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Reaction mass of sodium amino-bis{[4-(ethenylsubstituted)phenyl]diazenyl}-hydroxynaphthalenesulfonate and polysodium amino-{[4-(ethenylsubstituted)phenyl]diazenyl}-{[4-(ethenylsubstituted)-2-sulfonatophenyl]diazenyl}-hydroxynaphthalenesulfonate and polysodium amino-bis{[4-(ethenylsubstituted)-2-sulfonatophenyl]diazenyl}-hydroxynaphthalenesulfonate
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
Description of key information
The test substance was found to be not irritating as well as non corrosive to the skin and non irritating to eyes in respective in vitro tests.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
- Specific details on test material used for the study:
- None
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: Reconstituted human epidermis
- Source strain:
- not specified
- Vehicle:
- other: Dulbecco’s phosphate buffered saline (DPBS)
- Details on test system:
- EPISKIN Kit
- Duration of treatment / exposure:
- 15 minutes
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 68.1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- Basis: Assessment of Irritation Potential was based on the % Formazan production. Assessment was as follows: ≤ 50% of negative control- Irritant. > 50% of negative control - Non-irritant. Reversibility: other:. Remarks: The % viability of the test item was 68.1% and it was greater than 50% of the negative control. Hence under the conditions of the study the test item was found to be non-irritant to skin.
- Other effects:
- The negative controls mean OD was found to be 1.377, which is well within the acceptability range. The % viability of the positive control was 17.8% and it was lesser than 50% of the negative control, which reflects the irritant nature of positive control and the sensitivity of the tissues used in the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was found to be a non-irritant to skin.
- Executive summary:
An in vitro study was performed in accordance to OECD Guideline 439 in compilance with GLP to assess the skin irritation potential of test item FAT 40865/A . The percent viability of the test item was 68.1% and it was greater than 50% of the negative control. Hence under the conditions of the study the test item was found to be a non-irritant to skin in accordance with UN GHS.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
- Specific details on test material used for the study:
- None
- Test system:
- human skin model
- Remarks:
- EPISKIN
- Source species:
- human
- Cell type:
- other: Reconstituted Human Epidermis
- Justification for test system used:
- Recommended by guideline
- Duration of treatment / exposure:
- 3 Minutes / 60 Minutes / 240 Minutes
- Amount / concentration applied:
- None
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- > 74.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: 3 Minutes application period result: The % viability was 86.4% ; 60 minutes application period :The % viability was 84.2%; 240 minutes application period: The % viability was 74.2%;
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Based on the results, the % viability result of the test item FAT 40865/A TE was 74.2% and it was greater than 35% of the negative control. Hence under the conditions of the study the test item was found to be ‘Non-corrosive’ to skin in accordance with UN GHS as specified in the OECD Guideline for the Testing of Chemicals
- Executive summary:
An OECD 431 guideline study was performed in accordance to GLP to assess the corrosion potential of test item FAT 40865/A . Test item, FAT 40865/A TE was applied topically to the EPISKINTM epidermal model (two epidermis units were used per each test item and negative controls) for three exposure periods viz., 3 minutes, 60 minutes and 240 minutes, additionally two epidermis units were used for positive control for the exposure period of 240 minutes. Exposure to the test item was terminated by rinsing with Dulbecco’s phosphate buffered saline (DPBS). The viability was assessed by incubating the tissues for 3 hours with MTT solution in a 12 well plate (0.3 mg/ml in assay medium; 2 ml per well). The precipitated formazan was then extracted using acidified isopropanol (0.5 ml) for 4 hours at room temperature and quantified spectrophotometrically at 560 nm using 96 well plates (200 μl/well). Glacial acetic acid and Sodium chloride (9.0 g/ L) treated epidermis were used as positive (PC) and negative controls (NC) respectively. For each treated tissue, the viability was expressed as the % of the negative control tissues (mean).
3 minutes application:
The negative controls mean OD was found to be 0.863, which is well within the acceptability range (0.6 to 1.5). The variation within the replicates of negative control and test item was found to be lesser than 30%. The % viability of the test item was 86.4% and it was greater than 35% of the negative control. Hence no corrosive reaction observed with test item at 3 minutes application period.
