Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion:

The test item was tested for skin irritation/corrosion potential by two in vitro Human Skin Model Tests. In the test for skin corrosion potential according to EU method B.40 bis and OECD Guideline 431 the test item was not considered to show skin corrosion potential. In the test for skin irritation potential according to EU method B.46 and OECD Guideline 439 it was concluded that the test item SIKA Hardener MH showed skin irritation potential.

Eye irritation:

The test item was tested for eye irritation/corrosion potential in the in vitro BCOP test according to OECD Guideline 437. According to the requirements of Guideline OECD 437, the test item SIKA Hardener MH showed no potential for eye corrosion.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
from 2011-04-06 to 2011-05-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Version / remarks:
OECD 431; 13 April 2004
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
- Batch no.: 10191-AKm
- Purity. 100.5% (aldimine titration)
Test system:
human skin model
Cell type:
non-transformed keratinocytes
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
no
Remarks on result:
other: Sika Hardener MH was not considered corrosive in the Human Skin Model Test.
Other effects / acceptance of results:
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.

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.

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 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.

Interpretation of results:
GHS criteria not met
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.

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
from 2011-08-11 to 2011-10-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Version / remarks:
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:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Version / remarks:
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)
Specific details on test material used for the study:
- Batch no.: 10191-AKm
- Purity. 100.5% (aldimine titration)
Test system:
human skin model
Cell type:
non-transformed keratinocytes
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
no
Remarks on result:
other: Sika Hardener MH is considered as “irritant in the Human Skin Model Test”.
Other effects / acceptance of results:
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”.

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”.

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Sika Hardener MH is considered as “irritant in the Human Skin Model Test”.
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”.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
from 2011-08-08 to 2011-10-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Version / remarks:
OECD Guideline for the Testing of Chemicals, Method No. 437, edition adopted 07 Sept. 2009: “Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants”
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
- Batch no.: 10191-AKm
- Purity. 100.5% (aldimine titration)
Species:
cattle
Details on test animals or tissues and environmental conditions:
- isolated corneas from the eyes of freshly slaughtered cattle
Vehicle:
unchanged (no vehicle)
Controls:
no
Irritation parameter:
in vitro irritation score
Run / experiment:
Mean - after 10 minutes
Value:
19.783
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: The test item Sika Hardener MH showed mild effects (according to ICCVAM classification) on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 19.7830.
Other effects / acceptance of results:
The test item Sika Hardener MH was brought onto the cornea of a bovine eye which previously had been incubated with cMEM without Phenol red at 32 ± 1 °C for one hour and whose opacity had been determined. The test item was incubated on the cornea for 10 minutes/four hours at 32 ± 1 °C. After removal of the test item and two hours post-incubation, opacity and permeability values were measured.
Physiological sodium chloride solution was used as negative control, sodium hydroxide (10 % solution in 0.9 % NaCl solution) was used as positive control.
The negative control showed no irritation, mean IVIS was 0.6620.
The positive control induced a very severe irritation on the cornea, mean IVIS was 210.4020.
The test item was tested pure. A mean IVIS of 19.7830 was calculated, corresponding to a ICCVAM classification as mild eye irritant.
Interpretation of results:
GHS criteria not met
Conclusions:
The test item Sika Hardener MH showed mild effects (according to ICCVAM classification) on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 19.7830. According to OECD 437, Sika Hardener MH is considered as “non corrosive / no severe irritant”.
Executive summary:

The eye irritation potential of Sika Hardener MH was evaluated in the BCOP Test following OECD Guideline 437 dated September 2009. One valid experiment was performed. Bovine corneas were used. They were collected from slaughtered cattle which were between 12 and 60 months old. The test item Sika Hardener MH was brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32 ± 1°C for one hour and whose opacity had been measured. The test item was incubated on the cornea for 10 minutes at 32 ± 1°C. After removal of the test item and two hours post-incubation, opacity and permeability values were measured. Physiological sodium chloride solution was used as negative control. The negative control showed no irritating effect on the cornea. 10 % sodium hydroxide solution was used as positive control. The positive control induced a very severe irritation on the cornea. The test item Sika Hardener MH showed mild effects (according to ICCVAM classification) on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 19.7830. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Sika Hardener MH possesses a mild eye irritation potential. According to OECD 437, Sika Hardener MH is considered as “non-corrosive / no severe irritant”.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion:

OECD 431

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.

OECD 439

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”.

Eye irritation/corrosion:

OECD 437

The eye irritation potential of the test item was evaluated in the BCOP Test following OECD Guideline 437 dated September 2009. One valid experiment was performed. Bovine corneas were used. They were collected from slaughtered cattle which were between 12 and 60 months old. The test item Sika Hardener MH was brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32 ± 1°C for one hour and whose opacity had been measured. The test item was incubated on the cornea for 10 minutes at 32 ± 1°C. After removal of the test item and two hours post-incubation, opacity and permeability values were measured. Physiological sodium chloride solution was used as negative control. The negative control showed no irritating effect on the cornea. 10 % sodium hydroxide solution was used as positive control. The positive control induced a very severe irritation on the cornea. The test item Sika Hardener MH showed mild effects (according to ICCVAM classification) on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 19.7830. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item possesses a mild eye irritation potential. According to OECD 437, the test item is considered as “non-corrosive / no severe irritant”.

OECD 492

Acute ocular irritation potential of the test item was investigated on three-dimensional RhCE tissue in the EpiOcular™ model in vitro according to OECD TG 492.

Disks of EpiOcular™ (two units) were treated with test item (50 μL/units) and incubated for 30 ± 2 minutes at standard culture conditions. Exposure of test material was terminated by rinsing. After rinsing, the tissues were incubated for a 12 ± 2 minutes immersion incubation (Post-Soak) at room temperature. At the end of the Post-Soak immersion test items treated tissues were incubated for 120 ± 15 minutes at standard culture conditions (Post-treatment Incubation). The viability of each disk was assessed by MTT assay. Sterile deionized water and methyl acetate treated tissues were used as negative and positive controls respectively. The test item showed significantly reduced cell viability in comparison to the negative control (mean viability: 4 %). All viability results obtained after test item treatment were below 60 % when compared to the viability values obtained from the negative control. Positive and negative controls showed the expected cell viability values within acceptable limits. The experiment was considered to be valid. The results obtained from this in vitro eye irritation test, using the EpiOcular™ model, with the test item indicated that the test item is Irritant (UN GHS Category 2) and/or Corrosive (UN GHS Category 1) to eyes. However, this test method (OECD 492) cannot resolve between UN GHS Categories 1 and 2.

Overall conclusion on eye irritation:

In vitro testing on eye irritation properties of the test item followed integrated alternative testing approach (IATA) as required by the authorities in order to comply with animal welfare. The first in vitro test (OECD 437) revealed that the test item does not need to be classified as eye corrosive. However, mild irritation effects were observed in this test. Results of the second test (OECD 492) indicated that the test item cannot be considered to not require classification, i. e. it should be classified as Cat 1 or 2 for eye irritation.

Based on a weight of evidence evaluation of the available data and taking into account, that no further (animal) tests should be conducted, the test item shall be classified as eye irritating Cat. 2 according to CLP.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No. 1272/2008. As a result the substance is classified as irritationg skin Cat 2 (H315) and irritating to the eye (H319) under Regulation (EC) No. 1272/2008, as amended for the twelfth time in Regulation (EU) No. 2019/521.