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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
Basic blue 99 did not induce DNA repair synthesis
Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from peer reviewed journal
Qualifier:
according to guideline
Guideline:
other: as per mentioned below
Principles of method if other than guideline:
Mutation study was performed on Salmonella typhimurium strain TA1535 to evaluate the mutagenic nature of the test compound Basic Blue 99
GLP compliance:
not specified
Type of assay:
bacterial gene mutation assay
Target gene:
Salmonella typhimurium strains TA1535
Species / strain / cell type:
S. typhimurium TA 1535
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
With and without S9 metabolic activation system
Test concentrations with justification for top dose:
4 to 2500 μg/plate
Vehicle / solvent:
No data
Untreated negative controls:
no
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
no data
Details on test system and experimental conditions:
Details on test system and conditionsMETHOD OF APPLICATION: in agar (plate incorporation)DURATION- Preincubation period: No data available- Exposure duration: No data available- Expression time (cells in growth medium): No data available- Selection time (if incubation with a selection agent): No data available- Fixation time (start of exposure up to fixation or harvest of cells): No data availableSELECTION AGENT (mutation assays): No data availableSPINDLE INHIBITOR (cytogenetic assays): No data availableSTAIN (for cytogenetic assays): No data availableNUMBER OF REPLICATIONS: No data availableNUMBER OF CELLS EVALUATED: No data availableDETERMINATION OF CYTOTOXICITY- Method: mitotic index; cloning efficiency; relative total growth; other: No data availableOTHER EXAMINATIONS:- Determination of polyploidy: No data available- Determination of endoreplication : No data available- Other:OTHER: No data available
Evaluation criteria:
Increase in the revertants/plate
Statistics:
No data available
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
No data available
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'. Remarks: Bacterial tester strain used
Conclusions:
Interpretation of results (migrated information):negative Negative (with and without)Basic Blue 99 failed to induce reverse mutations in the presence and absence of S9 in strains TA1535 and hence is a non-mutagenic in vitro.
Executive summary:

Mutation study was performed onSalmonella typhimuriumstrain TA1535 to evaluate the mutagenic nature of the test compound Basic Blue 99 with and without activation. Sodium azide was used as a positive control.

Basic blue was found to be non-mutagenic in strains TA1535 with and without S9 metabolic activation.

According to the CLP classification, the test material Basic Blue 99 does not classify as a mutagen in vitro.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

In vitro gene toxicity:

In a study conducted by American College of Toxicology (2007), in vitro gene toxicity was evaluated in Salmonella typhimurium strain TA1535 by using Basic Blue 99 with and without activation. Basic blue was found to be non-mutagenic in strains TA1535 with and without S9 metabolic activation. Therefore, Basic blue 99 did not induce DNA repair synthesis and hence is a non mutagen.

In the above similar reference, in vitro bacterial mutagenicity was carried out on E. coli strain 343/113 by using Basic Blue 99 in the concentrations of 1, 10, and 100μg/ml and a volume of 0.1 ml in a dark place at 37⁰C for 2 h. Cells were spread over four selected media and incubated for 20 to 72 h. Cells were counted and analyzed for reverse mutations of arg− to arg+ and nad− to nad+, forward mutations of 5-methyl-dl-trytophan-sensitivity to MT resistance, and forward and reverse mutations of gal Rs 18 to gal+. No mutant colonies were observed. Therefore, Basic blue 99 is non mutagenic in the E. coli strain 343/113.

In the above similar reference, in vitro structural chromosome aberrations in V79 cells of the male Chinese hamster in vitro with and without metabolic activation were assessed by using Basic Blue 99 in dimethylsulfoxide for 24 hours at 0, 0.1, 0.3, 0.5, 1.0, 2.5, 3.0, 5.0, or 10.0 μg/ml without S9 and for 2 h at 3, 10, 25, 30, 50, 100, 125, 150, or 250 μg/ml with S9. Basic Blue 99 did not induce an increase of thioguanine-resistant clone growth in cultured V79 Chinese hamster cells and hence, is a non mutagen.

In the above similar reference, in vitro DNA repair in rat hepatocytes in unscheduled DNA synthesis (UDS) assay in two replicate studies by using Basic Blue 99 in the concentration of 1.00, 3.33, 10.00, 33.33, and 100.00 μg/ml and incubated for 3 h. UDS was determined using liquid scintillation counting. A reduction in the incorporation of radioactivity occurred at 33.33 and 100.00 μg/ml in experiment I, which indicated weak toxicity. Concentrations higher than 100.00 μg/ml were very toxic. However, the incorporation of thymidine into rat hepatocytes was not dose related in either experiment. Therefore, Basic blue 99 did not induce DNA repair synthesis and hence is a non mutagen.

According to the CLP classification, the test material Basic Blue 99 (CAS no 68123-13-7) does not classify as a mutagen in vitro.

Justification for selection of genetic toxicity endpoint
Available study is of klimisch 2 and the quality of data is good

Justification for classification or non-classification

Basic Blue 99 (CAS no 68123-13-7) does not classify as a mutagen in vitro on the basis of CLP classification

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