Summary of Classification and Labelling
Harmonised classification - Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation)
General Information
Index Number EC / List no. CAS Number International Chemical Identification
613-283-00-6 265-667-4 65277-42-1 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

ATP Inserted / Updated: ATP01
CLP Classification (Table 3)
Classification Labelling Specific Concentration limits, M-Factors, Acute Toxicity Estimates (ATE) Notes
Hazard Class and Category Code(s) Hazard Statement Code(s) Hazard Statement Code(s) Supplementary Hazard Statement Code(s) Pictograms, Signal Word Code(s)
Acute Tox. 3 * H301 H301 GHS08
GHS09
GHS06
Dgr
STOT RE 2 * H373 ** H373 **
Aquatic Acute 1 H400
Aquatic Chronic 1 H410 H410
Repr. 1B H360F *** H360F ***

Signal Words Pictograms
Danger
GHS08
Health hazard
GHS09
Environment
GHS06
Skull and crossbones
Seveso III Data
Disclaimer: Please note that some of the substances covered by the Seveso Directive can belong to more than one Seveso categories. It will be up to the users to decide whether their substance or mixture fall in one or in more of these classification categories depending on the tonnage bands and the concentrations.
Please also note that ECHA is not an authority for the Seveso Directive and that the Seveso categorisation below is provided for information only. The Seveso III Directive (Directive 2012/18/EU repealing Directive 96/82/EC (Seveso II) from 1 June 2015) is the only authentic legal reference and that the information in this inventory does not constitute legal advice. For further information on Seveso, please ask your national authority.

Seveso Data
Seveso Substance Seveso Categories
Yes E1
Notified classification and labelling
General Information
EC / List no.
Name CAS Number
265-667-4 Ketoconazole 65277-42-1

Notified classification and labelling according to CLP criteria
Classification Labelling Specific Concentration limits, M-Factors Notes Classification affected by Impurities / Additives

Additional Notified Information

Number of Notifiers

Joint Entries

Hazard Class and Category Code(s) Hazard Statement Code(s) Hazard Statement Code(s) Supplementary Hazard Statement Code(s) Pictograms, Signal Word Code(s)
Acute Tox. 3 H301 H301 GHS08
GHS09
GHS06
Dgr
State/Form
54 View details
Repr. 1B H360 (F) H360 (F)
STOT RE 2 H373 H373
STOT RE 2 H373 (other:-) H373
Aquatic Acute 1 H400  
Aquatic Chronic 1 H410 H410
Acute Tox. 3 H301 H301 GHS08
GHS09
GHS06
Dgr
State/Form
38 View details
Repr. 1B H360 (F) H360 (F)
STOT RE 2 H373 H373
Aquatic Acute 1 H400  
Aquatic Chronic 1 H410 H410
Acute Tox. 3 H301 H301 GHS08
GHS09
GHS06
Dgr
28 View details
Repr. 1B H360F (H360F:May damag...) H360F (May damage fert...)
STOT RE 2 H373 (other:No specif...) H373 (May cause damag...)
Aquatic Acute 1 H400  
Aquatic Chronic 1 H410 H410
Acute Tox. 3 H301 H301 GHS08
GHS09
GHS06
Dgr
State/Form
5 View details
Repr. 1B H360 (H360F May damag...) H360
STOT RE 2 H373 (Bones) H373
Aquatic Acute 1 H400  
Aquatic Chronic 1 H410 H410
Acute Tox. 3 H301 H301 GHS08
GHS09
GHS06
Dgr
State/Form
3 View details
Repr. 1B H360 (F) H360
STOT RE 2 H373 H373
Aquatic Acute 1 H400  
Aquatic Chronic 1 H410 H410
Acute Tox. 3 H301 H301 GHS08
GHS09
GHS06
Dgr
State/Form
1 View details
Repr. 1B H360 (oral) (H360F: May dama...) H360
STOT RE 2 H373 (Damage to organ...) H373
Aquatic Chronic 1 H410 H410
Skin Irrit. 2 H315 H315 GHS07
Wng
1 View details
Eye Irrit. 2 H319 H319
STOT SE 3 H335 (not specified) H335
STOT SE 3 H335 (Not Specified) H335
Acute Tox. 3 H301 H301 GHS08
GHS09
GHS06
Dgr
State/Form
1 View details
Repr. 1B H360 H360
Aquatic Acute 1 H400 H400
Aquatic Chronic 1 H410 H410
Acute Tox. 3 H301 H301 GHS08
GHS09
GHS06
Dgr
1 View details
Repr. 1B H360 (May damage fert...) H360
STOT RE 2 H373 (other:Damage to...) H373
STOT RE 2 H373 (Damage to organ...) H373
Aquatic Acute 1 H400  
Aquatic Chronic 1 H410 H410
Acute Tox. 3 H311   GHS08
GHS09
GHS06
Dgr
1 View details
Repr. 1B H360 H360
STOT RE 2 H373 (other:data lack...) H373
STOT RE 2 H373 (data lacking) H373
Aquatic Acute 1 H400  
Aquatic Chronic 1 H410 H410
Acute Tox. 3 H301 H301 GHS08
GHS09
GHS06
Dgr
Note E
State/Form
1 View details
Repr. 1B H360 (H360F May damag...)  
STOT RE 2 H373 (other:Not provi...) H373
STOT RE 2 H373 (Not provided) H373
Aquatic Acute 1 H400 H400
Aquatic Chronic 1 H410 H410
  H301 GHS08
GHS06
Dgr
1 View details
  H361
Acute Tox. 3 H301 H301 GHS08
GHS07
GHS09
GHS06
Dgr
State/Form
1 View details
Repr. 1A H360 H360
STOT RE 2 H373 (other:unknown) H373
Aquatic Acute 1 H400  
Aquatic Chronic 1 H410 H410
Acute Tox. 3 H301 H301 GHS08
GHS09
GHS06
Dgr
1 View details
Repr. 1B H360 (F) H360
STOT RE 2 H373 (other:-) H373
Aquatic Acute 1 H400  
Aquatic Chronic 1 H410 H410

Number of Aggregated Notifications: 14