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EC number: 257-776-0 | CAS number: 52238-92-3
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD guideline and GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- Deviations:
- yes
- Remarks:
- Only one positive control (2-AA) in treatments with S9-mix used
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- (2000)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- (1998)
- Qualifier:
- according to guideline
- Guideline:
- other: "Testing Methods for New Chemical Substances", November 21, 2003 (Yakushokuhatsu No. 1121002, Heisei 15.11.13 Seikyoku No. 2 and Kanpokihatsu No. 031121002).
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N,N'-phenylene-1,4-bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
- EC Number:
- 223-460-6
- EC Name:
- N,N'-phenylene-1,4-bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
- Cas Number:
- 3905-19-9
- Molecular formula:
- C40H24Cl4N6O4
- IUPAC Name:
- 3,3'-[(2,2'',5,5''-tetrachloro-1,1':4',1''-terphenyl-4,4''-diyl)bis(triaz-2-ene-3,1-diylcarbonyl)]di(2-naphthol)
- Test material form:
- not specified
- Details on test material:
- - Physical state: solid, red
- Lot/batch No.: 38852FC5
- Expiration date of the lot/batch: 2010-04-26
- Storage condition of test material: room temperature, protected from light
Constituent 1
Method
- Target gene:
- Histidine mutation
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: TA 98: rfa-, uvrB-, R-factor; TA 100: rfa-, uvrB-, R-factor; TA 1535: rfa-, uvrB-; TA 1537: rfa-, uvrB-
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other: trp-; uvr A-
- Metabolic activation:
- with and without
- Metabolic activation system:
- uninduced hamster liver S9 (Syrian hamster)
- Test concentrations with justification for top dose:
- concentrations in pre-experiment (cytotoxicity) were 3.16, 10, 31.6, 100, 316, 1000, 2500, 5000 µg/plate for S9 unactivated strains
concentrations in pre-experiment (cytotoxicity) were 31.6, 100, 316, 1000, 2500, 5000 µg/plate for S9 activated strains
concentrations in experiment 1 were 31.6, 100, 316, 1000, 2500, 5000 µg/plate
concentrations in experiment 2 were 190, 375, 750, 1500, 3000, 5000 µg/plate - Vehicle / solvent:
- DMSO used as a vehicle
The solvent was compatible with the survival of the bacteria and the S9-activity
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- aqua dest.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- (without S9-mix)
- Positive control substance:
- other: sodium azide for TA 100, TA 1535; 4-nitro-o-phenylene-diamine (4-NOPD) for TA 98, TA 1537, methylmethanesulfonate for E. coli: WP2 uvrA
- Remarks:
- TA 100, TA 1535
- Positive controls:
- yes
- Remarks:
- (with S9-mix)
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA 98, TA 100, TA 1535, TA 1537, E. coli: WP2 uvrA
- Details on test system and experimental conditions:
- The preincubation method was used
METHOD OF APPLICATION:
following components were mixed:
100 µl test solution or solvent (as negative control), or reference mutagen (as positive control)
100 µl of tester strains
500 µl of metabolic activation system
preincubation time: 30 min
temperature: 37 °C
afterwards mixture is added to 2000 µl overlay agar and poured onto the surface of a minimal agar plate
DURATION (for both applications)
- Exposure duration: at least 48 hrs , temperature 37°C, darkness
Counting of colonies: The colonies were counted using a Protocol counter (Meintrup DWS Laborgerate GmbH). If precipitation of the test item precluded automatic counting the revertant colonies were counted by hand. In addition, tester strains with a low spontaneous mutation frequency like TA 1535 and TA 1537 were counted manually.
Evaluation of the mutation factor:
The mutation factor is calculated by dividing the mean value of the revertant counts through the mean values of the solvent control (the exact and not the rounded values are used for calculation). - Evaluation criteria:
- A test is considered acceptable if for each strain:
- the bacteria demonstrate their typical responses to crystal violet and ampicillin
- the preculture shows a number of 10^9 cells/mL (quantified by optical density)
- the control plates without S9 mix are within the historical control range of the testing facility (mean values)
- corresponding background growth on both negative control and test plates is observed.
- the positive controls show a distinct enhancement of revertant rates over the control plate.
