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EC number: 247-368-0 | CAS number: 25956-17-6
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from publication
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Gene mutation toxicity study of the test chemical
- Author:
- Errol Zeiger et. al.
- Year:
- 2 000
- Bibliographic source:
- Mutation Research, 2000
- Reference Type:
- other: Secondary source
- Title:
- Gene mutation toxicity study of the test chemical
- Author:
- NTRL
- Year:
- 2 010
- Bibliographic source:
- NTP (National Toxicological Program) A81251, 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Gene mutation toxicity study of the test chemical
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- EC Number:
- 247-368-0
- EC Name:
- Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- Cas Number:
- 25956-17-6
- Molecular formula:
- C18H16N2O8S2.2Na
- IUPAC Name:
- disodium 6-hydroxy-5-[(2-methoxy-3-methyl-4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate
- Test material form:
- solid
- Details on test material:
- IUPAC name: Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
Mol. formula: C18H14N2Na2O8S2
Molecular Weight: 496.4266 gm/mol
Smiles: c12c(cc(cc2)S(=O)(=O)[O-])ccc(c1/N=N/c1c(cc(c(c1)C)S(=O)(=O)[O-])OC)O.[Na+].[Na+]
InChI: 1S/C18H16N2O8S2.2Na/c1-10-7-14(16(28-2)9-17(10)30(25,26)27)19-20-18-13-5-4-12(29(22,23)24)8-11(13)3-6-15(18)21;;/h3-9,21H,1-2H3,(H,22,23,24)(H,25,26,27);;/q;2*+1/p-2/b20-19+;;
Constituent 1
Method
- Target gene:
- Histidine
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 97
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- with 10 % & 30 % HLI = induced male Syrian hamster liver S9 and 10% & 30 % RLI = induced male Sprague Dawley rat liver S9
- Test concentrations with justification for top dose:
- 100-10000 µg/Plate
- Vehicle / solvent:
- Water
Controlsopen allclose all
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- For strains tested with S9
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- For strains TA100 and TA1535 tested in the absence of S9
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- For strain TA97 tested in the absence of S9
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- For strain TA98 tested in the absence of S9
- Details on test system and experimental conditions:
- PREINCUBATION : In the standard protocol (preincubation) for conducting the Ames assay, a test tube containing a suspension of one strain of Salmonella typhimurium plus S9 mix or plain buffer without S9, is incubated for 20 minutes at 37º C with the test chemical.
Control cultures, with all the same ingredients except the test chemical, are also incubated. In addition, positive control cultures are prepared; these contain the particular bacterial tester strain under investigation, the various culture ingredients, and a known potent mutagen.
After 20 minutes, agar is added to the cultures and the contents of the tubes are thoroughly mixed and poured onto the surface of Petri dishes containing standard bacterial culture medium. The plates are incubated, and bacterial colonies that do not require an excess of supplemental histidine appear and grow.
