Sodium fluoride

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: Results of this study are scentifically acceptable, the testing procedures and resulting data are sufficient and well documented.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Reference 2

Reference Type:

publication

Title:

Salmonella mutagenicity test results for 250 chemicals

Author:

Haworth, Steve, Timothy Lawlor, Kristien Mortelmans, William Speck and Errol Zeiger

Year:

1983

Bibliographic source:

Environmental Mutagenesis, Supplement 1: 3-142, 1983.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Ames Salmonella/mammalian microsome test

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Sodium fluoride

EC Number:

231-667-8

EC Name:

Sodium fluoride

Cas Number:

7681-49-4

Molecular formula:

FNa

IUPAC Name:

sodium fluoride

Details on test material:

- Name of test material (as cited in study report): sodium fluoride
- Analytical purity: 99%
- Lot/batch No.: DC 030887

Method

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:

Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver S9

Test concentrations with justification for top dose:

0, 100, 333, 1000, 3333 and 10000 ug NaF/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Dimethylsulfoxide
- Justification for choice of solvent/vehicle:

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

dimethylsulfoxide (DMSO)

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene was tested for all strains in the presence of S9. In the absence of S9, 4-nitro-o-phenylenediamine was tested with TA98, sodium azide was tested with TA100 and TA1535, and 9-aminoacridine was tested with TA1537.

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation); refer to Haworth (1983) for details

DURATION
- Preincubation period: 20 minutes at 37 degrees C
- Exposure duration: 48 hours
- Expression time (cells in growth medium):

NUMBER OF REPLICATIONS: Two

Evaluation criteria:

A positive response was defined as a reproducible, dose-related increase in histidine-independent (revertant) colonies in any one strain/activation combination. An equivocal response was defined as an increase in revertants that was not dose-related, not reproducible, or of insufficient magnitude to support a determination of mutagenicity. A negative response was obtained when no increase in revertant colonies was observed following chemical treatment.

Statistics:

Revertants were presented as mean +/- the SD from 3 plates.

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

Remarks:

Sodium fluoride did not induce gene mutations in any of the strains of Salmonella t. tested

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Remarks:

Definitive cytotoxicity was not observed in any Salmonella t. strains at doses up to 10,000 ug/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'. Remarks: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Sodium fluoride did not induce gene mutations in Salmonella typhimurium strains TA100, TA1535, TA1537 and TA98 when tested with a preincubation protocol at doses of 100 to 10,000 ug/plate. All strains were tested with or without Aroclor 1254-induced male Sprague-Dawley or Syrian hamster liver S9.