention. · Information for medical personnel: · The following symptoms may occur: Liver effects Kidney effects Headache Dizziness Disorientation Respiratory irritation · Medical conditions aggravated by exposure: Pre-existing liver condition Pre-existing renal ailments Pre-existing cardiovascular ailments Pre-existing nervous system ailments Pre-existing respiratory ailments
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Page 2/4

Material Safety Data Sheet
Release date 02/20/2006 Last alteration on 02/20/2006

Product name: TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Antibody (mouse monoclonal) Solution

Pregnancy (possible risk to the unborn child) 5 Fire Fighting Measures · Suitable extinguishing agents: Dry Chemical, CO2, water spray or regular foam. Fight larger fires with water spray, fog or regular foam. · Protective equipment: For large fires, wear appropriate heat and flame resistant personal protective equipment and a NIOSH/MSHA approved positive pressure, self contained breathing apparatus. 6 Accidental Release Measures · Safe work practices: If material is released or spilled, minimize exposure by using appropriate personal protective equipment as listed in section 8. If possible, stop leak. Keep unprotected persons away. · Measures for environmental protection: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil. · Measures for cleaning / collecting: Absorb with liquid-binding materials such as sand, diatomite, acid binders, or sawdust. Wash spill area with appropriate cleaning materials. Dispose of spilled and contaminated material in accordance with Federal, State and Local regulations. 7 Handling and Storage · Information for safe handling: Avoid direct contact with material and wash after handling. Practice general safety precautions. · Information about protection against explosions and fires: No special measures required. · Requirements to be met by storerooms and receptacles: Refer to the package insert or product label for additional information on storage conditions. · Information about storage in one common storage facility: Store in original packaging. · Further information about storage conditions: Protect from heat and direct sunlight. * 8 Exposure Controls and Personal Protection · Components with Occupational Exposure Limits 107-21-1 ethylene glycol (2.00%) TLV STEL/C: C 100 mg/m³ (H) 26628-22-8 sodium azide (0.11%) REL STEL/C: C 0.3** mg/m³, C 0.1* ppm *as HN3 vapor; **as NaN3 TLV STEL/C: C 0.29** mg/m³, C 0.11* ppm *as HN3 vapor; **as NaN3 · General protective and hygienic measures: Always maintain good housekeeping. Do not eat, drink or store food and beverages in areas where chemicals are used. Wash hands before breaks and at the end of the workshift. · Breathing equipment: Not necessary if room is well-ventilated. Use appropriate NIOSH/MSHA air purifying respirator if airborne chemical concentrations exceed the exposure limit (if any) listed above. · Hand protection: Wear impervious gloves if hand contact with the material is anticipated. · Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles. · Body protection: Wear laboratory coat or appropriate protective clothing when working with material. 9 Physical and Chemical Properties Liquid · Form: Colorless · Color: Odorless · Odor:
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Page 3/4

Material Safety Data Sheet
Release date 02/20/2006 Last alteration on 02/20/2006

Product name: TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Antibody (mouse monoclonal) Solution

· Boiling point/Boiling range: Not determined Not applicable · Flash point: Product is not self-igniting. · Auto igniting: Product does not present an explosion hazard. · Danger of explosion: Not determined · Density: · Solubility in / Miscibility with Fully miscible Water: 6.5 · pH-value at 20°C (68°F): 88.0 % · Water: 10 Stability and Reactivity · Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications. · Dangerous reactions: Reactions with heavy metals may form explosive substances. Contact with acids may release toxic gas (i.e. hydrazoic acid HN3). · Dangerous products of decomposition: No dangerous decomposition products known. * 11 Toxicological Information · LD50/LC50 values for hazardous ingredients per OSHA criteria: · Ingredients (100% pure substance/s) 107-21-1 ethylene glycol Oral LD50 1650-6610 mg/kg (mammal) LDLo 398-796 mg/kg (human) Dermal LD50 9530 mg/kg (rabbit) Mutagenicity Negative (Ames Assay) Target Organ Effects (mammal) Excessive intake of ethylene glycol may produce toxicity to the central nervous system, kidney, liver, respiratory system, and heart. In animal studies, ethylene glycol affected fertility, embryo and fetal development, and produced fetal abnormalities. Inhalation of 200 mg/m3 ethylene glycol may produce respiratory irritation and burning of the throat. Higher concentrations may produce headache, dizziness and drowsiness. · Primary toxicological effects of the final product: · Skin irritation: No irritant effect. · Eye irritation: No irritant effect. · Sensitization: No sensitizing effects known. · Target organs/systems: Reproductive system Liver Kidneys Cardiovascular system Central Nervous System Respiratory System 12 Ecological Information · General notes: Do not allow undiluted product or large quantities of it to reach ground water, water course, or sewage system. 13 Disposal Considerations · Recommendation for disposal of unused product: Dispose in accordance with Federal, State and Local regulations. · Recommendation for disposal of packaging: Dispose in accordance with Federal, State and Local regulations. · Recommended cleansing agent: Water, if necessary with cleansing agents.
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Page 4/4

