Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
The test material shows negative genetic toxicity with and without metabolic activation on mammalian cell line, other: In vitro mammalian chromosome aberration test with CHO cells, duplicate test, one harvest time in first test, two harvest time in repeat test
Link to relevant study records
Reference
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: Data is from test report
Qualifier:
according to guideline
Guideline:
other: OECD Guideline 473 and B.10 EEC Method concil Dir. 67/548 17th Amendment
Principles of method if other than guideline:
Data is from test report
GLP compliance:
yes
Type of assay:
other: in vitro mammalian cytogenicity (B10)
Species / strain / cell type:
mammalian cell line, other: In vitro mammalian chromosome aberration test with CHO cells, duplicate test, one harvest time in first test, two harvest time in repeat test.
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): >= 5 ... <= 2500 μg/ml
Concentration range in the main test (without metabolic activation): >= 5 ... <= 2500 μg/ml
Vehicle / solvent:
DMSO
Details on test system and experimental conditions:
Exposure period (with metabolic activation): 4 hours
Exposure period (without metabolic activation): 18 hours
Expression time: 14 Hours
Fixation time: 18 and 32 Hours.
Species / strain:
mammalian cell line, other: In vitro mammalian chromosome aberration test with CHO cells, duplicate test, one harvest time in first test, two harvest time in repeat test.
Metabolic activation:
with
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 2500 μg/ml)
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
mammalian cell line, other: In vitro mammalian chromosome aberration test with CHO cells, duplicate test, one harvest time in first test, two harvest time in repeat test.
Metabolic activation:
without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 2500 μg/ml)
Species / strain:
mammalian cell line, other: In vitro mammalian chromosome aberration test with CHO cells, duplicate test, one harvest time in first test, two harvest time in repeat test.
Metabolic activation:
with
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(>= 833 μg/ml)
Species / strain:
mammalian cell line, other: In vitro mammalian chromosome aberration test with CHO cells, duplicate test, one harvest time in first test, two harvest time in repeat test.
Metabolic activation:
without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(>= 833 μg/ml)
Positive controls validity:
valid
Additional information on results:
Observations:
In neither chromosome aberration tests, RA3643 induced a biologically relevant and statistically significant increase in the percentage of cells with structural chromosome aberrations at any of the concentrations and time points analysed, when compared with the vehicle control value.
Positive control substance were Cyclophosphamide (in the presence of S-9) and Mitomycin C (in the absence of S-9) respectively.
Remarks on result:
other: other: preliminary test
Remarks:
Migrated from field 'Test system'.
Conclusions:
Interpretation of results (migrated information):
other: negative with and witout metabolic activation

The test material shows negative genetic toxicity with and without metabolic activation on mammalian cell line, other: In vitro mammalian chromosome aberration test with CHO cells, duplicate test, one harvest time in first test, two harvest time in repeat test
Executive summary:

The test material shows negative genetic toxicity with and without metabolic activation on mammalian cell line, other: In vitro mammalian chromosome aberration test with CHO cells, duplicate test, one harvest time in first test, two harvest time in repeat test

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

From the study report and prediction from QSAR Toolbox Version 3.3, the test material shows negative genetic toxicity with and without metabolic activation on mammalian cell line, other: In vitro mammalian chromosome aberration test with CHO cells, duplicate test, one harvest time in first test, two harvest time in repeat test. From estimated prediction found to be non-genotoxic without metabolic activation to S. typhimurium TA 1535, TA 1537, TA 98 and TA 100


Justification for selection of genetic toxicity endpoint
Data from K2 publication

Justification for classification or non-classification

Categories Display