Registration Dossier

Administrative data

Description of key 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.   

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

In all studies performed dermally, N-methylaniline 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 N-methylaniline 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 N-methylaniline does not induce significant irritation, even at toxic concentrations.



Effects on eye irritation: irritating

Justification for classification or non-classification

N-methylaniline is not irritant to the skin or respiratory tissue. According to the GHS and the EU-CLP classification schemes of the ICE,N-methylaniline is considered to be Category 2B: “Mild irritant/causes eye irritation” (GHS classification) and Category 2: “Irritating to eyes” (EU-CLP classification).