Microsoft word - msds95801a 13 10 2009.doc

REF : 95801
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:

F-02160 MAIZY (FRANCE) ORFILA Phone: (33) (0) 145 42 59 59 Headquarter: 02220 PAARS (FRANCE) WEB : http://www.biolabo.fre-mail: 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: (*) None present above minimum guidelines set out in the European Directive No 1999/45/CE dated 31st May 1999. REF : 95801
3- Hazards

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 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
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.

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
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

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
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

Appearance: White powder
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
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
exposure to this preparation is not yet available.
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
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
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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