Registration Dossier

Classification & Labelling & PBT assessment

GHS

General Information

Name:
Fluvoxamine Base
Implementation:
EU
Remarks:

Fluvoxamine Base provides the pharmacologic and toxicological propierties of this compound.

Maleate counterion is pharmacologically acceptable and not dangerous.

Thus, Fluvoxamine Base classification is based on Fluvoxamine Maleate.

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:
data lacking
Aerosols
Reason for no classification:
data lacking
Oxidising gases
Reason for no classification:
data lacking
Gases under pressure
Reason for no classification:
data lacking
Flammable liquids
Reason for no classification:
data lacking
Flammable solids
Reason for no classification:
data lacking
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 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 lacking
Oxidising solids
Reason for no classification:
data lacking
Organic peroxides
Reason for no classification:
data lacking
Corrosive to metals
Reason for no classification:
data lacking
Desensitized explosives
Reason for no classification:
data lacking
Acute toxicity - oral
Hazard category:
Acute Tox. 4
Hazard statement:
H302: Harmful if swallowed.
Acute toxicity - dermal
Reason for no classification:
conclusive but not sufficient for classification
Acute toxicity - inhalation
Hazard category:
Acute Tox. 3
Hazard statement:
H331: Toxic if inhaled.
Skin corrosion / irritation
Reason for no classification:
data lacking
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
Reason for no classification:
data lacking
Aspiration hazard
Reason for no classification:
data lacking
Reproductive toxicity
Reason for no classification:
conclusive but not sufficient for classification
Effects on or via lactation
Reason for no classification:
data lacking
Germ cell mutagenicity
Reason for no classification:
conclusive but not sufficient for classification
Carcinogenicity
Reason for no classification:
conclusive but not sufficient for classification
1. Specific target organ toxicity - single
Hazard category:
STOT Single Exp. 3
Hazard statement:
H335: May cause respiratory irritation.
Affected organs:
respiratory system
Route of exposure:
Inhalation
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)
Hazard category:
Aquatic Chronic 1
Hazard statement:
H410: Very toxic to aquatic life with long lasting effects.
Hazardous to the ozone layer
Reason for no classification:
data lacking

Labelling

Signal word:
Danger

Hazard pictogram

GHS09: environment
GHS06: skull and crossbones
GHS07: exclamation mark

Hazard statements

H302: Harmful if swallowed.
H331: Toxic if inhaled.
H335: May cause respiratory irritation.
H319: Causes serious eye irritation.
H410: Very toxic to aquatic life with long lasting effects.

Precautionary statements

P273: Avoid release to the environment.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P311: Call a POISON CENTER/doctor/…
P301+P312: IF SWALLOWED: Call a POISON CENTER/doctor/... if you feel unwell.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P391: Collect spillage.

Notes