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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: not irritant


Eye: irritant

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 adverse effect observed (not irritating)

Additional information

The value for skin irriation is initially based on a QSAR prediction and a study with rabbits. In addition, reference is made to observations during other dermal studies. The value for eye irritation is based on a recent GLP study according to the present guidelines. The value for respiratory irritation is derived from the available inhalation studies. 


 


In all studies performed dermally, the test substance was not irritating to skin. In fact, dermally applied dosages causing severe effects in the bodies of test animals, including death, did not reveal significant irritation of the skin.


A GLP in vitro test with chicken eyes showed that the test substance caused slight corneal swelling, slight to moderate opacity, and slight fluorescein retention. The calculated Irritation Index was 65 out of a maximum possible score of 200.


The different inhalation studies in this dossier indicate that exposing of respiratory tissue to the test substance does not induce significant irritation, even at toxic concentrations.



Effects on eye irritation: irritating

Justification for classification or non-classification

Test substance is not irritant to the skin or respiratory tissue. According to CLP regulation 1272/2008 the test substance is considered to be Category 2: “Irritating to eyes”.