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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
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.

Data source

Reference
Reference Type:
other: QSAR model
Title:
In vivo mutagenicity (Micronucleus) alerts by ISS Dipotassium oxide
Author:
Romualdo Benigni, Cecilia Bossa, Olga Tcheremenskaia
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 ToxMic rulebase of the software Toxtree. This rulebase provides a list of 35 structural alerts (SAs) for a preliminary screening of potentially in vivo mutagens. These SAs are molecular functional groups or substructures that are known to be linked to the induction of effects in the in vivo micronucleus assay. The compilation of SAs for the in vivo micronucleus assay in rodents provided here, is based on both the existing knowledge on the mechanisms of toxic action and on a structural analysis of the chemicals tested in the assay.
GLP compliance:
no
Remarks:
not applicable. QSAR model
Type of assay:
other: An assessment was conducted based on an examination of the composition of the substance and the potential of its constituents to induce chromosomal aberration in mammalian cells.

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

Test animals

Species:
other: QSAR model
Strain:
other: QSAR model
Sex:
male/female

Administration / exposure

Route of administration:
other: QSAR model
Details on exposure:
This method is based on the ToxMic rulebase of the software Toxtree. This rulebase provides a list of 35 structural alerts (SAs) for a preliminary screening of potentially in vivo mutagens. These SAs are molecular functional groups or substructures that are known to be linked to the induction of effects in the in vivo micronucleus assay. The compilation of SAs for the in vivo micronucleus assay in rodents provided here, is based on both the existing knowledge on the mechanisms of toxic action and on a structural analysis of the chemicals tested in the assay.
Duration of treatment / exposure:
QSAR model
Frequency of treatment:
QSAR model
Post exposure period:
QSAR model
Doses / concentrations
Remarks:
Doses / Concentrations:

Basis:
other: QSAR model
No. of animals per sex per dose:
QSAR model
Control animals:
other: QSAR model

Examinations

Tissues and cell types examined:
This profiler is based on the ToxMic rulebase of the software Toxtree. This rulebase provides a list of 35 structural alerts (SAs) for a preliminary screening of potentially in vivo mutagens. These SAs are molecular functional groups or substructures that are known to be linked to the induction of effects in the in vivo micronucleus assay. The compilation of SAs for the in vivo micronucleus assay in rodents provided here, is based on both the existing knowledge on the mechanisms of toxic action and on a structural analysis of the chemicals tested in the assay.
Evaluation criteria:
An assessment was conducted based on an examination of the composition of the substance and the potential of its constituents to induce chromosomal aberration in mammalian cells, supported by data from a QSAR prediction.

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
not specified
Additional information on results:
Available QSAR methods does not identify Dipotassium oxide as genotoxic/non-genotoxic mutagen.

Any other information on results incl. tables

See attached background material and QSAR study report

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Available QSAR methods does not identify Dipotassium oxide as genotoxic/non-genotoxic mutagen.
Executive summary:

Based on QSAR in vivo mutagenicity (Micronucleus) examination of the constituents of the substance and the potential of its constituents to induce structural chromosomal aberration in mammalian cells, it is concluded that Dipotassium oxide is not expected to induce structural chromosomal aberration in mammalian cells.