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EC number: 225-862-7 | CAS number: 5124-25-4
- 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:
- HRPT Locus (V79)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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:
- EU Method B.17 (Mutagenicity - 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
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Germany)
- Type of assay:
- in vitro mammalian cell gene mutation test using the Hprt and xprt genes
Test material
- Reference substance name:
- 4-anilino-3-nitro-N-phenylbenzenesulphonamide
- EC Number:
- 225-862-7
- EC Name:
- 4-anilino-3-nitro-N-phenylbenzenesulphonamide
- Cas Number:
- 5124-25-4
- Molecular formula:
- C18H15N3O4S
- IUPAC Name:
- 4-anilino-3-nitro-N-phenylbenzenesulfonamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name: FAT 36014/Z TE
Product: TERASIL YELLOW GWL CRUDE MOIST (LAB DRIED) Disperse Yellow 042
Chemical Name: 3-Nitro-N-phenyl-4-(phenylamino)benzene sulfonamide
Batch No.: Q30661AASY
Physical State: solid
Storage Conditions: room temperature, protected from light
Expiry Date: 08/08/2018
Colour: yellow
pH (specify): 9.0 (2%(w/w) aqu. Suspension), RT
Melting point: 158 °C
Active components: > 90 %
Purity (qualitative and quantitative): 94.0 % (w/w)
Molecular Weight: 369.40 g/mol
Date of Analysis: 07 August 2013
Hazards and Precautions: safety glasses with side shields
Solubility in water: 5.72 mg/l
Constituent 1
- Specific details on test material used for the study:
- Name: FAT 36014/Z
Product: Terasil Yellow GWL crude moist (Lab dried)
Disperse Yellow 042
Batch No.: Q30661AASY
Physical State: solid
Storage Conditions: room temperature, protected from light
Expiry Date: 08/08/2018
Colour: Yellow
pH (specify): 9 (2 %(w/w) aqu. Suspension), RT
Melting point: 158 °C
Active components: >90 %
Purity (qualitative and quantitative): 94 % (w/w)
Molecular Weight: 369.40 g/mol
Date of Analysis: 07 August 2013
Hazards and Precautions: safety glasses with side shields
Solubility in water: 5.72 mg/l
Safety Precautions: safety gloves, mask and safety glasses were worn while handling the test item.
Method
- Target gene:
- hypoxanthine-guanine-phosphoribosyl-transferase (HPRT)
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- -Type and identity of media: MEM
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically "cleansed" against high spontaneous background: yes - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 of Wistar Phenobarbital and ß-Naphthoflavone-induced rat liver S9 mix
- Test concentrations with justification for top dose:
- Pre-experiment for experiment I (with and without metabolic activation):
10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 150, 200 µM
Pre-experiment for experiment II (only without metabolic activation, 20 h long-term exposure assay):
0.5, 1, 2.5, 5, 10, 20, 35, 50, 75, 100 µM
Experiment I
without metabolic activation: 0.5, 1, 2.5, 5.0, 10, 11, 12.5, 14, 15.5, 17 µM
and with metabolic activation: 10, 20, 30, 40, 45, 50, 55, 60, 65, 70 µM
Experiment II
without metabolic activation: 5, 10, 20, 30, 40, 50, 55, 60, 65, 70 µM
and with metabolic activation: 8, 16, 22, 30, 38, 46, 52, 58, 60 µM - Vehicle / solvent:
- Vehicle (Solvent) used: DMSO (1% v/v).
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation; 300 µg/mL
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Remarks:
- with metabolic activation; 0.8 and 1.0 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: dissolved in DMSO
DURATION: 4 h (short-term exposure), 20 h (long-term exposure)
Expression time (cells in growth medium): 5 days
Selection time (if incubation with selection agent): about one week
SELECTION AGENT (mutation assay) 11 µg/mL 6-thioguanine (TG)
NUMBER OF REPLICATIONS: two separate experiments (I + II) with single exposure; 5 individual flasks were seeded and evaluated
NUMBER OF CELLS EVALUATED: 400000 cells per flask
DETERMINATION OF CYTOTOXICITY: Method: relative growth - Evaluation criteria:
- A test is considered to be negative if there is no biologically relevant increase in the number of mutants. There are several criteria for determining a positive result:
-a reproducible three times higher mutation frequency than the solvent control for at least one of the concentrations;
-a concentration related increase of the mutation frequency; such an evaluation may be considered also in the case that a three-fold increase of the mutant frequency is not observed;
-if there is by chance a low spontaneous mutation rate in the corresponding negative and solvent controls a concentration related increase of the mutations within their range has to be discussed. - Statistics:
- A statistical analysis of the test data was not performed. At present the use of statistical methods concerning this particular test system is not generally recommended.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Experiment I without S9: ≥ 11.0 µM; experiment I with S9: ≥ 50 µM; Experiment II without S9: ≥ 20 µM; Experiment II with S9:≥ 38 µM
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- None
- Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
Precipitation:
Precipitation of the test item was noted in the pre-experiment at a concentration of 200 μM (with and without metabolic activation). No precipitation of the test item was noted in the main experiments.
Cytotoxicity:
A biologically relevant growth inhibition (reduction of relative growth below 70 %) was observed after the treatment with the test item in experiment I and II with and without metabolic activation. In experiment I without metabolic activation the relative growth was 23.6 % for the highest concentration (17 μM) evaluated. The highest biologically relevant concentration evaluated with metabolic activation was 70 μM with a relative growth of 12.1 %.
In experiment II without metabolic activation the relative growth was 12.6 % for the highest concentration (70 μM) evaluated. The highest concentration evaluated with metabolic activation was 60 μM with a relative growth of 11.7 %.
Mutagenicity:
In experiment I without metabolic activation all mutant values of the negative controls, the solvent controls and test item concentrations found were within the historical control data of the test facility BSL BIOSERVICE (about 5-43 mutants per 106 cells). No dose-response relationship could be observed. The mutation frequencies found in the groups treated with the test item did not show a biologically relevant increase as compared to the solvent controls. Mutation frequencies with the negative control were found to be 34.95 and 21.95, of the solvent control 25.27 and 19.66 mutants/106 cells and in the range of 18.99 to 35.74 mutants/10E6 cells with the test item, respectively. The highest mutation rate (compared to the solvent control values) of 1.59 was found at a concentration of 17 μM with a relative growth of 23.6 %. With metabolic activation most mutant values of the negative controls, the solvent controls and test item concentrations found were within the historical control data of the test facility BSL BIOSERVICE (about 5-44 mutants per 10E6 cells). No dose-response relationship could be observed. The mutation frequencies found in the groups treated with the test item did not show a biologically relevant increase as compared to the solvent controls. Mutation frequencies with the negative control were found to be 26.59 and 24.79, of the solvent control 33.53 and 24.71 mutants/106 cells and in the range of 11.18 to 46.63 mutants/10E6 cells with the test item, respectively. The highest mutation rate (compared to the solvent control values) of 1.60 was found at a concentration of 70 μM with a relative growth of 12.1 %. In experiment II without metabolic activation most mutant values of the negative controls, the solvent controls and test item concentrations found were within the historical control data of the test facility BSL BIOSERVICE (about 5-43 mutants per 106 cells). No dose-response relationship couldbe observed. The mutation frequencies found in the groups treated with the test item did not show a biologically relevant increase as compared to the solvent controls. Mutation frequencies with the negative control were found to be 21.50 and 24.26, of the solvent control 38.06 and 40.96 mutants/106 cells and in the range of 19.44 to 64.86 mutants/106 cells with the test item, respectively. The highest mutation rate (compared to the solvent control values) of 1.64 was found at a concentration of 65 μM with a relative growth of 16.6 %. In experiment II with metabolic activation all mutant values of the negative controls, the solvent controls and test item concentrations found were within the historical control data of the test facility BSL BIOSERVICE (about 5-44 mutants per 10E6 cells). No dose-response relationship could be observed. The mutation frequencies found in the groups treated with the test item did not show a biologically relevant increase as compared to the solvent controls. Mutation frequencies with the negative control were found to be 41.21 and 24.93, of the solvent control 17.37 and 22.05 mutants/106 cells and in the range of 12.56 to 40.00 mutants/10E6 cells with the test item, respectively. The highest mutation rate (compared to the solvent control values) of 2.03 was found at a concentration of 52 μM with a relative growth of 15.7 %. DMBA (0.8 and 1 μg/mL) and EMS (300 μg/mL) were used as positive controls and showed distinct and biologically relevant effects in mutation frequency.
