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EC number: 444-090-3 | CAS number: 204848-45-3
- 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
The test material itself did not show mutagenic or clastogenic activity in vitro in a bacterial reverse mutagenicity assay and a chromosome aberration test (according to OECD guidelines 471 and 473, GLP). Two analgue substances did not induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster (according OECD guideline 476, GLP). Therefore, the test substance is not considered to be genotoxic.
Link to relevant study records
- Endpoint:
- in vitro gene mutation 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
- Reason / purpose for cross-reference:
- read-across source
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Result #1refers to CAS 204583-39-1; Result #2 refers to CAS 446824-06-2
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25-Nov-2002 to 30-Jan-2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study (OECD test guideline 473)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- adopted on 21st July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- 19 March 2000
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5375 - In vitro Mammalian Chromosome Aberration Test
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- lymphocytes: human, cultured in vitro
- Metabolic activation:
- with and without
- Metabolic activation system:
- post-mitochondrial fraction from Aroclor 1254 induced rat liver (S9 mix)
- Test concentrations with justification for top dose:
- First test: 15.6, 31.3 and 62.5 µg/mL (with and without S9 mix)
Second test:
62.5, 125 and 500 µg/mL ( without S9 mix)
250, 500 and 1000 µg/mL ( with S9 mix)
The following concentration were selected for metaphase analysis: 7.8, 15.6, 31.3, 62.5, 125, 250, 500, 1000 µg/mL (first and second test with and without S9 mix) - Vehicle / solvent:
- - Solvent used: acetone
- Justification for choice of solvent:
Prior to commencing testing, the solubility of the test substance in solvents compatible with the test system was assessed. The test item was found to be soluble in Acetone at 465 mg/mL. On dosing at 1% (v/v) into aqueous tissue culture medium, precipitates were observed at final concentrations of 290.63 µg/mL and above. Concentrations with high ionic strength and osmolality may cause chromosomal aberrations (Galloway et al. 1987). Therefore, concentrations greater than 5000 µg/mL or 10 mM are not used in this test system. In this case, the highest final concentration used for subsequent testing was 1000 µg/mL, in order to include at least two precipitating dose levels in the concentration range. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 0.2 µg/mL (3-hour treatment) 0.1 µg/mL (Continuous treatment)
- Positive control substance:
- mitomycin C
- Remarks:
- without metabolic activation
- Positive controls:
- yes
- Remarks:
- 10 µg/mL
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
First test:
- Exposure duration: 3 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 20 hours
Two hours before the cells were harvested, mitotic activity was arrested by addition of Colcemid® (Sigma) to each cultare at a final concentration of 0.1 µg/mL. After 2 hours incubation, each cell suspension was transferred to a centrifuge tabe and centrifuged for 5 minutes at 500 g. The cell pellets
were treated with a hypotonic solution (0.075M KCl prewarmed at 37 °C). After a 10 minute period of hypotonic incubation at 37 °C, the suspensions were centrifuged at 500 g for 5 minutes and the cell pellets fixed by addition of freshly prepared cold fixative (3 parts methanol : 1 part glacial acetic acid)
Second test:
- Exposure duration: continuously (without S9 mix), 3 hours (with S9 mix)
- Fixation time (start of exposure up to fixation or harvest of cells): 20 hours
NUMBER OF REPLICATIONS: duplicate
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
OTHER EXAMINATIONS:
- Determination of chromosome aberrations, polyploidy and endoreplication:
Prepared slides were examined by light microscopy using a low power objective. The proportion of mitotic cells per 1000 cells in each culture was recorded except for positive control treated cultures. From these results the dose level causing a decrease in mitotic index of approximately 50% of the solvent control value or, if there was no decrease, the maximum concentration was used as the highestdose level for the metaphase analysis. The intermediate and low dose levels were also selected. One hundred metaphase figures were examined from each culture. This number was reduced in cultures showing a high level of aberrant cells. Chromosome aberrations were scored according to the classification of the ISCN (1985). Only cells with 44-48 chromosomes were analysed. Polyploid and endoreduplicated cells were noted when seen. The vernier readings of all aberrant metaphase figures were recorded.
