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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Aug 25 - Sep 15,2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was performed in compliance with the “OECD Principles of Good Laboratory Practice“, as revised in 1997 [C(97)186/Final]. OECD Guidelines for Testing of Chemicals, Updated Guideline 429: Skin Sensitisation: Local Lymph Node Assay (adopted 22 July 2010). Commission regulation (EC) No. 440/2008, "European Union Method B.42: “Skin Sensitization: Local Lymph Node Assay”, dated May 30, 2008"
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
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
- Details on test material:
- Purity: 99.8 %
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
Source: Harlan Netherlands B.V. Postbus 6174 NL - 5960 AD Horst / The Netherlands
Age at study initiation: 8 - 12 weeks (beginning of treatment)
Weight at study initiation: 22 +/- 1.5
Acclimation
At least 5 days prior to the start of dosing under test conditions after health examination. Only animals without any visible signs of illness were used for the study.
Identification
The animals were distributed into the test groups at random. All animals belonging to the same experimental group were kept in one cage. In the main experiment, the animals were identified by tail tags. In the pre-experiment, animals were identified by cage number.
ENVIRONMENTAL CONDITIONS
Housing: group
Cage Type: Makrolon Type II, with wire mesh top (EHRET GmbH, 79302 Emmendingen, Germany)
Bedding: granulated soft wood bedding (Rettenmaier & Söhne GmbH + Co. KG, 73494 Rosenberg, Germany)
Feed: pelleted standard diet, ad libitum (Harlan Laboratories B.V., 5960 AD Horst / Netherlands)
Water: tap water, ad libitum, (Gemeindewerke, 64380 Rossdorf, Germany)
Environment: temperature 22 + 2°C
relative humidity 45-70%
artificial light 6.00 a.m. - 6.00 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- other: 1% Lutrol® F 68 in water
- Concentration:
- 1.25, 2.5, 7.5 %
- No. of animals per dose:
- Total 20 animals
3 test groups with 4 animals
1 negative control group with 4 animals (vehicle control)
1 positive control group with 4 animals (20% -alpha-Hexylcinnamaldehyde, tech. 85%) - Details on study design:
- according to guideline
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables.
Results and discussion
- Positive control results:
- Experiment performed in May 2010.
Positive control substance: 2-Hexylcinnamaldehyde
Vehicle: acetone:olive oil (4+1)
Test item concentration % (w/v) Group Measurement DPM Calculation Result
DPM-BG a) number of lymph nodes DPM per lymph node b) S.I.
--- BG I 13 --- --- --- ---
--- BG II 12 --- --- --- ---
0 1 4561 4549 8 568.6 1.00
5 2 9275 9263 8 1157.8 2.04
10 3 15507 15495 8 1936.8 3.41
25 4 27961 27949 8 3493.6 6.14
BG = Background (1 ml 5% trichloroacetic acid) in duplicate
1 = Control Group
2-4 = Test Group
S.I. = Stimulation Index
a) = The mean value was taken from the figures BG I and BG II
b) = Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see DPMs
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Test item concentration % (w/w) Group Measurement DPM Calculation Result DPM-BGa) number of lymph nodes DPM per lymph nodeb) S.I. --- BG I 12 --- --- --- --- --- BG II 23 --- --- --- --- --- 1 1728 1711 8 213.8 1.00 1.25 2 1556 1539 8 192.3 0.90 2.5 3 932 915 8 114.3 0.53 7.5 4 1118 1101 8 137.6 0.64 positive control in Lutrol 20 5 7437 7420 8 927.4 4.34
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test item Potassium bromate was not a skin sensitiser under the test conditions of this study.
- Executive summary:
Purpose
The purpose of this Local Lymph Node assay was to identify the contact allergenic potential of Potassium bromate when administered to the dorsum of both ears of mice.
This study should provide a rational basis for risk assessment to the sensitising potential of the test item in man.
Study Design
In order to study a possible allergenic potential of Potassium bromate, three groups each of four female mice were treated with different concentrations of the test item by topical application at the dorsum of each ear once daily each on three consecutive days. A further group of four mice was treated with the positive control item and a control group of four mice was treated with the vehicle only. Five days after the first topical application, the mice were intravenously injected into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed and the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a beta-scintillation counter.
Results
In this study, Stimulation Indices (S.I.) of 0.90, 0.53, and 0.64 were determined with the test item at concentrations of 1.25, 2.5, and 7.5% (w/v) in 1% Lutrol® F 68, respectively. The EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3. With the positive control, a S.I. of 4.34 was determined.
Conclusion
The test item Potassium bromate was not a skin sensitiser in this assay.
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