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EC number: 250-774-0 | CAS number: 31714-55-3
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 Nov 2007 - 17 Dec 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Hydrogen bis[1-[(5-chloro-2-hydroxyphenyl)azo]-2-naphtholato(2-)]chromate(1-)
- EC Number:
- 250-774-0
- EC Name:
- Hydrogen bis[1-[(5-chloro-2-hydroxyphenyl)azo]-2-naphtholato(2-)]chromate(1-)
- Cas Number:
- 31714-55-3
- Molecular formula:
- C32H19Cl2CrN4O4
- IUPAC Name:
- [1-{[5-chloro-2-(hydroxy-kappaO)phenyl]diazenyl}-2-naphtholato(2-)-kappaO]{1-[(5-chloro-2-hydroxyphenyl)diazenyl]-2-naphtholato-kappaO}chromium
- Test material form:
- solid: particulate/powder
- Details on test material:
- Appearance: Black purple powder
Storage: Room temperature in dark place
Constituent 1
Method
- Target gene:
- - S. typhimurium: Histidine gene
- E. coli: Tryptophan gene
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:
- Rat liver S9-mix induced by a combination of phenobarbital and 5,6-Benzoflavone
- Test concentrations with justification for top dose:
- Preliminary test (without and with S9)
TA1535, TA1537, TA98 TA100 and WP2uvrA : 0.305, 1.22, 4.88, 19.5, 78.1, 313, 1250 and 5000 µg/plate
Microbial growth inhibition: Microbial growth inhibition was observed at following dose levels.
Without S9 mix:
TA1535, TA100,TA1537, WP2uvrA: 78.1 µg/plate and above
TA98: 313 µg/plate and above
With S9 mix:
TA1535, TA100,TA98 WP2uvrA: 1250 µg/plate and above
TA1537: 313 µg/plate and above
Precipitation for all strains in preliminary test was observed at following dose levels.
Without S9: 313 µg/plate and above
With S9: 78.1 µg/plate and above
Main experiment 1 and 2
Without S9:
TA1535, TA100, TA1537: 2.44, 4.88, 9.77, 19.5, 39.1, 78.1, 156 and 313 µg/plate
TA98: 9.77, 19.5, 39.1, 78.1, 156, 313, 625 and 1250 µg/plate
WP2uvrA: 2.44, 4.88, 9.77, 19.5, 39.1, 78.1, 156, 313, 625 and 1250 µg/plate
With S9
TA1535, TA100: 39.1, 78.1, 156, 313, 625 and 1250 µg/plate
TA98, WP2uvrA: 39.1, 78.1, 156, 313, 625, 1250, 2500 and 5000 µg/plate
TA1537: 9.77, 19.5, 39.1, 78.1, 156, 313, 625 and 1250 µg/plate - Vehicle / solvent:
- - solvent used: DMSO
- Justification for choice of solvent:
Test compound was stable in DMSO and DMSO has been accepted and approved by authorities and international guidelines
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl) acrylamide
- Remarks:
- without S9 0.01 µg/plate in DMSO for TA100
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl) acrylamide
- Remarks:
- Without S9: 0.1 µg/plate in DMSO for TA98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Without S9: 80 µg/plate in DMSO for TA1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without S9: 2.0 µg/plate in DMSO for WP2uvrA
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9, 80 µg/plate in water for TA1535
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene in DMSO for all tester strains
- Remarks:
- with S9: TA100: 1.0 µg/plate, TA1535, TA1537: 2.0 µg/plate, TA98: 0.5 µg/plate, WP2uvrA: 10 µg/plate,
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Pre-incubation method (20 min at 37°C).
DURATION
- Exposure duration: 48 hour
NUMBER OF REPLICATIONS:
- Preliminary test: 1 plate/dose (2 plates/dose for the negative (solvent) and positive controls)
- Main experiment 1 and 2: 3 plates/dose
NUMBER OF CELLS EVALUATED:
ca. 10E8 per plate
OTHER EXAMINATIONS:
Microbial growth inhibtion was determined.
The presence of precipitation of the test compound on the plates was determined. - Evaluation criteria:
- Test substance was judged to have mutagenicity (positive) when the test substance induced a dose-dependent increase in the number of the revertant colonies (mean) to a level equal to or greater than 2-fold of the negative (solvent) control value (mean value) in any one of the tester strains with or without S9 mix, and when the dose-dependent increase was reproducible. Other results were judged to be negative. When the test substance was positive mutation activitity (number of revertant colonies/mg) was calculated.
- Statistics:
- No statistical analysis was performed with the test results in this study.
Results and discussion
Test resultsopen allclose all
- 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
- 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
Microbial growth inhibition: Microbial growth inhibition was observed at following dose levels in the preliminary screen.
Without S9 mix:
78.1 µg/plate TA1535, TA100,TA1537, WP2uvrA
313 µg/plate TA98
With S9 mix:
1250 µg/plate TA1535, TA100,TA98 WP2uvrA
313 µg/plate TA1537
Additional information on main studies (see attached illustration).
Microbial inhibition growth rates in main experiments.
Without S9
TA1535,WP2uvrA, TA100: 39.1 µg/plate and above
TA1537: 78/1 µg/plate and above
TA98: 156 µg/plate and above
with S9
TA100, TA1535: 625 µg/plate and above
WP2uvrA, TA98: 1250 µg/plate and above
TA 1537: 313 µg/plate and above
Precipitation in main experiments :
Without S9 mix: 156 µg/plate and above
With S9 mix: 78.1 µg/plate and above
Applicant's summary and conclusion
- Conclusions:
- In an AMES test, performed according to OECD guideline 471 and GLP principles, 34P was found not to be mutagenic with or without metabolic activation.
- Executive summary:
An AMES test was performed according to OECD guideline 471 and GLP principles. The strains TA1535, TA1537, TA98 TA100 and WP2uvrA were tested with the pre-incubation method and showed negative responses up to concentratios that inhibited bacterial growth, i.e. no significant dose-related increase in the number of revertants with or without metabolic activation was seen. Precipitation of the test substance was observed in dose levels above 156 µg/plate without S9 and 78.1 µg/plate with S9. The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly. Based on the results of this study it is concluded that 34P is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay with or without metabolic activation.
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