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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Name of test material (as cited in study report): SAT 001193
- Physical state: liquid
- Analytical purity/active matter: 99%
- Lot/batch No.: CB00940009

Method

Species / strain
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
2.5, 5 and 10 µg/mL
Vehicle / solvent:
acetone
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: EMS and CPA

Results and discussion

Test results
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Substance not clastogen in this test.
Executive summary:

The test substance dissolved in acetone was assessed for its potential to induce structural chromosome aberrations in V79 cells of the Chinese hamster in-vitro in two independent experiments according to OECD guideline 473. The following study design was performed:

 

without S9-mix

with S9-mix

 

exp. I

exp. II

exp. I

exp. II

Exposure period

4 h

18 h

28 h

4 h

4 h

Recovery

14 h

-

-

14 h

24 h

Preparation interval

18 h

18 h

28 h

18 h

28 h

 

In each experimental group two parallel cultures were set up. Per culture at least 100 metaphase cells were scored for structural chromosome aberrations, except for the positive control in experiment II (without S9, interval 28 h) where only 50 metaphase cells were scored. The highest applied concentration in the pre‑test on toxicity (2500 µg/ml; approx. 10 mM) was chosen with regard to the molecular weight of the test item with respect to the current OECD Guideline 473. Due to strong toxicity in the absence of S9 mix a second range finding pre-test was performed. Test item concentrations between 0.2 and 20 µg/ml were applied in the absence of S9 mix only. Dose selection for the cytogenetic experiments was performed considering the toxicity data and the occurrence of precipitation. In both independent experiments, no biologically relevant increase in the number of cells carrying structural chromosomal aberrations was observed after treatment. No increase in the frequencies of polyploid metaphases was found after treatment as compared to the frequencies of the controls. In conclusion, it can be stated that in the study described and under the experimental conditions reported, the test substance did not induce structural chromosome aberrations as determined by the chromosome aberration test in V79 cells (Chinese hamster cell line) in-vitro.