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Description of key information

Not skin irritating.
Eye irrit. 2 (H319)

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

Reliable GLP studies with New Zealand White rabbits were performed for skin and eye irritation, according to the OECD guidelines 404 and 405, respectively.

No changes were seen at any test article application site in the skin irritation test.

Moderate conjunctival redness and slight to moderate chemosis were noted in all rabbits at the readings carried out 1 hour after application. At the subsequent observations, 24 and 48 hours after treatment, conjunctuval redness became severe, while chemosis decreased to very slight. Conjunctival changes decreased in severity and/or frequency 72 hours after application and disappeared by the last observation time, 7 days after exposure. No residual ocular changes were detected at the last observation time, 7 days after exposure.


Justification for selection of skin irritation / corrosion endpoint:
Test conducted according to internationally accepted testing procedures and according to the GLP.

Justification for selection of eye irritation endpoint:
Test conducted according to internationally accepted testing procedures and according to the GLP.

Effects on eye irritation: irritating

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.

The mean value is less than 2.3 for erythema/eschar and for oedema in all the tested animals, from gradings at 24, 48 and 72 hours after patch removal. In conclusion, the substance is not classify as skin irritant, according to the CLP Regulation (EC 1272/2008).

According to the Regulation EC 1272/2008 (CLP) 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 rating 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, in all the tested rabbits

- lower than 1 for irtitis, in all the tested rabbits

- lower than 2 for oedema in two of three tested animals

- higher than 2 for conjunctival in all the tested animals.

All reactions recorded were fully reverses within an observation period of 7 days.

Thus, the test item is classified as irritating to eye, category 2 (H319) according to the CLP (EC 1272/2008) Regulation.