Registration Dossier
Registration Dossier
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EC number: 254-100-6 | CAS number: 38720-66-0
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:
- From 3 SEP 2003 to 25 SEP 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 471)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione
- EC Number:
- 254-100-6
- EC Name:
- Dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione
- Cas Number:
- 38720-66-0
- Molecular formula:
- C20H10Cl2N2O2
- IUPAC Name:
- 1,8-dichloro-5,7,12,14-tetrahydro-5,12-diazapentacene-7,14-dione; 1,9-dichloro-5,7,12,14-tetrahydro-5,12-diazapentacene-7,14-dione; 2,9-dichloro-5,7,12,14-tetrahydro-5,12-diazapentacene-7,14-dione
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- induced rat liver S9 (Aroclor 1254 used for induction)
- Test concentrations with justification for top dose:
- 50, 160, 500, 1600 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle used: DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium-azide (TA 100, TA 1535); 9-aminoacridine (TA1537); 2-nitrofluorene (TA 98); 4-nitroquinoline-N-oxide (WP2uvrA)
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (all strains)
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
plate incorporation and preincubation, each with and without metabolic activation
DURATION
- Preincubation period: 20 to 30 minutes at 30 °C
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 3 plates per strain and dose level, including controls - Evaluation criteria:
- A test compound is classified as mutagenic if it has either of the following effects:
- it produces at least a 2-fold increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control at complete bacterial background lawn
- it induces a dose-related increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control in at least two to three concentrations of the test compound at complete bacterial background lawn
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:
- no 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: visible at concentrations of 500 µg/plate and above
COMPARISON WITH HISTORICAL CONTROL DATA:
- control plates without mutagen resulted within the historical range of revertant colonies with most strains
- positive control plates showed expected increase of revertant colonies
-TA 98: in the preincubation test (without metabolic activation) the number of revertant colonies of the solvent controls was slightly below historical control data range
- WP2uvrA: in the preincubation test (with metabolic activation) the number of revertant colonies of the solvent controls was slightly above historical control data range
- WP2uvrA: in the preincubation test (without metabolic activation) the mean revertant colonies of the positive control was slightly above historical control data range - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The test item (C. I. Pigment Red 209) showed no mutagenic activity in both experiments (plate incorporation assay, preincubation assay) each with and without metabolic activation.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
The test item (C. I. Pigment Red 209) did not exert mutagenic activity in the reverse bacterial mutation assay (plate incorporation assay and preincubation assay) with and without metabolic activation. - Executive summary:
Mutagenic activity of the test item (C. I. Pigment Red 209) was investigated in Salmonella typhimurium strains TA 1535, TA 1537, TA98, TA100 and Escherichia coli strain WP2uvrA with (induced rat liver S9 mix) and without metabolic activation at concentrations of 50, 160, 500, 1600, and 5000 µg/plate using the plate incorporation assay as well as an independently performed preincubation assay.
The test item did not reveal any mutagenic activity under the conditions tested. The appropriate reference mutagenes showed distinct positive mutagenic effects.
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