Registration Dossier

Administrative data

Description of key information

The substance was found to be not irritant to the skin in a recent in vitro key study.

The test substance was not eye irritating in an in vivo assay.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not 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

There is an in vitro study available assessing possible irritation effects of the test substance to the skin.

The key in vitro study (2017) was performed to assess the irritation potential of the test substance by means of the Human Skin Model Test. The test was according to OECD 439 and GLP.

Each three tissues of the human skin model EpiDerm™ were treated with the test item, the negative or the positive control for 60 minutes. After treatment with the test item, the mean relative absorbance value was 105.4% compared to the relative absorbance value of the negative control. This value is above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential.

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test substance was not irritant to skin

Eye irritation

There is one study available assessing possible irritation or corrosion potential of the test substance to the eye. The study was performed according to GLP and internationally accepted guidelines.

The eye irritant effect of the test substance was investigated according to the OECD 405. Four female albino rabbits were exposed to 0.1 mL of the test article in the left eye, while the other eye remained untreated and served as control.

The eyes were examined and the changes were graded according to a numerical scale one hour, 24, 48 and 72 hours alter dosing.

Very slight signs of irritation were observed on the treated eyes one hour after exposure. However, the effects were fully reversible as they were no longer observed after 24 hours. According to the CLP regulation the test item shall not be classified as eye irritating.

Justification for selection of skin irritation / corrosion endpoint:

The study is well documented and according to GLP and internationally accepted guidelines.

Justification for selection of eye irritation endpoint:

The study is well documented and according to GLP and internationally accepted guidelines.

Justification for classification or non-classification

Skin irritation

In the key in vitro study according to OECD 439 no potential for skin irritation by the test item was observed. In conclusion, classification of the test substance is not required according to the criteria set out in the CLP regulation.

Eye irritation

Very slight signs of irritation were observed one hour after exposure. However, after 24 hours all signs of irritation were gone, resulting in a score of 0 for all tested animals.

The cut-off value according to the CLP regulation is 2, and the observed effects should be fully reversible, therefore classification of the test substance is not required according to the criteria set out in the EU Regulation No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP).