Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate

Genetic toxicity: in vitro

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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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Well performed GLP and OECD guideline study, but using a different set of tester strains

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

Using a different set of tester stains

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Test material form:

solid: bulk

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254(R) induced rat liver S9-mix

Test concentrations with justification for top dose:

Experiment I: 0, 4, 20, 100, 500, 2500, 10000 µg/plate
Experiment II: 0, 4, 20, 100, 500, 2500, 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: Na-azide, 9-aminoacridine, 2-nitrofluorene, benzo[a]pyrene, 2-aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION:
in agar (plate incorporation)

DURATION
- Exposure duration: incubation for at least 48 to 72 hours at 37°C

NUMBER OF REPLICATIONS: 3 plates per strain and dose level, including controls, two independent experiments

Evaluation criteria:

Positive:

The test compound cause a significant increase in the number of revertant colonies with any of the tester strains either in the absence or presence
of S-9 Mix.

A dose dependent effect was obtained.


Negative:

The test compound does not cause a significant increase in the number of revertant colonies with any of the tester strains either in the absence or presence
of S-9 Mix.

No dose dependent effect was obtained.

Statistics:

Arithmetic means of the counted colonies were calculated.

Results and discussion

Test results

Key result

Species / strain:

other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

incipient at 500 µg/plate without metabolic acivation

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

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

The test item did not cause a significant increase in the number of revertant colonies with any of the tester strains in the Salmonella typhimurium reverse mutation assay (plate incorporation test) either in the absence or presence of metabolic activation. No dose dependent effect was observed. Therefore the test item is not considered to be mutagenic under the conditions in this Salmonella typhimurium reverse mutation assay.

Executive summary:

Mutagenic activity of the test item was investigated in Salmonella typhymurium strains 1535, 1537, 98, 100 and 1538 with and without metabolic activation (induced rat liver S9-mix) at concentrations of 0, 4, 20, 100, 500, 2500, 5000 and 10 000 µg/plate (experiment I) and concentrations of

0, 4, 20, 100, 500, 2500, 5000 µg/plate (experiment II). Each concentration was tested in triplicate. Initial Toxic effects and precipitation were evident at 500 µg/plate.

Under the conditions tested the test compound did not cause a significant increase in the number of revertant colonies and no dose dependent effect was observed. Therefore the test item is not considered mutagenic under the conditions in this Salmonella typhimurium reverse mutation assay.