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EC number: 205-685-1 | CAS number: 147-14-8
- 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
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Objective of study:
- distribution
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The study examined, whether or not systemic absorption of copper occured after 90 day high dose feed exposure to the test material. Copper analyses were conducted in livers and kidneys of the animals.
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Analytical purity: The chemical analysis, performed at Midwest Research Institute indicated that the purity was 104.7 % +- 1.1 % (elemental analysis)
- Radiolabelling:
- no
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Industries
- Age at study initiation: 8.5 weeks
- Weight at study initiation: males: 16 - 23 g; females: 16 - 19 g
- Housing: polycarbonate cages: groups of 5 mice per cage
- Diet: weighed portions of Purina Lab Chow in meal form, mixed together with weighed portions of the test material (see details at "doses/concentrations")
- Water: ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 - 23 °C
- Humidity: 40 - 60 %
- Air changes: at least 15 per hour
- Photoperiod: 12 hrs dark / 12 hrs light - Route of administration:
- oral: feed
- Vehicle:
- other: 12 % water was added to the test material as a dust control agent
- Details on exposure:
- Dose levels of 5.0, 2.5, 1.25, 0.6 and 0.3 % (w/w) were selected for both males and females. The selected doses were prepared by mixing weighed portions of purina Lab Chow in meal form with weighed portions of the test material. 12 % water was added to the test material as a dust control agent prior to mixing with the meal. For each dose level, one weekly lot of 4500 g (+ 12 % water compensation) was prepared.
The actual mixtures were composed of the following ingredients:
- Dose level 5.0 % (w/w): 252 g test material and water + 4275 g meal
- Dose level 2.5 % (w/w): 126 g test material and water + 4387.5 g meal
- Dose level 1.25 % (w/w): 63 g test material and water + 4443.75 g meal
- Dose level 0.6 % (w/w): 30.24 g test material and water + 44735 g meal
- Dose level 0.3 % (w/w): 15.12 g test material and water + 4486.5 g meal
Each diet was mixed in a Patterson-Kelly twin shelled V blender for 15 min.
The doses were mixed one or two days prior to the week of their use in the study, and stored at 23 °C.
One analysis was perfomed to determine the accuracy of the mixture concentration. - Duration and frequency of treatment / exposure:
- 90 days
- Dose / conc.:
- 0.3 other: % in the diet
- Dose / conc.:
- 0.6 other: % in the diet
- Dose / conc.:
- 1.25 other: % in the diet
- Dose / conc.:
- 2.5 other: % in the diet
- Dose / conc.:
- 5 other: 5% in the diet
- No. of animals per sex per dose / concentration:
- 10 males and 10 females per dose
- Control animals:
- yes, plain diet
- Details on study design:
- - 10 animals were used per sex and dose group.
- Five dose levels of 0.0, 0.3, 0.6, 1.25 and 5.0 % in feed were used in this study (approx. 1000, 2000, 4000, 8000 and 16000 mg/kg bw for males [based on 7.3 g/d average food consumption, 0.023 kg average bw] and approx. 1100, 2200, 4700, 9300 and 18700 mg/kg bw for females [based on 7.1 g/d average food consumption, 0.019 kg average bw], respectively).
- The selected doses were prepared by mixing together weighed portions of Purina Lab Chow in meal form with weighed portions of the chemical. 12% water was added to the chemical as a dust control agent prior to mixing with the meal.
- Each dosed group received on 91 consecutive days of dosed feed mixture.
- Mice were necropsied on day 92 and 93.
Copper analyses were completed in the liver and kidney tissues and the formalin preserving those tissues from male mice in the highest dose group (5 % w/w) and control groups:
- Tissue samples were prepared for analysis by digesting in 10 ml of concentrated nitric acid until most of the organic material was destroyed. Perchloric acid was then added and the solutions were evaporated to strong fumes, additional nitric acid being added as required. The solutions were then fumed to dryness, the residues were dissolved in 5 % nitric acid and the solutions were diluted to 10 ml.
- Formalin samples were filtered through a Millex-GS 0.22 µm filter unit and 5 ml portions of each sample were prepared for analysis by the procedure used to prepare the tissue samples.