Material Safety Data Sheet
Release date 02/20/2006 Last alteration on 02/20/2006

Product name: TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Antibody (mouse monoclonal) Solution

14 Transport Information · Road: DOT class Not restricted for transportation. · Remarks: · Sea: IMDG Class No · Marine pollutant: Not restricted for transportation. · Remarks: · Air: ICAO/IATA Class Not restricted for transportation. · Remarks: * 15 National and International Regulations · SARA (Superfund Amendments and Reauthorization Act of 1986 - USA): · Section 302/304 (40CFR355.30 / 40CFR355.40): 26628-22-8 sodium azide · Section 313 (40CFR372.65): 107-21-1 ethylene glycol 26628-22-8 sodium azide · California Proposition 65 (USA): · Chemicals known to cause cancer: The product does not contain listed substances. · Chemicals known to cause reproductive toxicity: The product does not contain listed substances. · Markings according to European guidelines: Observe the general safety regulations when handling chemicals. The product does not require any hazard warnings according to respective European Community (EC) Directives. 16 Other Information This information is based on our present knowledge. However, this shall not constitute a guarantee for any specific product features and shall not establish a legally valid contractual relationship. · Contact: - general information: ABBOTT Laboratories Diagnostics Division Safety, Health and Environmental Assurance Department 3A4 100 Abbott Park Road Abbott Park, IL 60064 Phone: 847-937-3386 - 24 hour EMERGENCY PHONE: 847-937-7970 · * Sections marked with an asterisk (*) have been altered since the previous version.
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Page 1/4

Material Safety Data Sheet
Release date 02/20/2006 Last alteration on 02/20/2006

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1 Identification of Substance · Product name: TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Fluorescein Tracer Solution · ADD List number: 9797T · Manufacturer / Supplier: ABBOTT Laboratories Abbott Diagnostics Division (ADD) 100 Abbott Park Road Abbott Park, IL 60064 · Department issuing MSDS: Abbott Diagnostics Division Safety, Health and Environmental Assurance 2 Composition / Information on Ingredients · Chemical characterization: Mixture of chemical and/or biological substances for diagnostic use. · Hazardous ingredients per OSHA criteria: 107-21-1 ethylene glycol 10101-89-0 trisodium phosphate, dodecahydrate

*

4.48% 1.40%

*

3 Hazards Identification / Emergency Overview · Routes of Exposure: None anticipated, when used as directed. · Classification system: The classification was made according to OSHA 29 CFR 1910.1200 and 1910.1030 and applicable European Community Directives, and is expanded upon from company and/or literature data. · National Fire Protection Association (NFPA) ratings (scale 0-4) Health = 0 Fire = 0 Reactivity = 0 · Hazard Overview · Health: Minimal risk if used as directed · Fire: Noncombustible · Reactivity: Minimal Risk · Special Hazards: None · Carcinogenicity information · OSHA (Occupational Safety and Health Administration) None of the ingredients is listed. · NTP (National Toxicology Program) None of the ingredients is listed. · IARC (International Agency for Research on Cancer) None of the ingredients is listed. 4 First Aid Measures · After inhalation: Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention. · After skin contact: Wash effected area with soap and water. If irritation or signs of toxicity occur, seek medical attention. · After eye contact: Flush with copious amounts of water. If irritation or signs of toxicity occur, seek medical attention. · After swallowing: If irritation or signs of toxicity occur, seek medical attention. · Information for medical personnel: · The following symptoms may occur: Liver effects Kidney effects Headache Dizziness Disorientation Respiratory irritation · Medical conditions aggravated by exposure: Pre-existing liver condition Pre-existing renal ailments Pre-existing cardiovascular ailments Pre-existing nervous system ailments
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Page 2/4

Material Safety Data Sheet
Release date 02/20/2006 Last alteration on 02/20/2006

Product name: TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Fluorescein Tracer Solution

