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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 916-632-3 | 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:
- 2018-02-15 till 2018-02-22
- 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:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Disodium 4-amino-3-[[4-[(2-amino-4-hydroxyphenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
- EC Number:
- 270-629-5
- EC Name:
- Disodium 4-amino-3-[[4-[(2-amino-4-hydroxyphenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
- Cas Number:
- 68460-07-1
- Molecular formula:
- C28H22N8O8S2.2Na
- IUPAC Name:
- disodium 4-amino-3-({4-[(2-amino-4-hydroxyphenyl)diazenyl]phenyl}diazenyl)-5-hydroxy-6-(phenyldiazenyl)naphthalene-2,7-disulfonate
- Reference substance name:
- Disodium 4-amino-3-[[4-[(2,4-diaminophenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
- EC Number:
- 272-559-0
- EC Name:
- Disodium 4-amino-3-[[4-[(2,4-diaminophenyl)azo]phenyl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate
- Cas Number:
- 68877-33-8
- Molecular formula:
- C28H23N9O7S2.2Na
- IUPAC Name:
- disodium 4-amino-3-({4-[(2,4-diaminophenyl)diazenyl]phenyl}diazenyl)-5-hydroxy-6-(phenyldiazenyl)naphthalene-2,7-disulfonate
Constituent 1
Constituent 2
Method
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 applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/Beta-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
- Vehicle / solvent:
- Solvent used: DMSO
Justification for choice of solvent: best suitable solvent, because of its solubility properties and its relative nontoxicity to the bacteria
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar plate incorporation
DURATION:
exposure duration: 72 hours
NUMBER OF REPLICATIONS: 3 plates for each concentration including the controls
DETERMINATION OF CYTOTOXICITY: Evident as 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, and WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- strain TA 98 with and without S9 mix
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- strain WP2 uvrA with and without S9 mix
- 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: Thick suspension
Other confounding effects: Due to the intense color of the test item the colonies were partly counted manually.
COMPARISON WIT HISTORICAL CONTROL DATA: performed, no deviations
ADDITIONAL INFORMATION ON CYTOTOXICITY: Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), were observed in strain WP2 uvrA with and without S9 mix at 5000 µg/plate. In the remaining strains no toxic effects were observed.
Any other information on results incl. tables
Summary of Experiment I
Study Name: 1888600 |
Study Code: Envigo 1888600 |
Experiment: 1888600 VV Plate |
Date Plated: 15.02.2018 |
Assay Conditions: |
Date Counted: 22.02.2018 |
Metabolic Activation |
Test Group |
Dose Level (per plate) |
TA 1535 Revertant Colony Counts (Mean ±SD) |
TA 1537 Revertant Colony Counts (Mean ±SD) |
TA 98 Revertant Colony Counts (Mean ±SD) |
TA 100 Revertant Colony Counts (Mean ±SD) |
WP2 uvrA Revertant Colony Counts (Mean ±SD) |
|
|
|
|
|
|
|
|
Without |
DMSO |
|
10 ± 4 |
9 ± 3 |
26 ± 6 |
118 ± 6 |
36 ± 9 |
Activation |
Untreated |
|
9 ± 3 |
13 ± 4 |
25 ± 3 |
169 ± 21 |
33 ± 2 |
|
Aluminium |
3 µg |
9 ± 3 |
9 ± 2 |
26 ± 6 |
119 ± 21 |
30 ± 4 |
|
Black CRO |
10 µg |
12 ± 4 |
10 ± 4 |
22 ± 8 |
133 ± 5 |
32 ± 10 |
|
|
33 µg |
12 ± 5 |
8 ± 2 |
24 ± 6 |
