Registration Dossier

Administrative data

Description of key information

The test substance is classified non irritating for eyes.

The test substance is classified non irritating for skin.

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:

Test substance shows a very low interaction when applied to intact or abraded rabbit skin.

The key study was conducted with test material 75 % pure. The substance shows a very low irritation score during the first day of observation period. The test item was found to be non irritating (the highest reaction score after 24, 48 and 72 hours is 0.66 for intact skin). After 48 hours all parameters were negative.

The study conducted in 1990 is only an short abstract, the substance had a purity around 85 %. The test can not be evaluable according to the CLP Regulation (EC n. 1272/2008), therfore the test was disregarded.

Eye irritation:

Test substance shows a very low interaction when applied into conjunctival sac.

The key study was conducted in 1973, the test material was 75 % pure. Only transient minimal reactions were seen in rinsed eyes (mean reaction score after 24, 48 and 72 hours). The irritation consisted of conjunctival reaction and of reflex hyperemia of the iris. After 6 days all findings were regressed.

The study conducted in 1990 is only a short abstract, the substance had a purity around 85 % and the conclusions support the results written in the key study. There is only a weakly irritations signs within the first 24 hours of observation period. All signs of damage to the cornea and mucous membranes disappeared within 72 hours.

Justification for classification or non-classification

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. Moreover in the key study, no mean values from gradings at 24, 48 and 72 hours after patch removal exceed the threshold value of 2.3 for both erythema/eschar and oedema reactions.

 

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 iris ≥ 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.

The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iris, lower than 2 for both conjunctival redness and oedema, in all animals in the key study.

 

In conclusion, the substance is not classified for the eye/skin irritation, according to the CLP Regulation (EC 1272/2008).