Registration Dossier
Registration Dossier
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EC number: 477-710-6 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Apr 01 - Oct 21, 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was performed according to GLP and the methods applied are fully compliant with OECD TG 431.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD TG 431
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Details on test animals or test system and environmental conditions:
- CELL CULTURE
- Supplier: SkinEthic Laboratories (Nice, France).
- Source: culturing adult human keratinocytes on a polycarbonate filter in conditions which permit their terminal differentiation
- kit consists of a 12-well plate with 12 collagen inserts
- Batch: 09-EKIN-013
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 25 mg
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 min, 1 hour, 4 hours
- Details on study design:
- The study was performed according to OECD TG 431.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: tissue viability
- Value:
- 23.01
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 3 min. Remarks: 23.01 %. (migrated information)
- Irritation / corrosion parameter:
- other: other: tissue viability
- Value:
- 12.66
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 1 hour. Remarks: 12.66 %. (migrated information)
- Irritation / corrosion parameter:
- other: other: tissue viability
- Value:
- 12.49
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 4 hours. Remarks: 12.49 %. (migrated information)
In vivo
- Irritant / corrosive response data:
- The mean relative tissue viability after treatment with the test item was significantly decreased after 3 minutes (23.01 %), 1 hour (12.66 %) and 4 hours (12.49 %) treatment. Therefore, the test item is considered to possess a corrosive potential.
- Other effects:
- For details see executive summary
Any other information on results incl. tables
For details see executive summary
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Under the experimental conditions reported, the test item is corrosive to skin.
- Executive summary:
Study Design
This in vitro study was performed to assess the corrosive potential of the test material by means of the Human Skin Model Test. The test consisted of a topical exposure of the test item to a human reconstructed model followed by a cell viability test. Cell viability was measured by dehydrogenase conversion of MTT into a blue formazan salt, that was quantitatively measured after extraction from tissues. The percent reduction of cell viability in comparison to untreated negative controls was used to predict skin corrosion.
Triplicates of the human skin model Episkin® were treated either with the negative or the positive control for 4 hours. 25 µL of the negative control (deionised water) or 25 µL of the positive control (glacial acetic acid) were applied to three tissues, respectively. For the test item, one tissue per time point (3 minutes, 1 hour or 4 hours) was used. 25 mg of the solid test item were applied to each tissue, spread to match the tissue size.
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 431.
Results
Treatment with the positive control induced a sufficient decrease in the relative absorbance as compared to the negative control for the 4 hours treatment interval thus ensuring the validity of the test system.
After treatment with the negative control the absorbance values reached the required acceptability criterion of an optical density (OD) between 0.115 and 0.4 for the 4 hours treatment interval thus showing the quality of the tissues.
The mean relative tissue viability after treatment with the test item was significantly decreased after 3 minutes (23.01 %), 1 hour (12.66 %) and 4 hours (12.49 %) treatment. Therefore, the test item is considered to possess a corrosive potential.
Conclusion
Under the experimental conditions reported, the test item corrosive to skin.
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