MATERIAL SAFETY DATA SHEET | ![](http://www.astellas.us/images/logos/astellas_horizontal_tag_254x95.gif) |
| Date Prepared: 02/20/2003 |
MYCAMINE (MICAFUNGIN SODIUM) FOR INJECTION | Date Reviewed: 02/20/2003 |
1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION Product Identifier: Micafungin
General Use: Antifungal
MANUFACTURED FOR | EMERGENCY TELEPHONE NUMBER |
Astellas Pharma US, Inc. | (800) 727-7003 |
3 Parkway North | |
Deerfield, IL 60015-2538 | |
(847) 317-8800 | |
2. COMPOSITION/INFORMATION ON INGREDIENTS Component: | Citric Acid | CAS Registry #: | 77-92-9 |
| | UN Number: | |
OSHA PEL: | NE | mg/m3 | OSHA PEL: | NE | ppm |
ACGIH TLV: | NE | mg/m3 | ACGIH TLV: | NE | ppm |
STEL: | NE | mg/m3 | STEL: | NE | ppm |
Percent of Product: | NG | Note: | NG |
Component: | Lactose | CAS Registry #: | 63-42-3 |
| | UN Number: | NG |
OSHA PEL: | NE | mg/m3 | OSHA PEL: | NE | ppm |
ACGIH TLV: | NE | mg/m3 | ACGIH TLV: | NE | ppm |
STEL: | NE | mg/m3 | STEL: | NE | ppm |
Percent of Product: | NG | Note: | NG |
Component: | Micafungin Sodium | CAS Registry #: | 208538-73-2 |
| | UN Number: | NG |
Chemical Name: | (-) - Sodium 5-[1S, 2S) - 2 - [( 3S, 6S, 9S, 11R, 15S, 18S, 20R, 21R, 24S, 25S, 26S,) -18 -3- [(R) - 2 - carbamoyl- 1 - hydroxyethyl] - 11, 20, 21, 25 - tetrahydroxy - 15 - [(R)-1- hydroxyethyl] - 26-methyl- 2,5,8,14,17,23 - hexaoxo - 18- [4 -[5-(4-pentyloxyphenyl) isoxazol - 3 - yl] benzoylamino] -1,4,7,13,16,22, - hexaazatricyclo [ 22.3.0.0 9,13] heptacos-6-yl] - 1,2-dihydroxyethyl]-2- hydroxyphenyl sulfate |
OSHA PEL: | NE | mg/m3 | OSHA PEL: | NE | ppm |
ACGIH TLV: | NE | mg/m3 | ACGIH TLV: | NE | ppm |
STEL: | NE | mg/m3 | STEL: | NE | ppm |
Percent of Product: | NG | Note: | 50mg |
Component: | Sodium Hydroxide | CAS Registry #: | 1310-73-2 |
| | UN Number: | NG |
OSHA PEL: | 2 | mg/m3 | OSHA PEL: | NE | ppm |
ACGIH TLV: | 2 | mg/m3 | ACGIH TLV: | NE | ppm |
STEL: | 2 | mg/m3 | STEL: | NE | ppm |
Percent of Product: | NG | Note: | NG |
3. HAZARD IDENTIFICATION
PRIMARY ROUTES OF EXPOSURE - Inhalation, Eye/Skin Absorption and Ingestion.
COMPONENT | CAS No. | NTP | IARC | OSHA | COMMENT |
Citric Acid | 77-92-9 | NO | NO | NO | NA |
Lactose | 63-42-3 | No Data | No Data | No Data | NA |
Micafungin Sodium | 208538-73-2 | No Data | No Data | No Data | |
Sodium Hydroxide | 1310-73-2 | No Data | No Data | No Data | Sodium hydroxide is considered an eye irritant. |
4. EMERGENCY AND FIRST AID PROCEDURESInhalation: Move person to fresh air immediately. Give artificial respiration and Cardiopulmonary Resuscitation (CPR) if required. Seek medical attention.
Ingestion: Flush mouth out with woater immediately. Seek medical attention.
Skin Contact: Remove contaminated clothing immediately. Flush area with water for at least 15 minutes. Seek medical attention.
Eye Contact: Immediately flush with water for at least 15 minutes. If irritation persists, seek medical attention.
For Adverse Drug Reaction Information: phone: (847) 317-1276; fax: (847)-317-1241; email:[email protected]
5. FIRE FIGHTING MEASURES
Fire and Explosion Data:
Product Flammability: | Non-Flammable | Closed Cup Flash Pt.: | NA |
Autoignition: | NA | Open Cup Flash Pt.: | NA |
Flammability Limits: | NA | | |
Products of Combustion: | NA |
Fire Hazards in the Presence of Various Subtances: | None |
Explosion Hazards in the Presense of Various Substances: | - Risk of explosion of the product in presence of mechanical impact: NA - Risk of explosion of the product in presence of static discharge: NA |
Firefighting Media and Instructions: | NG |
Firefighting Equipment: | Water |
Protective Clothing (fire): | USe extinguishing media suitable for surrounding materials |
Special Remarks on Fire Hazards: | None |
6. ACCIDENTAL RELEASE MEASURESClean up: Wear recommended personal protective equipment. Use absorbent towels or booms to clean up spills. Wipe surfaces clean and wash with soap and water.
7. HANDLING AND STORAGEWhen handling pharmaceutical products, avoid all contact and inhalation of dust, fumes, mist,and/or vapors associated with the product.