Pre-existing respiratory ailments Pregnancy (possible risk to the unborn child) 5 Fire Fighting Measures · Suitable extinguishing agents: Dry Chemical, CO2, water spray or regular foam. Fight larger fires with water spray, fog or regular foam. · Protective equipment: For large fires, wear appropriate heat and flame resistant personal protective equipment and a NIOSH/MSHA approved positive pressure, self contained breathing apparatus. 6 Accidental Release Measures · Safe work practices: If material is released or spilled, minimize exposure by using appropriate personal protective equipment as listed in section 8. If possible, stop leak. Keep unprotected persons away. · Measures for environmental protection: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil. · Measures for cleaning / collecting: Absorb with liquid-binding materials such as sand, diatomite, acid binders, or sawdust. Wash spill area with appropriate cleaning materials. Dispose of spilled and contaminated material in accordance with Federal, State and Local regulations. 7 Handling and Storage · Information for safe handling: Avoid direct contact with material and wash after handling. Practice general safety precautions. · Information about protection against explosions and fires: No special measures required. · Requirements to be met by storerooms and receptacles: Refer to the package insert or product label for additional information on storage conditions. · Information about storage in one common storage facility: Store in original packaging. · Further information about storage conditions: Protect from heat and direct sunlight. * 8 Exposure Controls and Personal Protection · Components with Occupational Exposure Limits 107-21-1 ethylene glycol (4.48%) TLV STEL/C: C 100 mg/m³ (H) 67-56-1 Methanol (0.20%) PEL 260 mg/m³, 200 ppm REL STEL/C: 325 mg/m³, 250 ppm TWA: 260 mg/m³, 200 ppm Skin TLV STEL/C: 328 mg/m³, 250 ppm TWA: 262 mg/m³, 200 ppm Skin; BEI 26628-22-8 sodium azide (0.10%) REL STEL/C: C 0.3** mg/m³, C 0.1* ppm *as HN3 vapor; **as NaN3 TLV STEL/C: C 0.29** mg/m³, C 0.11* ppm *as HN3 vapor; **as NaN3 · General protective and hygienic measures: Always maintain good housekeeping. Do not eat, drink or store food and beverages in areas where chemicals are used. Wash hands before breaks and at the end of the workshift.
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Page 3/4

Material Safety Data Sheet
Release date 02/20/2006 Last alteration on 02/20/2006

Product name: TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Fluorescein Tracer Solution

· Breathing equipment: Not necessary if room is well-ventilated. Use appropriate NIOSH/MSHA air purifying respirator if airborne chemical concentrations exceed the exposure limit (if any) listed above. · Hand protection: Wear impervious gloves if hand contact with the material is anticipated. · Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles. · Body protection: Wear laboratory coat or appropriate protective clothing when working with material. * 9 Physical and Chemical Properties Liquid · Form: Colorless · Color: Odorless · Odor: · Boiling point/Boiling range: 100°C (212°F) Not applicable · Flash point: Product is not self-igniting. · Auto igniting: Product does not present an explosion hazard. · Danger of explosion: 1.00 g/cm³ · Density at 20°C (68°F): · Solubility in / Miscibility with Fully miscible Water: 7.5 · pH-value at 20°C (68°F): 92.9 % · Water: 10 Stability and Reactivity · Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications. · Dangerous reactions: Reactions with heavy metals may form explosive substances. Contact with acids may release toxic gas (i.e. hydrazoic acid HN3). · Dangerous products of decomposition: No dangerous decomposition products known. * 11 Toxicological Information · LD50/LC50 values for hazardous ingredients per OSHA criteria: · Ingredients (100% pure substance/s) 107-21-1 ethylene glycol Oral LD50 1650-6610 mg/kg (mammal) LDLo 398-796 mg/kg (human) Dermal LD50 9530 mg/kg (rabbit) Mutagenicity Negative (Ames Assay) Target Organ Effects (mammal) Excessive intake of ethylene glycol may produce toxicity to the central nervous system, kidney, liver, respiratory system, and heart. In animal studies, ethylene glycol affected fertility, embryo and fetal development, and produced fetal abnormalities. Inhalation of 200 mg/m3 ethylene glycol may produce respiratory irritation and burning of the throat. Higher concentrations may produce headache, dizziness and drowsiness. 10101-89-0 trisodium phosphate, dodecahydrate Oral LD50 7400 mg/kg (rat) Dermal LD50 7940 mg/kg (rabbit) · Primary toxicological effects of the final product: · Skin irritation: No irritant effect. · Eye irritation: No irritant effect. · Sensitization: No sensitizing effects known. · Target organs/systems: Reproductive system Liver Kidneys
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Page 4/4

