Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Non 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

Justification for classification or non-classification

Skin Irritation/Corossion

According to CLP regulation (EC) n. 1272/2008:

Skin Corrosion means the production of irreversible damage to the skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test substance for up to 4 hours. Corrosive reactions are typified by ulcers, bleeding, bloody scabs, and, by the end of observation at 14 days, by discolouration due to blanching of the skin, complete areas of alopecia, and scars. Histopathology shall be considered to evaluate questionable lesions, and

Skin Irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours

The substance did not cause any redness or irritation, however, the available information from the in vivo study is not sufficient for classification purposes according to the CLP regulation (EC) n. 1272/2008.

For the classification of the study, the results from the in vitro study are also considered. After the exposure of the tissues to the substance for 60 minutes and after a 42 -hour post-incubation period, the average tissue viability was 90.3 % which is much higher than the OECD 439 guideline threshold (50% tissue viability) to be considered as skin irritant. The substance is not classified for skin irritation according to the CLP Regulation (EC) No.1272/2008.

Eye Irritation

According to CLP regulation (EC) n. 1272/2008:

Serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application, and

Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application.

The tissue viability result of the in-vitro eye irritation test using a Reconstructed human Cornea-like Epithelium (RhCE) model, is lower than 60 % therefore the substance should be classified for eye irritation or eye corrosion. It is notable that the tissue viability obtained (58.9 %) is very close to the cut-off value (of OECD 492 guideline) however a non-classification is not permitted. For the evaluation of the classification of the substance, the in-vivo study is also taken into consideration. The substance does produce a slight redness and edema 1 and 24 hours-post treatment, however, these signs are fully reversible after 8 days.

The combination of the two studies suggests that the substance is not expected to be an eye corrosive and is thus classified as an eye irritant (H319) according to the CLP Regulation (EC) No.1272/2008.