Baxter Healthcare Corporation

Baxter Healthcare Corporation
Baxter Healthcare Corporation

Heparin Sodium Injection, USP

Manufacturer MSDS Number: 1102325

MSDS Name: Heparin Sodium Injection, USP
Chemtrec: For emergencies in the US, call CHEMTREC: 800-424-9300
Manufacturer MSDS Revision Date: 05/28/2003
Synonyms:
None
Chemical Family: Anticoagulant

Distributor Name: Baxter Healthcare Corporation
Distributor Address:
DEERFIELD, ILLINOIS 60015

Emergency telephone number:
PROSAR:
USA: (888) 990-0996
OUTSIDE USA: (615) 917-6114

CHEMTREC:
OUTSIDE USA: (743) 741-6089
Distributor Telephone: (800) 422-9837 or (847) 948-4770
General Use:
Product Use: Pharmaceutical
Container Information: 1 ml dosette® vials and 4, 10, and 30 ml multiple dose vials


Product Codes:
1102325, NDC 0641-0391-25, NDC 0641-2440-45, NDC 0641-2450-45, NDC 0641-0400-25, NDC 0641-2460-45, NDC 0641-0410-25, NDC 0641-2470-45

UN Number: None

Classification: None
Chemical Name
Benzyl Alcohol
CAS#
100-51-6
% Weight
1%
Hazard Symbols: Xn
Risk Phrases:
R20/22

UN Number: None
Chemical Name
Sodium Chloride
CAS#
7647-14-5
% Weight
< 1%
Hazard Symbols: Xi
UN Number: None
Chemical Name
Water
CAS#
7732-18-5
% Weight
> 91%

UN Number: None

Classification: None
SECTION 3 : HAZARDS IDENTIFICATION
Emergency Overview:
May cause skin and eye irritation.
Applies to All Ingredients:
Route of Exposure:
Absorbed through skin. Eye contact. Ingestion.
Potential Health Effects:
Eye Contact:
May cause eye irritation.
Skin Contact:
May cause skin irritation.
Inhalation:
Inhalation not likely under normal use conditions.
Ingestion:
No known effect according to our database.
SECTION 4 : FIRST AID MEASURES
Eye Contact:
In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Get medical attention if irritation develops.
Skin Contact:
In case of contact, immediately flush skin with plenty of water. Get medical attention if irritation develops.
Inhalation:
If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention if symptoms appear.
Ingestion:
Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. If large quantities of this material are swallowed, call a physician immediately.
Note to Physicians:
See patient package insert in shipping carton for complete information.
SECTION 5 : FIRE FIGHTING MEASURES
Flash Point:
Not determined
Upper Flammable or Explosive Limit:
In air (%): Not applicable
Lower Flammable or Explosive Limit:
In air (%): Not applicable
Auto Ignition Temperature:
Not applicable
Extinguishing Media:
Use foam or all purpose dry chemicals to extinguish.
Protective Equipment:
Special protective equipment for firefighters: Fire fighters should wear positive pressure self-contained breathing apparatus (SCBA) and full turnout gear.

Specific methods: No information available
SECTION 6 : ACCIDENTAL RELEASE MEASURES
Personal Precautions:
Use suitable protective equipment (Section 8). Follow all fire fighting procedures (Section 5).
Spill Cleanup Measures:
If emergency personnel are unavailable, contain spilled material. For small spills add absorbent (soil may be used in the absence of other suitable materials) scoop up material and place in a sealed, liquid-proof container for disposal. For large spills dike spilled material or otherwise contain material to ensure runoff does not reach a waterway. Place spilled material in an appropriate container for disposal. Minimize contact of spilled material with soils to prevent runoff to surface waterways.
Environmental Precautions:
No information available.
SECTION 7 : HANDLING and STORAGE
Handling:
Technical measures/precautions: Wash thoroughly after handling.
Storage:
Technical measures/storage conditions: Keep containers tightly closed in a cool, well-ventilated place. Store at room temperature between 20 deg C and 25 deg C (68 deg F and 77 deg F).

