Registration Dossier
Registration Dossier
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EC number: 943-389-0 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- January from 21st to 22nd, 2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- The reliability of the source read-across study was established to be R1: guideline study
- Justification for type of information:
- Justification for read-across is detailed at section 13.
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:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- April 2004
- GLP compliance:
- no
Test material
- Reference substance name:
- Parent substance #1
- IUPAC Name:
- Parent substance #1
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: three-dimensional RhE model (EpiDermTM).
- Souce: Mattek (USA)
- Tissue batch number: lot 10810/A.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during exposure: 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: 20 washings using PBS.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- Reagent: 3-[4,5-dimethylthiazol-2yl]-2,5-diphenyl tetrazolium bromide (MTT).
- MTT concentration: 300 µl/plate.
- Incubation time: 3 hours.
- Extraction: isopropanol (2000 µl).
- Wavelength: 550 nm. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 20 mg of test item per unit of epidermis.
- Duration of treatment / exposure:
- 3 minutes and 60 minutes (at 37 °C, 5 % CO2)
- Duration of post-treatment incubation (if applicable):
- 3 hours
- Number of replicates:
- Test material and controls (positive and negative) were applied on each unit of epidermis in duplicate.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Time point: 3 minutes
- Value:
- ca. 105.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- Standard deviation: 7.5.
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Time point: 60 minutes
- Value:
- ca. 122.5
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- Standard deviation: 26.6.
- Other effects / acceptance of results:
- Classification: non corrosive
Any other information on results incl. tables
RESULTS
SAMPLE |
Mean cell viability (SD)-3 minutes exposure |
Mean cell viability (SD)-60 minutes exposure |
Classification |
SET RETARD PLUS |
105.1 (7.5) |
122.5 (26.6) |
NON CORROSIVE |
KOH 8N |
6.0 (0.6) |
5.8 (1.1) |
CORROSIVE |
NEGATIVE CONTROL |
100.0 (4.8) |
100.0 (2.0) |
-- |
Applicant's summary and conclusion
- Interpretation of results:
- other: non corrosive, i.e. the substance does not meet the criteria to be classified as Skin Corr. 1A/B/C, according to the CLP Regulation
- Conclusions:
- Non corrosive.
- Executive summary:
Method
Corrosion characteristics of test item were evaluated according to the guideline OECD 431 (April 13, 2004), on reconstitued epidermis 3D (EpiDerm™), through MTT test cytotoxicity analysis.
The test item was applied on each epidermis unit in duplicate for 3 minutes and 1 hour at 37°C, 5% CO2. At the end of the exposure, the test item was removed, and cell viability evaluated through MTT test.
Observations
The percentage of mean cell viability for treated cells resulted to be:
- after 3 minutes: 105.1 %
- after 60 minutes: 122.5 %
Results
Non corrosive, i.e. the substance does not meet the criteria to be classified as Skin Corr. 1A/B/C, according to the CLP Regulation
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