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Diss Factsheets

Toxicological information

Acute Toxicity: other routes

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Administrative data

acute toxicity: other routes
Type of information:
other: Evaluation of collected data.
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Collection of data by the Scientific Committee on Occupational Exposure Limits, a committee of the European Commission established in 1995 to advise on occupational exposure limits for chemicals in the workplace within the framework of Directive 98/24/EC, the chemical agents directive; and Directive 90/394/EEC, the carcinogens at work directive.

Data source

Reference Type:
review article or handbook
Handbook of Intermediary Metabolism of Aromatic CompoundsRecommendation from the Scientific Committee on Occupational Exposure Limits for N-methylaniline
Scientific Committee on Occupational Exposure Limits
Bibliographic source:
Scientific Committee on Occupational Exposure Limits (SCOEL), SCOEL/SUM/178, September 2010.

Materials and methods

Principles of method if other than guideline:
Tests were performed before the existence of international guidelines, references:
1. Treon, J.F. et al., 1949. The toxic properties of xylidine and monomethylaniline I. J. of industrial hygiene & toxicology, 31, 1949, pages: 1-20.
2. Treon, J.F. et al., 1950. The toxic properties of xylidine and monomethylaniline II. Arch. of industrial hygiene & occupational medicine Vol. 1, pages: 506-524.
3. Lin JK, Hsu SM, Wu YH. Methemoglobin induced by carcinogenic aminoazo dyes in rats. Biochem Pharmacol. 1972 Aug 1;21(15):2147-50.
4. Holzer N. & Kiese M., 1960. Bildung von Nitrosobenzol, anilin und Haemiglobin in Katzen und Hunden nach intravenoeser Injektion von N-Alkylanilinenj. Naunyn-Schmiedebergs Archiv fuer experimejntelle Pathologie und Pharmakologie, 238:546-556.

GLP compliance:
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:

Test animals

other: Rabbits, rats, guinea pigs, cats, dogs and monkeys.
not specified
not specified

Administration / exposure

Route of administration:
not specified
Doses specified: 18 to 54 mg/kg, but broader ranges were probably tested.
No. of animals per sex per dose:
Not specified.
Control animals:
not specified

Results and discussion

Effect levelsopen allclose all
not specified
Dose descriptor:
other: minimum lethal dose
Effect level:
24 mg/kg bw
Based on:
test mat.
Remarks on result:
other: in cats and rabbits
not specified
Dose descriptor:
other: LOEL
Effect level:
18 mg/kg bw
Based on:
test mat.
Dosed i.v. in cats
Remarks on result:
other: Based on aenemia.

Any other information on results incl. tables

After a single i.v. injection of 18 -24 mg test substance per kg in cats caused a rapid increase of MetHb up to levels > 60 -70%.

In rabbits and cats, Heinz-bodies were observed in erythrocytes (inclusions composed of denatured hemoglobin) after i.v. injection of 36 mg/kg bw or higher.

Aenemia was observed after i.v. injection of test substance at 18 mg/kg in cats (LOEL).

Applicant's summary and conclusion

In comparison to aniline, test substance is about twice as potent in causing MetHb formation. The LOEL (i.v.) for aenemia in cats was 18 mg/kg bw.