Registration Dossier

Classification & Labelling & PBT assessment

DSD-DPD

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
Status:
other: This substance classification is based upon that of the final drug active Voriconazole on a precautionary basis.

Related composition

Related composition:
Composition 1

Classification

Explosiveness

Reason for no classification:
data lacking

Oxidising properties

Reason for no classification:
data lacking

Flammability

Reason for no classification:
data lacking

Thermal stability

Reason for no classification:
data lacking

Acute toxicity

Classification:
Xn; R22 Harmful if swallowed.

Acute toxicity - irreversible damage after single exposure

Reason for no classification:
data lacking

Repeated dose toxicity

Reason for no classification:
data lacking

Irritation / corrosion

Reason for no classification:
data lacking

Sensitisation

Reason for no classification:
data lacking

Carcinogenicity

Classification:
Carc. Cat. 3; R40 Limited evidence of a carcinogenic effect.

Mutagenicity - genetic toxicity

Reason for no classification:
data lacking

Toxicity to reproduction - fertility

Reason for no classification:
data lacking

Toxicity to reproduction - development

Classification:
Repr. Cat. 2; R61 May cause harm to the unborn child.

Toxicity to reproduction - breastfed babies

Reason for no classification:
data lacking

Environment

Classification:
R52/53 Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

Labelling

Indication of danger

T - toxic

Risk phrases

R22 - Harmful if swallowed
R40 - Limited evidence of a carcinogenic effect
R52/53 - Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment
R61 - May cause harm to the unborn child

Specific concentration limits

Notes