Registration Dossier
Registration Dossier
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EC number: 432-240-0 | CAS number: 12056-51-8
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
- Study period:
- no data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- The study was performed according to a valid guideline without any deviations and was conducted under GLP conditions. Furthermore, the data were submitted by another legal entity, under Directive 67/548/EEC, at least 12 years previously. The registrant has been granted permission to use the information, which has been extracted from the ECHA databases, for REACH registration purposes. No full information related to the experimental result are available but these deficiencies do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V (Ames test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 432-240-0
- EC Name:
- -
- Cas Number:
- 12056-51-8
- Molecular formula:
- K2Ti6O13
- IUPAC Name:
- hydrate potassium hydride titanium
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
- Specific details on test material used for the study:
- no data
Method
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium: TA1535, TA1537, TA98 and TA100. Escherichia coli WP2uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced, rat-liver S9.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 50 ... 5000 microg/plate
Concentration range in the ma in test (without metabolic activation): 50 ... 5000 microg/plate - Vehicle / solvent:
- Sterile distilled water
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 5000 microg/plate
- Rationale for test conditions:
- no data
- Evaluation criteria:
- no data
- Statistics:
- no data
Results and discussion
Test resultsopen allclose all
- Species / strain:
- bacteria, other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >5000 micro g/plate
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- bacteria, other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >5000 micro g/plate
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- bacteria, other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >5000 micro g/plate
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- Observations:
Solvent control plates gave counts of revertant colonies within the normal range.
All positive control chemicals gave increases in revertants, either with or without the metabolising system as appropriate, within expected ranges.
No statistically significant increase in the numbers of revertant colonies was recorded for any of the bacterial strains with any dose of the substance, either with or without metabolic activation. - Remarks on result:
- other: other: preliminary test
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
no data
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
negative with metabolic activation - Executive summary:
The genotoxicity of the test material was investigated in a study which was conducted under GLP conditions and following the Ames test method.
Four strains of S. typhimuriumand one strain of E. coliwere treated with and without metabolic activation. Under the test conditions, no evidence of mutagenic activity in the bacterial system was observed.
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