1.Identification
1.1 GHS Product identifier
| Product name | amphotericin B |
|---|
1.2 Other means of identification
| Product number | - |
|---|---|
| Other names | LNS-AmB |
1.3 Recommended use of the chemical and restrictions on use
| Identified uses | For industry use only. |
|---|---|
| Uses advised against | no data available |
1.4 Supplier's details
1.5 Emergency phone number
| Emergency phone number | - |
|---|---|
| Service hours | Monday to Friday, 9am-5pm (Standard time zone: UTC/GMT +8 hours). |
2.Hazard identification
2.1 Classification of the substance or mixture
Skin irritation, Category 2
Eye irritation, Category 2
Specific target organ toxicity – single exposure, Category 3
2.2 GHS label elements, including precautionary statements
| Pictogram(s) |  |
|---|---|
| Signal word | Warning |
| Hazard statement(s) | H315 Causes skin irritation H319 Causes serious eye irritation H335 May cause respiratory irritation |
| Precautionary statement(s) | |
| Prevention | P264 Wash ... thoroughly after handling. P280 Wear protective gloves/protective clothing/eye protection/face protection. P261 Avoid breathing dust/fume/gas/mist/vapours/spray. P271 Use only outdoors or in a well-ventilated area. |
| Response | P302+P352 IF ON SKIN: Wash with plenty of water/... P321 Specific treatment (see ... on this label). P332+P313 If skin irritation occurs: Get medical advice/attention. P362+P364 Take off contaminated clothing and wash it before reuse. P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P337+P313 If eye irritation persists: Get medical advice/attention. P304+P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing. P312 Call a POISON CENTER/doctor/…if you feel unwell. |
| Storage | P403+P233 Store in a well-ventilated place. Keep container tightly closed. P405 Store locked up. |
| Disposal | P501 Dispose of contents/container to ... |
2.3 Other hazards which do not result in classification
none
3.Composition/information on ingredients
3.1 Substances
| Chemical name | Common names and synonyms | CAS number | EC number | Concentration |
|---|---|---|---|---|
| amphotericin B | amphotericin B | 1397-89-3 | none | 100% |
4.First-aid measures
4.1 Description of necessary first-aid measures
General advice
Consult a physician. Show this safety data sheet to the doctor in attendance.
If inhaled
If breathed in, move person into fresh air. If not breathing, give artificial respiration. Consult a physician.
In case of skin contact
Wash off with soap and plenty of water. Consult a physician.
In case of eye contact
Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician.
If swallowed
Never give anything by mouth to an unconscious person. Rinse mouth with water. Consult a physician.
4.2 Most important symptoms/effects, acute and delayed
SYMPTOMS: Symptoms of exposure to this compound (through ingestion) may include fever; anorexia; flushing; generalized pain; convulsions; chills; phlebitis; headache; anemia; anaphylaxis; thrombocytopenia; vomiting; mild renal tubular acidosis; decreased renal function; hypokalemia; hypomagnesemia; nerve palsies, including foot drop; weight loss; malaise; dyspepsia; diarrhea; azotemia; hyposthenuria; nephrocalcinosis; and less frequently, anuria; oliguria; arrhythmias; ventricular fibrillation; cardiac arrest; hypertension; hypotension; coagulation effects; leukopenia; agranulocytosis; eosinophilia; melena or hemorrhagic gastroenteritis; rash; hearing loss; tinnitus; transient vertigo; and blurred vision. ACUTE/CHRONIC HAZARDS: When heated to decomposition this compound emits toxic fumes of NOx.
4.3 Indication of immediate medical attention and special treatment needed, if necessary
In the event of overdosage with any amphotericin B formulation, therapy with the drug should be discontinued and the patient's clinical status (eg, cardiorespiratory, renal, and liver function, hematologic status, serum electrolytes) monitored. Supportive therapy should be administered as required. ... The patient's condition should be stabilized, including correction of electrolyte abnormalities, prior to reinstituting amphotericin B therapy.
5.Fire-fighting measures
5.1 Extinguishing media
Suitable extinguishing media
Fires involving this material can be controlled with a dry chemical, carbon dioxide or Halon extinguisher.
