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Coupling reaction products of diazotized 2-amino-6-[(2-substitued ethyl)sulfonyl]naphthalene-1-substituted acid with 4-({4-chloro-6-[ethyl(3-{[2-(substituted oxy)ethyl]sulfonyl}phenyl)amino]-heteromonocycl-2-yl}amino)-5-hydroxynaphthalene-2,7-disubstituted acid and their sodium and potassium salts
EC number: - | CAS number: -
- 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:
- 2009-11-11 till 2010-02-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: "Kanpoan No. 287 -- Environment Protection Agency" "Eisei No. 127 -- Ministry of Health &Welfarew "Heisei 09110131 Kikyoku No. 2 -- Ministry of International Trade & Industry"
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - public name of test material : Coupling reaction on diazotized (aminonaphthalen)sulfonyl)ethanol polysulfanate with 6-chloro-N-ethyl-N-(3-(ethylsulfonyl)phenyl)-N'-naphthalen-1-yl-1,3,5-triazine polysulfonate, polyhydroxide, polyamine, sodium and potassium salts
- Substance type: textile dyestuff
- Physical state: red powder
- Analytical purity: ca. 63 % of all colored components
- Lot/batch No.: BOP 07-09
- Expiration date of the lot/batch: 2014-07-31
- Storage condition of test material: At room temperature at about 20 °C
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:
- Phenobarbital/beta-Naphthoflavone induced rat liver S9 mix
- Test concentrations with justification for top dose:
- Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
- Vehicle / solvent:
- deionised water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: without metabolic activation: sodium azide (TA1535, TA100), 4-nitro-o-phenylene-diamine (TA 1537, TA 98), methyl methane sulfonate (WP2 uvrA); with mitabolic activation: 2-aminoanthracene (all strains)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: approx 72h
NUMBER OF REPLICATIONS: 3 plates
DETERMINATION OF CYTOTOXICITY
- Method:reduction in the number of revertants (below the indication factor of 0.5) - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold 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 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 98
- Metabolic activation:
- without
- Genotoxicity:
- positive
- 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:
- without
- Genotoxicity:
- positive
- 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
- 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:
- The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without metabolic activation. No toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in the test groups with and without metabolic activation.
A biologically relevant increase in revertant colony numbers were observed following treatment with the test material in strains TA 98 and TA 100 (table 1).
The number of colonies in strain TA 98 exceeded the threshold of twice the number of the corresponding solvent control at concentrations 1000 µg/plate and above in the absence of metabolic activation and at 5000 µg/plate in the presence of metabolic activation.
In strain TA 100, the number of colonies exceeded the threshold of twice the number of the corresponding solvent control at concentrations 1000 µg/plate and above in the absence of metabolic activation.
A slight and dose dependent increase in the number of revertants was also detected at 5000 µg/plate in strain TA 1537 in the absence of metabolic activation and in strain TA 100 with metabolic activation but the threshold was not quite reached.
With metabolic activation, the number of colonies did not quite reach the lower limit of our historical control data (table 2) in strain TA 1537 (solvent control). Since this deviation is rather small, this effect is judged to be based upon statistical fluctuations and has no detrimental impact on the outcome of the study.
Appropriate reference mutagens were used as positive controls. They showed a distinct increase of induced revertant colonies. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Summary of results
Metabolic activation |
Test group |
Dose level [µg/plate] |
Revertant colony counts (mean ± SD) |
||||
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2uvrA |
|||
without |
water |
|
12±5 |
8±2 |
30±4 |
122±12 |
65±12 |
untreated |
|
15±2 |
7±3 |
25±4 |
141±3 |
57±8 |
|
test material |
3 |
12±3 |
10±5 |
23±1 |
122±18 |
56±4 |
|
10 |
15±3 |
11±3 |
30±4 |
136±18 |
64±12 |
||
33 |
13±1 |
12±3 |
28±4 |
145±24 |
57±1 |
||
100 |
11±3 |
10±3 |
28±2 |
151±18 |
56±1 |
||
333 |
15±4 |
8±1 |
33±5 |
197±17 |
62±10 |
||
1000 |
