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EC number: 235-426-8 | CAS number: 12225-08-0
- 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
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guidelline study (OECD TG 471), performed under GLP
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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxy-4-[[2,5-dimethoxy-4-[(methylamino)sulphonyl]phenyl]azo]naphthalene-2-carboxamide
- EC Number:
- 235-426-8
- EC Name:
- N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxy-4-[[2,5-dimethoxy-4-[(methylamino)sulphonyl]phenyl]azo]naphthalene-2-carboxamide
- Cas Number:
- 12225-08-0
- Molecular formula:
- C27H24N6O7S
- IUPAC Name:
- 4-{[2,5-dimethoxy-4-(methylsulfamoyl)phenyl]diazenyl}-3-hydroxy-N-(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)-2-naphthamide
- Test material form:
- solid: nanoform, no surface treatment
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100, and Escherichia coli WP2 uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9 (induced with phenobarbital/beta-naphtoflavone; experiment I); hamster liver S9 (non-induced; experiment II)
- Test concentrations with justification for top dose:
- Pre-experiment/Experiment I and II: 3, 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The solvent was chosen because of its solubility properties and its relative non-toxicity to the bacteria.
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 1535 and TA 100), 4-Nitro-o-phenylene-diamine (TA 1537 and TA 98), methyl methane sulfonate (WP2 uvrA)
- 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 (for all strains)
- Remarks:
- with metabolic activation (rat liver S9)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (TA 1535, TA 100, TA 1537, WP2 uvrA), congo red (TA 98)
- Remarks:
- with metabolic activation (hamster liver S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar,
Experiment I: plate incorporation; with and without metabolic activation (induced rat liver S9-mix)
Experiment II: preincubation; with and without metabolic activation (uninduced hamster liver S9-mix)
DURATION
- Preincubation period (expeiment II): 30 minutes
- Exposure duration: at least 48 hours
NUMBER OF REPLICATIONS: 3 plates
DETERMINATION OF CYTOTOXICITY
A reduction in the number of spontaneous revertants (below the induction factor of 0.5) or a clearing of the bacterial background lawn.
- Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
Results and discussion
Test results
- Key result
- Species / strain:
- other: TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- minor effects: experiment I: TA 98 at 5000 µg/plate with S9 mix; experiment II: TA 1535 from 1000 - 5000 µg/plate and WP2 uvrA at 5000 µg/plate with S9 mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation:
The test item precipitated in the overlay agar in the test tubes from 1000 to 5000 µg/plate. Precipitation of the test item in the overlay agar on the incubated agar plates was observed from 333 to 5000 µg/plate with and without S9 mix in experiment I and with S9 mix in experiment II, and from 1000 - 5000 µg/plate without S9 mix in experiment II . The undissolved particles had no influence on the data recording.
COMPARISON WITH HISTORICAL CONTROL DATA: performed
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Minor toxic effects, evident as a reduction in the number of revertants, were observed in strain TA 98 at 5000 µg/plate with S9 mix in experiment I. In experiment II, minor toxic effects were observed in strain TA 1535 from 1000 - 5000 µg/plate and in strain WP2 uvrA at 5000 µg/plate with S9 mix.
