Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study according to international guideline but not GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Episkin: reconstructed human epidermis
Principles of method if other than guideline:
EPISKIN Human Skin Model Test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch: CFPPN-2C4.4

Results and discussion

In vitro

Results
Remarks on result:
other:
Remarks:
Remarks: EPISKIN Human Skin Model Test. (migrated information)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CFPPN, an intermediate product of Ketoprofen synthesis, was non-irritant to the skin.