Metronidazole

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 and they are considered in support to the available data.

# 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:

Metronidazole

Classification

Physical hazards

Explosives

Reason for no classification:

data lacking

Flammable gases and chemically unstable gases

Reason for no classification:

hazard class not applicable

Aerosols

Reason for no classification:

hazard class not applicable

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:

hazard class not applicable

Flammable liquids

Reason for no classification:

hazard class not applicable

Flammable solids

Reason for no classification:

data lacking

Self-reactive substances and mixtures

Reason for no classification:

data conclusive but not sufficient for classification

Pyrophoric liquids

Reason for no classification:

hazard class not applicable

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:

hazard class not applicable

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 conclusive but not sufficient for classification

Health hazards

Acute toxicity - oral

Reason for no classification:

data conclusive but not sufficient for classification

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 (STOT-SE)

Reason for no classification:

data lacking

1. Specific target organ toxicity - repeated (STOT-RE)

Reason for no classification:

data lacking

Environmental hazards

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>.

H350: May cause cancer <state route of exposure if it is conclusively proven that no other routes 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 ...