Registration Dossier

Classification & Labelling & PBT assessment

GHS

General Information

Name:
Betamethasone
Implementation:
EU

Related composition

Related composition:
Composition 4

Classificationopen allclose all

Explosives
Reason for no classification:
conclusive but not sufficient for classification
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:
conclusive but not sufficient for classification
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:
conclusive but not sufficient for classification
Self-heating substances and mixtures
Reason for no classification:
conclusive but not sufficient for classification
Substances and mixtures which in contact with water emit flammable gases
Reason for no classification:
conclusive but not sufficient for classification
Oxidising liquids
Reason for no classification:
conclusive but not sufficient for classification
Oxidising solids
Reason for no classification:
conclusive but not sufficient for classification
Organic peroxides
Reason for no classification:
conclusive but not sufficient for classification
Corrosive to metals
Reason for no classification:
conclusive but not sufficient for classification
Desensitized explosives
Reason for no classification:
data lacking
Acute toxicity - oral
Reason for no classification:
conclusive but not sufficient for classification
Acute toxicity - dermal
Reason for no classification:
conclusive but not sufficient for classification
Acute toxicity - inhalation
Reason for no classification:
conclusive but not sufficient for classification
Skin corrosion / irritation
Reason for no classification:
conclusive but not sufficient for classification
Serious eye damage / eye irritation
Reason for no classification:
conclusive but not sufficient for classification
Respiratory sensitisation
Reason for no classification:
conclusive but not sufficient for classification
Skin sensitisation
Reason for no classification:
conclusive but not sufficient for classification
Aspiration hazard
Reason for no classification:
conclusive but not sufficient for classification
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>.
Specific effect:
H360D. May produce resorption of embryos or cleft palate on newborns when exposed to Betamethasone on the first trimester of pregnancy. Prenatal treatment with betamethasone may result in long term effects for offspring.
Effects on or via lactation
Reason for no classification:
conclusive but not sufficient for classification
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
Reason for no classification:
conclusive but not sufficient for classification
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:
Liver, kidneys. Endocrine system.
Hazardous to the aquatic environment (acute / short-term)
Reason for no classification:
conclusive but not sufficient for classification
Hazardous to the aquatic environment (long-term)
Reason for no classification:
conclusive but not sufficient for classification
Hazardous to the ozone layer
Reason for no classification:
conclusive but not sufficient for classification

Labelling

Signal word:
Danger

Hazard pictogram

GHS08: health hazard

Hazard statements

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>.
D
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

P202: Do not handle until all safety precautions have been read and understood.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P281: Use personal protective equipment as required.
P314: Get medical advice/attention if you feel unwell.
P308+P313: IF exposed or concerned: Get medical advice/attention.
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.
Dispose of contents/container in accordance with local/regional/national/international

Notes