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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Justification for type of information:
As m-toluidine hydrochloride dissociates into m-toluidine and hydrochloride the studies concerning the ecotoxicology of m-toludine are considered relevant for the registration according to REACH.

Data source

Reference
Reference Type:
publication
Title:
Screening-level hazard characterization: Monocyclic aromatic amines category
Author:
U.S. Environmental Protection Agency
Year:
2009
Bibliographic source:
U.S. Environmental Protection Agency, September 2009, pp1-32

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Cultured Chinese hamster lung (CHL/IU) cells were exposed to m-toluidine up to 1.1 mg/mL with and without metabolic activation. The positive controls gave expected re-sponses.
GLP compliance:
not specified
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Constituent 1
Chemical structure
Reference substance name:
m-toluidine
EC Number:
203-583-1
EC Name:
m-toluidine
Cas Number:
108-44-1
Molecular formula:
C7H9N
IUPAC Name:
m-toluidine
Test material form:
not specified

Method

Species / strain
Species / strain / cell type:
Chinese hamster lung (CHL/IU)
Test concentrations with justification for top dose:
Highest concentration: 1.1 mg/mL
Details on test system and experimental conditions:
Cultured Chinese hamster lung (CHL/IU) cells were exposed to m-toluidine up to 1.1 mg/mL with and without metabolic activation. The positive controls gave expected re-sponses. Structural chromosomal aberrations were not induced up to the highest con-centrations tested. Polyploidy was significantly increased (p < 0.05), but remained within historical controls and was not considered positive.

Results and discussion

Test results
Key result
Species / strain:
Chinese hamster lung (CHL/IU)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified

Applicant's summary and conclusion

Conclusions:
Cultured Chinese hamster lung (CHL/IU) cells were exposed to m-toluidine up to 1.1 mg/mL with and without metabolic activation. The positive controls gave expected re-sponses. Structural chromosomal aberrations were not induced up to the highest con-centrations tested. Polyploidy was significantly increased (p < 0.05), but remained within historical controls and was not considered positive. m-Toluidine did not induce chromo-somal aberrations in this assay.
Executive summary:

As m-toluidine HCl dissociates into m-toluidine and hydrochloride the study is considered relevant for the registration according to REACH.


Cultured Chinese hamster lung (CHL/IU) cells were exposed to m-toluidine up to 1.1 mg/mL with and without metabolic activation. The positive controls gave expected re-sponses. Structural chromosomal aberrations were not induced up to the highest con-centrations tested. Polyploidy was significantly increased (p < 0.05), but remained within historical controls and was not considered positive. m-Toluidine did not induce chromo-somal aberrations in this assay.


As the information has been published by the EPA and is publicly available, the study has been rated as Klimisch 2.


m-toluidine HCL is not deemed genotoxic.