Material Cat.-No. Assay Name RE11061 Total Intact PTH IRMA RE11081 ACTH IRMA RE13031 Calcitonin IRMA Contains MSDS for following single components with dangerous ingredients: Standards and Controls 125 I-Tracer Wash Buffer Concentrate (30x) Not listed single components contains no hazardous substances in concentrations to be declared, a labelling is not required. I B L I N T E R N A T I O N A L G M B H Flughafenstrasse 52a Phone: +49 (0)40-53 28 91-0 IBL@IBL-International.com D-22335 Hamburg, Germany Fax: +49 (0)40-53 28 91-11 www.ibl-international.com
Page 1/4 * 1 Identification of substance: Product details: Trade name: IRMA Standards and Controls Article number: RE11061 RE11081 RE13031 Application of the substance / the preparation: laboratory reagent The product is intended for professional use. Manufacturer/Supplier: IBL International GmbH Tel.: ++49-40-53 28 91-0 Flughafenstr. 52 a Fax.: ++49-40-53 28 91-11 D-22335 Hamburg E-Mail: IBL@IBL-International.com http: //www.ibl-international.com Further information obtainable from: Safety Representative Information in case of emergency: ++49-40-53 28 91-0 * 2 Hazards identification Hazard description: not applicable Information concerning to particular hazards to man and environment The product does not have to be labelled due to the calculation procedure of the "General Classification guideline for preparations of the EU" in the latest valid version. No special remarkable hazards. Please observe the informations given in this safety data sheet. Classification system The classification is according to the latest editions of the EU-lists, and extended by company and literature data. GHS label elements Void * 3 Composition/information on ingredients Chemical characterization Preparation Mixture of substances listed below with nonhazardous additions. Description: Lyophilized powder Dangerous components: 26628-22-8 sodium azide T+, N; R 28-32-50/53 < 0,1% Danger: 3.1.O/2 Warning: 4.1.C/1 Additional information The reagents can contain material of human origin which has been tested and confirmed negative for HBsAg and antibodies directed against HIV. Since no test method offers complete assurance that infectious agents are absent, these reagents should be treated as potentially infectious. The data and advices relate to the concentrations not of the lyophilized powder, but of the prepared solution. For the wording of the listed risk phrases refer to section 16. 4 First aid measures General information No special measures required. After inhalation Supply fresh air; consult doctor in case of complaints. After skin contact Generally the product does not irritate the skin. After eye contact Rinse opened eye for several minutes under running water. (Contd. on page 2)
Page 2/4 Trade name: IRMA Standards and Controls After swallowing If symptoms persist consult doctor. (Contd. of page 1) 5 Fire fighting measures Suitable extinguishing agents CO2, powder or water spray. Fight larger fires with water spray or alcohol resistant foam. Protective equipment: No special measures required. 6 Accidental release measures Person-related safety precautions: Not required. Measures for environmental protection: No special measures required. Measures for cleaning/collecting: Absorb with liquid-binding material. Additional information: No dangerous substances are released. 7 Handling and storage Handling Information for safe handling: No special measures required. Information about fire - and explosion protection: No special measures required. Storage Requirements to be met by storerooms and receptacles: No special requirements. Information about storage in one common storage facility: Not required. Further information about storage conditions: None. * 8 Exposure controls and personal protection gear Additional information about design of technical facilities: No further data; see item 7. Ingredients with limit values that require monitoring at the workplace: The product does not contain any relevant quantities of materials with critical values that have to be monitored at the workplace. Additional information: The lists valid during the making were used as basis. Personal protective equipment General protective and hygienic measures The usual precautionary measures are to be adhered to when handling chemicals. Respiratory protection: Not required. Protection of hands: Protective gloves. Material of gloves The quality of the protective gloves must be chosen as a function of the specific working place concentration and quantity of hazardous substances. The glove material has to be impermeable and resistant to the product/ the substance/ the preparation. Eye protection: Goggles recommended during refilling. Body protection: lab coat * 9 Physical and chemical properties: General Information Form: Powder liquid (Contd. on page 3)
