SAFETY DATA SHEET
8377GR
Bayer Corporation; Diagnostics Emergency Telephone HMIS Hazard Rating
Division 1-219-264-8400 (BAYER) HEALTH 1
511 Benedict 1-800-424-9300 (Chemtrec) FLAMMABILITY 0
Tarrytown, NY 10591; USA Technical Information REACTIVITY 0
1-800-348-8100 PERSONAL_PROTECTION C
SECTION 1: PRODUCT INFORMATION
Product Name: Hemoglobin A1c Normal Control
Product Number: 8377GR
Date Prepared: 11/28/1998
Revision Number: 2
SECTION 2: COMPOSITION/HAZARDOUS INGREDIENTS
Pursuant to United States OSHA Regulations 29 CFR Part 1910.1200, This Product
Is Not Considered To Contain Hazardous Materials.
(Note: This product does contain material derived from human sources and may be
considered a biohazard and/or Regulated Medical Waste in your state. Check your
Local Environmental Regulations.)
EU Classification (90/492/EEC): Not applicable
EU Risk and Safety Phrases: None
SECTION 3: CRITICAL HAZARDS
Man: None determined.
Environment: None determined.
SECTION 4: EMERGENCY FIRST AID PROCEDURES
Emergency First Aid Procedures: Call a physician immediately. Arrange for
transport to the nearest ER (emergency room).
While awaiting the physician or transport to the ER:
Inhalation: If it occurs move patient to fresh air. If not breathing, give artificial
respiration. If breathing is difficult, give oxygen.
Ingestion: If the patient is conscious, wash out mouth with water, give one or two
glasses of water or milk to dilute immediately. Transport to hospital for further
medical attention.
Skin Contact: Remove any contaminated clothing. Wash off with soap and water.
Wash contaminated clothing before re-use.
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 1
SAFETY DATA SHEET
8377GR
Eye Contact: In case of eye contact immediately flush eyes with copious amounts
of water for at least 15-20 minutes. Transport to hospital to see an ophthalmologist.
SECTION 5: FIRE AND EXPLOSION HAZARD DATA
Flash Point (Method Used): None
Flammable Limits: LEL: Not Applicable UEL: Not Applicable
Extinguishing Media: Use whatever is required for the surrounding area.
Special Fire Fighting Procedures: It is always best to wear a self-contained
breathing apparatus.
Unusual Fire and Explosion Hazards: None determined.
SECTION 6: SPILL OR LEAK PROCEDURES
Steps to be taken in case material is released or spilled: Wear chemical
resistant rubber gloves and laboratory apron. Sweep up, avoiding dust and place in a
biohazard container. Wipe up area with a damp paper towel and discard in a
biohazard container. Disinfect spill area with a 10% bleach solution.
SECTION 7: HANDLING AND STORAGE
Store at temperatures and conditions as indicated on the product label. Handle as a
human serum sample. Prevent contact with the eyes, skin and clothing. Do not
breathe dust. Wash hands before breaks and immediately after handling the
product.
SECTION 8: PERSONAL PROTECTION
Ventilation: Use general room ventilation.
Respiratory Equipment: None required.
Protective Gloves: Standard laboratory chemical rubber or latex gloves.
Eye Protection: Standard laboratory safety glasses recommended. Contact
lenses should not be worn in the laboratory.
Other Protective Equipment/Clothing: A laboratory coat or apron is
recommended.
SECTION 9: PHYSICAL DATA
Appearance and odor: Reddish-brown lyophilized powder.
pH: N/A
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 2
SAFETY DATA SHEET
8377GR
Specific Gravity (H2O=1): N/D
Boiling Point (F): N/A
Melting Point (F): N/D
Vapor Pressure: N/A
Evaporation Rate: N/A
Solubility in Water: Soluble
N/A = Not Applicable N/D = Not Determined
SECTION 10: REACTIVITY DATA
Stability: Stable
Conditions to Avoid: Avoid excessive heat which may cause product
decomposition.
Substances to Avoid: None determined.
Hazardous Decomposition Products: Thermal decomposition may yield
oxides of carbon and nitrogen.
Hazardous Polymerization: Will Not Occur
SECTION 11: TOXICOLOGICAL INFORMATION
Chronic Effects of Overexposure: None currently known.
Carcinogen or Suspected Carcinogen: None of the components are listed as
a carcinogen or suspected carcinogen.
Medical Conditions Aggravated by Exposure: None currently known.
Acute Toxicity:
Inhalation: Inhalation of dust may cause minor respiratory discomfort.
Ingestion: Contains human serum or other human source material. May cause
gastrointestinal irritation and other adverse effects.
Skin Contact: Contact may cause mild irritation.
Eye Contact: May cause mild irritation.
Acute Toxicity Values: Not applicable
SECTION 12: ECOLOGICAL INFORMATION
Ecological effects of this mixture have not been determined.
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 3
SAFETY DATA SHEET
8377GR
SECTION 13: DISPOSAL
Primary Container Type: The product container is glass.
Waste Disposal Method: Each disposal facility must determine proper disposal
methods to comply with Local, State and Federal Environmental Regulations.
SECTION 14: TRANSPORTATION (IATA REGULATIONS)
Proper Shipping Name: Not regulated
Technical Name:
UN Number: N/A
Hazard Class and Packaging Group: Not regulated
Label(s): N/A
Packing Instruction (Passenger Aircraft): N/A
Packing Instruction (Cargo Aircraft): N/A
Unit Volume: 0.25 mL before lyophilization
Primary Container Type: 1 mL Glass
Sales Unit: 2 Bottles / kit
SECTION 15: OTHER REGULATORY INFORMATION
Canadian WHMIS Classification: Not a controlled product.
EU Classification (90/492/EEC): Not applicable
EU Risk and Safety Phrases: None
SECTION 16: OTHER INFORMATION
WARNING - POSSIBLE HAZARDOUS MATERIAL
Any product prepared from human blood, plasma, or serum should be handled
cautiously as a hazardous material according to good laboratory practices. Each
donor unit used in the preparation of this product was tested by a United States
FDA approved method for the presence of the antibody to HIV as well as for
hepatitis B surface antigen and found to be negative (was not repeatedly reactive).
Because no test method can offer complete assurance that human T-lymphotropic
virus types III (HIV), hepatitis B virus, or other infectious agents are absent, this
product should be handled at the Biosafety Level 2 as recommended for any
potentially infectious human serum or blood specimen in the United States Centers
for Disease Control/National Institutes of Health manual "Biosafety in
Microbiological and Biomedical Laboratories," 1984.
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 4
SAFETY DATA SHEET
8377GR
Reason for Revision: Conversion to Standard Phrase Database.
Prepared by: A. Holle, Manager Regulatory Affairs
The opinions expressed herein are those of qualified experts within Bayer
Corporation. We believe that the information contained herein is current as of the
date of this Material Safety Data Sheet. Since the use of this information and these
opinions and the conditions of use of the product are not within the control of Bayer
Corporation, it is the users' obligation to assure safe use of the product.
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 5
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