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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 04, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was performed in compliance with the Good Laboratory Practice (GLP) regulations (revised in 1997, ENV/MC/CHEM(98)17). The method followed that described in the OECD Guidelines for Testing of Chemicals, Updated Guideline No 437 Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants (September, 2009).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 437
- Deviations:
- no
- Principles of method if other than guideline:
- none
- GLP compliance:
- yes (incl. QA statement)
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
Constituent 1
Test system
- Details on study design:
- according to guideline
Results and discussion
In vivo
Results
- Irritation parameter:
- other:
- Basis:
- mean
- Time point:
- other: 240 min
- Score:
- 6.16
- Max. score:
- 8.06
Any other information on results incl. tables
Test Group | Opacity value = Difference (t240-t0) of Opacity* | Permeability at 490 nm (OD490) | In vitroScore | Proposedin vitroIrritation Scale | |||
Individual | Mean | Individual | Mean | Individual | Mean | ||
Negative Control | 0 | 0.33 | 0.070 | 0.065 | 1.05 | 1.31 | Non eye irritant |
1 | 0.060 | 1.90 | |||||
0 | 0.065 | 0.98 | |||||
Positive Control | 187.67 * | 0.106 * | 189.26 | 191.42 | Very severe eye irritant | ||
182.67 * | 0.046 * | 183.36 | |||||
198.67 * | 0.198 * | 201.64 | |||||
Potassium Bromate | 5.67 * | 0.036 * | 6.21 | 6.61 | Mild eye irritant | ||
5.67 * | -0.007 * | 5.56 | |||||
7.67 * | 0.026 * | 8.06 |
* corrected values
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The study performed shows that the test item is considered to be a mild eye irritant in vitro under the described conditions. According to CLP no classification is rewarded.
- Executive summary:
Purpose
This study should provide a rational basis for risk assessment in humans. Ocular contact is a possible route of human exposure. This in vitro study was performed to assess the corneal irritation and damage potential of potassium bromate by means of the BCOP assay using fresh bovine corneae.
Study Design
Damage is assessed by quantitative measurements of changes in corneal opacity and permeability with an opacitometer and a visible light spectrophotometer, respectively. Both measurements are used to calculate an in vitro irritation score, which is used to assign an in vitro irritancy category. After a first opacity measurement of the fresh bovine corneae (t0), the test item/saline (0.9% (w/v) NaCl in deionised water) stock, the positive, or the negative controls were applied to the epithelial surface of three corneae each and incubated for 240 minutes at 32 +/- 2 °C. After the incubation phase, the cornea were each rinsed and opacity was measured again (t240). Thereafter the permeability of the corneae was determined. Therefore, 1 mL of a fluorescein solution was added to the anterior chamber of the corneal holder and after 90 min incubation in a horizontal position at 32 +/- 2 °C, the permeability of the corneae was measured quantitatively using the increase in fluorescence in the posterior chamber medium at 490 nm.
Results
The negative control (0.9% NaCl solution) yields no increase of opacity nor permeability of the corneae, while the the positive control (10% (w/v) Benzalconium chloride) showed clear opacity and distinctive permeability of the corneae, thus demonstrating the validity of the assay. The test item caused weak opacity but no permeability of the corneaecompared with the results of the negative control.
The calculated mean in vitro score was 6.61 and therefore, the test item was classified as mild eye irritant.
Conclusion
The study performed shows that the test item is considered to be a mild eye irritant in vitro under the described conditions.
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