Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 276-423-1 | CAS number: 72152-71-7
- 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:
- 2016-04-19 till 2016-05-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Guideline-conform study under GLP without deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Disodium [6-hydroxy-5-[(2-hydroxy-5-sulphophenyl)azo]naphthalene-2-sulphonato(4-)]cuprate(2-)
- EC Number:
- 276-423-1
- EC Name:
- Disodium [6-hydroxy-5-[(2-hydroxy-5-sulphophenyl)azo]naphthalene-2-sulphonato(4-)]cuprate(2-)
- Cas Number:
- 72152-71-7
- Molecular formula:
- C16H8CuN2O8S2.2Na
- IUPAC Name:
- Cuprate(2-), [6-(hydroxy-kO)-5-[2-[2-(hydroxy-kO)-5-sulfophenyl]diazenyl-kN1]-2-naphthalenesulfonato(4-)]-, sodium
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/ß-Naphthoflavone induced rat liver S9 in experiment I and not induced hamster S9
- Test concentrations with justification for top dose:
- experiment I: 3.49 ; 10.47; 34.91; 104.73; 349.11; 1047.23; 2618.35; 5236.69
experiment II: 3, 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Aqua deion.
- Justification for choice of solvent/vehicle:best suitable solvent
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- congo red
- other: sodium azide; 4-nitro-o-phenylene-diamine; methyl methane sulfonate, 2-aminoanthracene,
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation;
DURATION
- Preincubation period: 30 min; 30°C
- Exposure duration: 72 hours
NUMBER OF REPLICATIONS: 3 plates
DETERMINATION OF CYTOTOXICITY
A reduction in the number of spontaneous revertants (below the induction factor of 0.5) or a clearing of the bacterial background lawn.
- Evaluation criteria:
- 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:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
Results and discussion
Test results
- Key result
- Species / strain:
- other: TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: none
- Water solubility: yes
- Precipitation:IIn Experiment II precipitation of the test item in the overlay agar on the incubated agar plates was observed from 2500 to 5000 µg/plate in the absence of S9 mix and from 1000 to 5000 µg/plate in the presence of S9 mix. The undissolved particles had no influence on the data recording. In Experiment I the minimal agar plates were densely colored after treatment with the test items at concentrations ranging from 2618.35 to 5236.69 µg/plate. This had no impact on the automatical evaluation.
- Other confounding effects:
COMPARISON WITH HISTORICAL CONTROL DATA: In experiment II, the number of colonies exceeded the upper limit of our historical control data in strain TA 98 in the 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.
ADDITIONAL INFORMATION ON CYTOTOXICITY:TToxic effects, evident as a reduction in the number of revertants (below the induction factor of 0.5), were observed at the following concentrations (µg/plate):
Strain Experiment I Experiment II
without S9 mix with S9 mix without S9 mix with S9 mix
TA 1535 / / / /
TA 1537 / / / 5000
TA 98 / / / 5000
TA 100 / / / /
WP2 uvrA 5236.69 / 5000 / - Remarks on result:
- other: other: reverse mutation assay
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table1 Summary of Experiment I
Study Name: 1763602 |
Study Code: Envigo CRS 1763602 |
