Phenytoin

GHS

General Information

Name:

CLP

Implementation:

EU

Remarks:

This substance is currently listed on the substances list published by ECHA of those whose 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 acutely toxic via the oral route: The Danish QSAR database contains information indicating that the substance is predicted as toxic via the oral route.

# Suspected carcinogen: 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 96h LC50 to fish of 25.12 mg/L; The Danish QSAR database contains information indicating that the substance has a 48h EC50 to Daphnia of 5.93 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 outcome in CTA assay is positive according to ISSCTA # Suspected persistent in the environment: Biodegradation NITE database in the Toolbox contains at least one experimental data from 28 days ready biodegradability test (OECD TG 301C or 301D) reporting a value lower than 60%;The Danish QSAR database contains information indicating that the substance is predicted as non readily biodegradable

# Suspected toxic for reproduction: The Toolbox profiler 'DART scheme v.1.0' gives an alert for toxicity to reproduction;CAESAR developmental toxicity model in VEGA (Q)SAR platform predicts that the chemical is Toxicant (EXPERIMENTAL value); Developmental/Reproductive Toxicity library (PG) in VEGA (Q)SAR platform predicts that the chemical is Toxicant (EXPERIMENTAL value); DART database in the Toolbox reports that this substance as Known developmental potential

Related composition

Related composition:

boundary composition

legal entity composition

Classification

Physical hazards

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

Health hazards

Acute toxicity - oral

Hazard category:

Acute Tox. 4

Hazard statement:

H302: Harmful 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

Environmental hazards

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

GHS07: exclamation mark

GHS08: health hazard

Hazard statements

H302: Harmful 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>.

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.

P280: Wear protective gloves/protective clothing/eye protection/face protection/hearing protection/...

P308+P313: IF exposed or concerned: Get medical advice/attention.

P501: Dispose of contents/container to ...