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EC number: 276-771-4 | CAS number: 72705-26-1
- 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:
- other: experimental data on similar substance
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- only four strains tested
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted: 26 May 1983
- Deviations:
- yes
- Remarks:
- only four strains
- Principles of method if other than guideline:
- References:
Ames BN, Durson WE, Yamasaki E, and Lee FD (1970). Proc. Nat. Acad. Sci. USA, 70, 2285.
Ames BN, McCann J, and Yamasaki E (1975) Mutation Research 31, 347. - GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ammonium sodium 2-[4-[[1-[[(2-methoxy-5-methyl-4-sulphonatophenyl)amino]carbonyl]-2-oxopropyl]azo]phenyl]-6-methylbenzothiazole-7-sulphonate
- EC Number:
- 276-770-9
- EC Name:
- Ammonium sodium 2-[4-[[1-[[(2-methoxy-5-methyl-4-sulphonatophenyl)amino]carbonyl]-2-oxopropyl]azo]phenyl]-6-methylbenzothiazole-7-sulphonate
- Cas Number:
- 72705-24-9
- Molecular formula:
- C26H24N4O9S3.H3N.Na
- IUPAC Name:
- ammonium sodium 2-[4-({1-[(2-methoxy-5-methyl-4-sulfonatophenyl)carbamoyl]-2-oxopropyl}diazenyl)phenyl]-6-methyl-1,3-benzothiazole-7-sulfonate
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 Mix; Microsomal Enzyme Fraction prepared from animals pre-treated with Arochlor 1254.
- Test concentrations with justification for top dose:
- 20, 100, 500, 2500, 12500 µg/plate
- Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Justification for choice of solvent/vehicle: Good solubility of the test substance, readily soluble in DMSO.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO alone
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- Furthermore, 2-amino-anthracene which does not revert in the absence of metabolic activation was added at a dose of 10 µg/plate (activity check of liver enzyme preparation)
- Positive control substance:
- other: see remarks
- Remarks:
- M-Methyl-N-Nitro-N-Nitrosoguanidine (MNNG) 2 µg/plate (TA1535 & TA100); 9 Amino Acridine (9AA) 100 µg/plate (TA 1537); 4-Nitro-O-phenyldiamine (4NOPD) 10 µg/plate (TA 98).
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Test tubes containing 9 mL portions of molten histidine deficient top agar at 45°C.
- Addition of 0.1 mL test solution or negative/positive control solution, 0.1 mL bacterial suspension, and optional, 0.5 mL S-9 Mix.
- Pouring of samples of 3 mL onto Vogel-Bonner agar plates (minimal medium).
- A solution containing 0.5 mM Histidine and 0.5 mM Biotin was added to top agar to enable that a background lawn of growth was possible in the test.
- Growth indicates that a reverse mutation has reverted the his- gene back to an active form.
DURATION
- Preincubation period: no
- Exposure duration: Incubation at 37°C °C for 48 hours
NUMBER OF REPLICATIONS: 3 (Petri dishes prepared per strain and per group)
CELLS EVALUATED: The bacterial colonies (his+ revertants) are counted.
DETERMINATION OF CYTOTOXICITY
- Method: bacterial growth (colony formation)
OTHER INFORMATION
Microsomal Enzyme Fraction: A commercial preparation was obtained from Uniscience Limited, 8 Jesus Lane, Cambridge, CBS 8BA, UK. This fraction is obtained from animals pre-treated with Arochlor 1254 (a mixture of polychlorinated biphenyls) and was stated to be from batch no. 03300 with a protein level of 40 mg/mL (Aryl hydrocarbon hydroxylase activity: 6.4 nmol hydroxy benzo(a)pyrene/20 minutes/mg protein).
Reference:
SPECIFICATIONS FOR RAT LIVER S-9 PRODUCT, AROCLOR 1254 INDUCED, CATOLOG NOS. 8360-01 AND 8360-03. Date prepared: 1984-04-25, Uniscience Limited, UK. - Evaluation criteria:
- Positive result: Dose-related and statistically significant increase in mutation rate (of at least twice the spontaneous reversion rate) in one or more strains of bacteria in the presence and/or absence of the S-9 Mix.