Experiment: 1763602 VV Plate |
Date Plated: 19/04/2016 |
Assay Conditions: |
Date Counted: 22/04/2016 |
Metabolic Activation |
Test Group |
Dose Level (per plate) |
|
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|
|
|
|
|
|
|
|
|
Without Activation |
Deion.water |
|
|
9 ± 4 |
10 ± 2 |
36 ± 4 |
151 ± 21 |
58 ± 0 |
Untreated |
|
|
11 ± 4 |
9 ± 4 |
30 ± 3 |
163 ± 11 |
56 ± 3 |
|
Sanodal- |
3.49 µg |
|
11 ± 3 |
10 ± 3 |
27 ± 3 |
163 ± 23 |
58 ± 7 |
|
Rot B3LW |
10.47 µg |
|
12 ± 2 |
10 ± 3 |
34 ± 4 |
176 ± 18 |
65 ± 14 |
|
|
34.91 µg |
|
13 ± 2 |
13 ± 3 |
32 ± 9 |
181 ± 18 |
56 ± 6 |
|
|
104.73 µg |
|
8 ± 2 |
13 ± 4 |
33 ± 3 |
175 ± 23 |
60 ± 8 |
|
|
349.11 µg |
|
7 ± 2 |
9 ± 3 |
29 ± 6 |
177 ± 13 |
44 ± 7 |
|
|
1047.23 µg |
|
12 ± 2 |
8 ± 3 |
31 ± 4 |
170 ± 14 |
53 ± 4 |
|
|
2618.35 µg |
|
9 ± 2D |
8 ± 3D |
31 ± 9D |
165 ± 9D |
32 ± 9D |
|
|
5236.69 µg |
|
10 ± 3D |
6 ± 1D |
26 ± 9D |
154 ± 14D |
26 ± 3D |
|
NaN3 |
10 µg |
|
1243 ± 62 |
|
|
2442 ± 141 |
|
|
4-NOPD |
10 µg |
|
|
|
462 ± 12 |
|
|
|
4-NOPD |
50 µg |
|
|
94 ± 2 |
|
|
|
|
MMS |
2.0 µL |
|
|
|
|
|
1006 ± 47 |
|
|
|
|
|
|
|
|
|
|
With Activation |
Deion.water |
|
|
13 ± 4 |
13 ± 1 |
42 ± 2 |
168 ± 4 |
67 ± 3 |
Untreated |
|
|
12 ± 4 |
13 ± 4 |
40 ± 2 |
174 ± 19 |
58 ± 4 |
|
Sanodal- |
3.49 µg |
|
10 ± 2 |
11 ± 5 |
37 ± 10 |
159 ± 13 |
63 ± 3 |
|
Rot B3LW |
10.47 µg |
|
10 ± 3 |
13 ± 2 |
34 ± 4 |
179 ± 8 |
59 ± 3 |
|
|
34.91 µg |
|
12 ± 3 |
13 ± 1 |
36 ± 3 |
184 ± 14 |
69 ± 7 |
|
|
104.73 µg |
|
10 ± 3 |
16 ± 3 |
37 ± 6 |
161 ± 7 |
62 ± 7 |
|
|
349.11 µg |
|
11 ± 3 |
11 ± 2 |
33 ± 14 |
178 ± 3 |
69 ± 10 |
|
|
1047.23 µg |
|
11 ± 3 |
7 ± 1 |
32 ± 11 |
138 ± 3 |
57 ± 6 |
|
|
2618.35 µg |
|
12 ± 4D |
8 ± 1D |
20 ± 6D |
169 ± 10D |
49 ± 6D |
|
|
5236.69 µg |
|
9 ± 1D |
7 ± 1D |
27 ± 3D |
135 ± 2D |
43 ± 17D |
|
2-AA |
2.5 µg |
|
394 ± 6 |
197 ± 22 |
5311 ± 166 |
4669 ± 88 |
|
|
2-AA |
10.0 µg |
|
|
|
|
|
380 ± 42 |
|
|
|
|
|
|
|
|
|
|
Key to Positive Controls |
Key to Plate Postfix Codes |
||
|
|
||
NaN3 2-AA 4-NOPD MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine methyl methane sulfonate |
D |
Densely coloured plate |
Table2 Summary of Experiment II
Study Name: 1763602 |
Study Code: Envigo CRS 1763602 |
Experiment: 1763602 HV2 Pre |
Date Plated: 12.05.2016 |
Assay Conditions: |
Date Counted: 18.05.2016 |
Metabolic Activation |
Test Group |
Dose Level (per plate) |
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
|
|
|
|
|
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|
|
|
|
|
|
|
|
Without Activation |
Deion. water |
|
10 ± 2 |
10 ± 1 |
25 ± 4 |
172 ± 19 |
40 ± 7 |
Untreated |
|
13 ± 5 |
15 ± 5 |
20 ± 4 |
182 ± 17 |
42 ± 4 |
|
Sanodal-Rot |
3 µg |
14 ± 3 |
13 ± 1 |
23 ± 2 |
171 ± 17 |
43 ± 2 |
|
B3LW |
10 µg |
9 ± 2 |
11 ± 4 |
33 ± 7 |
169 ± 27 |
42 ± 5 |
|
|
33 µg |
11 ± 3 |
14 ± 2 |
33 ± 7 |
169 ± 16 |
41 ± 6 |
|
|
100 µg |
9 ± 3 |
11 ± 4 |
26 ± 1 |
157 ± 9 |
31 ± 5 |
|
|
333 µg |
10 ± 4 |
12 ± 4 |
27 ± 5 |
170 ± 5 |
30 ± 2 |
|
|
1000 µg |
11 ± 3 |
10 ± 4 |
19 ± 5 |
158 ± 10 |
24 ± 11 |
|
|
2500 µg |
14 ± 2P |
7 ± 2P |
20 ± 5P |
121 ± 15P M |
18 ± 3M P |
|
|
5000 µg |
9 ± 2P |
5 ± 1P M |
13 ± 3P M |
127 ± 16P M |
15 ± 4M P |
|
NaN3 |
10 µg |
1164 ± 65 |
|
|
2289 ± 68 |
|
|
4-NOPD |
10 µg |
|
|
401 ± 15 |
|
|
|
4-NOPD |
50 µg |
|
70 ± 15 |
|
