Registration Dossier
Registration Dossier
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EC number: 812-526-5 | CAS number: 53831-80-4
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Read across to multiple in vitro studies
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Considering the structural similarities of both molecules and the probability to act via a common mode of action, it is acceptable to utilise EC 202-429-0 as a read-across source. See attached document for full justification.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: read across to multiple studies, detail not available on each study
- Deviations:
- not specified
- Principles of method if other than guideline:
- read across to multiple studies, detail not available on each study
- GLP compliance:
- not specified
- Remarks:
- Endpoint is from a collection of studies. Details on the study conduct are not available.
- Type of assay:
- other: Studies conducted in bacterial, yeast and mammalian cell lines.
Test material
- Reference substance name:
- o-toluidine
- EC Number:
- 202-429-0
- EC Name:
- o-toluidine
- Cas Number:
- 95-53-4
- Molecular formula:
- C7H9N
- IUPAC Name:
- o-toluidine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Endpoint is from a collection of studies. Details on the study conduct are not available.
Method
- Target gene:
- Studies conducted in bacterial, yeast and mammalian cell lines. Endpoint is from a collection of studies. Details on the study conduct are not available.
Species / strainopen allclose all
- Species / strain / cell type:
- bacteria, other: Endpoint is from a collection of studies. Details on the study conduct are not available.
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- yeast, other: Endpoint is from a collection of studies. Details on the study conduct are not available.
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- mammalian cell line, other: Endpoint is from a collection of studies. Details on the study conduct are not available.
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- Not specified
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Remarks:
- Endpoint is from a collection of studies. Details on the study conduct are not available.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- bacteria, other: Endpoint is from a collection of studies. Details on the study conduct are not available.
- Metabolic activation:
- with and without
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- yeast, other: Endpoint is from a collection of studies. Details on the study conduct are not available.
- Metabolic activation:
- with and without
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- mammalian cell line, other: Endpoint is from a collection of studies. Details on the study conduct are not available.
- Metabolic activation:
- with and without
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- Genotoxicity test results are as typical for the class of aromatic amines. o-Toluidine showed positive as well as
negative results in point mutation assays in bacteria and yeast. Results from tests with mammalian cell systems
(HPRT, TK, UDS) were inconsistent, too, and appear to be protocol dependent. However, positive and negative
results were independent of the presence or absence of a metabolic activation system. In in-vitro tests for
chromosomal aberrations o-toluidine yielded positive results in several cell systems and did induce micronuclei
in human lymphocytes in-vitro. - Remarks on result:
- other: Positive and Negative results obtained.
Applicant's summary and conclusion
- Conclusions:
- Genotoxicity test results are as typical for the class of aromatic amines. o-Toluidine showed positive as well as negative results in point mutation assays in bacteria and yeast. Results from tests with mammalian cell systems (HPRT, TK, UDS) were inconsistent, too, and appear to be protocol dependent. However, positive and negative results were independent of the presence or absence of a metabolic activation system. In in-vitro tests for chromosomal aberrations o-toluidine yielded positive results in several cell systems and did induce micronuclei in human lymphocytes in-vitro.
Overall, otoluidine showed potential for mutagenic activity in vitro and clastogenic activity in vitro. - Executive summary:
Genotoxicity test results are as typical for the class of aromatic amines. o-Toluidine showed positive as well as negative results in point mutation assays in bacteria and yeast. Results from tests with mammalian cell systems (HPRT, TK, UDS) were inconsistent, too, and appear to be protocol dependent. However, positive and negative results were independent of the presence or absence of a metabolic activation system. In in-vitro tests for chromosomal aberrations o-toluidine yielded positive results in several cell systems and did induce micronuclei in human lymphocytes in-vitro.
Overall, otoluidine showed potential for mutagenic activity in vitro and clastogenic activity in vitro.
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