Negative result: The number of induced revertants compared to spontaneous revertants should be less than two fold at all dose levels employed, the intervals of which should be between 3 and 5 fold and extend to the limits imposed by toxicity or solubility. - Statistics:
- The arithmetic mean was calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- 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:
- not examined
- Positive controls validity:
- valid
- Key result
- 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:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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
- Key result
- Species / strain:
- S. typhimurium TA 100
- 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
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
No inhibition was observed at any of the concentrations of the test substance employed in this test and the main mutation study was set up using test substance at concentrations in the range 20 to 12500 µg/plate.
ADDITIONAL INFORMATION:
No significant increase in the number of revertant colonies was recorded for any of the strains at any of the dose levels employed in this study, either with or without metabolic activation.
All counts of revertant colonies were similar to those recorded for the negative control plates and were within the range expected for spontaneous reversion for each strain.
The positive control substances all produced marked increases in the number of revertant colonies and the activity of the S9 fraction was found to be satisfactory.
Any other information on results incl. tables
Plate incorporation with S-9 Mix (colony number = mean values):
Dose (µg/per 0.1 mL [plate]) |
TA 98 |
TA 100 |
TA 1535 |
TA1537 |
0 (DMSO) |
27 |
102 |
19 |
7 |
20 |
25 |
104 |
20 |
7 |
100 |
24 |
109 |
25 |
8 |
500 |
25 |
109 |
26 |
6 |
2500 |
26 |
103 |
24 |
8 |
12500 |
28 |
112 |
22 |
8 |
---------- |
|
|
|
|
Positive controls: |
|
|
|
|
4-NOP (10 µg/plate) |
850 |
|
|
|
MNNG (2 µg/plate) |
|
> 1000 |
797 |
|
9-AA (100 µg/plate) |
|
|
|
880 |
---------- |
|
|
|
|
9-AA (10 µg/plate) |
> 1000 |
> 1000 |
487 |
617 |
Three plates per tester strain were evaluated. |
Plate incorporation without S-9 Mix (colony number = mean values):
Dose (µg/per 0.1 mL [plate]) |
TA 98 |
TA 100 |
TA 1535 |
TA1537 |
0 (DMSO) |
24 |
93 |
21 |
8 |
20 |
25 |
100 |
22 |
8 |
100 |
22 |
113 |
25 |
6 |
500 |
25 |
101 |
26 |
6 |
2500 |
26 |
107 |
28 |
6 |
12500 |
25 |
107 |
32 |
8 |
---------- |
|
|
|
|
Positive controls: |
|
|
|
|
4-NOP (10 µg/plate) |
917 |
|
|
|
MNNG (2 µg/plate) |
|
> 1000 |
683 |
|
9-AA (100 µg/plate) |
|
|
|
> 1000 |
---------- |
|
|
|
|
9-AA (10 µg/plate) |
28 |
103 |
20 |
6 |
Three plates per tester strain were evaluated. |
VIABILITY AND SPONTANEOUS REVERSION TESTS
Strain Salmonella typhimurium |
Total Counts on Histidine deficient agar (x 10E7) |
Minimal agar with overlay of Histidine/Biotin top agar |
||
|
1 mL of overnight nutrient broth |
|
||
TA 98 |
21 |
26 |
28 |
28 |
TA 100 |
30 |
97 |
98 |
101 |
TA 1535 |
15 |
18 |
18 |
17 |
TA 1537 |
19 |
6 |
6 |
8 |
STERILITY CHECKS
Sample |
Count |
||
Top Agar + His/Biotin |
0 |
0 |
0 |
Top Agar only |
0 |
0 |
0 |
Top Agar + His/Biotin + S9 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Conclusions:
- Not mutagenic in Ames test
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