Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 231-912-9 | CAS number: 7778-74-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 March 2008 to 24 February 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell gene mutation tests using the thymidine kinase gene
- Target gene:
- TK (thymidine kinase) locus
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Since the test item was freely soluble and non-toxic in the preliminary test, the highest dose-level selected for the main test was 5000 µg/mL.
Using a treatment volume of 100 µL/20 mL, the selected dose-levels were 156.3, 312.5, 625, 1250, 2500 and 5000 µg/mL for both mutagenicity
experiments with and without S9 mix. - Vehicle / solvent:
- - Vehicle used: Water for injection; batch number IVE14A, supplied by Fresenius-Kabi (92316 Sèvres, France).
- Justification for choice of vehicle: Solubility (the substance is freely soluble in water) - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- vehicle only
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- methylmethanesulfonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation; in suspension;
DURATION
- Preincubation period: one week
- Exposure duration: 3 hours and 24 hours
- Expression time (cells in growth medium): 48 hours
- Selection time (if incubation with a selection agent): 2 days
- Fixation time (start of exposure up to fixation or harvest of cells): 2 days
SELECTION AGENT (mutation assays): N/A
SPINDLE INHIBITOR (cytogenetic assays): N/A
STAIN (for cytogenetic assays): N/A
NUMBER OF REPLICATIONS: 2 per dose concentration including negative and positive controls
NUMBER OF CELLS EVALUATED:
Viability plates:
An average of 1.6 cells/well (two 96-well plates/culture = four plates/dose-level) to define the number of viable cells (CE2). After at least 7 days of
incubation at 37°C in a humidified atmosphere of 5% CO2/95% air, the clones were counted.
Mutant plates:
2000 cells/well (four 96-well plates/culture = eight plates/dose-level) to select the TFTR (trifluo
rothymidine resistant) mutant cells (for the
determination of CEmutant). After 11-12 days of incubation at 37°C in a humidified atmosphere of
5% CO2/95% air in the presence of 4 µg TFT/mL of culture medium, the clones were counted, differentiating small and large colonies:
· size of small colonies: < 25% of the diameter of the well,
· size of large colonies: > 25% of the diameter of the well.
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth (adjusted)
For scoring of colonies in mutant plates, the following parameters were considered:
· Well containing mutant colony (small or large),
· Well not containing mutant colony,
· When both small and large colonies are present in the same well both mutant colonies were counted (one small and one large).
OTHER EXAMINATIONS:
- Determination of polyploidy:
- Determination of endoreplication: - Evaluation criteria:
- at least at one dose-level the mutation frequency minus the mutation frequency of the vehicle control equals or exceeds the global evaluation factor
(126 x 10-6 for the microtiter method),
· and a dose-related trend is demonstrated by a statistically significant trend test.
Unless considered as clearly positive, the reproducibility of a positive effect should be confirmed.
Noteworthy increases in the mutation frequency observed only at high levels of cytotoxicity (RTG lower than 10%), but with no evidence of
mutagenicity at dose-levels with RTG between 10 and 20%, is considered as positive result. A test
item may be determined to be non-mutagenic when there is no culture showing an Adj. RTG value
between 10-20% if (e):
· there is at least one negative data point between 20 and 25% Adj. RTG and no evidence on mutag
enicity in a series of data points between 100 to 20% Adj. RTG,
· there is no evidence of mutagenicity in a series of data points between 100 to 25% and there is also a negative data point between 10 and
1% Adj. RTG. - Statistics:
- No statistical analyses were performed.
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: slight at 5000 µg/mL in the second experiment shown by a a 39% decrease in adjusted relative total growth
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No effects; the pH values were equivivalent to those of the vehicle control culture
- Effects of osmolality: No effects; the osmalality values were equivalent to those of the vehicle control culture
- Evaporation from medium: Not reported
- Water solubility: The test substance is freely soluble in water
- Precipitation: None
- Other confounding effects: None
RANGE-FINDING/SCREENING STUDIES:
Using a treatment volume of 100 µL/20mL of culture medium, the final dose-level of 5000 µg/mL
showed no precipitate. At this dose-level, the pH was approximately 7.4 (as for the vehicle control) and the osmolality equal to 344 mOsm/kg H2O (296 for the vehicle control).