Any other information on results incl. tables
Pre -Experiment and Experiment I:
Study Name: 1485302 |
Study Code: Harlan CCR1485302 |
Experiment: 1485302 VV Plate |
Date Plated: 13/06/2012 |
Assay Conditions: |
Date Counted: 19/06/2012 |
Metabolic Activation |
Test Group |
Dose Level (per plate) |
|
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
||||||
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|
|
|
|
|
|
|
|
|
|
Without Activation |
DMSO |
|
|
17 ± 4 |
18 ± 3 |
25 ± 5 |
128 ± 3 |
49 ± 12 |
Untreated |
|
|
16 ± 8 |
20 ± 1 |
30 ± 3 |
142 ± 8 |
52 ± 8 |
|
test item |
3 µg |
|
15 ± 5 |
18 ± 4 |
22 ± 3 |
118 ± 4 |
56 ± 5 |
|
10 µg |
|
14 ± 1 |
19 ± 2 |
25 ± 2 |
144 ± 5 |
45 ± 11 |
||
33 µg |
|
20 ± 3 |
18 ± 1 |
22 ± 3 |
137 ± 6 |
45 ± 7 |
||
|
100 µg |
|
17 ± 4 |
20 ± 3 |
24 ± 4 |
123 ± 10 |
51 ± 8 |
|
|
333 µg |
|
15 ± 4P |
15 ± 1P |
28 ± 6P |
116 ± 3P |
42 ± 2P |
|
|
1000 µg |
|
14 ± 1P |
13 ± 1P |
21 ± 6P |
102 ± 14P |
46 ± 9P |
|
|
2500 µg |
|
13 ± 2P M |
12 ± 3P M |
18 ± 2P M |
103 ± 11P M |
51 ± 4P M |
|
|
5000 µg |
|
11 ± 3P M |
9 ± 2P M |
14 ± 3P M |
87 ± 6P M |
40 ± 9P M |
|
NaN3 |
10 µg |
|
2054 ± 71 |
|
|
2146 ± 47 |
|
|
4-NOPD |
10 µg |
|
|
|
330 ± 19 |
|
|
|
4-NOPD |
50 µg |
|
|
70 ± 2 |
|
|
|
|
MMS |
3.0 µL |
|
|
|
|
|
1196 ± 58 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
With Activation |
DMSO |
|
|
23 ± 5 |
27 ± 0 |
44 ± 12 |
159 ± 22 |
65 ± 15 |
Untreated |
|
|
19 ± 8 |
22 ± 2 |
42 ± 1 |
165 ± 11 |
64 ± 8 |
|
Test item |
3 µg |
|
24 ± 5 |
29 ± 7 |
44 ± 3 |
152 ± 16 |
64 ± 3 |
|
10 µg |
|
30 ± 4 |
22 ± 6 |
44 ± 8 |
153 ± 17 |
60 ± 3 |
||
33 µg |
|
25 ± 3 |
30 ± 4 |
46 ± 10 |
154 ± 19 |
60 ± 4 |
||
|
100 µg |
|
25 ± 5 |
27 ± 3 |
38 ± 7 |
173 ± 19 |
66 ± 5 |
|
|
333 µg |
|
23 ± 3P |
28 ± 3P |
41 ± 9P |
154 ± 15P |
64 ± 6P |
|
|
1000 µg |
|
27 ± 6P |
24 ± 6P |
33 ± 8P |
143 ± 31P |
65 ± 14P |
|
|
2500 µg |
|
23 ± 3P M |
17 ± 3P M |
34 ± 2P M |
143 ± 9P M |
50 ± 3P M |
|
|
5000 µg |
|
15 ± 5P M |
14 ± 3P M |
20 ± 2P M |
115 ± 12P M |
48 ± 6P M |
|
2-AA |
2.5 µg |
|
336 ± 20 |
297 ± 3 |
2303 ± 97 |
2406 ± 101 |
|
|
2-AA |
10.0 µg |
|
|
|
|
|
326 ± 12 |
|
|
|
|
|
|
|
|
|
|
Key to Positive Controls |
Key to Plate Postfix Codes |
||
|
|
||
NaN3 2-AA 4-NOPD MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine methyl methane sulfonate |
P M |
Precipitate Manual count |
Experiment II:
Study Name: 1485302 |
Study Code: Harlan CCR1485302 |
Experiment: 1485302 HV2 Pre |
Date Plated: 03/07/2012 |
Assay Conditions: |
Date Counted: 06/07/2012 |
Metabolic Activation |
Test Group |
Dose Level (per plate) |
|
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
||||||
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|
|
|
|
|
|
|
|
|
|
Without Activation |
DMSO |
|
|
16 ± 2 |
25 ± 1 |
28 ± 3 |
140 ± 5 |
54 ± 8 |
Untreated |
|
|
19 ± 8 |
22 ± 7 |
31 ± 4 |
169 ± 15 |
52 ± 7 |
|
Test item |
3 µg |
|
16 ± 6 |
23 ± 4 |
31 ± 6 |
141 ± 12 |
54 ± 6 |
|
10 µg |
|
18 ± 7 |
25 ± 4 |
31 ± 2 |
145 ± 9 |
57 ± 4 |
||
33 µg |
|
16 ± 1 |
27 ± 11 |
24 ± 2 |
144 ± 13 |
58 ± 7 |
||
|
100 µg |
|
12 ± 3 |
27 ± 1 |
28 ± 3 |
133 ± 5 |
45 ± 4 |
|
|
333 µg |
