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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The assessment of ciclopirox olamine genetic toxicity has been based on experimental data on neutral form of its ionic components: ciclopirox and 2-aminoethanol.

Link to relevant study records

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Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Principles of method if other than guideline:
Data published. No detailed information about principles of method are available.
GLP compliance:
not specified
Remarks:
Data published. No detailed information about GLP compliance.
Type of assay:
bacterial reverse mutation assay
Species / strain:
S. typhimurium, other: not specified
Metabolic activation:
not specified
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Species / strain:
E. coli, other: not specified
Metabolic activation:
not specified
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Remarks on result:
other: no mutagenic potential
Conclusions:
2-aminoethanol (the neutral formo of Ethanolaminium cation) was negative in in vitro gene mutation study in bacteria.
Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Principles of method if other than guideline:
Data published. No detailed information about principles of method are available.
GLP compliance:
not specified
Remarks:
Data published. No detailed information about GLP compliance.
Type of assay:
other: In vitro mammalian chromosome aberration test
Species / strain:
hepatocytes: rat hepatocytes
Metabolic activation:
not specified
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Conclusions:
2-aminoethanol (the neutral form of Ethanolaminium cation) was negative in vitro cytogenicity / chromosome aberration study in mammalian cells.
Endpoint:
in vitro gene mutation study in mammalian cells
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Principles of method if other than guideline:
Data published. No detailed information about principles of method are available.
GLP compliance:
not specified
Remarks:
Data published. No detailed information about GLP compliance.
Type of assay:
other: in vitro gene mutation Chinese hamster lung fibroblasts
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Additional strain / cell type characteristics:
not specified
Metabolic activation:
not specified
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
not specified
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Remarks on result:
other: no mutagenic potential
Conclusions:
2-aminoethanol (the neutrla form of Ethanolaminium cation) was negative in in vitro gene mutation study in mammalian cell.
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Principles of method if other than guideline:
Data published. No detailed information about principles of method are available.
GLP compliance:
not specified
Remarks:
Data published. No detailed information about GLP compliance.
Type of assay:
bacterial reverse mutation assay
Species / strain:
S. typhimurium, other: not specified
Metabolic activation:
not specified
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Species / strain:
E. coli, other: not specified
Metabolic activation:
not specified
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Remarks on result:
other: no mutagenic potential
Conclusions:
Ciclopirox (the neutral form of 6-cyclohexyl-4-methyl-2-oxopyridin-2(1H)-olate anion) was negative in in vitro gene mutation study in bacteria.
Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Principles of method if other than guideline:
Data published. No detailed information about principles of method are available.
GLP compliance:
not specified
Remarks:
Data published. No detailed information about GLP compliance.
Type of assay:
other: In vitro mammalian chromosome aberration test
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Species / strain:
Chinese hamster lung fibroblasts (V79)
Remarks:
in the presence of supplemental Fe3+
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Endpoint:
in vitro gene mutation study in mammalian cells
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Principles of method if other than guideline:
Data published. No detailed information about principles of method are available.
GLP compliance:
not specified
Remarks:
Data published. No detailed information about GLP compliance.
Type of assay:
other: in vitro gene mutation Chinese hamster lung fibroblasts
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Additional strain / cell type characteristics:
not specified
Metabolic activation:
not specified
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
not specified
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Remarks on result:
other: no mutagenic potential
Conclusions:
Ciclopirox (the netutral form of 6-cyclohexyl-4-methyl-2-oxopyridin-2(1H)-olate anion) was negative in in vitro gene mutation study in mammalian cell.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification