: perform sterile cleaner ND

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1 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1 identifier Trade name : 1.2 Relevant identified uses of the substance or mixture and uses advised against Use of the Substance/Mixture : Cleaning agent Recommended restrictions on use : Restricted to professional users. 1.3 Details of the supplier of the safety data sheet Producer/Supplier : Schülke & Mayr GmbH Robert-Koch-Str Norderstedt Germany Telephone: Telefax: mail@schuelke.com Contact person : Application Department HI +49 (0)40/ ADHI@schuelke.com (Schülke & Mayr UK Ltd.: ) 1.4 Emergency telephone number Emergency telephone number Emergency telephone number : UK Poisons Emergency number: : +49 (0)40 / SECTION 2: Hazards identification 2.1 Classification of the substance or mixture Classification (REGULATION (EC) No 1272/2008) Eye irritation, Category 2 H319: Causes serious eye irritation. 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) Hazard pictograms : Z11820 ZSDB_P_ALL EN Page 1/9

2 Signal word : Warning Hazard statements : H319 Causes serious eye irritation. Precautionary statements : P280 Wear protective gloves/ eye protection. P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Special labelling of certain mixtures 2.3 Other hazards : Labelling according to Regulation (EC) No. 648/2004: (< 5 % non-ionic surfactants,) This mixture contains no substance considered to be persistent, bioaccumulating and toxic (PBT). No special risks known. SECTION 3: Composition/information on ingredients 3.2 Mixtures Chemical nature : Aqueous solution Hazardous components Chemical Name Tridecylpolyethylenglycolether Index-Number CAS-No. EC-No. Registration number Polymer Classification (67/548/EEC) Xn; R22 Xi; R41 Classification (REGULATION (EC) No 1272/2008) Acute Tox. 4; H302 Eye Dam. 1; H318 Concentration (%) < 5 % For explanation of abbreviations see section 16. SECTION 4: First aid measures 4.1 Description of first aid measures In case of skin contact In case of eye contact If swallowed : Wash with water and soap as a precaution. If symptoms persist, call a physician. : In the case of contact with eyes, rinse immediately with plenty of water and seek medical advice. If eye irritation persists, consult a specialist. : Do NOT induce vomiting. Rinse mouth with water. Drink water as a precaution. Consult a physician if necessary. 4.2 Most important symptoms and effects, both acute and delayed Symptoms : Treat symptomatically. 4.3 Indication of any immediate medical attention and special treatment needed Treatment : For specialist advice physicians should contact the Poisons Information Service. Z11820 ZSDB_P_ALL EN Page 2/9

3 SECTION 5: Firefighting measures 5.1 Extinguishing media Suitable extinguishing media Unsuitable extinguishing media : Dry powder, Foam, Water spray jet, Carbon dioxide (CO2) : High volume water jet 5.2 Special hazards arising from the substance or mixture Specific hazards during firefighting : No information available. Specific risk from the substance or the product itself, its combustion products or evolved gases : No special risks to be expected. 5.3 Advice for firefighters Special protective equipment for firefighters : In the event of fire, wear self-contained breathing apparatus. SECTION 6: Accidental release measures 6.1 Personal precautions, protective equipment and emergency procedures Personal precautions : No special precautions required. 6.2 Environmental precautions Environmental precautions : Do not flush into surface water or sanitary sewer system. 6.3 Methods and material for containment and cleaning up Methods for cleaning up 6.4 Reference to other sections see Section : Wipe up with absorbent material (e.g. cloth, fleece). Soak up with inert absorbent material (e.g. sand, silica gel, acid binder, universal binder, sawdust). SECTION 7: Handling and storage 7.1 Precautions for safe handling Advice on safe handling Advice on protection against fire and explosion Hygiene measures : not required under normal use : No special protective measures against fire required. : Keep away from food and drink. Z11820 ZSDB_P_ALL EN Page 3/9

4 7.2 Conditions for safe storage, including any incompatibilities Requirements for storage areas and containers Further information on storage conditions : Store at room temperature in the original container. : Keep away from heat. Keep away from direct sunlight. Keep container tightly closed. Advice on common storage : No materials to be especially mentioned. 7.3 Specific end use(s) Specific use(s) : none SECTION 8: Exposure controls/personal protection 8.1 Control parameters none 8.2 Exposure controls Personal protective equipment Eye protection : If splashes are likely to occur, wear: Safety glasses with side-shields conforming to EN166 Hand protection Protective measures : Splash protection: disposable nitrile rubber gloves e.g. Dermatril (layer thickness: 0,11 mm) made by KCL or gloves from other manufacturers offering the same protection. Prolonged contact: Nitrile rubber gloves e.g. Camatril (>480 Min., layer thickness: 0,40 mm) or butyl rubber gloves e.g. Butoject (>480 Min., layer thickness: 0,70 mm) made by KCL or gloves from other manufacturers offering the same protection. : Avoid contact with eyes. Environmental exposure controls General advice : Do not flush into surface water or sanitary sewer system. SECTION 9: Physical and chemical properties 9.1 Information on basic physical and chemical properties Appearance : liquid Colour : colourless Odour : characteristic Odour Threshold : not determined Flash point : Not applicable Auto-ignition temperature : Not applicable Lower explosion limit : Not applicable Upper explosion limit : Not applicable Flammability : does not ignite Explosive properties : Not explosive Oxidizing properties : Not applicable ph : ca. 5,8, 20 C, concentrate Melting point/freezing point : ca. 0 C Z11820 ZSDB_P_ALL EN Page 4/9

