Liposomal Amphotericin B

Material Safety Data Sheet
Amphotericin B

ACC# 60942

Section 1 - Chemical Product and Company Identification

MSDS Name: Amphotericin B
Catalog Numbers: BP928 250, BP928-250, BP928250
Synonyms: Amphotericin Beta; Amphozone; Mysteclin-F.
Company Identification:
Fisher Scientific
1 Reagent Lane
Fair Lawn, NJ 07410
For information, call: 201-796-7100
Emergency Number: 201-796-7100
For CHEMTREC assistance, call: 800-424-9300
For International CHEMTREC assistance, call: 703-527-3887

Section 2 - Composition, Information on Ingredients

CAS#	Chemical Name	Percent	EINECS/ELINCS
1397-89-3	Amphotericin B	app. 100	215-742-2

Section 3 - Hazards Identification

EMERGENCY OVERVIEW

Appearance: yellow solid.
Warning! Prolonged or repeated contact causes defatting of the skin with irritation, dryness, and cracking. May cause eye irritation. May cause respiratory and digestive tract irritation. Light sensitive. May cause kidney damage. Moisture sensitive. Ingestion may result in an allergic reaction. May cause adverse reproductive effects based upon animal studies.
Target Organs: Kidneys.

Potential Health Effects
Eye: May cause eye irritation.
Skin: May cause skin irritation. Prolonged and/or repeated contact may cause irritation and/or dermatitis. May cause skin sensitization, an allergic reaction, which becomes evident upon re-exposure to this material.
Ingestion: May cause gastrointestinal irritation with nausea, vomiting and diarrhea. Intravenous or intraperitoneal administration of this antifungal agent may cause various toxic effects including; fever, cardiac abnormalities, blood abnormalities, muscle and joint pain, and convulsions. Kidney damage and acidosis may also
Inhalation: May cause respiratory tract irritation.
Chronic: Prolonged or repeated skin contact may cause defatting and dermatitis. Prolonged or repeated exposure may cause adverse reproductive effects.

Section 4 - First Aid Measures

Eyes: Flush eyes with plenty of water for at least 15 minutes, occasionally lifting the upper and lower eyelids. Get medical aid.
Skin: Get medical aid. Wash clothing before reuse. Flush skin with plenty of soap and water.
Ingestion: Do not induce vomiting. If victim is conscious and alert, give 2-4 cupfuls of milk or water. Get medical aid.
Inhalation: Remove from exposure and move to fresh air immediately. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical aid. Do NOT use mouth-to-mouth resuscitation. If breathing has ceased apply artificial respiration using oxygen and a suitable mechanical device such as a bag and a mask.
Notes to Physician: Treat symptomatically and supportively.

Section 5 - Fire Fighting Measures

General Information: As in any fire, wear a self-contained breathing apparatus in pressure-demand, MSHA/NIOSH (approved or equivalent), and full protective gear. Dusts at sufficient concentrations can form explosive mixtures with air. Combustion generates toxic fumes.
Extinguishing Media: For small fires, use water spray, dry chemical, carbon dioxide or chemical foam.
Flash Point: Not applicable.
Autoignition Temperature: Not applicable.
Explosion Limits, Lower:Not available.
Upper: Not available.
NFPA Rating: (estimated) Health: 1; Flammability: 0; Instability: 0

Section 6 - Accidental Release Measures

General Information: Use proper personal protective equipment as indicated in Section 8.
Spills/Leaks: Vacuum or sweep up material and place into a suitable disposal container. Clean up spills immediately, observing precautions in the Protective Equipment section. Avoid generating dusty conditions. Provide ventilation.

Section 7 - Handling and Storage

Handling: Wash thoroughly after handling. Remove contaminated clothing and wash before reuse. Use with adequate ventilation. Minimize dust generation and accumulation. Avoid contact with eyes, skin, and clothing. Avoid ingestion and inhalation.
Storage: Do not store in direct sunlight. Store in a cool, dry, well-ventilated area away from incompatible substances. Keep away from water.

Section 8 - Exposure Controls, Personal Protection

Engineering Controls: Facilities storing or utilizing this material should be equipped with an eyewash facility and a safety shower. Use adequate ventilation to keep airborne concentrations low.
Exposure Limits

Chemical Name	ACGIH	NIOSH	OSHA - Final PELs
Amphotericin B	none listed	none listed	none listed

OSHA Vacated PELs: Amphotericin B: No OSHA Vacated PELs are listed for this chemical.
Personal Protective Equipment
Eyes: Wear appropriate protective eyeglasses or chemical safety goggles as described by OSHA's eye and face protection regulations in 29 CFR 1910.133 or European Standard EN166.
Skin: Wear appropriate protective gloves to prevent skin exposure.
Clothing: Wear appropriate protective clothing to prevent skin exposure.
Respirators: Follow the OSHA respirator regulations found in 29 CFR 1910.134 or European Standard EN 149. Use a NIOSH/MSHA or European Standard EN 149 approved respirator if exposure limits are exceeded or if irritation or other symptoms are experienced.

