Registration Dossier
Registration Dossier
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EC number: 485-120-5 | 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:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
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:
- Name of test material (as cited in study report): PQ-159
- Molecular weight (if other than submission substance): 848.11
- Substance type: toner additive; charge control agent
- Physical state: solid
- Analytical purity: 98.5%
- Impurities (identity and concentrations): unknown
- Lot/batch No.: FCI-148
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Additional strain: E. coli WP2 uvrA
- Type and identity of media: Nutrient broth (OXOID LIMITED; lot# 349916)/Na-phosphate buffer (pH 7.4)
- Properly maintained: yes - Additional strain / cell type characteristics:
- not applicable
- 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 5000µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: most suitable dispersion medium for test item
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
- Statistics:
- None
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:
- cytotoxicity
- Additional information on results:
- None
Any other information on results incl. tables
Neither an increase in the number of revertant colonies (more than twice as many as that of the negative control) nor a dose-related response was observed at any doses in any strains (of base-pair substitution type or frame-shift type; with or without metabolic activation)
Applicant's summary and conclusion
- Conclusions:
- Mutagenic potential of Bis[4-(5-chloro-2-hydroxyphenylazo)-3-methyl-1-(3,4-dichlorophenyl)-5-pyrazolate]Ferrate, hydrogen was assessed with S. typhimurium TA100, TA1535, TA98, TA1537 and E. coli WP2 uvrA. Neither an increase in the number of revertant colonies more than twice in comparison with that of the negative control nor a dose-related response was observed in any strains of base-pair substitution type or frame-shift type, with or without metabolic activation. Bis[4-(5-chloro-2-hydroxyphenylazo)-3-methyl-1-(3,4-dichlorophenyl)-5-pyrazolate]Ferrate is not mutagenic forward to bacteria.
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