- The samples were then subjected to atomic absorption spectrophotometry to determine copper content:
A Perkin-Elmer Model 5000 atomic absorption spectrophotometer was utilized for the work. A series of 10 ml standard solutions, ranging from 0.05 to 2.0 ppm were prepared in 5 % nitric acid by dilution of a certified standard copper stock solution. These solutions were used to calibrate the instrument, which was programmed to print out data as total microgramms of copper per sample. The prepared sample solutions were used in the same manner as the standards. Concentrations of copper in the tissue samples were calculated by dividing the total microgramms found by the weight of the sample. Concentrations of copper in the formalin samples were calculated on a volume basis. - Statistics:
- Student´s T-test (alpha = 0.05) was used to compare the highest dose group results with control results.
- Preliminary studies:
- No data given.
- Details on absorption:
- No data given.
- Details on distribution in tissues:
- Slight, but statistically significant increases of copper incorporation were reported in the liver tissues (3.98 ppm +- 1.16 ppm; p < 0.05) and kidney (7.47 ppm +- 2.86 ppm; p < 0.05) tissues of treated male animals of the highest dose group, compared to controls (liver: 3.0 ppm +- 0.34 ppm; kidney: 4.66 ppm +- 0.6 ppm). From all the formalin analyses performed, the authors drawed the conclusion that no detectable levels of copper were leached from the preserved tissue into the formalin bath.
However, an evaluation of the results was conducted by expert judgement and the author draw the following conclusions:
The results of the study do not provide unequivocal evidence for a lack of absorption of the test material. However, the total lack of findings during the 13 week study, coupled with the insolubility of the test material and the minimal changes in tissue copper residues strongly suggests that the test material was not appreciably absorbed.
- Details on excretion:
- No data given.
- Metabolites identified:
- not measured
- Details on metabolites:
- No data given.
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Objective of study:
- distribution
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The study examined, whether or not systemic absorption of copper occured after 90-day high dose feed exposure to the test material. Copper analyses were conducted in livers and kidneys of the animals.
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Analytical purity: The chemical analysis, performed at Midwest Research Institute indicated that the purity was 104.7 % +- 1.1 % (elemental analysis)
- Radiolabelling:
- no
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Industries
- Weight at study initiation: males: 70 - 105 g; females: 70 - 100 g
- Housing: polycarbonate cages: groups of 5 rats per cage
- Diet: weighed portions of Purina Lab Chow in meal form, mixed together with weighed portions of the test material (see details at "doses/concentrations")
- Water: ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 - 23 °C
- Humidity: 40 - 60 %
- Air changes: at least 15 per hour
- Photoperiod: 12 hrs dark / 12 hrs light - Route of administration:
- oral: feed
- Vehicle:
- other: 12 % water was added to the test material as a dust control agent
- Details on exposure:
- Dose levels of 5.0, 2.5, 1.25, 0.6 and 0.3 % (w/w) were selected for both males and females. The selected doses were prepared by mixing weighed portions of purina Lab Chow in meal form with weighed portions of the test material. 12 % water was added to the test material as a dust control agent prior to mixing with the meal. For each dose level, one weekly lot of 4500 g (+ 12 % water compensation) was prepared.
The actual mixtures were composed of the following ingredients:
- Dose level 5.0 % (w/w): 252 g test material and water + 4275 g meal
- Dose level 2.5 % (w/w): 126 g test material and water + 4387.5 g meal
- Dose level 1.25 % (w/w): 63 g test material and water + 4443.75 g meal
- Dose level 0.6 % (w/w): 30.24 g test material and water + 44735 g meal
- Dose level 0.3 % (w/w): 15.12 g test material and water + 4486.5 g meal
Each diet was mixed in a Patterson-Kelly twin shelled V blender for 15 min.
The doses were mixed one or two days prior to the week of their use in the study, and stored at 23 °C.
One analysis was perfomed to determine the accuracy of the mixture concentration. - Duration and frequency of treatment / exposure:
- 90 days
- Dose / conc.:
- 0.3 other: % in the diet
- Dose / conc.:
- 0.6 other: % in the diet
- Dose / conc.:
- 1.25 other: % in the diet
- Dose / conc.:
- 2.5 other: % in the diet
- Dose / conc.:
- 5 other: % in the diet
- No. of animals per sex per dose / concentration:
- 10 males per dose and 10 females per dose
- Control animals:
- yes, plain diet
- Details on study design:
- The concentrations of the chemical mixture were the same for male and female rats. All dose levels were prepared on a weight per weight basis. There were 5 dose level groups with 10 individuals of each sex in each dosage and control group. Each dosed group received 90 consecutive days of dosed feed mixture. After one day of observation, the animals were necropsied. Animals were observed twice each day for clinical signs, with at least 6 hours between observations. All observations were recorded daily. Additionally, blood sampling was conducted from 10 control rats, 6 males and 4 females.
Copper analyses were completed in the liver and kidney tissues and the formalin preserving those tissues from male rats in the highest dose group (5 % w/w) and control groups:
- Tissue samples were prepared for analysis by digesting in 10 ml of concentrated nitric acid until most of the organic material was destroyed. Perchloric acid was then added and the solutions were evaporated to strong fumes, additional nitric acid being added as required. The solutions were then fumed to dryness, the residues were dissolved in 5 % nitric acid and the solutions were diluted to 10 ml.
- Formalin samples were filtered through a Millex-GS 0.22 µm filter unit and 5 ml portions of each sample were prepared for analysis by the procedure used to prepare the tissue samples.
- The samples were then subjected to atomic absorption spectrophotometry to determine copper content:
A Perkin-Elmer Model 5000 atomic absorption spectrophotometer was utilized for the work. A series of 10 ml standard solutions, ranging from 0.05 to 2.0 ppm were prepared in 5 % nitric acid by dilution of a certified standard copper stock solution. These solutions were used to calibrate the instrument, which was programmed to print out data as total microgramms of copper per sample. The prepared sample solutions were used in the same manner as the standards. Concentrations of copper in the tissue samples were calculated by dividing the total microgramms found by the weight of the sample. Concentrations of copper in the formalin samples were calculated on a volume basis. - Details on dosing and sampling:
- PHARMACOKINETIC STUDY (distribution)
- Tissues and body fluids sampled: liver and kidneys - Statistics:
- Student´s T-test (alpha = 0.05) was used to compare the highest dose group results with control results.
- Details on absorption:
- No data given.
- Details on distribution in tissues:
- No statistically significant increase of residual copper incorporation was neither reported for the liver tissues (2.82 ppm +- 0.34 ppm) nor for the kidney tissues (5.62 ppm +- 0.49 ppm) of the treated male rats of the highest dose group, compared to residual copper incorporation found in controls (liver 2.78 ppm +- 0.51 ppm; kidney 5.30 ppm +- 0.83 ppm). From all the formalin analyses performed, the authors drawed the conclusion that no detectable levels of copper were leached from the preserved tissue into the formalin bath.
- Details on excretion:
- No data given.
- Metabolites identified:
- not measured
- Details on metabolites:
- No data given.
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Objective of study:
- other: abiotic dissolution
- Principles of method if other than guideline:
- - Principle of test:
Abiotic flow-through method:
For the determination of the abiotic dissolution the established flow-through testing of the dissolution kinetics of mineral fibers (Guldberg et al., 1995; IARC, 2002) was used with the following adaptations:
- 1 mg of the test material was weighed onto a membrane (cellulose triacetate, Sartorius Stedim Biotech GmbH, Goettingen, Germany): 47mm diameter, 5 kDa pore size, topped by another membrane, and enclosed in flow-through cells.
- Standard conditions are 1 mg initial solid mass in the flow-through cell, and 2 mL/h flow.
- The phagolysosomal simulant fluid (PSF), an acidic buffer simulating the phagolysosomal compartment of macrophages was employed at 37 ± 0.5 °C.
The ion concentrations of the eluates from different time points were determined by inductively coupled plasma-optical emission spectrometry (ICP-OES Agilent 5100 and Varian 725 ES) with a limit of detection of 0.1 mg/L or by inductively coupled plasma-mass spectrometry (ICP-MS Perkin Elmer Nexion 2000b) with a limit of detection of 0.1 ppb. Duplicate measurements were taken and averaged.
After the experiment, the remaining solids were rinsed off the membrane and the resulting suspension was then pelleted onto a TEM grid held at the bottom of a centrifuge vial within 30 min, then dried for the inspection of the morphology of the remaining solids.
