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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Guideline:
other: no data
GLP compliance:
not specified
Species:
rabbit
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24h
Score:
0.7
Max. score:
8
Reversibility:
fully reversible within: 48h
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
80 mg
Duration of treatment / exposure:
21 days
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
1
Irritation parameter:
other: clinical observations
Basis:
animal #1
Time point:
other: 21 days
Score:
> 75
Max. score:
110
Reversibility:
not fully reversible within: 21 days
Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Effects on eye irritation: corrosive

Justification for classification or non-classification