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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
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001
Reference Type:
secondary source
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
GLP compliance:
yes
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
- Batch No.: 4879

Method

Species / strain
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
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:
short-term treatment (-S9 mix): 4.88, 9.77, 19.5, 39.1, 78.1 µg/mL;
short-term treatment (+S9 mix): 19.5, 39.1, 78.1, 156, 313, 625, 1250 µg/mL;
continuous treatment (-S9 mix): 4.88, 9.77, 19.5, 39.1, 78.1 µg/mL
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: water
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: -S9: Mitomycin C; +S9: Cyclophosphamide
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium

NUMBER OF CELLS EVALUATED: 200
Evaluation criteria:
The results were judged to be: negative in the case where the appearance frequency of abnormal cells was less than 5 %; equivocal in the case where the frequency was 5 % or more and less than 10 % and also the reproducibility was observed; and positive in the case where the frequency was 10 % or more and also the reproducibility or the dependency on the test substance dose was observed.

Results and discussion

Test results
Key result
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
Cytotoxicity was observed at more than 39.1, 78.1, and 19.5 µg/mL in -S9 mix, +S9 mix and continuous treatments, respectively.
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified

Applicant's summary and conclusion