Dipotassium oxide

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:

2015

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

Test material information

Constituent 1

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

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