General Information
Version
5.0
Revision date
2023-09-30
Product name
Ezetimibe / Simvastatin Formulation
1.2.1 Relevant identified uses
Pharmaceutical
Emergency telephone
+1-551-430-6000, +1-215-631-6999
Icons in SDS
Company Information
company name
Organon & Co
e-mail address of the competent person responsible for the Safety Data Sheet
EHSSTEWARD@organon.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H315, H317, H372, H411
Hazard statements
Code
Statements
H315
Causes skin irritation
Section 2
SECTION 2: Hazards identification
Regulation (EC) No. 1272/2008 Classification of the substance or mixture
Signal word
Danger
Hazard statements
H315 Causes skin irritation. H317 May cause an allergic skin reaction. H372 Causes damage to organs through prolonged or repeated exposure. H411 Toxic to aquatic life with long lasting effects.
Prevention
P260 Do not breathe dust. P264 Wash skin thoroughly after handling. P273 Avoid release to the environment. P280 Wear protective gloves.
Response
P314 Get medical advice/ attention if you feel unwell. P391 Collect spillage.
Hazardous Ingredients
Simvastatin
2.3 Other hazards
This substance/mixture contains no components considered to be either persistent, bioaccumula- tive 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 regu- lation (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. Dust contact with the eyes can lead to mechanical irritation. May form explosive dust-air mixture during processing, handling or other means.
2.1 Classification of the substance or mixture
Classification (REGULATION (EC) No 1272/2008) Skin irritation, Category 2 H315: Causes skin irritation. Skin sensitisation, Category 1 H317: May cause an allergic skin reaction. Specific target organ toxicity - repeated H372: Causes damage to organs through pro- exposure, Category 1 longed or repeated exposure. Long-term (chronic) aquatic hazard, Cat- H411: Toxic to aquatic life with long lasting effects. egory 2
