Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate)

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD Guideline Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

adopted May 26, 1983

Deviations:

yes

Remarks:

according to newest guideline: E. coli or S. typhimurium TA102 are missing and a second positive control accept 2-aminoanthracene required

GLP compliance:

yes

Remarks:

LMP, Laboratory for Mutagenicity Testing, Darmstadt, Germany

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate)

EC Number:

248-421-0

EC Name:

Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate)

Cas Number:

27344-41-8

Molecular formula:

C28H22O6S2.2Na

IUPAC Name:

disodium 2,2'-(biphenyl-4,4'-diyldiethene-2,1-diyl)dibenzenesulfonate

Details on test material:

- Name of test material (as cited in study report): FAT 65029/G
- Physical state: solid, yellow
- Analytical purity: about 90%
- Impurities (identity and concentrations): 7 % NaCl, 3 % H2O
- Lot/batch No.: EN 372980, Op. 247/248
- Storage condition of test material: room temperature, light protected

Method

Target gene:

his

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA98, TA100, TA1535, TA1537, TA1538

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254 induced rat liver S9-mix

Test concentrations with justification for top dose:

0, 10, 33.3, 100, 333.3, 1000, 5000 µg/plate

Vehicle / solvent:

- H2O bidest
- Justification for choice of solvent/vehicle: The solvent was chosen to its solubility properties and its relative nontoxicity for the bacteria.

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: see table 1

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 72 hours

NUMBER OF REPLICATIONS: 3 plates per strain and dose

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

The generally accepted conditions for the evaluation of the results are:
- corresponding background growth on both negative control and test plates
- normal range of spontaneous reversion rates.
A test article is considered as positive if either a significant dose-related increase in the number of revertants or a significant and reproducible increase for at least one test concentration is induced. A test article producing neither a significant dose-related increase in the number of revertants nor a significant and reproducible positive response at any one of the test points is considered non-mutagenic in this system.
A significant response is described as follows:
A test article is considered as mutagen if in strain TA 100 the number of reversions is at least twice as high and in strains TA 1535, TA 1537, TA 1538, and TA 98 it is at least three times higher as compared to the spontaneous reversion rate.
Also, a dose-dependent increase in the number of revertants is regarded as an indication of possibly existing mutagenic potential of the test article regardless whether the highest dose induced the above described enhancement factors or not.

Statistics:

Due to international guidelines a statistical evaluation of the results is recommended. However, no evaluated statistical procedure can be recommended for analysis of data from the bacterial assays at this time (1989).

Results and discussion

Test results

Species / strain:

S. typhimurium, other:

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

see additional information

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no

RANGE-FINDING/SCREENING STUDIES: To evaluate the toxicity of the test article a pre-study was performed with strains TA 98 and TA 100. The plates with the test article showed normal background growth up to 1000.0 µg/plate in strain TA 98 and TA 100, respectively. At 5000.0 µg/plate the background growth was slightly reduced.

ADDITIONAL INFORMATION ON CYTOTOXICITY: Toxic effects, evidenced by a reduction in the number of spontaneous revertants, occurred in strain TA 1538 at 1000.0 and 5000.0 (µg/plate with metabolic activation and in strain TA 98 at 5000.0 µg/plate with and without metabolic activation, all in experiment I and II.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test article did not induce point mutations by base pair substitutions or frameshifts in the genome of the strains used.