The dose-levels used for treatment were 10, 100, 500, 1000, 2500, 5000 µg/mL.
No noteworthy toxicity was noted, either following the 3- and 24-hour treatments without S9 mix or following the 3-hour treatment with S9 mix.
COMPARISON WITH HISTORICAL CONTROL DATA:
Control data were included as an appendix in the Report, which covered experiments during the the period April 2005 to September 2006. It includedresults from 12 experiments without metabolic
activation (S9 mix) and 24 experiments with metabolic activation using negative controls and using the positive controls methylmethanesulfonate (MMS) and cyclophosphamide (CPA). The results are in line with those of the current study.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Not reported - Remarks on result:
- other: all strains/cell types tested
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the experimental conditions, the test item ANHYDROUS SODIUM PERCHLORATE (batch No. "
Lot moyen du 10/01/08 test"; purity: 98.21%) did
not show any mutagenic activity in the mouse lymphoma assay. - Executive summary:
A study was performed at CIT Laboratories France to investigate the potential of Anhydrous Sodium Perchlorate to induce mutations at the TK (thymidine kinase) locus in L5178Y mouse lymphomacells. The study was performed according to the international guidelines (OECD 476 and Commission Directive No. B17) and in compliance with the Principles of Good Laboratory Practice Regulations. Aftera preliminary toxicity test, Anhydrous Sodium Perchlorate was tested in two independent experiments,in the absence and presence of a rat liver metabolising system (S9 mix). Cytotoxicity was measuredby assessment of adjusted relative total growth (Adj. RTG) and relative suspension growth (Adj. RSG)as well as cloning efficiency following the expression time (CE2). The number of mutant clones(differentiating small and large colonies) were checked after the expression of the mutant phenotype.Using a treatment volume of 100 µL/20 mL, the selected dose-levels were 156.3, 312.5, 625, 1250, 2500and 5000 µg/mL for both mutagenicity experiments with and without the S9 mix. Following the 3-hourtreatment and the 24-hour treatment without S9 mix, no noteworthy cytotoxicity was found. Similarlythere was no evidence of mutagenicity, either following either the 3-hour or the 24-hour treatment. Experiments with the S9 mix revealed no noteworthy cytotoxicity in the first experiment but the second experiment showed evidence of slight toxicity at the highest doselevel (5000 µg/mL), shown by a 39% decrease in Adj. RTG. However, there was no significant mutationfrequency noted following the 3-hour treatment in either experiment. Under the experimental conditions,the test item did not show any mutagenic activity in the mouse lymphoma assay.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 25 March 2008 to 24 February 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- In water, potassium perchlorate will rapidly dissolve and completely dissociate into the perchlorate anion and the corresponding cation. Toxicity is determined only by the perchlorate moiety of the salt. as potassium is known to be non-toxic. Based on that, read-across is possible to other perchlorate salt dissociating in water without any toxic cation.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell gene mutation tests using the thymidine kinase gene
- Target gene:
- TK (thymidine kinase) locus
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Since the test item was freely soluble and non-toxic in the preliminary test, the highest dose-level selected for the main test was 5000 µg/mL.
Using a treatment volume of 100 µL/20 mL, the selected dose-levels were 156.3, 312.5, 625, 1250, 2500 and 5000 µg/mL for both mutagenicity
experiments with and without S9 mix. - Vehicle / solvent:
- - Vehicle used: Water for injection; batch number IVE14A, supplied by Fresenius-Kabi (92316 Sèvres, France).
- Justification for choice of vehicle: Solubility (the substance is freely soluble in water) - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- vehicle only
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- methylmethanesulfonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation; in suspension;
DURATION
- Preincubation period: one week
- Exposure duration: 3 hours and 24 hours
- Expression time (cells in growth medium): 48 hours
- Selection time (if incubation with a selection agent): 2 days
- Fixation time (start of exposure up to fixation or harvest of cells): 2 days
SELECTION AGENT (mutation assays): N/A
SPINDLE INHIBITOR (cytogenetic assays): N/A
STAIN (for cytogenetic assays): N/A
NUMBER OF REPLICATIONS: 2 per dose concentration including negative and positive controls
NUMBER OF CELLS EVALUATED:
Viability plates:
An average of 1.6 cells/well (two 96-well plates/culture = four plates/dose-level) to define the number of viable cells (CE2). After at least 7 days of
incubation at 37°C in a humidified atmosphere of 5% CO2/95% air, the clones were counted.
Mutant plates:
2000 cells/well (four 96-well plates/culture = eight plates/dose-level) to select the TFTR (trifluo
rothymidine resistant) mutant cells (for the
determination of CEmutant). After 11-12 days of incubation at 37°C in a humidified atmosphere of
5% CO2/95% air in the presence of 4 µg TFT/mL of culture medium, the clones were counted, differentiating small and large colonies:
· size of small colonies: < 25% of the diameter of the well,
· size of large colonies: > 25% of the diameter of the well.
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth (adjusted)
For scoring of colonies in mutant plates, the following parameters were considered:
· Well containing mutant colony (small or large),
· Well not containing mutant colony,
· When both small and large colonies are present in the same well both mutant colonies were counted (one small and one large).
OTHER EXAMINATIONS:
- Determination of polyploidy:
- Determination of endoreplication: - Evaluation criteria:
- at least at one dose-level the mutation frequency minus the mutation frequency of the vehicle control equals or exceeds the global evaluation factor
(126 x 10-6 for the microtiter method),
· and a dose-related trend is demonstrated by a statistically significant trend test.
Unless considered as clearly positive, the reproducibility of a positive effect should be confirmed.
Noteworthy increases in the mutation frequency observed only at high levels of cytotoxicity (RTG lower than 10%), but with no evidence of
mutagenicity at dose-levels with RTG between 10 and 20%, is considered as positive result. A test
item may be determined to be non-mutagenic when there is no culture showing an Adj. RTG value
between 10-20% if (e):
· there is at least one negative data point between 20 and 25% Adj. RTG and no evidence on mutag
enicity in a series of data points between 100 to 20% Adj. RTG,
· there is no evidence of mutagenicity in a series of data points between 100 to 25% and there is also a negative data point between 10 and
1% Adj. RTG. - Statistics:
- No statistical analyses were performed.
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: slight at 5000 µg/mL in the second experiment shown by a a 39% decrease in adjusted relative total growth
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No effects; the pH values were equivivalent to those of the vehicle control culture
- Effects of osmolality: No effects; the osmalality values were equivalent to those of the vehicle control culture
- Evaporation from medium: Not reported
- Water solubility: The test substance is freely soluble in water
- Precipitation: None
- Other confounding effects: None
RANGE-FINDING/SCREENING STUDIES:
Using a treatment volume of 100 µL/20mL of culture medium, the final dose-level of 5000 µg/mL
showed no precipitate. At this dose-level, the pH was approximately 7.4 (as for the vehicle control) and the osmolality equal to 344 mOsm/kg H2O (296 for the vehicle control).
The dose-levels used for treatment were 10, 100, 500, 1000, 2500, 5000 µg/mL.
No noteworthy toxicity was noted, either following the 3- and 24-hour treatments without S9 mix or following the 3-hour treatment with S9 mix.
