Registration Dossier

Administrative data

Description of key information

not a skin irritant

eye irritant

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:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The irritation potential of the substance to the skin and eye was evaluated by considering data on the substance and on a similar substance


Skin irritation

Three studies are available: two on the similar substance and one on the target substance. The two key studies were conducted according to the OECD Guideline 404 and USDA Regulation (Federal Register 34, No. 64, April 4, 1969), instead no guideline was followed for the supporting study.

Mean scores for erythema and edema was 0 in one of the key studies, while scores for redness and swelling was lower than 0 in the second key study. On the contrary, in the supporting study irritation of the skin was observed. However, the latter study cannot be used for classification as there are no scores obtained in order to be classified as per the CLP Regulation criteria and the number of animals is not sufficient for the evaluation.

The substance is therefore not considered as a skin irritant.

Eye irritation

Three studies are available: two on the similar substance and one on the target substance. The two key studies were conducted according to the OECD Guideline 405 and USDA Regulation ( Federal Register 34, No. 64, April 4, 1969), instead no guideline was followed for the supporting study.

In all three studies, the test material caused an eye irriation to the exposed animals.

The substance is therefore considered as an eye irritant.

Justification for classification or non-classification

Based on the obtained results and according to the criteria in Annex I: 3.3.2.1.1. (table 3.3.1) and Annex I: 3.3.2.1.2. (table 3.3.2) of he CLP Regulation EC No.1272/2008, the substance is classified as follows:

Eye Irrit. 2, H319: Causes serious eye irritation.

No classification is attributed for skin irritation/corrosion as per the CLP Regulation (EC) No. 1272/2008 considering the obtained results.