Potassium permanganate

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

Study period:

10.3.2006-21.4.2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was carried out in accordance with internationally valid GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Potassium permanganate

EC Number:

231-760-3

EC Name:

Potassium permanganate

Cas Number:

7722-64-7

Molecular formula:

HMnO4.K

IUPAC Name:

potassium manganesoylolate

Details on test material:

- Name of test material (as cited in study report): Potassium permanganate
- Molecular formula (if other than submission substance): KMnO4
- Molecular weight (if other than submission substance): 158.03
- Substance type: technical product
- Physical state: solid; crystalline powder
- Analytical purity: 99.42 wt.
- Impurities (identity and concentrations): Manganese dioxide cca 0.1 % wt.
- Lot/batch No.: 69
- Stability under test conditions: stable
- Storage condition of test material: at current laboratory conditions, in delivered glass containers

Method

Target gene:

gene for synthesis histidine or tryptphan

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

other: histidine requing strain

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Additional strain / cell type characteristics:

other: tryptophan requing strain

Metabolic activation:

with and without

Metabolic activation system:

post-mitochondrial fraction (S9)

Test concentrations with justification for top dose:

1.5, 5, 15, 50, 100, 150 μg in 0.1 ml per plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: solubility of the test substance

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

water

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

water

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminofluorene

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

water

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Controls 4

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

water

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylenediamine

Controls 5

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

water

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 9-aminoacridine hydrochloride monohydrate

Controls 6

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

water

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: N-methyl-N'-nitro-N-nitrosoguanidine

Details on test system and experimental conditions:

METHOD OF APPLICATION: minimal glucose agar plate
DURATION
- Exposure duration: 48 - 72 hours

NUMBER OF REPLICATIONS: 2 series; each with and without metabolic activation, with positive control and solvent control
triplicate plating was used at each dose level

DETERMINATION OF CYTOTOXICITY
- Method: total growth

Evaluation criteria:

The main criterion for evaluation of results was modified two-fold increase rule, its using is comparable with using of statistical methods. After this rule the result is positive, when reproducible dose-effect and/or doubling of ratio Rt/Rc is reached.
Rt number of revertants at tested dose
Rc number of revertants at negative control (water)

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

500 micrograms See table A.

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 5

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

COMPARISON WITH HISTORICAL CONTROL DATA:
Spontaneous reversions, negative controls (solvent), and positive controls were compared with historical controls in our laboratory.

ADDITIONAL INFORMATION ON CYTOTOXICITY:
Test substance was dissolved in demineralized water till the final concentration 5 000 g per 0.1 mL (plate). This dose is recommended as maximum for mutagenicity testing in the Ames test. With regard to expected toxicity, maximum dose used for toxicity testing was 10 times lower – 500 g/0.1 mL. The toxicity test showed last non-toxic dose of 50 g/0.1 mL (see table A). Since the method accepts (recommends) including of one toxic dose, the presumably toxic dose of 150 g/0.1mL was used as maximum for first mutagenicity test. The other lower doses were diluted according to the guidelines (at maintenance of recommended range among doses) .

Remarks on result:

other: all strains/cell types tested

Applicant's summary and conclusion

Conclusions:

Interpretation of results:
negative with metabolic activation
negative without metabolic activation

Under the above-described experimental design, the test substance Potassium permanganate was nonmutagenic for all the Salmonella typhimurium as well as Escherichia coli strains both in experiments without as well as with metabolic activation.

Executive summary:

Test substance Potassium permanganate was assayed for the mutagenicity by the Bacterial Reverse Mutation Test. The test was performed according to EU method B.13/14 Mutagenicity – Reverse mutation test using bacteria,which is analogous to the OECD Test Guideline No. 471.

Four  indicator Salmonella typhimurium strains TA 98, TA 100,  TA 1535  and

TA 1537 and one indicator Escherichia coli WP2 uvrA strainwere used. The test substance was dissolved in demineralized vater and assayed in doses of 1.5-150mg which were applied to plates in volume of 0.1 mL.

Two series of experiments were performed with each strain - without metabolic activation and with a supernatant of rat liver and a mixture of cofactors.

In the arrangement given above, the test substance Potassium permanganate was nonmutagenic for all the used bacterial strains with as well as without metabolic activation.