Sodium perchlorate

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:

01 April - 01 July 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Sodium perchlorate

EC Number:

231-511-9

EC Name:

Sodium perchlorate

Cas Number:

7601-89-0

Molecular formula:

ClHO4.Na

IUPAC Name:

sodium perchlorate

Details on test material:

- Name of test material (as cited in study report): Anhydrous Sodium Perchlorate
- Physical state: white powder
- Analytical purity: 98.21%
- Impurities (identity and concentrations): H2O 1.67%, ClO3 0.081%
- Purity test date: 10 January 2008
- Lot/batch No.: 10/01/08; Sponsor's filing No. GRL 0005/08
- Expiration date of the lot/batch: February 2010
- Storage condition of test material: Room temperature, keep hermatically closed. Store away from heat and ignition sources

Method

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:

not applicable

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 102

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

The selected treatment dose-levels were:
⋅ 312.5, 625, 1250, 2500 and 5000 μg/plate, for the first and the second mutagenicity experiments with and without S9 mix,
⋅ 625, 1250, 2500, 3750 and 5000 μg/plate, for the third mutagenicity experiment with S9 mix.

Vehicle / solvent:

- Vehicle used: Water for injections; Batch Nos. IVE 14A and IVK 26A
- Justification for choice of solvent/vehicle: highly soluble in water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: See table 1

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk


DURATION
- Preincubation period: 60 minutes
- Exposure duration: 72 hours
- 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):



DETERMINATION OF CYTOTOXICITY
- Method: on the basis of the observation of any decrease in the number of revertant colonies and any thinning of the bacterial lawn.

Evaluation criteria:

A reproducible 2-fold increase (for the TA 98, TA 100 and TA 102 strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-relationship was considered as
a positive result. Reference to historical data, or other considerations of biological relevance may also be taken into account in the evaluation of the
data obtained.

Statistics:

No statistical analyses were performed.

Results and discussion

Test results

Test results 1

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

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: None
- Effects of osmolality: None
- Evaporation from medium: None
- Water solubility: None
- Precipitation: No precipitate was observed in the Petri plates when scoring the revertants at any dose-levels.
- Other confounding effects: None


RANGE-FINDING/SCREENING STUDIES:


COMPARISON WITH HISTORICAL CONTROL DATA: N/A


ADDITIONAL INFORMATION ON CYTOTOXICITY:

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

The number of revertants for the vehicle and positive controls was as specified in the acceptance criteria. The study was therefore considered valid. Since the test item was freely soluble and non-toxic, the highest dose-level was 5000 μg/plate, according to the criteria specified in the international guidelines.

No precipitate was observed in the Petri plates when scoring the revertants at any dose-levels. No noteworthy toxicity was noted in any strains, either with or without S9 mix. No noteworthy increase in the number of revertants, which could be considered to be biologically significant, was noted in any tester strains, in any experiments, with and without S9 mix.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Under the experimental conditions, the test item ANHYDROUS SODIUM PERCHLORATE (purity: 98.21%) did not show any mutagenic activity in the bacterial reverse mutation test with the recommended Salmonella typhimurium tester strains.

Executive summary:

The study was conducted at CIT Laboratories France to evaluate the potential of the test item (Anhydrous Sodium Perchlorate) to induce reverse mutation in Salmonella typhimurium. The study was designed in accordance with OECD guideline No. 471 and EU Method B.13/.14. The evaluation of the toxicity was performed on the basis of the observation of any decrease in the number of revertant colonies and any thinning of the bacterial lawn using five strains of the bacteria. No noteworthy increase in the number of revertants, which could be considered to be biologically significant, was noted in any tester strains, in any experiments, with and without a metabolic activation system (S9 mix). Under the experimental conditions, Anhydrous Sodium Perchlorate did not show any mutagenic activity in the bacterial reverse mutation test with recommended Salmonella typhimurium tester strains.