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A mixture of: N,N-diethylpropane-1,3-diamine 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2,2-iminodiethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2-methylaminoethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate
EC number: 403-410-1 | CAS number: 114565-65-0 C.I. DIRECT YELLOW 166; DIRECT YELLOW 166; GIALLO DIRETTO 166; JAUNE DIRECT 166; MONOAZO YELLOW MA 2822
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted according to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1983)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- A mixture of: N,N-diethylpropane-1,3-diamine 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2,2-iminodiethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2-methylaminoethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate
- EC Number:
- 403-410-1
- EC Name:
- A mixture of: N,N-diethylpropane-1,3-diamine 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2,2-iminodiethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2-methylaminoethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate
- Cas Number:
- 114565-65-0
- Molecular formula:
- C18 H16 N8 O3 S2 . x C7 H18 N2 . x C4 H11 N O2 . x C3 H9 N O
- IUPAC Name:
- (3-aminopropyl)diethylamine; 2-(methylamino)ethan-1-ol; 2-[(2-hydroxyethyl)amino]ethan-1-ol; 6-methyl-2-{4-[2-(2,4,6-triaminopyrimidin-5-yl)diazen-1-yl]phenyl}-1,3-benzothiazole-7-sulfonic acid
- Details on test material:
- - Name of test material (as cited in study report): FAT 11´184/B
- Physical state: solid
- Analytical purity: 89.6%
- Lot/batch No.: Op. 1 BD 823/8
- Expiration date of the lot/batch: January, 1993
- Stability under test conditions: >8 h in water, ethanol, acetone, DMSO and DMF
Constituent 1
Method
- Target gene:
- All Salmonella Typhimurium strains are histidine auxotrophic mutants.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: TA 1537: his C 3076, rfa-, uvrB-; TA 98: his D 3052, rfa-, uvrB-, R-factor; TA 1535: his G 46, rfa-, uvrB-; TA 100: his G 46, rfa-, uvrB-, R-factor
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- other: TA 1538: his D 3052, rfa-, uvrB-
- Metabolic activation:
- with and without
- Metabolic activation system:
- Mixture of co-factors with S9 fraction of liver from Wistar rats induced with Aroclor 1254.
- Test concentrations with justification for top dose:
- A preliminary toxicity test was carried out with concentrations of 1, 3.3, 10, 33.3, 100, 333.3, 1000, and 5000 µg/plate with strains TA 98 and TA 100. Since no effects on background growth were seen, the top dose level was chosen as highest concentration in the main experiments:
Experiment I: 10, 33.3, 100, 333.3, 1000, 5000 µg/plate
Experiment II: 10, 100, 333.3, 1000, 3333.3, 5000 µg/plate
Results of the preliminary test were reported as part of the main experiment I. - Vehicle / solvent:
- DMSO; The solvent was chosen because of its solubility properties and its relative non-toxicity to the bacteria.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- concurrent untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see below
- Positive controls:
- yes
- Remarks:
- without S9-mix
- Positive control substance:
- sodium azide
- Remarks:
- TA1535, TA 100
Migrated to IUCLID6: 10 µg/plate
- Positive controls:
- yes
- Remarks:
- without S9-mix
- Positive control substance:
- other: 50 µg/plate 4-nitro-o-phenylene-diamine
- Remarks:
- TA 1537, TA 1538, TA 98
- Positive controls:
- yes
- Remarks:
- with S9-mix
- Positive control substance:
- other: 10 µg/plate 2-aminoanthracene
- Remarks:
- TA 1535, TA 1537, TA 1538, TA 98, TA 100
- Details on test system and experimental conditions:
- METHOD OF APPLICATION (plate incorporation test)
In each experiment 0.1 ml of the test substance or the vehicle, 0.1 ml of a bacterial culture (in nutrient broth), 0.5 ml S9-mix (with metabolic activation) or S9-mix substitution buffer (without metabolic activation) in 2.0 ml of overlay agar were mixed together. In the pre-incubation assay soft agar was added after an incubation period of 1 h at 37 °C. The plates were incubated for 72 hours at 37 °C in darkness. Each concentration and the controls were tested in triplicate.