Material Safety Data Sheet
Release date 02/20/2006 Last alteration on 02/20/2006

Product name: TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Fluorescein Tracer Solution

Cardiovascular system Central Nervous System Respiratory System * 12 Ecological Information · General notes: Do not allow undiluted product or large quantities of it to reach ground water, water course, or sewage system. 13 Disposal Considerations · Recommendation for disposal of unused product: Dispose in accordance with Federal, State and Local regulations. · Recommendation for disposal of packaging: Dispose in accordance with Federal, State and Local regulations. · Recommended cleansing agent: Water, if necessary with cleansing agents. 14 Transport Information · Road: DOT class Not restricted for transportation. · Remarks: · Sea: IMDG Class No · Marine pollutant: Not restricted for transportation. · Remarks: · Air: ICAO/IATA Class Not restricted for transportation. · Remarks: * 15 National and International Regulations · SARA (Superfund Amendments and Reauthorization Act of 1986 - USA): · Section 302/304 (40CFR355.30 / 40CFR355.40): 26628-22-8 sodium azide · Section 313 (40CFR372.65): 107-21-1 ethylene glycol 67-56-1 Methanol 26628-22-8 sodium azide · California Proposition 65 (USA): · Chemicals known to cause cancer: The product does not contain listed substances. · Chemicals known to cause reproductive toxicity: The product does not contain listed substances. · Markings according to European guidelines: Observe the general safety regulations when handling chemicals. The product does not require any hazard warnings according to respective European Community (EC) Directives. 16 Other Information This information is based on our present knowledge. However, this shall not constitute a guarantee for any specific product features and shall not establish a legally valid contractual relationship. · Contact: - general information: ABBOTT Laboratories Diagnostics Division Safety, Health and Environmental Assurance Department 3A4 100 Abbott Park Road Abbott Park, IL 60064 Phone: 847-937-3386 - 24 hour EMERGENCY PHONE: 847-937-7970 · * Sections marked with an asterisk (*) have been altered since the previous version.
USA

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Page 1/4

Material Safety Data Sheet
Release date 02/20/2006 Last alteration on 02/20/2006

*

1 Identification of Substance · Product name: TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Solubilization Reagent · ADD List number: 9797-30 · Manufacturer / Supplier: ABBOTT Laboratories Abbott Diagnostics Division (ADD) 100 Abbott Park Road Abbott Park, IL 60064 · Department issuing MSDS: Abbott Diagnostics Division Safety, Health and Environmental Assurance 2 Composition / Information on Ingredients · Chemical characterization: Mixture of chemical and/or biological substances for diagnostic use. · Hazardous ingredients per OSHA criteria: 8047-15-2 Saponin (from Qillaja Bark) 9016-45-9 polyoxyethylene ether

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2.00% 2.00%

*

3 Hazards Identification / Emergency Overview · Routes of Exposure: None anticipated, when used as directed. · Classification system: The classification was made according to OSHA 29 CFR 1910.1200 and 1910.1030 and applicable European Community Directives, and is expanded upon from company and/or literature data. · National Fire Protection Association (NFPA) ratings (scale 0-4) Health = 0 Fire = 0 Reactivity = 0 · Hazard Overview · Health: Minimal risk if used as directed · Fire: Noncombustible · Reactivity: Minimal Risk · Special Hazards: None · Carcinogenicity information · OSHA (Occupational Safety and Health Administration) None of the ingredients is listed. · NTP (National Toxicology Program) None of the ingredients is listed. · IARC (International Agency for Research on Cancer) None of the ingredients is listed. 4 First Aid Measures · After inhalation: Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention. · After skin contact: Wash effected area with soap and water. If irritation or signs of toxicity occur, seek medical attention. · After eye contact: Flush with copious amounts of water. If irritation or signs of toxicity occur, seek medical attention. · After swallowing: If irritation or signs of toxicity occur, seek medical attention. · Information for medical personnel: · The following symptoms may occur: Respiratory irritation · Medical conditions aggravated by exposure: Pre-existing hematopoietic ailments Pre-existing cardiovascular ailments Pre-existing respiratory ailments Pre-existing skin ailments Pre-existing eye ailments 5 Fire Fighting Measures · Suitable extinguishing agents: Dry Chemical, CO2, water spray or regular foam. Fight larger fires with water spray, fog or regular foam.
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Page 2/4

