Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Remarks:
other: human test
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Report date:
2011
Reference Type:
study report
Title:
Unnamed
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Human Repeat Insult Patch Test
Principles of method if other than guideline:
Reference: Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics published by The Association of Food and Drug Officials of The United States.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(3,4,5-trimethoxybenzylidene)pentane-2,4-dione
EC Number:
807-059-9
Cas Number:
945558-97-4
Molecular formula:
C15H18O5
IUPAC Name:
3-(3,4,5-trimethoxybenzylidene)pentane-2,4-dione

In vitro test system

Source species:
human
Amount/concentration applied:
0.2ml of 2% Synoxyl HSS in corn oil.
0.2ml of 5% Synoxyl HSS in Synovea DOI.
Number of replicates:
50

Results and discussion

In vitro

Results
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
The test material when tested under occlusive conditions at 2% dilution in corn oil and 5% dilution in Synovea DOI may be considered as a NON-PRIMARY IRRITANT to the skin according to the reference.