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EC number: 418-220-4 | CAS number: - RED JB 747
- 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
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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:
- January 04, 1994 - January 14, 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The study was performed only on 4 different strains instead of 5, since followed the OECD 471 of 1983, which was modified later in 1997.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 1992
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Trisodium bis[(3'-nitro-5'-sulfonato-(6-amino-2-[4-(2-hydroxy-1-naphtylazo)phenylsulfonylamino]pyrimidin-5-azo)benzene-2',4-diolato)]chromate(III)
- EC Number:
- 418-220-4
- EC Name:
- Trisodium bis[(3'-nitro-5'-sulfonato-(6-amino-2-[4-(2-hydroxy-1-naphtylazo)phenylsulfonylamino]pyrimidin-5-azo)benzene-2',4-diolato)]chromate(III)
- Molecular formula:
- C52H32CrN18Na3O20S4
- IUPAC Name:
- chromium(3+) trisodium bis(6-amino-2-{4-[2-(2-hydroxynaphthalen-1-yl)diazen-1-yl]benzenesulfonamido}-5-[2-(3-nitro-2-oxido-5-sulfonatophenyl)diazen-1-yl]pyrimidin-4-olate)
- Test material form:
- solid: particulate/powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Mutations of the bacterial strains used in the study can be described as follows:
Salmonella typhimirium
- TA 1537: his C 3076; rfa-; uvrB- (frame shift mutations)
- TA 98; his D 3052; rfa-; uvrB-;R-factor (frame shift mutations)
- TA 1535: his G 46; rfa-; uvrB- (base-pair substitutions)
- TA 100: his G 46; rfa-; uvrB-;R-factor (base-pair substitutions)
Regular checking of the properties of the Salmonella strains with regard to membrane permeability and ampicillin resistance as well as spontaneous mutation rates is performed in the testing laboratory according to Ames test. In this way it was ensured that the experimental conditions set down by Ames were fulfilled.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 hamster liver microsomal fraction
- Test concentrations with justification for top dose:
- 33.3, 100.0, 333.3, 1000.0, 2500.0, 5000.0 µg/plate. Concentrations covered two logarithmic decades. The choice of the top dose was based on a Range-Finding test.
- Vehicle / solvent:
- - Solvent: DMF
- Justification for choice of solvent: chosen to its solubility properties and its relative nontoxicity for bacteria.
Controls
- Untreated negative controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see Remarks
- Remarks:
- Sodium azide and 4-NOPD were used for "without metabilic activation" controls, while Congo Red and 2-AA for "with metabolic activation" controls.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation).
NUMBER OF REPLICATIONS
The experiment was conducted in two independent assays. For each strain an dose level, including the controls three plates were used as a minimum.
STORAGE
Strain were stored as stock cultures in ampoules with nutrient broth + 5 % DMSO in liquid nitrogen.
PRECULTURES
From the thawed ampoules of the strains 0.5 ml suspension was transferred to 250 ml Erlenmeyer flasks containing 20 ml nutrient medium. This nutrient medium contains per litre:
- 8 g Merck Nutrient Broth
- 5 g NaCl
The bacterial culture was incubated in a shaking water bath for 10 hours at 37 °C.
SELECTIVE AGAR
2.0 % Vogel-Bonner-Glucose-Minimal-Agar was used as selective agar. Each petri was filled with 20 ml of this nutrient medium.
The overlay agar contains per litre:
- 6.0 g Merck Agar Agar*
- 6.0 g NaCl*
- 10.5 mg L-histidine x HCl x H2O*
- 12,2 mg biotin*
* (MERCK, D-64 293 Darmstadt)
Sterilizations were performed at 121° C in an autoclave. - Statistics:
- No appropriate statistical method is available since no evaluated statistical procedure can be recommended for analysis of data from the bacterial assay at this time.
Results and discussion
Test results
- Species / strain:
- other: TA 98, TA 100, TA 1535 and TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES
To evaluate the toxicity of test item, a pre-study was performed with straings TA 98 and TA 100. The plates with the test article showed normal background growth up to 5000.0 ug/plate in both the tested strains.
