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EC number: 440-050-4 | CAS number: 243857-97-8
- 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 mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Nov. 17, 1999 to Apr. 10, 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive 87/302, L133, pp. 61 - 63, March 1987
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 440-050-4
- EC Name:
- -
- Cas Number:
- 243857-97-8
- Molecular formula:
- Hill formula: C23H(19-x-y)ClLixN8NayO14S4 (x+y=3), x and y > 0
- IUPAC Name:
- lithium(1+) disodium 2-{[4-chloro-6-(cyanoamino)-1,3,5-triazin-2-yl]amino}-5-hydroxy-6-(2-{2-methoxy-5-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-1,7-disulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Reaktiv Orange DYPR 1466
Constituent 1
Method
- Target gene:
- HRPT locus (V79 Chinese hamster cells)
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- Source: cell bank of "Genetic Toxicology", Aventis Pharma Deutschland GmbH, ProTox
Cell culture medium: MEM (minimal essential medium) with Hankssalts and 25 mM Hepes-buffer
pH values and osmolality of the treatment media: Determined before treatment
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- Main mutation experiment (First):
- without S9-mix: 100, 250, 500, 1000, 1750, 2500, 3750 and 5000* µg/mL
- with S9-mix: 100, 250, 500, 1000, 1750, 2500, 3750 and 5000 µg/mL
* = because of high toxicity in the first main experiment no mutant selection was performed
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle:
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9,10-dimethylbenzanthracene
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Seeded in each well of a microtiter plate
DURATION (Preliminary toxicity)
- Preincubation period: 12 h (overnight)
- Exposure duration: 4 h
- Incubation period: 24 h
- Fixation and staining: Crystal violet
NUMBER OF REPLICATIONS: 6 (For each concentration at least 6 wells)
DURATION (Main experiment)
- Preincubation period: 24 h
- Exposure duration: 4 h (Medium+ test substance+ buffer/S9-mix)
- Incubation period: 24 h
- Fixation and staining: Crystal violet - Evaluation criteria:
- The test item was considered positive if
(a) It reproducibly induces with one of the test compound concentrations a mutation frequency that is three times higher than the spontaneous mutant frequency in this experiment.
(b) There is a reproducible concentration-related increase in the mutation frequency. Such an evaluation may be considered independently from the enhancement factor for induced mutants.
(c) Survival of the responding dose group is at least 30 %.
However, in a case by case evaluation both decisions depend on the level of the corresponding negative control data.
- Statistics:
- - The biometry of the results for the test compound is performed off-line with the Mann-Whitney- U-Test
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- 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:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No effects
- Effects of osmolality: No effects
RANGE-FINDING/SCREENING STUDIES:
Evaluation of the solubility of the suspension in cell culture medium showed that 5000 µg/mL was the highest concentration at which no visible precipitation was observed.
Preliminary toxicity study: Was carried out using a maximum concentration of 5000 µg/mL and a range of lower dose levels down to 10 µg/mL.
Based on the preliminary study results, 5000 µg/mL was selected as the maximum dose level for the main mutation experiments in both the absence and in the presence of S9-mix. Seven lower concentrations down to 100 µg/mL were also included.
COMPARISON WITH HISTORICAL CONTROL DATA: Yes
Any other information on results incl. tables
The sensitivity of the test system and efficacy of the S9-mix was demonstrated by the enhanced mutation frequency in the cell cultures treated with the positive control substances.
Mutation results:
Main experiment: A significant increase of the mutation frequency was observed in the presence of metabolic activation at the concentrations of 250, 2500 and 3750 µg/mL.
These results were not reproducible and not three fold higher than the corresponding controls and were therefore considered to be of no biological relevance.
No relevant reproducible increase in the mutant colonies or mutant frequency over the range of the solvent control was found with any other concentration, either with or without metabolic activation by S9-mix.
Applicant's summary and conclusion
- Conclusions:
- The test substance is considered to be non-mutagenic in the HPRT-test with V79 Chinese hamster cells, either in the presence or in the absence of metabolic activation.
- Executive summary:
The study was performed to investigate the potential of test substance to induce gene mutations at the HPRT locus in V 79 cells of the Chinese hamster in vitro according to OECD Guideline 476, EPA OPPTS 870.5300 and EEC Directive 87/302, L133 in compliance with GLP.
Two independent experiments were conducted both with and without an exogenous rat liver microsomal activation system (S9-mix). The test substance was dissolved in cell culture medium and tested at the following concentrations:
- without S9-mix: 100, 250, 500, 1000, 1750, 2500, 3750 and 5000 µg/mL
- with S9-mix: 100, 250, 500, 1000, 1750, 2500, 3750 and 5000 µg/mL
Due to the limitation of the OECD guideline 5000 µg/mL is the highest tolerated dose.
The concentration ranges were based on the results of preliminary tests for solubility and toxicity. The highest concentration showed toxic effects with and without metabolic activation.
Test substance produced no macroscopical precipitation. Up to the highest investigated dose no relevant and reproducible increase in mutant colony numbers was obtained in two independent experiments.
Appropriate reference mutagens used as positive controls showed a distinct increase in induced mutant colonies, thus indicating the sensitivity of the assay and the efficacy of the S9-mix.
Test substance does not induce gene mutations in the HPRT-test with V79 Chinese hamster cells, both in the presence as well as in the absence of a metabolic activation system.
Under the test conditions, the test substance is considered to be non-mutagenic in the HPRT-test with V79 Chinese hamster cells, either in the presence or absence of metabolic activation.
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