Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Conducted at GLP-accredited facility to current guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: compact

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: MTT reduction, OD 652 of tissues
Value:
ca. 0.902
Remarks on result:
other:
Remarks:
Basis: other: reconstructed human epeodermis. Time point: 42h. Max. score: 0.955. Reversibility: no data. (migrated information)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was classified as non-irritant.
Executive summary:

The test item was classified as non-irritant.