Registration Dossier
Registration Dossier
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EC number: 807-821-0 | 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:
- 27 January to 10 February 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed in accordance with OECD guidelines in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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
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:
- S9
- Test concentrations with justification for top dose:
- 1.2, 4.9, 20, 78, 313, 1250 and 5000 µg/plate
- Vehicle / solvent:
- water.Based on the information from the sponsor that the test substance was soluble at 150000 mg/L in water. Therefore water for injection was used as the solvent for the test substance.
Controls
- Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- benzo(a)pyrene
- furylfuramide
- other: 2-Methoxy-6-chloro-9-[3-(2-chloroethyl)aminopropylamino]acridine·2HC1
Results and discussion
Test results
- 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
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):negativeUnder the conditions of the test the substance is not mutagenic.
- Executive summary:
Mutagenicity potential of BK-659 was assessed with Salmonella typhimurium TA100, TA1535, TA98,TA1537and Escherichia coli WP2uvrA according to the OECD 471 test guideline compliant with GLP..
The substance did not induce an increase in the number of revertant colonies more than twice in comparison with that of the negative control nor was a dose-related response observed in any strains of base-pair substitution type or frame-shift type, with or without metabolic activation.
Under the conditions of the test the substance is not mutagenic.
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