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EC number: 228-788-3 | CAS number: 6358-87-8
- 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
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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 23 MAY 2005 to 9 JUN 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 471 with Prival modification for Azo Dyes), GLP compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Diethyl 4,4'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4,5-dihydro-5-oxo-1-phenyl-1H-pyrazole-3-carboxylate]
- EC Number:
- 228-788-3
- EC Name:
- Diethyl 4,4'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4,5-dihydro-5-oxo-1-phenyl-1H-pyrazole-3-carboxylate]
- Cas Number:
- 6358-87-8
- Molecular formula:
- C36H28Cl2N8O6
- IUPAC Name:
- diethyl 4,4'-[(3,3'-dichlorobiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis(5-oxo-1-phenyl-4,5-dihydro-1H-pyrazole-3-carboxylate)
- Test material form:
- solid: nanoform
Constituent 1
Method
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 from Phenobarbital/beta-Naphthoflavone induced Wistar rats and uninduced hamster liver S9
- Test concentrations with justification for top dose:
- Pre-Experiment/Experiment 1: 0, 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate
Experiment 2: 0, 33, 100, 333, 1000, 2500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: 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:
- sodium azide
- Remarks:
- TA 1535 and TA100 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-o-phenylene-diamine
- Remarks:
- TA1537 and TA98 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2 uvrA 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
- Remarks:
- all strains with metabolic activation by rat liver S9 and TA 1535, TA1537, TA 100 and WP2 uvrA with metabolic activation by hamster liver S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- congo red
- Remarks:
- TA98 with metabolic activation by hamster liver S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: experiment 1: plate incorporation assay without and with rat liver S9; experiment 2: pre-incubation assay without and with hamster liver S9 (Prival modification)
DURATION
- Preincubation period: 30 min at 30 °C (only experiment 2)
- Exposure duration: at least 48 h at 37 °C
NUMBER OF REPLICATIONS: 3 plates per concentration
DETERMINATION OF CYTOTOXICITY
- Method: other: reductions of spontaneous revertants or cleaning of background lawn - Evaluation criteria:
- The Salmonella typhimurium and Escherichia coli reverse mutation assay is considered
acceptable if it meets the following criteria:
- regular background growth in the negative and solvent control
- the spontaneous reversion rates in the negative and solvent control are in the range of our historical data
- the positive control substances should produce a significant increase in mutant colony frequencies
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:
- not required
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100, E. coli WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- other: S. Typhimurium TA 1535, TA 1537, TA 100, Escherichia coli WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- not valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Precipitation experiment 1: >= 2500 µg/plate without metabolic activation; >=333 µg/plate with metabolic activation