5 Decomposition temperature No data available Boiling point/boiling range : ca. 100 C, Vapour pressure : not determined, Relative vapour density : No data available Density : ca. 1,00 g/cm3, 20 C Water solubility : > 100 g/l, 20 C Partition coefficient: n- : Not applicable octanol/water Viscosity, dynamic : not determined Evaporation rate : No data available 9.2 Other information No data available SECTION 10: Stability and reactivity 10.1 Reactivity No dangerous reaction known under conditions of normal use Chemical stability The product is chemically stable Possibility of hazardous reactions None reasonably foreseeable Conditions to avoid Extremes of temperature and direct sunlight Incompatible materials None reasonably foreseeable Hazardous decomposition products None reasonably foreseeable. SECTION 11: Toxicological information 11.1 Information on toxicological effects Acute toxicity Acute oral toxicity Acute dermal toxicity Acute inhalation toxicity : No data available Skin corrosion/irritation Z11820 ZSDB_P_ALL EN Page 5/9 : Acute toxicity estimate: > mg/kg, Estimation of acute oral toxicity, in accordance with the calculation methode presented in the GHS (Globally Harmonized System), Part 3, Chapter 3.1) : Acute toxicity estimate: > mg/kg, in accordance with the calculation methode presented in the GHS (Globally Harmonized System), Part 3, Chapter 3.1)

6 No skin irritation, Rabbit, OECD Test Guideline 404 Serious eye damage/eye irritation Causes serious eye irritation., Calculation method Respiratory or skin sensitisation Did not cause sensitisation on laboratory animals. Maximisation Test (GPMT), Guinea pig Germ cell mutagenicity Genotoxicity in vitro : Not mutagenic in Ames Test Germ cell mutagenicity- Assessment : Not mutagenic in Ames Test Carcinogenicity Carcinogenicity - Assessment : Based on available data, the classification criteria are not met. Reproductive toxicity Effects on fertility : Two-generation study, Rat, NOAEL: > 250 mg/kg, F1: > 250 mg/kg, F2: > 250 mg/kg Effects on foetal development Rat, Dermal, NOAEL: > 250 mg/kg, NOAEL: 250 mg/kg : Rat, Oral, NOAEL: > 50 mg/kg, NOAEL: 50 mg/kg Reproductive toxicity - Assessment : Based on available data, the classification criteria are not met. Teratogenicity - Assessment : Based on available data, the classification criteria are not met. STOT - single exposure The substance or mixture is not classified as specific target organ toxicant, single exposure. STOT - repeated exposure The substance or mixture is not classified as specific target organ toxicant, repeated exposure. Aspiration toxicity No data available Further information Z11820 ZSDB_P_ALL EN Page 6/9

7 The product has not been tested. SECTION 12: Ecological information 12.1 Toxicity Toxicity to fish Toxicity to daphnia and other aquatic invertebrates Toxicity to algae 12.2 Persistence and degradability : LC50 (Cyprinus carpio (Carp)): 1-10 mg/l, 96 h, OECD Test Guideline 203 : EC50 (Daphnia magna): 1-10 mg/l, 48 h, OECD Test Guideline 202 : EC50 (Desmodesmus subspicatus (green algae)): 1-10 mg/l, 72 h, OECD Test Guideline 201 Biodegradability : Readily biodegradable OECD 301D / EEC 84/449 C6 Biodegradability : Readily biodegradable OECD 301B/ ISO 9439/ EEC 84/449 C Bioaccumulative potential Partition coefficient: n- : Not applicable octanol/water Bioaccumulation : Bioaccumulation is unlikely Mobility in soil Mobility : The product evaporates slowly. Adsorbs on soil Results of PBT and vpvb assessment This mixture contains no substance considered to be persistent, bioaccumulating and toxic (PBT) Other adverse effects Additional ecological information : none SECTION 13: Disposal considerations 13.1 Waste treatment methods : Dispose of the product according to the defined EWC (European Waste Code) No. Contaminated packaging Z11820 ZSDB_P_ALL EN Page 7/9 : Take empty packaging to the recycling plant.

8 Waste key for the unused product Waste key for the unused product(group) : European waste catalog (EWC) : Waste material of HZVA from fats, lubricants, soaps, detergents, disinfectants and personal protection products. SECTION 14: Transport information 14.1 UN number 14.2 UN proper shipping name 14.3 Transport hazard class(es) 14.4 Packing group 14.5 Environmental hazards 14.6 Special precautions for user For personal protection see section Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code Not applicable for product as supplied. SECTION 15: Regulatory information 15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture Legislation on the control of major-accident hazards involving dangerous substances : Directive 96/82/EC does not apply Volatile organic compounds Other regulations : none, Directive 2010/75/EU on the limitation of emissions of volatile organic compounds : The surfactant(s) contained in this mixture complies(comply) with the biodegradability criteria as laid down in Regulation (EC) No.648/2004 on detergents. Data to support this assertion are held at the disposal of the competent authorities of the Member States and will be made available to them, at their direct request or at the request of a detergent manufacturer Chemical Safety Assessment Exempt Z11820 ZSDB_P_ALL EN Page 8/9

9 SECTION 16: Other information Full text of R-Phrases R22 R41 Full text of H-Statements H302 H318 : Harmful if swallowed. : Risk of serious damage to eyes. : Harmful if swallowed. : Causes serious eye damage. Full text of other abbreviations Acute Tox. Eye Dam. Further information Acute toxicity Serious eye damage Changes compared with the previous edition!!! 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. Z11820 ZSDB_P_ALL EN Page 9/9