Registration Dossier
Registration Dossier
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EC number: 470-780-9 | CAS number: 55312-97-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 January 2006 to 11 April 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- draft guideline
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 470-780-9
- EC Name:
- -
- Cas Number:
- 55312-97-5
- Molecular formula:
- C10 H11 Cl O
- IUPAC Name:
- 2-(2,5-dimethylphenyl)acetyl chloride
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The methods used for this protocol have already been described in the literature and relevant guidelines or guideline drafts. Unless internationally recognised standardised reference values or validation tests are available, the method used here must be viewed with this in mind.
The draft guideline was approved after conduction of the test, hence, it is a standard method according to Regulation (EU) No. 1907/2008. - Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: The experiment was carried out on a reconstructed human epidermis EST-1000 (CellSystems, St. Katharinen, Germany).
- Tissue batch number(s): Kit contents EST-1000; CellSystems, Cat.-No.CS-1001).
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 3 min at roomtemperature and 60 min at 37°C, 5% CO2, maximum humidity
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: with PBS three times, volume not reported
- Observable damage in the tissue due to washing: not reported
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 2h
- Spectrophotometer: automatic reader (EL808, Bio-Tek; 96 well format, 200 µL).
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: triplicate
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%. - Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50µL
- Concentration (if solution): 100%
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50µL
- Concentration (if solution): 0.9% NaCl solution - Duration of treatment / exposure:
- 3 min at room temperature and 60 min at 37°C
- Number of replicates:
- triplicates
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean or three runs, negative control, 3 min
- Value:
- 100
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Remarks:
- 100%, mean OD 1.39
- Positive controls validity:
- not examined
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean of three runs, 3 min
- Value:
- 20.28
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Remarks:
- 100%
- Positive controls validity:
- not examined
- Remarks on result:
- other: mean OD 0.28
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean of three runs, negative control, 60 min
- Value:
- 100
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Remarks:
- 100% viability, mean OD 1.12
- Positive controls validity:
- not examined
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean of three runs, 60 min
- Value:
- 0.74
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- not examined
- Remarks on result:
- other: mean OD 0.01
Any other information on results incl. tables
Summary of results:
Sample No. | Test item | Time [min] | OD mean* | StdDev | % Viability |
1-3 | control NaCl 0.9% | 60 | 1.12 | 0.05 | 100.0 |
4-6 | Test item | 60 | 0.01 | 0.01 | 0.74 |
16-18 | control NaCl 0.9% | 3 | 1.39 | 0.05 | 100.0 |
19-21 | Test item | 3 | 0.28 | 0.01 | 20.28 |
* 6 values | |||||
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (corrosive) based on GHS criteria
- Conclusions:
- The test item was characterised by a significant impact on cell viability after the 3 min and after the 60 min period. Thus, the test item should be labelled as corrosive to skin.
- Executive summary:
In a dermal irritation/corrosion study performed in accordance with OECD Guideline 431 (In Vitro Skin Irritation) (draft guideline (2006)), 2,5-dimethylphenylacetyl chloride(100% a.i.) was applied to the three-dimensional human epidermis model tissue for an exposure period of 3 min and 60 min, respectively, in triplicates. 50 μL of the undiluted test item were topically applied to the epidermal surface.
After 3 min or 60 min exposure at room temperature and at 37°C, respectively, the tissues were washed with phosphate buffered saline to remove any residual test material. Subsequently the cytotoxicity (irritancy) was determined by means of a MTT-viability test expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.
The negative (0.9 % NaCl) control gave responses that were within the acceptance criteria and as such demonstrated the validity of the study.
The relative mean tissue viability obtained after 3 min and 60 min treatment with 2,5-dimethylphenylacetyl chloride compared to the negative control tissues was 20.28% and 0.74%. Since the mean relative tissue viability for the test substance was below 50% after 3 min and below 15% after 60 min exposure, 2,5-dimethylphenylacetyl chloride is identified to be corrosive.
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