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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:
2 May 2012 - 4 May 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed to the standardised guidelines OECD 431 and EU Method B.40 and in line GLP. The study was reported to a high standard, sufficient to assess the quality of the data presented.
Justification for data waiving:
other:

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid (not specified)
Details on test material:
- Name of test material (as cited in study report): Di-n-octyltin oxide
- Physical state: white solid
- Storage conditions: room temperature in the dark

Test animals

Details on test animals and environmental conditions:
EPISKIN Model Kit 0.38 cm2
Supplier: SkinEthic Laboratories, Nice, France

Test system

Amount / concentration applied:
20 mg of the solid test item was applied topically.
Duration of treatment / exposure:
3, 60 and 240 minutes.
Observation period:
3 hours ± 5 minutes
Number of animals:
Not applicable

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other:
Value:
0.238
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 240 minutes. Max. score: 0.224. (migrated information)
Irritation / corrosion parameter:
other:
Value:
0.244
Remarks on result:
other:
Remarks:
Basis: mean duplicate tissues. Time point: 60 minutes. Max. score: 0.224. (migrated information)
Irritation / corrosion parameter:
other:
Value:
0.296
Remarks on result:
other:
Remarks:
Basis: mean duplicate tissues. Time point: 3 minutes. Max. score: 0.224. (migrated information)
Irritation / corrosion parameter:
other:
Value:
106.3
Remarks on result:
other:
Remarks:
Basis: mean duplicate tissues. Time point: 240 minutes. Max. score: 100.0. (migrated information)
Irritation / corrosion parameter:
other:
Value:
108.9
Remarks on result:
other:
Remarks:
Basis: mean duplicate tissues. Time point: 60 minutes. Max. score: 100.0. (migrated information)
Irritation / corrosion parameter:
other:
Value:
132.1
Remarks on result:
other:
Remarks:
Basis: mean duplicate tissues. Time point: 3 minutes. Max. score: 100.0. (migrated information)

Any other information on results incl. tables

Direct MTT Reduction

The MTT solution containing the test item did not turn blue. This was taken to indicate the test item did not reduce MTT.

 

Test Item, Positive Control Item and Negative Control Item

Mean OD540 values and viabilities for the negative control, positive control and test item are given in Table 1.

The relative mean viability of the test item treated tissues was as follows:

240 minutes exposure: 106.3 %

60 minutes exposure: 108.9 %

3 minutes exposure: 132.1%

Quality Criteria

The relative mean tissue viability for the positive control treated tissues was 1.3 % relative to the negative control treated tissues following the 240 minute exposure period. The positive control acceptance criterion was therefore satisfied.

The mean OD540 for the negative control treated tissues was 0.224. The negative control acceptance criterion was therefore satisfied.

 

Table 1 Mean OD540 Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item

Item

Exposure Period

(Minutes)

Mean OD540 of Duplicate Tissues

Relative Mean Viability %

Negative Control Item

240

0.224

100*

Positive Control Item

240

0.003

1.3

 

Test Item

240

0.238

106.3

60

0.244

108.9

3

0.296

132.1

*The mean viability of the negative control tissues is set at 100 %.

Applicant's summary and conclusion

Interpretation of results:
other: under the conditions of the test, the test substance can be considered not to require a classification for corrosion. Irritancy cannot be assessed with this method.
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test item was considered to be Non-Corrosive to the skin.
Executive summary:

The purpose of the test was to evaluate the corrosivity potential of the test item using the EPISKIN in vitro Reconstructed Human Epidermis (RHE) Model. This method was designed to be compatible with theOECD Guideline for the Testing of Chemicals No. 431 “In Vitro Skin Corrosion: Human Skin Model Test” (adopted 13 April 2004) and Method B.40 of Commission Regulation (EC) No. 440/2008.

 

Duplicate tissues were treated with the test item for exposure periods of 3, 60 and 240 minutes. At the end of the exposure period the test item was rinsed from each tissue before each tissue was taken for MTT-loading. After MTT loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT-loaded tissues. 

At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 µL samples were transferred to the appropriate wells of a pre labelled 96 well plate. The optical density (OD) was measured at 540 nm (OD540).

Data are presented in the form of percentage viability (MTT reduction in the test item treated tissues relative to negative control tissues).

 

The relative mean viability of the test item treated tissues were:

240 minutes exposure: 106.3 %

60 minutes exposure: 108.9 %

3 minutes exposure: 132.1 %

The test item was considered to be Non-Corrosive to the skin.