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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:
27 November 2012 to 29 November 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 with GLP. The study was reported to a high standard, sufficient to assess the quality of the data presented.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

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 (unspecified)
Details on test material:
- Appearance: pale brown solid
- Storage conditions: room temperature in the dark

Test system

Amount / concentration applied:
20 mg of the solid test material was applied topically.
The test material was prepared by cutting suitable sized pellets for dosing onto the tissue surface.
Duration of treatment / exposure:
3, 60 and 240 minutes.

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other:
Value:
104
Remarks on result:
other:
Remarks:
Basis: mean duplicate tissues. Time point: 240 minutes. (migrated information)
Irritation / corrosion parameter:
other:
Value:
124.5
Remarks on result:
other:
Remarks:
Basis: mean duplicate tissues. Time point: 60 minutes. (migrated information)
Irritation / corrosion parameter:
other:
Value:
110.5
Remarks on result:
other:
Remarks:
Basis: mean duplicate tissues. Time point: 3 minutes. (migrated information)

Any other information on results incl. tables

Direct MTT Reduction

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

 

Test Material, Positive Control Item and Negative Control Item

Mean OD540 values and viabilities for the negative control, positive control and test material are given in Table 2.

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

240 minutes exposure: 104.0 %

60 minutes exposure: 124.5 %

3 minutes exposure: 110.5 %

 

Quality Criteria

The relative mean tissue viability for the positive control treated tissues was 2.4 % 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 0.868. The negative control acceptance criterion was therefore satisfied.

 

Table 2: 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

0.868

100*

Positive Control Item

240

0.021

2.4

 

Test material

240

0.903

104.0

60

1.081

124.5

3

0.959

110.5

*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 material 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 material 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 material using the EPISKIN™ in vitro Reconstructed Human Epidermis (RHE) Model. This method was designed to be compatible with the OECD 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 material for exposure periods of 3, 60 and 240 minutes. At the end of the exposure period the test material 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 material treated tissues relative to negative control tissues).

 

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

240 minutes exposure: 104.0 %

60 minutes exposure: 124.5 %

3 minutes exposure: 110.5 %

Since the relative mean viability was ≥ 35 % at 240 minutes, the test material was considered to be non-corrosive to skin.