Registration Dossier
Registration Dossier
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EC number: 202-870-9 | CAS number: 100-61-8
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- other: Evaluation of collected data.
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- 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
- Reference Type:
- review article or handbook
- Title:
- Handbook of Intermediary Metabolism of Aromatic CompoundsRecommendation from the Scientific Committee on Occupational Exposure Limits for N-methylaniline
- Author:
- Scientific Committee on Occupational Exposure Limits
- Year:
- 2 010
- 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:
- no
- Limit test:
- no
Test material
- Reference substance name:
- N-methylaniline
- EC Number:
- 202-870-9
- EC Name:
- N-methylaniline
- Cas Number:
- 100-61-8
- Molecular formula:
- C7H9N
- IUPAC Name:
- N-methylaniline
Constituent 1
Test animals
- Species:
- other: Rabbits, rats, guinea pigs, cats, dogs and monkeys.
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- intravenous
- Vehicle:
- not specified
- Doses:
- 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
- Sex:
- 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
- Sex:
- not specified
- Dose descriptor:
- other: LOEL
- Effect level:
- 18 mg/kg bw
- Based on:
- test mat.
- Remarks:
- 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
- Conclusions:
- 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.
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