Ketoconazole SDS
SECTION 1: Identification of the substance/mixture and of the company/undertaking
Product identifier
- Product name： Ketoconazole
- CAS： 65277-42-1
Relevant identified uses of the substance or mixture and uses advised against
- Relevant identified uses： For R&D use only. Not for medicinal, household or other use.
- Uses advised against： none
Company Identification
- Company：Chemicalbook.in
- Address：5 vasavi Layout Basaveswara Nilayam Pragathi Nagar Hyderabad, India -500090
- Telephone：+91 9550333722
SECTION 2: Hazards identification
Classification of the substance or mixture
Acute toxicity - Category 3, Oral
Specific target organ toxicity – repeated exposure, Category 2
Hazardous to the aquatic environment, short-term (Acute) - Category Acute 1
Hazardous to the aquatic environment, long-term (Chronic) - Category Chronic 1
Reproductive toxicity, Category 1B
GHS label elements, including precautionary statements
-
Pictogram(s)
- Signal word Danger
H301 Toxic if swallowed
H373 May cause damage to organs through prolonged or repeated exposure
H410 Very toxic to aquatic life with long lasting effects
P264 Wash ... thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P260 Do not breathe dust/fume/gas/mist/vapours/spray.
P273 Avoid release to the environment.
P203 Obtain, read and follow all safety instructions before use.
P280 Wear protective gloves/protective clothing/eye protection/face protection/hearing protection/...
P301+P316 IF SWALLOWED: Get emergency medical help immediately.
P321 Specific treatment (see ... on this label).
P330 Rinse mouth.
P319 Get medical help if you feel unwell.
P391 Collect spillage.
P318 IF exposed or concerned, get medical advice.
P405 Store locked up.
P501 Dispose of contents/container to an appropriate treatment and disposal facility in accordance with applicable laws and regulations, and product characteristics at time of disposal.
Other hazards which do not result in classification
no data available
SECTION 3: Composition/information on ingredients
Substance
- Chemical name: Ketoconazole
- Common names and synonyms: Ketoconazole
- CAS number: 65277-42-1
- EC number: 265-667-4
- Concentration: 100%
SECTION 4: First aid measures
Description of necessary first-aid measures
Fresh air, rest.
Rinse and then wash skin with water and soap.
Rinse with plenty of water (remove contact lenses if easily possible).
Rinse mouth. Give a slurry of activated charcoal in water to drink. Refer immediately for medical attention.
Most important symptoms/effects, acute and delayed
no data available
Indication of immediate medical attention and special treatment needed, if necessary
Immediate first aid: Ensure that adequate decontamination has been carried out. If patient is not breathing, start artificial respiration, preferably with a demand valve resuscitator, bag-valve-mask device, or pocket mask, as trained. Perform CPR if necessary. Immediately flush contaminated eyes with gently flowing water. Do not induce vomiting. If vomiting occurs, lean patient forward or place on the left side (head-down position, if possible) to maintain an open airway and prevent aspiration. Keep patient quiet and maintain normal body temperature. Obtain medical attention. Poisons A and B
SECTION 5: Firefighting measures
Suitable extinguishing media
Suitable extinguishing media: Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.
Specific hazards arising from the chemical
Not combustible.
Special protective actions for fire-fighters
In case of fire in the surroundings, use appropriate extinguishing media.
SECTION 6: Accidental release measures
Personal precautions, protective equipment and emergency procedures
Personal protection: filter respirator for organic gases and particulates adapted to the airborne concentration of the substance. Do NOT let this chemical enter the environment. Sweep spilled substance into covered containers. If appropriate, moisten first to prevent dusting. Carefully collect remainder. Then store and dispose of according to local regulations.
Environmental precautions
Personal protection: filter respirator for organic gases and particulates adapted to the airborne concentration of the substance. Do NOT let this chemical enter the environment. Sweep spilled substance into covered containers. If appropriate, moisten first to prevent dusting. Carefully collect remainder. Then store and dispose of according to local regulations.
Methods and materials for containment and cleaning up
Accidental Release Measures. Personal precautions, protective equipment and emergency procedures: Wear respiratory protection. Avoid dust formation. Avoid breathing vapors, mist or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. Avoid breathing dust. 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. Methods and materials for containment and cleaning up: Pick up and arrange disposal without creating dust. Sweep up and shovel. Keep in suitable, closed containers for disposal.
SECTION 7: Handling and storage
Precautions for safe handling
Handling in a well ventilated place. Wear suitable protective clothing. Avoid contact with skin and eyes. Avoid formation of dust and aerosols. Use non-sparking tools. Prevent fire caused by electrostatic discharge steam.
Conditions for safe storage, including any incompatibilities
Provision to contain effluent from fire extinguishing. Well closed. Separated from food and feedstuffs. Store in an area without drain or sewer access.Store at controlled room temperature 15 deg - 25 deg C (59 deg - 77 deg F). Protect from moisture.
SECTION 8: Exposure controls/personal protection
Control parameters
no data available
no data available
Appropriate engineering controls
Ensure adequate ventilation. Handle in accordance with good industrial hygiene and safety practice. Set up emergency exits and the risk-elimination area.
Individual protection measures, such as personal protective equipment (PPE)
Wear safety goggles.
Protective gloves.
