General Information
Version
3.0
Revision date
2022-12-15
Product name
Trajenta film-coated tablets
Product Synonyms
Trajenta® film-coated tablets 5 mg; Trazenta® film-coated
1.2.1 Relevant identified uses
Pharmaceutical
1.2.2. Uses advised against
Safety Data Sheet only for the professional user., Refer to the on use product insert for complete instructions on usage
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
Section 2
SECTION 2: Hazards identification
Regulation (EC) No. 1272/2008 Classification of the substance or mixture
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. This drug is not subject to the labelling requirements under the Globally Harmonized System (GHS) The pharmacological effect of the medicament has to be considered (see package leaflet). This product does not contain titanium dioxide in its respirable form and would not be considered carcinogenic; however, upon crushing, grinding or other processing that could result in the gener- ation of respirable particulates, the Category 2 carcinogenic classification would apply.
2.1 Classification of the substance or mixture
Classification (REGULATION (EC) No 1272/2008) Not a hazardous substance or mixture.
