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EC number: 929-915-1 | 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
Skin:
in-vitro skin corrosion: not corrosive
in-vitro skin irritation: irritating Cat. 2
Eye:
in-vitro Eye irritation: not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 16/0438-1, Batch 360-71-3
- The test substance was homogenous by visual inspection.
- pH 5
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: undiluted test substance moistened with deionized water
FORM AS APPLIED IN THE TEST (if different from that of starting material): moistened with water - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Source strain:
- not specified
- Details on animal used as source of test system:
- - Tissue model: EPI-200
- Tissue Lot Number: 23388
- Origin: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia - Justification for test system used:
- The test system is part of an integrated approach on testing and assessment (IATA) for skin corrosion and irritation and is one of the accepted guideline studies.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm model
- Tissue batch number(s): 23388
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C and room temperature
- Temperature of post-treatment incubation (if applicable): 37°C
NUMBER OF REPLICATE TISSUES: 2 tissues per exposure time
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 45%.
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is higher than 45%, or if the viability after 3 minutes exposure is greater than or equal to 45 % and the viability after 1 hour exposure is less than 10%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than 55% and the viability after 1 hour exposure is greater than 20%.
- The borderline evaluation was determined statistically using historic data and hence considers the variance of the test method.This evaluation is an amendment to the evaluation provided in OECD Guideline 431. - Control samples:
- yes, concurrent vehicle
- other: Positive control: 8-N potassium hydroxide solution
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Fifty microliters (50 µL) undiluted, at ca. 37 °C heated test substance were applied by using a pipette. - Duration of treatment / exposure:
- 3 minutes at room temperature and 1h in the incubator
- Duration of post-treatment incubation (if applicable):
- Rinsed tisuues were kept in 24-well plates at room temperature on assay medium until all tissues per application time were dosed and rinsed.
- Number of replicates:
- 2 tissues per exposure time
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean (Exposure period. 3min)
- Value:
- 83.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean (Exposure period: 1h)
- Value:
- 92.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results observed and by applying the evaluation criteria it was concluded that the test substance does not show a skin corrosion potential under the test conditions chosen.
- Executive summary:
The objective was to assess the skin irritation and corrosion potential of the test substance. By using the currently available methods a single in vitro assay is not sufficient to cover the full range of
skin irritating/corrosion potential. Therefore, two in vitro assays were part of this in vitro skin irritation and corrosion test strategy: The Skin Corrosion Test (SCT) and Skin Irritation Test (SIT).
The potential of the test substance to cause dermal corrosion was assessed by a single topical application of 50 μL of the undiluted test substance to a reconstructed three-dimensional human epidermis model (EpiDerm™).
For the corrosion test, two EpiDerm™ tissues were incubated with the test substance for 3 minutes and 1 hour, each. Tissue destruction was determined by measuring the metabolic activity of the tissue after
exposure by using a colorimetric test. The reduction of mitochondrial dehydrogenase activity measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.
The final mean viability of the tissues treated with the test substance determined after an exposure period of 3 minutes was 83.9% and 92.2% after an exposure period of 1 hour.
Based on the results observed and by applying the evaluation criteria it was concluded that the test substance does not show a skin corrosion potential under the test conditions chosen.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 16/0438-1, Batch 360-71-3
- The test substance was homogenous by visual inspection.
- pH 5
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: undiluted test substance moistened with deionized water
FORM AS APPLIED IN THE TEST (if different from that of starting material): moistened with water - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Source strain:
- not specified
- Details on animal used as source of test system:
- - Tissue model: EPI-200
- Tissue Lot Number: 23388
- Origin: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia - Justification for test system used:
- The test system is part of an integrated approach on testing and assessment (IATA) for skin corrosion and irritation and is one of the accepted guideline studies.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm model
- Tissue batch number(s): 23388
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
- Temperature of post-treatment incubation (if applicable): 37°C
NUMBER OF REPLICATE TISSUES: 3
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant if the viability is less than 45% compared to negative control.
- The test substance is considered to be non-irritant if the viability is higher than 55% compared to control.
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 45%, or if the viability after 3 minutes exposure is greater than or equal to 45 % and the viability after 1 hour exposure is less than 10%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than 55% and the viability after 1 hour exposure is greater than 20%.