Page 3/4 Trade name: IRMA Standards and Controls Colour: Odour: colorless Odourless Change in condition Melting point/melting range: undetermined Boiling point/boiling range: undetermined Flash point: Not applicable Self-igniting: Product is not selfigniting. Danger of explosion: Product does not present an explosion hazard. Density: Not determined Solubility in / Miscibility with Water: Solvent content: Organic solvents: 0 % Fully miscible (Contd. of page 2) 10 Stability and reactivity Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications. Dangerous reactions No dangerous reactions known Dangerous decomposition products: No dangerous decomposition products known 11 Toxicological information Acute toxicity: Primary irritant effect: on the skin: No irritant effect. on the eye: No irritant effect. Sensitization: No sensitizing effects known. Additional toxicological information: The product is not subject to classification according to the calculation method of the General EU Classification Guidelines for Preparations as issued in the latest version. When used and handled according to specifications, the product does not have any harmful effects to our experience and the information provided to us. 13 Disposal considerations Product: Recommendation Dispose of waste according to applicable local, state, and federal regulations. Uncleaned packaging: Recommendation: Dispose of packaging according to applicable local, state, and federal regulations. Completely emptied packages can be recycled. (Contd. on page 4)
Page 4/4 Trade name: IRMA Standards and Controls (Contd. of page 3) 14 Transport information Land transport A/RID (cross-border) Inland shipping ADN: Maritime transport IMDG: Marine pollutant: No Air transport ICAO-TI and IATA-DGR: Transport/Additional information: Not dangerous according to the above specifications. This product is part of a kit. Information in this section refers to the kit as a whole. * 15 Regulations Labelling according to EU guidelines: Observe the general safety regulations when handling chemicals The product is not subject to identification regulations under EU Directives and the Ordinance on Hazardous Materials (German GefStoffV). 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. Relevant R-phrases 28 Very toxic if swallowed. 32 Contact with acids liberates very toxic gas. 50/53 Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. Department issuing MSDS: Safety Representative Contact: IBL International Abbreviations and acronyms: A: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the International Carriage of Dangerous Goods by Road) RID: Règlement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations Concerning the International Transport of Dangerous Goods by Rail) IMDG: International Maritime Code for Dangerous Goods IATA: International Air Transport Association IATA-DGR: Dangerous Goods Regulations by the "International Air Transport Association" (IATA) ICAO: International Civil Aviation Organization ICAO-TI: Technical Instructions by the "International Civil Aviation Organization" (ICAO) GHS: Globally Harmonized System of Classification and Labelling of Chemicals * Data compared to the previous version altered.
Page 1/5 * 1 Identification of substance: Product details: Trade name: IRMA Tracer Article number: RE11061 RE11081 RE13031 Application of the substance / the preparation: laboratory reagent The product is intended for professional use. Manufacturer/Supplier: IBL International GmbH Tel.: ++49-40-53 28 91-0 Flughafenstr. 52 a Fax.: ++49-40-53 28 91-11 D-22335 Hamburg E-Mail: IBL@IBL-International.com http: //www.ibl-international.com Further information obtainable from: Safety Representative Information in case of emergency: ++49-40-53 28 91-0 * 2 Hazards identification Hazard description: not applicable Information concerning to particular hazards to man and environment The product does not have to be labelled due to the calculation procedure of the "General Classification guideline for preparations of the EU" in the latest valid version. radioactive Material No special remarkable hazards. Please observe the informations given in this safety data sheet. Classification system The classification is according to the latest editions of the EU-lists, and extended by company and literature data. GHS label elements Void * 3 Composition/information on ingredients Chemical characterization Preparation Mixture of substances listed below with nonhazardous additions. Description: Tracer contains sodium azide Dangerous components: 125-Iodine Radionuclide Activity: < 370 kbq 26628-22-8 sodium azide T+, N; R 28-32-50/53 < 0,1% Danger: 3.1.O/2 Warning: 4.1.C/1 Additional information The regulation (EC) No. 1907/2006 does not cover radioaktive material. Its receipt,acquisition, possession use and/or transfer are subject to the regulations and a specific license issued by the Nuclear Regulatory Comission or issued by a state with wich the Nuclear Regulatory Comission has entered into an agreement for the exercise of regulatory authority. For the wording of the listed risk phrases refer to section 16. 4 First aid measures General information No special measures required. (Contd. on page 2)
