Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Based on publications of the American Conference of Governmental Industrial Hygienists, 2001, and the National Library of Medicine, 2005.

Data source

Reference
Reference Type:
review article or handbook
Title:
Recommendation from the Scientific Committee on Occupational Exposure Limits for N-methylaniline
Author:
Scientific Committee on Occupational Exposure Limits
Year:
2010
Bibliographic source:
Scientific Committee on Occupational Exposure Limits (SCOEL), SCOEL/SUM/178, September 2010.

Materials and methods

Type of study / information:
Further based on:
1. NRC, National Research Council, 2000, Acute exposure guideline levels for selected airborne chemicals Vol. I, Nat. Acamedy Press, Washington DC.
2. Henschler D., 1992. Gesundheitsschaedliche Arbeitsstoffe, Toxicologisch-arbeitsmedizinische Begruendungen van MAK-Werten, Loseblattsammlung, 18.Deuatsche Forschungsgemeinschaft, VCH Verlag Weinheim.
3. Health & Safety Executive, 1997. Risk Assessment Document. EH72/8. Aniline. Suffolk, UK.
Endpoint addressed:
acute toxicity: oral
acute toxicity: inhalation
acute toxicity: dermal
Test guideline
Qualifier:
no guideline required
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Details on study design:
There are no data available regarding the acute toxictiy of NMA in humans but it is expected that acute N-methylaniline poisoning will resemble the acute toxicity of aniline, including induction of MetHb with cyanosis, weakness, dizziness and severe headache.
Exposure assessment:
estimated

Results and discussion

Results:
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.

Applicant's summary and conclusion

Conclusions:
Like aniline, N-methylaniline 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.