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EC number: 228-906-3 | CAS number: 6372-81-2
- 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:
- 2014-11-07 to 2014-11-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Barium bis[2-[(2-hydroxy-1-naphthyl)azo]benzoate]
- EC Number:
- 228-906-3
- EC Name:
- Barium bis[2-[(2-hydroxy-1-naphthyl)azo]benzoate]
- Cas Number:
- 6372-81-2
- Molecular formula:
- C17H12N2O3.1/2Ba
- IUPAC Name:
- barium bis{2-[(2-hydroxy-1-naphthyl)diazenyl]benzoate}
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 non-induced hamster S9 in experiment II
- Test concentrations with justification for top dose:
- 3, 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate / pre-experiment/experiment I
10; 33; 100; 333; 1000; 2500; and 5000 µg/plate / experiment II - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: DMSO resulting a homogeneous suspension
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide; 4-nitro-o-phenylene-diamine; methyl methane sulfonate, 2-aminoanthracene, congo red
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation; preincubation;
DURATION
- Preincubation period: 30 minutes
- 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
- Species / strain:
- other: TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- minor
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: none
- Water solubility: unsoluble
- Precipitation:
The test item precipitated in the overlay agar in the test tubes from 33 to 5000 µg/plate in experiment I and from 333 to 5000 µg/plate in experiment II. Precipitation of the test item in the overlay agar on the incubated agar plates was observed from 1000 to 5000 µg/plate in experiment II. The undissolved particles had no influence on the data recording.
- Other confounding effects:
COMPARISON WITH HISTORICAL CONTROL DATA: performed
ADDITIONAL INFORMATION ON CYTOTOXICITY:
No toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in nearly all test groups. A reduction in the number of revertants (below the indication factor of 0.5), was observed in the presence of metabolic activation at 5000 µg/plate in experiment I in strains TA 1535 and TA 98 and in experiment II in strains TA 1535 and WP2 uvrA. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table1 Summary of Experiment I
Study Name: 1664301 |
Study Code: Harlan CCR 1664301 |
Experiment: 1664301 VV Plate |
Date Plated: 07/11/2014 |
Assay Conditions: |
Date Counted: 10/11/2014 |
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 |
DMSO |
|
|
12 ± 2 |
11 ± 3 |
19 ± 5 |
165 ± 13 |
35 ± 2 |
Untreated |
|
|
11 ± 3 |
11 ± 4 |
19 ± 4 |
181 ± 3 |
39 ± 2 |
|
Pigment Red |
3 µg |
|
10 ± 4 |
9 ± 1 |
22 ± 4 |
156 ± 6 |
34 ± 1 |
|
50:1 |
10 µg |
|
12 ± 3 |
11 ± 1 |
21 ± 7 |
154 ± 10 |
27 ± 3 |
|
|
33 µg |
|
11 ± 2 |
13 ± 3 |
21 ± 6 |
145 ± 9 |
28 ± 9 |
|
|
100 µg |
|
12 ± 3 |
12 ± 2 |
21 ± 3 |
151 ± 13 |
32 ± 4 |
|
|
333 µg |
|
10 ± 3 |
12 ± 3 |
23 ± 4 |
163 ± 14 |
29 ± 6 |
|
|
1000 µg |
|
11 ± 2D |
11 ± 3D |
19 ± 5D |
147 ± 13D |
27 ± 1D |
|
|
2500 µg |
|
10 ± 1D M |
8 ± 1D M |
21 ± 2D M |
151 ± 13D M |
22 ± 4D M |
|
|
5000 µg |
|
10 ± 2D R M |
7 ± 2D M |
12 ± 2D M R |
137 ± 13D M |
24 ± 3D M |
|
NaN3 |
10 µg |
|
1110 ± 130 |
|
|
1742 ± 116 |
|
|
4-NOPD |
10 µg |
|
|
|
323 ± 36 |
|
|
|
4-NOPD |
50 µg |
|
|
85 ± 8 |
|
|
|
|
MMS |
2.0 µL |
|
|
|
|
|
965 ± 7 |
|
|
|
|
|
|
|
|
|
|
With Activation |
DMSO |
|
|
11 ± 2 |
12 ± 4 |
27 ± 8 |
140 ± 16 |
43 ± 5 |
Untreated |
|
|
10 ± 0 |
13 ± 1 |
29 ± 2 |
176 ± 14 |
46 ± 4 |
|
Pigment Red |
3 µg |
|
11 ± 2 |
11 ± 3 |
29 ± 6 |
153 ± 29 |
39 ± 7 |
|
50:1 |
10 µg |
|
9 ± 2 |
12 ± 2 |
30 ± 4 |
158 ± 7 |
40 ± 6 |
|
|
33 µg |
|
9 ± 2R |
10 ± 2 |
25 ± 2 |
158 ± 14 |
41 ± 5 |
|
|
100 µg |
|
11 ± 3R |
11 ± 4 |
26 ± 8 |
141 ± 9 |
39 ± 5 |
|
|
333 µg |
|
11 ± 2R |
11 ± 3 |
25 ± 8 |
146 ± 3 |
36 ± 6 |
|
|
1000 µg |
|
11 ± 1R D |
9 ± 1D |
26 ± 6D |
130 ± 6D |
22 ± 2D |
|
|
2500 µg |
|
10 ± 3R D M |
8 ± 2D M |
21 ± 4D M |
137 ± 14D M |
23 ± 3D M |
|
|
5000 µg |
|
2 ± 1R D M |
7 ± 1D M |
10 ± 2D M |
134 ± 9D M |
