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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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