Substance profile
Ketoconazole
Ketoconazole is crystals from 4-methylpentanone.
01 · Identification
What Ketoconazole is
Ketoconazole is crystals from 4-methylpentanone. Its molecular formula is C26H28Cl2N4O4 and its molecular weight is 531.4 g/mol. It melts at 146 °C.
Under the GHS it carries the signal word Danger.
02 · Identifiers
Ketoconazole identifiers and molecular data
Ketoconazole CAS number and EC number
Ketoconazole molecular formula and molecular weight
Other names for Ketoconazole
- 1-[4-[4-[[(2SR,4RS)-2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]ethanone
03 · GHS classification
Ketoconazole hazard classification
Harmonised classification under CLP Annex VI. This is the legally binding classification in the EU; other jurisdictions may differ.
Ketoconazole pictograms and signal word
Ketoconazole hazard class and category
| Hazard class | Category | From code | Pictogram |
|---|---|---|---|
| Acute toxicity - oral GHS chapter 3.1 | Category 3 | H301 | GHS06 |
| Specific target organ toxicity - repeated exposure GHS chapter 3.9 | Category 2 | H373 | GHS08 |
| Hazardous to the aquatic environment - acute GHS chapter 4.1 | Category 1 | H400 | GHS09 |
| Hazardous to the aquatic environment - chronic GHS chapter 4.1 | Category 1 | H410 | GHS09 |
Ketoconazole hazard statements (H-codes)
| Code | Hazard statement |
|---|---|
| H360F | May damage fertility. |
| H301 | Toxic if swallowed. |
| H373 | May cause damage to organs <or state all organs affected, if known> through prolonged or repeated exposure <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>. |
| H400 | Very toxic to aquatic life. |
| H410 | Very toxic to aquatic life with long lasting effects. |
This page lists only the codes assigned to Ketoconazole. The full reference lives on the hazard statements hub, the precautionary statements hub and the GHS pictograms hub.
Safety Data Sheet
Getting an SDS for Ketoconazole
A Safety Data Sheet is written for a product, not for a substance: the supplier of the grade you actually buy issues it, so two suppliers of Ketoconazole issue two different sheets. That is why there is no single authoritative SDS for a substance to download — what there is, is the job of collecting the sheets for the products you hold and keeping them current as suppliers revise them.
04 · Precautionary statements
Ketoconazole precautionary statements
CLP Annex VI assigns 9 precautionary statements to Ketoconazole. They are grouped the way a label groups them: what to do before handling, what to do when something has already happened, how to store it and how to dispose of it.
Prevention
What to do before and during handling so the hazard never happens.
Response
What to do once exposure, spillage or fire has already happened.
Disposal
What has to happen to the contents and the empty container.
Reading the notation. … is a blank the supplier fills in — not a truncated sentence.· [square brackets] mark a part printed only when it applies.
05 · Names in the regulation
Ketoconazole name in 23 EU languages
CLP Annex VI Part 3 is published in every language edition of the regulation, and the identification column is written out in each of them. Nothing below is translated by us: each line is the name as that edition prints it. Under Art. 18(2) the substance name from Annex VI is a lawful product identifier, so this is the wording to put on a label going to that market — and where the cell lists several designations, any one of them qualifies.
| Language | Name in CLP Annex VI Part 3 |
|---|---|
| Bulgarian български | кетоконазол 1-[4-[4-[[(2 SR ,4 RS )-2-(имидазол-1-илметил)-2-(2,4-дихлорофенил)-1,3-диоксолан-4-ил]метокси]фенил]пиперазин-1-ил]етанон |
| Spanish español | Ketoconazol 1-[4-[4-[[(2 SR ,4 RS )-2-(2,4-diclorofenil)-2-(imidazol-1-ilmetil)-1,3-dioxolan-4-il]metoxi]fenil]piperazin-1-il]etanona |
