113 Hartwell Ave., Lexington, MA 02421-3125
Emergency Number: 1-800-678-0710
MATERIAL SAFETY
DATA SHEET
1. IDENTIFICATION OF PRODUCT
This Material Safety Data Sheet applies to:
Product Name: Part No.
GEM Premier 3000 PAK with iQM (BG/Hct) 00024403584
00024307584
00024315084
00024330084
00024345084
00024360084
00024407584
GEM Premier 3000 PAK with iQM (BG/Hct/Electrolytes) 00024307587
00024315087
00024330087
00024345087
00024360087
00024407587
GEM Premier 3000 PAK with iQM (BG/Hct/Electrolytes/Glucose/Lactate) 00024307589
00024315089
00024330089
00024345089
00024360089
2. COMPOSITION
INGREDIENT NAME CONCENTRATION
PERCENT BY WEIGHT
Process Control Solution A:
MOPS
3-(N-Morpholino) propane sulfonic acid 1.3%
CAS No.: 1132-61-2
EINECS No.: 214-478-5
Hazard Classification: Xi (as raw material)
Risk Code: R36/37/38
R36/37/38: irritating to eyes, respiratory system and skin
MOPS sodium salt 1.3%
CAS No.: 71119-22-7
EINECS No.: not applicable
Hazard Classification: data not available
MIT (N-Methylisothiazolone hydrochloride) 0.03%
CAS No.: 2682-20-4
EINECS No.: 220-239-6
Hazard Classification: Xn (as raw material)
Rick Code: R22-26-24/25
R22: harmful if swallowed
R34: causes burns
R43: may cause sensitization by skin contact
CO #402237 Sheet 1 or 6 Part No. 190836-62 Rev 03
Eff. Date: 01/27/2007
113 Hartwell Ave., Lexington, MA 02421-3125
Emergency Number: 1-800-678-0710
2. COMPOSITION (Continued)
INGREDIENT NAME CONCENTRATION
PERCENT BY WEIGHT
Process Control Solution B:
MOPS
3-(N-Morpholino) propane sulfonic acid 0.5%
CAS No.: 1132-61-2
EINECS No.: 214-478-5
Hazard Classification: Xi (as raw material)
Risk code: R36-37-38
R36/37/38: irritating to eyes, respiratory system and skin
MOPS sodium salt 1.7%
CAS No.: 71119-22-7
EINECS No.: not applicable
Hazard Classification: data not available
MIT (N-Methylisothiazolone hydrochloride) 0.03%
CAS No.: 2682-20-4
EINECS No.: 220-239-6
Hazard Classification: Xn (as raw material)
Risk Code: R22-34-43
R22: harmful if swallowed
R34: causes burns
R43: may cause sensitization by skin contact
Process Control Solution C:
m-Phenylenediamine 0.2%
CAS No.: 108-45-2
EINECS No.: 203-584-7
Hazard Classification: T (as raw material)
Risk core: R23/24/25-36/37/38-42/43-40
R23/24/25: toxic by inhalation, in contact with skin and id swallowed
R36/37/38: irritating to eyes, respiratory system and skin
R42/43: may cause sensitization by inhalation and skin contact
R40: possible risk of irreversible effects
Reference Solution:
Potassium Nitrate 8.4%
CAS No.: 7757-79-1
EINECS No.: 231-818-8
Hazard Classification: O (as raw material)
Risk Code: R8-22-36/37/38
R8: contact with combustible material may cause fire
R22: harmful is swallowed
R36/37/38: irritating to eyes, respiratory system and skin
CO #402237 Sheet 2 or 6 Part No. 190836-62 Rev 03
Eff. Date: 01/27/2007
113 Hartwell Ave., Lexington, MA 02421-3125
Emergency Number: 1-800-678-0710
2. COMPOSITION (Continued)
INGREDIENT NAME CONCENTRATION
PERCENT BY WEIGHT
Reference Solution (Continued):
Brij (Ethozylated dodecyl alcohol) 3.4%
CAS No.: 9002-92-0
EINECS No: not applicable
Hazard Classification: Xi (as raw material)
Risk Code: R36/37/38
R36/37/38: irritating to eyes, respiratory system and skin
Glycerol 52.9%
CAS No.: 56-81-5
EINECS No: 200-289-5
Hazard Classification: not applicable (as raw material)
Risk Code: not applicable
3. HAZARD IDENTIFICATION
POTENTIAL HEALTH EFFECTS
EYES
Direct eye contact may cause redness and irritation. Avoid contact with eyes.
