Registration Dossier
Registration Dossier
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EC number: 432-690-8 | CAS number: -
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:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study using standard method
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Details on test material:
- yellow powder
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbitone / ß-napthoquinone induced, rat-liver S9.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 50 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 50 ... 5000 µg/plate - Vehicle / solvent:
- Sterile distilled water.
- Details on test system and experimental conditions:
- Positive control sunbstances:
without activation: N-Ethyl-N'nitro-N-nitrosoguanidine (TA100, TA 1535, E.coli); 9-Aminoacridine (TA 1537); 4-Nitroquinolin-1-oxide (TA98)
with activation: 2-Aminoantharcene; Benzopyrene - Evaluation criteria:
- - all cultures show the strain specific number of spontaneous mutations in vehicle & untreated controls
- at least 2-fold increase of revertants in positive controls
- at least 4 non-toxic dose levels
- the testmaterial has induced a reproducible, dose-related and statistically significant increase in revertant count in at least 1 strain of bacteria
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: TA 100 & E.coli in co-culture
- Metabolic activation:
- with and without
- Genotoxicity:
- other: preliminary toxicity assay
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- (0,15- 5000 µg/plate)
- Vehicle controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Concentrations tested with & without S9-mix: 0-50-150-500-1500-5000 µg/plate
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 for toxicity
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
The substance did not show a mutagenic potential with and without metabolic activation in the Ames test in S. typhimurium and E. coli.
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