Registration Dossier

Toxicological information

Carcinogenicity

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Administrative data

Endpoint:
carcinogenicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
2g. 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:
2010
Bibliographic source:
Scientific Committee on Occupational Exposure Limits (SCOEL), SCOEL/SUM/178, September 2010.

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Reference: WHITE J, MORI-CHAVEZ P. 1952, Acute necrotizing renal papillitis experimentally produced in rats fed mono-N-methylaniline, J Natl Cancer Inst. 1952 Feb;12(4):777-87. Study was performed before the existence of International guidelines on carcinogenicity studies.
GLP compliance:
no
Remarks:
Performed before existence of GLP guidelines.

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Osborne-Mendel
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
other: food
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
272-758 days
Frequency of treatment:
not specified
Post exposure period:
not applicable
Doses / concentrations
Remarks:
Doses / Concentrations:
0.06%
Basis:
nominal in diet
No. of animals per sex per dose:
20
Control animals:
no

Results and discussion

Results of examinations

Relevance of carcinogenic effects / potential:
Although reliability of these data are limited, they indicate that chronic exposure of rats to N-methilaniline shows no high carcinogenic potential.

Effect levels

Dose descriptor:
NOEC
Effect level:
0.06 other: % in food
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Haemorrhagic foci observed in the liver, but no tumors in this or any other organ.
Remarks on result:
other: Effect type: carcinogenicity (migrated information)

Applicant's summary and conclusion

Conclusions:
At estimated daily doses of 42 to 46 mg/kg bw, no significant occurrences of tumor were recorded. No control group was described in this study.