Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to the recommended guidelines and GLP, and without deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test - adopted 13 April 2004)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- other: Human-derived epidermal keratinocytes, EpiDerm Skin Model (EPI-200, Lot no.: 4651 kit I)
- Strain:
- other: Human-derived epidermal keratinocytes, EpiDerm Skin Model (EPI-200, Lot no.: 4651 kit I)
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl was applied undiluted directly on top of the tissue.
DNM was spread to match the size of the tissue.
- Concentration (if solution): 100% (undiluted) - Duration of treatment / exposure:
- The substance was topically applied on the skin tissue for a 3 minutes and 1 hour exposure, followed by immediate determination of the cytotoxic (corrosive) effect.
- Number of animals:
- Not applicable
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: absorbance (540 nm)
- Basis:
- mean
- Time point:
- other: 3 minutes
- Score:
- 1.563
- Max. score:
- 1.576
- Reversibility:
- no data
- Irritation parameter:
- other: absorbance (540mn)
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1.713
- Max. score:
- 1.739
- Reversibility:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- It is concluded that this test is valid and that the test substance is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
There were no deviations from guideline; validity criteria have been fulfilled.
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