danazol

CAS No. 17230-88-5

Formula: C22H27NO2
Basic Info

Danazol (INN, USAN, BAN, JAN) (brand names Danocrine, Danol, Danazol, Danatrol, Danoval, Cyclomen, many others), also known as 17α-ethinyl-17β-hydroxy-4-androsten-[2,3-d]isoxazole, is a synthetic steroid that is used primarily in the treatment of endometriosis and is marketed widely throughout the world. It is the derivative of ethisterone (17α-ethynyltestosterone) where the 3-ketone is replaced with a 2,3-isoxazole moiety. Danazol was approved by the US Food and Drug Administration as the first drug to specifically treat endometriosis in 1971. Although effective for endometriosis, its use is limited by its masculinizing side effects. Since their introduction, danazol has largely been replaced by gonadotropin-releasing hormone (GnRH) agonists in the treatment of the condition.

Formula
C22H27NO2
Molecular Weight
337.455
Exact Mass
337.204
LogP
4.221
PSA
46.26
Synonyms

Cyclomen

Danazolum

Danol

Danzol

Danatrol

Ladogal

Winobanin

Chronogyn

Danocrine

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Properties
Appearance & Physical State
White solid
Density
1.21 g/cm3
Boiling Point
478.2ºC at 760 mmHg
Melting Point
224.4-226.8ºC
Flash Point
243ºC
Refractive Index
1.604
Stability
Stable at normal temperatures and pressures.
Vapor Pressure
0mmHg at 25°C
Safety Info
Safety Statements
S22-S36
WGK Germany
3
Risk Statements
R20/21/22; R63
HS Code
2937290014
Hazard Codes
MSDS
SDS 1.0
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SAFETY DATA SHEETS

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

Version: 1.0

Creation Date: Aug 16, 2017

Revision Date: Aug 16, 2017

1.Identification

1.1 GHS Product identifier

Product name danazol

1.2 Other means of identification

Product number -
Other names Danatrol

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

Acute toxicity - Dermal, Category 4

Acute toxicity - Inhalation, Category 4

Reproductive toxicity, Category 2

2.2 GHS label elements, including precautionary statements

Pictogram(s)
Signal word

Warning

Hazard statement(s)

H312 Harmful in contact with skin

H332 Harmful if inhaled

H361 Suspected of damaging fertility or the unborn child

Precautionary statement(s)
Prevention

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.

P201 Obtain special instructions before use.

P202 Do not handle until all safety precautions have been read and understood.

Response

P302+P352 IF ON SKIN: Wash with plenty of water/...

P312 Call a POISON CENTER/doctor/…if you feel unwell.

P321 Specific treatment (see ... on this label).

P362+P364 Take off contaminated clothing and wash it before reuse.

P304+P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing.

P308+P313 IF exposed or concerned: Get medical advice/ attention.

Storage

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
danazol danazol 17230-88-5 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 White solid
Colour no data available
Odour no data available
Melting point/ freezing point 224.4-226.8ºC
Boiling point or initial boiling point and boiling range 478.2ºC at 760 mmHg
Flammability no data available
Lower and upper explosion limit / flammability limit no data available
Flash point 243ºC
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 0mmHg at 25°C
Density and/or relative density 1.21 g/cm3
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
danazol danazol 17230-88-5 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) Not Listed.
Philippines Inventory of Chemicals and Chemical Substances (PICCS) 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 16, 2017
Revision Date Aug 16, 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.
MSDS
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Section 1. Chemical Product and Company Identification
    Danazol
    Common Name/
    Trade Name
    Danazol

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. 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.    
    Ingestion        Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to 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.    
    Flammable Limits        Not available.    
    Products of Combustion        These products are carbon oxides (CO, CO2), nitrogen oxides (NO, NO2...).    
    Fire Hazards in Presence of Slightly flammable to flammable in presence of heat.
    Various Substances        Non-flammable in presence of shocks.    
    Explosion Hazards in Presence Risks of explosion of the product in presence of mechanical impact: Not available.
    Slightly explosive in presence of open flames and sparks.
    of Various Substances
    SMALL FIRE: Use DRY chemical powder.
    Fire Fighting Media
    and Instructions        LARGE FIRE: Use water spray, fog or foam. Do not use water jet.    
    Not available.
    Special Remarks on
    Fire Hazards
    Special Remarks on Explosion Fine dust dispersed in air in sufficient concentrations, and in the presences of an ignition source is a potential dust
    Hazards        explosion hazard.    

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.
    Danazol

Section 7. Handling and Storage
    Precautions        Keep locked up.. Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk,    
    evaporate the residue under a fume hood. Ground all equipment containing material. Do not ingest. Do not
    breathe dust. Wear suitable protective clothing. If ingested, seek medical advice immediately and show the
    container or the label.
    Storage        Keep container tightly closed. Keep container in a cool, well-ventilated area. Sensitive to 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 used
    a Large Spill        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. (Solid crystalline powder.)        Odor        Not available.    
    Not available.
    Taste
    Molecular Weight        337.46 g/mole    
    White to yellowish.
    Color
    Not applicable.
    pH (1% soln/water)
    Boiling Point        Not available.    
    Melting Point        Decomposition temperature: 225°C (437°F)    
    Critical Temperature        Not available.    
    Specific Gravity        Not available.    
    Not applicable.
    Vapor Pressure
    Vapor Density        Not available.    
    Not available.
    Volatility
    Odor Threshold        Not available.    
    Water/Oil Dist. Coeff.        Not available.    
    Ionicity (in Water)        Not available.    
    Dispersion Properties        See solubility in water, acetone.    
    Solubility        Soluble in acetone.    
    Insoluble in cold water.

