Nystatin|1400-61-9 - MOLBASE Encyclopedia

Nystatin, sold under the brandname Mycostatin among others, is an antifungal medication. It is used to treat Candida infections of the skin including diaper rash, thrush, esophageal candidiasis, and vaginal yeast infections. It may also be used to prevent candidiasis in those who are at high risk. Nystatin may be used by mouth, in the vagina, or applied to the skin.
Common side effects when applied to the skin include burning, itching, and a rash. Common side effects when taken by mouth include vomiting and diarrhea. During pregnancy use in the vagina is safe while other formulations have not been studied in this group. It works by disrupting the cell membrane of the fungal cells.
Nystatin was discovered in 1950 by Rachel Fuller Brown and Elizabeth Lee Hazen. It is on the World Health Organization's List of Essential Medicines, the most important medications needed in a basic health system. It is available as a generic medication. The wholesale price of the cream in the developing world is about 0.70 USD per 30 gram tube. In the United States it is less than 25 USD for a course of treatment. It is made from the bacterium, Streptomyces noursei.

biofanal

stamycin

nystatin A1

Nystex

nilstat

nystatin A2

nystan

MORONAL

Nystain

Nystop

Fungicidin Mycostatin

Nyotran

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1.Identification

1.1 GHS Product identifier

Product name	Nystatin

1.2 Other means of identification

Product number	-
Other names	Fungicidin Mycostatin

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

Company	MOLBASE (Shanghai) Biotechnology Co., Ltd.
Address	Floor 4 & 5, Building 12, No. 1001 North Qinzhou Road, Xuhui District, Shanghai, China
Telephone	+86(21)64956998
Fax	+86(21)54365166

1.5 Emergency phone number

Emergency phone number	+86-400-6021-666
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

Not classified.

2.2 GHS label elements, including precautionary statements

Pictogram(s)	No symbol.
Signal word	No signal word.
Hazard statement(s)	none
Precautionary statement(s)
Prevention	none
Response	none
Storage	none
Disposal	none

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
Nystatin	Nystatin	1400-61-9	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

no data available

4.3 Indication of immediate medical attention and special treatment needed, if necessary

no data available

5.Fire-fighting measures

5.1 Extinguishing media

Suitable extinguishing media

Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.

5.2 Specific hazards arising from the chemical

no data available

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

Store in cool place. Keep container tightly closed in a dry and well-ventilated place.

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	yellow suspension
Colour	no data available
Odour	no data available
Melting point/ freezing point	no data available
Boiling point or initial boiling point and boiling range	476ºC at 760mmHg
Flammability	no data available
Lower and upper explosion limit / flammability limit	no data available
Flash point	127.3ºC
Auto-ignition temperature	no data available
Decomposition temperature	no data available
pH	no data available
Kinematic viscosity	no data available
Solubility	no data available
Partition coefficient n-octanol/water (log value)	no data available
Vapour pressure	1.6E-07mmHg at 25°C
Density and/or relative density	no data available
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

Stable under recommended storage conditions.

10.3 Possibility of hazardous reactions

no data available

10.4 Conditions to avoid

no data available

10.5 Incompatible materials

no data available

10.6 Hazardous decomposition products

no data available

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: no data available

IMDG: no data available

IATA: no data available

14.2 UN Proper Shipping Name

ADR/RID: no data available

IMDG: no data available

IATA: no data available

14.3 Transport hazard class(es)

ADR/RID: no data available

IMDG: no data available

IATA: no data available

14.4 Packing group, if applicable

ADR/RID: no data available

IMDG: no data available

IATA: no data available

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
Nystatin	Nystatin	1400-61-9	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)			Not Listed.
Vietnam National Chemical Inventory			Listed.
Chinese Chemical Inventory of Existing Chemical Substances (China IECSC)			Not Listed.

16.Other information

Information on revision

Creation Date	Aug 13, 2017
Revision Date	Aug 13, 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/

Disclaimer: The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions. It does not represent any guarantee of the properties of the product. We as supplier shall not be held liable for any damage resulting from handling or from contact with the above product.

Section 1. Chemical Product and Company Identification
    Nystatin
    Common Name/
    Trade Name
    Nystatin

Section 3. Hazards Identification
    Potential Acute Health        Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation.
    Effects
    CARCINOGENIC EFFECTS: Not available.
    Potential Chronic Health
    MUTAGENIC EFFECTS: Not available.
    Effects
    TERATOGENIC EFFECTS: Not available.
    DEVELOPMENTAL TOXICITY: Not available.
    Repeated or prolonged exposure is not known to aggravate medical condition.

Section 4. First Aid Measures
    Eye Contact        Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water
    for at least 15 minutes. Cold water may be used. WARM water MUST be used. Get medical attention if
    irritation occurs.
    Skin Contact        Wash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation
    develops.
    Serious Skin Contact        Not available.
    Inhalation        If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen.
    Get medical attention.
    Serious Inhalation        Not available.
    Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to
    Ingestion
    an unconscious person. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention
    if symptoms appear.
    Serious Ingestion        Not available.

