Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

No specific studies are available for assessment of the possible effect of N-methylaniline exposure on fertility. However, the repeated dose studies available (oral and inhalation), show no significant effects on reproductive organs of either male or female at concentrations that induce significant effects in the blood system and the target organ, the spleen. For aniline, a similar conclusion can be drawn. Therefore, no hazard is expected to be present for fertility at concentrations, which are at or below the NOEL(C) for repeated dose toxicity.

Effects on developmental toxicity

Description of key information
The key value is derived from key study with aniline and is supported by another developmental study with aniline and N,N-dimethylaniline. Considering the high rate of similarity in the mode of action between aniline and methylaniline, the value for N-methylaniline is copied from the study with aniline. A NOEL of 10 mg/kg/day was found for all embryotoxic, teratologic, and postnatal endpoints for the offspring.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
10 mg/kg bw/day
Additional information

Since aniline has proven to pass the placental barrier relatively easy, this is believed to be also true for N-methylaniline. Both substances are also easily absorbed by skin. Further, the type of route of exposure does not affect the mode of action of these anilines. Hence, here the NOAEL recorded for the teratological potential of aniline can be safely used as an estimated value for N-methylaniline.

Justification for classification or non-classification

Non-classification is based on the fact that N-methylaniline (and its impurities) does not affect fertility or embryonic or foetal development at concentrations, which induce significant toxicity in case of repeated dosing.