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EC number: 231-829-8 | CAS number: 7758-01-2
- 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
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:
- from-to
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study is considered acceptable for the purpose of registration under REACH. The method followed that described in the OECD Guidelines for Testing of Chemicals (Adopted: 4 April 1984) No 471 "Bacterial Reverse Mutation Test".
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guidelineopen allclose all
- 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:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Potassium bromate
- EC Number:
- 231-829-8
- EC Name:
- Potassium bromate
- Cas Number:
- 7758-01-2
- Molecular formula:
- BrHO3.K
- IUPAC Name:
- potassium bromate
- Reference substance name:
- 7758-01 -2
- IUPAC Name:
- 7758-01 -2
- Details on test material:
- Supplier: Aldrich
Purity > 99 %
Constituent 1
Constituent 2
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- other: mutations in the histidine operon
- Species / strain / cell type:
- S. typhimurium TA 1537
- Additional strain / cell type characteristics:
- other: mutations in the histidine operon
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: mutations in the histidine operon
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: mutations in the histidine operon
- Species / strain / cell type:
- S. typhimurium TA 97
- Additional strain / cell type characteristics:
- other: mutations in the histidine operon
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver homogenate (S9 mix) with standard co-factors with metabolic activation (Aroclor)
- Test concentrations with justification for top dose:
- three series using 0, 33, 100, 333, 1000, 3333, 6667, and 10000 µg/plate
- Vehicle / solvent:
- H2O
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylenediamine
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Positive controls:
- yes
- Positive control substance:
- other: methyl methanesulfonate
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with S9
- Details on test system and experimental conditions:
- Bacterial strains
Salmonella typhimurium strains TA97, TA98, TA100, TA102, TA104, TA153.5, TA1.537 and TA1.538 were obtained from Dr. Bruce Ames (University of California, Berkeley) and stored as recommended [Maron and Ames,1981]. Cultures were grown at 37°C overnight, with shaking, in Oxoid #2 broth, or in defined minimal medium supplemented with biotin (0.8 µg/ml) and histidine (40 µgiml). The phenotypes of the strains were analyzed at the time of their use in mutagenicity assays.
Preparation of Liver S-9 Fractions
The S-9 (9,000 x g supernatant) fractions of Aroclor 1254-induced, male Sprague-Dawley rat and male Syrian hamster livers were prepared as described previously [Haworth et al., 1983]. The S-9 mixes were prepared immediately prior to use and contained either 10% or 30% S-9; occasionally, 5% S-9 was also used. The specific S-9 concentrations used are indicated in the Appendix 2 tables. All chemicals were tested in the absence of metabolic activation, and with rat and hamster S-9 fractions.
Experimental Protocols
The preincubation procedure was performed as described previously [Haworth et al., 1983], with some differences, as described below.
The test chemical (0.05 ml), overnight culture of Salmonella (0.10 ml), and S-9 mix or buffer (0.50 ml), were incubated at 37°C, without shaking, for 20 min. The top agar was added and the contents of the tubes were mixed and poured onto the surface of petri dishes containing Vogel-Bonner medium [Vogel and Bonner, 1956].
Histidine-independent (his+) colonies arising on these plates were counted following two days incubation at 37°C. Plates were machine counted (New Brunswick; Artek) unless precipitate was present which interfered with the count, or the color of the test chemical on the plate reduced the contrast between the colonies and the agar. At the discretion of the investigators, plates with low numbers of colonies, containing precipitated test chemical, or having excessivelyreduced contrast because of chemical color, were counted by hand. - Evaluation criteria:
- 1) mutagenic response: a dose-related, reproducible increase in the number of revertants over background, even if the increase was less than twofold;
2) nomutagenic response: when no increase in the number of revertants was elicited by the chemical;
3) questionable response: when there was an absence of a clear-cut dose-related increase in revertants; when the dose-related increases in the number of revertants were not reproducible; or when the response was of insufficient magnitude to support a determination of mutagenicity.
