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EC number: 240-894-1 | CAS number: 16871-71-9
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- other: evidence from degradation product
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 990
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Testing was performed as reported by Ames et aL (1975) with modifications as listed below and described in greater detail by Haworth et aL (1983). Sodium fluoride, sent to the laboratory coded from Radian Corporation (Austin, TX), was incubated with the Salmonella typhimurium tester strains (TA98, TA100, TA1535, TA1537) either in buffer or S9 mix (metabolic activation enzymes and cofactors from Aroclor 1254- induced male Sprague-Dawley rat or Syrian hamster liver) for 20 minutes at 37° C prior lo the addition of soft agar supplemented with 1-histidine and d-biolin, and subsequent plating on minimal glucose agar plates. Incubation continued for an additional 48 hours. Each lest consisted of replicate plates of concurrent positive and negative controls and of at least five doses of lest chemical. High dose was limited to 10 mg/plate. All trials were repeated.
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 inrevertants 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. - GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 7681-94-4
- IUPAC Name:
- 7681-94-4
- Reference substance name:
- Sodium fluoride
- EC Number:
- 231-667-8
- EC Name:
- Sodium fluoride
- Cas Number:
- 7681-49-4
- IUPAC Name:
- sodium fluoride
- Details on test material:
- Sodium fluoride (CAS 7681-94-4), obtained from Sigma Chemical Co., MO, USA, Lot no. 109F0102. No trace element impurities were detected in the sample. Sodium fluoride (NaF) was the test substance, and the authors were specifically looking at the effects of fluoride. The test substance readily dissociates in aqueous conditions producing fluoride ions.
Constituent 1
Constituent 2
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
- Test concentrations with justification for top dose:
- 100 to 10,000 p.glplate
- Vehicle / solvent:
- nor specified
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Details on test system and experimental conditions:
- Testing was performed as reported by Ames et aL (1975) with modifications as listed below and described
in greater detail by Haworth et aL (1983). Sodium fluoride, sent to the laboratory coded from Radian
Corporation (Austin, TX), was incubated with the Salmonella typhimurium tester strains (TA98, TA100,
TA1535, TA1537) eilher in buffer or S9 mix (metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver) for 20 minutes at 37° C prior lo the addition of soft agar supplemented with 1-histidine and d-biolin, and subsequent plating on minimal glucose agar plates.Incubation continued for an additional 48 hours. Each lest consisted of replicate plates of concurrent positive and negative controls and of al least five
doses of lest chemical. High dose was limited to 10 mg/plate. All trials were repeated. - Evaluation criteria:
- 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.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Sodium fluoride was negative for
gene mutation induction in Salmonella typhimurium
strains TA100, TA1535, TA1537, and TA98 with and
Soclium Fluoride, NTP TR 393
without S9. - Executive summary:
Sodium Fuoride did not induce gene mutations in Salmonella typhimurium when tested with a pre incubation
protocol at doses of 100 to 10,000 µg/plate in strains TA100, TA1535, TA1537, and TA98; all strains were
tested with and without Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver S9 (Hawonh
et aL, 1983).
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