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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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
Experimental start date of May 1 – 21, 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented, acceptable study according to OECD guideline and GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Potassium sulphate
IUPAC Name:
Potassium sulphate
Details on test material:
Purity: 100%
- Lot/batch No.: July 8, 2000; AA43RD
- Expiration date of the lot/batch: -
- Stability under test conditions:
- Storage condition of test material: room temperature protected from light and moisture

Method

Target gene:
see below
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced rat liver - S9
Test concentrations with justification for top dose:
75, 200, 600, 1,800, and 5,000 μg/plate
Vehicle / solvent:
sterile distilled water
Controls
Untreated negative controls:
yes
Remarks:
vehicle only
Negative solvent / vehicle controls:
yes
Remarks:
Distilled water
Positive controls:
yes
Details on test system and experimental conditions:
When vortexed for more than 1 minute, the test article was soluble and clear in water at approximately 50 mg/mL, the maximum concentration tested.
METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk


DURATION
- Preincubation period:
- Exposure duration:
- Expression time (cells in growth medium):
- Selection time (if incubation with a selection agent):
- Fixation time (start of exposure up to fixation or harvest of cells):


SELECTION AGENT (mutation assays):

NUMBER OF REPLICATIONS:
Evaluation criteria:
The following criteria must be met for the mutagenicity assay to be considered valid. All Salmonella tester strain cultures must demonstrate the presence of the deep rough mutation (rfa) and the deletion in the uvrB gene. Cultures of the tester strains TA98 and TA100 must demonstrate the presence of the pKM101 plasmid R-factor. All WP2 uvrA cultures must demonstrate the deletion in the uvrA gene. All cultures must demonstrate the characteristic mean number of spontaneous revertants in the nehicle controls as follows (inclusive): TA98, 10-50; TA100, 80-240; TA1535; 5-45; TA1537, 3-21; WP2uvrA, 10-60. To ensure that appropriate numbers of bacteria are plated, tester strain culture must exhibit at least a three fold increase in the number of revertants over then mean value of the respective vehicle control. Aminimum of three non-toxic dose levels are required to evaluate assay data. A dose level is considered toxic if one or both of the following criteria are met: (1) A >50% reduction in the mean number of revertants per plate as compared to the mean vehicle control value. This reduction must be accompanied by an abrupt dose-dependent drop in the revertant count. (2) A reduction in the background lawn.
Statistics:
no data

Results and discussion

Test resultsopen allclose all
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 nor precipitates, but tested up to recommended limit concentrations
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Additional information on results:
Cytotoxicity conc:       With metabolic activation: None observed
Cytotoxicity conc:       Without metabolic activation: None observed
Precipitation conc:       None observed
Genotoxic effects:       Not with metabolic activation
Genotoxic effects:       Not without metabolic activation:  
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The test substance is not mutagenic.