The initial determination of mutagenic, nonmutagenic, or equivocal was made by the testing laboratory; the final determination was made by the project officer (E.Z.). The chemicals were decoded by the chemical repository (Radian Corporation) only after the mutagenicity or nonmutagenicity of the chemicals had been determined.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- for details see publication
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Dose | TA 100 | ||
NA | 30 % HLI | 30 % RLI | |
? | ? | ? | |
0 | 145±6.7 | 159±3.5 | 150±6.4 |
33 | |||
100 | 114±9.0 | 158±4.6 | 157±7.6 |
333 | 153±2.1 | 158±11.2 | 122±14.7 |
1000 | 148±8.5 | 226±13.5 | 180±10.1 |
3333 | 177±10.0 | 148±21.5 | 210±2.3 |
6667 | 184±7.8 | 162±11.7 | 182±13.5 |
10000 | 189±6.1 | 175±14.2 | 179±10.7 |
Control | 704±52.1 | 957±66.4 | 902±38.9 |
Dose | TA 1535 | ||||
NA | 10 % HLI | 10 % HLI | 30 % HLI | 30 % HLI | |
- | + | + | + | - | |
0 | 27±0.6 | 11±1.8 | 11±2.2 | 13±3.4 | 15±2.0 |
33 | |||||
100 | 18±1.5 | 18±0.6 | |||
333 | 24±3.5 | 13±2.5 | 17±4.9 |
15±2.4 | 17±0.3 |
1000 | 32±1.2 | 16±2.2 | 18±2.6 | 18±1.8 | 22±3.3 |
3333 | 32±3.7 | 23±3.8 | 14±2.7 | 21±1.7 | 26±0.9 |
6667 | 34±1.2 | 26±0.6 | 28±1.9 | ||
10000 | 28±2.9 | 28±1.5 | 21±0.9 | 13±1.5 | 19±1.2s |
Control | 532±7.7 | 50±1.0 | 910±38.4 | 190±7.3 | 493±180.8 |
Dose | TA 1535 | |||
10 % RLI | 10 % RLI | 30 % RLI | 30 % RLI | |
+ | - | ? | + | |
0 | 11±2.6 | 16±3.5 | 14±1.9 | 13±1.8 |
33 | ||||
100 | 16±2.3 | |||
333 | 12±0.3 | 16±2.8 | 16±0.9 | 20±2.7 |
1000 | 17±1.9 | 16±1.2 | 18±3.0 | 24±0.9 |
3333 | 31±0.9 | 19±6.5 | 23±3.1 | 27±1.8 |
6667 | 36±4.1 | 25±2.7 | 27±3.1 | |
10000 | 36±3.0 | 21±1.7 | 16±3.5 | 32±2.3 |
Control | 282±14.8 | 166±15.0 | 142±0.9 | 222±15.6 |
Dose | TA 1537 | ||||
NA | 10 % HLI | 30 % HLI | 10 % RLI | 30 % RLI | |
- | - | - | - | - | |
0 | 17±3.6 | 16±1.9 | 16±2.9 | 20±1.2 | 21±4.3 |
33 | |||||
100 | |||||
333 | 24±0.7 | 17±2.9 | 19±1.0 | 21±0.9 | 18±3.8 |
1000 | 19±2.3 | 22±4.7 | 21±0.7 | 23±0.7 | 26±3.2 |
3333 | 14±2.3 | 18±2.6 | 21±2.1 | 23±3.3 | 18±3.5 |
6667 | 13±3.7 | 12±0.9 | 20±1.2 | 22±2.8 | 17±4.9 |
10000 | 15±1.2 | 15±1.2 | 13±1.2 | 16±2.6 | 13±0.7 |
Control | 77±5.7 | 428±30.1 | 128±5.2 | 940±12.2 | 175±5.4 |
Dose | TA 97 | ||||||||
NA | NA | 10 % HLI |
30 % HLI |
30 % HLI |
10 % RLI |
10 % RLI |
30 % RLI |
30 % RLI |
|
+ | +W | +W | +W | +W | +W | + | +W | +W | |
0 | 110±4.4 | 105±2.9 | 233±6.7 | 130±6.0 | 161±14.1 | 182±17.8 | 107±2.1 | 119±5.4 | 155±5.4 |
33 | 171±7.7 | 176±8.6 | |||||||
100 | 125±6.7 | 100±4.9 | 143±8.0 | 183±3.2 | 159±5.7 | 152±4.9 | |||
333 | 151±11.2 | 165±11.0 | 256±11.8 | 205±15.0 | 223±13.7 | 271±10.9 | 118±3.8 | 173±5.9 | 208±7.5 |
1000 | 219±14.2 | 223±11.3 | 265±7.5 | 205±7.5 | 257±13.0 | 284±8.3 | 204±25.8 | 216±8.7 | 270±8.5 |
