Registration Dossier
Registration Dossier
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EC number: 942-380-9 | CAS number: 131796-64-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- 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 (incl. QA statement)
Test material
- Reference substance name:
- 2-isobutyl-4-methyltetrahydro-2H-pyran-4-yl acetate
- EC Number:
- 942-380-9
- Cas Number:
- 131796-64-0
- Molecular formula:
- C12H22O3
- IUPAC Name:
- 2-isobutyl-4-methyltetrahydro-2H-pyran-4-yl acetate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch identification ZH 291 A1 Fr.2-4
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm TM, EPI-200, MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
- Tissue batch number(s): Lot Number 23362
- Date of initiation of testing: 2016-09-06
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature (25 min, laminar flow hood) followed by 37 °C (35 min, incubator)
- Temperature of post-treatment incubation: 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: at least one washing step with sterile PBS
- Observable damage in the tissue due to washing: No
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg/mL
- Incubation time: 3 h
- Spectrophotometer: Sunrise Absorbance Reader
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES:
3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Killed tissues
- Procedure used to prepare the killed tissues: freezing
- N. of replicates : 3
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritating to skin if the mean relative tissue viability with a test material is less than or equal to 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 30 µL
NEGATIVE CONTROL
- Amount applied: 30 µL PBS, sterile
POSITIVE CONTROL
- Amount applied: 30 µL sodium dodecyl sulfate in water
- Concentration: 5 % (w/v) - Duration of treatment / exposure:
- 25 min (laminar flow hood) followed by 35 min (incubator)
- Duration of post-treatment incubation (if applicable):
- 42 ± 4 h
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 73.2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
|
|
Tissue 1 |
Tissue 2 |
Tissue 3 |
Mean |
SD |
CV [%] |
Test substance
|
Mean OD570 |
1.248 |
1.377 |
1.375 |
1.333 |
|
|
Viability [% of NC] |
68.5 |
75.6 |
75.5 |
73.2 |
4.1 |
5.6 |
|
NC
|
Mean OD570 |
1.973 |
1.838 |
1.654 |
1.821 |
|
|
Viability [% of NC] |
108.3 |
100.9 |
90.8 |
100.0 |
8.8 |
8.8 |
|
PC
|
Mean OD570 |
0.054 |
0.063 |
0.065 |
0.060 |
|
|
Viability [% of NC] |
3.0 |
3.4 |
3.5 |
3.3 |
0.3 |
9.2 |
The negative results derived with the Skin Irritation Test on pyranyl acetate pure alone were sufficient for a final assessment. Therefore further testing in the Skin Corrosion Test was waived.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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