Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