Applicant's summary and conclusion
- Conclusions:
- FAT 36014/Z is considered to be non-mutagenic in the HPRT assay using V79 cells of the Chinese Hamster.
- Executive summary:
The study was conducted according to OECD guideline no. 476 and in accordance with GLP. In a mammalian cell gene mutation assay (HPRT locus), V79 cells cultured in vitro were exposed to FAT 36014/Z TE dissolved in DMSO at concentrations of
- 0.5, 1.0, 2.5, 5.0, 10.0, 11.0, 12.5, 14.0, 15.5, 17.0 µM (without metabolic activation, Experiment I)
- 10, 20, 30, 40, 45, 50, 55, 60, 65, 70 µM (with metabolic activation, Experiment I)
- 5, 10, 20, 30, 40, 50, 55, 60, 65, 70 µM (without metabolic activation, Experiment II)
- 8, 16, 22, 30, 38, 46, 52, 58, 60 µM (with metabolic activation, Experiment II).
FAT 36014/Z was tested up to cytotoxic concentrations.
Biologically relevant growth inhibition was observed in experiment I and II with and without metabolic activation. In experiment I without metabolic activation the relative growth was 23.6 % for the highest concentration (17 µM) evaluated. The highest biologically relevant concentration evaluated with metabolic activation was 70 µM with a relative growth of 12.1 %. In experiment II without metabolic activation the relative growth was 12.6 % for the highest concentration (70 µM) evaluated. The highest concentration evaluated with metabolic activation was 60 µM with a relative growth of 11.7 %.
In experiment I without metabolic activation the highest mutation rate (compared to the solvent control values) of 1.59 was found at a concentration of 17 µM with a relative growth of 23.6 %.
In experiment I with metabolic activation the highest mutation rate (compared to the solvent control values) of 1.60 was found at a concentration of 70 µM with a relative growth of 12.1 %.
In experiment II without metabolic activation the highest mutation rate (compared to the solvent control values) of 1.64 was found at a concentration of 65 µM with a relative growth of 16.6 %.
In experiment II with metabolic activation the highest mutation rate (compared to the solvent control values) of 2.03 was found at a concentration of 52 µM with a relative growth of 15.7 %.
In experiment I without metabolic activation the requirements of testing one concentration with relative growth between 10 % and 20 % could not be fulfilled.
The highest concentration of 17 µM resulted in a relative growth of 23.6 %. Due to the fact that in this experiment the gradient of toxicity is very steep and that all stages of toxicity have been detected without any hint at mutagenicity, this deficiency is considered to be not biologically relevant. The positive controls did induce the appropriate response. There was no evidence of a concentration related positive response of induced mutant colonies over background. This study is classified as acceptable. This study satisfies the requirement for Test Guideline OPPTS 870.5300, OECD 476 for in vitro mutagenicity (mammalian forward gene mutation) data. In conclusion, in the described in vitro cell gene mutagenicity test under the experimental conditions reported, the test item FAT 36014/Z is considered to be non-mutagenic in the HPRT locus using V79 cells of the Chinese Hamster.
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