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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011-04-06 to 2011-05-27
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: EU-Method B.40 BIS. „IN VITRO SKIN CORROSION: HUMAN SKIN MODEL TEST“, 31 May 2008
Deviations:
no
Qualifier:
according to
Guideline:
other: OECD 431; 13 April 2004
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
other: no animal testing
Details on test animals and environmental conditions:
NA

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
NA
Duration of treatment / exposure:
NA
Observation period:
NA
Number of animals:
NA
Details on study design:
NA

Results and discussion

In vitro

Results
Remarks on result:
other:
Remarks:
Remarks: Sika Hardener MH was not considered corrosive in the Human Skin Model Test.. (migrated information)

In vivo

Irritant / corrosive response data:
After three minutes treatment with the test item, the relative absorbance values were reduced to 80.9 %. This value is well above the threshold for corrosion potential (50 %). After one hour treatment, relative absorbance values were reduced to 19.1 %. This value, too, is above the threshold for corrosion potential (15 %).
Therefore, Sika Hardener MH was not considered corrosive in the Human Skin Model Test.

Any other information on results incl. tables

Findings and Results:

One valid experiment was performed. Two tissues of the human skin model EpiDermTM were treated withSika Hardener MH for three minutes and one hour, respectively.

50µL of the liquid test item were applied to each tissue and spread to match the tissue size.

Deionised water was used as negative control, 8-m KOH was used as positive control.

After treatment with the negative control the absorbance values were well above the required acceptability criterion of mean OD > 0.8 for both treatment intervals thus showing the quality of the tissues. The positive control showed clear corrosive effects for the 3 min experiment.

After three minutes treatment with the test item, the relative absorbance values were reduced to 80.9 %. This value is well above the threshold for corrosion potential (50 %). After one hour treatment, relative absorbance values were reduced to 19.1 %. This value, too, is above the threshold for corrosion potential (15 %). Therefore, Sika Hardener MH was not considered corrosive in the Human Skin Model Test.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Sika Hardener MH was not considered corrosive in the Human Skin Model Test.
Executive summary:

The determination of Skin Corrosion Potential of Sika Hardener MH was performed in the Human Skin Model Test following OECD Guideline 431 and EU Method B.40-BIS

One valid experiment was performed.

Two tissues of the human skin model EpiDermTM were treated with Sika Hardener MH for three minutes and one hour, respectively.

50 µL of the liquid test item were applied to each tissue and spread to match the tissue size.

Deionised water was used as negative control, 8-m KOH was used as positive control.

After three minutes treatment with the test item, the relative absorbance values were reduced to 80.9 %. This value is well above the threshold for corrosion potential (50 %). After one hour treatment, relative absorbance values were reduced to 19.1 %. This value, too, is above the threshold for corrosion potential (15 %).

Therefore, Sika Hardener MH was not considered corrosive in the Human Skin Model Test.