Incompatible products: No special restrictions on storage with other products.
SECTION 8 : EXPOSURE CONTROLS, PERSONAL PROTECTION
Engineering Controls:
No special containment is required. Good general ventilation should be sufficient to control airborne levels.
Skin Protection Description:
Work uniform or laboratory coat.
Hand Protection Description:
Use chemical resistant, impervious gloves.
Eye/Face Protection:
Safety glasses. Goggles, face shield, or other full-face protection if potential exists for direct exposure to aerosols or splashes.
Protective Clothing/Body Protection:
Work uniform or laboratory coat.
Respiratory Protection:
Perform exposure monitoring for this product and its components to ensure that employees are not exposed to levels greater than applicable regulatory limits. If exposure levels exceed regulatory limits, implement a respiratory protection program including respiratory protection that is in compliance with OSHA 29 CFR1910.134 (in the US) or equivalent regulation in other regions. Fire fighting requires the use of a self-contained breathing apparatus with full face piece and positive pressure mode.
Ingredient Guidelines
Ingredient: Heparin Sodium
Guideline Type:ACGIH TLV-TWA
Guideline Information:Time Weighted Average: None
Guideline Type:OSHA PEL-TWA
Guideline Information:Time Weighted Average: None
Guideline Type:OSHA PEL-STEL
Guideline Information:Short Term Exposure Limit: None; Ceiling Limits: None
Guideline Type:ACGIH TLV-STEL
Guideline Information:Short Term Exposure Limit: None; Ceiling Limit Value: None
Ingredient: Benzyl Alcohol
Guideline Type:OSHA PEL-STEL
Guideline Information:Short Term Exposure Limit: None; Ceiling Limits: None
Guideline Type:OSHA PEL-TWA
Guideline Information:Time Weighted Average: None
Guideline Type:ACGIH TLV-STEL
Guideline Information:Short Term Exposure Limit: None; Ceiling Limit Value: None
Guideline Type:ACGIH TLV-TWA
Guideline Information:Time Weighted Average: None
Ingredient: Sodium Chloride
Guideline Type:ACGIH TLV-STEL
Guideline Information:Short Term Exposure Limit: None; Ceiling Limit Value: None
Guideline Type:ACGIH TLV-TWA
Guideline Information:Time Weighted Average: None
Guideline Type:OSHA PEL-STEL
Guideline Information:Short Term Exposure Limit: None; Ceiling Limits: None
Guideline Type:OSHA PEL-TWA
Guideline Information:Time Weighted Average: None
Ingredient: Water
Guideline Type:ACGIH TLV-STEL
Guideline Information:Short Term Exposure Limit: None; Ceiling Limit Value: None
Guideline Type:ACGIH TLV-TWA
Guideline Information:Time Weighted Average: None
Guideline Type:OSHA PEL-STEL
Guideline Information:Short Term Exposure Limit: None; Ceiling Limits: None
Guideline Type:OSHA PEL-TWA
Guideline Information:Time Weighted Average: None
SECTION 9 : PHYSICAL AND CHEMICAL PROPERTIES
Physical State/Appearance:
Aqueous solution
Color:
Colorless
Odor:
No information available
Physical State:
Liquid
pH:
5.0 - 7.0
Vapor Pressure:
Not available.
Boiling Point:
Not available.
Melting Point:
Not available.
Solubility:
Not available.
Density:
Not available.
Evaporation Point:
Not available.
Percent Volatile:
By Volume: Not available.
Viscosity:
Not available.
Molecular Weight:
Not available.
Coefficient of Water/Oil Distribution:
Not available.
Flashpoint:
Not determined
Auto Ignition Temp:
Not applicable
Upper Flammable Explosive Limit:
In air (%): Not applicable
Lower Flammable Explosive Limit:
In air (%): Not applicable
SECTION 10 : STABILITY AND REACTIVITY
Chemical Stability:
Stable under recommended storage conditions.
Incompatibilities with Other Materials:
Materials to avoid: Acids. Bases. Oxidizing agents.
Hazardous Polymerization:
Not applicable
Hazardous Decomposition Products:
Not available.
SECTION 11 : TOXICOLOGICAL INFORMATION
Applies to all ingredients:
Acute Health Effects:
Overexposure may include nosebleeds, blood in urine, tarry stools, easy bruising, and petechial formations (minute hemorrhagic spots).
Chronic Effects:
Contains material which may cause damage to the following organs: skin, eye, lens or cornea.
Carcinogenicity:
Not classified or listed by IARC, NTP, OSHA, EU and ACGIH. No data is available on the product itself.
Mutagenicity:
No data is available on the product itself.
Reproductive Toxicity:
No data is available on the product itself.
Other Toxicological Information:
FDA Pregnancy Catagory: C
Heparin Sodium:
Acute Health Effects:
Intravenous LD50 Rat = 2449 mg/kg
Intravenous LD50 Mouse = 2800 mg/kg
Ingestion Effects:
Oral LD50 Rat = 4869 mg/kg
Oral LD50 Mouse = > 5 gm/kg
Benzyl Alcohol:
Skin Effects:
Dermal LD50 Rabbit = 2 gm/kg
Ingestion Effects:
Oral LD50 Rat = 1230 mg/kg
Oral LD50 Mouse = 1360 mg/kg
Sodium Chloride:
Skin Effects:
Dermal LD50 Rabbit: > 10 gm/kg
Ingestion Effects:
Oral LD50 Rat = 3 gm/kg
Oral LD50 Mouse = 4 gm/kg
Inhalation Effects:
LC50 Rat: > 42 gm/m3/1H
Water:
Ingestion Effects:
Oral LD50 Rat: > 50000 mg/kg
SECTION 12 : ECOLOGICAL INFORMATION
Ecological Paragraph:
Environmental properties:
Component: Heparin Sodium
CAS Number: 9041-08-1
Microtox Etoxicity Data: None.