The incidence for polyploidy metaphase cells, out of 500 metaphase cells, was determined quantitatively for all cultures used in the analysis for chromosomal aberrations. The number of aberrant and polyploid metaphase cells in each treatment group was compared with the solvent control value using the one-tailed Fisher exact test (Fisher, 1973). - Evaluation criteria:
- The test substance is considered to cause a positive response if the following conditions are met:
Statistically significant increases (P < 0.01) in the frequency of metaphases with aberrant chromosomes (excluding gaps) are observed at one or more test concentration. The increases exceed the negative control range, taken at the 99% confidence limit. The increases are reproducible between replicate cultures. The increases are not associated with large changes in osmolality of the treatment medium or
extreme toxicity. Evidence of a dose-relationship is considered to support the conclusion. A negative response is claimed if no statistically significant increases in the number of aberrant cells above concurrent control frequencies are observed, at any dose level. A further evaluation may be carried out if the above criteria for a positive or a negative response are not met. - Statistics:
- An assay is considered to be acceptable if the negative and positive confrol values lie within the current historical control range.
- Species / strain:
- lymphocytes: human, cultured in vitro
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: low
- Precipitation: at 1000 µg/mL (without S9 mix)
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In the absence of S9 mix, the test item caused a reduction in the mitotic index to 64% of the solvent control value at 1000 µg/mL. In the presence of S9 mix, the test item failed to cause a significant reduction in the mitotic index compared to the solvent control value. Dose levels were selected accordingly. - Conclusions:
- The test substance showed no evidence of clastogenic activity in a in vitro cytogenetic test system.
- Executive summary:
A GLP-compliant study according to OECD TG 473 was performed to assess the ability of the test substance to induce chromosomal aberrations in human lymphocytes cultured in vitro. Human lymphocytes, in whole blood culture, were stimulated to divide by addition of phytohaemagglutinin, and exposed to the test substance both in the presence and absence of S9 mix derived firom rat livers. Two hours before the end of the incubation period, cell division was arrested using Colcemid , the cells harvested and slides prepared, so that metaphase cells could be examined for chromosomal damage. In the first test (with and without S9 mix, 3 hours treatment) and in the second test (without S9 mix, 20 hours continuous treatment or in presence of S9 mix, 3 hours treatment) the test material caused no statistically significant increases in the proportion of metaphase figures containing chromosomal aberrations at any dose level, when compared with the solvent control, in either test. A quantitative analysis for polyploidy was made in cultures treated with the negative control and highest dose level. No statistically significant increases in the proportion of polyploid cells were seen.
It is concluded that the test substance has shown no evidence of clastogenic activity in this in vitro cytogenetic test system under the experimental conditions described.
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11-Nov 2002 to 21-Jan-2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study (according OECD 471)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted on 12th July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, 12 Nohsan No 8747, 24 November 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- mammalian microsomal fraction S9 mix from Aroclor 1254 induced liver of male Sprague-Dawley derived rats
- Test concentrations with justification for top dose:
- 5; 15; 50; 150; 500; 1500 and 5000 µg/plate
- Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent:
The solubility of the test item in water was low (-100 µg/L). Its solubility was, therefore, assessed at 50 mg/mL in dimethyl sulphoxide (DMSO), in which it dissolved following sonication for 45 minutes. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 0.5 µg/plate for strains TA1535 and TA100
- Positive control substance:
- sodium azide
- Remarks:
- Without metabolic activation
- Positive controls:
- yes
- Remarks:
- 50 µg/plate for strain TA1537
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Without metabolic activation
- Positive controls:
- yes
- Remarks:
- 1 µg/plate for strain TA98
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Without metabolic activation
- Positive controls:
- yes
- Remarks:
- 0.05 µg/plate for strain WP2uvrA/pKM101
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-fiiryl) acrylamide
- Remarks:
- Without metabolic activation
- Positive controls:
- yes
- Remarks:
- 2 µg/plate for strain TA1535; 10 µg/plate for strain WP2MuvrA/pKM101
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- With metabolic activation
- Positive controls:
- yes
- Remarks:
- 5 µg/plate for strains TA 153 7, TA98 and TA 100