These colonies are comprised of bacteria that have undergone reverse mutation to restore function of the histidine-manufacturing gene. The number of colonies is usually counted after 2 days.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: No mutagenic potential observed
Any other information on results incl. tables
Strain: TA100
Dose |
No Activation |
No Activation |
30% RLI |
30% HLI |
10% RLI |
10% HLI |
||||||
Protocol |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
||||||
ug/Plate |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
0 |
111 |
9.5 |
123 |
2.7 |
126 |
2.3 |
120 |
5 |
138 |
4.7 |
116 |
6.4 |
100 |
118 |
16.9 |
134 |
6.3 |
138 |
7.3 |
119 |
9.1 |
126 |
3.7 |
128 |
1.5 |
333 |
123 |
7.8 |
120 |
5 |
136 |
3.3 |
120 |
5.8 |
134 |
5.3 |
134 |
11.3 |
1000 |
105 |
4.6 |
123 |
6.1 |
132 |
5.7 |
131 |
2.9 |
122 |
10.5 |
136 |
4.9 |
3333 |
127 |
3.8 |
133 |
4.2 |
126 |
3.2 |
137 |
4.7 |
125 |
3.5 |
119 |
5.5 |
10000 |
122 |
5.3 |
110 |
5.5 |
116 |
8 |
116 |
6 |
136 |
10.2 |
126 |
8.5 |
Positive Control |
845 |
23.7 |
861 |
20.1 |
483 |
10.7 |
544 |
17.6 |
548 |
16.5 |
592 |
7.9 |
Strain: TA1535
Dose |
No Activation |
No Activation |
30% RLI |
30% HLI |
10% RLI |
10% HLI |
||||||
Protocol |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
||||||
ug/Plate |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
0 |
10 |
1 |
12 |
1.5 |
11 |
1.2 |
12 |
1.2 |
14 |
1.9 |
13 |
1.5 |
100 |
10 |
.3 |
10 |
.9 |
10 |
0 |
11 |
.7 |
10 |
.9 |
9 |
.7 |
333 |
10 |
1.2 |
9 |
.6 |
10 |
.7 |
11 |
.9 |
13 |
3 |
8 |
.7 |
1000 |
10 |
.3 |
10 |
2.1 |
11 |
2.3 |
9 |
.3 |
13 |
1.3 |
11 |
1.3 |
3333 |
9 |
.3 |
9 |
.6 |
9 |
.9 |
12 |
1.2 |
12 |
2 |
10 |
1.2 |
10000 |
9 |
.3 |
10 |
.6 |
10 |
1 |
11 |
2.5 |
10 |
1 |
11 |
2 |
Positive Control |
890 |
19.6 |
857 |
11.9 |
90 |
6.7 |
94 |
5.4 |
117 |
7.5 |
142 |
4.9 |
Strain: TA97
Dose |
No Activation |
No Activation |
30% RLI |
30% HLI |
10% RLI |
10% HLI |
||||||
Protocol |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
||||||
ug/Plate |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
0 |
140 |
6.5 |
163 |
9.7 |
165 |
8.6 |
167 |
15.1 |
189 |
11.1 |
178 |
3.2 |
100 |
148 |
11 |
161 |
8.8 |
164 |
3.2 |
175 |
7.2 |
194 |
3.5 |
191 |
3.2 |
333 |
140 |
2.5 |
158 |
14.7 |
170 |
10.8 |
164 |
3 |
184 |
8.5 |
163 |
3.7 |
1000 |
154 |
3.8 |
167 |
5.5 |
164 |
17.7 |
176 |
6.4 |
178 |
5.2 |
165 |
8.5 |
3333 |
131 |
4.2 |
138 |
6.1 |
165 |
12.3 |
164 |
8.7 |
199 |
.3 |
180 |
16 |
10000 |
120 |
3.8 |
163 |
21.8 |
171 |
2.1 |
156 |
15.6 |
192 |
9.5 |
183 |
20.7 |
Positive Control |
426 |
16.4 |
458 |
5.6 |
510 |
7 |
631 |
24.1 |
541 |
13.5 |
565 |
22.6 |
Applicant's summary and conclusion
- Conclusions:
- In bacterial gene mutation study, the test chemical in water at doses 100-10000 µg/Plate were observed to be not mutagenic in Salmonella typhimurium strains TA100,TA1535,TA97 and TA98 with and without addition of S9 liver fractions from Aroclor induced hamsters. The same has been observed for rats as well.
- Executive summary:
Genetic toxicity in vitro study was assessed for test chemical. For this purpose AMES test was performed.The test material was exposed to Salmonella typhimurium TA100, TA1535, TA98 and TA97 in the presence and absence of metabolic activation S9. The concentration of test material used in the presence and absence of metabolic activation were 0, 10, 30,100, 333, 1000 and 3333 µg/plate. Mutagenic effects were observed in neither strains, in the presence and absence of metabolic activation. Therefore test chemical was considered not to be mutagenic in Salmonella typhimurium TA100, TA1535, TA98 and TA97 by AMES test. Hence the substance cannot be classified as gene mutant in vitro.
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