Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 December 2017 to 15 December 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Cetyl Acetate and Stearyl Acetate and Oleyl Acetate and Acetylated Lanolin Alcohol
- Molecular formula:
- C18H36O2-C20H38O2-C20H40O2-C29H48O2
- IUPAC Name:
- Cetyl Acetate and Stearyl Acetate and Oleyl Acetate and Acetylated Lanolin Alcohol
- Test material form:
- other: paste
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: reconstructed human skin
- Cell source:
- other: EpiDerm TM (EPI-200-MatTek Corporation)
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm TM (EPI-200-MatTek Corporation)
- Tissue batch number(s): (Lot 25864)
- Delivery date: 12 December 2017
- Date of initiation of testing: no data
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 60 minutes (25 minutes at room temperature and 35 minutes at 37°C, 5% CO2)
- Temperature of post-treatment incubation: 42 hour post-dose incubation at 37°C, 5% CO2
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: not indicated (according to MatTEek SOP)
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE: no data (according to MatTEek SOP)
- MTT concentration: not specified
- Incubation time: no data
- Spectrophotometer: not identified measured at 570 nm
- Wavelength: 570 nm
- Filter: none
- Linear OD range of spectrophotometer: no data
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: yes (1.601 ± 0.007 (mean and SD of MTT value of 3 tissues exposed to H2O) )
- Barrier function: yes (ET 50% of tissues exposed to 100 µL Triton X-100 1% (n=3): 5.84 h)
- Morphology: yes ( Histological examination demonstrates human epidermis-like structure: including multiple layers (at least 4) of viable epithelial cells (basal layer, stratum spinosum, stratum granulosum) which are present under multilayered stratum corneum ; Tissue thickness: 128 µm )
- Contamination: No contamination reported
- Reproducibility: yes (The mean OD of the 6 wells containing extraction solvent alone (blanks) should be ≤ 0.1., but was 0.149 evaluated not to have affected the measurements, based upon historical system data for blanks; < 0.244) - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 µl
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µl PBS
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µl SDS
- Concentration (if solution): 5% in water - Duration of treatment / exposure:
- 60 minutes (25 minutes at room temperature and 35 minutes at 37°C, 5% CO2)
- Duration of post-treatment incubation (if applicable):
- 42 hour post-dose incubation at 37°C, 5% CO2
- Number of replicates:
- 3/treatment
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 106.9
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- mean viability 4.5%
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- No colour interference or interference with MTT reduction as tested in a pre-test
Any other information on results incl. tables
Name |
Code |
Mean of OD |
SD of OD |
Mean of viability (%) |
SD of viability (%) |
CV % |
Classification |
DPBS |
NC |
1.768 |
0.210 |
100.000 |
11.904 |
11.904 |
Non-Irritant |
SDS 5% |
PC |
0.080 |
0.016 |
4.535 |
0.909 |
20.046 |
Irritant |
Substance |
TA2 |
1.889 |
0.142 |
106.873 |
8.008 |
7.493 |
Non-Irritant |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is non-irritant in the EpiDermTM model
- Executive summary:
The substance was tested for skin irritation in the EpiDermTM model according to OECD 439. 30 uL of the substance, positive control (5% SDS) and negative control (PBS) was applied to the tissue for 60 minutes (25 minutes at room temperature and 35 minutes at 37°C, 5% CO2) and thereafter incubated for 42 hour post-dose at 37°C, 5% CO2. The substance did not interfere by colour or by direct MTT reduction. Tissue viability was 106.9% of negative controls, while validity criteria were evaluated to be met. The substance is concluded to be non-irritant.
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