- The borderline evaluation was determined statistically using historic data and hence considers the variance of the test method.This evaluation is an amendment to the evaluation provided in OECD Guideline 431. - Control samples:
- other: Negative control: PBS; positive control: 5% SDS
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 µL undiluted, at 37°C heated test substance
- Concentration (if solution): undiluted
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µl sterile PBS
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µl SDS solution
- Concentration (if solution): 5% - Duration of treatment / exposure:
- 1h
- Duration of post-treatment incubation (if applicable):
- 24h
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean
- Value:
- 10
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Based on the results observed and by applying the evaluation criteria, it was concluded that the test item show a skin irritation potential in the EpiDerm™ in vitro skin irritation and corrosion test strategy under the test conditions chosen.
- Executive summary:
The objective was to assess the skin irritation and corrosion potential of the test substance. By using the currently available methods a single in vitro assay is not sufficient to cover the full range of skin irritating/corrosion potential. Therefore, two in vitro assays were part of this in vitro skin irritation and corrosion test strategy: The Skin Corrosion Test (SCT) and Skin Irritation Test (SIT).
The potential of the test substance to cause dermal corrosion/irritation was assessed by a single topical application of 30µl of the undiluted test substance to a reconstructed three-dimensional human epidermis model (EpiDerm™).
The irritation test was performed with three EpiDerm™ tissues, which were incubated with the test substance for 1 hour, followed by a 42-hour post-incubation period.
Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation by using a colorimetric test. The reduction of mitochondrial dehydrogenase activity measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.
The final mean viability of the tissues treated with the test substance determined after an exposure period of 1 hour with an about 42-hour post-incubation was 10%.
Based on the results observed and by applying the evaluation criteria, it was concluded that the test substance show a skin irritation potential in the EpiDerm™ in vitro skin irritation and corrosion test strategy under the test conditions chosen.
Referenceopen allclose all
Exposure period 3 minutes: Individual and mean OD570 values, individual and mean viability values and standard deviations
Test substance | Tissue 1 | Tissue 2 | Mean | SD | |
NC | Mean OD570 | 1.527 | 1.721 | 1.624 | |
NC | Viability (% of NC) | 94.0 | 106.0 | 100.0 | 8.5 |
Test substance | Mean OD570 | 1.249 | 1.475 |
1.362 |
|
Test substance |
Viability (% of NC) |
76.9 |
90.8 |
83.9 |
9.8 |
PC |
Mean OD570 |
0.159 |
0.244 |
0.202 |
|
PC |
Viability (% of NC) |
9.8 |
15.0 |
12.4 |
3.7 |
Exposure period 1h: Individual and mean OD570 values, individual and mean viability values and standard deviations
Test substance |
|
Tissue 1 |
Tissue 2 | Mean | SD |
NC | Mean OD570 | 1.659 | 1.564 | 1.612 | |
NC | Viability (% of NC) | 102.9 |
97.1 |
100.0 |
4.1 |
Test substance |
Mean OD570 |
1.348 |
1.625 |
1.487 |
|
Test substance |
Viability (% of NC) |
83.6 |
100.9 |
92.2 |
12.2 |
PC |
Mean OD570 |
0.097 |
0.085 |
0.091 |
|
PC |
Viability (% of NC) |
6.0 |
5.3 |
5.6 |
0.5 |
Individual and mean OD570 values, individual and mean viability values and standard deviations
Test substance | Tissue 1 | Tissue 2 | Tissue 3 | Mean | SD | |
NC | Mean OD570 | 1.900 | 1.797 | 1.810 |
1.836 |
|
NC |
Viability (% of NC) |
103.5 |
97.9 |
98.6 |
100.0 |
3.1 |
Test substance |
Mean OD570 |
0.049 |
0.455 |
0.047 |
0.184 |
|
Test substance |
Viability (% of NC) |
2.7 |
24.8 |
2.6 |
10.0 |
12.8 |
PC |
Mean OD570 |
0.036 |
0.041 |
0.036 |
0.037 |
|
PC |
Viability (% of NC) |
1.9 |
2.2 |
1.9 |
2.0 |
0.2 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 16/438-1, 360-71-3
- pH 5
- The test substance was homogenous by visual inspection.
