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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was performed following GLP standards and EEC, B.10 guidelines. However, full study report is not available as the data is > 12 year old and summaries have been prepared using data provided by ECHA.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
GLP compliance:
yes
Type of assay:
other: non-bacteriological in vitro 6th amendment data

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Metabolic activation system:
Aroclor-induced rat liver S9-mix.
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 1 to 6 µg/mL
Concentration range in the main test (without metabolic activation): 1 to 6 µg/mL
Vehicle / solvent:
DMSO
Details on test system and experimental conditions:
Exposure period (with metabolic activation): 4 hours
Exposure period (without metabolic activation): 4 hours

Fixation time:
6th Amendment fixation time : 18

Results and discussion

Test results
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Additional information on results:
Observations: Due to the poor solubility of the test substance the study was conducted as a suspension. There was no reproducible reduction of the miotic indices.
A second test was conducted with an fixation time of 28 h but showed the same results

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

In a study carried out in accordance with GLP and EEC guideline B.10, test substance (EC No. 413-920-6) was evaluated for its genotoxicity potential by in vitro mammalian chromosome aberration test with and without aroclor induced metabolic activation at test concentration of 1 to 6 µg/mL in Chinese hamster lung fibroblast (V79) cell lines. No genotoxicity was observed at tested concentration.

Test substance was not found to be genotoxic with and without metabolic activation under test conditions.