|
10 ± 1 |
21 ± 1 |
25 ± 2 |
129 ± 10 |
47 ± 4 |
|
|
1000 µg |
|
9 ± 1P |
22 ± 2P |
15 ± 2P |
126 ± 4P |
50 ± 2P |
|
|
2500 µg |
|
10 ± 3P M |
20 ± 3P M |
23 ± 6P M |
127 ± 15P M |
42 ± 4P M |
|
|
5000 µg |
|
9 ± 2P M |
13 ± 4P M |
15 ± 3P M |
108 ± 6P M |
32 ± 4P M |
|
NaN3 |
10 µg |
|
1931 ± 56 |
|
|
1977 ± 45 |
|
|
4-NOPD |
10 µg |
|
|
|
271 ± 7 |
|
|
|
4-NOPD |
50 µg |
|
|
83 ± 6 |
|
|
|
|
MMS |
3 µL |
|
|
|
|
|
917 ± 25 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
With Activation |
DMSO |
|
|
25 ± 9 |
29 ± 1 |
43 ± 4 |
135 ± 26 |
73 ± 3 |
Untreated |
|
|
18 ± 3 |
31 ± 2 |
50 ± 4 |
138 ± 5 |
53 ± 9 |
|
Test item |
3 µg |
|
24 ± 5 |
31 ± 4 |
50 ± 1 |
152 ± 5 |
68 ± 14 |
|
10 µg |
|
27 ± 5 |
37 ± 8 |
54 ± 6 |
139 ± 15 |
66 ± 9 |
||
33 µg |
|
21 ± 2 |
26 ± 2 |
43 ± 1 |
138 ± 5 |
72 ± 11 |
||
|
100 µg |
|
20 ± 8 |
26 ± 2 |
44 ± 12 |
138 ± 9 |
56 ± 2 |
|
|
333 µg |
|
18 ± 2P |
35 ± 3P |
39 ± 3P |
126 ± 1P |
48 ± 3P |
|
|
1000 µg |
|
11 ± 5P M |
29 ± 2P M |
38 ± 4P M |
123 ± 6P M |
41 ± 4P M |
|
|
2500 µg |
|
10 ± 2P M |
26 ± 8P M |
23 ± 7P M |
115 ± 7P M |
34 ± 8P M |
|
|
5000 µg |
|
6 ± 2P M |
23 ± 3P M |
19 ± 4P M |
106 ± 6P M |
26 ± 4P M |
|
2-AA |
2.5 µg |
|
|
|
|
1865 ± 3 |
|
|
2-AA |
2.5 µg |
|
702 ± 14 |
154 ± 14 |
|
|
|
|
2-AA |
10 µg |
|
|
|
|
|
320 ± 80 |
|
Congo red |
500 µg |
|
|
|
1143 ± 39 |
|
|
|
|
|
|
|
|
|
|
|
|
Key to Positive Controls |
Key to Plate Postfix Codes |
||
|
|
||
NaN3 2-AA 4-NOPD Congo red MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine Congo red methyl methane sulfonate |
P M |
Precipitate Manual count |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative with and without metabolic activation
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. - Executive summary:
Mutagenic activity of the test item was investigated in Salmonella typhimurium strains TA 1535, TA 1537, TA98 and TA100 as well as Escherichia coli strain WP2 uvrA with (induced rat liver S9 mix) and without metabolic activation at concentrations of 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate using the plate incorporation assay (experiment I). Due to the test items characteristic as an azo-dye the test was also conducted using the Prival modification, i.e. testing the above mentioned bacterial strains in the preincubation assay without and with uninduced hamster liver S9 mix for metabolic activation (experiment II). This test was performed using the concentrations 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate.
Minor toxic effects, evident as a reduction in the number of revertants, were observed in strain TA 98 at 5000 µg/plate with S9 mix in experiment I. In experiment II, minor toxic effects were observed in strain TA 1535 from 1000 - 5000 µg/plate and in strain WP2 uvrA at 5000 µg/plate with S9 mix.
The test item did not reveal any mutagenic activity under the conditions tested. There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
The appropriate reference mutagenes showed distinct positive mutagenic effects.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
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