COMPARISON WITH HISTORICAL CONTROL DATA:
Control data were included as an appendix in the Report, which covered experiments during the the period April 2005 to September 2006. It includedresults from 12 experiments without metabolic
activation (S9 mix) and 24 experiments with metabolic activation using negative controls and using the positive controls methylmethanesulfonate (MMS) and cyclophosphamide (CPA). The results are in line with those of the current study.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Not reported - Remarks on result:
- other: all strains/cell types tested
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the experimental conditions, the test item ANHYDROUS SODIUM PERCHLORATE (batch No. "
Lot moyen du 10/01/08 test"; purity: 98.21%) did
not show any mutagenic activity in the mouse lymphoma assay. - Executive summary:
A study was performed at CIT Laboratories France to investigate the potential of Anhydrous Sodium Perchlorate to induce mutations at the TK (thymidine kinase) locus in L5178Y mouse lymphomacells. The study was performed according to the international guidelines (OECD 476 and Commission Directive No. B17) and in compliance with the Principles of Good Laboratory Practice Regulations. Aftera preliminary toxicity test, Anhydrous Sodium Perchlorate was tested in two independent experiments,in the absence and presence of a rat liver metabolising system (S9 mix). Cytotoxicity was measuredby assessment of adjusted relative total growth (Adj. RTG) and relative suspension growth (Adj. RSG)as well as cloning efficiency following the expression time (CE2). The number of mutant clones(differentiating small and large colonies) were checked after the expression of the mutant phenotype.Using a treatment volume of 100 µL/20 mL, the selected dose-levels were 156.3, 312.5, 625, 1250, 2500and 5000 µg/mL for both mutagenicity experiments with and without the S9 mix. Following the 3-hourtreatment and the 24-hour treatment without S9 mix, no noteworthy cytotoxicity was found. Similarlythere was no evidence of mutagenicity, either following either the 3-hour or the 24-hour treatment. Experiments with the S9 mix revealed no noteworthy cytotoxicity in the first experiment but the second experiment showed evidence of slight toxicity at the highest doselevel (5000 µg/mL), shown by a 39% decrease in Adj. RTG. However, there was no significant mutationfrequency noted following the 3-hour treatment in either experiment. Under the experimental conditions,the test item did not show any mutagenic activity in the mouse lymphoma assay.
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 01 April - 01 July 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- In water, potassium perchlorate will rapidly dissolve and completely dissociate into the perchlorate anion and the corresponding cation. Toxicity is determined only by the perchlorate moiety of the salt. as potassium is known to be non-toxic. Based on that, read-across is possible to other perchlorate salt dissociating in water without any toxic cation.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- 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
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and 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 - 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.
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium 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
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- 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'.
- 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.
Based on the read-across justification potassium perchlorate can be considered as not genetic toxic. - 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.
- 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:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- 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
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and 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 - 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.
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium 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
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- 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
- True 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'.
- 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.
Referenceopen allclose all
Experiments without S9 mix: Cytotoxicity: Following the 3-hour treatment and the 24-hour treatment, no noteworthy toxicity was noted. Mutagenicity: No significant increase in the mutation frequency was noted, either following the 3-hour treatment or following the 24-hour treatment. Experiments with S9 mix: Cytotoxicity: In the first experiment, no noteworthy toxicity was noted. In the second experiment, a slight toxicity was noted at the dose-level of 5000 µg/mL, as shown by 39% decrease in Adj. RTG. Mutagenicity: No significant increase in the mutation frequency was noted following the 3-hour treatment in either experiment.
Experiments without S9 mix: Cytotoxicity: Following the 3-hour treatment and the 24-hour treatment, no noteworthy toxicity was noted. Mutagenicity: No significant increase in the mutation frequency was noted, either following the 3-hour treatment or following the 24-hour treatment. Experiments with S9 mix: Cytotoxicity: In the first experiment, no noteworthy toxicity was noted. In the second experiment, a slight toxicity was noted at the dose-level of 5000 µg/mL, as shown by 39% decrease in Adj. RTG. Mutagenicity: No significant increase in the mutation frequency was noted following the 3-hour treatment in either experiment.
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.
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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
With ammonium perchlorate no test-material-related changes in bone marrow micronucleus formation or polychromatic erythrocyte/normochromatic erythrocyte ratio were observed in both sex groups after 90 days of treatment at a dose of 10 mg/kg/day. The perchlorat moiety of ammonium perchlorate can be stated as non-genotoxic. As potassium perchlorate dissociated rapidly and potassium in known to be non-genotoxic, an eqivalent dose of 11.8 mg/kg/day potassium perchlorate can be stated as non-genotoxic.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.