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Toxicological information

Skin irritation / corrosion

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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:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Deviations:
no
Qualifier:
according to
Guideline:
other: OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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)

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
(mean of 2 replicate tissues)

2.460*

2.288

0.413

mean relative tissue
viability [%]

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
(mean of 3 aliquots)

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
(mean of 2 replicate tissues)

2.458*

2.442

0.179

mean relative tissue
viability [%]

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.