Page 2/5 Trade name: IRMA Tracer After inhalation Call a doctor immediately. After skin contact Immediately wash with water and soap and rinse thoroughly. After eye contact Rinse opened eye for several minutes under running water. After swallowing Do not induce vomiting; call for medical help immediately. (Contd. of page 1) 5 Fire fighting measures Suitable extinguishing agents CO2, powder or water spray. Fight larger fires with water spray or alcohol resistant foam. Protective equipment: No special measures required. 6 Accidental release measures Person-related safety precautions: Not required. Measures for environmental protection: No special measures required. Measures for cleaning/collecting: Absorb with liquid-binding material. Dispose contaminated material as waste according to item 13. Additional information: No dangerous substances are released. 7 Handling and storage Handling Information for safe handling: No special precautions are necessary if used correctly. Information about fire - and explosion protection: No special measures required. Storage Requirements to be met by storerooms and receptacles: Store in separated, identified rooms. Information about storage in one common storage facility: Not required. Further information about storage conditions: None. * 8 Exposure controls and personal protection gear Additional information about design of technical facilities: No further data; see item 7. Ingredients with limit values that require monitoring at the workplace: This product contains radioactive material. Additional information: The lists valid during the making were used as basis. Personal protective equipment General protective and hygienic measures The usual precautionary measures are to be adhered to when handling chemicals and radioactive material. Respiratory protection: Not required. Protection of hands: Protective gloves. Material of gloves The quality of the protective gloves must be chosen as a function of the specific working place concentration and quantity of hazardous substances. The glove material has to be impermeable and resistant to the product/ the substance/ the preparation. Eye protection: Goggles recommended during refilling. Body protection: lab coat (Contd. on page 3)
Page 3/5 Trade name: IRMA Tracer (Contd. of page 2) 9 Physical and chemical properties: General Information Form: Colour: Odour: liquid colorless Odourless Change in condition Melting point/melting range: undetermined Boiling point/boiling range: undetermined Flash point: Not applicable Self-igniting: Product is not selfigniting. Danger of explosion: Product does not present an explosion hazard. Density: Not determined Solubility in / Miscibility with Water: Solvent content: Organic solvents: 0 % Fully miscible 10 Stability and reactivity Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications. Dangerous reactions No dangerous reactions known Dangerous decomposition products: No dangerous decomposition products known 11 Toxicological information Acute toxicity: Primary irritant effect: on the skin: No irritant effect. on the eye: No irritant effect. Sensitization: No sensitizing effects known. Additional toxicological information: The product is not subject to classification according to the calculation method of the General EU Classification Guidelines for Preparations as issued in the latest version. When used and handled according to specifications, the product does not have any harmful effects to our experience and the information provided to us. * 12 Ecological information: General notes: Do not allow product to reach ground water, water course or sewage system. * 13 Disposal considerations Product: Recommendation Must be specially treated adhering to official regulations. (Contd. on page 4)
Page 4/5 Trade name: IRMA Tracer Uncleaned packaging: Recommendation: Packagings that may not be cleansed are to be disposed of in the same manner as the product. Dispose of packaging according to applicable local, state, and federal regulations. (Contd. of page 3) 14 Transport information Land transport A/RID (cross-border) A/RID class: - 7.1 Radioactive material. Inland shipping ADN: Maritime transport IMDG: IMDG Class: - Marine pollutant: No Air transport ICAO-TI and IATA-DGR: ICAO/IATA Class: - UN "Model Regulation": - Transport/Additional information: Not dangerous according to the above specifications. This product is part of a kit. Information in this section refers to the kit as a whole. * 15 Regulations Labelling according to EU guidelines: Observe the general safety regulations when handling chemicals The product is not subject to identification regulations under EU Directives and the Ordinance on Hazardous Materials (German GefStoffV). National regulations Waterhazard class: Generally not hazardous for water. 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. Relevant R-phrases 28 Very toxic if swallowed. 32 Contact with acids liberates very toxic gas. 50/53 Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. Department issuing MSDS: Safety Representative Contact: IBL International Abbreviations and acronyms: A: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the International Carriage of Dangerous Goods by Road) (Contd. on page 5)
Page 5/5 Trade name: IRMA Tracer (Contd. of page 4) RID: Règlement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations Concerning the International Transport of Dangerous Goods by Rail) IMDG: International Maritime Code for Dangerous Goods IATA: International Air Transport Association IATA-DGR: Dangerous Goods Regulations by the "International Air Transport Association" (IATA) ICAO: International Civil Aviation Organization ICAO-TI: Technical Instructions by the "International Civil Aviation Organization" (ICAO) GHS: Globally Harmonized System of Classification and Labelling of Chemicals * Data compared to the previous version altered.
Page 1/5 * 1 Identification of substance: Product details: Trade name: IRMA Wash Buffer, Conc. Article number: RE11061 RE11081 RE13031 Application of the substance / the preparation: laboratory reagent The product is intended for professional use. Manufacturer/Supplier: IBL International GmbH Tel.: ++49-40-53 28 91-0 Flughafenstr. 52 a Fax.: ++49-40-53 28 91-11 D-22335 Hamburg E-Mail: IBL@IBL-International.com http: //www.ibl-international.com Further information obtainable from: Safety Representative Information in case of emergency: ++49-40-53 28 91-0 * 2 Hazards identification Hazard description: T Toxic Information concerning to particular hazards to man and environment The product has to be labelled due to the calculation procedure of the "General Classification guideline for preparations of the EU" in the latest valid version. R 25 Toxic if swallowed. R 52/53 Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment. Classification system The classification is according to the latest editions of the EU-lists, and extended by company and literature data. GHS label elements Danger 3.1/3 - Toxic if swallowed. 4.1/3 - Harmful to aquatic life with long lasting effects. Prevention: Wash thoroughly after handling. Do no eat, drink or smoke when using this product. Avoid release to the environment. Response: IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician. Specific treatment (see on this label). Rinse mouth. Storage: Store locked up. Disposal: Dispose of contents/container in accordance with local/regional/national/international regulations. (Contd. on page 2)
Page 2/5 Trade name: IRMA Wash Buffer, Conc. (Contd. of page 1) * 3 Composition/information on ingredients Chemical characterization Preparation Description: Mixture consisting of the following components. Dangerous components: 26628-22-8 sodium azide T+, N; R 28-32-50/53 Danger: 3.1.O/2 Warning: 4.1.C/1 Additional information For the wording of the listed risk phrases refer to section 16. 1,0-2,0% 4 First aid measures General information Immediately remove any clothing soiled by the product. In case of irregular breathing or respiratory arrest provide artificial respiration. After inhalation In case of unconsciousness place patient stably in side position for transportation. After skin contact Immediately wash with water and soap and rinse thoroughly. After eye contact Rinse opened eye for several minutes under running water. After swallowing Do not induce vomiting; call for medical help immediately. 5 Fire fighting measures Suitable extinguishing agents CO2, powder or water spray. Fight larger fires with water spray or alcohol resistant foam. Protective equipment: No special measures required. * 6 Accidental release measures Person-related safety precautions: Not required. Measures for environmental protection: Inform respective authorities in case of seepage into water course or sewage system. Dilute with plenty of water. Do not allow to enter sewers/ surface or ground water. Measures for cleaning/collecting: Absorb with liquid-binding material. Dispose contaminated material as waste according to item 13. Ensure adequate ventilation. * 7 Handling and storage Handling Information for safe handling: Ensure good ventilation/exhaustion at the workplace. Prevent formation of aerosols. Information about fire - and explosion protection: No special measures required. Storage Requirements to be met by storerooms and receptacles: No special requirements. Information about storage in one common storage facility: Not required. (Contd. on page 3)
Page 3/5 Trade name: IRMA Wash Buffer, Conc. Further information about storage conditions: None. (Contd. of page 2) * 8 Exposure controls and personal protection gear Additional information about design of technical facilities: No further data; see item 7. Ingredients with limit values that require monitoring at the workplace: 26628-22-8 sodium azide IOELV (European Union) Short-term value: 0,3 mg/m³ Long-term value: 0,1 mg/m³ Skin Additional information: The lists valid during the making were used as basis. Personal protective equipment General protective and hygienic measures Immediately remove all soiled and contaminated clothing Wash hands before breaks and at the end of work. Respiratory protection: In case of brief exposure or low pollution use respiratory filter device. In case of intensive or longer exposure use self-contained respiratory protective device. Protection of hands: Protective gloves. Material