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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
Qualifier:
according to guideline
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
GLP compliance:
yes
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Constituent 1
Chemical structure
Reference substance name:
3,5-xylidine
EC Number:
203-607-0
EC Name:
3,5-xylidine
Cas Number:
108-69-0
Molecular formula:
C8H11N
IUPAC Name:
3,5-dimethylaniline
Details on test material:
Purity 99.9%

Method

Species / strain
Species / strain / cell type:
other: Chinese hamster CHL/IU cells
Metabolic activation:
with and without
Controlsopen allclose all
Positive controls:
yes
Positive control substance:
benzo(a)pyrene
Remarks:
Migrated to IUCLID6: + S9 mix
Positive controls:
yes
Positive control substance:
mitomycin C
Remarks:
Migrated to IUCLID6: - S9 mix

Results and discussion

Test results
Species / strain:
other: Chinese hamster CHL/IU cells
Metabolic activation:
with
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified

Any other information on results incl. tables

Test results:

Cytogenetic effects were seen as follows.

At the highest concentration (900 µg/ml) after 6 hr short-term treatment with and without exogenous metabolic activation, 22.5 and 12.0% cells demonstrated structural chromosomal aberrations including gaps.

Genotoxic effects: clastogenicity    polyploidy

+ ? -              + ? -

Without metabolic activation:       [ ] [ ] [ * ]              [ ] [ ] [ * ]

With metabolic activation: [ * ] [ ] [ ]              [ ] [ ] [ * ]

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
other: weekly positive with metabolic activation