Material Safety Data Sheet

Date Prepared: 10/15/03                                     X-GEN Pharmaceuticals

Prepared By: RC Park                                        PO Box 445

Technical Assistance: 607-562-2700                          Big Flats, NY 14814

BACITRACIN



                                       IDENTIFICATION



Common Name: Bacitracin

Chemical Name: Bacitracin

Synonym: n/f                                       Formula: C66H103N17O16S (Bacitracin A)

CAS Number: 1405-87-4                              RTECS Number: CP0175000

Chemical Family: Polypeptide complex

Therapeutic Category: Antibacterial

                               INGREDIENT INFORMATION



Principle Components                       Percent                   Exposure Limits

Bacitracin                                 Pure Material             n/f



                            HEALTH HAZARD INFORMATION



Usual Adult Dose: Bacitracin is mainly applied externally to the skin or eyes.



Adverse Effects: Adverse effects may include nausea, vomiting, or other gastrointestinal upset.

Systemic administration may cause kidney toxicity. Possible allergic reaction to material if

inhaled, ingested or in contact with skin.



Overdose Effects: n/f

Acute: Possible eye, skin, gastrointestinal and/or respiratory tract irritation.

Chronic: Possible hypersensitization.



Inhalation: May cause irritation. Remove to fresh air.



Eye: May cause irritation. Flush with copious quantities of water.



Skin: May cause irritation, but is not absorbed through intact skin. Flush with copious quantities

of water.



Ingestion: May cause irritation. Flush out mouth with water. This material is not appreciably

absorbed from the gastrointestinal tract.

n/f = not found

BACITRACIN



HEALTH HAZARD INFORMATION CONTINUED



Medical Conditions Aggravated by Exposure: Hypersensitivity to material and impaired

kidney function.



Cross Sensitivity: n/f



Pregnancy Comments: Adequate and well-controlled pregnancy studies with bacitracin have not

been conducted in either humans or animals.



Pregnancy Category: C



                                  FIRST AID MEASURES



General: Remove from exposure. Remove contaminated clothing. Persons developing serious

hypersensitivity (anaphylactic) reactions must receive immediate medical attention. If person is

not breathing give artificial respiration. If breathing is difficult give oxygen. Obtain medical

attention.



Overdose Treatment: n/f



                          TOXICOLOGICAL INFORMATION



Oral Rat: LD50: n/f

Oral Mouse: LD50: >3750 mg/kg

Irritancy Data: n/f

Target Organ(s): Kidneys

Listed as a Carcinogen? NTP: No                  IARC: No                 OSHA: No

                        Other: No



                                FIREFIGHTING MEASURES



Flash Point: n/f                                         Upper Flammable Limit: n/f



Auto-Ignition Temperature: n/f                           Lower Flammable Limit: n/f



Extinguisher Media: Water spray, dry chemical, carbon dioxide or foam as appropriate for

surrounding fire and materials.



Fire and Explosion Hazards: This material is assumed to be combustible. As with all dry

powders it is advisable to ground mechanical equipment in contact with dry material to dissipate

the potential buildup of static electricity.



Firefighting Procedures: As with all fires, evacuate personnel to a safe area. Firefighters should

use self-contained breathing equipment and protective clothing.









                                                                                                   2

n/f = not found

BACITRACIN



                                   PHYSICAL HAZARDS



Conditions to Avoid: Avoid exposure to light, heat, and moisture.

Incompatibilities: Strong oxidizing agents, alkaline solutions and heavy metal salts.



Decomposition Products: When heated to decomposition material emits acrid smoke and

irritating fumes. Emits toxic fumes under fire conditions.



Stable? Yes                      Hazardous Polymerization? No



                     HANDLING / SPILL / DISPOSAL MEASURES



Handling: As a general rule, when handling USP Reference Standards avoid all contact and

inhalation of dust, mists, and/or vapors associated with the material. Wash thoroughly after

handling.



Storage: Store in tight, light-resistant container as defined in the USP-NF. This material should

be handled and stored per label instructions to ensure product integrity. Store in a cold place



Spill Response: Wear approved respiratory protection, chemically compatible gloves and

protective clothing. Wipe up spillage or collect spillage using a high efficiency vacuum cleaner.

Avoid breathing dust. Place spillage in appropriately labeled container for disposal. Wash spill

site.



Disposal: Dispose of waste in accordance with all applicable Federal, State and local laws.



               EXPOSURE CONTROLS / PERSONAL PROTECTION



 Respiratory Protection: When working with small quantities in a well-ventilated area,

respiratory protection may not be required. The use of an approved dust mask is recommended.



Ventilation: No special ventilation requirements. Protective Clothing: Protect exposed skin.

Gloves: Rubber                                      Eye Protection: Safety Glasses



                     PHYSICAL AND CHEMICAL PROPERTIES



NOTE: The data reported below is general information, and is not specific to the USP

Reference Standard Lot provided!



Appearance and Odor: White to pale buff powder; odorless or slight odor.

Melting Point: 221 - 225° C

Solubility in Water: Freely soluble                          Vapor Density: n/f

Solubility in Water: Insoluble                               Evaporation Rate: n/f

Boiling Point: n/f                                           Evaporation Rate: n/f

Specific Gravity: n/f                                        Reactivity in Water: n/f

Vapor Pressure: n/f                                          % Volatile by Volume: n/f









                                                                                                    3

n/f = not found