3333 | 261±1.0 | 179±7.4 | 386±16.6 | 201±18.2 | 270±12.5 | 350±3.1 | 262±7.8 | 139±25.9 | 249±2.3 |
6667 | 92±10.6 | 340±10.7 | 331±1.5 | 205±21.1 | |||||
10000 | 0±0.0 | 334±26.0s | 57±7.7s | 256±20.3s | 178±16.0 | 0±0s | |||
Control | 4230±224 | 94±3.3 | 804±19.5 | 1592±34.9 | 1478±6.7 | 3178±123 | 724±10.7 | 2102±81.4 |
Dose | TA 98 | ||
NA | 30 % HLI | 30 % RLI | |
- |
- | - |
|
0 | 26±4.3 | 32±4.0 | 30±2.4 |
33 | |||
100 | 22±5.4 | 42±2.3 | 37±2.7 |
333 | 25±0.7 | 41±1.8 | 39±2.0 |
1000 | 26±2.5 | 34±2.1 | 33±5.7 |
3333 | 32±1.9 | 37±5.0 | 45±1.8 |
6667 | 36±3.2 | 28±1.5 | 41±4.3 |
10000 | 25±0.7 | 23±3.3 | 35±0.6 |
Control | 152±18.0 | 766±39.1 | 314±24.6 |
Abbreviations
NA, not activated
HLI, Aroclor 1254-induced hamster liver S-9
RLI, Aroclor 1254-induced rat liver S-9
s, slight clearing of background lawn
t, complete clearing of background lawn (colonies not counted)
p, precipitate present in plates
x, precipitate present with toxicity
+, mutagenic
+W, weakly mutagenic
?, questionable response
- , nonmutagenic.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with and without metabolic activation
With and without addition of S9 mix as the external metabolizing system, the test item was mutagenic under the experimental conditions described. - Executive summary:
Purpose
The purpose of this assay was to provide information on possible health hazards for the test material and serve as a rational basis for risk assessment to the genotoxic potential of the test item in man.
Study Design
The investigations for the mutagenic potential were performed using Salmonella typhimurium tester strains TA 97, TA98, TA 100, TA 1535 and TA 1537. Further details on study design are published in E. Zeiger et al., Environmental & Molecular Mutagenesis 1992, 19 Suppl 21, 2-141.
Results
The test item dissolved in water was tested at concentrations ranging from 33 up to 10000 µg/plate. Precipitation of the test material on the agar plates occurred as indicated in the tables enclosed. Toxicity to the bacteria was not observed.
Each treatment with positive controls led to a clear increase in revertant colonies, thus, showing the expected reversion properties of all strains and good metabolic activity of the S9 mix used.
The increase in the number of revertant colonies observed for TA 1535 with metabolic activation and TA 97 with and without metabolic activation was significant and shows dose response relationship thus indicating that the test item was mutagenic under the described experimental conditions.
Conclusion
With and without addition of S9 mix as the external metabolizing system, the test item was mutagenic under the experimental conditions described.
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