Safety Data Sheet. Eco Jet 2 Disinfectant for instruments. Safety Data Sheet dated 12/01/2005, version 0

Transcription

1 Safety Data Sheet Eco Jet 2 Disinfectanf for instruments Safety Data Sheet dated 12/01/2005, version 0 1. IDENTIFICATION OF THE AND OF THE COMPANY Trade name: Eco Jet 2 Disinfectant for instruments Trade code: ( Cattani code) Product type and use: Disinfectant detergent for surgical instruments Company: MAGNOLIA SRL Via Natta 6/A PARMA ITALY Tel Fax Emergency telephone number of the company and/or of an authorised advisory centre: Phone n.: COMPOSITION/INFORMATION ON INGREDIENTS Hazardous components within the meaning of EEC directive 67/548 and corresponding classification: 15% - 20% orthophtalaldehyde CAS: EINECS: T R25 R37/38 R41 R % - 15% alkyl polyglycosides Xi R % - 15% ethanol N.67/548/CEE: CAS: EINECS: % - 10% propan-2-ol N.67/548/CEE: CAS: EINECS: F Xi R11 R36 R67 3. HAZARDS IDENTIFICATION The product is harmful following acute exposure to it and poses a serious health threat if ingested. If brought into contact with the eyes, the product causes serious eye injury, such as opacity of the cornea or lesions to the iris. If brought into contact with the skin, the product may cause sensitisation of the skin. 4. FIRST AID MEASURES Contact with skin: Immediately take off all contaminated clothing. Areas of the body that have - or are only even suspected of having - come into contact with the product must be rinsed immediately with plenty of running water and possibly with soap. Contact with eyes: Wash immediately and thoroughly with running water, keeping eyelids raised, for at least 10 minutes. Following this, protect the eyes with sterile gauze or a clean, dry, handkerchief. OBTAIN A MEDICAL EXAMINATION. Do not use eyewash or ointment of any kind (before obtaining an examination or advice from an eye specialist). Swallowing: Do not under any circumstances induce vomiting. OBTAIN A MEDICAL EXAMINATION IMMEDIATELY. A suspension of activated charcoal in water, or liquid paraffin may be administered. Inhalation: Ventilate the premises. The patient is to be removed immediately from the contaminated premises and made to rest in a well ventilated area. Should the patient feel unwell, OBTAIN MEDICAL ATTENTION. 5. FIRE-FIGHTING MEASURES Recommended extinguishers: Water, CO2, Foam, Chemical powders, according to the materials involved in the fire. Extinguishers not to be used: None in particular. Risks arising from combustion: Avoid inhaling the fumes. Protective equipment: Use protection for the respiratory tract. 6. ACCIDENTAL RELEASE MEASURES Measures for personal safety: Use a mask, gloves and protective clothing. Environmental measures: /1 Page n. 1 of 3