- Parameters analysed / observed: dissolution (based on ion concentrations), morphology of the remaining solids
Guldberg, M., et al., 1995. Method for determining in-vitro dissolution rates of man-made vitreous fibres. Glas. Sci. Technol. 68 (6), 181–187.
IARC, I.A.F.R.O.C, 2002. Man-made Vitreous Fibres. World Health Organization, pp. 1–433. - GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Name as cited in the publication: Cu_Phthalocyanine_nano (Pigment Blue 15)
- Source: BASF SE - Radiolabelling:
- no
Referenceopen allclose all
Table 1: Copper determinations in tissues and formalin of male mice from the subchronic study, treated with the test material for 91 days
male animal # |
ppm copper |
|
||
|
liver |
kidney |
formalin |
remark |
highest dose group (5 % w/w) |
|
|
|
|
1 |
7.0 |
14.5 |
-- |
|
2 |
3.2-3.6 * |
6.8 |
-- |
* results of 2 analyses |
3 |
3.4 |
7.7 |
-- |
|
4 |
3.4 |
4.8 |
-- |
|
5 |
3.5 |
6.3 |
-- |
|
6 |
3.7 |
7.3 |
-- |
|
7 |
3.9 |
6.4 |
-- |
|
8 |
4.1 |
8.2 |
-- |
|
9 |
3.3-3.6 * |
5.2 |
-- |
* results of 2 analyses |
control |
|
|
|
|
1 |
3.5 |
4.2 |
0.1 |
|
2 |
3.1 |
3.8 |
0.1 |
|
3 |
3.1 |
4.6 |
0.1 |
|
4 |
2.8 |
4.6 |
0.1 |
|
5 |
2.9 |
4.2 |
0.1 |
|
6 |
3.2 |
4.7 |
0.1 |
|
7 |
3.2 |
5.8 |
0.1 |
|
8 |
2.9 |
5.3 |
0.1 |
|
9 |
2.3 |
4.7 |
0.1 |
|
Table 1: Copper determinations in tissues and formalin of male rats from the subchronic study, treated with the test material for 90 days
male animal # |
ppm copper |
|
||
|
liver |
kidney |
formalin |
remark |
highest dose group (5 % w/w) |
|
|
|
|
1 |
4.6 - 4.3* |
8.4 |
0.1 |
* results of 2 analyses |
2 |
5.9 |
12.3 |
0.1 |
|
3 |
4.1 - 4.4* |
8.6 - 10.1* |
0.1 |
* results of 2 analyses |
4 |
6.4 |
7.7 |
0.1 |
|
5 |
3.2 |
6.7 |
0.1 |
|
6 |
3.5 |
5.8 |
0.1 |
|
7 |
3.7 |
8.1 |
0.1 |
|
8 |
3.5 - 4.1 |
8.1 |
0.1 |
|
9 |
3.1 |
8.7 - 8.6* |
0.1 |
* results of 2 analyses |
10 |
4.6 - 4.5 |
7.2 |
0.1 |
|
control |
|
|
|
|
1 |
3.1 |
3.7 - 4.0* |
0.1 |
* results of 2 analyses |
2 |
3.3 |
4.1 |
0.1 |
|
3 |
3.2 |
4.9 - 4.6* |
0.1 |
* results of 2 analyses |
4 |
3.7 - 4.0* |
5.1 |
0.1 |
* results of 2 analyses |
5 |
3.0 |
4.1 |
0.1 |
|
6 |
2.8 |
5.4 |
0.1 |
|
7 |
2.9 |
2.9 - 3.4* |
0.1 |
* results of 2 analyses |
8 |
2.6 |
5.5 |
0.1 |
|
9 |
2.6 |
5.4 |
0.1 |
|
10 |
3.3 - 3.6* |
5.4 |
0.1 |
* results of 2 analyses |
The test material did not show significant solubility (0.4 % of the initial amount dissolved within 7 days in phagolysosomal simulant fluid at pH 4.5 and a continuous flow-rate of 2 mL/h).
The analysis of changes during dissolution showed, that the test material tended to form aggregates, as no smaller particles remained.
