Registration Dossier

Administrative data

Description of key information

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)

Additional information

Effects on skin irritation

No effect on skin was observed in the skin irritation test on rabbits. Some effects on eye of all the treated rabbits was observed, fully reversible within 14 days.

Effects on eye irritation

Irritating

Justification for classification or non-classification

The CLP Regulation inidcates the following values for the classification fo skin and eye irritation.

Skin irritant cat 2:

1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions;

or

2) Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling;

or

3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

Eye irritant Cat 2: at least in 2 of 3 tested animals, a positive response of:

1) corneal opacity ≥ 1

and/or

2) iritis ≥ 1

and/or

3) conjunctival redness ≥ 2

and/or

4) conjunctival oedema (chemosis) ≥ 2 5calculated 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.

Based on the test results the substance is considered to be:

- not skin irritant

- eye irritant

The classification based on Regulation 1272/2008 is Eye Irritant Cat. 2, H319, Causes serious eye irritation.