Registration Dossier

Administrative data

Description of key information

The key values are based on the results of the key studies for oral and inhalation routes, which are qualified as Klimisch code 1 studies. The value for dermal exposure should be used with caution as it is based on a much older publication of a study, which was not performed according to modern standards.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
5 mg/kg bw/day
Study duration:
subacute
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Dose descriptor:
LOAEC
13.3 mg/m³
Study duration:
subacute
Species:
rat

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
100 mg/kg bw/day
Study duration:
subacute
Species:
rabbit

Additional information

The results of both key studies for repeated exposure to N-methylaniline by oral administration and inhalation show that the toxic effects are irrespective the route of exposure. Also the data from the dermal study supports this hypothesis. Main effects are the induction of methaemoglobine, effects on blood parameters and histological changes in spleen and bone marrow. The target organ appears to be the spleen with significant effects at the LOAECs. At higher concentrations, the induction of methaemoglobin causes cyanosis and pathological changes are observed in liver and kidneys. These effects are similar to those observed in toxicity tests with aniline suggesting the same mode of action. In addition, the efeect concentrations for N-methylaniline are in the same range as recorded for aniline.


Repeated dose toxicity: via oral route - systemic effects (target organ) cardiovascular / hematological: bone marrow; cardiovascular / hematological: spleen

Repeated dose toxicity: inhalation - systemic effects (target organ) cardiovascular / hematological: spleen

Justification for classification or non-classification

The test substance is legally classified as STOT RE 2, H373 according to the CLP regulation 1272/2008, and R33 according to the Directive 67/548/CEE.