Description of key information
The test item is a solid of very low water and n-octanol solubility. Based on its physico-chemical properties as well as the outcome of several experimental in vivo toxicity studies, a poor absorption is assumed. Single administration via the oral and dermal route did not overt acute toxicity. Repeated oral and inhalative application did not induce signs of local or systemic toxicity as well. Colored feces was observed after oral adminstration, indicating that the test item is excreted unchanged.
Upon inhalation, inhalable forms of the pigment are considered to behave like an inert dust.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
1. Chemical and physico-chemical description of the substance
The test substance is a synthetic blue pigment from the group of phthalocyanine pigments. It is an organometallic complex of phthalocyanine and copper.
Description of the physico-chemical properties:
• physical state (20°C): solid: powder
• vapour pressure: n/a
• molecular weight: 576.07 g/mol
• log Pow (23 °C): -1
• water solubility: 4 - 9 µg/L at ambient temperature
• boiling point: n/a
2. Toxicokinetic assessment
Besides the examination of the copper content in liver and kidneys in subchronic feeding studies and data from an abiotic dissolution study in a phagolysosomal simulant fluid, no experimental data on absorption, metabolism, distribution and excretion are available for the substance. Therefore, the toxicokinetic behavior was evaluated based on the structure and the physico-chemical properties of the substance as well as data from experimental in vivo toxicity studies.
2.1 Absorption
There are no ionisable groups within the structure of the target substance. The low water solubility combined with the large molecular weight of 576.07 g/mol point to a poor absorption of the substance. The low log Pow of -1 is also not favourable for a passive diffusion.
Copper phthalocyanine has a very low solubility in water (0.004 - 0.009 mg/L) and in octanol (0.0001 - 0.0004 mg/L). In an abiotic dissolution study, the pigment did not show significant solubility in a phagolysosomal simulant fluid at pH 4.5 as well.
In the acute oral toxicity study available for the substance no toxicity was observed up to the limit dose of 5000 mg/kg body weight. The same was true in a repeated 90-day oral dose toxicity study in rats, where the substance was applied with the diet. Here no adverse effects were observed up to the highest tested dose of approx. 4500 mg/kg body weight/d. This is in support of the low absorption potential of the substance derived from its structure and the physico-chemical properties.
In subchronic feeding studies the copper content of liver and kidneys was examined at the end of the study period. No statistically significant increases of copper incorporation were reported in the liver and kidney tissues of rats. Therefore, the authors strongly suggested that the test material was not absorbed under the test conditions chosen. The slight increase of copper incorporation in the liver and kidneys of mice was attributed to copper residues in the test material.
The relatively high molecular weight and the low log Pow suggest a poor dermal uptake of the substance. Due to the low water solubility solubilisation in the surface moisture of the skin is unlikely as well.
Experimental studies show no acute systemic and local effects after dermal exposure and no skin sensitizing potential of the test substance, which could be due to a poor absorption or/and to relatively non-toxic properties of the substance.
Regarding the inhalation route, the pigment is considered to behave like an inert dust.
Based on its low water solubility, large molecular weight and low log Pow value a poor absorption in the respiratory tract is assumed as well. As no systemic toxicity was observed in oral and dermal toxicity studies the same outcome is expected after inhalative exposure. This is confirmed by a short-term inhalation toxicity study in rats. Herein, no adverse effects were observed at the highest tested concentration of 29.3 mg/m³ air. Pigment-laden macrophages were seen in the lungs. However, this finding was considered to be part of the clearance function of the test substance and was therefore regarded as non-adverse. Moreover, this finding supports the assumption, that the test substance can be regarded as an inert particle.
2.2 Distribution and Accumulative potential
The physico-chemical information point to a poor distribution of the substance, which might be due to the poor absorption. For the same reason accumulation is assumed to be unlikely.
2.3 Metabolism and Excretion
With regard to metabolism, no information is available. However, single or repeated oral application of the test item at high concentrations did not reveal mortality or signs of toxicity. Instead, excretion of blue stained feces was observed indicating a lack of enzymatic or bacterial degradation.
In view of the absence of relevant findings and the expected low bioavailability, it can be assumed that the test substance is rapidly excreted after oral uptake. This is underlined by the observation of colored feces following oral administration.
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