Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin Irritation: non irritant
Eye Irritation, category 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

Justification for classification or non-classification

Skin corrosion/irritation and eye irritation potentials were evaluated based on the CLP Regulation (EC 1272/2008).

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 key study, the mean values from gradings at 24, 48 and 72 hours after patch removal were lower than the threshold of 2.3 in at least 2 of 3 animals for both erythema/eschar and oedema reactions.

As for eye irritation, a positive response in at least 2/3 animals, in terms of corneal opacity ≥ 1 and/or iritis ≥ 1, and/or conjunctival redness ≥ 2 and/or conjunctival oedema (chemosis) ≥ 2, calculated as mean scores of gradings at 24, 48 and 72 hours after instillation, leads to a classification in category 2 (eye irritant) under the CLP Regulation, if such effects fully reverse within 21 -days.

Except for chemosis, mean values from gradings at 24, 48 and 72 hours for both rinsed and not-rinsed eyes indicated a positive response in 3/3 animals. Despite in all cases symptoms were not fully recovered within the observation period of 8 days, the severity decreased and they were expected to be recovered within 21 days. On these bases, the substance is not expected to be cause severe eye damage.

In conclusion, the substance does not meet the criteria to be classified as skin irritant; on the contrary, a classification as eye irritant, category 2 (H319), according to the CLP Regulation (EC 1272/2008), is applied.