Material Safety Data Sheet
Revision date: 08/22/2006
Print Date: 08/30/2006
Version: 1
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING
Product name: Preciset TDM II
Product number: 03375781190
Business area: Centralized Diagnostics
Product line: Roche/Hitachi, TDM, Mira
Supplier: Emergency telephone number:
Roche Diagnostics Corporation CHEMTREC:
9115 Hague Road 1-800-424-9300 (U.S. or Canada)
Indianapolis, IN 46250 1-703-527-3887 (International)
Site Phone Number: 1-800-428-5074
2. COMPOSITION/INFORMATION ON INGREDIENTS
Description 1: TDM II Calibrators
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
Lidocaine 137-58-6 0.5-10 ug/mL NA NA NA NA
Amikacin 37517-28-5 2.5-40 ug/mL NA NA NA NA
Procainamide 51-06-9 1-16 ug/mL NA NA NA NA
Quinidine 56-54-2 0.5-8 ug mL NA NA NA NA
Digitoxin 71-63-6 7.5-65 ng/mL NA NA NA NA
Human serum NONE 99-100 None NA NA NA
N-acetylprocainamide None 2.5-30 ug/mL NA NA NA NA
Description 2: Diluent
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
Human serum NONE 99-100 None NA NA NA
3. HAZARDS IDENTIFICATION
Emergency Overview
NFPA Ratings: Health= 1 Flammability= 0 Reactivity= 0 Special= PB
Special Definitions: A=Allergen CA=Carcinogen CO=Corrosive F=Flammable H=Harmful I=Irritant Ox=Oxidizer PB=Potential Biohazard
R=Reproductive S=Sensitizer T=Toxic T+=Highly Toxic W=Water Reactive
Principle routes of exposure: Ingestion, skin and/or eye contact. Injection.
Inhalation: None
Ingestion: Ingestion may cause gastrointestinal irritation, nausea, vomiting and diarrhea
Skin contact: None
Eye contact: Contact with eyes may cause irritation
Sensitization or Odor threshold: The following chemical(s) may cause sensitization, be absorbed via skin, and/or has an odor threshold for
detection:
Medical conditions aggravated by None known
exposure:
Additional information: With FDA approved methods, the human source material in this product has been tested and is shown to
be free from HBsAg and antibodies to HCV and HIV. All human material should be considered potentially
infectious. It is recommended to handle this product in accordance with Universal Precautions and the
OSHA Bloodborne Pathogen Standard (29CFR1910.1030). Digitoxin has a therapeutic range in acute
exposures at 10-25 nanograms/mL via injection. Some of the calibrators have a digitoxin concentration
greater than 25 ng/mL. The hazard is small since the bottles contain only 5 mL each and the entire
content of one 5 mL bottles is not enough to deliver a toxic dose. However, contact a physician if there is
any accidental injection of this product.
4. FIRST AID MEASURES
Inhalation: Consult a physician. Move to fresh air. If not breathing, give artificial respiration. If breathing is difficult,
give oxygen
Skin contact: Rinse with plenty of water. If skin irritation persists, call a physician. Remove and wash contaminated
clothing before re-use
Ingestion: Consult a physician. Do not induce vomiting without medical advice
Eye contact: In the case of contact with eyes, rinse immediately with plenty of water and seek medical advice
Notes to physician: None determined
5. FIRE-FIGHTING MEASURES
Suitable extinguishing media: Use dry chemical, CO2, water spray or `alcohol` foam
Unusual hazards: None known
Special protective equipment for Wear self contained breathing apparatus for fire fighting if necessary
firefighters:
6. ACCIDENTAL RELEASE MEASURES
Personal precautions: Use personal protective equipment. Evacuate personnel to safe areas
Environmental precautions: Prevent further leakage or spillage if safe to do so. Prevent product from entering drains.
Methods for cleaning up: Never return spills in original containers for re-use. Sweep up or vacuum (if powder) or soak up with inert
absorbent material (if liquid), then place into a suitable clean, dry, closed container, and label for disposal
7. HANDLING AND STORAGE
Handling: For human source material, handle as if containing infectious material.
Storage: No special precautions required
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Engineering measures: Not applicable
Personal Protective Equipment
Respiratory protection: Respiratory protection is not required under normal use of this product. If respiratory protection is needed,
follow the OSHA regulation, 29CFR1910.134. Always use a NIOSH approved respirator when necessary
Hand protection: Wear appropriate protective gloves to prevent skin contact. Replace torn or punctured gloves promptly
Skin and body protection: Wear appropriate body protection to prevent skin contact
Eye protection: Wear appropriate eye protection to prevent eye contact
Hygiene measures: Avoid contact with skin, eyes and clothing
9. PHYSICAL AND CHEMICAL PROPERTIES
Color: Yellow. Brown.
