Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Additional information

Odour threshold of the test substance is 1.7 ppm (7.4 mg/m3).


 


Some data on the sensitisation potential of the substance on humans can be found in literature (Uter. W., Stropp G., Schnuch A. and Lessmann H.).
Basing on the results of examination, none of 40 patients resulted positive when tested with 5% test substance and N,N-dimethylaniline; 37/58 patients were positive when tested with 2% p-toluidine.


In contrast to 4-methylaniline, test substance did not induce an allergic reaction in patients hypersensitive to p-phenylenediamine.


 


According to literature data (Scientific Committee on Occupational Exposure Limits (SCOEL), SCOEL/SUM/178, September 2010) there are no data available regarding the acute toxicity of the test substance in humans but it is expected that acute test substance poisoning will resemble the acute toxicity of aniline, including induction of MetHb with cyanosis, weakness, dizziness and severe headache.


 In most human individuals, the background MetHb level is between 1 and 2% and an increase up to 15% will be without significant signs or symptoms. Clinical cyanosis will develop at about 15-20% MetHb and more. Fatigue, anxiety, headache, weakness, dizziness, tachycardia, dyspnoea, and syncope will occur at 30-45% MetHb. Higher concentrations will cause a reduced level of consciousness and finally coma, heart failure and death at more than 60-70% MetHb.


Like aniline, test substance exposure can cause induction of MetHb in humans, which may lead to clinical signs of intoxication when MetHb concentrations increase to levels above 15% MetHb.