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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June - September 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
16JSVA015
- Expiration date of the lot/batch:
14. September 2018
- Purity test date:
not state

RADIOLABELLING INFORMATION (if applicable)
not applicable

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Room Temperature: (20 ± 5°C), keep container tightly closed, store under inert gas
- Stability under test conditions:
assumed stable


TREATMENT OF TEST MATERIAL PRIOR TO TESTING
none

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: not specified
Source strain:
other: Keratinocyte Strain: 00267
Justification for test system used:
according to Guideline
Vehicle:
unchanged (no vehicle)
Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava.
Designation of the kit: EPI-200-SCT
Day of delivery: 20. Jun. 2017
Batch: 25822

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: Room temperature (3 min) and 37 °C (1 h)
- Temperature of post-treatment incubation (if applicable): 37 °C

REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 1 washing step by thoroughly rinsing
- Observable damage in the tissue due to washing: none noted
- Modifications to validated SOP:

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: e h
- Spectrophotometer: 96-well-plate photometer, Anthos Reader
- Wavelength: 570 nm.
- Filter:
- Filter bandwidth:
- Linear OD range of spectrophotometer:

FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
see additional information incl. tables section

NUMBER OF REPLICATE TISSUES: 2

CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
not applicable, no direct MTT interference observed

NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:

PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
according to GL
- Justification for the selection of the cut-off point(s) if different than recommended in TG 431 and 439:
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
50 μL
Duration of treatment / exposure:
3 min and 1 h
Duration of post-treatment incubation (if applicable):
3 h
Number of replicates:
2

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 min exposure
Value:
95.5
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1 hour exposure
Value:
102.5
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Therefore, Bis(neodecanoyloxy)dioctylstannane is considered
non-corrosive to skin in the Reconstructed Human Epidermis (RHE) Test Method.
Executive summary:

One valid experiment was performed.

Two tissues of the human skin model EpiDermTM were treated with the test item

Bis(neodecanoyloxy)dioctylstannane for 3 minutes and 1 hour, respectively. The test item

was applied to each tissue and spread to match the tissue size.

Demineralised water was used as negative control, 8 M KOH was used as positive control.

After treatment, the respective substance was rinsed from the tissues. Then, cell viability of

the tissues was evaluated by addition of MTT, which can be reduced to a blue formazan.

Formazan production was evaluated by measuring the optical density (OD) at 570 nm of the

resulting solution.

After treatment with the negative control, the absorbance values were within the required

acceptability criterion of mean OD ≥ 0.8 and ≤ 2.8 for both treatment intervals thus showing

the quality of the tissues. The OD was 1.8 (3 minutes experiment) and 1.6 (1 hour experiment).

The positive control showed clear corrosive effects for both treatment intervals. The

mean relative tissue viability value was reduced to 7.8 % after the 1 hour treatment (and

reduced to 19.5 % after the 3 min treatment).

After 3 minutes treatment with the test item, the mean value of relative tissue viability was

reduced to 95.5 %. This value is above the threshold for corrosion potential (50%). After 1

hour treatment, the mean value of relative tissue viability was increased to 102.5 %. This

value, too, is above the threshold for corrosion potential (15%).

Therefore, Bis(neodecanoyloxy)dioctylstannane is considered

non-corrosive to skin in the Reconstructed Human Epidermis (RHE) Test Method.