Material Safety Data Sheet
Release date 02/20/2006 Last alteration on 02/20/2006

Product name: TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Solubilization Reagent

· Protective equipment: For large fires, wear appropriate heat and flame resistant personal protective equipment and a NIOSH/MSHA approved positive pressure, self contained breathing apparatus. 6 Accidental Release Measures · Safe work practices: If material is released or spilled, minimize exposure by using appropriate personal protective equipment as listed in section 8. If possible, stop leak. Keep unprotected persons away. · Measures for environmental protection: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil. · Measures for cleaning / collecting: Absorb with liquid-binding materials such as sand, diatomite, acid binders, or sawdust. Wash spill area with appropriate cleaning materials. Dispose of spilled and contaminated material in accordance with Federal, State and Local regulations. 7 Handling and Storage · Information for safe handling: Avoid direct contact with material and wash after handling. Practice general safety precautions. · Information about protection against explosions and fires: No special measures required. · Requirements to be met by storerooms and receptacles: Refer to the package insert or product label for additional information on storage conditions. · Information about storage in one common storage facility: Store in original packaging. · Further information about storage conditions: Protect from heat and direct sunlight. * 8 Exposure Controls and Personal Protection · Components with Occupational Exposure Limits 26628-22-8 sodium azide (0.10%) REL STEL/C: C 0.3** mg/m³, C 0.1* ppm *as HN3 vapor; **as NaN3 TLV STEL/C: C 0.29** mg/m³, C 0.11* ppm *as HN3 vapor; **as NaN3 · General protective and hygienic measures: Always maintain good housekeeping. Do not eat, drink or store food and beverages in areas where chemicals are used. Wash hands before breaks and at the end of the workshift. · Breathing equipment: Not necessary if room is well-ventilated. Use appropriate NIOSH/MSHA air purifying respirator if airborne chemical concentrations exceed the exposure limit (if any) listed above. · Hand protection: Wear impervious gloves if hand contact with the material is anticipated. · Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles. · Body protection: Wear laboratory coat or appropriate protective clothing when working with material. 9 Physical and Chemical Properties Liquid · Form: Colorless · Color: Odorless · Odor: · Boiling point/Boiling range: 100°C (212°F) Not applicable · Flash point: Product is not self-igniting. · Auto igniting: Product does not present an explosion hazard. · Danger of explosion: Not determined · Density: · Solubility in / Miscibility with Fully miscible Water: 6.4 · pH-value at 20°C (68°F):
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Material Safety Data Sheet
Release date 02/20/2006 Last alteration on 02/20/2006

Product name: TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Solubilization Reagent

· Water:

95.9 %

10 Stability and Reactivity · Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications. · Dangerous reactions: Reactions with heavy metals may form explosive substances. Contact with acids may release toxic gas (i.e. hydrazoic acid HN3). · Dangerous products of decomposition: No dangerous decomposition products known. * 11 Toxicological Information · LD50/LC50 values for hazardous ingredients per OSHA criteria: · Ingredients (100% pure substance/s) 8047-15-2 Saponin (from Qillaja Bark) Oral LD50 3000 mg/kg (mouse) LDLo Dermal LD50 900 mg/kg (mouse) Subcutaneous, LDLo. Glycosides are powerful hemolytics when injected into the bloodstream, causing destruction of red blood cells. Target Organ Effects (mammal) Causes severe destruction to tissues of the mucous membranes and upper respiratory tract. Symptoms include a burning sensation, coughing, wheezing, laryngitis, shortness of breath, headache, nausea and vomiting. Severe cases may be fatal as a result of spasms, inflammation and edema of the larynx and bronchi, chemical pneumonitis and pulmonary edema. (Source: Occupational Health Service (OHS)). 9016-45-9 polyoxyethylene ether Oral LD50 50.000 mg/kg (mouse) 2590 mg/kg (rat) Dermal LD50 2830 mg/kg (rbt) Target Organ Effects 1000 mg/kg/day (dog) In repeat dose studies in dogs, oral dosages of 1000 mg/kg produced cardiac effects, nausea, and vomiting. · Primary toxicological effects of the final product: · Skin irritation: No irritant effect. · Eye irritation: No irritant effect. · Sensitization: No sensitizing effects known. · Target organs/systems: Skin Respiratory tract Hematopoietic system Cardiovascular system Eye 12 Ecological Information · General notes: Do not allow undiluted product or large quantities of it to reach ground water, water course, or sewage system. 13 Disposal Considerations · Recommendation for disposal of unused product: Dispose in accordance with Federal, State and Local regulations. · Recommendation for disposal of packaging: Dispose in accordance with Federal, State and Local regulations. · Recommended cleansing agent: Water, if necessary with cleansing agents.
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Material Safety Data Sheet
Release date 02/20/2006 Last alteration on 02/20/2006

