Registration Dossier

Classification & Labelling & PBT assessment

GHS

General Information

Name:
Reaction mass of betahistine and 2-Pyridineethanamine, N-methyl-N-[2-(2-pyridinyl)ethyl]-
Implementation:
EU
Remarks:

Self classification.

The substance is classified as Skin Irritant Category 2, Eye Irritant Category 2, Skin sensitiser Category 1 and STOT single Exp. 3 due to the concentration (% w/w) of the components that are present in the Reaction mass.

Related composition

Related composition:
Composition 1
Composition 2

Classificationopen allclose all

Explosives
Reason for no classification:
data conclusive but not sufficient for classification
Flammable gases and chemically unstable gases
Reason for no classification:
data conclusive but not sufficient for classification
Aerosols
Reason for no classification:
data conclusive but not sufficient for classification
Oxidising gases
Reason for no classification:
data conclusive but not sufficient for classification
Gases under pressure
Reason for no classification:
data conclusive but not sufficient for classification
Flammable liquids
Reason for no classification:
data lacking
Flammable solids
Reason for no classification:
data conclusive but not sufficient for classification
Self-reactive substances and mixtures
Reason for no classification:
data lacking
Pyrophoric liquids
Reason for no classification:
data lacking
Pyrophoric solids
Reason for no classification:
data conclusive but not sufficient for classification
Self-heating substances and mixtures
Reason for no classification:
data lacking
Substances and mixtures which in contact with water emit flammable gases
Reason for no classification:
data lacking
Oxidising liquids
Reason for no classification:
data conclusive but not sufficient for classification
Oxidising solids
Reason for no classification:
data conclusive but not sufficient for classification
Organic peroxides
Reason for no classification:
data conclusive but not sufficient for classification
Corrosive to metals
Reason for no classification:
data lacking
Desensitized explosives
Reason for no classification:
data lacking
Acute toxicity - oral
Reason for no classification:
data lacking
Acute toxicity - dermal
Reason for no classification:
data lacking
Acute toxicity - inhalation
Reason for no classification:
data lacking
Skin corrosion / irritation
Hazard category:
Skin Irrit. 2
Hazard statement:
H315: Causes skin irritation.
Serious eye damage / eye irritation
Hazard category:
Eye Irrit. 2
Hazard statement:
H319: Causes serious eye irritation.
Respiratory sensitisation
Reason for no classification:
data lacking
Skin sensitisation
Hazard category:
Skin Sens. 1
Hazard statement:
H317: May cause an allergic skin reaction.
Aspiration hazard
Reason for no classification:
data lacking
Reproductive toxicity
Reason for no classification:
data lacking
Effects on or via lactation
Reason for no classification:
data lacking
Germ cell mutagenicity
Reason for no classification:
data lacking
Carcinogenicity
Reason for no classification:
data lacking
1. Specific target organ toxicity - single
Hazard category:
STOT Single Exp. 3
Hazard statement:
H335: May cause respiratory irritation.
Affected organs:
Respiratory tract
1. Specific target organ toxicity - repeated
Reason for no classification:
data lacking
Hazardous to the aquatic environment (acute / short-term)
Reason for no classification:
data lacking
Hazardous to the aquatic environment (long-term)
Reason for no classification:
data lacking
Hazardous to the ozone layer
Reason for no classification:
data lacking

Labelling

Signal word:
Warning

Hazard pictogram

GHS07: exclamation mark

Hazard statements

H315: Causes skin irritation.
H319: Causes serious eye irritation.
H335: May cause respiratory irritation.
H317: May cause an allergic skin reaction.

Notes