Trisodium hexafluoroaluminate

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: GLP compliant, guideline study, no restrictions, fully adequate for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): Cryolite
- Molecular formula (if other than submission substance): AlF6Na3
- Composition of test material, percentage of components: 53% F, 32.3% Na, 12.5% Al, 3.2% Al2O3, 0.25% SiO2, 0.027% P2O5
- Lot/batch No.: 26061987
- Storage condition of test material: refrigerator

Method

Target gene:

his

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

S9 (induced with Aroclor 1254) from male SD rats

Test concentrations with justification for top dose:

20, 100, 500, 2500, 12500 µg/plate

Vehicle / solvent:

deionized water

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: sodium azide (TA1535), nitrofurantoin (TA100), 4-nitro-1,2-phenylenediamine (TA 1537 and TA98), 2-aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION:
in agar (plate incorporation)

DURATION
Exposure duration: 48 hours at 37 °C

Four plates per strain and concentration, both with and without S9 mix, were used for mutant count. The same number of plates made up the negative control; these being filled with the solvent without test substance. Four plates per strain were also used for each positive control.

Evaluation criteria:

A reproducible (confirmation by two additional independent experiments) and dose-related increase (i.e., > twice the negative control count) in mutant counts for at least one strain is considered positive. Otherwise, the result is evaluated negative.

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

Concentrations up to 12500 µg/plate did not cause mutagenic activity. Furthermore, bacteriotoxic effects were not observed.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.