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EC number: 221-264-5 | CAS number: 3049-71-6
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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:
- 06 Dec 2011 - 19 Dec 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Principles of method if other than guideline:
- The Prival preincubation test is a modification of the standard Ames reverse mutation assay, in which flavin mononucleotide (FMN), liver S9 mix from uninduced hamsters and a preincubation step are used to facilitate azo reduction and the detection of the resulting mutagenic aromatic amines.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,9-bis[4-(phenylazo)phenyl]anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone
- EC Number:
- 221-264-5
- EC Name:
- 2,9-bis[4-(phenylazo)phenyl]anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone
- Cas Number:
- 3049-71-6
- Molecular formula:
- C48H26N6O4
- IUPAC Name:
- 2,9-bis[4-(phenyldiazenyl)phenyl]isoquino[4',5',6':6,5,10]anthra[2,1,9-def]isoquinoline-1,3,8,10(2H,9H)-tetrone
- Details on test material:
- Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.
Constituent 1
- Specific details on test material used for the study:
- - Physical state: solid, red
- Storage condition of test material: room temperature
- Lot/batch No.:35613-116A
- Expiration date of the lot/batch: 25 Oct 2013
Method
- Target gene:
- his, trp
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat liver S-9 mix and uninduced hamster liver S-9 mix
- Test concentrations with justification for top dose:
- 33 μg - 5 000 μg/plate (SPT)
33 μg - 5 000 μg/plate (PIT) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Due to the limited solubility of the test substance in water, DMSO was used as vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: with rat S9 (SPT): 2-aminoanthracene (all strains) - with hamster S9 (PIT): 2-aminoanthracene (all strains), Congo red (TA98), benzidine (TA98)
- Remarks:
- with S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine (TA1535, TA100), 4-nitro-o-phenylendiamine (TA98), 9-aminoacridine (TA1537), 4-nitroquinoline-N-oxide (E. coli WP2 uvrA)
- Remarks:
- without S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); Prival preincubation
The Prival preincubation test is a modification of the standard Ames reverse mutation assay, in which flavin mononucleotide (FMN), liver S9 mix from uninduced hamsters and a preincubation step are used to facilitate azo reduction and the detection of the resulting mutagenic aromatic amines
DURATION
- Preincubation period: 30 min
- Exposure duration: 48 – 72 hours
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- The test chemical is considered positive in this assay if the following criteria are met:
• A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.
A test substance is generally considered non-mutagenic in this test if:
• The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in at least two experiments carried out independently of each other.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- 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:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Test substance precipitation was found from 333 μg/plate onward with and without S9 mix.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
A weak bacteriotoxic effect (slight decrease in the number of his+ revertants) was occasionally observed in the Ames standard plate test depending on the strain and test conditions from 2500 μg/plate onward. In the Prival preincubation assay weak bacteriotoxicity (slight decrease in the number of his+ or trp+ revertants) was observed depending on the strain and test conditions at 5000 μg/plate.
Any other information on results incl. tables
According to the results of the present study, the test substance did not lead to a biologically relevant increase in the number of revertant colonies either without S9 mix or after adding a metabolizing system in two experiments carried out independently of each other (Ames standard plate test and Prival preincubation assay). Besides, the results of the negative as well as the positive controls performed in parallel corroborated the validity of this study, since the values fulfilled the acceptance criteria of this study. In this study with and without S9 mix, the number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain. In addition, the positive control substances both with and without S9 mix induced a significant
increase in the number of revertant colonies within the range of the historical positive control data or above.
