Registration Dossier

Diss Factsheets

Classification & Labelling & PBT assessment

GHS

General Information

Name:
(2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol (1R)-10-camphorsulfonate
Implementation:
EU
Remarks:
This substance classification is based upon that of the final drug active Voriconazole on a precautionary basis.

Related composition

Related composition:
(2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol (1R)-10-camphorsulfonate

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 lacking
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 lacking
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
Hazard category:
Repr. 1B
Hazard statement:
H360: May damage 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>.
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)
Reason for no classification:
data lacking
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:
Danger

Hazard pictogram

GHS08: health hazard
GHS06: skull and crossbones

Hazard statements

H301: Toxic if swallowed.
H351: Suspected of causing cancer <state route of exposure if it is conclusively proven that no other routs of exposure cause the hazard>.
H360: May damage 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>.
H360D - May damage the unborn child

Precautionary statements

P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P281: Use personal protective equipment as required.
P301+P310: IF SWALLOWED: Immediately call a POISON CENTER/doctor/…
P330: Rinse mouth.
P308+P313: IF exposed or concerned: Get medical advice/attention.
P405: Store locked up.
P501: Dispose of contents/container to ...

Notes