1. Identification of the substance / preparation and of the company

Transcription

1 1. Identification of the substance / preparation and of the company 1.1 Product identifiers Product name: Catalogue number: AbCross HLA Control Kit component: PC-I (positive control HLA class I) (kit) AbCross HLA ELISA is an Enzyme Linked Immuno Sorbent Assay (ELISA) for the detection of donor anti-hla class I/II IgG antibodies and consists of three kits. AbCross HLA Plate Catalogue number: AbCross HLA Reagent Catalogue number: AbCross HLA Control Catalogue number: Relevant identified uses of the substance or mixture and uses advised against Identified uses: in-vitro diagnostic medical device AbCross HLA ELISA can be used for detection of donor-specific IgG antibodies (AB) directly against HLA class I and class II antigens, respectively. AbCross HLA ELISA based on solid phase ELISA techniques offer a sensitive method for anti- HLA antibodies detection allowing the recognition of donor-recipient combinations with elevated antibody-based risk for kidney graft rejection. In addition the test can be helpful to appraise the risk of a graft rejection after transplantation of other organs. 1.3 Details of the supplier of the safety data sheet Microcoat Biotechnologie GmbH Am Neuland Bernried, Germany Telephone +49(0) Fax +49(0) (competent person) m.walter@microcoat.de 1.4 Emergency telephone number Emergency Phone: +49(0) (8.00 am pm) 2. Hazards identification 2.1 Classification of the substance or mixture Not a hazardous substance or mixture according to Regulation (EC) No. 1272/ Label elements Not a hazardous substance or mixture according to Regulation (EC) No. 1272/ Other hazards This mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vpvb) at levels of 0.1 % or higher. 3. Composition / information on ingredients 3.1 Substances The product is a mixture Page 1(7)

2 3.2 Mixtures No components need to be disclosed according to the applicable regulations. Hazard ingredients according to Regulation (EC) No 1272/2008 Ingredient Classification Concentration Labeling required Mixture of 5-Chloro-2-methyl- - <0.1 % (w/v) no 4-isothiazolin-3-one and 2- Methyl-2H-isothiazol-3-one (3:1) CAS-No.: EC-No.: - Index No.: Ammonium 8-anilinonaphtalene-1-sulphonate - <0.1 % (w/v) no CAS-No.: EC-No.: Phenoxymethylpenicillin acid - <0.1 % (w/v) no potassium salt CAS-No.: EC-No.: Streptomycin sulphate CAS-No.: EC-No.: <0.1 % (w/v) no 4. FIRST AID MEASURES 4.1 Description of first aid measures General advice Consult a physician. Remove contaminated clothing and shoes immediately. Show this material safety data sheet to the doctor in attendance. After inhalation If breathed in, move affected person into fresh air. If not breathing, give artificial respiration. After skin contact Wash off immediately with soap and plenty of water. After eye contact Separate eyelids and wash the eyes thoroughly with water (at least 15 minutes). Consult a physician. After ingestion Never give anything by mouth to an unconscious person. Rinse mouth with water. Consult a physician. 4.2 Most important symptoms and effects, both acute and delayed The most important known symptoms and effects are described in the labelling (see section 2.2) and/or in section Indication of any immediate medical attention and special treatment needed 5. FIREFIGHTING MEASURES 5.1 Suitable extinguishing media Product itself is non-combustible. Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide Page 2(7)

3 5.2 Special exposure hazards arising from the substance or mixture Nature of decomposition products is not known. 5.3 Special protective equipment for fire fighting Use self-contained breathing apparatus. Wear protective clothing. 6. ACCIDENTAL RELEASE MEASURES 6.1 Personal precautions, protective equipment and emergency procedures Use personal protective equipment. Ensure adequate ventilation. Evacuate personnel to safe areas. Refer to protective measures listed in sections 7 and Environmental precautions No special environmental precautions required. 6.3 Methods and materials for containment and cleaning up Keep in suitable, closed containers for disposal. 6.4 Reference to other sections For disposal see section HANDLING AND STORAGE 7.1 Precautions for safe handling Follow the specific instructions in the package insert of AbCross HLA ELISA Kit. Avoid contact with skin and eyes. Avoid inhalation of vapour or mist. 7.2 Conditions for safe storage, including any incompatibilities Recommend storage temperature 2-8 C. Keep container tightly closed in a dry and wellventilated place. Containers which are opened must be carefully resealed and kept upright to prevent leakage. 7.3 Specific end use(s) A part from the uses mentioned in section 1.1 and 1.2 no other specific uses are stipulated. 8. EXPOSURE CONTROLS/PERSONAL PROTECTION 8.1 Control parameters Components with workplace control parameters Not applicable 8.2 Exposure controls Appropriate engineering controls Follow standard laboratory practice. Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday. Personal protective equipment Eye/face protection Tightly fitting safety goggles. Face shield (8-inch minimum). Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166 (EU) Page 3(7)