Results of Experiment I (Standard Plate Test with and without rat liver S-9 mix):
TA98 | TA100 | TA1535 | TA1537 | WP2 uvrA | ||||||
concentration | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 |
DMSO | 20 | 22 | 79 | 84 | 11 | 14 | 6 | 7 | 47 | 48 |
33 | 19 | 23 | 76 | 82 | 11 | 15 | 6 | 7 | 45 | 51 |
100 | 19 | 24 | 79 | 78 | 13 | 15 | 6 | 8 | 44 | 53 |
333 | 21 | 21 | 87 | 81 | 10 | 15 | 6 | 6 | 43 | 49 |
1000 | 20 | 25 | 86 | 75 | 12 | 16 | 6 | 8 | 19 | 49 |
2500 | 17 | 19 | 74 | 78 | 11 | 14 | 5 | 5 | 46 | 52 |
5000 | 20 | 16 | 73 | 70 | 14 | 14 | 4 | 5 | 47 | 47 |
MNNG | 675 | 1176 | ||||||||
2-AA | 864 | 790 | 174 | 123 | 237 | |||||
AAC | 363 | |||||||||
NOPD | 531 | |||||||||
4-NQO | 608 |
Controls:
MNNG: N-methyl-N'-nitro-N-nitrosoguanidine (5 µg/plate)
2 -AA: 2-aminoanthracene (2.5 µg/plate for TA 98, 100, 1535, 1537; 60 µg/plate for WP2 uvrA)
AAC: 9-aminoacridine (100 µg/plate)
NOPD: 4-nitro-o-phenylendiamnine (10 µg/plate)
4 -NQO: 4-nitroquinoline-N-oxide (5 µg/plate)
Results of Experiment II (Pre-incubation Test with and without hamster liver S-9 mix):
TA98 | TA100 | TA1535 | TA1537 | WP2 uvrA | ||||||
concentration | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 |
DMSO | 28 | 40 | 120 | 133 | 16 | 18 | 8 | 10 | 51 | 51 |
33 | 29 | 36 | 125 | 1217 | 16 | 17 | 8 | 11 | 45 | 52 |
100 | 26 | 38 | 113 | 130 | 16 | 16 | 8 | 13 | 49 | 46 |
333 | 26 | 31 | 123 | 130 | 18 | 20 | 8 | 9 | 50 | 46 |
1000 | 26 | 34 | 119 | 117 | 16 | 17 | 6 | 10 | 50 | 47 |
2500 | 26 | 31 | 118 | 115 | 19 | 16 | 7 | 9 | 39 | 57 |
5000 | 21 | 37 | 105 | 102 | 14 | 13 | 7 | 10 | 49 | 38 |
MNNG | 854 | 740 | ||||||||
2-AA | 852 | 1695 | 742 | 142 | 252 | |||||
AAC | 478 | |||||||||
NOPD | 708 | |||||||||
4-NQO | 235 | |||||||||
CONGOR. | 639 | |||||||||
BENZID. | 655 |
Controls:
MNNG: N-methyl-N'-nitro-N-nitrosoguanidine (5 µg/plate)
2 -AA: 2-aminoanthracene (10 µg/plate)
AAC: 9-aminoacridine (100 µg/plate)
NOPD: 4-nitro-o-phenylendiamnine (10 µg/plate)
4 -NQO: 4-nitroquinoline-N-oxide (5 µg/plate)
CONGOR: Congo red (0.3 µmol/plate)
benzid: benizidine (0.3 µmol/plate)
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions chosen here, it is concluded that the test article is not a mutagenic substance in the bacterial reverse mutation test (Ames standard plate test and Prival preincubation assay) in the absence and the presence of metabolic activation.
- Executive summary:
The test substance was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of Salmonella typhimurium strains TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA in a reverse mutation assay (Ames standard plate test and Prival preincubation test). The Prival preincubation test is a modification of the standard Ames reverse mutation assay, in which flavin mononucleotide (FMN), liver S9 mix from uninduced hamsters and a preincubation step are used to facilitate azo reduction and the detection of the resulting mutagenic aromatic amines .This test is therefore the most appropriate method for the investigation of azo-dyes and diazo compounds such as the test compound. Both assays were performed in the presence and absence of a metabolic activation system at a concentration range of 33 – 5000 µg/plate. Precipitation of the test substance was found from a concentration of 333 μg/plate onward with and without S9 mix. A weak bacteriotoxic effect (slight decrease in the number of his+ revertants) was occasionally observed in the Ames standard plate test depending on the strain and test conditions from 2500 μg/plate onward. In the Prival preincubation assay weak bacteriotoxicity (slight decrease in the number of his+ or trp+ revertants) was observed depending on the strain and test conditions at 5000 μg/plate. According to the results of the present study, the test substance did not lead to a biologically relevant increase in the number of revertant colonies either without S9 mix or after adding a metabolizing system in two experiments carried out independently of each other (Ames standard plate test and Prival preincubation assay). Besides, the results of the negative as well as the positive controls performed in parallel corroborated the validity of this study, since the values fulfilled the acceptance criteria of this study. In this study with and without S9 mix, the number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain. In addition, the positive control substances both with and without S9 mix induced a significant increase in the number of revertant colonies within the range of the historical positive control data or above. Thus, under the experimental conditions of this study, the test substance is not mutagenic in the Ames standard plate test and in the Prival preincubation test in the absence and the presence of metabolic activation.
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