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:
no
Species:
human
Type of coverage:
occlusive
Vehicle:
other: a sunscreen formulation
Controls:
yes
Amount / concentration applied:
5% in vehicle
Duration of treatment / exposure:
48 h
Observation period:
96 h
Number of animals:
50
Irritation parameter:
other: see SCCP report
Basis:
mean
Time point:
other: 96 h
Score:
0
Max. score:
70
Remarks on result:
other: 5% solution of the substance in a sunscreen formulation
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
Remarks:
other: read across
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:
other: no data
Basis:
mean
Score:
0
Max. score:
110
Reversibility:
fully reversible
Remarks on result:
other: not irritating
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)

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 skin irritation, eye irritation or STOT SE