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Toxicological information

Genetic toxicity: in vitro

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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:
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
Name:
Unnamed
Type:
Constituent
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