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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

N-methylaniline has got a not negligible acute toxicity: oral LD50 rabbit is  280 mg/kg/bw, dermal LD100 ≥ 3000 mg/kg/bw but no data for inhalator acute toxicity are available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
280 mg/kg bw
Quality of whole database:
SCOEL/SUM/178 of December 2012 for N-methylaniline

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Quality of whole database:
In SCOEL/SUM/178 of December 2012 for N-methylaniline with reference to Treon et all, J Ind Hyg Toxicol 31:1-20, 1949 LD100≥ 3000 mg/kg/ is reported. This value is of concern but insufficient for classification.

Additional information

Oral exposure:

As reported in SCOEL/SUM/178 of December 2012 for N-methylaniline with reference to NISH Japan 2010 after oral administration by gavage (in corn oil) to rats, LD50 between 700 and 800 mg/kg bw were determined following current OECD guidelines. The minimum lethal dose in this study was 640 mg/kg for both sexes. In an older study (see Treon et all, J Ind Hyg Toxicol 31:1-20, 1949) the minimum lethal oral dose of N-methylaniline for rabbits was 280 mg/kg. Following the precautionary approach, the lowest LD50 (280 mg/kg) must be used for the risk assessment.

N-methylaniline is included in annex VI of CLP Regulation (EC n. 1272/2008) and it is classified H301 (acute oral toxicity cat.3).

 

Inhalation exposure:

As reported in SCOEL/SUM/178 of December 2012 for N-methylaniline data on the inhalation toxicity of NMA after a single exposure were not available.

However, N-methylaniline is included in annex VI of CLP Regulation (EC n. 1272/2008) and it is classified H311 (acute inhalator toxicity cat.3)

 

Dermal  exposure:

As reported in SCOEL/SUM/178 of December 2012 for N-methylaniline with reference to Treon et all, J Ind Hyg Toxicol 31:1-20, 1949 cyanosis and death were observed in all rabbits after dermal application on the intact skin of ≥ 3 000 mg/kg for 1 hour or longer. It is not possible to classified the substance according CLP using this data. According to CLP Regulation (EC n. 1272/2008) for the classification the value LD50 ≤ 2000 mg/kg/bw is required.

However, N-methylaniline is included in annex VI of CLP Regulation (EC n. 1272/2008) and it is classified H331 (acute dermal toxicity cat.3).


Justification for selection of acute toxicity – oral endpoint
Data from reliable source (Scientific Commitee on Occupational Exposure Limit SCOEL)

Justification for selection of acute toxicity – dermal endpoint
In the study Treon et all, J Ind Hyg Toxicol 31:1-20, 1949 is reported only LD100

Justification for classification or non-classification

N-methylaniline has got a not negligible acute toxicity: ral LD50 rabbit is 280 mg/kg/bw, dermal LD100 ≥3000 mg/kg/bw but no data for inhalator acute toxicity are available.

Regarding acute dermal toxicity, LD100 = 3000 mg/kg/bw is not sufficient for classification accrding to CLP Regulation (EC n. 1272/2008). However, N-methylaniline is included in annex VI of CLP Regulation (EC n. 1272/2008) and it is classified H301 (acute oral toxicity cat.3), H311 ( acute inhalator toxicity cat.3) and H331 (acute dermal toxicity cat.3).