Registration Dossier

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:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): PQ-126
- Molecular weight (if other than submission substance): 710.33
- Substance type: toner additive; charge control agent
- Physical state: solid
- Analytical purity: 99.6%
- Impurities (identity and concentrations): unknown
- Lot/batch No.: SP-015

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


DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
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-phenyl-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-phenyl-5-pyrazolate]Ferrate is not mutagenic forward to bacteria.