Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Jan 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well reported GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: OECD 431 guideline draft
Qualifier:
according to guideline
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-({(5S)-2-Oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)-1H-isoindole-1,3(2H)-dione
EC Number:
610-201-0
Cas Number:
446292-08-6
Molecular formula:
C22 H19 N3 O6
IUPAC Name:
2-({(5S)-2-Oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)-1H-isoindole-1,3(2H)-dione
Details on test material:
Oxaphthalimid, white powder, batch number BXR34BR, content 99.8%

Results and discussion

Any other information on results incl. tables

The MTT method has determined the following values of viability:

after 3 min of incubation: 97.36%

after 60 min of incubation: 95.27%

Applicant's summary and conclusion

Executive summary:

The study on a reconstructed human epidermis EST-1000 was carried out for detection of topically applied skin corrosives with the test item Oxaphthalimid.

A 100% concentration was tested on the skin/epidermal equivalents in triplets. For the determination of time related cytotoxic effects the incubation periods were 3 minutes (room temperature) and 60 minutes (incubator), respectively. Using the MTT (methylthiazoletetrazolium) method the cell viability after 3 minutes or after 60 minutes of incubation was determined to be 97.26% and 95.27%, respectively. Thus, Oxaphthalimid was not characterised by a significant impact on cell viability and it therefore showed no corrosive properties.