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EC number: - | CAS number: -
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
FAT 41048 is considered to be neither mutagenic nor clastogenic.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- other: Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and the Escherichia coli strain WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- exception in strain TA 1537 with metabolic activation in experiment I at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- FAT 41039/A, a structural analogue of FAT 41048, did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used in this bacterial reverse mutation assay.
- Executive summary:
FAT 41039/A, a structural analogue of FAT 41048, was assessed for its potential to induce gene mutations in the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and the Escherichia coli strain WP2 uvrA. The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration and the controls were tested in triplicate. The test item was tested at the following concentrations:
Pre-Experiment/Experiment I: 3; 10, 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II: 33; 100; 333; 1000; 2500; and 5000 µg/plate
The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without metabolic activation in both independent experiments, with the exception in strain TA 1537 with metabolic activation in experiment I, reduced background growth was observed at 5000 µg/plate. No toxic effects, evident as a reduction in the number of revendants, occurred in the test groups with and without metabolic activation with the exception in strain TA 1537 with metabolic activation in experiment I, a reduction in the number of revendants was observed at 5000 µg/plate. No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with FAT 41039/A at any dose level, neither in the presence nor absence of metabolic activation (S9 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 mutagens were used as positive controls. They showed a distinct increase of induced revertant colonies. In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 1055 µg/ml)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 1055 µg/ml)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 40 µg/ml)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 40 µg/ml)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- FAT 41039/A, a structural analgue of FAT 41048, did not induce structural chromosome aberrations in V79 cells (Chinese hamster cell line) when tested up to precipitating concentrations.
- Executive summary:
FAT 41039/A, a structural analogue of FAT 41048, suspended in DMSO, was assessed for its potential to induce structural chromosome aberrations in V79 cells of the Chinese hamster in vitro in the absence and the presence of metabolic activation by S9 mix.
Two independent experiments were performed. In Experiment I, the exposure period was 4 hrs with and without metabolic activation. In Experiment II the exposure period was 4 hrs with S9 mix and 18 hrs and 28 hrs without S9 mix. The chromosomes were prepared 18 hrs (Exp. I and II) and 28 hrs (Exp. II) after start of treatment with the test item. In each experimental group two parallel cultures were set up. Per culture 100 metaphase plates were scored for structural chromosome aberrations.
- In a range finding pre-test on toxicity cell numbers 24 hrs after start of treatment were scored as an indicator for cytotoxicity. Concentrations between 8.2 and 1055 µg/mL were applied. No clear toxic effects were observed after treatment up to the highest applied test item concentration.
- In the pre-experiment, precipitation of the test item in culture medium was observed after treatment with 8.2 µg/mL and above in the absence and the presence of S9 mix. In both cytogenetic experiments no relevant influence of the test item on the pH value or osmolality was observed (e.g. Exp. I: solvent control 374 mOsm, pH 7.5 versus 380 mOsm and pH 7.4 at 40 µg/mL).
- In all experimental parts test item precipitation in culture medium was observed 4 hrs after start of treatment with 10 µg/mL and above, except in Experiment II at preparation interval 28 hrs, in the presence of S9 mix, where precipitation occurred at 5 µg/mL and above.
- In this study, neither reduced mitotic indices nor reduced cell numbers of below 50 % of control was observed up to the highest applied test item concentrations being far in the range of test item precipitation.
- In both experiments, in the absence and presence of S9 mix, no biologically relevant increase in the number of cells carrying structural chromosome aberrations was observed. The aberration rates of the cells after treatment with the test item (0.0 - 3.0 % aberrant cells, exclusive gaps) were close to the range of the solvent control values (0.5 - 2.0 % aberrant cells, exclusive gaps) and within the range of our historical control data: 0.0 - 4.0 % aberrant cells, exclusive gaps. A single statistical significant (p < 0.05) increase was observed in Experiment I, in the presence of S9 mix, after 4 hrs treatment with 5 µg/mL Although this increase of 3.0 % aberrant cells was statistically significant compared to the low response (0.5 % aberrant cells, exclusive gaps) in the solvent control data, the response is within the historical control data range (0.0 - 4.0 % aberrant cells, exclusive gaps). Therefore, the statistical significance has to be regarded as being biologically irrelevant.
