Registration Dossier

Classification & Labelling & PBT assessment

GHS

General Information

Name:
(2R,3R,11bR)-3-Isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-ol [(1S,4R)-7,7-Dimethyl-2-oxobicyclo[2.2.1]hept-1-yl]methanesulfonic acid (NBI-98782 CSA)
Implementation:
EU
Type of classification:
self-classification
Remarks:

NBI-98782 is the active metabolite of a class of compounds (tetrabenazine) that have caused an increase in serum prolactin in clinical trials due to dopamine depletion. Oral administration has caused symptoms of headache, fatigue, and dizziness.

Related composition

Related composition:
Composition 1

Classificationopen allclose all

Explosives
Reason for no classification:
data lacking
Flammable gases and chemically unstable gases
Reason for no classification:
conclusive but not sufficient for classification
Aerosols
Reason for no classification:
conclusive but not sufficient for classification
Oxidising gases
Reason for no classification:
conclusive but not sufficient for classification
Gases under pressure
Reason for no classification:
conclusive but not sufficient for classification
Flammable liquids
Reason for no classification:
conclusive but not sufficient for classification
Flammable solids
Reason for no classification:
data lacking
Self-reactive substances and mixtures
Reason for no classification:
conclusive but not sufficient for classification
Pyrophoric liquids
Reason for no classification:
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:
conclusive but not sufficient for classification
Oxidising solids
Reason for no classification:
data lacking
Organic peroxides
Reason for no classification:
conclusive but not sufficient for classification
Corrosive to metals
Reason for no classification:
data lacking
Desensitized explosives
Reason for no classification:
conclusive but not sufficient for classification
Acute toxicity - oral
Hazard category:
Acute Tox. 3
Hazard statement:
H301: Toxic if swallowed.
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
Reason for no classification:
data lacking
1. Specific target organ toxicity - single
Hazard category:
STOT Single Exp. 3
Hazard statement:
H336: May cause drowsiness or dizziness.
Affected organs:
central nervous system
1. Specific target organ toxicity - repeated
Hazard category:
STOT Rep. Exp. 2
Hazard statement:
H373: May cause damage to organs <or state all organs affected, if known> through prolonged or repeated exposure <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
Affected organs:
central nervous system
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:
Danger

Hazard pictogram

GHS06: skull and crossbones
GHS08: health hazard

Hazard statements

H301: Toxic if swallowed.
H336: May cause drowsiness or dizziness.
H373: May cause damage to organs <or state all organs affected, if known> through prolonged or repeated exposure <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.

Precautionary statements

P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
hands
P301+P310: IF SWALLOWED: Immediately call a POISON CENTER/doctor/…
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P312: Call a POISON CENTER/doctor/.../if you feel unwell.
P501: Dispose of contents/container to ... …in accordance with local/regional/national /international regulations (to be specified). Manufacturer/supplier or the competent authority to specify whether disposal requirements apply to contents, container or both.
location

Notes