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EC number: 424-310-4 | CAS number: 178452-66-9 BLUE PE 3811
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From June 20th to July 5th, 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- May 26th, 1983
- Deviations:
- yes
- Remarks:
- Salmonella Typhimurium Reverse Mutation Assay Modified Version for Azo-Dyes
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-(2,4-bis(4-((5-(4,6-bis(2-aminopropylamino)-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-disulfonaphthalen-3-yl)azo)phenylamino)-1,3,5-triazin-6-ylamino)propyldiethylammonium lactate
- EC Number:
- 424-310-4
- EC Name:
- 3-(2,4-bis(4-((5-(4,6-bis(2-aminopropylamino)-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-disulfonaphthalen-3-yl)azo)phenylamino)-1,3,5-triazin-6-ylamino)propyldiethylammonium lactate
- Cas Number:
- 178452-66-9
- Molecular formula:
- Hill formula: C63 H83 N27 O17 S4 CAS formula: C60 H77 N27 O14 S4 . C3 H6 O3
- IUPAC Name:
- 2-hydroxypropanoic acid; 5-({4,6-bis[(2-aminopropyl)amino]-1,3,5-triazin-2-yl}amino)-3-{2-[4-({4-[(4-{2-[8-({4,6-bis[(2-aminopropyl)amino]-1,3,5-triazin-2-yl}amino)-1-hydroxy-3,6-disulfonaphthalen-2-yl]diazen-1-yl}phenyl)amino]-6-{[3-(diethylamino)propyl]amino}-1,3,5-triazin-2-yl}amino)phenyl]diazen-1-yl}-4-hydroxynaphthalene-2,7-disulfonic acid
- Test material form:
- solid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Test I (plate incorporation test): rat liver S9 mix
Test II (pre-incubation test): hamster liver S9 mix - Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 33.3, 100.0, 333.3, 1000.0, 2500.0, 5000.0 μg/plate
Concentration range in the main test (without metabolic activation): 33.3, 100.0, 333.3, 1000.0, 2500.0, 5000.0 μg/plate - Vehicle / solvent:
- Bi-distilled water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: 4-nitro-o-phenylene-diamine
- Remarks:
- without metabolic activation - rat liver S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with metabolic activation - rat liver S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- congo red
- other: 2-aminoanthracene
- Remarks:
- with metabolic activation - hamster liver S9 mix
- Details on test system and experimental conditions:
- According to the results of the pre-experiment, the concentrations applied in the main experiment were chosen. The maximum concentration was 5000.0 μg/plate. According to the dose selection criteria the test article was tested at the following concentrations: 33.3, 100.0, 333.3, 1000.0, 2500.0, 5000.0 μg/plate. For each strain and dose level, including the controls, three plates were used. The following materials were mixed in a test tube and poured into the selective agar plates:
- 100 μl test solution at each dose level, solvent (negative control) or reference mutagen solution (positive control).
- 500 μl S9 mix (for the test with metabolic activation) or S9 mix substitution buffer (for test without metabolic activation).
- 100 μl bacteria suspension. - Rationale for test conditions:
- A pre-experiment on toxicity was run on TA 98 and TA 100. The plates incubated with the test article showed normal background growth up to 5000.0 μg/plate with and without S9 mix in all strains used.
- Evaluation criteria:
- A test article is considered mutagenic if in strains TA 98 and TA 100 the number of reversions is at least twice higher and in strains TA 1535 and TA 1537 at least three times higher as compared to the spontaneous reversion rate.
Also, a dose-dependent increase in the number of revertants is regarded as an indication of possibly existing mutagenic potential of the test article regardless whether the highest dose induced the above described enhancement factors or not.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- exp. I and II
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- exp. I and II
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- exp. I and II
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- exp. I and II
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- No toxic effects, evident as a reduction in the number of revertants, occured in the test groups with and without metabolic activation up to the highest investigated dose. An isolated and moderate reduction of revertant colonies occured in the strain TA 98 in the absence of metabolic activation at 2500 μg/plate in the second experiment. This effect was considered as a fluctuation of the frequency of spontaneous reversions rather than a true toxic effect. The reduction was not observed at any other concentration of the test article and did not occur in the first experiment.
The plates incubated with the test article showed normal background growths up to 5000.0 μg/plate with and without S9 mix in all strains used.
No substantial increase in revertant colony numbers of any of the four tester strains were observed following treatment with the test substance at any concentration level, neither in the presence nor absence of metabolic activation 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 mutagen were used as positive controls. They showed a distinct increase in induced revertant colonies.
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 article did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
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