Product name: TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Solubilization Reagent

14 Transport Information · Road: DOT class Not restricted for transportation. · Remarks: · Sea: IMDG Class No · Marine pollutant: Not restricted for transportation. · Remarks: · Air: ICAO/IATA Class Not restricted for transportation. · Remarks: * 15 National and International Regulations · SARA (Superfund Amendments and Reauthorization Act of 1986 - USA): · Section 302/304 (40CFR355.30 / 40CFR355.40): 26628-22-8 sodium azide · Section 313 (40CFR372.65): 26628-22-8 sodium azide · California Proposition 65 (USA): · Chemicals known to cause cancer: The product does not contain listed substances. · Chemicals known to cause reproductive toxicity: The product does not contain listed substances. · Markings according to European guidelines: Observe the general safety regulations when handling chemicals. The product does not require any hazard warnings according to respective European Community (EC) Directives. 16 Other Information This information is based on our present knowledge. However, this shall not constitute a guarantee for any specific product features and shall not establish a legally valid contractual relationship. · Contact: - general information: ABBOTT Laboratories Diagnostics Division Safety, Health and Environmental Assurance Department 3A4 100 Abbott Park Road Abbott Park, IL 60064 Phone: 847-937-3386 - 24 hour EMERGENCY PHONE: 847-937-7970 · * Sections marked with an asterisk (*) have been altered since the previous version.
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Material Safety Data Sheet
Release date 02/20/2006 Last alteration on 02/20/2006

*

1 Identification of Substance · Product name: X-SYSTEMS Cyclosporine Monoclonal Whole Blood Precipitation Reagent / Probe Wash · ADD List number: 9797-32, 9797-33 · Manufacturer / Supplier: ABBOTT Laboratories Abbott Diagnostics Division (ADD) 100 Abbott Park Road Abbott Park, IL 60064 · Department issuing MSDS: Abbott Diagnostics Division Safety, Health and Environmental Assurance 2 Composition / Information on Ingredients · Chemical characterization: Mixture of chemical and/or biological substances for diagnostic use. · Hazardous ingredients per OSHA criteria: 67-56-1 Methanol 107-21-1 ethylene glycol 7446-20-0 zinc sulfate heptahydrate

*

42.70% 34.70% 1.80%

*

3 Hazards Identification / Emergency Overview · Emergency Overview May cause blindness. Highly toxic by dermal absorption. Highly toxic by inhalation. Toxic by ingestion. Flammable. Combustible. · Routes of Exposure: Inhalation · Classification system: The classification was made according to OSHA 29 CFR 1910.1200 and 1910.1030 and applicable European Community Directives, and is expanded upon from company and/or literature data. Testing has been done to determine the hazards of this material. · National Fire Protection Association (NFPA) ratings (scale 0-4) Health = 3 Fire = 3 Reactivity = 0 · Hazard Overview · Health: Highly toxic by inhalation Highly toxic by dermal route Toxic by ingestion May cause blindness. · Fire: Flammable Combustible · Reactivity: Minimal Risk · Special Hazards: See section 11 for details. · Carcinogenicity information · OSHA (Occupational Safety and Health Administration) None of the ingredients is listed. · NTP (National Toxicology Program) None of the ingredients is listed. · IARC (International Agency for Research on Cancer) None of the ingredients is listed. 4 First Aid Measures · General information: Immediately remove any clothing soiled by the product.
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Material Safety Data Sheet
Release date 02/20/2006 Last alteration on 02/20/2006

Product name: X-SYSTEMS Cyclosporine Monoclonal Whole Blood Precipitation Reagent / Probe Wash