2 Safety Data Sheet Eco Jet 2 Disinfectanf for instruments Limit leakages with earth or sand. If the product has escaped into a water course, into the drainage system, or has contaminated the ground or vegetation, notify the competent authorities. Cleaning methods: Rapidly recover the product. To do so, wear a mask and protective clothing. If the product is in a liquid form, stop it from entering the drainage system. Recover the product for re-use if possible, or for elimination. The product might, where appropriate, be absorbed by inert material. After the product has been recovered, rinse the area and materials involved with water. 7. HANDLING AND STORAGE Handling precautions: Avoid contact and inhalation of the vapours. See, too, paragraph 8 below. Do not eat or drink while working. Incompatible materials: None in particular. Storage conditions: Always keep the containers tightly closed. Instructions as regards storage premises: Adequately ventilated premises. 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Precautionary measures: Give adequate ventilation to the premises where the product is stored and/or handled. Respiratory protection: Not needed for normal use. Protection for hands: Use protective gloves that provides comprehensive protection, e.g. P.V.C., neoprene or rubber. Eye protection: Use close fitting safety goggles and/or visor conforming to BS 2092 GRADE 1). Protection for skin: Use clothing that provides comprehensive protection to the skin, e.g. cotton, rubber, PVC or viton. Exposure limit(s) (ACGIH): ethanol TLV TWA: 1000 ppm, A mg/m3, A4 propan-2-ol TLV TWA: 400 ppm mg/m3 TLV STEL: 500 ppm mg/m3 9. PHYSICAL AND CHEMICAL PROPERTIES Appearance and colour: Yellowish liquid Odour: aldehydic ph: 5-8 Flash point: 38 C Relative density: 1,048 approx. Solubility in water: total 10. STABILITY AND REACTIVITY Conditions to avoid: Stable under normal conditions. Substances to avoid: None in particular. Hazardous decomposition products: It may generate flammable gases on contact with dithiocarbamates, elementary metals (alkalis, alkaline earth), and nitrides. It may generate toxic gases on contact with dithiocarbamates. It may catch fire on contact with oxidising mineral acids, elementary metals (alkalis and alkaline earth), nitrides, powerful oxidising agents, and powerful reducing agents. 11. TOXICOLOGICAL INFORMATION The concentration of each substance should be borne in mind in assessing the toxicological effects deriving from the preparation. Set out below is the toxicological information relating to the main substances in the preparation. ethanol LD50 (RABBIT) ORAL: 6300 MG/KG LD50 (RAT) ORAL SINGLE DOSE: 7060 MG/KG 12. ECOLOGICAL INFORMATION Adopt good working practices, so that the product is not released into the environment /1 Page n. 2 of 3

3 Safety Data Sheet Eco Jet 2 Disinfectanf for instruments 13. DISPOSAL CONSIDERATIONS Recover, if possible. Send to authorised disposal plants or for incineration under controlled conditions. In so doing, comply with the local and national regulations currently in force. 14. TRANSPORT INFORMATION ADR-UNo number 1987 ADR-Class: 3 Code: F1 Packing group: III Label: REGULATORY INFORMATION 88/379/EEC (Classification and Labelling): Symbols: Xn Harmful R Phrases: R41 Risk of serious damage to eyes. R22 Harmful if swallowed. R43 May cause sensitization by skin contact. S Phrases: S26 In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S24 Avoid contact with skin. S37/39 Wear suitable gloves and eye/face protection. S7 Keep container tightly closed. Contents: Ortho-phthalaldeyde. Where applicable, refer to the following regulatory provisions : Directive 82/501/EEC ('Activities linked to risks of serious accidents') and subsequent amendments. 16. OTHER INFORMATION Text of R phrases referred to under heading 2: R25 Toxic if swallowed. R37/38 Irritating to respiratory system and skin. R41 Risk of serious damage to eyes. R43 May cause sensitization by skin contact. R36 Irritating to eyes. R11 Highly flammable. R67 Vapours may cause drowsiness and dizziness. Main bibliographic sources: ECDIN - Environmental Chemicals Data and Information Network - Joint Research Centre, Commission of the European Communities SAX's DANGEROUS PROPERTIES OF INDUSTRIAL MATERIALS - Eight Edition - Van Nostrand Reinold ACGIH - Treshold Limit Values edition The information contained herein is based on our state of knowledge at the above-specified date. It refers solely to the product indicated and constitutes no guarantee of particular quality. It is the duty of the user to ensure that this information is appropriate and complete with respect to the specific use intended. This MSDS cancels and replaces any preceding release /1 Page n. 3 of 3

