Registration Dossier

Administrative data

Description of key information

Not skin irritating.

Not eye irritating.

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

Justification for classification or non-classification

SKIN IRRITATION

According to the CLP Regulation (EC 1272/2008), 3.2 Skin corrosion/irritation section, skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.

In the studies available, the substance did not show a potential to be skin irritant.

Considering the available data, the substance can be considered as not classified for skin irritation.

EYE IRRITATION

According to the CLP Regulation (EC 1272/2008) substances that have the potential to induce reversible eye irritation are classified in Category 2 (irritating to eyes) if, when applied to the eye of an animal, a substance produces at least in 2 of 3 tested animals, a positive response of corneal opacity ≥ 1 and/or iritis ≥ 1, and/or conjunctival redness ≥ 2 and/or conjunctival oedema (chemosis) ≥ 2, calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.

In two of the studies conducted on the Similar Substance 01, the substance does not show ocular effects that can give a warning for eye irritation nevertheless, they can't be used for the classification pourpose because the report results were calculated according to a different scoring criteria. Anyway, only conjunctiva was affected, and the symptoms related were reversible in a few days.

In the third study the eye irritation was evaluated using a substance with a low purity (28%) moreover, the treated eyes haven't been rinsed after the application of the substance.

In order to give a complete assessment of the eye irritationpotential of the substance, another study conducted on Similar Substance 02 was taken into account. During the study no ocular effects were obserbed.

Considering the available data and the consideration above the substance can be considered as not classified for Eye irritation according to the CLP Regulation