|
|
|
MMS |
2 µL |
|
|
|
|
863 ± 15 |
|
|
|
|
|
|
|
|
|
With Activation |
Deion. water |
|
18 ± 7 |
21 ± 1B M |
52 ± 11 |
124 ± 9 |
52 ± 9 |
Untreated |
|
17 ± 4 |
23 ± 4B M |
55 ± 8 |
109 ± 23 |
54 ± 4 |
|
Sanodal-Rot |
3 µg |
14 ± 2 |
25 ± 3B M |
51 ± 3 |
108 ± 20 |
54 ± 4 |
|
B3LW |
10 µg |
17 ± 5 |
23 ± 6B M |
60 ± 6 |
126 ± 14 |
57 ± 5 |
|
|
33 µg |
20 ± 5 |
21 ± 5B M |
58 ± 6 |
135 ± 14 |
54 ± 6 |
|
|
100 µg |
14 ± 6 |
18 ± 4B M |
54 ± 7 |
145 ± 8 |
54 ± 3 |
|
|
333 µg |
18 ± 2 |
12 ± 2B M |
53 ± 4 |
124 ± 4 |
43 ± 7 |
|
|
1000 µg |
14 ± 3P |
13 ± 3P B M |
45 ± 6P |
127 ± 20P |
29 ± 6M P |
|
|
|
2500 µg |
13 ± 3P M |
13 ± 1P B M |
25 ± 6P |
125 ± 10P M |
27 ± 2M P |
|
|
5000 µg |
14 ± 4P M |
9 ± 1P B M |
21 ± 3P M |
125 ± 5P M |
23 ± 5M P |
|
2-AA |
2.5 µg |
|
|
|
1032 ± 68 |
|
|
2-AA |
2.5 µg |
362 ± 28 |
114 ± 13B M |
|
|
|
|
2-AA |
10 µg |
|
|
|
|
1089 ± 83 |
|
Congo red |
500 µg |
|
|
322 ± 15 |
|
|
|
|
|
|
|
|
|
|
Key to Positive Controls |
Key to Plate Postfix Codes |
||
|
|
||
NaN3 2-AA 4-NOPD Congo red MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine Congo red methyl methane sulfonate |
P M B |
Precipitate Manual count Extensive bacterial growth |
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
- Executive summary:
This study was performed to investigate the potential of the test item to induce gene mutations according to the plate incorporation test (experiment I) with and without rat S9 mix and the pre-incubation test (experiment II) with and without hamster S9 mix 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 both with and without liver microsomal activation. Each concentration and the controls were tested in triplicate. The test item was tested at the following concentrations in both experiments:
Experiment I: 3.49; 10.47; 34.91; 104.73; 349.11; 1047.23; 2618. 35; and 5236.69 µg/plate
Experiment II: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
In Experiment II precipitation of the test item in the overlay agar on the incubated agar plates was observed from 2500 to 5000 µg/plate in the absence of S9 mix and from 1000 to 5000 µg/plate in the presence of S9 mix. The undissolved particles had no influence on the data recording. In Experiment I the minimal agar plates were densely colored after treatment with the test items at concentrations ranging from 2618.35 to 5236.69 µg/plate. This had no impact on the automatical evaluation.
The plates incubated with the test item showed normal background growth up to 5236.69 µg/plate with and without S9 mix in all strains used.
Toxic effects, evident as a reduction in the number of revertants (below the induction factor of 0.5), were observed at the following concentrations (µg/plate):
Strain
Experiment I
Experiment II
without S9 mix
with S9 mix
without S9 mix
with S9 mix
TA 1535
/
/
/
/
TA 1537
/
/
/
5000
TA 98
/
/
/
5000
TA 100
/
/
/
/
WP2 uvrA
5236.69
/
5000
/
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Sanodal-Rot B3LW at any concentration level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls. They showed a distinct increase in induced revertant colonies. In experiment II, the number of colonies exceeded the upper limit of our historical control data in strain TA 98 in the 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.