131 ± 13 |
33 ± 9 |
|
|
100 µg |
10 ± 5 |
11 ± 1 |
23 ± 5 |
101 ± 4 |
32 ± 3 |
|
|
333 µg |
7 ± 3D |
11 ± 1D |
61 ± 6D M |
123 ± 5D M |
33 ± 11D |
|
|
1000 µg |
6 ± 1M D |
11 ± 5M D |
87 ± 5M D |
129 ± 12M D |
20 ± 8M D |
|
|
2500 µg |
6 ± 1M D |
13 ± 2M D |
125 ± 7M D |
126 ± 15M D |
20 ± 4M D |
|
|
5000 µg |
6 ± 3M D |
10 ± 1M D |
152 ± 14M D |
75 ± 15M D |
11 ± 4M D |
|
NaN3 |
10 µg |
1070 ± 73 |
|
|
1740 ± 120 |
|
|
4-NOPD |
10 µg |
|
|
340 ± 9 |
|
|
|
4-NOPD |
50 µg |
|
61 ± 7 |
|
|
|
|
MMS |
2.0 µL |
|
|
|
|
742 ± 59 |
|
|
|
|
|
|
|
|
With |
DMSO |
|
12 ± 3 |
13 ± 5 |
37 ± 1 |
109 ± 2 |
42 ± 6 |
Activation |
Untreated |
|
16 ± 3 |
13 ± 2 |
48 ± 9 |
146 ± 13 |
44 ± 1 |
|
Aluminium |
3 µg |
14 ± 0 |
11 ± 1 |
46 ± 3 |
112 ± 4 |
35 ± 8 |
|
Black CRO |
10 µg |
9 ± 2 |
13 ± 3 |
64 ± 3 |
119 ± 8 |
42 ± 1 |
|
|
33 µg |
8 ± 3 |
18 ± 2 |
94 ± 2 |
135 ± 12 |
36 ± 6 |
|
|
100 µg |
11 ± 4 |
19 ± 3 |
151 ± 30 |
133 ± 11 |
36 ± 7 |
|
|
333 µg |
7 ± 2D |
14 ± 2D |
202 ± 9D M |
114 ± 12D M |
31 ± 5D |
|
|
1000 µg |
8 ± 2M D |
15 ± 2M D |
86 ± 15M D |
125 ± 16M D |
27 ± 3M D |
|
|
2500 µg |
8 ± 3M D |
13 ± 2M D |
119 ± 8M D |
120 ± 18M D |
26 ± 2M D |
|
|
5000 µg |
6 ± 1M D |
9 ± 2M D |
131 ± 13M D |
125 ± 9M D |
12 ± 4M D |
|
2-AA |
2.5 µg |
355 ± 9 |
220 ± 14 |
3739 ± 231 |
2586 ± 60 |
|
|
2-AA |
10.0 µg |
|
|
|
|
467 ± 36 |
|
|
|
|
|
|
|
|
Key to Plate Postfix Codes:
M: Manuel Count
D: Densely Colored Plate
Key to positive controls:
NaN3: sodium azide
4 -NOPD: 4 -nitro-o-phenylene-diamine
MMS: methyl methane sulfonate
2-AA: 2 -aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- During the described mutagenicity test and under the experimental conditions reported, the test item did induce gene mutations by frameshifts in the genome of strain TA 98 with and without metabolic activation (S9 mix).
- Executive summary:
This study was performed to investigate the potential of Aluminium Black CRO to induce gene mutations according to the plate incorporation test using theSalmonella typhimuriumstrains TA 1535, TA 1537, TA 98, TA 100, and theEscherichia colistrain WP2 uvrA.
The assay was performed with and without liver microsomal activation (S9 mix). 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
No precipitation of the test item occurred up to the highest investigated dose.
The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without S9 mix in all strains used.
Toxiceffects, evident as a reduction in the number of revertants (below the indication factor of 0.5), were observed in strain WP2uvrAwith and without S9 mix at 5000µg/plate. In the remaining strains no toxic effects were observed.
A substantial increase in revertant colony numbers was observed following treatment with Aluminium Black CRO in strain TA 98 in the presence and absence of metabolic activation (S9 mix).The number of colonies exceeded the threshold of twice the number of the corresponding solvent control at concentrations of 333 µg/plate and above without S9 mix and at concentrations of 33 µg/plate and above with S9 mix. In strain TA 98 with S9 mix the revertant colony count decreases at concentrations of 1000 µg/plate and above, but the values did not fall below the threshold of twice the number of the corresponding solvent control.
Appropriate reference mutagens were used as positive controls. They showed a distinct increase in induced revertant colonies.
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.