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

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990
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:
other: Ames Salmonella/mammalian microsome test
GLP compliance:
not specified
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): 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.