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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
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Chromosome Aberration and Sister Chromatid Exchange Tests in Chinese Hamster Ovary Cells In Vitro. V: Results with 46 Chemicals
Author:
Loveday et al.
Year:
1990
Bibliographic source:
Environmental and Molecular Mutagenesis 16:272-303 (1990)

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
Deviations:
yes
Remarks:
Not all results displayed.
GLP compliance:
not specified
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
n.a.
Species / strain
Species / strain / cell type:
Chinese hamster Ovary (CHO)
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
501, 1500, 5010 µg/mL
Vehicle / solvent:
water
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
water
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: mitomycin, 5 µg/mL (-S9); cyclophosphamide, 50µg/mL (+S9)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium
Evaluation criteria:
According to guideline.

Results and discussion

Test results
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative

The test item was not considered to be clastogenic.
Executive summary:

No enhanced aberration rate in the presence or absence of metabolic activation was observed in this chromosomal aberration assay. Therefore, the test substance was not considered to be clastogenic.