Registration Dossier

Classification & Labelling & PBT assessment

GHS

General Information

Name:
16,17 alpha-Epoxypregnenolone
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; ISS Carcinogenicity model in VEGA (Q)SAR platform predicts that the chemical is Carcinogen (moderate reliability)

# Suspected hazardous to the aquatic environment: Fathead Minnow toxicity model (EPA) in VEGA (Q)SAR platform predicts that the chemical has a 96h LC50 of 0.405 mg/L (moderate reliability); Fish toxicity classification (SarPy/IRFMN) model in VEGA (Q)SAR platform predicts that the chemical is Toxic-2 (between 1 and 10 mg/l) (moderate reliability); Fish Acute Toxicity model (KNN/Read-Across) in VEGA (Q)SAR platform predicts that the chemical has a 96h LC50 of 1.81 mg/L (good reliability);The Danish QSAR database contains information indicating that the substance has a 96h LC50 to fish of 3.0 mg/L; The Danish QSAR database contains information indicating that the substance has a 48h EC50 to Daphnia of 3.55 mg/L; The Danish QSAR database contains information indicating that the substance has a 96h EC50 to green algae of 2.63 mg/L

# Suspected mutagen: The Toolbox profiler in vitro mutagenicity (Ames test) alerts by ISS gives an alert for mutagenicity

# Suspected persistent in the environment: Ready biodegradability model (IRFMN) in VEGA (Q)SAR platform predicts that the chemical is NON Readily Biodegradable (moderate reliability);The Danish QSAR database contains information indicating that the substance is predicted as non readily biodegradable

# Suspected respiratory sensitiser: The Toolbox profiler Respiratory sensitisation gives an alert for respiratory sensitisation

# Suspected skin sensitiser: The Toolbox profiler Protein binding alerts for skin sensitization by OASIS v1.3 gives an alert for skin sensitisation; CAESAR skin sensitisation model in VEGA (Q)SAR platform predicts that the chemical is Sensitizer (good reliability)

# 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 (good reliability)

Related composition

Related composition:
Composition 1
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
Hazard category:
Eye Irrit. 2
Hazard statement:
H319: Causes serious eye irritation.
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
Reason for no classification:
data lacking
Carcinogenicity
Reason for no classification:
data lacking
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)
Reason for no classification:
data lacking
Hazardous to the ozone layer
Reason for no classification:
data lacking

Labelling

Signal word:
Warning

Hazard pictogram

GHS07: exclamation mark

Hazard statements

H319: Causes serious eye irritation.

Precautionary statements

P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

Notes