60 minutes application:
The negative controls mean OD was found to be 0.843, which is well within the acceptability range (0.6 to 1.5). The variation within the replicates of negative control and test item was found to be lesser than 30%. The % viability of the test item was 84.2% and it was greater than 35% of the negative control. Hence no corrosive reaction observed with test item at 60 minutes application period
240 minutes application:
The negative controls mean OD was found to be 0.817, which is well within the acceptability range (0.6 to 1.5). The variation within the replicates of negative control and test item was found to be lesser than 30%. The % viability of the positive control was 5.6% and it was lesser than 50% of the negative control, which reflects the corrosive nature of positive control and the sensitivity of the tissues used in the study. The % viability of the test item was 74.2% and it was greater than 35% of the negative control. Hence no corrosive reaction observed with test item at 240 minutes application period.
The % viability of test item at the application periods of 3 minutes and 60 minutes showed greater than 35% mean tissue viability in terms of % negative control. Hence the test item is not categorized as corrosive 1A, 1B and 1C.
Referenceopen allclose all
RESULTS
BLANK CORRECTED OPTICAL DENSITY (OD) VALUES FOR EACH TISSUE
Blank Corrected ODs |
|||
Replicate |
NC |
PC |
Test item |
Rep 1 |
NCR1a |
PCR1a |
4819R1a |
1.351 |
0.294 |
0.985 |
|
NCR1b |
PCR1b |
4819R1b |
|
1.290 |
0.226 |
0.842 |
|
Rep 2 |
NCR2a |
PCR2a |
4819R2a |
1.505 |
0.232 |
0.946 |
|
NCR2b |
PCR2b |
4819R2b |
|
1.439 |
0.257 |
1.112 |
|
Rep 3 |
NCR3a |
PCR3a |
4819R3a |
1.336 |
0.242 |
0.848 |
|
NCR3b |
PCR3b |
4819R3b |
|
1.341 |
0.226 |
0.898 |
Mean OD of blank: 0.070
MEAN OPTICAL DENSITY (OD) VALUES FOR EACH TISSUE
Mean ODs |
|||
Replicate |
NC |
PC |
Test item |
Rep 1 |
1.320 |
0.260 |
0.913 |
Rep 2 |
1.472 |
0.244 |
1.029 |
Rep 3 |
1.338 |
0.234 |
0.873 |
Mean |
1.377 |
0.246 |
0.938 |
SD |
0.083 |
0.013 |
0.081 |
%RSD |
6.01 |
5.32 |
8.63 |
Key: Rep/R: Replicate; NC: Negative control; PC: Positive control; SD: Standard deviation; %RSD: Percent relative standard deviation; 4819= study number for test item FAT 40865/A TE
PERCENT VIABILITY (%)
% Viability |
||
Replicate |
PC |
Test item |
Rep 1 |
18.852 |
66.328 |
Rep 2 |
17.726 |
74.718 |
Rep 3 |
16.963 |
63.385 |
Mean |
17.847 |
68.144 |
SD |
0.950 |
5.881 |
% RSD |
5.32 |
8.63 |
RESULTS
BLANK CORRECTED OPTICAL DENSITY (OD) VALUES FOR EACH TISSUE
Blank Corrected ODs |
|||||||
3 minutes application |
60 minutes application |
240 minutes application |
|||||
Replicate |
NC |
Test item |
NC |
Test item |
NC |
PC |
Test item |
Rep 1 |
NCR1a |
4818R1a |
NCR1a |
4818R1a |
NCR1a |
PCR1a |
4818R1a |
0.942 |
0.745 |
1.085 |
0.938 |
0.854 |
0.152 |
0.835 |
|
NCR1b |
4818R1b |
NCR1b |
4818R1b |
NCR1b |
PCR1b |
4818R1b |
|
0.828 |
0.668 |
0.849 |
0.758 |
0.739 |
-0.018 |
0.614 |
|
Rep 2 |
NCR2a |
4818R2a |
NCR2a |
4818R2a |
NCR2a |
PCR2a |
4818R2a |
0.823 |
0.762 |
0.666 |
0.531 |
0.786 |
0.026 |
0.521 |
|
NCR2b |
4818R2b |
NCR2b |
4818R2b |
NCR2b |
PCR2b |
4818R2b |
|
0.858 |
0.806 |
0.772 |
0.613 |
0.886 |
0.022 |
0.589 |
|
Mean OD of blank |
0.120 |
0.285 |
0.142 |
Key: Rep/R: Replicate; NC: Negative control; PC: Positive control; SD: Standard deviation; 4818= study number for test item FAT 40865/A TE
MEAN OPTICAL DENSITY (OD) VALUES FOR EACH TISSUE
Mean ODs |
|||||||
3 minutes application |
60 minutes application |
240 minutes application |
|||||
Replicate |
NC |
Test item |
NC |
Test item |
NC |
PC |
Test item |
Rep 1 |
0.885 |
0.707 |
0.967 |
0.848 |
0.797 |
0.067 |
0.725 |
Rep 2 |
0.841 |
0.784 |
0.719 |
0.572 |
0.836 |
0.024 |
0.555 |
Mean |
0.863 |
0.746 |
0.843 |
0.710 |
0.817 |
0.046 |
0.640 |
SD |
0.031 |
0.055 |
0.175 |
0.195 |
0.028 |
0.030 |
0.120 |
%RSD |
3.65 |
7.35 |
20.80 |
27.48 |
3.42 |
66.46 |
18.73 |
Key: Rep/R: Replicate; NC: Negative control; PC: Positive control; SD: Standard deviation; %RSD: Percent relative standard deviation; 4818= study number for test item FAT 40865/A TE
