REF : 95801 MATERIAL SAFETY DATA SHEET According to Regulation (EC) N° 1907/2006 Annexe II (18/12/2006) 1- Identification of the preparation and of company undertaking Product Name: Lipase Calibrator.
REF : 95801: R1: 1 X 3 mL R2: 1 X 5 mL
For the calibration of assays using BIOLABO LIPASE Reagent REF 99881; REF 99891
Company/Undertaking identification and emergency phone number:
Manufacturer:
F-02160 MAIZY (FRANCE) ORFILA Phone: (33) (0) 145 42 59 59 Headquarter: 02220 PAARS (FRANCE)
WEB : http://www.biolabo.fre-mail: [email protected]2- Composition and Information on Ingredients See § 16 to know the signification of security and risk symbols. Vial Preparation Hazardous ingredients Concentration N° Einecs N° cas/ Carn
NOTE - Lipase - Enzyme source: Human pancreas, Enzyme Commission number: 3.1.1.3 (*) None present above minimum guidelines set out in the European Directive No 1999/45/CE dated 31st May 1999.
REF : 95801 3- Hazards Identification
Emergency Overview: The chemical, physical and toxicological properties of this preparation, pertaining directly to occupational exposures, have not been thoroughly characterized. Precautionary Statements: May be irritating to eyes, respiratory system and skin. Avoid contact with eyes and skin. Do not ingest or inhale. The bovine serum albumin (BSA) in this product is of US origin. The BSA was obtained from a supplier who holds a Certificate of Origin, Certificate of Analysis, and/or an EDQM Certificate of Suitability documenting the evaluation of reduction of TSE (Transmissible Spongiform Encephalopathy) risk. The lipase in this preparation is derived from human pancreas. The donors have been tested by FDA-approved methods and found to be negative for the presence of hepatitis B virus surface antigen (HBsAg), human immunodeficiency virus (HIV) 1 & 2 and hepatitis C virus (HCV). However, because no test method can provide complete assurance that infectious agents are absent, this product should be handled as a potentially biohazardous material in accordance with universal/standard precautions. Preparation appearance: white powder. Routes of Exposure: Typical occupational exposure routes are inhalation, eye and skin contact. Potential Health Effects: Inhalation Inhalation may be irritating to the nasal passages and throat. Eye Eye exposure may cause irritation, redness and watering. Skin Skin contact may cause irritation, dryness and redness. Ingestion Ingestion may produce digestive irritation or discomfort. Chronic Effects Chronic effects from repeated or long-term occupational exposure to this preparation are unknown. Target Organs None expected. Regulatory Status: This preparation is classified as hazardous under U.S. OSHA 29 CFR 1910.1200; E.C. Directive 1999/45/EC; Canadian R.S. 1985, c. H-3; U.K. CHIPS 2002 No. 1689; and/or U.N. GHS ST/SG/AC 10/30. Refer to Sec. 15, Regulatory Information, for details regarding hazard classification. None of the components present in this preparation at concentrations equal to or greater than 0.1% are listed by IARC, NTP, OSHA or ACGIH as a carcinogen. Measures Symptoms: Not available. First aid: If overexposed, remove affected clothing and shower off remaining material. Move to a clean wel ventilated area. Excessive amount of material comes in contact with the eyes, flush wel with water. Ensure adequate flushing of the eye by separating the eyelids with the fingers. If breathing becomes difficult, a rash develops, or other allergic symptoms present, seek medical attention immediately. REF : 95801 5- Fire Fighting Measures
Fire: Not to be considered to be a fire hazard. Explosion: Not to be considered to be an explosion hazard. Extinguishing media: Use water spray, carbon dioxide or Chemical Foam. Special fire fighting procedures: Not available. 6- Accidental measures
Protect exposed skin with a protective coat and gloves, nose and mouth with a dust mask, and the eyes with safety glasses or a face shield. Certain individuals may have an allergic reaction to over-exposure, and individuals showing signs of allergic reactions should be removed to a clean well ventilated area as soon as symptoms present. Disinfect the spil site with a freshly prepared 10% sodium hypochlorite bleach solution al owing sufficient contact time (30 minutes) before wiping up. After material pickup is complete, wipe spill site with water-moistened paper towels to remove any remaining material. Discard towels with the spilled waste in an appropriate waste container. Dispose of spilled material and contaminated waste in accordance with all applicable federal, state, local and provincial environmental regulations.
