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Reaction mass of pentasodium 2-{[4-chloro-6-(ethyl{3-[(2-sulfonatoethyl)sulfonyl]phenyl}amino)-1,3,5-triazin-2-yl]amino}-5-hydroxy-6-({2-sulfonato-4-[(4-sulfonatophenyl)diazenyl]phenyl}diazenyl)naphthalene-1,7-disulfonate and tetrasodium 2-[(4-chloro-6-{ethyl[3-(vinylsulfonyl)phenyl]amino}-1,3,5-triazin-2-yl)amino]-5-hydroxy-6-({2-sulfonato-4-[(4-sulfonatophenyl)diazenyl]phenyl}diazenyl)naphthalene-1,7-disulfonate
EC number: 459-580-2 | 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:
- 16 December 2005 to 10 Febuary 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Commission Directive 2000/32/EC, L1362000, Annex 4D
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Jananese guideline: Kanpoan No. 287 - Environment Protection Agency;Eisei No. 127 - Ministry of Health & Welfare; Heisei 09/10/31 Kikyoku No. 2 - Ministry of International Trade & Industry
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- -Batch No.: ROE 805 BOP 04/05
-Colour: Dark red
-Solubility in water: >100g/L at 20 °C
-Solubility in vehicle: Miscible
-Stability in solvent: 7 days in Water, Saline, Polyethylene Glycol, Carboxymethylcellulose, and 1 day in Vaseline and FCA at room temperature.
-Storage: At room temperature, in the desicator
-Expiration Date: October 01, 2010
-Purity: Approx. 82 % organic part (Na-salt),
all coloured components = 80.3 %;
Main component 1: 36.2 %,
Main component 2: 27.5 %, Oligomers: 10 %
Constituent 1
- Specific details on test material used for the study:
- Identity: FAT 40824/A
Batch: Red ROE 805 BOP 04/05
Appearance: dark red powder
Purity: Organic part (Na-salt): approx. 82 %; Main component 1 : approx. 36.2 %; Main component 2: approx. 27.5 %; Oligomers: 10 %
Expiration date: 01 October 2010
Stability in water: Max. 7 days at room temperature
Solubility in water: >100g/L at 20 °C
Storage: At room temperature at about 20 °C, in a desiccator because test substance is hygroscopic, away from direct sunlight
Method
- Target gene:
- histidine dependent S. typhimurium and Escherichia coli strains
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- s9 mix
- Test concentrations with justification for top dose:
- Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 μg/plate
Experiment II and Wa: 33; 100; 333; 1000; 2500; and 5000 μg/plate - Vehicle / solvent:
- Deionised water
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:
- for TA 1535, TA 100 without S9
- 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, 4-NOPD
- Remarks:
- for TA 1537, TA 98 without S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- for WP2 uvrA without S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- for all strains with S9
- Details on test system and experimental conditions:
- -Precultures:
From the thawed ampoules of the strains 0.5 mL suspension was transferred into 250 mL Erlenmeyer flasks containing 20 mL nutrient medium. A solution of 20 μL ampicillin (25 μg/mL) was added to the strains TA 98 and TA 100. This nutrient medium contains per litre:
8 g Merck Nutrient Broth (MERCK, D-64293 Darmstadt)
5 g NaCI (MERCK, D-64293 Darmstadt)
The bacterial cultures were incubated in a shaking water bath for 4 hours at 37 °C.
-S9Mix:
Before the experiment an appropriate quantity of S9 supernatant was thawed and mixed with S9 co-factor solution. The amount of S9 supernatant was 15% v/v in the S9 mix. Cofactors are added to the S9 mix to reach the following concentrations in the S9 mix:
8mM MgCI2
33 mM KCl
5mM Glucose-6-phosphate
5mM NADP
in 100 mM sodium-ortho-phosphate-buffer, pH 7.4. During the experiment the S9 mix was stored in an ice bath. - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revenants 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.
- 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 1537
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
HISTORICAL CONTROL DATA
Strain |
|
without S9 mix |
with S9 mix |
||||||
Mean |
SD |
Min |
Max |
Mean |
SD |
Min |
Max |
||
TA 1535
|
Solvent control |
19 |
6 |
9 |
35 |
21 |
7 |
7 |
41 |
Negative control |
18 |
5 |
10 |
30 |
21 |
6 |
9 |
38 |
|
Positive control |
1681 |
789 |
1003 |
4900 |
387 |
126 |
172 |
695 |
|
TA 1537 |
Solvent control |
12 |
3 |
4 |
29 |
18 |
6 |
6 |
36 |
Negative control |
11 |
3 |
5 |
29 |
19 |
6 |
8 |
33 |
|
Positive control |
87 |
18 |
52 |
191 |
337 |
191 |
94 |
746 |
|
TA 98
|
Solvent control |
26 |
6 |
14 |
•58 |
39 |
9 |
21 |
57 |
Negative control |
26 |
6 |
15 |
€0 |
41 |
9 |
17 |
64 |
|
Positive control |
361 |
204 |
176 |
1818 |
2386 |
1195 |
296 |
4854 |
|
TA 100 |
Solvent control |
131 |
24 |
91 |
198 |
147 |
25 |
109 |
281 |
Negative control |
140 |
21 |
101 |
189 |
154 |
23 |
103 |
254 |
|
Positive control |
2030 |
340 |
1178 |
2872 |
2629 |
1326 |
546 |
•5230 |
|
WP2uvrA
|
Solvent control |
52 |
8 |
31 |
67 |
55 |
10 |
34 |
75 |
Negative control |
50 |
8 |
36 |
64 |
52 |
8 |
33 |
•64 |
|
Positive control |
998 |
515 |
320 |
1976 |
342 |
134 |
221 |
930 |
Mean = mean value of revertants/plate; SD s standard deviation; Min = minimal value; Max = maximal value
Applicant's summary and conclusion
- Conclusions:
- FAT 40824/A did induce gene mutations by frameshifts in the genome of strain TA 1537 in the absence of metabolic activation.
- Executive summary:
The test substance was assessed for its potential to induce gene mutations in the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and the Escherichia coli strain WP2 uvrA with and without liver microsomal activation. 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate were administered in Pre-Experiment/Experiment I; 33; 100; 333; 1000; 2500; and 5000 μg/plate were administrated in Experiment II and VVa test. No toxic effects, evident as a reduction in the number of revertants, occurred in the test groups with and without metabolic activation. A minor but dose dependent increase in revertant colony numbers was observed following treatment with test substance in strain TA 1537 in the absence of metabolic activation (S9 mix). The number of colonies reached the threshold of thrice (strain TA 1537) the number of the corresponding solvent control at 5000 μg/plate in the pre-experiment. Since the threshold was just reached only at 5000 μg/plate and the values were still in the range of the laboratories historical data, the plate incorporation assay was repeated with strain TA 1537 without metabolic activation (reported as VVa) in parallel to the second experiment (pre-incubation). Both experiments showed a substantial and dose dependent increase in revertant colony numbers. The number of colonies exceeded the threshold of thrice the number of the corresponding solvent control at 1000 μg/plate and above in the pre- incubation assay and at 2500 μg/plate and above in the repeated plate incorporation. Appropriate reference mutagens were used as positive controls. They showed a distinct increase of induced revertant colonies. Thus, it can be concluded that the test item can induce gene mutations by frameshifts in the genome of strain TA 1537 in the absence of metabolic activation.
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