- In both experiments, no biologically relevant increase in the rate of polyploid metaphases was found after treatment with the test item (1.2- 3.5%) as compared to the rates of the solvent controls (1.3-2.3%).
- In both experiments, EMS (300 and 400 µg/mL, respectively) and CPA (1.4 and 2.0 µg/mL, respectively) were used as positive controls and showed distinct increases in cells with structural chromosome aberrations.
In conclusion, it can be stated that under the experimental conditions reported, the test item FAT 41039/A did not induce structural chromosome aberrations in V79 cells (Chinese hamster cell line) when tested up to precipitating concentrations.
Referenceopen allclose all
Discussion of Results:
- The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without metabolic activation in both independent experiments, with the exception in strain TA 1537 with metabolic activation in experiment I, reduced background growth was observed at 5000 µg/plate.
- No toxic effects, evident as a reduction in the number of revendants, occurred in the test groups with and without metabolic activation with the exception in strain TA 1537 with metabolic activation in experiment I, a reduction in the number of revendants was observed at 5000 µg/plate.
- No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with FAT 41039/A at any dose level, neither in the presence nor absence of metabolic activation (S9 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 mutagens were used as positive controls. They showed a distinct increase of induced revertant colonies.
- In the range finding pre-test on toxicity cell numbers 24 hrs after start of treatment were scored as an indicator for cytotoxicity. Concentrations between 8.2 and 1055 µg/mL were applied. No clear toxic effects were observed after treatment up to the highest applied test item concentration.
- In the pre-experiment, precipitation of the test item in culture medium was observed after treatment with 8.2 µg/mL and above in the absence and the presence of S9 mix. In both cytogenetic experiments no relevant influence of the test item on the pH value or osmolality was observed (e.g. Exp. I: solvent control 374 mOsm, pH 7.5 versus 380 mOsm and pH 7.4 at 40 µg/mL).
- In all experimental parts test item precipitation in culture medium was observed 4 hrs after start of treatment with 10µg/mL and above, except in Experiment II at preparation interval 28 hrs, in the presence of S9 mix, where precipitation occurred at 5 µg/mL and above.
- In this study, neither reduced mitotic indices nor reduced cell numbers of below 50 % of control was observed up to the highest applied test item concentrations being far in the range of test item precipitation.
- In both experiments, in the absence and presence of S9 mix, no biologically relevant increase in the number of cells carrying structural chromosome aberrations was observed. The aberration rates of the cells after treatment with the test item (0.0 - 3.0 % aberrant cells, exclusive gaps) were close to the range of the solvent control values (0.5 - 2.0 % aberrant cells, exclusive gaps) and within the range of our historical control data: 0.0 - 4.0 % aberrant cells, exclusive gaps. A single statistical significant (p < 0.05) increase was observed in Experiment I, in the presence of S9 mix, after 4 hrs treatment with 5 µg/mL Although this increase of 3.0 % aberrant cells was statistically significant compared to the low response (0.5 % aberrant cells, exclusive gaps) in the solvent control data, the response is within the historical control data range (0.0 - 4.0 % aberrant cells, exclusive gaps). Therefore, the statistical significance has to be regarded as being biologically irrelevant.
In both experiments, no biologically relevant increase in the rate of polyploid metaphases was found after treatment with the test item (1.2- 3.5%) as compared to the rates of the solvent controls (1.3-2.3%).
- In both experiments, EMS (300 and 400µg/mL, respectively) and CPA (1.4 and 2.0µg/mL, respectively) were used as positive controls and showed distinct increases in cells with structural chromosome aberrations.