Remove breathing apparatus only after contaminated clothing have been completely removed. In case of irregular breathing or respiratory arrest provide artificial respiration. · After inhalation: Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention. · After skin contact: Wash effected area with soap and water. If irritation or signs of toxicity occur, seek medical attention. · After eye contact: Flush with copious amounts of water. If irritation or signs of toxicity occur, seek medical attention. · After swallowing: If irritation or signs of toxicity occur, seek medical attention. · Information for medical personnel: · The following symptoms may occur: Liver effects Kidney effects Cramps Gastric or intestinal disorders Nausea Headache Dizziness Disorientation Respiratory irritation · Medical conditions aggravated by exposure: Pre-existing liver condition Pre-existing renal ailments Pre-existing gastrointestinal tract ailments Pre-existing pancreas ailments Pre-existing nervous system ailments Pre-existing cardiovascular ailments Pre-existing respiratory ailments Pre-existing skin ailments Pregnancy (possible risk to the unborn child) * 5 Fire Fighting Measures · Suitable extinguishing agents: Dry Chemical, CO2, water spray or alcohol resistant foam. Fight larger fires with water spray or alcohol resistant foam. · Protective equipment: For large fires, wear appropriate heat and flame resistant personal protective equipment and a NIOSH/MSHA approved positive pressure, self contained breathing apparatus. 6 Accidental Release Measures · Safe work practices: If material is released or spilled, minimize exposure by using appropriate personal protective equipment as listed in section 8. If possible, stop leak. Keep unprotected persons away. · Measures for environmental protection: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil. · Measures for cleaning / collecting: Absorb with liquid-binding materials such as sand, diatomite, acid binders, or sawdust. Ensure adequate ventilation. Wash spill area with appropriate cleaning materials. Dispose of spilled and contaminated material in accordance with Federal, State and Local regulations. 7 Handling and Storage · Information for safe handling: Keep containers tightly sealed. Ensure good ventilation in the workplace. · Information about protection against explosions and fires: Keep ignition sources away - Do not smoke.
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Material Safety Data Sheet
Release date 02/20/2006 Last alteration on 02/20/2006

Product name: X-SYSTEMS Cyclosporine Monoclonal Whole Blood Precipitation Reagent / Probe Wash

Protect against electrostatic charges. Keep respiratory protective device available. · Requirements to be met by storerooms and receptacles: Refer to the package insert or product label for additional information on storage conditions. · Information about storage in one common storage facility: Store in original packaging. · Further information about storage conditions: Keep containers tightly sealed. Protect from heat and direct sunlight. * 8 Exposure Controls and Personal Protection · Components with Occupational Exposure Limits 67-56-1 Methanol (42.70%) PEL 260 mg/m³, 200 ppm REL STEL/C: 325 mg/m³, 250 ppm TWA: 260 mg/m³, 200 ppm Skin TLV STEL/C: 328 mg/m³, 250 ppm TWA: 262 mg/m³, 200 ppm Skin; BEI 107-21-1 ethylene glycol (34.70%) TLV STEL/C: C 100 mg/m³ (H) · General protective and hygienic measures: Store protective clothing separately. Avoid contact with the skin. Always maintain good housekeeping. Do not eat, drink or store food and beverages in areas where chemicals are used. Wash hands before breaks and at the end of the workshift. · Breathing equipment: Not necessary if room is well-ventilated. Use appropriate NIOSH/MSHA air purifying respirator if airborne chemical concentrations exceed the exposure limit (if any) listed above. · Hand protection: Wear impervious gloves if hand contact with the material is anticipated. · Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles. · Body protection: Wear laboratory coat or appropriate protective clothing when working with material. 9 Physical and Chemical Properties Liquid · Form: Colorless · Color: Alcohol-like · Odor: · Boiling point/Boiling range: 64°C (147°F) 23°C (73°F) · Flash point: Product is not self-igniting. · Auto igniting: Product is not explosive. However, formation of explosive air/vapor mixtures are possible. · Danger of explosion: Not determined · Density: · Solubility in / Miscibility with Fully miscible Water: 5.6 · pH-value at 20°C (68°F): 20.8 % · Water: 10 Stability and Reactivity · Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications. · Dangerous reactions: Reacts with acids, alkalis and oxidizing agents.
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Material Safety Data Sheet
Release date 02/20/2006 Last alteration on 02/20/2006

Product name: X-SYSTEMS Cyclosporine Monoclonal Whole Blood Precipitation Reagent / Probe Wash

