MATERIAL SAFETY DATA SHEET

1. Product and Company Identification

Material name SAGM Additive Solution
Version # 03
Revision date 01-14-2011
CAS # Mixture
Product use Preservation solution.
Synonym(s) SAG-M Solution, SAGM Solution, SAG-Mannitol Solution, Saline Adenine Glucose Mannitol
Solution, SAG-M Red Blood Cell Preservation Solution, SAG-M Preservation Solution, SAG-M
Additive Solution.
Manufacturer information Fenwal Inc
Three Corporate Drive
Lake Zurich
IL 60047
United States
General Assistance: 1-847 550-2300
Contact person: Arlene Farrar, Fenwal, Inc.,
Environmental Health & Safety

2. Hazards Identification
Physical state Liquid.
Appearance Liquid.
Emergency overview No special precautionary health measures should be needed under anticipated conditions of use.
OSHA regulatory status This product is considered not hazardous under 29 CFR 1910.1200 (Hazard Communication).
This preparation is not classified as dangerous according to Directive 1999/45/EC and its
amendments.
Potential health effects
Routes of exposure Skin contact. Eye contact.
Eyes May cause temporary eye irritation. May cause redness and pain.
Skin Prolonged contact may cause dryness of the skin.
Inhalation Under normal conditions of intended use, this material is not expected to be an inhalation hazard.
Ingestion May cause discomfort if swallowed.
Target organs No specific target organs noted.
Chronic effects None known.
Potential environmental effects The product components are not classified as environmentally hazardous. However, this does not
exclude the possibility that large or frequent spills can have a harmful or damaging effect on the
environment.

3. Composition / Information on Ingredients

Components CAS # Percent
Water 7732-18-5 > 97
Dextrose, anhydrous, EP 14431-43-7 <1
Dextrose, hydrous, EP 77938-63-7 <1
Mannitol, EP 69-65-8 <1
Sodium chloride, EP 7647-14-5 <1

Composition comments All concentrations are in percent by weight unless ingredient is a gas. Gas concentrations are in
percent by volume.

4. First Aid Measures

First aid procedures
Eye contact Rinse with water. Get medical attention if irritation persists after washing.

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 Skin contact Rinse skin with water/shower. Get medical attention if irritation persists after washing.
Inhalation No specific first aid measures noted.
Ingestion Rinse mouth. Large quantities: Get medical attention if symptoms occur.
Notes to physician No specific indications.
General advice No recommendation given.

5. Fire Fighting Measures

Flammable properties The product is non-combustible. During fire, gases hazardous to health may be formed.
Extinguishing media
Suitable extinguishing Use fire-extinguishing media appropriate for surrounding materials.
media
Unsuitable extinguishing None.
media
Protection of firefighters
Specific hazards arising None known.
from the chemical
Protective equipment and Self-contained breathing apparatus, operated in positive pressure mode and full protective
precautions for firefighters clothing must be worn in case of fire.
Fire fighting Selection of respiratory protection for fire fighting: follow the general fire precautions indicated in
equipment/instructions the workplace.
Specific methods Use standard firefighting procedures and consider the hazards of other involved materials.
Hazardous combustion Carbon monoxide.
products

6. Accidental Release Measures

Personal precautions Avoid prolonged or repeated contact with skin. See Section 8 of the MSDS for Personal Protective
Equipment.
Environmental precautions Avoid discharge into drains, water courses or onto the ground unless allowed by local regulations.
Methods for containment Stop the flow of material, if this is without risk. Dike the spilled material, where this is possible.
Methods for cleaning up Absorb spillage with suitable absorbent material. For waste disposal, see section 13 of the MSDS.

7. Handling and Storage

Handling Avoid prolonged or repeated contact with skin. Observe good industrial hygiene practices.
Storage Store in closed original container in a dry place. Store away from incompatible materials.

8. Exposure Controls / Personal Protection

Occupational exposure limits No exposure limits noted for ingredient(s).
Engineering controls Provide adequate ventilation.
Personal protective equipment
Eye / face protection Not normally needed. Risk of splashes: Wear approved safety goggles.
Skin protection For prolonged or repeated skin contact use suitable protective gloves. Suitable gloves can be
recommended by the glove supplier. Risk of splashes: Use skin protection.
Respiratory protection No personal respiratory protective equipment normally required.
General hygiene Always observe good personal hygiene measures, such as washing after handling the material
considerations and before eating, drinking, and/or smoking. Routinely wash work clothing and protective
equipment to remove contaminants.

9. Physical & Chemical Properties

Appearance Liquid.
Color None.
Odor None.
Odor threshold Not available.
Physical state Liquid.
Form Liquid.
pH Not available.

