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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 235-227-6 | CAS number: 12136-45-7
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- (Q)SAR
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- Justification for type of information:
- QSAR prediction: Regulatory accepted QSAR method for chemicals properties assessment. An assessment was conducted based on an examination of the composition of the substance and the potential of its constituents to induce gene mutation in mammalian cells. This assessment was supported by data from a QSAR prediction on the registered substance and its components.
Data source
Reference
- Reference Type:
- other: QSAR model
- Title:
- In vitro mutagenicity (Ames test) alerts by ISS for Dipotassium oxide
- Author:
- Romualdo Benigni, Cecilia Bossa
- Year:
- 2 015
- Bibliographic source:
- OECD QSAR Toolbox Version 3.3.5.17
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: QSAR Toolbox Version 3.3.5.17
- Principles of method if other than guideline:
- This method is based on the Mutagenicity/Carcinogenicity module of the software Toxtree. It works as a decision tree for estimating in vitro (Ames test) mutagenicity, based on a list of 30 structural alerts (SAs). The SAs for mutagenicity are molecular functional groups or substructures known to be linked to the mutagenic activity of chemicals. As one or more SAs embedded in a molecular structure are recognised, the system flags the potential mutagenicity of the chemical. The present list of SAs is a subset of the original Toxtree list, obtained by eliminating the SAs for nongenotoxic carcinogenicity.
- GLP compliance:
- no
- Remarks:
- not applicable. QSAR model,
- Type of assay:
- other: Assessment based on an examination of the composition of the substance and the potential of its constituents to induce gene mutation in mammalian cells, supported by predictions using the QSAR toolbox.
Test material
- Reference substance name:
- Dipotassium oxide
- EC Number:
- 235-227-6
- EC Name:
- Dipotassium oxide
- Cas Number:
- 12136-45-7
- Molecular formula:
- K2O
- IUPAC Name:
- Potassium oxide
- Details on test material:
- -Name of test material (as cited in study report): Dipotassium oxideCAS Number: 12136-45-7SMILES : [K]O[K]CHEM : Potash (potassium oxide)MOL FOR: O1 K2 MOL WT : 94.20
Constituent 1
Method
- Target gene:
- QSAR model
Species / strain
- Species / strain / cell type:
- other: predictions using the QSAR toolbox
- Details on mammalian cell type (if applicable):
- Assessment based on an examination of the composition of the substance and the potential of its constituents to induce gene mutation in mammalian cells, supported by predictions using the QSAR toolbox
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- QSAR model
- Vehicle / solvent:
- QSAR model
Controls
- Untreated negative controls:
- other: QSAR model
- Negative solvent / vehicle controls:
- other: QSAR model
- True negative controls:
- other: QSAR model
- Remarks:
- This method is based on the Mutagenicity/Carcinogenicity module of the software Toxtree. It works as a decision tree for estimating in vitro (Ames test) mutagenicity, based on a list of 30 structural alerts (SAs).
Results and discussion
Test results
- Species / strain:
- other: An assessment was conducted based on an examination of the composition of the substance and the potential of its constituents to induce gene mutation in mammalian cells.
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Additional information on results:
- See attached assessment report for full details of the assessment methodology and results.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
An assessment was conducted based on an examination of the composition of the substance and the potential of its constituents to induce gene mutation in mammalian cells. This assessment used data from a QSAR prediction on the registered substance and its constituents, which was found to be negative in all cases. The results of the QSAR prediction for Dipotassium oxide and its constituents show that Dipotassium oxide is not expected to induce gene mutation in mammalian cells. On the basis of these results an experimental study on the potential of Dipotassium oxide to induce gene mutation in mammalian cells is not considered necessary since it is unlikely to provide additional relevant data about the in vivo mutagenicity potential of Dipotassium oxide in accordance with ECHA’s Endpoint Specific Guidance on Genotoxicity (ECHA, 2015), which states that the potential of a substance to induce gene mutation in mammalian cells does not need to be evaluated, if it can be demonstrated that it will not provide any further useful information about the potential in vivo mutagenicity of a substance
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results :negative
Based on an examination of the constituents of the substance and the potential of its constituents to induce gene mutation in mammalian cells, it is concluded that Dipotassium oxide is not expected to induce gene mutation in mammalian cells. - Executive summary:
An assessment was conducted based on an examination of the composition of the substance and the potential of its constituents to induce gene mutation in mammalian cells. This assessment used data from a QSAR prediction on the registered substance and its constituents, which was found to be negative in all cases. The results of the QSAR prediction for Dipotassium oxide and its constituents show thatDipotassium oxideis not expected to induce gene mutation in mammalian cells. On the basis of these results an experimental study on the potential of Dipotassium oxide to induce gene mutation in mammalian cells is not considered necessary since it is unlikely to provide additional relevant data about the in vivo mutagenicity potential ofDipotassium oxidein accordance with ECHA’s Endpoint Specific Guidance on Genotoxicity (ECHA, 2015), which states that the potential of a substance to induce gene mutation in mammalian cells does not need to be evaluated, if it can be demonstrated that it will not provide any further useful information about the potential in vivo mutagenicity of a substance
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.