Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Guideline:
other: read across
GLP compliance:
not specified
Species:
rabbit
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
1.74
Max. score:
8

See attached OECD Toolbox study for skin irritation/corrosion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Guideline:
other: acute inhalation toxicity
GLP compliance:
yes
Species:
rat
Strain:
Sprague-Dawley
Vehicle:
other: vapour
Amount / concentration applied:
80/120/180 mg/m3
Duration of treatment / exposure:
4h
Observation period (in vivo):
14d
Number of animals or in vitro replicates:
30
Irritation parameter:
other: number of rats with corneal opacity as percentage of total in the two highest dose groups (120 and 180 mg/m3/4h)
Basis:
mean
Time point:
other: 6 days
Score:
30
Max. score:
100
Reversibility:
not reversible
Remarks on result:
other: No corneal opacity was seen in the lowest dose group at 80 mg/m3/4h

See attached full study report

Interpretation of results:
Category I
Remarks:
Migrated information Criteria used for interpretation of results: EU

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Effect level: empty Endpoint conclusion: Adverse effect observed

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

With a primary dermal irritation of 1.74 (max 8) the substance must be classified as a skin irritant category 2 (with H315: causes skin irritation).

With irreversible effects observed on the eye the substance must be classified for eye damage category 1 (with H318: causes serious eye damage)

Based on the conservative principle the substance must be classified as STOT SE category 3 (with H335: may cause respiratory irritation)