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Toxicological information

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:
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:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
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'.

Applicant's summary and conclusion