4 MAGNOLIA SRL date 03/03/2010 PAGE 1 of 3 ECO-JET 2 INTENDED USE STANDARDS AND REGULATIONS APPLICABLE TO THE OFFICIAL CE EFFECTIVENESS TESTS CHEMICAL COMPOSITION HIGH-LEVEL DISINFECTANT DETERGENT FOR INSTRUMENTS HIGH-LEVEL DISINFECTANT DETERGENT FOR THE INITIAL DECONTAMINATION OF SURGICAL INSTRUMENTS BEFORE THE STERILIZATION CYCLE REG. CE 1272/2008 DANG. PROD. LABEL REG. 93/42/CE UNI CEI EN ISO 14971:2009 RISKS MANAG. GOV. DECREE 81/2008 HEALTH PROTECTION UNI EN ISO 13485:2004 MED. DEV. REQUIREMENT REG. 93/42/CE STANDARD UNI EN 13727: : BACTERICIDAL EFFECTIVENESS STANDARD UNI EN 13624: :2006 -FUNGICIDAL EFFECTIVENESS BIOLAB TEST REPORT AM 928 DTD BIOLAB TEST REPORT AM 1170 DTD STANDARD UNI EN 14476:2007 VIRUCIDAL EFFECTIVENESS BIOLAB TEST REPORT AM DTD STANDARD UNI EN 14348:2005 pren 14563:2002 TUBERCULICIDE EFFECTIVENESS BIOLAB TEST REPORT AM DTD BIOLAB TEST REPORT AM 1359 DTD % ORTHO-PHTHALALDEHYDE 0.9% NON-IONIC TENSIDE 12.5% ETHANOL 7.5% ISOPROPANOL 12.5% ALKYL POLYGLYCOSIDE CHEMICAL- PHYSICAL CHARACTERISTICS PERFORMANCES INSTRUCTION FOR USE SHELF LIFE STORAGE CONDITIONS FLAMMABILITY PH (as it is) 5-8 DENSITY AT + 20 C (g/cm 3 ) ± ASPECT AND COLOUR ODOUR LIGHT YELLOW TYPICAL phenolic REFRACTION INDEX (R.I.) ± SOLUBILITY IN WATER Complete EFFECTIVE AGAINST : - BACTERIA (STAPHYLOCOCCUS AUREUS, PSEUDOMONAS AERUGINOSA, ENTEROCOCCUS HIRAE) - FUNGI (CANDIDA ALBICANS, ASPERGILLUS NIGER) - VIRUSES (POLIOVIRUS TYPE 1, ADENOVIRUS TYPE 5) - MYCOBACTERIA (MYCOBACTERIUM TERRAE) SOLUBILIZED AT 3% IN WATER IS READY FOR USE (DIP OF USED INSTRUMENTS) 2 YEARS FROM PREPARATION (IN ORIGINAL CONTAINER ) AVOID DIRECT SUNLIGHT; KEEP AT TEMPERATURE < 40 C 38 C (FLAMMABLE ONLY FOR TRANSPORT)

5 MAGNOLIA SRL date 03/03/2010 PAGE 2 of 3 DANGER WARNING DANGER LABELLING BIODEGRADABILITY OF COMPONENTS UNIT CONTAINER MULTI-UNIT CONTAINER Xn R41 R22 R43 S 24 S26 S37/39 S7 ALL THE COMPONENTS ARE CLASSIFIED AS EASILY DEGRADABLE APART FROM: ORTHO-PHTHALALDEHYDE OF WHICH DATA ARE NOT AVAILABLE AT THE TIME BEING (IT IS NOT CLASSIFIED AS DANGEROUS FOR THE ENVIRONMENT = R50/53) ML HDPE PLASTIVALLE BOTTLE AS PER T.D.S WHITE (OUR CODE ) Pack characteristics CAP + 10 ML DISPENSER C457/C458 ZELLER PLASTIK ITALIA SRL ITEM 3.K555.99BA (OUR CODE ) Dimensions (mm) 95 X 60,5 X 251 H Weight (empty bottle) (g) 65 ± 1 Weight (cap dispenser) (g) 14 ± 1 Weight (content+bottle) (g) MINIMUM 1120 Label PE, WORK-AND-TURN PRINTING CORRUGATED QUADRICOLOUR PRINTED Pack characteristics CARTON (OUR CODE ) Dimensions(carton)(mm) 205 X 125 X 275 H (CONT. 4 BOTTLES) Content NO ML BOTTLES Weight (kg) 4,926

6 MAGNOLIA SRL date 03/03/2010 PAGE 3 of 3 PALLETTIZZATION LAYOUT (for EUROPALLET : of 128 CARTONS / no. 4 LAYERS / HEIGHT 160 CM) 1 st 3 rd Layer ( 32 cartons) 2 nd 4 th Layer ( 32 cartons)

7 MAGNOLIA SRL date 03/03/2010 PAGE 4 of 3 ATTACHEMENT A Label for 1 l. bottle DETERGENT-DISINFECTANT FOR INSTRUMENTS