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EC number: 309-913-1 | CAS number: 101357-16-8
- 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:
- 9 November 2009 - 3 December 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test method according to OECD Guideline 471. GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Benzenamine, reaction products with aniline hydrochloride and nitrobenzene, hydrochlorides
- EC Number:
- 309-913-1
- EC Name:
- Benzenamine, reaction products with aniline hydrochloride and nitrobenzene, hydrochlorides
- Cas Number:
- 101357-16-8
- Molecular formula:
- Not applicable. Multiconstituent substance.
- IUPAC Name:
- (2Z,7Z)-5-phenyl-2,7-bis(phenylimino)-2,7-dihydro-5λ⁵-phenazin-5-ylium (7Z)-N2,N3,5-triphenyl-7-(phenylimino)-5,7-dihydrophenazine-2,3-diamine N2,N3,5,7-tetraphenyl-5,7,12,14-tetrahydro-5,7,12,14-tetraazapentacene-2,3-diamine chloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): C.I. Solvent Black 5 (analogue CAS 11099-03-9).
- Lot/batch No.: 10137087
- Physical state: Blackish brown powder
- Storage condition of test material: Room temperature.
- Stability and uniformity were property has been confirmed.
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Without metabolic activation (all strains): 0.610, 1.22, 2.44, 4.88, 9.77 and 19.5 μg/plate.
With metabolic activation (TA100, TA1535, TA98 and TA1537): 19.5, 39.1, 78.1, 156, 313 and 625 μg/plate.
With metabolic activation (WP2uvrA): 156, 313, 625, 1250, 2500 and 5000 μg/plate. - Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamida (AF2)
- Remarks:
- TA100 (0.1 µg/mL), WP2uvrA (0.2 µg/mL), TA98 (1 µg/mL)
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- sodium azide
- Remarks:
- TA1535 (5 µg/mL)
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- other: 9-aminoacridine hydrochloride hydrate (9AA)
- Remarks:
- TA1537 (800 µg/mL)
- Positive controls:
- yes
- Remarks:
- with metabolic activation
- Positive control substance:
- other: 2-aminoanthracene (2AA)
- Remarks:
- TA100 (10 µg/mL), TA1535 (20 µg/mL), WP2uvrA (100 µg/mL), TA98 (5 µg/mL), TA1537 (20 µg/mL)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min at 37 ºC
- Exposure duration: 48 hours at 47 ºC
NUMBER OF REPLICATIONS: 3
NUMBER OF CELLS EVALUATED:
DETERMINATION OF CYTOTOXICITY: Yes - Evaluation criteria:
- Results are found to be positive when revertant frequency increase 2 times or more compared with vehicle control, with a dose-response relationship and the results are reproducible.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
Precipitation was observed in the doses with metabolic activation
RANGE-FINDING/SCREENING STUDIES:
First dose-finding test: With and without metabolic activation, for all test strains. Dosages: 5, 15, 50, 150, 1500 and 5000 μg /plate.
Second dose-finding test: Without metabolic activation, for all test strains. Dosages: 0.384, 0.960, 0.240, 6 and 15 μg/plate.
COMPARISON WITH HISTORICAL CONTROL DATA:
Negative and positive controls according with historical control data.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Cytototixicy was observed at highest dose both with and without metabolic activation. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Results obtained in the main test:
Metabolic activation |
µg/plate |
Revertant colonies / plate (triplicate, average) |
||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||
Without |
DMSO |
89 ± 10 |
7 ± 1 |
25 ± 2 |
19 ± 4 |
7 ± 3 |
0.610 |
89 ± 6 |
4 ± 1 |
21 ± 2 |
23 ± 6 |
4 ± 1 |
|
1.22 |
93 ± 11 |
6 ± 2 |
24 ± 4 |
18 ± 4 |
5 ± 1 |
|
2.44 |
95 ± 3 |
8 ±2 |
21 ± 7 |
17 ± 2 |
5 ± 3 |
|
4.88 |
72 ± 3 |
6 ± 1 |
21 ± 5 |
16 ± 9 |
6 ± 2 |
|
9.77 |
86 ± 11* |
4 ± 3 * |
24 ± 4 * |
21 ± 3 * |
5 ± 3 * |
|
19.5 |
82 ± 9 * |
6 ± 1 * |
25 ± 3 * |
21 ± 2 * |
2 ± 1 * |
|
AF-2 |
409 ± 16 |
-- |
427 ± |
551 ± 21 |
-- |
|
NaN3 |
-- |
251 ± 5 |
-- |
-- |
-- |
|
9AA |
-- |
-- |
-- |
-- |
404 ± 65 |
|
With |
DMSO |
98 22 |
7 ± 2 |
28 ± 4 |
30 ± 13 |
9 ± 1 |
19.5 |
118 ± 2 |
9 ± 4 |
-- |
44 ± 6 |
8 ± 3 |
|
39.1 |
117 ± 13 |
9 ± 3 |
-- |
43 ± 5 |
9 ± 1 |
|
78.1+ |
97 ± 5 |
7 ± 4 |
-- |
33 ± 6 |
8 ± 2 |
|
156 + |
103 ± 14 |
5 ± 1 |
29 ± 3 |
33 ± 3 |
6 ± 3 |
|
313 + |
101 ± 2 |
7 ± 2 |
27 ± 3 |
24 ± 2 |
6 ± 1 |
|
625 + |
115 ± 5 * |
8 ± 3 * |
23 ± 6 |
26 ± 9 * |
7 ± 4 * |
|
1250 + |
-- |
-- |
21 ± 2 |
-- |
-- |
|
2500 + |
-- |
-- |
18 ± 1 |
-- |
-- |
|
5000 + |
-- |
-- |
17 ± 5 |
-- |
-- |
|
2AA |
687 ± 41 |
147 ± 10 |
193 ± 18 |
548 ± 27 |
189 ± 10 |
(--) Not tested
(+) Precipitation
(*) Cytotoxicity
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative (with and without metabolic activation)
Test item did not induce gene mutation in bacteria in a reverse mutation assay with and without metabolic activation. - Executive summary:
A bacterial reverse mutation assay was performed on test item according to OECD Guideline 471 preincubation method. Based on preliminary works, Salmonella typhimurium TA100, TA1535, TA98, TA1537 strains and Escherichia coli WP2uvrA strain were exposed up to 19.5 µg/mL without metabolic activation and up to 625 µg/mL (S. typhimurium strains) and 5000 µg/mL (WP2 uvrA) with metabolic activation. Negative solvent and positive controls were performed satisfactorily. Precipitation of the test item and cytotoxicity was detected in some concentrations. Test item was determined to be nonmutagenic under test conditions since a 2 -fold or greater and dose-dependent increase in revertant colonies was not observed in any test strain with or without metabolic activation. Based on increase in revertant colonies compared to the negative control, test item was determined to be nonmutagenic under test conditions.
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