| Czech čeština | ketokonazol 1-[4-(4-{[(2 SR ,4 RS )-2-(2,4-dichlorfenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}fenyl)piperazin-1-yl]ethan-1-on |
| Danish dansk | ketoconazol 1-[4-[4-[[(2 SR ,4 RS )-2-(2,4-dichlorphenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]ethanon |
| German Deutsch | Ketoconazol 1-[4-[4-[[(2 SR , 4 RS )-2-(2,4- Dichlorphenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]ethanon |
| Estonian eesti | ketokonasool 1-[4-[4-[[(2 SR ,4 RS )-2-(2,4-diklorofenüül)-2-(imidasool-1-üülmetüül)-1,3-dioksolaan-4-üül]metoksü]fenüül]piperasiin-1-üül]etanoon |
| Greek ελληνικά | κετοκοναζόλη 1-[4-[4-[[(2 SR ,4 RS )-2-(2,4-διχλωροφαινυλ)-2-(ιμιδαζολ-1-υλομεθυλο)-1,3-διοξολαν-4-υλο]μεθοξυ]φαινυλο]πιπεραζιν-1-υλ]αιθανόνη |
| English English | ketoconazole 1-[4-[4-[[(2 SR , 4 RS )-2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]ethanone |
| French français | kétoconazole 1-[4-[4-[[(2 SR ,4 RS )-2-(2,4-dichlorophényl)-2-(imidazol-1-ylméthyl)-1,3-dioxolan-4-yl]méthoxy]phényl]pipérazin-1-yl]éthanone |
| Croatian hrvatski | ketoconazole 1-[4-[4-[[(2 SR , 4 RS )-2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]ethanone |
| Italian italiano | chetoconazolo 1-[4-[4-[[(2 SR ,4 RS )-2-(2,4-diclorofenil)-2-(imidazol-1-ilmetil)-1,3-diossolan-4-il]metossi]fenil]piperazin-1-il]etanone |
| Latvian latviešu | ketokonazols 1-[4-[4-[[(2 SR , 4 RS )-2-(2,4-dihlorfenil)-2-(imidazol-1-ilmetil)-1,3-dioksolān-4-il]metoksi]fenil]piperazīn-1-il]etanons |
| Lithuanian lietuvių | ketokonazolas 1-[4-[4-[[(2 SR ,4 RS )-2-(2,4-dichlorfenil)-2-(imidazol-1-ilmetil)-1,3-dioksolan-4-il]metoksi]fenil]piperazin-1-il]etanonas |
| Hungarian magyar | ketokonazol 1-[4-[4-[[(2 SR , 4 RS )-2-(2,4-diklórfenil)-2-(imidazol-1-ilmetil)-1,3-dioxolán-4-il]metoxi]fenil]piperazin-1-il]etanon |
| Maltese Malti | ketokonażol 1-[4-[4-[[(2 SR , 4 RS )-2-(2,4-diklorofenil)-2-(imidażol-1-ilmetil)-1,3-diossolan-4-il]metossi]fenil]piperażin-1-il]etanon |
| Dutch Nederlands | ketoconazool 1-[4-[4-[[(2 SR , 4 RS )-2-(2,4-dichloorfenyl)-2-(imidazool-1-ylmethyl)-1,3-dioxolaan-4-yl]methoxy]fenyl]piperazine-1-yl]ethanon |
| Polish polski | ketokonazol l-[4-[4-[[(2 SR ,4 RS )-2-(2,4-dichlorofenylo)-2-(imidazol-1-ilometylo)-1,3-dioksolan-4-ylo]metoksy]fenylo]piperazyn-1-ylo]etanon |
| Portuguese português | cetoconazole 1-[4-[4-[[(2 SR ,4 RS )-2-(2,4-diclorofenil)-2-(imidazol-1-ilmetil)-1,3-dioxolan-4-il]metoxi]fenil]piperazin-1-il]etanona |
| Romanian română | cetoconazol 1-[4-[4-[[(2 SR ,4 RS )-2-(2,4-diclorfenil)-2-(imidazol-1-ilmetil)-1,3-dioxolan-4-il]metoxi]fenil]piperazin-1-il]etanonă |
| Slovak slovenčina | ketokonazol 1-[4-(4-{[(2 SR ,4 RS )-2-(2,4-dichlórfenyl)-2-(imidazol-1-ylmetyl)-1,3-dioxolán-4-yl]metoxy}fenyl)piperazín-1-yl]etanón |
| Slovenian slovenščina | ketokonazol 1-[4-[4-[[(2 SR ,4 RS )-2-(2,4-diklorofenil)-2-(imidazol-1-ilmetil)-1,3-dioksolan-4-il]metoksi]fenil]piperazin-1-il]etanon |
| Finnish suomi | ketokonatsoli 1-[4-[4-[[(2 SR ,4 RS )-2-(2,4-dikloorifenyyli)-2-(imidatsol-1-yylimetyyli)-1,3-dioksolan-4-yyli]metoksi]fenyyli]piperatsin-1-yyli]etanoni |
| Swedish svenska | ketokonazol 1-[4-[4-[[(2 SR , 4 RS )-2-(2,4-diklorfenyl)-2-(imidazol-1-ylmetyl)-1,3-dioxolan-4-yl]metoxi]fenyl]piperazin-1-yl]etanon |
All 23 language editions of Annex VI carry this entry. Irish is the twenty-fourth official EU language and has no line here for a different reason: no consolidated CLP text has ever been published in Irish, so there is no Irish edition of Annex VI to quote a name from. Source: consolidated CLP, CELEX 02008R1272, language editions. © European Union, https://eur-lex.europa.eu — only the electronic Official Journal of the European Union is authentic.
