Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-11-06 to 2012-11-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [SPEC][/SPEC][SYN]Nitrososilane[/SYN]
- IUPAC Name:
- [SPEC][/SPEC][SYN]Nitrososilane[/SYN]
- Reference substance name:
- [CS]000000419807[/CS]
- IUPAC Name:
- [CS]000000419807[/CS]
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name: Carbamic acid, N-(3-(triethoxysilyl)propyl)2-(ethyl-(4-nitrosophenyl) amino) ethyl ester
- Internal Code: SAT 120009
- Batch No.: 12/34#
- CAS No.: 1195231-94-7
- Purity: 92.8 wt% (NMR), 93.3 area% (HPLC)
Constituent 1
Constituent 2
Test animals
- Species:
- other: Human skin model
- Strain:
- other: Epiderm
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: not applicable
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 25 mg + 5 µL H2O
- Duration of treatment / exposure:
- 60 min
- Observation period:
- not applicable
- Number of animals:
- 0
- Details on study design:
- The test was performed on EpiDerm, an organotypic reconstituted three-dimensional model of the human epidermis. 2 replicate tissues per treatment period are dosed with the neat test item, the negative control and the positive control, respectively. After each treatment period the test item and controls are rinsed off and the tissues are stained via MTT for 3 hours. Isopropanol extracts are measured photometrically at 550 nm.
Negative control: Distilled water (A. dest; Lot 110147, AlleMan Phanna)
Positive control: 8 N Potassium Hydroxide (KOH; CAS No.: 1310-58-3; Lot 10357-004, NeoLab)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: tissue viability (%)
- Basis:
- mean
- Time point:
- other: 3 min
- Score:
- 100
- Max. score:
- 100
- Reversibility:
- no data
- Remarks on result:
- other: negative control
- Irritation parameter:
- other: tissue viability (%)
- Basis:
- mean
- Time point:
- other: 3 min
- Score:
- 93
- Max. score:
- 100
- Reversibility:
- no data
- Remarks on result:
- other: test item
- Irritation parameter:
- other: tissue viability (%)
- Basis:
- mean
- Time point:
- other: 3 min
- Score:
- 17
- Max. score:
- 100
- Reversibility:
- no data
- Remarks on result:
- other: positive control
- Irritation parameter:
- other: tissue viability (%)
- Basis:
- mean
- Time point:
- other: 60 min
- Score:
- 100
- Max. score:
- 100
- Reversibility:
- no data
- Remarks on result:
- other: negative control
- Irritation parameter:
- other: tissue viability (%)
- Basis:
- mean
- Time point:
- other: 60 min
- Score:
- 99
- Max. score:
- 100
- Reversibility:
- no data
- Remarks on result:
- other: test item
- Irritation parameter:
- other: tissue viability (%)
- Basis:
- mean
- Time point:
- other: 60 min
- Score:
- 7
- Max. score:
- 100
- Reversibility:
- no data
- Remarks on result:
- other: positive control
- Other effects:
- The test item showed no direct MTT-reducing capability and no colouring potential.
Any other information on results incl. tables
TEST RESULTS
3 min. test
Name |
Negative Control |
Test Item |
Positive Control |
|||
Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
absolute OD550 -values |
2.370 |
2.631 |
2.206 |
2.406 |
0.465 |
0.373 |
2.289 |
2.622 |
2.118 |
2.426 |
0.454 |
0.370 |
|
2.354 |
2.491 |
2.163 |
2.408 |
0.446 |
0.369 |
|
mean OD550 (mean of 3 aliquots) |
2.338 |
2.581 |
2.162 |
2.413 |
0.455 |
0.371 |
SD |
0.043 |
0.078 |
0.044 |
0.011 |
0.010 |
0.002 |
total mean OD550 |
2.460* |
2.288 |
0.413 |
|||
mean relative tissue |
100 |
93 |
17** |
|||
mean inter tissue viability difference [%]*** |
9.9 |
11.0 |
20.5 |
|||
* mean OD550 >= 0.8
** mean relative tissue viability of the 3 min. positive control <= 30%
*** inter tissue viability difference <= 30%
60 min. test
Name |
Negative Control |
Test Item |
Positive Control |
|||
Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
absolute OD550 -values |
2.421 |
2.511 |
2.432 |
2.517 |
0.162 |
0.195 |
2.424 |
2.495 |
2.382 |
2.477 |
0.160 |
0.202 |
|
2.381 |
2.518 |
2.375 |
2.468 |
0.158 |
0.196 |
|
mean OD550 |
2.409 |
2.508 |
2.396 |
2.487 |
0.160 |
0.198 |
SD |
0.024 |
0.012 |
0.031 |
0.026 |
0.002 |
0.004 |
total mean OD550 |
2.458* |
2.442 |
0.179 |
|||
mean relative tissue |
100 |
99 |
7 |
|||
mean inter tissue viability difference [%]*** |
4.0 |
3.7 |
21.2 |
|||
* mean OD550 >= 0.8
*** inter tissue viability difference <= 30%
Applicant's summary and conclusion
- Interpretation of results:
- other: non corrosive
- Remarks:
- Criteria used for interpretation of results: other: OECD 431
- Conclusions:
- In this study under the given conditions the test item showed no corrosive effects. The test item is classified as "non corrosive".
- Executive summary:
SUMMARY
In the present study the skin corrosivity potential of SAT 120009 was analysed. Since corrosive chemicals are cytotoxic after a short time exposure to the stratum corneum of the epidermis the cytotoxic effects of the test item on Epiderm, a reconstructed three-dimensional human epidermis model, were determined. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 3 min and 60 min exposure period and compared to those of the concurrent negative controls.
In the in vitro skin corrosion test with SAT 120009 using the EpiDerm human epidermis model 25 mg of the test item (with 5 µL H2O to ensure good contact) were applied topically for 3 minutes and 60 minutes, respectively, followed by immediate determination of cytotoxic effects via MTT reduction assay.
The mean relative tissue viability of the test item (% negative control) was >= 50% after 3 min. treatment and >= 15% after 60 min. treatment. The test item is therefore classified as "non corrosive".
The controls confirmed the validity of the study. This study is classified as acceptable: the mean OD550 of the two negative control tissues of the 3 min. and the 60 min. treatment period is >= 0.8. The mean relative tissue viability of the two positive control tissues of the 3 min. treatment period is <= 30%. The maximum inter tissue viability difference betweeen two tissues treated identically is <= 30%.
This study satisfies the requirement for Test Guideline OECD 431 for in vitro skin corrosion.
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