Note: Ingredients listed on restricted chemical lists
EC/CAS
200-578-6/64-17-5
Name of the chemical
Ethanol
Concentration
>=1-<10 >=50%
EC/CAS
204-498-2/121-79-9
Name of the chemical
Propyl 3,4,5-trihydroxybenzoate
Concentration
=0,1-<0,25
General Information
Version
2.1
Revision date
2023-11-16
Product name
Aptivus capsules
Product Synonyms
Aptivus® capsules 250 mg, Elodius® capsules 250 mg
1.2.1 Relevant identified uses
Pharmaceutical
1.2.2. Uses advised against
Safety Data Sheet only for the professional user on use
Emergency telephone
+498007790900, +1 703-527-3887, +49800 1817059
Icons in SDS
Company Information
company name
Boehringer Ing. Pharma GmbH & Co. KG
e-mail address of the competent person responsible for the Safety Data Sheet
EHS-Services@Boehringer-Ingelheim.com
Hazard Codes
Hazard statements (CLP)
H412
Hazard statements
Code
Statements
H412
Harmful to aquatic life with long lasting effects
Section 2
SECTION 2: Hazards identification
Regulation (EC) No. 1272/2008 Classification of the substance or mixture
Hazard statements
H412 Harmful to aquatic life with long lasting effects.
Prevention
P273 Avoid release to the environment.
Disposal
P501 Dispose of contents/ container to an approved waste disposal plant.
Additional information
EUH208 Contains propyl 3,4,5-trihydroxybenzoate. May produce an allergic reaction.
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. 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. 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. 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. The pharmacological effect of the medicament has to be considered (see package leaflet). This drug is not subject to the labelling requirements under the Globally Harmonized System (GHS)
2.1 Classification of the substance or mixture
Classification (REGULATION (EC) No 1272/2008) Long-term (chronic) aquatic hazard, Cat- H412: Harmful to aquatic life with long lasting ef- egory 3 fects.