Section 5. Fire and Explosion Data
    Flammability of the Product May be combustible at high temperature.
    Auto-Ignition Temperature Not available.
    Flash Points        Not available.
    Not available.
    Flammable Limits
    Not available.
    Products of Combustion
    Fire Hazards in Presence of Slightly flammable to flammable in presence of heat.
    Various Substances
    Explosion Hazards in        Risks of explosion of the product in presence of mechanical impact: Not available.
    Presence of Various        Risks of explosion of the product in presence of static discharge: Not available.
    Substances
    SMALL FIRE: Use DRY chemical powder.
    Fire Fighting Media
    LARGE FIRE: Use water spray, fog or foam. Do not use water jet.
    and Instructions
    Material in powder form, capable of creating a dust explosion.
    Special Remarks on
    Fire Hazards
    Special Remarks on Explosion Fine dust dispersed in air in sufficient concentrations, and in the presence of an ignition source is a potential
    dust explosion hazard.
    Hazards
    Nystatin

Section 6. Accidental Release Measures
    Small Spill        Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by
    spreading water on the contaminated surface and dispose of according to local and regional authority
    requirements.
    Large Spill        Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading
    water on the contaminated surface and allow to evacuate through the sanitary system.

Section 7. Handling and Storage
    Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do
    Precautions
    not ingest. Do not breathe dust. If ingested, seek medical advice immediately and show the container or
    the label. Keep away from incompatibles such as oxidizing agents.
    Storage        Keep container tightly closed. Keep container in a cool, well-ventilated area. Do not store above 8°C
    (46.4°F). Refrigerate. Moisture sensitive. Sensitive t o light. Store in light-resistant containers.

Section 8. Exposure Controls/Personal Protection
    Engineering Controls        Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels
    below recommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep
    exposure to airborne contaminants below the exposure limit.
    Personal Protection        Safety glasses. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent.
    Gloves.
    Personal Protection in Case of Splash goggles. Full suit. Dust respirator. Boots. Gloves. A self contained breathing apparatus should be
    a Large Spill        used to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a
    specialist BEFORE handling this product.
    Exposure Limits        Not available.

Section 9. Physical and Chemical Properties
    Physical state and appearance Solid. (Powdered solid.)        Odor        Odor suggestive of cereal
    Not available.
    Taste
    Not available.
    Molecular Weight
    Color        Tan. Yellow. (Light.)
    pH (1% soln/water)        Not available.
    Boiling Point        Not available.
    Melting Point        Decomposition temperature: >160°C (320°F)
    Not available.
    Critical Temperature
    Specific Gravity        Not available.
    Not applicable.
    Vapor Pressure
    Vapor Density        Not available.
    Volatility        Not available.
    Odor Threshold        Not available.
    Water/Oil Dist. Coeff.        The product is more soluble in oil; log(oil/water) = 7.1
    Not available.
    Ionicity (in Water)
    Dispersion Properties        Not available.
    Very slightly soluble in cold water.
    Solubility
    Insoluble in diethyl ether.
    Solubility in Water: 360 mg/l at 24 C.
    Nystatin

Section 10. Stability and Reactivity Data
    The product is stable.
    Stability
    Instability Temperature        Not available.
    Excess heat, incompatible materials, light, moisture, dust generation.
    Conditions of Instability
    Incompatibility with various Reactive with oxidizing agents.
    substances
    Non-corrosive in presence of glass.
    Corrosivity
    Special Remarks on        Moisture sensitive Sensitive to light.
    Reactivity        Heat, light and oxygen accelerate decomposition.
    Special Remarks on        Not available.
    Corrosivity
    Will not occur.
    Polymerization

Section 11. Toxicological Information
    Routes of Entry        Inhalation. Ingestion.
    Toxicity to Animals        Acute oral toxicity (LD50): 8000 mg/kg [Mouse].
    Chronic Effects on Humans Not available.
    Other Toxic Effects on        Slightly hazardous in case of skin contact (irritant), of ingestion, of inhalation.
    Humans
    Special Remarks on        Not available.
    Toxicity to Animals
    Special Remarks on        May cause adverse reproductive effects and birth defects (teratogenic) based on animal test data.
    Chronic Effects on Humans May affect genetic material (mutagenic)
    Special Remarks on other        Acute Potential Health Effects:
    Toxic Effects on Humans        Skin: May cause skin irritation.
    Eyes: May cause eye irritation.
    Inhalation: May cause respiratory tract irritation.
    Ingestion: May cause gastrointestinal tract irritation with nausea, vomiting, diarrhea, and stomach pain.
    Chronic Potential Health Effects:
    Ingestion: Prolonged or repeated ingestion may cause weight loss. It may also affect behavior, blood
    (changes in serum composition), and urinary system (kidneys).
    Inhalation: Prolonged or repeated inhalation may cause allergic reaction.
    Skin: Prolonged or repeated skin contact may cause allergic contact dermatitis, although it is rare.