4 Skin protection Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique (without touching glove's outer surface) to avoid skin contact with this product. Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. Wash and dry hands. The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 derived from it. Full contact / Splash contact Material: Nitrile rubber Minimum layer thickness: 0.11 mm Break through time: 480 min Body protection Complete suit protection against chemicals, the type of protective equipment must be selected according to the concentrations and amount of the dangerous substance at the specific workplace. Respiratory protection Where risk assessment shows air-purifying respirators are appropriate use a full-face respirator with multi-purpose combination (US) or type ABEK (EN 14387) respirator cartridges as a backup to engineering controls. If the respirator is the sole means of protection, use a full-face supplied air respirator. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU). Control of environmental exposure No special environmental precautions required. 9. PHYSICAL AND CHEMICAL PROPERTIES 9.1 Information on basic physical and chemical properties (AbCross HLA ELISA PC-I) Appearance Form: clear, liquid, Colour: yellowish Odour Odour Threshold ph at 25 C Melting point/freezing point Initial boiling point and boiling range Flash point Evaporation rate Flammability (solid, gas) Upper/lower flammability or explosive limits Vapour pressure Vapour density Relative density Water solubility completely miscible Partition coefficient: n-octanol/water Auto-ignition temperature Decomposition temperature Viscosity Explosive properties Oxidizing properties 9.2 Other safety information Page 4(7)

5 10. STABILITY AND REACTIVITY 10.1 Reactivity 10.2 Chemical stability Stable under recommended storage conditions Possibility of hazardous reactions 10.4 Conditions to avoid 10.5 Incompatible materials Strong oxidizing agents 10.6 Hazardous decomposition products In the event of fire: see section TOXICOLOGICAL INFORMATION 11.1 Information on toxicological effects Acute toxicity Skin corrosion/irritation Serious eye damage/eye irritation Respiratory or skin sensitization Germ cell mutagenicity Carcinogenicity IARC: No component of this product present at levels greater than or equal to 0.1 % is identified as probable, possible or confirmed human carcinogen by IARC. Reproductive toxicity Specific target organ toxicity - single exposure Specific target organ toxicity - repeated exposure Aspiration hazard Additional Information To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated Page 5(7)

6 12. ECOLOGICAL INFORMATION 12.1 Toxicity 12.2 Persistence and degradability 12.3 Bioaccumulative potential 12.4 Mobility in soil 12.5 Results of PBT and vpvb assessment PBT/vPvB assessment not available as chemical safety assessment not required/not conducted Other adverse effects 13. DISPOSAL CONSIDERATIONS 13.1 Waste treatment methods Product Waste disposal must be in accordance with appropriate Federal, State and local regulations. Contaminated packaging Empty and dispose according to appropriate Federal, State and local regulations. 14. TRANSPORT INFORMATION 14.1 UN number ADR/RID: - IMDG: - IATA: UN proper shipping name ADR/RID: Not dangerous goods IMDG: Not dangerous goods IATA: Not dangerous goods 14.3 Transport hazard class(es) ADR/RID: - IMDG: - IATA: Packaging group ADR/RID: - IMDG: - IATA: Environmental hazards ADR/RID: no IMDG Marine pollutant: no IATA: no 14.6 Special precautions for user Page 6(7)

7 15. REGULATORY INFORMATION This material safety datasheet complies with the requirements of Regulation (EC) No. 1907/ Safety, health and environmental regulations specific for the substance or mixture 15.2 Chemical Safety Assessment For this product a chemical safety assessment was not carried out. 16. OTHER INFORMATION Warranty The information above is believed to be accurate and represents the best information currently available to us. However, we make no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assume no liability resulting from its use. Users should make their own investigations to determine the suitability of the information for their particular purposes. In no event shall Microcoat be liable for any claims, losses, or damages of any third party or for lost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if Microcoat has been advised of the possibility of such damages. Copyright 2016 Microcoat Biotechnologie GmbH. Disclaimer The above information is correct to the best of our knowledge. The information supplied by Microcoat Biotechnologie GmbH 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. It is the user's responsibility to satisfy himself as to the suitability and completeness of such information for his own particular use Page 7(7)