Precipitation experiment 2: no precipitation observed
No toxic effects, evident as a reduction in the number of revertants, were observed with and without metabolic activation in all strains in experiment 1 and 2. - Remarks on result:
- other: other: Experiment 1, rat liver S9 mix
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
|
|
Test Group |
Dose Level (µg/plate) |
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
Without |
DMSO |
|
23 ± 2 |
15 ± 2 |
30 ± 10 |
137 ± 14 |
59 ± 17 |
Activation |
Untreated |
|
18 ± 7 |
9 ± 4 |
35 ± 8 |
158 ± 31 |
59 ± 13 |
|
Test Item |
3 |
23 ± 6 |
16 ± 5 |
32 ± 6 |
138 ± 27 |
59 ± 8 |
|
|
10 |
17 ± 5 |
15 ± 3 |
32 ± 3 |
152 ± 6 |
60 ± 3 |
|
|
33 |
17 ± 2 |
15 ± 8 |
31 ± 4 |
138 ± 8 |
60 ± 5 |
|
|
100 |
19 ± 6D |
15 ± 1D |
31 ± 9D |
142 ± 10D |
64 ± 7D |
|
|
333 |
18 ± 5D |
15 ± 1D |
27 ± 4D |
148 ± 10D |
69 ± 9D |
|
|
1000 |
18 ± 4D |
11 ± 5D |
29 ± 1D |
131 ± 14D |
59 ± 5D |
|
|
2500 |
20 ± 1D M P |
10 ± 2D M P |
27 ± 5DMP |
133 ± 21D M P |
69 ± 4D M P |
|
|
5000 |
15 ± 3D M P |
9 ± 2DMP |
38 ± 4DMP |
109 ± 12D M P |
60 ± 6D M P |
|
NaN3 |
10 |
1493 ± 44 |
|
|
2232 ± 91 |
|
|
4-NOPD |
10 |
|
|
322 ± 15 |
|
|
|
4-NOPD |
50 |
|
100 ± 7 |
|
|
|
|
MMS |
4.0 µL |
|
|
|
|
1658 ± 27 |
With |
DMSO |
|
26 ± 2 |
19 ± 4 |
35 ± 5 |
184 ± 18 |
63 ± 10 |
Activation |
Untreated |
|
31 ± 6 |
18 ± 4 |
40 ± 6 |
194 ± 12 |
62 ± 10 |
|
Test Item |
3 |
19 ± 3 |
23 ± 5 |
42 ± 9 |
174 ± 6 |
72 ± 13 |
|
|
10 |
27 ± 12 |
23 ± 10 |
42 ± 7 |
179 ± 2 |
68 ± 6 |
|
|
33 |
28 ± 7 |
21 ± 1 |
36 ± 7 |
169 ± 8 |
77 ± 11 |
|
|
100 |
24 ± 4D |
23 ± 6D |
47 ± 6D |
184 ± 13D |
69 ± 4D |
|
|
333 |
20 ± 3D P |
19 ± 6D P |
34 ± 8D P |
160 ± 20D P |
69 ± 6D P |
|
|
1000 |
26 ± 6D P |
14 ± 1D P |
47 ± 12D P |
169 ± 13D P |
65 ± 5D P |
|
|
2500 |
20 ± 1D M P |
10 ± 2D M P |
43 ± 4DMP |
113 ± 11D M P |
64 ± 5D M P |
|
|
5000 |
16 ± 3D M P |
11 ± 3D M P |
38 ± 3DMP |
104 ± 9D M P |
42 ± 4D M P |
|
2-AA |
2.5 |
321 ± 12 |
368 ± 139 |
3228 ± |
4189 ± 67 |
|
|
2-AA |
10.0 |
|
|
|
|
344 ± 13 |
NaN3 |
sodium azide |
|
D |
Densely coloured plate |
|
||
2-AA |
2-aminoanthracene |
|
M |
Manual count |
|
||
4-NOPD |
4-nitro-o-phenylene-diamine |
|
P |
Precipitate |
|
||
MMS |
methyl methane sulfonate |
|
|
|
|
|
Experiment II (Pre-Incubation)
|
Test Group |
Dose Level (µg/plate) |
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
Without |
DMSO |
|
16 ± 5 |
14 ± 4 |
30 ± 7 |
141 ± 10 |
62 ± 8 |
Activation |
Untreated |
|
14 ± 1 |
13 ± 8 |
31 ± 4 |
169 ± 7 |
49 ± 8 |
|
Test item |
33 |
18 ± 4 |
11 ± 4 |
34 ± 7 |
134 ± 10 |
53 ± 5 |
|
|
100 |
14 ± 3 |
11 ± 3 |
25 ± 10 |
154 ± 6 |
52 ± 5 |
|
|
333 |
11 ± 3 |
12 ± 4 |
27 ± 1 |
149 ± 15 |
51 ± 6 |
|
|
1000 |
10 ± 3D |
8±1D |
27 ± 7D |
138 ± 9D |
51 ± 20D |
|
|
2500 |
11 ± 3D |
11 ± 1D |
25 ± 3D |
130 ± 10D |
41 ± 13D |
|
|
5000 |
11 ± 3D M |
6±2DM |
30 ± 4D M |
115 ± 7D M |
47 ± 6D M |
|
NaN3 |
10 |
1314 ± 98 |
|
|
2072 ± 27 |
|
|
4-NOPD |
10 |
|
|
595 ± 19 |
|
|
|
4-NOPD |
50 |
|
102 ± 14 |
|
|
|
|
MMS |
4.0 µL |
|
|
|
|
696 ± 139 |
With |
DMSO |
|
12 ± 2M |
12 ± 2M |
26 ± 3M |
113 ± 6M |
37 ± 2M |
Activation |
Untreated |
|
16 ± 5 |
19 ± 0 |
33 ± 7 |
142 ± 17 |
