Registration Dossier
Registration Dossier
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EC number: 215-181-3 | CAS number: 1310-58-3
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was given Klimish 2 in OECD SIDS (Guideline study with acceptable restrictions).
Data source
Reference
- Reference Type:
- publication
- Title:
- No information
- Author:
- Fujita H et al
- Year:
- 1 992
- Bibliographic source:
- Kenkyu Nenpo-Tokyo-Toritsu Eisei Kenkyusho, 43, 219-227.
Materials and methods
- Principles of method if other than guideline:
- Ames test
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Potassium hydroxide
- EC Number:
- 215-181-3
- EC Name:
- Potassium hydroxide
- Cas Number:
- 1310-58-3
- Molecular formula:
- HKO
- IUPAC Name:
- potassium hydroxide
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 97
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Species and cell type: S9 mix prepared from the liver homogenate of male SD rats (Jcl:SD). Quantity: S9 mix containing 10% S9 fraction, 50μl/plate. Induced: Aroclor 1254 induced rats.
- Test concentrations with justification for top dose:
- 0.01, 0.05, 0.1, 0.5, 1mg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: distilled water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
NUMBER OF REPLICATIONS:3
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other:
OTHER:number of metaphases analysed: no data - Evaluation criteria:
- Number of revertants/plate
- Statistics:
- Kruskal-Wallis test and regression analysis
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA97 and TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- No. revertants/plate in function of dose mg/plate:
mg/TA97-S9/TA97+S9/TA102-S9/TA102+S9
0/162/211/227/378
0.01/148/215/250/350
0.05/141/193/248/359
0.1/153/201/239/351
0.5/122/200/256/390
1/159/200/232/354 - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Potassium hydroxide is not genotoxic based on the Ames test (with and without metabolic activation).
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