SKIN
Prolonged or repeated contact may cause skin irritation. Avoid contact with skin.
INGESTION
No information found, but compound should be handled as a potential health hazard.
INHALATION
Inhalation of vapors or mists may irritate respiratory tract.
4. FIRST AID MEASURES
EYES
In case of eye contact, flush eyes with plenty of water for at least 15 minutes. Ensure adequate flushing by separating the eyelids
with fingers. Obtain medical attention if irritation persists.
SKIN
Wash exposed area with soap and water. If skin is broken or material enters an open wound, obtain medical attention.
INGESTION
Flush mouth with water, without swallowing. Obtain medical attention or contact the local Poison Control Center.
INHALATION
Remove individual to fresh air. Obtain medical attention.
CO #402237 Sheet 3 or 6 Part No. 190836-62 Rev 03
Eff. Date: 01/27/2007
113 Hartwell Ave., Lexington, MA 02421-3125
Emergency Number: 1-800-678-0710
5. FIRE FIGHTING MEASURES
EXTINGUISHING MEDIA
Use any extinguishing agent, which is suitable for the surrounding fire.
FIRE FIGHTING INSTRUCTIONS
Wear self-contained breathing apparatus and protective clothing that is appropriate for fighting a typical fire involving chemical
materials.
6. ACCIDENTAL RELEASE MEASURES
Wear appropriate personal protective equipment as specified in Section 8.
Clean up spills in a manner that does not disperse dust into the air or create aerosols of prepared solutions. Dry spills should be
moistened with water or an EPA approved disinfectant. Contain spill and decontaminate the area. Pick up material and dispose
in biohazard/sharps container as appropriate.
Do not empty into drains.
7. HANDLING AND STORAGE
HANDLING AND STORAGE PRECAUTIONS
Reference the product labeling for handling and storage instructions.
SPECIAL REQUIREMENTS:
Keep in a tightly closed container, stored in a cool, dry, ventilated area. Protect against physical damage. Containers of this
material may be hazardous when empty since they retain product residues (vapors, liquid); observe all warnings and precautions
listed for the product.
WORK/HYGIENIC PRACTICES
Wash hands with soap and water after use.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
The product does not contain great amounts of dangerous substances. The threshold limit value (TLV) does not have to be under
control for the export to people in the workplace.
EYE/FACE PROTECTION
Safety glasses or splash goggles are recommended.
SKIN PROTECTION
Wear protective (latex/non-latex) gloves and laboratory coat as required to prevent skin contact.
RESPIRATORY PROTECTION
None normally required with adequate ventilation.
AIRBORNE EXPOSURE LIMITS:
-OSHA Permissible Exposure Limit (PEL):
10 mg/m?total dust, 5 mg/m?respirable fraction for glycerin (mists)
-ACGIH Threshold Limit Value (TLV):
10 mg/m?for glycerin mist containing no asbestos and <1% crystalline silica.
OTHER/GENERAL PROTECTION
None normally required.
CO #402237 Sheet 4 or 6 Part No. 190836-62 Rev 03
Eff. Date: 01/27/2007
113 Hartwell Ave., Lexington, MA 02421-3125
Emergency Number: 1-800-678-0710
9. PHYSICAL AND CHEMICAL PROPERTIES
Process Solutions A, B & C and Reference Solution
Appearance: liquid
Color: colorless
Odor: odorless
Density: not available
pH: not available
Vapor Pressure: not determined
Specific Gravity: not determined
Solubility (H20): complete
Evaporation Rate: not determined
Viscosity: not determined
Boiling Point (C?: not determined
Melting Point (C?: not applicable
Flash Point: not applicable
Lower Explosive Limit (%) not applicable
Upper Explosive Limit (%) not applicable
Fire and Explosion Hazards: not applicable
10. STABILITY AND REACTIVITY
STABILITY: Stable under ordinary conditions of use and storage.
INCOMPATIBLE MATERIALS: Strong oxidizer, strong bases.
HAZARDOUS DECOMPOSITION PRODUCTS: May emit carbon oxides, nitrogen oxides and sulfur oxides when heated to
decomposition.
HAZARDOUS POLYMERIZATION: Will not occur.
11. TOXICOLOGICAL INFORMATION
MISCELLANEOUS TOXICOLOGICAL INFORMATION
MOPS 3-(N-Morpholino) propane sulfonic acid: Orl-Qal LD50: >316 mg/kg.
MIT (N-Methylisothiazolone hydrochloride): toxicological properties have not been thoroughly investigated.
m-Phenylenediamine: Orl-Rat LD50: 280 mg/kg; Ipr-Rat LD50: 283 mg/kg; Unr-Rat LD50: 351 mg/kg.
Potassium Nitrate: Orl-Rat LD50: 3750 mg/kg; Orl-Rbt LD50:1901 mg/kg; terathogenic, mutagenic and reproductivity effects
experimental data (NIOSH).
Brij (Ethozylated dodecyl alcohol): Orl-Rat LD50: 8600 mg/kg. Orl-Mus LD50: 3500 mg/kg.
Glycerol: Orl-rat LD50: 12600 mg/kg. Orl-Mus LD50: 4090 mg/kg. Ihl-rat LC50: >570 mg/m? 1 Hr.
The health effects noted above are based on the extrapolation of data on the pure product ingredients. To the best of our
knowledge, no health effects have been identified for the product mixture under normal conditions of use, although the health
effects of the product have not been thoroughly investigated.
MEDICAL CONDITIONS AGGRAVATED BY EXPOSURE
None known
CO #402237 Sheet 5 or 6 Part No. 190836-62 Rev 03
Eff. Date: 01/27/2007
113 Hartwell Ave., Lexington, MA 02421-3125
Emergency Number: 1-800-678-0710
12. ECOLOGICAL INFORMATION
OTHER ENVIRONMENTAL INFORMATION
No ecotoxicological data are available for this product.
Use in accordance with good laboratory practice. Do not waste in the environment.
13. DISPOSAL CONSIDERATIONS
The product waste is classified as non-toxic and harmful.
It is up to the user to classify the waste correctly prior to disposal. Dispose of in accordance with local regulations. Following
use with blood, cartridges should be handled as contaminated material and dispose in compliance with federal, state and local
regulations. If unsure of the applicable requirements, contact the authorities for information.
14. TRANSPORT INFORAMTION
ADR (Road) None
IMDG (Sea) None
RID (Rail) None
ICAO/IATA (Air) None
No special precaution is required.
15. REGULATORY INFORMATION
This product is classified and labeled in accordance with Directive 1999/45/EC and following modifications. The health hazard
classification has been determined based on composition and hazard data of each ingredient. Physical and health hazard
information on the reagent mixture has not been determined. Any physical and health hazard information noted is based on a)
evaluation of data of the pure ingredient and b) concentration of each ingredient.
Kit Hazard Classification
- EEC Symbol: Not Applicable
- Risk Code: Not Applicable
- Safety Code: S24/25-29-36
S24/25: avoid contact with skin and eyes
S29: do not empty into drains
S36: wear suitable protective clothing
16. OTHER INFORMATION
REFERENCE DOCUMENTATION
Primary references used in the preparation of this document:
1. Product Specification.
NOTE
The information supplied in this Material Safety Data Sheet represents the data and best information available at the date of
preparation. It is provided with the aim of allowing proper and safe use, storage, transport and disposal of the product. It is not
to be considered as a warranty or specification of product quality. It is related to the materials specifically indicated and does
not apply if these are used in combination with other materials or during processes not specifically indicated in the text of this
Material Safety Data Sheet.
CO #402237 Sheet 6 or 6 Part No. 190836-62 Rev 03
Eff. Date: 01/27/2007
|