PERCENT VIABILITY (%)
% Viability |
||||
3 minutes application |
60 minutes application |
240 minutes application |
||
Replicate |
Test item |
Test item |
PC |
Test item |
Rep 1 |
81.895 |
100.593 |
8.236 |
83.980 |
Rep 2 |
90.875 |
67.862 |
2.970 |
64.340 |
Mean |
86.385 |
84.228 |
5.603 |
74.160 |
SD |
6.350 |
23.144 |
3.724 |
13.888 |
%RSD |
7.35 |
27.48 |
66.46 |
18.73 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- 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
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Principles of method if other than guideline:
- The measurement of the opacity was performed with a photometer (570 nm) instead of an opacitometer. This can be seen as uncritical, because the opacity can be calculated from the absorption. The deviation was signed and assessed by the study director on 07. Aug. 2014.
- GLP compliance:
- yes
- Specific details on test material used for the study:
- None
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Fresh bovine eyes (Bos primigenius Taurus (Fresh bovine corneas)) were obtained from the slaughterhouse Müller Fleisch GmbH, Enzstr. 2 -4, 75217 Birkenfeld, Germany, on the day of the test. The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hank’s balanced salt solution (supplemented with 0.01% streptomycin and 0.01% penicillin). Then, the corneas were dissected and incubated in medium at 32 ± 1 °C in an incubation chamber for 1 hour.
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 750 μL of the test item were tested as suspension at 20% concentration in 0.9% sodium chloride solution.
- Duration of treatment / exposure:
- Incubation time: 4 hours
- Observation period (in vivo):
- No data
- Number of animals or in vitro replicates:
- No data
- Details on study design:
- Refer to "Any other information on materials and methods incl. tables".
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- -0.29
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritant / corrosive response data:
- None
- Other effects:
- None
- Interpretation of results:
- not irritating
- Conclusions:
- Under the conditions of this test, the test item FAT 40865/A TE showed no effects on the cornea of the bovine eye. Hence, it was considered to be non-irritating to eyes.
- Executive summary:
An OECD 437 guideline study was performed in accordance to GLP to assess the irritation potential of test item FAT 40865/A to eyes using bovine corneas. They were collected from slaughtered cattle which were between 12 and 60 months old. The test item FAT 40865/A TE was brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32 ± 1 °C for one hour and whose opacity had been measured. The test item was incubated on the cornea for 4 hours at 32 ± 1 °C. After removal of the test item, opacity and permeability values were measured. Physiological sodium chloride solution was used as negative control. The negative control showed no irritating effect on the cornea. 20% Imidazole solution was used as positive control. The positive control induced serious eye damage on the cornea. The calculated IVIS (in vitro irritancy score) was - 0.290. According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS≤3 requires no classification for eye irritation or serious eye damage. Hence, under the conditions of this test system, the test item FAT 40865/A TE showed no effects on the cornea of the bovine eye and considered to be non-irritating to eyes.
Reference
Opacity and Permeability Values
The absorption (570 nm) and opacity values which were measured before and after exposition are given in the following table:
Parameter |
Negative Control |
||
Absorption before exposition |
0.1703 |
0.1803 |
0.1790 |
Absorption after exposition |
0.2574 |
0.2851 |
0.5227 |
Opacity before exposition |
1.4801 |
1.5146 |
1.5101 |
Opacity after exposition |
1.8088 |
1.9280 |
3.3320 |
Opacity Difference |
0.3287 |
0.4134 |
1.8219 |
Mean opacity difference of the negative control is 0.8547.