06 · Label elements
Ketoconazole GHS label elements
Everything CLP Annex VI fixes for Ketoconazole, laid out the way it appears on a label. The greyed lines are the parts only the supplier can fill in.
Danger
Ketoconazole
- May damage fertility.
- Toxic if swallowed.
- May cause damage to organs <or state all organs affected, if known> through prolonged or repeated exposure <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
- Very toxic to aquatic life.
- Very toxic to aquatic life with long lasting effects.
- Do not breathe dust/fume/gas/mist/vapours/spray.
- Do not eat, drink or smoke when using this product.
- Avoid release to the environment.
- IF SWALLOWED:
- Immediately call a POISON CENTER/doctor/…
- Get medical advice/attention if you feel unwell.
- Rinse mouth.
- Collect spillage.
- Dispose of contents/container to …
Supplier name, address and telephone number· Product identifier·Nominal quantity
Need this as an actual label? Open Ketoconazole in the GHS label constructor →
07 · Physical and chemical properties
Ketoconazole properties
Every value is shown with the conditions it was measured under and the source it came from. Where sources disagree, all values are listed rather than one being picked — the difference is usually a different form of the substance, not an error.
Ketoconazole melting point
| Property | Value | Conditions | Source |
|---|---|---|---|
| Melting point | 146 °C (294.8 °F) | HSDB | |
| 150 °C (302 °F) | range, midpoint shown | ICSC |
Ketoconazole solubility
| Property | Value | Conditions | Source |
|---|---|---|---|
| Solubility | Solubility in water: none | ICSC | |
| 0.0866 mg/L | HMDB |
Ketoconazole vapor pressure
| Property | Value | Conditions | Source |
|---|---|---|---|
| Vapor pressure | Vapor pressure, Pa at 25 °C: (negligible) | at 25 °C | ICSC |
Values compiled from PubChem Laboratory Chemical Safety Summary. Temperatures converted to Fahrenheit for reference.
08 · Fire and explosion
Ketoconazole fire and explosion behaviour
These are descriptions rather than measured values, so they are kept out of the table above and quoted here with the source that reported them.
Ketoconazole fire potential
Not combustible.
Source: Hazardous Substances Data Bank (HSDB)
09 · Handling and storage
Ketoconazole storage and handling
Ketoconazole safe storage
Provision to contain effluent from fire extinguishing. Well closed. Separated from food and feedstuffs. Store in an area without drain or sewer access.
Source: ILO-WHO International Chemical Safety Cards (ICSCs)
Ketoconazole storage conditions
Store at controlled room temperature 15 deg - 25 °C (59 deg - 77 °F). Protect from moisture.
Source: Hazardous Substances Data Bank (HSDB)
Ketoconazole incompatible materials
Incompatible materials: Strong oxidizing agents.
Source: Hazardous Substances Data Bank (HSDB)
Planning storage for a mix of chemicals? Check Ketoconazole in the storage compatibility matrix →
10 · Questions
Ketoconazole — frequently asked questions
What is the CAS number of Ketoconazole?
The CAS number of Ketoconazole is 65277-42-1. Its EC number is 265-667-4.
What is the chemical formula of Ketoconazole?
The molecular formula of Ketoconazole is C26H28Cl2N4O4 and its molecular weight is 531.4 g/mol.
What does a Ketoconazole label have to show?
Under CLP Annex VI the label for Ketoconazole carries the pictograms Skull and crossbones, Health hazard and Environment and the signal word is Danger.
Is Ketoconazole flammable?
CLP Annex VI assigns Ketoconazole no flammability hazard class. That is not a statement that it cannot burn: the harmonised list only records the hazards that were assessed for it.
Is Ketoconazole a carcinogen?
CLP Annex VI records no harmonised carcinogenicity classification for Ketoconazole. Annex VI is a list of agreed classifications, not a list of substances found safe, so this is an absence of a classification rather than a clean bill of health.
What is the melting point of Ketoconazole?
The melting point reported for Ketoconazole is 146 °C (294.8 °F) (HSDB).
How should Ketoconazole be stored?
Store at controlled room temperature 15 deg - 25 °C (59 deg - 77 °F). Protect from moisture. (Hazardous Substances Data Bank (HSDB))
Nearby
Substances next to Ketoconazole
Keep going: substances starting with K, or search the whole database by name, CAS number, pictogram or signal word.