24 ± 3D M |
|
2-AA |
2.5 µg |
|
406 ± 25 |
292 ± 48 |
3275 ± 632 |
4099 ± 56 |
|
|
2-AA |
10.0 µg |
|
|
|
|
|
264 ± 25 |
|
|
|
|
|
|
|
|
|
|
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 M R |
Densely coloured plate Manual count Reduced background growth |
Table2 Summary of Experiment II
Study Name: 1664301 |
Study Code: Harlan CCR 1664301 |
Experiment: 1664301 HV2 Pre |
Date Plated: 19/11/2014 |
Assay Conditions: |
Date Counted: 24/11/2014 |
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 |
DMSO |
|
|
11 ± 3 |
11 ± 3 |
24 ± 5 |
173 ± 11 |
35 ± 2 |
Untreated |
|
|
13 ± 1 |
10 ± 3 |
22 ± 2 |
195 ± 4 |
39 ± 2 |
|
Pigment Red |
10 µg |
|
11 ± 1 |
11 ± 4 |
20 ± 7 |
153 ± 18 |
34 ± 6 |
|
50:1 |
33 µg |
|
12 ± 4 |
10 ± 3 |
21 ± 5 |
135 ± 6 |
34 ± 3 |
|
|
100 µg |
|
13 ± 3 |
9 ± 1 |
20 ± 1 |
162 ± 12 |
37 ± 6 |
|
|
333 µg |
|
14 ± 2 |
12 ± 4 |
20 ± 4 |
165 ± 9 |
28 ± 6 |
|
|
1000 µg |
|
11 ± 4P |
12 ± 3P |
23 ± 8P |
136 ± 25P |
28 ± 5P |
|
|
2500 µg |
|
10 ± 2P M |
11 ± 2P M |
23 ± 1P M |
151 ± 19P M |
34 ± 2P M |
|
|
5000 µg |
|
6 ± 1P M |
5 ± 2P M |
17 ± 4P M |
153 ± 12P M |
25 ± 2P M |
|
NaN3 |
10 µg |
|
1043 ± 4 |
|
|
1997 ± 183 |
|
|
4-NOPD |
10 µg |
|
|
|
300 ± 16 |
|
|
|
4-NOPD |
50 µg |
|
|
72 ± 2 |
|
|
|
|
MMS |
2 µL |
|
|
|
|
|
918 ± 34 |
|
|
|
|
|
|
|
|
|
|
With Activation |
DMSO |
|
|
26 ± 5 |
29 ± 2 |
43 ± 6 |
142 ± 21 |
49 ± 4 |
Untreated |
|
|
13 ± 1 |
29 ± 1 |
44 ± 11 |
160 ± 16 |
48 ± 9 |
|
Pigment Red |
10 µg |
|
28 ± 4 |
32 ± 6 |
41 ± 7 |
136 ± 12 |
49 ± 6 |
|
50:1 |
33 µg |
|
24 ± 4 |
30 ± 8 |
39 ± 4 |
148 ± 31 |
53 ± 5 |
|
|
100 µg |
|
24 ± 6 |
28 ± 6 |
45 ± 3 |
153 ± 36 |
49 ± 6 |
|
|
333 µg |
|
18 ± 5 |
24 ± 2 |
43 ± 2 |
154 ± 17 |
32 ± 3 |
|
|
1000 µg |
|
16 ± 1P |
26 ± 3P |
42 ± 9P |
155 ± 19P |
32 ± 1P |
|
|
2500 µg |
|
14 ± 3P M |
21 ± 2P M |
35 ± 3P M |
146 ± 17P M |
23 ± 1P M |
|
|
5000 µg |
|
10 ± 1P M |
14 ± 4P M |
26 ± 3P M |
127 ± 7P M |
21 ± 1P M |
|
2-AA |
2.5 µg |
|
|
|
|
3058 ± 178 |
|
|
2-AA |
2.5 µg |
|
398 ± 1 |
308 ± 16 |
|
|
|
|
2-AA |
10 µg |
|
|
|
|
|
728 ± 90 |
|
Congo red |
500 µg |
|
|
|
542 ± 94 |
|
|
|
|
|
|
|
|
|
|
|
|
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 |
Precipitate Manual count |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without hamster and rat S9
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 Pigment Red 50:1 to induce gene mutations according to the plate incorporation assay with rat liver S9 (experiment I), and the pre-incubation test with hamster liver S9 (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and the Escherichia coli strain WP2uvrA.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations:
Experiment I: 3; 10; 33; 100; 333; 1000; 2500 and 5000 µg/plate
Experiment II: 10; 33; 100; 333; 1000; 2500 and 5000 µg/plate
The test item precipitated in the overlay agar in the test tubes from 33 to 5000 µg/plate in experiment I and from 333 to 5000 µg/plate in experiment II. Precipitation of the test item in the overlay agar on the incubated agar plates was observed from 1000 to 5000 µg/plate in experiment II. The undissolved particles had no influence on the data recording.
The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without S9 mix in nearly all strains used. Reduced background growth was observed in experiment I at 5000 µg/plate in strains TA 1535 and TA 98 in the absence of metabolic activation and from 1000 to 5000 µg/plate in strain TA 1535 in the presence of metabolic activation.
No toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in nearly all test groups. A reduction in the number of revertants (below the indication factor of 0.5), was observed in the presence of metabolic activation at 5000 µg/plate in experiment I in strains TA 1535 and TA 98 and in experiment II in strains TA 1535 and WP2uvrA.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Pigment Red 50:1 at any dose level, neither in the presence nor absence of metabolic activation (S9 mix).
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
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