Zirconium vanadium blue zircon

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:

supporting study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Only two S. typhimurium strains were used: TA 100 (basepair substitution) and TA98 (frameshift).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

only two bacteria strains were tested

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

yes

Remarks:

only two bacteria strains were tested

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Zirconium vanadium blue zircon

EC Number:

269-057-9

EC Name:

Zirconium vanadium blue zircon

Cas Number:

68186-95-8

Molecular formula:

(Zr, V)SiO4

IUPAC Name:

silicon(4+) vanadium(4+) zirconium(4+) hexaoxidandiide

Details on test material:

- Name of test material (as cited in study report): Sicocer F Tuerkis 2504
- Physical state: solid, blue powder
- Storage condition of test material: at room temperature

Method

Target gene:

not applicable

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 98

Additional strain / cell type characteristics:

other: rfa; uvrB; ampicillin resistence (R factor plamid pKM 101); and a modified postreplication DNA repair system, which increases the mutation rate by inducing a defective repair in the DNA

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 100

Additional strain / cell type characteristics:

other: rfa; uvrB; ampicillin resistence (R factor plamid pKM 101); and a modified postreplication DNA repair system, which increases the mutation rate by inducing a defective repair in the DNA

Metabolic activation:

with and without

Metabolic activation system:

S9-mix

Test concentrations with justification for top dose:

standard plate test: 0, 20, 100, 500, 2500 and 5000 µg/plate
preincubation test: 0, 20, 100, 500, 2500 and 5000 µg/plate

Vehicle / solvent:

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

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

Parallel with each experiment with and without S9-mix a solvent control is carried out.

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene (2.5 µg/plate), dissolved in DMSO

Remarks:

with metabolic activation; strains TA 98 and TA 100

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

Parallel with each experiment with and without S9-mix a solvent control is carried out.

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: N-methyl-N'-nitro-N-nitroso-guanidine (5 µg/plate), dissolved in DMSO

Remarks:

without metabilic activation; strain TA 100

Controls 3

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

Parallel with each experiment with and without S9-mix a solvent control is carried out.

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylendiamine (10 µg/plate), dissolved in DMSO

Remarks:

without metabolic activation; strain TA 98

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation) and preincubation

DURATION
- Preincubation period: 20 minutes at 37°C (preincubation test only)
- Exposure duration: 48 hours at 37°C in the dark

NUMBER OF REPLICATIONS: 3

EVALUATION
- The frequency of revertant colonies was assessed by counting.

DETERMINATION OF CYTOTOXICITY
- Method: Examination of the background growth.

Titer determination :
-The titer is determined only in the experiments with S9-mix both without test substance (solvent only) and after adding the two highest amounts of substance. The effects of a 10E-6 dilution of the bacteria suspensions on the growth of the bacteria were examined. The frequency of revertant colonies was assessed by counting.

No further details are given.

Evaluation criteria:

A substance to be characterised as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose response relationship
- reproducibility of the results

Statistics:

not mandatory for this test system

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

In the standard plate test and in the preincubation test, no toxicological significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material.

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Remarks:

The test material was non-toxic under the conditions tested.

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

In the standard plate test and in the preincubation test, no toxicological significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material.

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Remarks:

The test material was non-toxic under the conditions tested.

Vehicle controls validity:

valid

Untreated negative controls validity:

not valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation of the test substance was observed.

ADDITIONAL INFORMATION ON CYTOTOXICITY:
- No bacteriotoxic effect (reduced his- background growth) was observed.

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 substance Sicocer F Türkis 2504 was considered to be non-mutagenic under the conditions of the test.