Note: Ingredients listed on restricted chemical lists
EC/CAS
265-667-4/65277-42-1
Name of the chemical
Ketoconazol; 1-[4-[4-[[(2SR,4RS)-2-(2,4-Dichlorphenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]ethanon (790/2009)
Concentration
>=90-<=100
General Information
Version
6.13
Revision date
2025-12-28
Product name
Ketoconazole
CAS No.
65277-42-1
REACH No
A
Emergency telephone
+56 2 2581 4934
Icons in SDS
Company Information
company name
Merck S.A
e-mail address of the competent person responsible for the Safety Data Sheet
atencionclientes@merckgroup.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H301, H360F, H373, H400, H410
Hazard statements
Code
Statements
H301
Toxic if swallowed
Section 2
SECTION 2: Hazards identification
Regulation (EC) No. 1272/2008 Classification of the substance or mixture
Signal word
Danger Danger
Hazard statements
H301 Toxic if swallowed. H360F May damage fertility. H373 May cause damage to organs through prolonged or repeated exposure. H410 Very toxic to aquatic life with long lasting effects. H301 Toxic if swallowed. H360F May damage fertility.
Precautionary statements
P202 Do not handle until all safety precautions have been read and understood. P260 Do not breathe dust. P264 Wash skin thoroughly after handling. P273 Avoid release to the environment. P280 Wear protective gloves/ protective clothing/ eye protection/ face protection. P202 Do not handle until all safety precautions have been read and understood. P264 Wash skin thoroughly after handling. P280 Wear protective gloves/ protective clothing/ eye protection/ face protection. P301 + P310 IF SWALLOWED: Immediately call a POISON CENTER/ doctor.
Response
P301 + P310 IF SWALLOWED: Immediately call a POISON CENTER/ doctor.
Additional information
Restricted to professional users. Reduced Labelling (<= 125 ml)
Supplemental label elements
none
2.3 Other hazards
This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher.
ECOLOGICAL INFORMATION
The substance/mixture does not contain components considered to have endocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.
TOXICOLOGICAL INFORMATION
The substance/mixture does not contain components considered to have endocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.
2.1 Classification of the substance or mixture
Classification (REGULATION (EC) No 1272/2008) Acute toxicity, Category 3 H301: Toxic if swallowed. Reproductive toxicity, Category 1B H360F: May damage fertility. Specific target organ toxicity - H373: May cause damage to organs through repeated exposure, Category 2 prolonged or repeated exposure. Short-term (acute) aquatic hazard, H400: Very toxic to aquatic life. Category 1 Long-term (chronic) aquatic hazard, H410: Very toxic to aquatic life with long Category 1 lasting effects.
