Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Toxicological information

Carcinogenicity

Currently viewing:

Administrative data

Endpoint:
carcinogenicity: oral
Adequacy of study:
other information

Data source

Referenceopen allclose all

Title:
No information
Author:
National Cancer Institute: Bioassay of 3-chloro-p-tolu-|idine for possible carcinogenicity. NCI Carcinogenesis|Technical Report Series No. 145 (1978)
Reference Type:
publication
Title:
3-Chloro-p-Toluidine
Author:
Bureau of National Affairs
Year:
1995
Bibliographic source:
Bureau of National Affairs, INC, Washington, D.C. 20037

Materials and methods

GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Reference substance 002
Details on test material:
IUCLID4 Test substance: other TS: 3-chloro-p-toluidine; high purity (no further data)

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Duration of treatment / exposure:
78 w
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
see remarks
Basis:

Control animals:
yes
Details on study design:
Post-exposure period: 25 w (24 w only for the males and at the higher concentration)

Results and discussion

Any other information on results incl. tables

Although a dosage-dependent increased incidence of endometrial stromal polyps was observed in the female rats, it was found to be statistically insignificant (incidences: 0 % (control), 8 % (low dose), 18 % (high dose)); the authors contend that this lesion is common in aged female Fischer 344 rats, and the variation in its incidence among
the control and dosed rats is attributed to the low number of control females; an incidence of 28/284 (10 %) was noted for the historical control; under the test conditions,
the study did not provide any convincing indications of carcinogenicity of 3-chloro-p-toluidine in Fischer 344 rats.

Applicant's summary and conclusion