MAIN ASSSAYS
Toxic effects, evidenced by a reduction in the number of revertants, occurred in strain TA 1535 at 2500.0 µg/plate (without S9 mix) and in strain TA 98 at 1000.0; 2500.0 and 5000.0 µg/plate (with and without S9 mix) in experiment I.
In experiment II toxic effects occurred at 2500.0 and 5000.0 (without S9 mix) and at 1000.0; 2500.0 and 5000.0 µg/plate (with S9 mix) in the strains TA 1535, TA 1537, and TA 98. The background growth of the bacteria (as an additional indication of toxicity) was not influenced. 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.
No substantial and dose-dependent increases in revertant colony numbers of any of the four tester strains were observed following treatment with test article at any concentration level, either in the presence or absence of metabolic activation (S9 mix) in experiment I. There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance in experiment II with and without S9 mix in all strains used.
Appropriate reference mutagens were used as positive controls. They showed a distinct increase in induced revertant colonies.
Any other information on results incl. tables
Revertants/plate mean from three plates. Without S9 mix.
Concentration µg/plate | TA 1535 | TA 1537 | TA 98 | TA 100 | ||||
Experiment | I | II | I | II | I | II | I | II |
Neg. control | 20 | 17 | 13 | 7 | 40 | 36 | 191 | 143 |
Solv. control | 13 | 7 | 14 | 6 | 21 | 13 | 108 | 168 |
33.3 | 14 | 8 | 8 | 8 | 21 | 17 | 114 | 176 |
100.0 | 16 | 6 | 10 | 8 | 19 | 12 | 111 | 168 |
333.3 | 13 | 11 | 9 | 8 | 20 | 14 | 134 | 164 |
1000.0 | 10 | 6 | 10 | 8 | 11 | 9 | 101 | 152 |
2500.0 | 7 | 3 | 8 | 2 | 4 | 7 | 81 | 140 |
5000.0 | 8 | 2 | 8 | 1 | 0 | 4 | 89 | 164 |
Positive controls | ||||||||
Sodium azide (10 µg/plate) | 850 | 793 | 734 | 708 | ||||
4-NOPD (10 µg/plate) | 78 | 66 | 453 | 404 |
Revertants/plate mean from three plates. With S9 mix.
Concentration µg/plate | TA 1535 | TA 1537 | TA 98 | TA 100 | ||||
Experiment | I | II | I | II | I | II | I | II |
Neg. control | 15 | 12 | 22 | 15 | 35 | 45 | 156 | 127 |
Solv. control | 15 | 15 | 11 | 17 | 39 | 53 | 165 | 140 |
33.3 | 21 | 15 | 9 | 18 | 35 | 56 | 182 | 144 |
100.0 | 21 | 17 | 20 | 18 | 38 | 50 | 163 | 128 |
333.3 | 17 | 17 | 19 | 11 | 31 | 43 | 198 | 106 |
1000.0 | 12 | 7 | 13 | 7 | 24 | 20 | 171 | 155 |
2500.0 | 10 | 5 | 9 | 2 | 10 | 5 | 226 | 130 |
5000.0 | 8 | 2 | 8 | 0 | 5 | 0 | 224 | 101 |
Positive controls | ||||||||
2-AA (2.5 µg/plate) | 251 | 216 | 365 | 400 | 1530 | 1297 | ||
Congo Red (500 µg/plate) | 263 | 259 |
Applicant's summary and conclusion
- Conclusions:
- The test substance did not induce gene mutations by base pair changes or frameshifts, both with and without metabolic activation.
- Executive summary:
The test substance was tested for detecting its potential gene mutagenic activity using the Salmonella typhimurium strains TA 98, TA 100, TA 1535 and TA 1537. It should be noted that the study was performed only on 4 different strains of microorganisms instead of 5. This difference is due to the fact that the study was performed according to OECD 471 (1983) which was modified later in 1997.The tests were performed with and without metabolic activation. The test item was examined in two independent assays at 6 concentrations from 3.33 to 5000 µg/plate.
In the experiments performed, no relevant increase of the revertant colony numbers was observed in any Salmonella typhimurium strain tested, in the presence and in the absence of S9 mix. The test substance did not induced point mutations by base pair changes and frameshifts in the genome of the strains of Salmonella typhimurium used.
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