Registration Dossier
Registration Dossier
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EC number: 221-331-9 | CAS number: 3069-19-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 06-Jul-2012
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit
Test material
- Reference substance name:
- Hexyltrimethoxysilane
- EC Number:
- 221-331-9
- EC Name:
- Hexyltrimethoxysilane
- Cas Number:
- 3069-19-0
- Molecular formula:
- C9H22O3Si
- IUPAC Name:
- hexyltrimethoxysilane
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: human donors
- Source strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: reconstituted three-dimensional human skin model EpiDerm (MatTek)
- Tissue batch number(s): 25885
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1°C
- Temperature of post-treatment incubation (if applicable): 37 ± 1°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: tissues were washed by filling and emptying the inserts 15 times with Dulbecco’s phosphate buffered saline (DPBS) using a constant stream in about 1.5 cm distance from the tissue surface, staggered again in e.g. one-minute intervals.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: MTT stock solution (i.e., 5 mg/mL MTT in PBS) diluted 1 + 4 with Dulbecco’s Modified Eagle Medium (DMEM)-based medium (final concentration 1 mg/mL)
- Incubation time: 3 h ± 5 min
- Spectrophotometer: Yes, plate spectrophotometer
- Wavelength: 570 nm
- Filter: Yes
- Filter bandwidth: ± 30 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: 1.52 ± 0.086
- Barrier function: 7.27 h
NUMBER OF REPLICATE TISSUES: 3
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
The irritant potential was predicted from the relative mean tissue viabilities compared to the negative control. If the mean relative tissue viability is > 50% the test material is not considered an irritant. If the mean relative tissue viability is ≤ 50%, the test material is considered an irritant.
The test meets acceptance criteria if:
- mean absolute OD570 of the three negative control tissues is ≥ 0.8 and ≤ 2.8
- mean relative tissue viability of the three positive control tissues is ± 20%
- standard deviation (SD) of relative tissue viability obtained from each three concurrently tested tissues is ≤ 18%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 30 µL (undiluted)
NEGATIVE CONTROL
- Amount(s) applied: 30 µL DPBS
POSITIVE CONTROL
- Amount(s) applied: 30 µL SDS
- Concentration: 5% - Duration of treatment / exposure:
- 60 min
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean out of 3 replicates
- Value:
- 102.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: The mixture of 30 µL test item per 1 mL MTT medium showed no reduction of MTT compared to the solvent.
- Colour interference with MTT: The mixture did not turn blue/purple.
DEMONSTRATION OF TECHNICAL PROFICIENCY: The controls confirmed the validity of the study. The mean absolute OD570 of the three negative control tissues was ≥ 0.8 and ≤ 2.8 (2.002). The mean relative tissue viability (% negative control) of the positive control was ≥ 20% (3.0%). Standard deviation of viability of replicate tissues of all dose groups was ≤ 18% (0.1% - 9.8%).
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
Any other information on results incl. tables
Table 1: Result of the Test Item Hexyltrimethoxysilane
Name |
Negative Control |
Positive Control |
Test Item |
||||||
Tissue |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
Absolute OD570 |
2.070 |
1.785 |
2.187 |
0.100 |
0.101 |
0.100 |
2.000 |
2.062 |
2.028 |
2.045 |
1.789 |
2.133 |
0.103 |
0.107 |
0.100 |
2.061 |
2.072 |
2.056 |
|
OD570(Blank Corrected) |
2.027 |
1.741 |
2.144 |
0.057 |
0.057 |
0.056 |
1.957 |
2.018 |
1.985 |
2.002 |
1.746 |
2.090 |
0.060 |
0.063 |
0.057 |
2.017 |
2.029 |
2.012 |
|
Mean OD570of the Duplicates (Blank Corrected) |
2.014 |
1.743 |
2.117 |
0.058 |
0.060 |
0.056 |
1.987 |
2.023 |
1.998 |
Total Mean OD570of 3 Replicate Tissues (Blank Corrected) |
1.958* |
0.058 |
2.003 |
||||||
SD OD570 |
0.193 |
0.002 |
0.019 |
||||||
Relative Tissue Viability [%] |
102.9 |
89.0 |
108.1 |
3.0 |
3.1 |
2.9 |
101.5 |
103.3 |
102.1 |
Mean Relative Tissue Viability [%] |
100.0 |
3.0** |
102.3 |
||||||
SD Tissue Viability [%]*** |
9.8 |
0.1 |
1.0 |
||||||
CV [% Viabilities] |
9.8 |
3.2 |
0.9 |
||||||
* Blank-corrected mean OD570 nmof the negative control corresponds to 100% absolute tissue viability.
** Mean relative tissue viability of the three positive control tissues is ≤ 20%.
*** Standard deviation (SD) obtained from the three concurrently tested tissues is≤ 18%
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008.
- Conclusions:
- In this in vitro skin irritation study conducted in accordance with OECD 439 and in compliance with GLP, the test item showed no irritant effects.
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