1.Identification
1.1 GHS Product identifier
| Product name | Ketoconazole |
|---|
1.2 Other means of identification
| Product number | - |
|---|---|
| Other names | fungoral |
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
Acute toxicity - Oral, Category 3
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
2.2 GHS label elements, including precautionary statements
| Pictogram(s) |    |
|---|---|
| Signal word | Danger |
| Hazard statement(s) | H301 Toxic if swallowed H410 Very toxic to aquatic life with long lasting effects |
| Precautionary statement(s) | |
| Prevention | 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. P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. P280 Wear protective gloves/protective clothing/eye protection/face protection. |
| Response | P301+P310 IF SWALLOWED: Immediately call a POISON CENTER/doctor/… P321 Specific treatment (see ... on this label). P330 Rinse mouth. P314 Get medical advice/attention if you feel unwell. P391 Collect spillage. 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 |
|---|---|---|---|---|
| Ketoconazole | Ketoconazole | 65277-42-1 | 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
Fresh air, rest.
In case of skin contact
Rinse and then wash skin with water and soap.
In case of eye contact
Rinse with plenty of water (remove contact lenses if easily possible).
If swallowed
Rinse mouth. Give a slurry of activated charcoal in water to drink. Refer immediately for medical attention.
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
/SRP:/ 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/
5.Fire-fighting measures
5.1 Extinguishing media
Suitable 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
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.
6.3 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.
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
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°C (59 deg - 77 deg F). Protect from moisture.
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 to off white crystalline powder |
|---|---|
| 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 (log value) | no data available |
| Vapour pressure | 6.41X10-14 mm Hg at 25°C (est) |
| Density and/or relative density | 1.38g/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
Not combustible.
10.4 Conditions to avoid
no data available
10.5 Incompatible materials
Incompatible materials: Strong oxidizing agents.
10.6 Hazardous decomposition products
When heated to decomposition it emits toxic fumes of /hydrogen chloride and nitrogen oxides/.
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
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: EC50; Species: Daphnia magna (Water Flea) age <24 hr neonate; Conditions: freshwater, static, 20°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
12.2 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.
12.3 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).
12.4 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).
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: UN2811 | IMDG: UN2811 | IATA: UN2811 |
14.2 UN Proper Shipping Name
| ADR/RID: TOXIC SOLID, ORGANIC, N.O.S. |
| IMDG: TOXIC SOLID, ORGANIC, N.O.S. |
| IATA: TOXIC SOLID, ORGANIC, N.O.S. |
14.3 Transport hazard class(es)
| ADR/RID: 6.1 | IMDG: 6.1 | IATA: 6.1 |
14.4 Packing group, if applicable
| ADR/RID: III | IMDG: III | IATA: III |
14.5 Environmental hazards
| ADR/RID: yes | IMDG: yes | IATA: yes |
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 |
|---|---|---|---|
| Ketoconazole | Ketoconazole | 65277-42-1 | 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 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/