Component: Benzyl Alcohol
CAS Number: 100-51-6
Microtox Etoxicity Data: 5 min EC50 Photobacterium phosphoreum: 63.7 mg/L; 15 min EC50 Photobacterium phosphoreum: 63.7 mg/L; 30 min EC50 Photobacterium phosphoreum: 71.4 mg/L

Component: Sodium Chloride
CAS Number: 7647-14-5
Microtox Etoxicity Data: None.

Component: Water
CAS Number: 7732-18-5
Microtox Etoxicity Data: None.
Ecotoxicity:
No data available
Bioaccumulation:
No data available
Effect of Material On Aquatic Life:
Environmental properties:
Component: Heparin Sodium
CAS Number: 9041-08-1
Ecotoxicity - Water Flea Data: None.
Fish Species Ecotoxicity: None.
Ecotoxicity - Freshwater Algae Data: None.

Component: Benzyl Alcohol
CAS Number: 100-51-6
Ecotoxicity - Water Flea Data: 48 Hr EC50 water flea: 23 mg/L
Fish Species Ecotoxicity: LC50 (96 hr) fathead minnow: 460 mg/L: Static, 18-22 deg C.; LC50 (96 hr) bluegill: 10 mg/L: Static.
Ecotoxicity - Freshwater Algae Data: None.

Component: Sodium Chloride
CAS Number: 7647-14-5
Ecotoxicity - Water Flea Data: None.
Fish Species Ecotoxicity: None.
Ecotoxicity - Freshwater Algae Data: None.

Component: Water
CAS Number: 7732-18-5
Ecotoxicity - Water Flea Data: None.
Fish Species Ecotoxicity: None.
Ecotoxicity - Freshwater Algae Data: None.
SECTION 13 : DISPOSAL CONSIDERATIONS
Waste Disposal:
Waste Classification: Not regulated.