Absorption and Opacity Values Test Item and Positive Control
Parameter |
Test ItemFAT 40865/A TE |
Positive Control |
||||
Absorption before exposition |
0.1908 |
0.2072 |
0.1664 |
0.1583 |
0.1376 |
0.1975 |
Absorption after exposition |
0.2762 |
0.3804 |
0.4183 |
1.7073 |
1.6212 |
1.6112 |
Opacity before exposition |
1.5517 |
1.6114 |
1.4669 |
1.4398 |
1.3728 |
1.5758 |
Opacity |
1.8889 |
2.4010 |
2.6200 |
50.9683 |
41.8023 |
40.8507 |
Opacity |
0.3372 |
0.7897 |
1.1531 |
49.5285 |
40.4295 |
39.2750 |
For the permeability measurement, three replicates for each treatment group were measured. The optical density values at 490 nm are given in the following table:
Repl. |
Negative Control |
Test ItemFAT 40865/A TE |
Positive Control |
||||||
Meas. |
0.0058 |
0.0065 |
0.0051 |
0.0022 |
0.0029 |
0.0045 |
0.3828 |
0.3462 |
0.4711 |
Corr. |
0.0290 |
0.0325 |
0.0255 |
0.0110 |
0.0145 |
0.0225 |
1.9140 |
1.7310 |
2.3555 |
Mean |
0.0290 |
-- |
The calculated IVIS for each replicate and the corresponding means are presented in the following table:
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control |
0.764 |
1.290 |
61.6 % |
0.901 |
|||
2.204 |
|||
Test Item |
- 0.788 |
- 0.290 |
170.4 % |
- 0.283 |
|||
0.201 |
|||
Positive Control |
76.949 |
71.790 |
8.5 % |
65.105 |
|||
73.318 |
Classification
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation
or serious eye damage.
IVIS |
UN GHS Category Eye Damage |
≤ 3 |
No Category |
> 3;≤ 55 |
No prediction can be made |
> 55 |
Eye damage Category I |
In the negative control, no signs of eye irritation were observed. The positive control induced serious eye damage, which would be classified as GHS category 1. The test item FAT 40865/A TE showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is - 0.290
Validity
According to the guideline, the test is considered as valid if the positive control causes an IVIS that falls within two standard deviations of the current historical mean. The negative or solvent control has to show an IVIS between 0 and 3.
The validity criteria and findings are given in the following table:
Parameter |
Criterion |
Found |
Assessment |
IVIS of negative control 0.9% NaCl |
0 - 3 |
1.290 |
ok |
IVIS of positive control |
35.6 – 130.4 |
71.790 |
ok |
Values for negative and positive controls were within the range of historical data of the test facility. Therefore, the test system was acceptable.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Three key in vitro tests were performed as per OECD test guideline to evaluate irritation and corrosion potential of FAT 40865/A TE.
An OECD 423 guideline study was performed in accordance to GLP to assess the skin corrosion potential of test item FAT 40865/A using EPISKIN epidermal model for three exposure periods viz., 3 minutes, 60 minutes and 240 minutes. Based on the results, the % viability result of the test item FAT 40865/A TE was 74.2% and it was greater than 35% of the negative control. Hence under the conditions of the study the test item was found to be ‘Non-corrosive’ to skin in accordance with UN GHS as specified in the OECD Guideline for the Testing of Chemicals.
An OECD 439 guideline study was performed in accordance to GLP to assess the skin irritation potential of test item FAT 40865/A . The percent viability of the test item was 68.1% and it was greater than 50% of the negative control. Hence under the conditions of the study the test item was found to be Non-irritant to skin in accordance with UN GHS as specified in the OECD Guideline for the Testing of Chemical.
An OECD 437 guideline study was performed in accordance to GLP to assess the irritation potential of test item FAT 40865/A to eyes using bovine corneas. They were collected from slaughtered cattle which were between 12 and 60 months old. The test itemFAT 40865/A TEwas brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32 ± 1 °C for one hour and whose opacity had been measured. The test item was incubated on the cornea for 4 hours at 32 ± 1 °C. After removal of the test item, opacity and permeability values were measured.Physiological sodium chloride solution was used as negative control. The negative control showed no irritating effect on the cornea. 20% Imidazole solution was used as positive control. The positive control induced serious eye damage on the cornea. The calculated IVIS (in vitro irritancy score) was - 0.290. According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤3 requires no classification for eye irritation or serious eye damage. Hence, under the conditions of this test system, the test item FAT 40865/A TE showed no effects on the cornea of the bovine eye and considered to be non-irritating to eyes.
Justification for classification or non-classification
The test substance was not irritating as well as non corrosive to skin and non irritating to eyes. Hence, it does not require classification for irritation/corrosion as per the CLP (Regulation 1272/2008) criteria.
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