Registration Dossier
Registration Dossier
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EC number: 929-513-6 | CAS number: 1400584-86-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 01 - November 07, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- 2004
- GLP compliance:
- yes
Test material
- Reference substance name:
- sodium (5s,8s)-8-methoxy-2,4-dioxo-1,3-diazaspiro[4.5]decan-3-ide
- EC Number:
- 929-513-6
- Cas Number:
- 1400584-86-2
- Molecular formula:
- C9H13N2O3 · Na
- IUPAC Name:
- sodium (5s,8s)-8-methoxy-2,4-dioxo-1,3-diazaspiro[4.5]decan-3-ide
- Test material form:
- solid: bulk
Constituent 1
In vitro test system
- Test system:
- human skin model
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min
- Value:
- 94.53
- Negative controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 100.83
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
Any other information on results incl. tables
No scores on irritation parameters can be provided as the study is an in vitro study using recontructed human epidermis.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was not characterised by a significant impact on cell viability after the 3 min and after the 60 min period.
Thus, it should not be labelled as corrosive to skin. - Executive summary:
This study for predicting non-specific, corrosive potentials of compounds by using reconstructed human skin (RHS) was performed in 2008. The experiment was carried out on a reconstructed human epidermis EST-1000 (CellSystems, St. Katharinen, Germany) for detection of topically applied skin corrosives with the test item.
A 100% concentration was tested on the skin/epidermal equivalents in triplicate. For the determination of time related cytotoxic effects the incubation periods were 3 min and 60 min, respectively. Thus the study was conducted in accordance with the OECD 431 guideline draft as well as with an EC draft guideline (amending Council Directive 67/548/EEC, B.40 Skin corrosion) using the test item concentrations and incubation periods recommended there.
The test item was applied at a 100% concentration, i.e. 25 mg per insert. The MTT (Methylthiazoletetrazolium) method has determined the following values of viability after 3 min. or after 60 min. of incubation: 100.83% and 94.53%, respectively.
Thus, the results show that no corrosive property of the test item was determined by the assay used.
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