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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-583-1 | CAS number: 108-44-1
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study and GLP
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- Procedure: plate incorporation method.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- m-toluidine
- EC Number:
- 203-583-1
- EC Name:
- m-toluidine
- Cas Number:
- 108-44-1
- Molecular formula:
- C7H9N
- IUPAC Name:
- 3-methylaniline
- Details on test material:
- Purity 99.8 %
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA 100, TA1535, TA98, TA1537, Eschericha coli WP2uvrA
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver induced with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- +/- S9-mix: 0, 313, 625, 1250, 2500, 5000 µg/plate
- Vehicle / solvent:
- dimethyl sulfoxide
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide, sodium azide, 9-aminoacridine, 2-aminoanthracene
- Details on test system and experimental conditions:
- preincubation methodology
- Evaluation criteria:
- positive when assay plates with the test substance show a significant increase in revertantcolony count as compared with that on negative control plates and when this effect is reasonably reproducible or dosedependent
- Statistics:
- yes, but method not mentioned
Results and discussion
Test results
- Species / strain:
- other: Salmonella typhimurium TA 100, TA1535, TA98, TA1537, Eschericha coli WP2uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- m-Toluidine was not mutagenic in Salmonella typhimurium TA 100, TA1535, TA98, TA1537, Eschericha coli WP2uvrA with and without an exogenous metabolic activation system.
- Remarks on result:
- other: other: Salmonella typhimurium TA 100, TA1535, TA98, TA1537, Eschericha coli WP2uvrA
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
m-Toluidine was not mutagenic in Salmonella typhimurium TA 100, TA1535, TA98, TA1537, Eschericha coli WP2uvrA with and without an exogenous metabolic activation system.
Applicant's summary and conclusion
- Conclusions:
- Negative in TA 100, TA1535, TA98, TA1537, Eschericha coli WP2uvrA with and without an exogenous metabolic activation system.
- Executive summary:
Genotoxicity of m-toluidine was studied by a Reverse Mutation test in bacteria (Ames test) according to OECD TG 471 and GLP. m-Toluidine was not mutagenic in Salmonella typhimurium TA 100, TA1535, TA98, TA1537, Eschericha coli WP2uvrA with and without an exogenous metabolic activation system (MHLW 2002).
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.