· Dangerous products of decomposition: No dangerous decomposition products known. * 11 Toxicological Information · LD50/LC50 values for hazardous ingredients per OSHA criteria: · Ingredients (100% pure substance/s) 67-56-1 Methanol Oral LD50 5000 - 7300 mg/kg (mammal) Dermal LD50 15800 mg/kg (rabbit) Inhalation LC50 4 h 64000 ppm (rat) 107-21-1 ethylene glycol Oral LD50 1650-6610 mg/kg (mammal) LDLo 398-796 mg/kg (human) Dermal LD50 9530 mg/kg (rabbit) Mutagenicity Negative (Ames Assay) Target Organ Effects (mammal) Excessive intake of ethylene glycol may produce toxicity to the central nervous system, kidney, liver, respiratory system, and heart. In animal studies, ethylene glycol affected fertility, embryo and fetal development, and produced fetal abnormalities. Inhalation of 200 mg/m3 ethylene glycol may produce respiratory irritation and burning of the throat. Higher concentrations may produce headache, dizziness and drowsiness. 7446-20-0 zinc sulfate heptahydrate Oral LD50 57-2949 mg/kg (mammal) in analogy to zinc sulfate Mutagenicity Negative (Ames Assay) In analogy to zinc sulfate: negative in Ames assay. Target Organ Effects (human) In analogy to zinc sulfate: Inhalation of zinc sulfate may produce irritation of the respiratory tract with sore throat, coughing, shortness of breath, pulmonary edema and may be corrosive to the mucous membranes. Excessive intake of zinc sulfate may produce gastrointestinal, liver, kidney, hematopoietic and central nervous system toxicity. · Primary toxicological effects of the final product: · Skin irritation: No irritant effect. · Eye irritation: No irritant effect. · Sensitization: No sensitizing effects known. · Additional toxicological information: Poisonous · Target organs/systems: Reproductive system Liver Kidneys Gastrointestinal tract Pancreas Nervous system Cardiovascular system Central Nervous System Respiratory System 12 Ecological Information · General notes: Do not allow product to reach ground water, water course, or sewage system. 13 Disposal Considerations · Recommendation for disposal of unused product: Dispose in accordance with Federal, State and Local regulations. · Recommendation for disposal of packaging: Dispose in accordance with Federal, State and Local regulations.
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Material Safety Data Sheet
Release date 02/20/2006 Last alteration on 02/20/2006

Product name: X-SYSTEMS Cyclosporine Monoclonal Whole Blood Precipitation Reagent / Probe Wash

· Recommended cleansing agent: Water, if necessary with cleansing agents. * 14 Transport Information 3 · Road: DOT class · Identification number: UN1993 III · Packing group: · Proper shipping name: FLAMMABLE LIQUID, N.O.S. (METHANOL) · Danger code (Kemler): 30 3 · Sea: IMDG Class 3 1993 · UN Number: III · Packing group: No · Marine pollutant: · Proper shipping name: FLAMMABLE LIQUID, N.O.S. (METHANOL) · Air: ICAO/IATA Class 3 1993 · UN Number: III · Packing group: · Proper shipping name: FLAMMABLE LIQUID, N.O.S. (METHANOL) 15 National and International Regulations · SARA (Superfund Amendments and Reauthorization Act of 1986 - USA): · Section 302/304 (40CFR355.30 / 40CFR355.40): The product does not contain listed substances. · Section 313 (40CFR372.65): 67-56-1 Methanol 107-21-1 ethylene glycol · California Proposition 65 (USA): · Chemicals known to cause cancer: The product does not contain listed substances. · Chemicals known to cause reproductive toxicity: The product does not contain listed substances. · Markings according to European guidelines: The product has been classified and labeled in accordance with applicable European Community (EC) Directives. · Hazard designation of product: T Toxic · Hazard determining substance/s of labeling: Methanol ethylene glycol · Risk phrases: 10 Flammable. 23/24/25 Toxic by inhalation, in contact with skin and if swallowed. 39/23/24/25 Toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed. 52/53 Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment · Safety phrases: 7/9 Keep container tightly closed and in a well-ventilated place. 16 Keep away from sources of ignition - No smoking. 35 This material and its container must be disposed of in a safe way. 36/37/39 Wear suitable protective clothing, gloves and eye/face protection. 45 In case of accident or if you feel unwell, seek medical advice immediately. 61 Avoid release to the environment. Refer to special instructions/Safety data sheets 16 Other Information This information is based on our present knowledge. However, this shall not constitute a guarantee for any specific product features and shall not establish a legally valid contractual relationship.
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Material Safety Data Sheet
Release date 02/20/2006 Last alteration on 02/20/2006

Product name: X-SYSTEMS Cyclosporine Monoclonal Whole Blood Precipitation Reagent / Probe Wash

· Contact: - general information: ABBOTT Laboratories Diagnostics Division Safety, Health and Environmental Assurance Department 3A4 100 Abbott Park Road Abbott Park, IL 60064 Phone: 847-937-3386 - 24 hour EMERGENCY PHONE: 847-937-7970 · * Sections marked with an asterisk (*) have been altered since the previous version.
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