Dibismuth trisulphide

Genetic toxicity: in vitro

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

Study period:

2007

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

no guideline available

Guideline:

other: no guideline available

Deviations:

not applicable

GLP compliance:

not specified

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

Bismuth citrate

EC Number:

212-390-1

EC Name:

Bismuth citrate

Cas Number:

813-93-4

IUPAC Name:

bismuth(3+) citrate

Test material form:

not specified

Method

Target gene:

not applicable

Species / strain

Species / strain / cell type:

other: lymphocytes, hepatocytes, and erythrocytes

Details on mammalian cell type (if applicable):

no data

Additional strain / cell type characteristics:

not specified

Metabolic activation:

without

Test concentrations with justification for top dose:

2.5, 5, 25, 50 and 250µM

Vehicle / solvent:

no data

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

not specified

True negative controls:

no

Positive controls:

yes

Remarks:

MMAIII (Monomethylarsonous acid)

Details on test system and experimental conditions:

Human lymphocytes were exposed to, Bi-Cit in a concentration runge from 2.5 to 250 ,uM for I h). Following incubation, cells were washed twice
and resuspended in 5 mL of McCoy's 5A medium. For the evaluation of first post-treatment metaphases with CA, cells were prelubeled with
20 ,uM BrdU (Serva, Heidelberg, Gennany). Thereafter, cells were cultivated for an additional 44 h for the examination of CA. CeII growth was stopped by treatment of lymphocytes with 0.08 ,ug/mL colcemid solution (Ciba.Basel, Switzerland) for a further 4 h. Metaphases were stained with Hoechst-Giemsa solution (Bisbenzimid, Merck, Germany) as described by Hill and Wolff. At least 100 uniformly stained first post-treatment metaphases were analyzed for CA. All experiments were performed in duplicate. The trivalent monomethylarsenic compound, monomethylarsonous acid [MMA(lll), 0.5µM, I und 24 h exposure],was run alongside as a positive control . The x square test was used for the statistical analysis of CA.

Evaluation criteria:

no data

Statistics:

The x square test was used for the statistical analysis of CA.

Results and discussion

Test results

Species / strain:

other: lymphocytes, hepatocytes, and erythrocytes

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

A chromosome aberration test of dibismuth trisulfide is not available. Consequently, read-across from the inorganic bismuth citrate was performed. Bismuth citrate did not induce chromosome aberrations up to the highest tested concentration of 250 µM. Bismuth citrate did not show any genotoxic effect. In contrast to inorganic bismuth compounds, organic bismuth compounds might show genotoxic potential. Therefore, dibismuth trisulfide was considered to be non-genotoxic in this test system.

Executive summary:

A chromosome aberration test of dibismuth trisulfide is not available. Consequently, read-across from the inorganic nismuth citrate was performed. Bismuth citrate did not induce chromosome aberrations up to the highest tested concentration of 250 µM. Bismuth citrate did not show any genotoxic effect. In contrast to inorganic bismuth compounds, organic bismuth compounds might show genotoxic potential. Therefore, dibismuth trisulfide was considered to be non-genotoxic in this test system.