Odor: Slight.
pH: Neutral.
Physical state: Liquid.
10. STABILITY AND REACTIVITY
Stability: Stable under recommended storage conditions
Polymerization: Not applicable
Hazardous decomposition products: Carbon oxides
Materials to avoid: Strong acids and strong bases. Strong oxidising agents
Product number: 03375781190 Page 2 of 4
Product name: Preciset TDM II
11. TOXICOLOGICAL INFORMATION
Description 1: TDM II Calibrators
Components NIOSH - NIOSH Pocket Guide -
Selected LD50s and LC50s: Target Organs:
Lidocaine = 220 mg/kg Oral LD50 Mouse
= 317 mg/kg Oral LD50 Rat
Amikacin > 6 g/kg Oral LD50 Mouse
Procainamide = 1950 mg/kg Oral LD50 Rat
= 525 mg/kg Oral LD50 Mouse
Quinidine = 263 mg/kg Oral LD50 Rat
= 535 mg/kg Oral LD50 Mouse
Digitoxin = 23750 碌g/kg Oral LD50 Rat
= 4950 碌g/kg Oral LD50 Mouse
Inhalation: No additional data available
Skin: No additional data available
Oral: No additional data available
Mutagenic effects: No data is available on the product itself
Reproductive toxicity: No data is available on the product itself
Carcinogenic effects:
12. ECOLOGICAL INFORMATION
Bioaccumulation: No data available
Aquatic toxicity: Not applicable
Ecotoxicity effects: No data is available on the product itself
13. DISPOSAL CONSIDERATIONS
Waste from residues / unused products: Waste disposal must be in accordance with appropriate Federal, State, and local regulations. This product,
if unaltered by use, may be disposed of by treatment at a permitted facility or as advised by your local
hazardous waste regulatory authority. Residue from fires extinguished with this material may be
hazardous.
14. TRANSPORT INFORMATION
Is product hazardous to ship? No
DOT
Proper shipping name: None
UN Number: Not applicable Hazard class: Not applicable Subsidiary risk: Not applicable Packing group: Not applicable
ICAO/IATA
Proper shipping name: None
UN Number: Not applicable Hazard class: Not applicable Subsidiary risk: Not applicable Packing group: Not applicable
15. REGULATORY INFORMATION
U.S. Regulations:
U.S. CERCLA/SARA/TSCA Regulatory Information: The following chemicals are listed under the following TSCA/SARA/CERCLA lists. Refer to
TSCA regulation if you need a definition for acronyms that may be shown in the TSCA Inventory field in the table below
Product number: 03375781190 Page 3 of 4
Product name: Preciset TDM II
Components CERCLA/SARA 302 CERCLA/SARA 304 SARA 313 TSCA Inventory
RQ and TPQ RQ Emission reporting
(40 CFR 355, App.A) (40 CFR Table 302.4)
Lidocaine Present
Quinidine Present
= 10,000 lb TPQ upper
Digitoxin Present
threshold
= 100 lb TPQ lower
threshold
U.S. Clean Water Act (CWA)/ California The following chemicals are listed under the CWA and/or California Proposition 65:
Proposition 65:
Canadian Regulations:
Canada DSL Inventory List - This product does not comply with DSL
Canada NDSL Inventory List - This product does not comply with NDSL
16. OTHER INFORMATION
Reason for revision: A component has been added to the formulation. SEE SECTION 2
References: None
Additional advice: None
Prepared by: Roche Diagnostics, Health & Safety Department, MSDS Contact: 317-521-7425 or 317-521-7505
The information, data and recommendations contained herein are based upon information believed by Roche Diagnostics Corporation, after reasonable investigation and
research, to be accurate; however, Roche Diagnostics Corporation does not warrant the accuracy of this information. All materials and mixtures may present unknown
hazards and should be used with caution. When necessary or appropriate, independent opinions regarding the risk of handling or exposure should be obtained from trained
professionals. Roche Diagnostics Corporation disclaims any warranty against patent infringement and the implied warranties of merchantability and fitness for a particular
purpose. Customer's sole and exclusive remedy shall be replacement of the product or return of the product and refund of the purchase price, at Roche Diagnostics
Corporation's option. In no case shall Roche Diagnostics Corporation be liable for incidental or consequential damages, including lost profits.
End of Safety Data Sheet
Product number: 03375781190 Page 4 of 4
Product name: Preciset TDM II
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