Microsoft word - msds95801a 13 10 2009.doc
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
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:
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.
Concentration N° Einecs
N° cas/ Carn
NOTE - Lipase - Enzyme source: Human pancreas, Enzyme Commission number: 18.104.22.168 (*) None present above minimum guidelines set out in the European Directive No 1999/45/CE dated 31st May 1999.
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
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
Preparation appearance: white powder. Routes of Exposure:
Typical occupational exposure routes are inhalation, eye and skin contact.
Potential Health Effects:
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 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
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
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
IARC, NTP, OSHA or ACGIH as a carcinogen.
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.
5- Fire Fighting Measures
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:
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
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:
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
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.
7.0 - 7.1 at 25°C (prior to lyophilizing) Solubility:
Unknown Specific Gravity:
Not available Boiling Point:
Not applicable Vapor Pressure:
Not applicable Melting Point:
Not available Partition Coefficient (n-octanol/water):
Not applicable Vapor Density:
10- Stability and reactivity
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
The human source material in this preparation presents a risk for exposure to infectious agents. May be
eyes, respiratory system and skin. Chronic Effects:
Data indicating the presence or absence of chronic effects in humans from repeated or long-term
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
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.
14- Transport information
Means of transport
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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