A test item is considered as mutagenic if
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains TA 100 and WP2 uvrA the number of reversions is at least twice as high as spontaneous reversion rate
- if in tester strains TA 1535, TA 1537 and TA 98 the number of reversions is at least three times higher as compared to the spontaneous reversion rate .
A test item producing neither a dose related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups is considered to be non-mutagenic in this system.
Toxicity may be detected by a clearing or rather diminution of the background lawn or a reduction in the number of revertants down to a mutation factor of approximately <= 0.5 in relation to the solvent control. - Statistics:
- According to the OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A mutation factor of 0.5 or lower was obtained for experiment I with strain TA 1535 and TA 1537, subst. conc. of 5000 µg/plate with S9-activation, for experiment II with strain TA 1535 at 3000 µg/plate and TA 1537 at 750 µg/plate, both without S9-mix.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Precipitation: It was observed for the test item in all tester strains in both experiments for concentrations of 316 µg/plate and higher (with and without metabolic activation).
Cytotoxicity: No toxic effects of the test item were observed in tester strains TA 98, TA 100 and E. coli WP2 uvrA. Toxic effects were seen in experiment I with strain TA 1535 and TA 1537, subst. conc. of 5000 µg/plate with S9-activation, for experiment II with strain TA 1535 at 3000 µg/plate and TA 1537 at 750 µg/plate, both without S9-mix.
Biological effects: No biologically relevant increases in any of the five tester strains were observed after treatment of test substance at any concentration level, neither in the presence nor in the absence of metabolic activation in both experiments. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Experiment 1 without S9-Mix [mean no. of mutations/ plate] |
|||||
Dosage [µg/plate] | TA 100 | TA 1535 | WP2uvrA | TA 98 | TA 1537 |
Solvent control | 104 | 11 | 45 | 31 | 15 |
31.6 | 88 | 12 | 54 | 27 | 14 |
100 | 98 | 17 | 44 | 28 | 12 |
316 | 72 | 12 | 46 | 22 | 9 |
1000 | 87 | 8 | 45 | 26 | 13 |
2500 | 93 | 10 | 37 | 27 | 11 |
5000 | 114 | 6 | 42 | 24 | 9 |
Positive control | 976 | 778 | 782 | 422 | 171 |
Experiment 1 with S9-Mix [mean no. of mutations/ plate] |
|||||
Dosage [µg/plate] | TA 100 | TA 1535 | WP2uvrA | TA 98 | TA 1537 |
Solvent control | 90 | 7 | 33 | 46 | 10 |
31.6 | 108 | 13 | 42 | 51 | 21 |
100 | 110 | 10 | 43 | 45 | 16 |
316 | 110 | 8 | 55 | 44 | 13 |
1000 | 99 | 8 | 49 | 45 | 9 |
2500 | 101 | 5 | 43 | 36 | 10 |
5000 | 103 | 3 | 46 | 57 | 4 |
Positive control | 560 | 75 | 133 | 442 | 58 |
Experiment 2 without S9-Mix [mean no. of mutations/ plate] |
|||||
Dosage [µg/plate] | TA 100 | TA 1535 | WP2uvrA | TA 98 | TA 1537 |
Solvent control | 101 | 16 | 56 | 23 | 17 |
190 | 105 | 12 | 44 | 24 | 16 |
375 | 89 | 11 | 52 | 23 | 14 |
750 | 76 | 11 | 49 | 18 | 8 |
1500 | 94 | 11 | 63 | 26 | 15 |
3000 | 94 | 8 | 49 | 23 | 14 |
5000 | 89 | 13 | 49 | 21 | 11 |
Positive control | 1122 | 1079 | 781 | 652 | 202 |
Experiment 2 with S9-Mix [mean no. of mutations/ plate] |
|||||
Dosage [µg/plate] | TA 100 | TA 1535 | WP2uvrA | TA 98 | TA 1537 |
Solvent control | 93 | 10 | 47 | 49 | 25 |
190 | 88 | 9 | 31 | 44 | 37 |
375 | 97 | 12 | 42 | 45 | 32 |
750 | 94 | 11 | 51 | 47 | 27 |
1500 | 91 | 9 | 51 | 54 | 26 |
3000 | 97 | 9 | 46 | 53 | 25 |
5000 | 100 | 7 | 52 | 64 | 20 |
Positive control | 1375 | 89 | 536 | 1717 | 202 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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