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EC number: 942-002-2 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
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- Density
- Particle size distribution (Granulometry)
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- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
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- Additional physico-chemical properties of nanomaterials
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- 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
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
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- Carcinogenicity
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- Additional toxicological data
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-02-05 to 2014-03-27
- 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:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Reaction products of [29H,31H-phthalocyaninato(2-)-k4N29,N30,N31,N32]copper, thionyl dichloride, and sulfurochloridic acid, further condensed with 2,4-diaminobenzenesulfonic acid and ammonia, further converted with sodium hydroxide 2,4,6-trichloro-1,3, -triazine, and ammonium chloride
- EC Number:
- 942-002-2
- Molecular formula:
- C42.53H20.97Cl1.17N15.41Na3.62O13.95S5.17
- IUPAC Name:
- Reaction products of [29H,31H-phthalocyaninato(2-)-k4N29,N30,N31,N32]copper, thionyl dichloride, and sulfurochloridic acid, further condensed with 2,4-diaminobenzenesulfonic acid and ammonia, further converted with sodium hydroxide 2,4,6-trichloro-1,3, -triazine, and ammonium chloride
- Test material form:
- solid: particulate/powder
- Remarks:
- powder
Constituent 1
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):
5, 10, 25, 50, 100, 250, 500, 1000, 2500, 5000 µg/mL
Pre-experiment for experiment II (only without metabolic activation, 20 h long-term exposure assay):
5, 10, 25, 50, 100, 200, 350, 500, 750, 1000 µg/mL
Experiment I
without metabolic activation: 25, 50, 75, 100, 125, 150, 200, 225 and 250 µg/mL
and with metabolic activation: 5, 10, 25, 50, 100, 250, 500 and 1000 µg/mL
Experiment II
without metabolic activation: 10, 20, 50, 100, 250, 500, 750, 1000, 1250 and 1500 µg/mL
and with metabolic activation: 70, 150, 300, 400, 500, 600, 700, 800 and 900 µg/mL - Vehicle / solvent:
- Vehicle (Solvent) used: cell culture medium (MEM + 0% FBS 4 h treatment; MEM + 10% FBS 20 h treatment).
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- 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:
- yes
- True negative controls:
- no
- 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 medium
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.
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: ≥ 50 μg/mL; experiment I with S9: ≥ 500 μg/mL; Experiment II without S9: ≥ 250 μg/mL; Experiment II with S9:≥ 400 μg/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
Precipitation:
No precipitation of the test item was noted in any of the experiments.
Toxicity:
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 11.5 % for the highest concentration (250 μg/mL) evaluated. The highest biologically relevant concentration evaluated with metabolic activation was 1000 μg/mL with a relative growth of 10.6 %.
In experiment II without metabolic activation the relative growth was 12.6 % for the highest concentration (1500 μg/mL) evaluated. The highest concentration evaluated with metabolic activation was 900 μg/mL with a relative growth of 11.5 %.
Mutagenicity:
In experiment I without metabolic activation all mutant values of the negative controls and test item concentrations found were within the historical control data of the test facility BSL BIOSERVICE (about 5-43 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 negative controls.
Mutation frequencies with the negative control were found to be 18.35 and 20.81 mutants/10E6 cells and in the range of 4.71 to 29.49 mutants/10E6 cells with the test item, respectively. The highest mutation rate (compared to the negative control values) of 1.51 was found at a concentration of 225 μg/mL with a relative growth of 11.1 %.
With metabolic activation all mutant values of the negative 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 negative controls.
Mutation frequencies with the negative control were found to be 16.30 and 11.84 mutants/10E6 cells and in the range of 6.29 to 18.71 mutants/10E6 cells with the test item, respectively. The highest mutation rate (compared to the negative control values) of 1.33 was found at a concentration of 10 μg/mL with a relative growth of 113.8 %.
In experiment II without metabolic activation all mutant values of the negative controls and test item concentrations found were within the historical control data of the test facility BSL BIOSERVICE (about 5-43 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 negative controls.
Mutation frequencies with the negative control were found to be 26.82 and 29.28 mutants/10E6 cells and in the range of 12.74 to 40.26 mutants/10E6 cells with the test item, respectively. The highest mutation rate (compared to the negative control values) of 1.44 was found at a concentration of 50 μg/mL with a relative growth of 90.4 %.
In experiment II with metabolic activation all mutant values of the negative 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 negative controls.
Mutation frequencies with the negative control were found to be 23.10 and 13.15 mutants/10E6 cells and in the range of 13.89 to 42.28 mutants/10E6 cells with the test item, respectively. The highest mutation rate (compared to the negative control values) of 2.33 was found at a concentration of 300 μg/mL with a relative growth of 77.4 %.
DMBA (0.8 and 1.0 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 40045/Z is considered to be not mutagenic in the HPRT locus using V79 cells of the Chinese Hamster.
- Executive summary:
In this mammalian cell gene mutation assay (HPRT locus), V79 cells cultured in vitro were exposed to FAT 40045/Z at concentrations of
- 25, 50, 75, 100, 125, 150, 200, 225 and 250 µg/mL (without metabolic activation, Experiment I)
- 5, 10, 25, 50, 100, 250, 500 and 1000 µg/mL (with metabolic activation, Experiment I)
- 10, 20, 50, 100, 250, 500, 750, 1000, 1250 and 1500 µg/mL (without metabolic activation, Experiment II)
- 70, 150, 300, 400, 500, 600, 700, 800 and 900 µg/mL (with metabolic activation, Experiment II).
FAT 40045/Z TE 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 11.5 % for the highest concentration (250 µg/mL) evaluated. The highest biologically relevant concentration evaluated with metabolic activation was 1000 µg/mL with a relative growth of 10.6 %. In experiment II without metabolic activation the relative growth was 12.6 % for the highest concentration (1500 µg/mL) evaluated. The highest concentration evaluated with metabolic activation was 900 µg/mL with a relative growth of 11.5 %.
In experiment I without metabolic activation the highest mutation rate (compared to the negative control values) of 1.51 was found at a concentration of 225 µg/mL with a relative growth of 11.1 %.
In experiment I with metabolic activation the highest mutation rate (compared to the negative control values) of 1.33 was found at a concentration of 10 µg/mL with a relative growth of 113.8 %. In experiment II without metabolic activation the highest mutation rate (compared to the negative control values) of 1.44 was found at a concentration of 50 µg/mL with a relative growth of 90.4 %. In experiment II with metabolic activation the highest mutation rate (compared to the negative control values) of 2.33 was found at concentrations of 300 µg/mL with a relative growth of 77.4 %.
The positive controls did induce the appropriate response.
There was no evidence of a concentration related positive response of induced mutant colonies over background. Hence FAT 40045/Z is considered to be not mutagenic in the HPRT locus using V79 cells of the Chinese Hamster.
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