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- With metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- Range-finding test: standard plate incorporation assay (first test)
The test substance was added to cultures of the five tester strains at seven concentrations separated by ca. half-log10 intervals. The highest concentration tested was 50 mg/mL in the chosen solvent, which provided a final concentration of 5000 µg/plate. The vehicle control was the chosen solvent, DMSO. The appropriate positive controls were also included. Aliquots of 0.1 mL of the test dilution, positive control or negative control were placed in glass vessels. S9 mix (0.5 mL) or 0.1 M pH 7.4 phosphate buffer (0.5 mL) was added, followed by 0.1 mL of a 10 hour bacterial culture and 2 mL of agar containing histidine (0.5 mM), biotin (0.5 mM) and tryptophan (0.5 mM). The mixture was thoroughly shaken and overlaid onto previously prepared Petri dishes containing 25 mL minimal agar. Three Petri dishes were used for each concentration. Plates were also prepared without the addition of bacteria in order to assess the sterility of the test item, S9 mix and sodium phosphate buffer. All plates were incubated at 37 °C for ca. 72 hours. After this period, the appearance of the background bacterial lawn was examined and revertant colonies counted using a Domino automated colony counter.
- Second test:
As a clear negative response was obtained in the first test, a variation to the test procedure was used for the second test. The variation used was the pre-incubation assay in which the tubes, which contained mixtures of bacteria, buffer or S9 mix and test dilution, were incubated at 37 °C for 30 minutes with shaking before the addition of the agar overlay. The top concentration chosen was again 5000 µg/plate, but only 5 concentrations were used.
DURATION
- Preincubation period: 30 minutes
- Exposure duration:
First test (range-finding): 72 hours
Second test: 30 minutes
NUMBER OF REPLICATIONS: three per concentration in each of two independent experiments
DETERMINATION OF CYTOTOXICITY
Any toxic effects would be detected by a substantial reduction in revertant colony counts or by the absence of a complete background bacterial lawn. - Evaluation criteria:
- If exposure to the test substance produces a reproducible increase in revertant colony numbers of at least twice (three times in the case of strains TA1535 and TA1537) the concurrent solvent/vehicle controls, with some evidence of a positive dose-response relationship, it will be considered to exhibit mutagenic activity in this test system. If exposure to the test substance does not produce a reproducible increase in revertant colony numbers, it will be considered to show no evidence of mutagenic activity in this test system.If the results obtained fail to satisfy the criteria for a clear "positive" or "negative" response, even after additional testing, the test data may be subjected to analysis to determine the statistical significance of any increases in revertant colony numbers.
- Statistics:
- The statistical procedures used will be those described by Mahon et al (1989) and will usually be Dunnett's test followed, if appropriate, by trend analysis. The mean number and standard deviation of revertant colonies were calculated for all groups. The means for all treatment groups were compared with those obtained for the solvent/vehicle control groups
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
No substantial increases in revertant colony numbers over control counts were obtained with any of the tester strains following exposure to the test item at any concentration in either the presence or absence of S9 mix. No visible thinning of the background lawn of non-revertant cells was obtained following exposure to the test item. A maximum exposure concentration of 5000 µg/plate was, therefore, selected for use in the second test.
COMPARISON WITH HISTORICAL CONTROL DATA:
The mean revertant colony counts for the solvent controls were within the 99% confidence limits of the current historical control range of the laboratory. Appropriate positive control chemicals (with S9 mix where required) induced substantial increases in revertant colony numbers with all strains, confirming sensitivity of the cultures and activity of the S9 mix. - Conclusions:
- The test substance showed no evidence of mutagenic activity in a bacterial system.
- Executive summary:
The mutagenic potential of the test substance was assessed in a GLP-compliant in vitro study according to OECD TG 471. Histidine dependent auxotrophic mutants of Salmonella typhimurium, strains TAI535, TAI537, TA98 and TA100, and a tryptophan dependent mutant of Escherichia coli, strain WP2uvrA, were exposed to the test item diluted in dimethyl sulphoxide (DMSO). Two independent mutation tests were performed in the presence and absence of liver preparations from Aroclor 1254-treated rats (S9 mix). The first (range-finding) test was a standard plate incorporation assay; the second involved a pre-incubation stage. Concentrations up to 5000 µg/plate were tested. No signs of toxicity were observed towards the tester strains in either mutation test. No evidence of mutagenic activity was seen at any concentration in either mutation test.