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Melting point Similar to water
Freezing point Similar to water
Boiling point Similar to water
Flash point Not flammable
Evaporation rate Similar to water
Flammability Not flammable
Flammability limits in air, upper, Not flammable
% by volume
Flammability limits in air, lower, Not flammable
% by volume
Vapor pressure Similar to water
Vapor density Similar to water
Specific gravity Similar to water
Solubility (water) Not applicable
Partition coefficient Not applicable
(n-octanol/water)
Auto-ignition temperature Not applicable
Decomposition temperature Not applicable

10. Chemical Stability & Reactivity Information

Chemical stability Material is stable under normal conditions.
Conditions to avoid Excessive heat. Freezing. Contact with incompatible materials.
Incompatible materials None noted.
Hazardous decomposition Carbon monoxide. Chlorine. Sodium oxides.
products
Possibility of hazardous Will not occur.
reactions

11. Toxicological Information

Toxicological data
Components Test Results

Dextrose, anhydrous, EP (14431-43-7) Acute Other LD Rabbit: 35 g/kg

Mannitol, EP (69-65-8) Acute Oral LD50 Mouse: 22 g/kg
Acute Oral LD50 Rat: 13500 mg/kg
Acute Other LD50 Mouse: 14 g/kg
Acute effects No additional adverse health effects noted.
Sensitization Not a skin sensitizer.
Chronic effects No additional adverse health effects noted.
Carcinogenicity Not classified.
Mutagenicity Not classified.
Reproductive effects Not classified.
Teratogenicity Not classified.
Symptoms and target May cause redness and pain.
organs

12. Ecological Information

Ecotoxicological data
Components Test Results

Sodium chloride, EP (7647-14-5) EC50 Water flea (Daphnia magna): 340.7 - 469.2 mg/l 48
hours
LC50 American eel (Anguilla rostrata): 0 - 27260 mg/l 96 hours

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Ecotoxicity The product components are not classified as environmentally hazardous. However, this does not
exclude the possibility that large or frequent spills can have a harmful or damaging effect on the
environment.
Persistence and No data available.
degradability
Bioaccumulation / No data available.
Accumulation
Partition coefficient Not applicable
(n-octanol/water)
Mobility in environmental No data available.
media

13. Disposal Considerations

Disposal instructions This product, in its present state, when discarded or disposed of, is not a hazardous waste
according to Federal regulations (40 CFR 261.4 (b)(4)). Under RCRA, it is the responsibility of
the user of the product to determine, at the time of disposal, whether the product meets RCRA
criteria for hazardous waste. Disposal recommendations are based on material as supplied.
Disposal must be in accordance with current applicable laws and regulations, and material
characteristics at time of disposal.
Waste from residues / unused Dispose in accordance with all local, State and Federal regulations.
products

14. Transport Information

DOT
Not regulated as dangerous goods.
IATA
Not regulated as dangerous goods.
IMDG
Not regulated as dangerous goods.
TDG
Not regulated as dangerous goods.

15. Regulatory Information

US federal regulations This product is not known to be a "Hazardous Chemical" as defined by the OSHA Hazard
Communication Standard, 29 CFR 1910.1200. This material is not listed on the US TSCA 8(b)
Inventory, therefore it may only be used for TSCA exempt purposes such as R&D or drug use.
Regulated by FDA under Compassionate Use regulations.
CERCLA/SARA Hazardous Substances - Not applicable.
CERCLA (Superfund) reportable quantity (lbs)
None
Superfund Amendments and Reauthorization Act of 1986 (SARA)
Hazard categories Immediate Hazard - No
Delayed Hazard - No
Fire Hazard - No
Pressure Hazard - No
Reactivity Hazard - No
Section 302 extremely No
hazardous substance
Section 311 hazardous No
chemical
Drug Enforcement Agency Not controlled
(DEA)
WHMIS status Non-controlled

Inventory status
Country(s) or region Inventory name On inventory (yes/no)*
Australia Australian Inventory of Chemical Substances (AICS) No
Canada Domestic Substances List (DSL) No

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 Country(s) or region Inventory name On inventory (yes/no)*
Canada Non-Domestic Substances List (NDSL) No
China Inventory of Existing Chemical Substances in China (IECSC) Yes
Europe European Inventory of Existing Commercial Chemical Yes
Substances (EINECS)
Europe European List of Notified Chemical Substances (ELINCS) No
Japan Inventory of Existing and New Chemical Substances (ENCS) No
Korea Existing Chemicals List (ECL) No
New Zealand New Zealand Inventory Yes
Philippines Philippine Inventory of Chemicals and Chemical Substances Yes
(PICCS)
United States & Puerto Rico Toxic Substances Control Act (TSCA) Inventory Yes
*A "Yes" indicates that all components of this product comply with the inventory requirements administered by the governing country(s)
State regulations This product does not contain a chemical known to the State of California to cause cancer, birth
defects or other reproductive harm.

16. Other Information

Further information HMIS® is a registered trade and service mark of the NPCA.
Other information For approved drug use in countries where registered. Keep out of reach of children.
HMIS® ratings Health: 0
Flammability: 0
Physical hazard: 0
NFPA ratings Health: 0
Flammability: 0
Instability: 0
Disclaimer The information in this MSDS was obtained for sources which we believe are reliable. However,
the information is provided without any representation or warranty, express or implied, regarding
its accuracy or correctness.
Issue date 01-14-2011

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