Registration Dossier

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:
2011-08-11 to 2011-10-17
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: Commission Regulation (EC) No. 761/2009, Method B.46, adopted 23 July 2009: “In Vitro Skin Irritation: Reconstructed human epidermis model test”
Deviations:
no
Qualifier:
according to
Guideline:
other: OECD Guideline for the Testing of Chemicals, Version 439, 22 July 2010, “In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method”
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 is considered as “irritant in the Human Skin Model Test”. . (migrated information)

In vivo

Irritant / corrosive response data:
After the treatment with the test item, the relative absorbance values were reduced to 6.7 %. This value is well below the threshold for irritation potential (50%). Therefore, Sika Hardener MH is considered as “irritant in the Human Skin Model Test”.

Any other information on results incl. tables

Findings and Results:

One valid experiment was performed.

Three tissues of the human skin model EpiDermTM were treated with Sika Hardener MH for 60 minutes.

30 µL of the liquid test item (using a nylon mesh) were applied to each tissue and spread to match the tissue size (0.63 cm2; as indicated by supplier).

DPBS-buffer was used as negative control, 5% SDS-solution was used as positive control.

After treatment with the negative control, the absorbance values were within the required acceptability criterion of 1.0 < mean OD < 2.5. The positive control showed clear irritating effects. Variation within tissues was acceptable (< 18%).

After the treatment with the test item, the relative absorbance values were reduced to 6.7 %. This value is well below the threshold for irritation potential (50%). Therefore, Sika Hardener MH is considered as “irritant in the Human Skin Model Test”.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

The determination of the skin irritation potential of Sika Hardener MH was performed in the Human Skin Model Test following Commission Regulation (EC) No. 761/2009, Method B.46, adopted 23 July 2009: “In Vitro Skin Irritation: Reconstructed human epidermis model test” and according to OECD Guideline for the Testing of Chemicals, Version 439, 22 July 2010, “In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method”

One valid experiment was performed.

Three tissues of the human skin model EpiDermTM were treated with Sika Hardener MH for 60 minutes.

30 µL of the liquid test item (using a nylon mesh) were applied to each tissue and spread to match the tissue size (0.63 cm²; as indicated by supplier).

DPBS-buffer was used as negative control, 5% SDS-solution was used as positive control.

After treatment with the negative control, the absorbance values were within the required acceptability criterion of 1.0 < mean OD < 2.5. The positive control showed clear irritating effects. Variation within tissues was acceptable (< 18 %).

After the treatment with the test item, the relative absorbance values were reduced to 6.7 %. This value is well below the threshold for irritation potential (50%). Therefore, Sika Hardener MH is considered as “irritant in the Human Skin Model Test”.