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
BACTERIAL REVERSE MUTATION ASSAY:
FAT 41039/A, a structural analogue to FAT 41048, was assessed for its potential to induce gene mutations in the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and the Escherichia coli strain WP2 uvrA. The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration and the controls were tested in triplicate. The test item was tested at the following concentrations:
Pre-Experiment/Experiment I: 3; 10, 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II: 33; 100; 333; 1000; 2500; and 5000 µg/plate
The plates incubated with the test item showed normal background growth up to 5000µg/plate with and without metabolic activation in both independent experiments, with the exception in strain TA 1537 with metabolic activation in experiment I, reduced background growth was observed at 5000µg/plate. No toxic effects, evident as a reduction in the number of revendants, occurred in the test groups with and without metabolic activation with the exception in strain TA 1537 with metabolic activation in experiment I, a reduction in the number of revendants was observed at 5000µg/plate. No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with FAT 41039/A at any dose level, neither in the presence nor absence of metabolic activation (S9 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 mutagens were used as positive controls. They showed a distinct increase of induced revertant colonies. In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
IN VITRO CHROMOSOMAL ABERRATION ASSAY
FAT 41039/A, a structural analogue to FAT 41048, suspended in DMSO, was assessed for its potential to induce structural chromosome aberrations in V79 cells of the Chinese hamster in vitro in the absence and the presence of metabolic activation by S9 mix.
Two independent experiments were performed. In Experiment I, the exposure period was 4 hrs with and without metabolic activation. In Experiment II the exposure period was 4 hrs with S9 mix and 18 hrs and 28 hrs without S9 mix. The chromosomes were prepared 18 hrs (Exp. I and II) and 28 hrs (Exp. II) after start of treatment with the test item. In each experimental group two parallel cultures were set up. Per culture 100 metaphase plates were scored for structural chromosome aberrations.
- In a range finding pre-test on toxicity cell numbers 24 hrs after start of treatment were scored as an indicator for cytotoxicity. Concentrations between 8.2 and 1055µg/mL were applied. No clear toxic effects were observed after treatment up to the highest applied test item concentration.
- In the pre-experiment, precipitation of the test item in culture medium was observed after treatment with 8.2µg/mL and above in the absence and the presence of S9 mix. In both cytogenetic experiments no relevant influence of the test item on the pH value or osmolality was observed (e.g. Exp. I: solvent control 374 mOsm, pH 7.5 versus 380 mOsm and pH 7.4 at 40µg/mL).
- In all experimental parts test item precipitation in culture medium was observed 4 hrs after start of treatment with 10µg/mL and above, except in Experiment II at preparation interval 28 hrs, in the presence of S9 mix, where precipitation occurred at 5µg/mL and above.
- In this study, neither reduced mitotic indices nor reduced cell numbers of below 50 % of control was observed up to the highest applied test item concentrations being far in the range of test item precipitation.
- In both experiments, in the absence and presence of S9 mix, no biologically relevant increase in the number of cells carrying structural chromosome aberrations was observed. The aberration rates of the cells after treatment with the test item (0.0 - 3.0 % aberrant cells, exclusive gaps) were close to the range of the solvent control values (0.5 - 2.0 % aberrant cells, exclusive gaps) and within the range of our historical control data: 0.0 - 4.0 % aberrant cells, exclusive gaps. A single statistical significant (p < 0.05) increase was observed in Experiment I, in the presence of S9 mix, after 4 hrs treatment with 5µg/mL Although this increase of 3.0 % aberrant cells was statistically significant compared to the low response (0.5 % aberrant cells, exclusive gaps) in the solvent control data, the response is within the historical control data range (0.0 - 4.0 % aberrant cells, exclusive gaps). Therefore, the statistical significance has to be regarded as being biologically irrelevant.
- In both experiments, no biologically relevant increase in the rate of polyploid metaphases was found after treatment with the test item (1.2- 3.5%) as compared to the rates of the solvent controls (1.3-2.3%).
- In both experiments, EMS (300 and 400µg/mL, respectively) and CPA (1.4 and 2.0µg/mL, respectively) were used as positive controls and showed distinct increases in cells with structural chromosome aberrations.
In conclusion, it can be stated that under the experimental conditions reported, the test item FAT 41039/A did not induce structural chromosome aberrations in V79 cells (Chinese hamster cell line) when tested up to precipitating concentrations.
Justification for classification or non-classification
The substance was considered to be neither mutagenic nor clastogenic, hence does not warrant classification for mutagenicity according to Regulation (EC) No. 1272/2008 (CLP) criteria.
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