Sedivet solution for injection

Boehringer Ing. Pharma GmbH & Co. KG

Revision date : 2023-08-11

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GHS08
Health risk rating 4
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

200-431-6/59-50-7

Name of the chemical

Chlorocresol

Concentration

N/A

General Information

Version

2.2

Revision date

2023-08-11

Product name

Sedivet solution for injection

Product Synonyms

Sedivet® solution for injection 1.0%, Romifidine hydrochloride

1.2.1 Relevant identified uses

Veterinary product

1.2.2. Uses advised against

Safety Data Sheet only for the professional user., For veteri- on use nary use only, Refer to the product insert for complete instruc- tions on usage

Emergency telephone

+498007790900, +1 703-527-3887, +49800 1817059

Icons in SDS

GHS08 M004 M009 M010 M011 M017 M059

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

GHS Information

Signal word

Warning

Hazard Codes

Hazard statements (CLP)

H371

Hazard statements

Code

Statements

H371

May cause damage to organs

Section 2

SECTION 2: Hazards identification

Regulation (EC) No. 1272/2008 Classification of the substance or mixture

Signal word

Warning

Hazard statements

H371 May cause damage to organs (Cardio-vascular system, Central nervous system).

Prevention

P260 Do not breathe mist or vapours. P264 Wash skin thoroughly after handling. P270 Do not eat, drink or smoke when using this prod- uct.

Response

P308 + P311 IF exposed or concerned: Call a POISON CENTER/ doctor.

Storage

P405 Store locked up.

Disposal

P501 Dispose of contents/ container to an approved waste disposal plant.

Hazardous Ingredients

1H-Imidazol-2-amine, N-(2-bromo-6-fluorophenyl)-4,5-dihydro-, monohydrochloride

Additional information

EUH208

Contains

4-chlorocresol. May produce an allergic reaction The following percentage of the mixture consists of ingredient(s) with unknown hazards to the aquatic environment: 1 %

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).

2.1 Classification of the substance or mixture

Classification (REGULATION (EC) No 1272/2008) Specific target organ toxicity - single ex- H371: May cause damage to organs. posure, Category 2, Cardio-vascular sys- tem, Central nervous system

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