Store product at room temperature 20 to 25C(68-77 F)
8. EXPOSURE CONTROLS/PERSONAL PROTECTIONENGINEERING CONTROLS:
Under indicated use, general room ventilation is usually satisfactory. Use local exhaust ventilation when necessary.
PERSONAL PROTECTION:
Respirators: With satisfactory ventilation, repiratory protection not usually required.
Eyes: Safety glasses or goggles recommended.
Gloves: Disposable latex (or other appropriate) gloves
Clothing: Disposable garments if direct skin contact is anticipated.
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance, other characteristics: Lyophilized powder
Boiling Point: | NA | Vapor Density: | NA |
Melting Point: | No clean point | Percent Volatiles: | NA |
Freezing Point: | NG | pH: | 5-6 |
Vapor Pressure: | NA | Molecular Weight: | 1292.27 |
Note: | None | Solubility: | More than 200mg/mL |
Color: | White to yellowish | Odor: | None noted |
Specific Gravity: | NG | LogK: | NE |
10. STABILITY AND REACTIVITY
Stability: | Stable |
Conditions/Materials to Avoid: | None |
Hazardous Polymerization: | Will not occur |
11. TOXICOLOGY INFORMATION
INGREDIENT NAME | TEST | RESULT | ROUTE | SPECIES |
Micafungin Sodium | LD50 | 125mg/kg | IV | Male rats |
Micafungin Sodium | LD50 | 250mg/kg | IV | Female rats |
Micafungin Sodium | LD50 | >200mg/kg | IV | Male and Female dogs |
SIGNS & SYMPTOMS OF OVEREXPOSURE MAY INCLUDE:
This product is intended for therapeutic use only when prescribed by a physician. Potential adverse reactions from prescribed doses and overdoses are described in the package insert, these may include:nausea, headache, diarrhea, pruritits and bilirubinemia. Occupational exposure has not been fully investigated.
MEDICAL CONDITIONS GENERALLY RECOGNIZED AS BEING AGGRAVATED BY EXPOSURE:
Pre-existing skin and respiratory conditions.
IMMEDIATE EFFECTS: Eye, skin and repiratory irritation may occur.
12. ECOLOGICAL INFORMATION
INGREDIENT NAME | SPECIES | PERIOD | RESULT |
** Not Available ** |
BOD and COD: | NA |
Biodegradable/OECD: | Not available |
Mobility: | Not available |
Products of Degradation: | The product itself and its products of degradation are not toxic |
Toxicity of the Products of Biodegradation: | Not available |
Special Remarks on the Products of Biodegradation: | Not available |
13. WASTE DISPOSALWaste Disposal: Waste product should be incinerated in accordance with all federal, state and local regulations
14. TRANSPORT INFORMATION
REGULATORY INFORMATION | UN Number | Proper Shipping | Class |
United States (DOT) | Not regulated | | |
PACKING GROUP: | LABEL: ADDITIONAL INFORMATION: | Canada (TDG) | Not regulated | | | PACKING GROUP: | LABEL: ADDITIONAL INFORMATION: | Mexico (NOM-004-SCT2-1994) | Not regulated | | | PACKING GROUP: | LABEL: ADDITIONAL INFORMATION: | | | |
15. REGULATORY INFORMATION
HCS Classification: | Not controlled under HCS (US) |
U.S. Federal Regulations: | TSCA 8(b) inventory: All components listed Clean Water Act (CWA) 307: No products were found Clean Water Act (CWA) 311: Sodium Hydroxide Clean Air Act (CAA)112 accidential release prevention: No products were found Clean Air Act (CAA) 112 flammable substances: No products were found Clean Air Act (CAA) 112 toxic substances: No products were found SARA 302/304/311/312 extremely hazardous substances- No products found SARA 302/304 emergency planning and notification: no products were found SARA 302/304/311/312 hazardous chemicals: No products were found SARA 311/312 MSDS distribution- chemical inventory-hazard identification: No products were found |
| |
SARA 313: | |
Form R - Reporting Requirements: | No products were found |
Supplier Notification: | No products were found |
State Regulations: | Pennsylvania RTK: Sodium hydroxide: (environmental hazard, generic environmental hazard) Massachusetts RTK: Sodium hydroxide New Jersey: Sodium hydroxide California prop 65: No products were found |
WHMIS (Canada): | Not controlled under WHMIS (Canada) CEPA DSL: All components listed |
Classification of the Degree of Risk (Mexico): | No hazardous ingredient |
16. OTHER INFORMATION
National Fire | ![](http://www.astellas.us/images/logos/nfpa_diamond_100x100.jpg) | Hazards |
Protection | Fire: 0 |
Association | Health: 1 |
(U.S.A) | Reactivity: 0 |
| Special: |
Label Requirements: | Follow good industrial hygiene practice |
References: | |
Abbreviations: |
ACGIH: American Conference Of Governmental Industrial Hygienists |
HEPA: High-Efficiency Particulate Air |
IARC: International Agency for Research on Cancer |
NA: Not Applicable |
NE: Not Established |
NG: Not Given |
NIOSH: National Institute for Occupational Safety and Health |
NTP: National Toxicology Program |
OSHA: Occupational Safety and Health Administration |
PEL: Permissable Exposure Limit |
PPM: Parts Per Million |
QS: Quantity Sufficient |
RCRA: Resource Conservation and Recovery Act |
STEL: Short Term Exposure Limit |
TLV: Threshold Limit Value |