Registration Dossier

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:
other: read across based on OECD Toolbox v3.4
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Justification for type of information:
see attached OECD Toolbox study
Guideline:
other: read across
GLP compliance:
not specified
Species:
other: rabbit, guinea pig, human
Strain:
not specified
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
2.8
Max. score:
8
Reversibility:
fully reversible
Remarks on result:
probability of moderate irritation
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
other: read across based on OECD Toolbox v3.4
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Justification for type of information:
see attached OECD Toolbox study
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Irritation parameter:
other: no data
Basis:
mean
Score:
0
Max. score:
110
Reversibility:
fully reversible
Remarks on result:
other: not irritating
Interpretation of results:
not irritating
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

At the effect levels found there is no requirement to classify the substance for eye irritation or STOT SE. However, the substance must be classified for skin irritation category 2