It is concluded that the test substance showed no evidence of mutagenic activity in this bacterial system under the test conditions employed.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Procedure and observations
In the in vitro assessment of the mutagenic potential of the test substance, histidine dependent auxotrophic mutants of Salmonella typhimurium, strains TAI535, TAI537, TA98 and TA100, and a tryptophan dependent mutant of Escherichia coli, strain WP2uvrA, were exposed to the test item diluted in dimethyl sulphoxide (DMSO). Two independent mutation tests were performed in the presence and absence of liver preparations firom Aroclor 1254-treated rats (S9 mix). The first (range-finding) test was a standard plate incorporation assay; the second involved a pre-incubation stage. Concentrations up to 5000 µg/plate were tested. No signs of toxicity were observed towards the tester strains in either mutation test. No evidence of mutagenic activity was seen at any concentration in either mutation test.
The second study was performed to assess the ability of the test material to induce chromosomal aberrations in human lymphocytes cultured in vitro. Human lymphocytes, in whole blood culture, were stimulated to divide by addition of phytohaemagglutinin, and exposed to the test substance both in the presence and absence of S9 mix derived firom rat livers. Two hours before the end of the incubation period, cell division was arrested using Colcemid , the cells harvested and slides prepared, so that metaphase cells could be examined for chromosomal damage. In the first test (with and without S9 mix, 3 hours treatment) and in the second test (without S9 mix, 20 hours continuous treatment or in presence of S9 mix, 3 hours treatment) the test material caused no statistically significant increases in the proportion of metaphase figures containing chromosomal aberrations.
The test substance was not examined for its potential to induce gene mutations in mammalian cells. Reliable experimental data on two read across substance are available (see justification attached to IUCLID section 7.6.1 and 13):
In a GLP conform study according to OECD guideline 476 the potential of the structural analogue (CAS 204583-39-1) to induce mutations V 79 cells was assessed. The assay was performed in two independent experiments, using two parallel cultures each. The first main experiment was performed with and without liver microsomal activation and a treatment period of 4 hours. The second experiment was performed with a treatment time of 4 hours with and 24 hours without metabolic activation. Due to limited solubility of the test item in a suitable solvent the highest concentration of the test item in the pre-experiment was 2666.6 mg/L resulting in strong test item induced precipitation at the end of the treatment period. As no cytotoxicity was observed the highest concentration applied in the main experiments was far above the limit of solubility of the test item in culture medium. No substantial and reproducible dose dependent increase of the mutation frequency was observed in the main experiments. Appropriate reference mutagens, used as positive controls, induced a distinct increase in mutant colonies and thus, showed the sensitivity of the test item and the activity of the metabolic activation system.
The potential of the structural analogue (CAS 446824-06-2) to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster was determined in an in vitro assay according to OECD TG 476 and GLP. The assay was performed in two independent experiments, using two parallel cultures each. The first main experiment was performed with and without liver microsomal activation and a treatment period of 4 hours.The second experiment was performed with a treatment time of 4 hours with and 24 hours without metabolic activation. The highest concentration of the pre-experiment and the main experiments (3600 µg/mL) was limited by the solubility properties of the test item. The test item was dissolved in acetone. No substantial and reproducible dose dependent increase of the mutation frequency was observed up to the maximum concentration with and without metabolic activation.
Conclusion
The test substance or analogue substance respectively, showed no evidence of mutagenic activity in bacterial or mammalian cells and it has shown no evidence of clastogenic activity in vitro. The substance is therefore not considered to be genotoxic.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No indication of genotoxicity was observed in the Ames test (OECD 471, GLP), the HPRT Test (OECD 476, GLP) and the in vitro chromosome aberration assay (OECD 473, GLP). As a result, the substance is not considered to be classified for mutagenicity under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.
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