Section 10. Stability and Reactivity Data
    Stability        The product is stable.    
    Instability Temperature        Not available.    
    Conditions of Instability        Excess heat, dust generation    
    Incompatibility with various Not available.
    substances
    Danazol
    Corrosivity        Not available.    
    Special Remarks on        Sensitive to light.    
    Reactivity
    Special Remarks on        Not available.    
    Corrosivity
    Polymerization        Will not occur.    

Section 11. Toxicological Information
    Routes of Entry        Inhalation. Ingestion.    
    Toxicity to Animals        Acute oral toxicity (LD50): 4830 mg/kg [Mouse].    
    Chronic Effects on Humans        TERATOGENIC EFFECTS: Classified POSSIBLE for human.    
    DEVELOPMENTAL TOXICITY: Classified Reproductive system/toxin/female, Reproductive system/toxin/male
    [POSSIBLE].
    May cause damage to the following organs: kidneys, the reproductive system, liver, pituitary gland.
    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).    
    Chronic Effects on Humans        May cause cancer.    
    May affect genetic material (mutagenic)
    Special Remarks on other
    Potential Health Effects:
    Toxic Effects on Humans
    Skin: May cause skin irritaiton.
    Eyes: May cause eye irritation.
    Inhalation: May cause respiratory tract irritation.
    Ingestion: May cause gastrointestinal tract irritation with nausea, vomiting, constipation, and rarely pancreatitis.
    May cause Thromboembolism, thrombotic aand threombophlebitic events, muscle cramps or spasms, or pains,
    joint pain, joint lockup, and joint swelling, pain in back, neck, or extremities and rarely carpal tunnel syndrome,
    androgen-like effects in women (weight gain, acne, seborrhea, mild hirsutism, emema, hair loss, voice change,
    hypertrophy), menstrual disturbances (spotting, amenorrhea), vaginal dryness, reduction in breast size,
    hypertrophy of the clitoris(rare)),flushing, sweating. May affect the liver (hepatic dysfunction, jaundice, hepatitis,
    hepatic adenoma), allergic Dermatitis or skin rashes, behavior/nervous system (CNS effects: headache,
    nervousness, emotional lability, dizziness, fainting, depression, fatigue, sleep disorders, tremor, paresthesias,
    weakness, visual disturbances, benign intracranial hypertension, anxiety, chills, changes in appetite; Perpherial
    Nervous system effects: Spastic paralysis), urinary system (hematuria), blood (leukocytosis or polycythemia,
    eosinophilia, thrombocytopenia). Other symptoms may include elevation in blood pressure, bleeding gums, fever,
    pelvic pain, nipple discharge.

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
    Danazol

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
    California prop. 65: This product contains the following ingredients for which the State of California has found to
    Federal and State
    cause cancer, birth defects or other reproductive harm, which would require a warning under the statute: Danazol
    Regulations
    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: Danazol
    Massachusetts RTK: Danazol
    California
    California prop. 65: This product contains the following ingredients for which the State of California has found
    Proposition 65
    to cause birth defects which would require a warning under the statute: Danazol
    Warnings
    Other Regulations        OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200).    
    EINECS: This product is on the European Inventory of Existing Commercial Chemical Substances.
    WHMIS (Canada) Not controlled under WHMIS (Canada).
    Other Classifications
    DSCL (EEC)        R40- Possible risks of irreversible        S2- Keep out of the reach of children.    
    effects.        S36/37- Wear suitable protective clothing and    
    R62- Possible risk of impaired fertility.        gloves.    
    R63- Possible risk of harm to the
    unborn child.
    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)
    Danazol
    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
Spectrum
NMR Spectrum 1H NMR : Predict
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Synthesis Route
1.Synthesis Route
Precursor
Toxicity
ACUTE TOXICITY DATA
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Type of Test
TDLo - Lowest published toxic dose
Exposure Route
Oral
Species Observed
Human - man
Dose/Duration
274 mg/kg/32D-I
Toxic Effects
Liver--jaundice, cholestatic<br>Liver--other changes<br>Skin and Appendages--dermatitis, other (after systemic exposure)
Reference
Postgraduate Medical Journal. (Blackwell Scientific Pub. Ltd., POB 88, Oxford, UK) V.1- 1925- Volume(issue)/page/year: 69,237,1993
ACUTE TOXICITY DATA
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Type of Test
TDLo - Lowest published toxic dose
Exposure Route
Oral
Species Observed
Human - woman
Dose/Duration
120 mg/kg/10D-I
Toxic Effects
Skin and Appendages--dermatitis, allergic (after systemic exposure)
Reference
Archives of Internal Medicine. (AMA, 535 N. Dearborn St., Chicago, IL 60610) V.1- 1908- Volume(issue)/page/year: 145,2251,1985
ACUTE TOXICITY DATA
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Type of Test
TDLo - Lowest published toxic dose
Exposure Route
Oral
Species Observed
Human - man
Dose/Duration
1029 mg/kg/17W-I
Toxic Effects
Liver--jaundice, cholestatic
Reference
Postgraduate Medical Journal. (Blackwell Scientific Pub. Ltd., POB 88, Oxford, UK) V.1- 1925- Volume(issue)/page/year: 68,984,1992

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