Section 12. Ecological Information
    Not available.
    Ecotoxicity
    Not available.
    BOD5 and COD
    Products of Biodegradation        Possibly hazardous short term degradation products are not likely. However, long term degradation
    products may arise.
    Toxicity of the Products        The product itself and its products of degradation are not toxic.
    of Biodegradation
    Special Remarks on the        Not available.
    Products of Biodegradation
    Nystatin

Section 13. Disposal Considerations
Waste Disposal Waste must be disposed of in accordance with federal, state and local environmental
control regulations.

Section 14. Transport Information
    DOT Classification        Not a DOT controlled material (United States).
    Not applicable.
    Identification
    Not applicable.
    Special Provisions for
    Transport
    DOT (Pictograms)

Section 15. Other Regulatory Information and Pictograms
    No products were found.
    Federal and State
    Regulations
    California        California prop. 65: This product contains the following ingredients for which the State of California has
    Proposition 65        found to cause cancer which would require a warning under the statute: No products were found.
    Warnings
    California prop. 65: This product contains the following ingredients for which the State of California has
    found to cause birth defects which would require a warning under the statute: No products were found.
    EINECS: This product is on the European Inventory of Existing Commercial Chemical Substances (EINECS
    Other Regulations
    No. 215-749-0).
    Canada: Listed on Canadian Domestic Substance List (DSL).
    China: Not listed on National Inventory.
    Japan: Not listed on National Inventory (ENCS).
    Korea: Not listed on National Inventory (KECI).
    Philippines: Not listed on National Inventory (PICCS).
    Australia: Listed on AICS.
    WHMIS (Canada) Not controlled under WHMIS (Canada).
    Other Classifications
    This product is not classified        Not applicable.
    DSCL (EEC)
    according to the EU regulations.
    Health Hazard
    HMIS (U.S.A.)        1 National Fire Protection
    1 Flammability
    1 Association (U.S.A.)
    Fire Hazard
    1 0 Reactivity
    Health
    Reactivity
    0
    Specific hazard
    Personal Protection
    E
    WHMIS (Canada)
    (Pictograms)
    DSCL (Europe)
    (Pictograms)
    Nystatin
    TDG (Canada)
    (Pictograms)
    ADR (Europe)
    (Pictograms)
    Protective Equipment
    Gloves.
    Lab coat.
    Dust respirator. Be sure to use an
    approved/certified respirator or
    equivalent.

SECTION 16 - ADDITIONAL INFORMATION
N/A

Nystatin

1400-61-9

C47H75NO17

Basic Info

Properties

Safety Info

MSDS

SAFETY DATA SHEETS

According to Globally Harmonized System of Classification and Labelling of Chemicals (GHS) - Sixth revised edition

1.Identification

1.1 GHS Product identifier

1.2 Other means of identification

1.3 Recommended use of the chemical and restrictions on use

1.4 Supplier's details

1.5 Emergency phone number

2.Hazard identification

2.1 Classification of the substance or mixture

2.2 GHS label elements, including precautionary statements

2.3 Other hazards which do not result in classification

3.Composition/information on ingredients

3.1 Substances

4.First-aid measures

4.1 Description of necessary first-aid measures

General advice

If inhaled

In case of skin contact

In case of eye contact

If swallowed

4.2 Most important symptoms/effects, acute and delayed

4.3 Indication of immediate medical attention and special treatment needed, if necessary

5.Fire-fighting measures

5.1 Extinguishing media

Suitable extinguishing media

5.2 Specific hazards arising from the chemical

5.3 Special protective actions for fire-fighters

6.Accidental release measures

6.1 Personal precautions, protective equipment and emergency procedures

6.2 Environmental precautions

6.3 Methods and materials for containment and cleaning up

7.Handling and storage

7.1 Precautions for safe handling

7.2 Conditions for safe storage, including any incompatibilities

8.Exposure controls/personal protection

8.1 Control parameters

Occupational Exposure limit values

Biological limit values

8.2 Appropriate engineering controls

8.3 Individual protection measures, such as personal protective equipment (PPE)

Eye/face protection

Skin protection

Respiratory protection

Thermal hazards

9.Physical and chemical properties

10.Stability and reactivity

10.1 Reactivity

10.2 Chemical stability

10.3 Possibility of hazardous reactions

10.4 Conditions to avoid

10.5 Incompatible materials

10.6 Hazardous decomposition products

11.Toxicological information

Acute toxicity

Skin corrosion/irritation

Serious eye damage/irritation

Respiratory or skin sensitization

Germ cell mutagenicity

Carcinogenicity

Reproductive toxicity

STOT-single exposure

STOT-repeated exposure

Aspiration hazard

12.Ecological information

12.1 Toxicity

12.2 Persistence and degradability

12.3 Bioaccumulative potential

12.4 Mobility in soil

12.5 Other adverse effects

13.Disposal considerations

13.1 Disposal methods

Product