Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Title:
No information
Author:
European Commission
Year:
2006
Bibliographic source:
SCCP/1008/06

Materials and methods

Test guideline
Guideline:
other: no data
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
human

Test system

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

Results and discussion

In vivo

Results
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

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU