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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:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
02-05-1990 to 13-08-1990
Reliability:
1 (reliable without restriction)
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FIFRA Guideline 84-1
Deviations:
no
Principles of method if other than guideline:
NA
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material: sodium persulfate
- Physical state: solid
- Analytical purity: not stated
- Lot/batch No.: E608244; Lot 0021
- Stability under test conditions: not stated
- Storage condition of test material: room temperature

Method

Target gene:
A Salmonella Mammalian-Microsome Mutagenicity Assay (Ames test) was conducted with sodium persulfate, E608244, Lot 0021. Five tester strains of Salmonella typhimurium: TA98, TA100, TA1535, TA1537 and TA1538 were utilized. The assay was conducted in the presence and absence of metabolic activation by Aroclor 1254 induced rat liver microsomes.
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1538
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254
Test concentrations with justification for top dose:
The test concentrations were: 10000, 3333, 1000, 333, 100 µg/plate.
Vehicle / solvent:
Water
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
DMSO, except sodium azide (sterile, deionised water)
True negative controls:
yes
Positive controls:
yes
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
For the S. typhimurium TA98, TA1538 without metabolic activation
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
For the S. typhimurium TA100 and TA1535 without metabolic activation.
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
For the S. typhimurium TA1537 without metabolic activation.
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
For the S. typhimurium TA98, TA100, TA1535, TA 1537, TA 1538 with metabolic activation.
Details on test system and experimental conditions:
Five doses of the test article were plated with all five tester strains (TA98, TA100, TA 1535, TA1537, TA1538) with and without metabolic activation. All solvent controls and test article doses were plated in triplicate. Without metabolic activation, 100 µL of tester strain and 50 µL of solvent or test article and 0.5 of S-9 mix were added to 2.0 mL of molten selective top agar at 45 +/- 2°C. After vortexing, the mixture was overlayed onto the surface of 25 mL of minimal bottom agar. After the overlay had solidified, the plates were inverted and incubated for 48 - 72 hours at 37 +/- 3°C. Plates which were not counted immediately following the incubation period were stored at 4 +/- 2 °C until such time that colony counting could be conducted.
Evaluation criteria:
Evaluation of mutagenicity assay data:
For a test article to be considered positive, it must cause at least a doubling in the mean number of revertants per plate of at least one strain. This increase in the mean number of revertants per plate must be accompanied by a dose response to increasing concentrations of the test article. In those cases where the observed dose response increase in TA1537 revertants per plate is less than three-fold, the response must be reproducible.
Statistics:
Mean values and standard deviation were calculated.

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
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:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Two independent mutagenicity assays were performed.
Under the conditions of this study, sodium persulfate, E 608244, Lot 0021 did not cause a positive response in any of the tester strains with or without metabolic activation by Aroclor induced rat liver microsomes.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

No remarks

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
other: non-mutagenic

Under the study experimental conditions, disodium persulfate did not cause a positive response in any of tester strains with or without metabolic activation. Therefore, disodium persulfate was considered non-mutagenic in this bacterial reverse mutation assay.
Executive summary:

The purpose of the study was to establish the potential of disodium persulfate to induce gene mutations in Salmonella typhimurium: TA98, TA100, TA1535, TA1537 and TA1538, using Salmonella/Mammalian-Microsome plate incorporation mutagenicity Assay (Ames test), performed according to FIFRA Guideline 84 -1. Disodium persulfate was tested at five dose levels ranging from 100 to 10000 µg/plate. The dose levels were based on a preliminary toxicity test. The assay was conducted in the presence and absence of metabolic activation by Aroclor 1254 induced rat liver microsomes (S9 Mix). Revertant colonies were counted. During the tests positive and negative controls were run concurrently. The reference mutagens (sodium azide, 9 -aminoacridine, 2 -nitrofluorene, 2 -anthramine) showed a distinct increase of induced relevant colonies. Results with the test substance showed that disodium persulfate did not cause a positive response in any of the tester strains with or without metabolic activation. Therefore, disodium persulfate was considered non-mutagenic in this bacterial reverse mutation assay.