Also known as: Piperazine, 1-acetyl-4-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-, rel-, (+/-)-Ketoconazole, cis-1-Acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazole-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine, Ethanone, 1-[4-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]-, rel-, Piperazine, 1-acetyl-4-(4-((2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl)methoxy)phenyl)-, cis- (+7 more)
CAS 65277-42-1
Ketoconazole (CAS 65277-42-1) is a chemical substance with GHS signal word Danger; key hazard signal: H360F ***; H301; H373 **; H400; H410. Key regulatory status: 7 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from ECHA CLP, EPA ToxValDB, EPA CPDat, ILO ICSC.
Ketoconazole is prohibited in EU cosmetics but has active industrial GHS classifications (H360F, H301, H373, H400, H410).
CAS, identifiers, formula, and alternate names for the matched substance record.
EU harmonized hazard classification, hazard statements, pictograms, and signal word.
| Hazard Class | H-Statements | Pictograms | Signal |
|---|---|---|---|
| Repr. 1B; Acute Tox. 3 *; STOT RE 2 *; Aquatic Acute 1; Aquatic Chronic 1 | H360F ***; H301; H373 **; H400; H410 | GHS08; GHS06; GHS09 | Danger |
International Chemical Safety Card hazard and exposure summary.
| Field | Value |
|---|---|
| GHS Signal Word | DANGER |
| GHS Hazard Statements | Toxic if swallowed May damage fertility or the unborn child Causes damage to endocrine system through prolonged or repeated exposure if swallowed Very toxic to aquatic life |
| Long-term Effects | 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. |
| Routes of Exposure | The substance can be absorbed into the body by ingestion. |
Industrial and product-use categories associated with this substance.
Inventory, screening, and regulatory list matches from public chemical databases.
| List | Keyword | Source |
|---|---|---|
| pharmaceutical | US International Trade Commission | CPCat |
| pharmaceutical | FDA | United States Food and Drug Administration (FDA) |
| Europe; pharmaceutical | European Medicines Agency | PROTECT ADR database |
| Canada; pharmaceutical | DrugBank | DrugBank |
| Canada; pharmaceutical | DrugBank | DrugBank |
| Europe; Personal care - hair styling and care - shampoo-dandruff | Danish Environmental Protection Agency | Danish EPA |
| banned; Europe; Personal care | European Commission | CosIng |
Toxicology endpoints rendered from public NOAEL study rows.
| Value | Unit | Endpoint | Route | Species | Source |
|---|---|---|---|---|---|
| 23.73 | uM | AC50 | - | - | NTP ICE endocrine |
| 44.93 | uM | AC50 | - | - | NTP ICE endocrine |
| 3.236e+4 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 5.888e+4 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 6.310e+4 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 6.400e+4 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 13.42 | uM | ACC | - | - | NTP ICE endocrine |
| 29.41 | uM | ACC | - | - | NTP ICE endocrine |
| 55 | uL/min/10^6 cells | Clint | - | Human | NTP ICE adme parameters |
| R9400W927I | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 0.062 | fraction | Fu | - | Human | NTP ICE adme parameters |
| <3000 | nM | IC25 | - | - | NTP ICE endocrine |
| =166 | mg/kg bw | LD50 | oral | Rat | NTP ICE acute oral |
| 0 | unitless | Model Score | - | - | NTP ICE endocrine |
| 0.015 | unitless | Model Score | - | - | NTP ICE endocrine |
| 0.204 | unitless | Model Score | - | - | NTP ICE endocrine |
| =30 | mg/kg bw/day | NOEC | oral | Mouse | ToxValDB ECOTOX |
| <6.25 | mg/kg bw/day | NOEL | oral | Rat | ToxValDB HESS |
| =100 | mg/kg/org | NOEL | oral | Rat | ToxValDB ECOTOX |
| 0.0006 | unitless | RBA | - | - | NTP ICE endocrine |
| 0.002 | unitless | RBA | - | - | NTP ICE endocrine |
| 0.0055 | unitless | RBA | - | - | NTP ICE endocrine |
Showing 22 of 22 studies
Same-CAS cosmetic ingredient record for cross-vertical context.
Same-CAS pharmaceutical records from drug and bioactivity sources.
Ketoconazole (CAS 65277-42-1) is classified under EU CLP Annex VI as Repr. 1B; Acute Tox. 3 *; STOT RE 2 *; Aquatic Acute 1; Aquatic Chronic 1 with signal word Danger. Hazard statements: H360F ***; H301; H373 **; H400; H410. Source: EU CLP Annex VI (ECHA).
Ketoconazole has 22 NOAEL studies in the database. The lowest reported value is 0 unitless. Source: NTP ICE endocrine.
Ketoconazole appears on 5 regulatory/inventory lists including pharmaceutical, Europe; pharmaceutical, Canada; pharmaceutical, and 2 more. Source: EPA CPDat.
Yes, Ketoconazole is also indexed as a cosmetic ingredient under the name Ketoconazole. View the full cosmetic safety profile on the ingredient page for detailed safety data, SCCS opinions, and regulatory status.
Safety data is sourced from ECHA CLP Annex VI, EPA ToxValDB, EPA CPDat, EPA DSSTox, ILO/WHO ICSC, CosIng / Ingredients DB, ChEMBL / DailyMed. All data traces to primary regulatory sources and is updated from official government databases.
Ketoconazole is prohibited in EU cosmetics but has active industrial GHS classifications (H360F, H301, H373, H400, H410).
Ketoconazole also appears in cosmetics, pharmaceutical databases.