Registration Dossier

Classification & Labelling & PBT assessment

GHS

General Information

Name:
4,4'-Oxydianiline
Implementation:
EU
Type of classification:
harmonised classification
Remarks:

This substance is only imported as a monomer within a polymer.

The labelling is in accordance with GHS / EU CLP Regulations, with the exception of:
H317: May cause an allergic skin reaction

This is based on the data utilised within this submission indicates that this labelling would apply in addition to that already proposed. In accordance with Article 37(6) of CLP, if information is available to suggest that the classification on Annex VI needs to be amended, then the manufacturer, importer or downstream user can then submit a proposal to amend the C&L to the competent authority in the Member State in which the substance is placed on the market. That member state can then decide if they wish to take that proposal forward. The registrant intends to examine this further.

Related composition

Related composition:
Composition 4

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 conclusive but not sufficient for classification
Flammable solids
Reason for no classification:
data conclusive but not sufficient for classification
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 conclusive but not sufficient for classification
Self-heating substances and mixtures
Reason for no classification:
data conclusive but not sufficient for classification
Substances and mixtures which in contact with water emit flammable gases
Reason for no classification:
data conclusive but not sufficient for classification
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 conclusive but not sufficient for classification
Desensitized explosives
Reason for no classification:
data lacking
Acute toxicity - oral
Hazard category:
Acute Tox. 3
Hazard statement:
H301: Toxic if swallowed.
Acute toxicity - dermal
Hazard category:
Acute Tox. 3
Hazard statement:
H311: Toxic in contact with skin.
Acute toxicity - inhalation
Hazard category:
Acute Tox. 3
Hazard statement:
H331: Toxic if inhaled.
Skin corrosion / irritation
Reason for no classification:
data conclusive but not sufficient for classification
Serious eye damage / eye irritation
Reason for no classification:
data conclusive but not sufficient for classification
Respiratory sensitisation
Reason for no classification:
data conclusive but not sufficient for classification
Skin sensitisation
Hazard category:
Skin Sens. 1
Hazard statement:
H317: May cause an allergic skin reaction.
Aspiration hazard
Reason for no classification:
data conclusive but not sufficient for classification
Reproductive toxicity
Hazard category:
Repr. 2
Hazard statement:
H361: Suspected of damaging fertility or the unborn child <state specific effect if known> <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
Specific effect:
Testicular effects.
Route of exposure:
Oral
Effects on or via lactation
Reason for no classification:
data conclusive but not sufficient for classification
Germ cell mutagenicity
Hazard category:
Muta. 1B
Hazard statement:
H340: May cause genetic defects <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
Route of exposure:
Oral
Carcinogenicity
Hazard category:
Carc. 1B
Hazard statement:
H350: May cause cancer <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
Route of exposure:
Oral
1. Specific target organ toxicity - single
Reason for no classification:
data lacking
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:
Thyroid, testes, seminal vesicles, kidneys, liver, eyes
Route of exposure:
Oral
Remarks:
(dietary administration)
1.
Concentration range (%):
0.1
Hazard categories:
Skin Sens. 1
Carc. 1B
Hazardous to the aquatic environment (acute / short-term)
Hazard category:
Aquatic Acute 1
Hazard statement:
H400: Very toxic to aquatic life.
Hazardous to the aquatic environment (long-term)
Hazard category:
Aquatic Chronic 1
Hazard statement:
H410: Very toxic to aquatic life with long lasting effects.
M-Factor acute:
1
M-Factor chronic:
1
Hazardous to the ozone layer
Reason for no classification:
data lacking

Labelling

Signal word:
Danger

Hazard pictogram

GHS06: skull and crossbones
GHS08: health hazard
GHS09: environment

Hazard statements

H317: May cause an allergic skin reaction.
H350: May cause cancer <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
by oral exposure
H340: May cause genetic defects <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
by oral exposure
H361: Suspected of damaging fertility or the unborn child <state specific effect if known> <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
F
H301+H311+H331: Toxic if swallowed, in contact with skin or if inhaled.
H400: Very toxic to aquatic life.
H410: Very toxic to aquatic life with long lasting effects.

Precautionary statements

P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
hands
P270: Do not eat, drink or smoke when using this product.
P271: Use only outdoors or in a well-ventilated area.
P273: Avoid release to the environment.
P280: Wear protective gloves/protective clothing/eye protection/face protection/hearing protection/...
P281: Use personal protective equipment as required.
P301+P310: IF SWALLOWED: Immediately call a POISON CENTER/doctor/…
P302+P352: IF ON SKIN: Wash with plenty of water/…
P304+P312: IF INHALED: Call a POISON CENTER or doctor/physician if you feel unwell.
P308+P313: IF exposed or concerned: Get medical advice/attention.
P311: Call a POISON CENTER/doctor/…
P312: Call a POISON CENTER/doctor/.../if you feel unwell.
P314: Get medical advice/attention if you feel unwell.
P321: Specific treatment (see ... on this label).
MSDS
P322: Specific measures (see ... on this label).
MSDS
P330: Rinse mouth.
P333+P313: If skin irritation or rash occurs: Get medical advice/attention.
P361: Take off immediately all contaminated clothing.
P363: Wash contaminated clothing before reuse.
P391: Collect spillage.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P405: Store locked up.
P501: Dispose of contents/container to ...
licensed waste disposal company.

Notes