5.2 Specific hazards arising from the chemical
Flash point data for this chemical are not available. It is probably combustible.
5.3 Special protective actions for fire-fighters
Wear self-contained breathing apparatus for firefighting if necessary.
6.Accidental release measures
6.1 Personal precautions, protective equipment and emergency procedures
Use personal protective equipment. Avoid dust formation. Avoid breathing vapours, mist or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. Avoid breathing dust. For personal protection see section 8.
6.2 Environmental precautions
Prevent further leakage or spillage if safe to do so. Do not let product enter drains. Discharge into the environment must be avoided.
6.3 Methods and materials for containment and cleaning up
Pick up and arrange disposal. Sweep up and shovel. Keep in suitable, closed containers for disposal.
7.Handling and storage
7.1 Precautions for safe handling
Avoid contact with skin and eyes. Avoid formation of dust and aerosols. Avoid exposure - obtain special instructions before use.Provide appropriate exhaust ventilation at places where dust is formed. For precautions see section 2.2.
7.2 Conditions for safe storage, including any incompatibilities
Conventional amphotericin B powder for injection should be stored at 2-8°C. Reconstituted colloidal dispersions of conventional amphotericin B should be protected from light and are stable for 24 hours at room temperature or 1 week when refrigerated at 2-8°C. Although the manufacturers state that reconstituted dispersions or IV infusions of amphotericin B should be protected from light during administration, potency is unaffected if the infusion is exposed to light for less than 8-24 hours.
8.Exposure controls/personal protection
8.1 Control parameters
Occupational Exposure limit values
no data available
Biological limit values
no data available
8.2 Appropriate engineering controls
Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday.
8.3 Individual protection measures, such as personal protective equipment (PPE)
Eye/face protection
Safety glasses with side-shields conforming to EN166. Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU).
Skin protection
Wear impervious clothing. The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace. Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique(without touching glove's outer surface) to avoid skin contact with this product. Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. Wash and dry hands. The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 derived from it.
Respiratory protection
Wear dust mask when handling large quantities.
Thermal hazards
no data available
9.Physical and chemical properties
| Physical state | Crystalline Yellow Solid |
|---|---|
| Colour | Deep yellow prisms or needles from n,n-dimethylformamide |
| Odour | ODORLESS OR PRACTICALLY SO |
| Melting point/ freezing point | >170oC |
| Boiling point or initial boiling point and boiling range | 1140.4oC at 760 mmHg |
| Flammability | no data available |
| Lower and upper explosion limit / flammability limit | no data available |
| Flash point | 643.5oC |
| Auto-ignition temperature | no data available |
| Decomposition temperature | no data available |
| pH | no data available |
| Kinematic viscosity | no data available |
| Solubility | less than 1 mg/mL at 21.11°C |
| Partition coefficient n-octanol/water (log value) | no data available |
| Vapour pressure | 0mmHg at 25°C |
| Density and/or relative density | 1.34 |
| Relative vapour density | no data available |
| Particle characteristics | no data available |
10.Stability and reactivity
10.1 Reactivity
no data available
10.2 Chemical stability
Solids and solutions appear stable for long periods between pH 4 and 10 when stored at moderate temperature out of light and air.
10.3 Possibility of hazardous reactions
Aqueous solutions may be more stable over prolonged periods of exposure to air and light if kept between pH 4 and 10. This compound yields a volatile base in concentrated sodium hydroxide and can bleach KMnO4 or Br2CCl4.
10.4 Conditions to avoid
no data available
10.5 Incompatible materials
no data available
10.6 Hazardous decomposition products
When heated to decomposition it emits toxic fumes of /nitrogen oxides/.