Use local exhaust or breathing protection.
no data available
SECTION 9: Physical and chemical properties and safety characteristics
-
Physical state：
Solid
-
Colour：
Crystals from 4-methylpentanone
-
Odour：
no data available
-
Melting point/freezing point：
10°C(lit.)
-
Boiling point or initial boiling point and boiling range：
200°C
-
Flammability：
Not combustible.
-
Lower and upper explosion limit/flammability limit：
no data available
-
Flash point：
178°C(lit.)
-
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：
4.35
-
Vapour pressure：
6.41X10-14 mm Hg at 25 deg C (est)
-
Density and/or relative density：
1.38g/cm3
-
Relative vapour density：
no data available
-
Particle characteristics：
no data available
SECTION 10: Stability and reactivity
Reactivity
no data available
Chemical stability
no data available
Possibility of hazardous reactions
Not combustible.
Conditions to avoid
no data available
Incompatible materials
Incompatible materials: Strong oxidizing agents.
Hazardous decomposition products
When heated to decomposition it emits toxic fumes of /hydrogen chloride and nitrogen oxides/.
SECTION 11: Toxicological information
Acute toxicity
- Oral: LD50 Rats oral 166 mg/kg
- 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
The substance may have effects on the endocrine system and liver. Animal tests show that this substance possibly causes toxicity to human reproduction or development.
Aspiration hazard
A harmful concentration of airborne particles can be reached quickly when dispersed, especially if powdered.
SECTION 12: Ecological information
Toxicity
- Toxicity to fish: no data available
- Toxicity to daphnia and other aquatic invertebrates: EC50; Species: Daphnia magna (Water Flea) age <24 hr neonate; Conditions: freshwater, static, 20 deg C; Concentration: 8100 ug/L for 24 hr (95% confidence interval: 4600-10800 ug/L); Effect: intoxication, immobilization /100% purity
- Toxicity to algae: no data available
- Toxicity to microorganisms: no data available
Persistence and degradability
AEROBIC: Residue of azole antifungals in the environment is of concern due to the environmental risks and persistence. Distribution, behavior, and fate of frequently used azole antifungal pharmaceuticals were investigated in wastewater at two sewage treatment plants (STPs) in China. Fluconazole, clotrimazole, econazole, ketoconazole, and miconazole were constantly detected at 1-1834 ng/L in the wastewater. The latter four were also ubiquitously detected in sewage sludge. Fluconazole passed through treatment in the STPs and largely remained in the final effluent. On the contrary, biotransformation and sorption to sludge occurred to the other azoles. Ketoconazole was more readily bio-transformed, whereas clotrimazole, econazole, and miconazole were more likely to be adsorbed onto and persisted in sewage sludge. Lipophilicity plays the governing role on adsorption. The highest concentrations in the raw wastewater were observed in winter for the azole pharmaceuticals except for fluconazole. The seasonal difference was smoothed out after treatment in the STPs.
Bioaccumulative potential
An estimated BCF of 340 was calculated in fish for ketoconazole(SRC), using a log Kow of 4.34(1) and a regression-derived equation(2). According to a classification scheme(3), this BCF suggests the potential for bioconcentration in aquatic organisms is high(SRC).
Mobility in soil
The Koc of ketoconazole is estimated as 3,000(SRC), using a log Kow of 4.34(1) and a regression-derived equation(2). According to a classification scheme(3), this estimated Koc value suggests that ketoconazole is expected to have slight mobility in soil. The estimated pKa value of 3.96(4) indicates that this compound will exist partially in the cation form in the environment and cations generally adsorb more strongly to soils containing organic carbon and clay than their neutral counterparts(5). Ketoconazole adsorption isotherms (Kd) of 9.7X10+3 L/kg and 8.5X10+3 L/kg were measured in primary sludge and long-age secondary sludge, respectively. Sludge was obtained from 2 wastewater treatment plants that were representative of plants utilized in industrialized countries(6).
Other adverse effects
no data available
SECTION 13: Disposal considerations
Disposal methods
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.
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.
SECTION 14: Transport information
UN Number
ADR/RID: UN2811 (For reference only, please check.)
IMDG: UN2811 (For reference only, please check.)
IATA: UN2811 (For reference only, please check.)
UN Proper Shipping Name
ADR/RID: TOXIC SOLID, ORGANIC, N.O.S. (For reference only, please check.)
IMDG: TOXIC SOLID, ORGANIC, N.O.S. (For reference only, please check.)
IATA: TOXIC SOLID, ORGANIC, N.O.S. (For reference only, please check.)
Transport hazard class(es)
ADR/RID: 6.1 (For reference only, please check.)
IMDG: 6.1 (For reference only, please check.)
IATA: 6.1 (For reference only, please check.)
Packing group, if applicable
ADR/RID: I (For reference only, please check.)
IMDG: I (For reference only, please check.)
IATA: I (For reference only, please check.)
Environmental hazards
ADR/RID: Yes
IMDG: Yes
IATA: Yes
Special precautions for user
no data available
Transport in bulk according to IMO instruments
no data available
SECTION 15: Regulatory information
Safety, health and environmental regulations specific for the product in question
SECTION 16: Other information
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/
Other Information
Synonyms for this substance are: (+)-cis-1-Acetyl-4-4-2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-ylmethoxyphenylpiperazine and 1-4-4-(2SR,4RS)-2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-ylmethoxyphenylpiperazin-1-ylethanone.