Registration Dossier
Registration Dossier
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EC number: 474-180-8 | 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
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Directive 2000/32/EC, B13/14 (Ames test).
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium: TA1535, TA1537, TA98 and TA100. E. coli: WP2uvrA-
- Metabolic activation system:
- Phenobarbitone/beta-naphthoflavone induced, rat-liver S9.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 15 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 15 ... 5000 µg/plate - Vehicle / solvent:
- Solvent: Dimethyl sulphoxide
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 5000 µg/plate
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 1500 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 1500 µg/plate)
- Additional information on results:
- Observations:
No significant increases in the frequency of revertant
colonies were recorded for any of the bacterial strains with
any dose of the substance, either with or without metabolic
activation.
The test material caused a visible reduction in the growth
of the bacterial lawn and or a significant decrease in the
frequency of revertant colonies to all Salmonella strains,
in the presence and absence of S9 initially from 1500 micro
grams per plate.
The substance was considered to be non-mutagenic under the
conditions of this test. - Remarks on result:
- other: other: preliminary test
- 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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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