Registration Dossier

Classification & Labelling & PBT assessment

GHS

General Information

Name:
4,7-Methano-1H-isoindole-1,3(2H)-dione, 2-[[(1R,2R)-2-[[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]methyl]cyclohexyl]methyl]hexahydro-, (3aR,4S,7R,7aS)-
Implementation:
EU
Type of classification:
self-classification
Remarks:

classification as for the final API

Related composition

Related composition:
4,7-Methano-1H-isoindole-1,3(2H)-dione, 2-[[(1R,2R)-2-[[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]methyl]cyclohexyl]methyl]hexahydro-, (3aR,4S,7R,7aS)-

Classificationopen allclose all

Explosives
Reason for no classification:
data lacking
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
Reason for no classification:
hazard class not assessed
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 conclusive but not sufficient for classification
Flammable solids
Reason for no classification:
data lacking
Self-reactive substances and mixtures
Reason for no classification:
data conclusive but not sufficient for classification
Pyrophoric liquids
Reason for no classification:
data conclusive but not sufficient for classification
Pyrophoric solids
Reason for no classification:
data lacking
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 lacking
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 conclusive but not sufficient for classification
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
Reason for no classification:
data lacking
Serious eye damage / eye irritation
Reason for no classification:
data lacking
Respiratory sensitisation
Reason for no classification:
data lacking
Skin sensitisation
Reason for no classification:
data lacking
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
Hazard category:
Carc. 2
Hazard statement:
H351: Suspected of causing cancer <state route of exposure if it is conclusively proven that no other routs of exposure cause the hazard>.
1. Specific target organ toxicity - single (STOT-SE)
Hazard category:
STOT Single Exp. 3
Hazard statement:
H336: May cause drowsiness or dizziness.
Affected organs:
other: central nervous system
1. Specific target organ toxicity - repeated (STOT-RE)
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

GHS08: health hazard
GHS07: exclamation mark

Hazard statements

H351: Suspected of causing cancer <state route of exposure if it is conclusively proven that no other routs of exposure cause the hazard>.
H336: May cause drowsiness or dizziness.

Precautionary statements

P202: Do not handle until all safety precautions have been read and understood.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P308+P313: IF exposed or concerned: Get medical advice/attention.

Notes