Registration Dossier

Classification & Labelling & PBT assessment

GHS

General Information

Name:
Metronidazole
Implementation:
EU
Type of classification:
self-classification
Remarks:

This substance is currently listed on the substances list published by ECHA of those who has met REACH Annex III criteria.

The Annex III inventory is an advisory list, there are not detailed information about the used model and the predictions do not follow OECD principles.

Therefore, the following data can only be used as screening information, but they are not to be considered relevant for the classification and labelling:

# Suspected carcinogen: The Toolbox profiler 'Carcinogenicity (genotox and nongenotox) alerts by ISS' gives an alert for carcinogenicity; CAESAR Carcinogenicity model in VEGA (Q)SAR platform predicts that the chemical is Carcinogen (EXPERIMENTAL value); ISS Carcinogenicity model in VEGA (Q)SAR platform predicts that the chemical is Carcinogen (EXPERIMENTAL value); IARC monographs classified the substance as carcinogenic or probably/possibly carcinogenic; carcinogen according to ISSCAN; reasonably anticipated to be a human carcinogen according to NTP 13th RoC

# Suspected hazardous to the aquatic environment: The Danish QSAR database contains information indicating that the substance has a 48h EC50 to Daphnia of 12.07 mg/L; The Danish QSAR database contains information indicating that the substance has a 96h EC50 to green algae of <1 mg/L

# Suspected mutagen: The Toolbox profiler 'DNA alerts for AMES, MN and CA by OASIS v.1.3' gives an alert for mutagenicity; The Toolbox profiler 'in vitro mutagenicity (Ames test) alerts by ISS' gives an alert for mutagenicity; CAESAR Mutagenicity model in VEGA (Q)SAR platform predicts that the chemical is Mutagen (EXPERIMENTAL value); ISS Mutagenicity model in VEGA (Q)SAR platform predicts that the chemical is Mutagen (EXPERIMENTAL value); KNN Mutagenicity model in VEGA (Q)SAR platform predicts that the chemical is Mutagen (EXPERIMENTAL value); SARPY Mutagenicity model in VEGA (Q)SAR platform predicts that the chemical is Mutagen (EXPERIMENTAL value); The outcome in CTA assay is positive according to ISSCTA; mutagen according to ISSSTY

# Suspected persistent in the environment: The Danish QSAR database contains information indicating that the substance is predicted as non readily biodegradable

# Suspected skin sensitiser: The Toolbox profiler 'Protein binding alerts for skin sensitization by OASIS v1.3' gives an alert for skin sensitisation

# Suspected toxic for reproduction: The Toolbox profiler 'DART scheme v.1.0' gives an alert for toxicity to reproduction

Related composition

Related composition:
Composition 2

Classificationopen allclose all

Explosives
Reason for no classification:
data lacking
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:
data lacking
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:
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:
conclusive but not sufficient for classification
Oxidising solids
Reason for no classification:
data lacking
Organic peroxides
Reason for no classification:
conclusive but not sufficient for classification
Corrosive to metals
Reason for no classification:
data lacking
Desensitized explosives
Reason for no classification:
conclusive but not sufficient for classification
Acute toxicity - oral
Reason for no classification:
data lacking
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
Reason for no classification:
data lacking
Effects on or via lactation
Reason for no classification:
data lacking
Germ cell mutagenicity
Hazard category:
Muta. 2
Hazard statement:
H341: Suspected of causing genetic defects <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
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>.
1. Specific target organ toxicity - single
Reason for no classification:
data lacking
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 3
Hazard statement:
H412: Harmful to aquatic life with long lasting effects.
Hazardous to the ozone layer
Reason for no classification:
data lacking

Labelling

Signal word:
Danger

Hazard pictogram

GHS08: health hazard

Hazard statements

H341: Suspected of causing genetic defects <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
H351: Suspected of causing cancer <state route of exposure if it is conclusively proven that no other routs of exposure cause the hazard>.
H412: Harmful 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.
P308+P313: IF exposed or concerned: Get medical advice/attention.
P405: Store locked up.
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.

Notes