7- Handling and storage
Handling: Follow instructions given on the package insert and Good Laboratory Practices. Storage: Store at temperatures and conditions as indicated on the Product label. Do not store together: Non applicable. REF : 95801 8- Exposure control/Personal protection
Exposure Guidelines: ACGIH - Threshold Limits Values - Time Weighted Averages (TLV-TWA) Sucrose 57-50-1 10 mg/m3 TWA ACGIH - Threshold Limits Values - TLV Basis - Critical Effects Sucrose 57-50-1 lung Australia - Occupational Exposure Standards - TWAs Sucrose 57-50-1 10 mg/m3 TWA Belgium - Occupational Exposure Limits - TWAs Sucrose 57-50-1 10 mg/m3 VLE Canada - Quebec - Occupational Exposure Limits - TWAEVs Sucrose 57-50-1 10 mg/m3 TWAEV France - Occupational Exposure Limits - TWAs (VMEs) Sucrose 57-50-1 10 mg/m3 VME Ireland - Occupational Exposure Limits - STELs Sucrose 57-50-1 20 mg/m3 STEL Ireland - Occupational Exposure Limits - TWAs Sucrose 57-50-1 10 mg/m3 TWA Korea - Occupational Exposure Limits - TWAs Sucrose 57-50-1 10 mg/m3 TWA Netherlands - Occupational Exposure Limits - TWAs (MACs) Sucrose 57-50-1 10 mg/m3 MAC NIOSH - Pocket Guide - TWAs Sucrose 57-50-1 10 mg/m3 TWA (total dust); 5 mg/m3 TWA (respirable dust) OSHA - Final PELs - Time Weighted Averages (TWAs) Sucrose 57-50-1 15 mg/m3 TWA (total dust); 5 mg/m3 TWA (respirable fraction) Spain - Occupational Exposure Limits - TWAs (VLA-ED) Sucrose 57-50-1 10 mg/m3 VLA-ED United Kingdom - Occupational Exposure Standards (OES) - TWAs Sucrose 57-50-1 10 mg/m3 TWA Ventilation:
Respiratory protection: Not required Skin:
Rubber or latex gloves and laboratory coat or other long sleeved garment.
Protection required. Wear safety glasses or goggles.
Good Laboratory Practices procedures should be followed.
9- Physical/Chemical properties
Appearance: White powder pH: 7.0 - 7.1 at 25°C (prior to lyophilizing) Solubility: Water-soluble Odor: Unknown Specific Gravity: Not available Boiling Point: Not applicable Vapor Pressure: Not applicable Melting Point: Not available Partition Coefficient (n-octanol/water): Not available Freezing Point: Not applicable Vapor Density: Not applicable REF : 95801 10- Stability and reactivity Chemical Stability: Stable under ordinary conditions of use and storage; (see handling and storage information in Section 7). Conditions to Avoid: Avoid heat, flames, sparks and ignition sources. Excessive heat may damage the product. Avoid prolonged exposure to direct sunlight. Incompatible Materials: Avoid strong oxidizing agents, strong acids and bases. Hazardous Decomposition Products: None expected under normal conditions of use. Possibility of Hazardous Reactions: Hazardous polymerization will not occur. 11- Toxicological information
Acute Effects: The human source material in this preparation presents a risk for exposure to infectious agents. May be irritating to eyes, respiratory system and skin. Chronic Effects: Data indicating the presence or absence of chronic effects in humans from repeated or long-term occupational exposure to this preparation is not yet available. Carcinogenicity: Argentina - Occupational Exposure Limits - Carcinogens Sucrose 57-50-1 A4 - Not classifiable as a human carcinogen Canada - New Brunswick - Occupational Exposure Limits - Carcinogens Sucrose 57-50-1 A4 - Not Classifiable as a Human CarcinogenThe toxicological properties have not been thoroughly investigated. 12- Ecological information
Take care to prevent chemicals from entering the ground, watercourses or drainage systems. 13- Disposal consideration
Disposal of the preparation and of the contaminated packaging should be via an approved contractor and may be subject to local laws.
REF : 95801 14- Transport information
Means of transport Air Transport Information 15- Regulatory information
see § : 2. Inventory - European Union - European Inventory of Existing Commercial Chemical Substances (EINECS) Bovine serum albumin, fraction V 9048-46-8 232-936-2 Sucrose 57-50-1 200-334-9 European Communities Dangerous Substances/Preparations: EC Hazard Class None Risk Phrases None Safety Phrases S22 Do not breathe dust. S24/25 Avoid contact with skin and eyes. 16- Other information
For in vitro diagnostic use. Any professional using our product is responsible for observing any local laws and guidelines applicable. The information contained herein is furnished without warranty of any kind. Users should consider this data only as supplement to other information collected by them and must make independent investigations to assure proper use and disposal of this material and to assure safety and health. Revised information is indicated in “italic”.
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