DETERMINATION OF CYTOTOXICITY
Toxicity was assessed as clearing of the bacterial background lawn and/or as reduction of spontaneous revertants. - Evaluation criteria:
- The test article was considered as positive if either a significant dose-response relationship in the increased number of revertants or a significant and reproducible increase for at least one test concentration was induced.
A test article was considered as mutagen if the number of revertants was at least twice as high in strain TA 100 and at least three times as high as the spontaneous reversion rate in strains TA 1535, TA 1537, TA 1538, and TA 98.
A dose-dependent increase in the number of revertants was regarded as an indication of possibly existing mutagenic potential of the test article regardless whether the highest dose induced the above described enhancement factors or not.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- 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:
- S. typhimurium TA 1537
- 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:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- a significant and reproducible dose-dependent increase of revertants was seen.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- a significant and reproducible dose-dependent increase of revertants was seen.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- In the absence of S9-mix the number of spontaneous revertants was decreased.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- A reduction of spontaneous revertants was seen for strain TA 100 without S9-mix only. No effect on the normal background growth was seen up to 5000 µg/plate with and without S9-mix in any strain.
A significant and reproducible dose-dependent increase in revertant colony numbers was seen in the Salmonella typhimurium strain TA 1538 with and without S9-mix and TA 98 without S9 mix. - Remarks on result:
- other: strain/cell type: see above
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Revertants/plate (mean of three plates) in the Ames test with and without metabolic activation
|
Revertants/plate, without S9 mix (mean of three plates) |
|||||||||
Strain |
TA 1535 |
TA1537 |
TA 98 |
TA 100 |
TA 1538 |
|||||
Experiment |
I |
II |
I |
II |
I |
II |
I |
II |
I |
II |
Negative control |
17 |
11 |
10 |
12 |
16 |
29 |
81 |
112 |
14 |
7 |
Solvent control |
13 |
15 |
8 |
13 |
18 |
23 |
86 |
94 |
14 |
12 |
Positive control |
1054 |
578 |
195 |
173 |
1856 |
1328 |
754 |
767 |
2102 |
1664 |
10 |
13 |
10 |
12 |
7 |
17 |
27 |
88 |
88 |
14 |
9 |
33.3 |
18 |
--- |
9 |
--- |
14 |
--- |
95 |
--- |
17 |
--- |
100 |
13 |
11 |
7 |
9 |
13 |
16 |
84 |
79 |
12 |
13 |
333.3 |
15 |
9 |
8 |
11 |
13 |
22 |
90 |
74 |
16 |
13 |
1000 |
11 |
8 |
10 |
8 |
34 |
30 |
72 |
87 |
32 |
29 |
3333.3 |
--- |
8 |
--- |
8 |
--- |
41 |
--- |
88 |
--- |
50 |
5000 |
13 |
11 |
9 |
10 |
49 |
66 |
46 |
71 |
89 |
81 |
|
Revertants/plate, with S9 mix (mean of three plates) |
|||||||||
Negative control |
10 |
8 |
14 |
10 |
26 |
29 |
79 |
83 |
25 |
17 |
Solvent control |
8 |
10 |
9 |
7 |
25 |
32 |
58 |
86 |
18 |
16 |
Positive control |
296 |
240 |
373 |
354 |
2024 |
1920 |
2229 |
1548 |
1840 |
990 |
10 |
10 |
7 |
12 |
6 |
26 |
24 |
65 |
70 |
21 |
20 |
33.3 |
10 |
--- |
14 |
--- |
29 |
--- |
57 |
--- |
20 |
--- |
100 |
14 |
8 |
12 |
9 |
36 |
20 |
72 |
88 |
27 |
21 |
333.3 |
12 |
12 |
10 |
10 |
32 |
30 |
66 |
95 |
29 |
21 |
1000 |
10 |
9 |
11 |
8 |
36 |
26 |
72 |
98 |
35 |
28 |
3333.3 |
--- |
6 |
--- |
11 |
--- |
29 |
--- |
100 |
--- |
34 |
5000 |
15 |
8 |
14 |
12 |
43 |
46 |
72 |
95 |
51 |
47 |
Experiment I and II: plate incorporation method |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
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