Section 9 - Physical and Chemical Properties

Physical State: Solid
Appearance: yellow
Odor: none reported
pH: Not available.
Vapor Pressure: Not available.
Vapor Density: Not available.
Evaporation Rate:Not available.
Viscosity: Not available.
Boiling Point: Not available.
Freezing/Melting Point:> 170 deg C
Decomposition Temperature:Not available.
Solubility: Insoluble in water.
Specific Gravity/Density:Not available.
Molecular Formula:C47H73NO17
Molecular Weight:923.5075

Section 10 - Stability and Reactivity

Chemical Stability: Stable under normal temperatures and pressures. May decompose on exposure to moist air or water.
Conditions to Avoid: High temperatures, light, dust generation, moisture, excess heat.
Incompatibilities with Other Materials: Strong oxidizing agents.
Hazardous Decomposition Products: Carbon monoxide, oxides of nitrogen, irritating and toxic fumes and gases, carbon dioxide.
Hazardous Polymerization: Has not been reported.

Section 11 - Toxicological Information

RTECS#:
CAS# 1397-89-3: BU2625000
LD50/LC50:
CAS# 1397-89-3:
Oral, rat: LD50 = >5 gm/kg;
.

Carcinogenicity:
CAS# 1397-89-3: Not listed by ACGIH, IARC, NTP, or CA Prop 65.

Epidemiology: No information available.
Teratogenicity: No information available.
Reproductive Effects: Paternal Effects: Prostate/seminal vesicle/Cowpers gland/urethra, oral-dog TDLo= 600mg/kg; Spermatogenesis, intravenous-rabbit TDLo= 20mg/kg.
Mutagenicity: Please refer to RTECS# BU2625000 for specific information.
Neurotoxicity: No information available.
Other Studies:

Section 12 - Ecological Information

Ecotoxicity: No data available. No information available.
Environmental: No information reported.
Physical: No information available.
Other: None.

Section 13 - Disposal Considerations

Chemical waste generators must determine whether a discarded chemical is classified as a hazardous waste. US EPA guidelines for the classification determination are listed in 40 CFR Parts 261.3. Additionally, waste generators must consult state and local hazardous waste regulations to ensure complete and accurate classification.
RCRA P-Series: None listed.
RCRA U-Series: None listed.

Section 14 - Transport Information

	US DOT	Canada TDG
Shipping Name:	Not regulated as a hazardous material	No information available.
Hazard Class:
UN Number:
Packing Group:

Section 15 - Regulatory Information

US FEDERAL

TSCA
     CAS# 1397-89-3 is not listed on the TSCA inventory. It is for research and development use only.
Health & Safety Reporting List
     None of the chemicals are on the Health & Safety Reporting List.
Chemical Test Rules
     None of the chemicals in this product are under a Chemical Test Rule.
Section 12b
     None of the chemicals are listed under TSCA Section 12b.
TSCA Significant New Use Rule
     None of the chemicals in this material have a SNUR under TSCA.
CERCLA Hazardous Substances and corresponding RQs
     None of the chemicals in this material have an RQ.
SARA Section 302 Extremely Hazardous Substances
     None of the chemicals in this product have a TPQ.
Section 313      No chemicals are reportable under Section 313.
Clean Air Act:
     This material does not contain any hazardous air pollutants.
     This material does not contain any Class 1 Ozone depletors.
     This material does not contain any Class 2 Ozone depletors.
Clean Water Act:
     None of the chemicals in this product are listed as Hazardous Substances under the CWA.
     None of the chemicals in this product are listed as Priority Pollutants under the CWA.
     None of the chemicals in this product are listed as Toxic Pollutants under the CWA.
OSHA:
     None of the chemicals in this product are considered highly hazardous by OSHA.
STATE
     CAS# 1397-89-3 is not present on state lists from CA, PA, MN, MA, FL, or NJ.

California Prop 65

California No Significant Risk Level: None of the chemicals in this product are listed.

European/International Regulations
European Labeling in Accordance with EC Directives
Hazard Symbols:
     T
Risk Phrases:
     R 25 Toxic if swallowed.
     R 36/37/38 Irritating to eyes, respiratory system and skin.

Safety Phrases:

WGK (Water Danger/Protection)
     CAS# 1397-89-3: 3
Canada - DSL/NDSL
None of the chemicals in this product are listed on the DSL or NDSL list.
Canada - WHMIS
     This product has a WHMIS classification of D2B.
This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations and the MSDS contains all of the information required by those regulations.
Canadian Ingredient Disclosure List

Section 16 - Additional Information

MSDS Creation Date: 7/13/1999
Revision #3 Date: 10/03/2005

The information above is believed to be accurate and represents the best information currently available to us. However, we make no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assume no liability resulting from its use. Users should make their own investigations to determine the suitability of the information for their particular purposes. In no event shall Fisher be liable for any claims, losses, or damages of any third party or for lost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if Fisher has been advised of the possibility of such damages.