Registration Dossier

Administrative data

Description of key information

The test item SIKA Hardener MH 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. 
The test item SIKA Hardener MH 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

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion:

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 (LAUS, 2011). 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” (LAUS, 2011).

Eye irritation/corrosion:

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 non corrosive / no severe irritant.

 


Justification for selection of skin irritation / corrosion endpoint:
Only one study available for skin irritating.

Justification for selection of eye irritation endpoint:
Only one study available.

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Based on the results obtained from testing SIKA Hardener MH was classified and labled as R38 (irritating to skin) and Skin Irritation cat. 2 (H315: causes skin irritation) according to Directive 67/548/EEC (DSD) and to Regulation (EC) No. 1272/2008 (CLP), respectively.

Eye irritation studies (BCOP test) showed that SIKA Hardener MH is non corrosive. Based on these results, SIKA Hardener MH is not classified and labelled as an eye damage category 1or C, respectively, according to Directive 67/548/EEC (DSD) and to Regulation (EC) No 1272/2008 (CLP).