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Toxicological information

Genetic toxicity: in vitro

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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:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
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:
other: Endpoint is from a collection of studies. Details on the study conduct are not available.
Additional strain characteristics:
not specified
Metabolic activation:
with and without
Species / strain:
other: Endpoint is from a collection of studies. Details on the study conduct are not available.
Additional strain characteristics:
not specified
Metabolic activation:
with and without
Species / strain:
other: Endpoint is from a collection of studies. Details on the study conduct are not available.
Additional strain characteristics:
not specified
Metabolic activation:
with and without
Test concentrations with justification for top dose:
Not specified
Controls
Negative controls:
not specified
Solvent 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:
other: Endpoint is from a collection of studies. Details on the study conduct are not available.
Metabolic activation:
with and without
Genotoxicity:
ambiguous
Cytotoxicity:
no
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Remarks on result:
other: Positive and Negative results obtained.
Key result
Species / strain:
other: Endpoint is from a collection of studies. Details on the study conduct are not available.
Metabolic activation:
with and without
Genotoxicity:
ambiguous
Cytotoxicity:
no
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Remarks on result:
other: Positive and Negative results obtained.
Key result
Species / strain:
other: Endpoint is from a collection of studies. Details on the study conduct are not available.
Metabolic activation:
with and without
Genotoxicity:
ambiguous
Cytotoxicity:
no
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Remarks on result:
other: Positive and Negative results obtained.
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.

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.