34 ± 5 |
|
Test item |
33 |
18 ± 3M |
14 ± 1M |
59 ± 10M |
119 ± 5M |
32 ± 3M |
|
|
100 |
15 ± 6M |
16 ± 4M |
133 ± 20M |
140 ± 5M |
31 ± 6M |
|
|
333 |
20 ± 1M |
15 ± 5M |
191 ± 10M |
147 ± 3M |
40 ± 4M |
|
|
1000 |
20 ± 2M D |
19 ± 3M D |
515 ± 73M D |
149 ± 15M D |
30 ± 5M D |
|
|
2500 |
13 ± 6M D |
16 ± 2M D |
639 ± 39M D |
171 ± 16M D |
38 ± 7M D |
|
|
5000 |
9±4MD |
9±5MD |
756 ± 32M D |
152 ± 12M D |
32 ± 6M D |
|
2-AA |
2.5 |
299 ± 19M |
50 ± 6M |
|
296 ± 162M |
|
|
2-AA |
10.0 |
|
|
|
|
400 ± 14 |
|
Congored |
500 |
|
|
1065 ± 35M |
|
|
NaN3 |
sodium azide |
|
D |
Densely coloured plate |
|
||
2-AA |
2-aminoanthracene |
|
M |
Manual count |
|
||
4-NOPD |
4-nitro-o-phenylene-diamine |
|
|
|
|
|
|
MMS |
methyl methane sulfonate |
|
|
|
|
|
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation in S. typhimurium TA98 (with Prival modification)
negative without metabolic activation in S. typhimurium TA98 (with Prival modification)
negative with metabolic activation in S. typhimurium TA 1535, TA 1537, TA 100, E. coli WP2 uvrA (with Prival modification)
negative without metabolic activation in S. typhimurium TA 1535, TA 1537, TA 100, E. coli WP2 uvrA (with Prival modification)
negative with and without metabolic activation in in S. typhimurium TA 1535, TA 1537, TA 100, TA 98 and E. coli WP2 uvrA (plate incorporation assay)
The test item induced gene mutations by frameshifts in the genome of the strain TA 98 in the presence of but not in the absence of metabolic activation in the pre-incubation assay (with Prival modification). The test item was not mutagenic in all other strains tested in the pre-incorporation assay nor in all strains tested in the plate-incorporation assay with and without metabolic activation. - Executive summary:
This study was performed to investigate the potential of the test item to induce gene mutations according to the plate incorporation assay without and with rat liver S9 (experiment I) and the pre-incubation test without and with hamster liver S9 (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA.
The assay was performed in two independent experiments with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations: Pre-Experiment/Experiment I: 0, 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate; Experiment II: 0, 33, 100, 333, 1000, 2500, and 5000 µg/plate
The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without metabolic activation in both experiments.Precipitation was observed in experiment I at concentrations >= 2500 µg/plate without metabolic activation and at concentrations >= 333 µg/plate with metabolic activation. No precipitation was observed in experiment II,
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with the test item at any dose level, neither in the presence nor absence of metabolic activation in experiment I (plate incorporation assay; all strains). The test item induced gene mutations by frameshifts in the genome of the strain TA 98 in the presence of but not in the absence of metabolic activation in experiment II. The test item was not mutagenic in all other strains tested in the pre-incubation assay with and without metabolic activation. Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
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