11.Toxicological information
Acute toxicity
- Oral: no data available
- Inhalation: no data available
- Dermal: no data available
Skin corrosion/irritation
no data available
Serious eye damage/irritation
no data available
Respiratory or skin sensitization
no data available
Germ cell mutagenicity
no data available
Carcinogenicity
no data available
Reproductive toxicity
no data available
STOT-single exposure
no data available
STOT-repeated exposure
no data available
Aspiration hazard
no data available
12.Ecological information
12.1 Toxicity
- Toxicity to fish: no data available
- Toxicity to daphnia and other aquatic invertebrates: no data available
- Toxicity to algae: no data available
- Toxicity to microorganisms: no data available
12.2 Persistence and degradability
no data available
12.3 Bioaccumulative potential
no data available
12.4 Mobility in soil
no data available
12.5 Other adverse effects
no data available
13.Disposal considerations
13.1 Disposal methods
Product
The material can be disposed of by removal to a licensed chemical destruction plant or by controlled incineration with flue gas scrubbing. Do not contaminate water, foodstuffs, feed or seed by storage or disposal. Do not discharge to sewer systems.
Contaminated packaging
Containers can be triply rinsed (or equivalent) and offered for recycling or reconditioning. Alternatively, the packaging can be punctured to make it unusable for other purposes and then be disposed of in a sanitary landfill. Controlled incineration with flue gas scrubbing is possible for combustible packaging materials.
14.Transport information
14.1 UN Number
| ADR/RID: UN1759 | IMDG: UN1759 | IATA: UN1759 |
14.2 UN Proper Shipping Name
| ADR/RID: CORROSIVE SOLID, N.O.S. |
| IMDG: CORROSIVE SOLID, N.O.S. |
| IATA: CORROSIVE SOLID, N.O.S. |
14.3 Transport hazard class(es)
| ADR/RID: 8 | IMDG: 8 | IATA: 8 |
14.4 Packing group, if applicable
| ADR/RID: III | IMDG: III | IATA: III |
14.5 Environmental hazards
| ADR/RID: no | IMDG: no | IATA: no |
14.6 Special precautions for user
no data available
14.7 Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code
no data available
15.Regulatory information
15.1 Safety, health and environmental regulations specific for the product in question
| Chemical name | Common names and synonyms | CAS number | EC number |
|---|---|---|---|
| amphotericin B | amphotericin B | 1397-89-3 | none |
| European Inventory of Existing Commercial Chemical Substances (EINECS) | Listed. | ||
| EC Inventory | Listed. | ||
| United States Toxic Substances Control Act (TSCA) Inventory | Not Listed. | ||
| China Catalog of Hazardous chemicals 2015 | Not Listed. | ||
| New Zealand Inventory of Chemicals (NZIoC) | Listed. | ||
| Philippines Inventory of Chemicals and Chemical Substances (PICCS) | Listed. | ||
| Vietnam National Chemical Inventory | Not Listed. | ||
| Chinese Chemical Inventory of Existing Chemical Substances (China IECSC) | Listed. | ||
16.Other information
Information on revision
| Creation Date | Aug 12, 2017 |
|---|---|
| Revision Date | Aug 12, 2017 |
Abbreviations and acronyms
- CAS: Chemical Abstracts Service
- ADR: European Agreement concerning the International Carriage of Dangerous Goods by Road
- RID: Regulation concerning the International Carriage of Dangerous Goods by Rail
- IMDG: International Maritime Dangerous Goods
- IATA: International Air Transportation Association
- TWA: Time Weighted Average
- STEL: Short term exposure limit
- LC50: Lethal Concentration 50%
- LD50: Lethal Dose 50%
- EC50: Effective Concentration 50%
References
- IPCS - The International Chemical Safety Cards (ICSC), website: http://www.ilo.org/dyn/icsc/showcard.home
- HSDB - Hazardous Substances Data Bank, website: https://toxnet.nlm.nih.gov/newtoxnet/hsdb.htm
- IARC - International Agency for Research on Cancer, website: http://www.iarc.fr/
- eChemPortal - The Global Portal to Information on Chemical Substances by OECD, website: http://www.echemportal.org/echemportal/index?pageID=0&request_locale=en
- CAMEO Chemicals, website: http://cameochemicals.noaa.gov/search/simple
- ChemIDplus, website: http://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp
- ERG - Emergency Response Guidebook by U.S. Department of Transportation, website: http://www.phmsa.dot.gov/hazmat/library/erg
- Germany GESTIS-database on hazard substance, website: http://www.dguv.de/ifa/gestis/gestis-stoffdatenbank/index-2.jsp
- ECHA - European Chemicals Agency, website: https://echa.europa.eu/