12±2 |
9±1 |
76±4 * |
300±7 * |
59±8 |
||
2500 |
14±2 d |
11±3 d |
112±8 d * |
411±30 d * |
79±2 d |
||
5000 |
11±2 d |
19±5 dm |
145±10 dm * |
408±18 dm * |
83±6 dm |
||
NaN3 |
10 |
1919±43 * |
|
|
2033±44 * |
|
|
4-NOPD |
10 |
|
|
234±2 * |
|
|
|
4-NOPD |
50 |
|
145±27 * |
|
|
|
|
MMS |
3.0 |
|
|
|
|
1373±35 * |
|
with |
water |
|
13±3 |
8±2 |
35±7 |
163±11 |
72±8 |
untreated |
|
21±1 |
11±2 |
40±3 |
153±6 |
67±8 |
|
test material |
3 |
15±5 |
13±2 |
33±3 |
136±13 |
52±4 |
|
10 |
19±4 |
12±4 |
41±6 |
145±12 |
64±21 |
||
33 |
15±3 |
11±2 |
36±7 |
164±23 |
66±7 |
||
100 |
17±3 |
9±5 |
39±4 |
145±12 |
75±12 |
||
333 |
18±3 |
8±1 |
32±2 |
174±22 |
69±10 |
||
1000 |
11±6 |
8±2 |
36±5 |
186±6 |
76±10 |
||
2500 |
12±2 d |
10±3 d |
54±3 d |
235±17 d |
76±7 d |
||
5000 |
12±4 d |
13±1 dm |
88±8 dm * |
303±17 dm |
81±9 dm |
||
2-AA |
2.5 |
449±18 * |
300±45 * |
2223±66 * |
2602±105 * |
|
|
2-AA |
10 |
|
|
|
|
381±184 * |
NaN3: sodium azide, 4-NOPD: 4-nitro-o-phenylene-diamine, MMS: methyl methane sulfonate
2-AA: 2-aminoanthracene,
d: densely coloured plate
m: manual count
* Value exceeds the respective threshold of twice (TA98, TA100, WP2uvrA) or thrice (TA1535, TA1537) the respective solvent control
Table 2: Laboratory’s historical control data from January 2008 until October 2008 representing approx. 600 experiments (WP2 uvrA the historical data are based on approx. 300 experiments).
Strain |
Control |
without S9 |
with S9 |
||||||
Mean |
SD |
min |
max |
Mean |
SD |
min |
max |
||
TA1535 |
solvent |
17 |
5.17 |
9 |
39 |
21 |
5.82 |
8 |
41 |
negative |
17 |
5.33 |
9 |
38 |
20 |
6.23 |
10 |
46 |
|
positive |
2024 |
315.8 |
1041 |
3138 |
294 |
140.0 |
102 |
945 |
|
TA1537 |
solvent |
13 |
3.12 |
6 |
25 |
17 |
3.90 |
9 |
35 |
negative |
13 |
3.38 |
5 |
26 |
18 |
4.05 |
8 |
31 |
|
positive |
116 |
30.52 |
68 |
407 |
204 |
69.54 |
72 |
454 |
|
TA98 |
solvent |
30 |
5.59 |
13 |
59 |
39 |
6.34 |
20 |
60 |
negative |
31 |
5.45 |
16 |
55 |
39 |
6.53 |
19 |
59 |
|
positive |
489 |
169.8 |
211 |
1694 |
1455 |
463.0 |
200 |
3553 |
|
TA100 |
solvent |
130 |
18.79 |
89 |
224 |
155 |
22.54 |
92 |
218 |
negative |
139 |
17.30 |
93 |
205 |
147 |
21.78 |
92 |
234 |
|
positive |
2160 |
342.7 |
588 |
3379 |
1839 |
621.27 |
404 |
3868 |
|
WP2uvrA |
solvent |
49 |
6.02 |
33 |
82 |
60 |
8.76 |
34 |
89 |
negative |
49 |
8.58 |
30 |
79 |
60 |
8.71 |
31 |
84 |
|
positive |
986 |
482.0 |
187 |
2367 |
414 |
158.56 |
164 |
1597 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive without metabolic activation
negative with metabolic activation
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did induce gene mutations by base pair changes and frameshifts in the genome of strains TA 98 and TA 100.
Therefore, the test material is considered to be mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay. - Executive summary:
This study was performed to investigate the potential of the test material to induce gene mutations in the plate incorporation test using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and the Escherichia coli strain WP2 uvrA according to OECD Guideline 471 and EC method B13/14.
The assay was performed with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations: 3, 10, 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.
No toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in the test groups with and without metabolic activation.
A biologically relevant increase in revertant colony numbers were observed following treatment with the test material in strains TA 98 and TA 100. The number of colonies in strain TA 98 exceeded the threshold of twice the number of the corresponding solvent
control at concentrations 1000 µg/plate and above in the absence of metabolic activation and at 5000 µg/plate in the presence of metabolic activation. The number of colonies in strain TA 100 exceeded the threshold of twice the number of the corresponding solvent control at concentrations 1000 µg/plate and above in the absence of metabolic activation. A slight and dose dependent increase in the number of revertants was also detected at 5000 µg/plate in strain TA 1537 in the absence of metabolic activation and in strain TA 100
with metabolic activation but the threshold was not quite reached.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did induce gene mutations by base pair changes and frameshifts in the genome of strains TA 98 and TA 100.
Therefore, the test material is considered to be mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
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