Waste from residues/unused products: Waste disposal must be in accordance with appropriate Federal, State, and local regulations.
SECTION 14 : TRANSPORT INFORMATION
DOT Shipping Name:
None
DOT UN Number:
None
DOT Hazard Class: None
DOT Packing Group: None
IATA:
Primary Hazard: None
IATA Shipping Name:
None
IATA UN Number: None
IATA Packing Group: None
RID/ADR: Official Transport Name: None

NA number: None
RID/ADR Shipping Name:
None
RID/ADR UN Number: None
RID/ADR Class:
None
Canadian TDG: NA Number: None
Canadian Shipping Name: None
Canadian Hazard Class: None
Canadian UN Number: None
NAERG Number: ICAO ERG Code: None
Maritime Transportation CGVS/GGVE/IMDG: Proper Shipping Name: None
CGVS/GGVE/IMDG Class: Division: None
CGVS/GGVE/IMDG Packaging Group: None
CGVS/GGVE/IMDG Subsidiary Risk Label: None

TDG (Canada):
TDG Packing Group: None
SECTION 15 : REGULATORY INFORMATION

Applies to All Ingredients:

TSCA 8(b): Inventory Status
The product is exempt from TSCA, it is FDA Regulated
Canada DSL: This product complies with DSL
European Community Chemical Inventory Status:
EU EINECS List - This product does not comply with EINECS
Japan Chemical Inventory Status:
(ENCS): This product does not comply with JPENCS
Risk Phrases:
NONE
Safety Phrase:
NONE

Heparin Sodium:

Section 302:
Not Listed
Section 304:
Not Listed
Section 304 CERCLA RQ: Not Listed
Section 313 Toxic Release Form:
Not Listed
RCRA 261.33 Code: Status: Not Listed
State:
California Prop 65: Not Listed
Minnesota Right-To Know: Not Listed
Florida Right- to-Know Reporting List: Not Listed
Rhode Island Right-to-Know List: Not Listed
Massachusetts Right-to-Know List: Not Listed
Pennsylvania Right-to-Know: Not Listed
New Jersey Right-to- Know: Not Listed

Benzyl Alcohol:

Section 302:
Not Listed
Section 304:
Not Listed
Section 304 CERCLA RQ: Not Listed
Section 313 Toxic Release Form:
Not Listed
RCRA 261.33 Code: Status: Not Listed
State:
California Prop 65: Not Listed
Minnesota Right-To Know: [present]
Florida Right- to-Know Reporting List: [present]
Rhode Island Right-to-Know List: Not Listed
Massachusetts Right-to-Know List: [present]
Pennsylvania Right-to-Know: [present]
New Jersey Right-to-Know: Not Listed

Sodium Chloride:

Section 302:
Not Listed
Section 304:
Not Listed
Section 304 CERCLA RQ: Not Listed
Section 313 Toxic Release Form:
Not Listed
RCRA 261.33 Code: Status: Not Listed
State:
California Prop 65: Not Listed
Minnesota Right-To Know: Not Listed
Florida Right- to-Know Reporting List: Not Listed
Rhode Island Right-to-Know List: Not Listed
Massachusetts Right-to-Know List: Not Listed
Pennsylvania Right-to-Know: Not Listed
New Jersey Right-to- Know: Not Listed

Water:

Section 302:
Not Listed
Section 304:
Not Listed
Section 304 CERCLA RQ: Not Listed
Section 313 Toxic Release Form:
Not Listed
RCRA 261.33 Code: Status: Not Listed
State:
California Prop 65: Not Listed
Minnesota Right-To Know: Not Listed
Florida Right- to-Know Reporting List: Not Listed
Rhode Island Right-to-Know List: Not Listed
Massachusetts Right-to-Know List: Not Listed
Pennsylvania Right-to-Know: Not Listed
New Jersey Right-to- Know: Not Listed
SECTION 16 : ADDITIONAL INFORMATION
MSDS Revision Date:
05/28/2003

This data sheet contains changes from the previous version in section(s)?: None
MSDS Author:
Prepared by: Technology Resources, Baxter Healthcare Corporation
Disclaimer:
To the best of our knowledge, the information contained herein is accurate. However, neither the above named supplier nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the information contained herein. Final determination of suitability of any material is the sole responsibility of the user. All materials may present unknown hazards and should be used with caution. Although certain hazards are described herein, we cannot guarantee that these are the only hazards that exist.

Additional information: Not Available.

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