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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information
Information is insufficient to assess the reprotoxic capacity of N-methylaniline.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
adverse effect observed
Quality of whole database:
Data from Scientific Commitee on Occupational Exposure Limit (SCOEL) of 2012 and recent public data from International Journal of Occupational Medicine and Environmental Health (2016).
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information
Justification for selection of Effect on developmental toxicity: via oral route:
Information is insufficient to assess the reprotoxic capacity of N-methylaniline

Toxicity to reproduction: other studies

Additional information

As indicated in SCOEL/SUM/178 of December 2012 for N-methylaniline there were no data available regarding fertility and developmental toxicity of the substance. Aniline can cross the placenta and induce foetal methaemoglobinaemia; a similar property can be expected for N-methylaniline. This assumption seems to be confirmed by a recent study of 2016 (see Sitarek et all, International Journal of Occupational Medicine and Environmental Health, 29 (3), 2016). In this study pregnant female rats were administered N-methylaniline in corn oil by gavage at daily doses of 0.8 mg/kg of body weight (b.w.), 4 mg/kg b.w., 20 mg/kg b.w. and 100 mg/kg b.w. from implantation (the 5th day post mating) to the day prior to the scheduled caesarean section (the 20th day of pregnancy). Lower weight gain during pregnancy and significantly higher N-methylaniline-dose-dependent absolute weight of the organs were noted in the exposed females. The females from the groups exposed at doses of 20 mg/kg b.w./day and 100 mg/kg b.w./day developed anemia and showed higher concentrations of free thyroxine (FT3) and free triiodothyronine (FT4) thyroid hormones. Total protein concentration exhibited an increase in all the exposed groups of females. In the prenatal toxicity study, administration of N-methylaniline throughout the embryonic and fetal periods produced embryotoxic effects at doses ranging 4–100 mg/kg b.w./day. Considering the data obtained in this study, it is reasonable to assume that N-methylaniline administered orally to pregnant rats is toxic for mothers even at a low dose of 0.8 mg/kg b.w./day. However, this dose was not associated with any significant effects to their offspring. This prenatal exposure level may be considered as no-observed-adverse-effect level (NOAEL) for the progeny and a dose of 4 mg/kg b.w./day as the lowest-observed-adverse-effect level (LOAEL) for the progeny.

However, this data is not sufficient for classification of N-methylaniline for reproductive toxicity.

Justification for classification or non-classification

Information is insufficient to assess the reprotoxic capacity of N-methylaniline. N-methylaniline is not classified for reproductive toxicity according to annex VI of CLP Regulation (EC n.1272/2008).

Additional information