of gloves The quality of the protective gloves must be chosen as a function of the specific working place concentration and quantity of hazardous substances. The glove material has to be impermeable and resistant to the product/ the substance/ the preparation. Eye protection: Goggles recommended during refilling. Body protection: lab coat 9 Physical and chemical properties: General Information Form: Colour: Odour: liquid colorless Odourless Change in condition Melting point/melting range: undetermined Boiling point/boiling range: undetermined Flash point: Not applicable Self-igniting: Product is not selfigniting. Danger of explosion: Product does not present an explosion hazard. Density: Not determined Solubility in / Miscibility with Water: Solvent content: Organic solvents: 0 % Fully miscible 10 Stability and reactivity Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications. (Contd. on page 4)
Page 4/5 Trade name: IRMA Wash Buffer, Conc. Dangerous reactions No dangerous reactions known Dangerous decomposition products: No dangerous decomposition products known (Contd. of page 3) 11 Toxicological information Acute toxicity: Primary irritant effect: on the skin: No irritant effect. on the eye: No irritant effect. Sensitization: No sensitizing effects known. Additional toxicological information: The product shows the following dangers according to the calculation method of the General EU Classification Guidelines for Preparations as issued in the latest version. Toxic * 12 Ecological information: Ecotoxical effects: Remark: Harmful to fish General notes: Water hazard class 1 (German Regulation) (Self-assessment): slightly hazardous for water. Do not allow undiluted product or large quantities of it to reach ground water, water course or sewage system. Harmful to aquatic organisms * 13 Disposal considerations Product: Recommendation Dispose of waste according to applicable local, state, and federal regulations. Uncleaned packaging: Recommendation: Dispose of packaging according to applicable local, state, and federal regulations. Completely emptied packages can be recycled. Recommended cleansing agents: Water, if necessary together with cleansing agents. 14 Transport information Land transport A/RID (cross-border) Inland shipping ADN: Maritime transport IMDG: Marine pollutant: No Air transport ICAO-TI and IATA-DGR: Transport/Additional information: Not dangerous according to the above specifications. (Contd. on page 5)
Page 5/5 Trade name: IRMA Wash Buffer, Conc. This product is part of a kit. Information in this section refers to the kit as a whole. (Contd. of page 4) 15 Regulations Labelling according to EU guidelines: The product has been classified and marked in accordance with EU Directives / Ordinance on Hazardous Materials Code letter and hazard designation of product: T Toxic Hazard-determining components of labelling: sodium azide Risk phrases: 25 Toxic if swallowed. 52/53 Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment. Safety phrases: 20 When using do not eat or drink. 23 Do not breathe gas/fumes/vapour/spray (appropriate wording to be specified by the manufacturer). 36/39 Wear suitable protective clothing and eye/face protection. 45 In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible). 61 Avoid release to the environment. Refer to special instructions/safety data sheets. National regulations Waterhazard class: Water hazard class 1 (Self-assessment): slightly hazardous for water. 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. Relevant R-phrases 28 Very toxic if swallowed. 32 Contact with acids liberates very toxic gas. 50/53 Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. Department issuing MSDS: Safety Representative Contact: IBL International Abbreviations and acronyms: A: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the International Carriage of Dangerous Goods by Road) RID: Règlement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations Concerning the International Transport of Dangerous Goods by Rail) IMDG: International Maritime Code for Dangerous Goods IATA: International Air Transport Association IATA-DGR: Dangerous Goods Regulations by the "International Air Transport Association" (IATA) ICAO: International Civil Aviation Organization ICAO-TI: Technical Instructions by the "International Civil Aviation Organization" (ICAO) GHS: Globally Harmonized System of Classification and Labelling of Chemicals * Data compared to the previous version altered.