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature - Species:
- human
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST SYSTEM
- Source: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
- Tissue model: OCL-200
- Tissue Lot Number: 23760
- Incubation conditions: 37°C +/- 1°C, 5% +/- 1% CO2, 90% +/- 5% relative humidity
- Detection agent: MTT
- Ectracting agent: Isopropanol
- Wash buffer: PBS - Controls:
- other: Negative control: deionized sterile water; positive control: Neat methyl acetate
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl undiluted test substance - Duration of treatment / exposure:
- 30 minutes
- Duration of post- treatment incubation (in vitro):
- 2h
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with sterile PBS
- Time after start of exposure: 30 minutes
SCORING SYSTEM:
Mean tissue viability
(% of negative control) Prediction
< 55 Irritant
55 - 65 Borderline
> 65 Non-irritant
- Irritation parameter:
- other: Tissue viability (% of NC)
- Run / experiment:
- Mean
- Value:
- 93.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results observed for the EpiOcular Test alone and by applying the evaluation criteria it was concluded that the test item does not show an eye irritation potential in the in vitro eye irritation test strategy under the test conditions chosen.
- Executive summary:
The objective was to assess the eye irritating potential of the test substance. By using the methods currently available a single in vitro assay is not sufficient to cover the full range of eye irritating potential. Therefore, two in vitro assays were part of this in vitro eye irritation test strategy: The Bovine Corneal Opacity and Permeability Test (BCOP Test) and EpiOcular Eye Irritation Test.
However, in case of the test substance, the results derived with EpiOcular alone were sufficient for a final assessment. Therefore, further testing in BCOP was waived.
The potential of the test substance to cause ocular irritation was assessed by a single topical application of undiluted test substance to a reconstructed three-dimensional, human cornea model (EpiOcular™). Two EpiOcular™ tissues were incubated with the test substance for 30 minutes followed by a 2-hour post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation by using a colorimetric test. The reduction of mitochondrial dehydrogenase activity measured by reduced formazan production after incubation with a
tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the epidermal tissues treated with the test substance is compared to that of negative control tissues. The ratio of the values indicates the relative tissue viability.
The following results were obtained in the EpiOcular™ eye irritation assay:
The test substance is not able to directly reduce MTT. The final mean viability of the tissues treated with the test substance was 93.8%.
Based on the results observed in the EpiOcular Test alone and by applying the evaluation criteria, it was concluded that the test substance does not show an eye irritation potential in the in vitro eye irritation test strategy under the test conditions chosen.
Reference
Individual and mean OD570 values, individual and mean viability values and inter-tissue variability
Test substance | Tissue 1 | Tissue 2 | Mean | Inter-tissue variability (%) | |
NC | Mean OD570 | 1.624 | 1.625 | 1.624 | |
NC | Viability (% of NC) | 100.0 |
100.0 |
100.0 |
0.1 |
Test item |
Mean OD570 |
1.545 |
1.502 |
1.523 |
|
Test item |
Viability (% of NC) |
95.1 |
92.5 |
93.8 |
2.6 |
PC |
Mean OD570 |
0.333 |
0.448 |
0.390 |
|
PC |
Viability (% of NC) |
20.5 |
27.6 |
24.0 |
7.1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion:
The objective was to assess the skin irritation and corrosion potential of the test substance. By using the currently available methods a single in vitro assay is not sufficient to cover the full range of skin irritating/corrosion potential.
Therefore, two in vitro assays were part of this in vitro skin irritation and corrosion test strategy: The Skin Corrosion Test (SCT) and Skin Irritation Test (SIT).
The potential of the test substance to cause dermal corrosion/irritation was assessed by a single topical application of ca. 50 μL (corrosion test) or 30µl (irritation test) of the undiluted test substance to a reconstructed three-dimensional human epidermis model (EpiDerm™).
For the corrosion test, two EpiDerm™ tissues were incubated with the test substance for 3 minutes and 1 hour, each. The irritation test was performed with three EpiDerm™ tissues, which were incubated with the test substance for 1 hour, followed by a 42-hour post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation by using a colorimetric test. The reduction of mitochondrial dehydrogenase activity measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.
The following results were obtained in the EpiDerm™ skin corrosion/irritation test:
The test substance is not able to directly reduce MTT.
Results of the Corrosion Test (SCT):
The final mean viability of the tissues treated with the test substance determined after an exposure period of 3 minutes was 83.9% and 92.2% after an exposure period of 1 hour.
Results of the Irritation Test (SIT):
The final mean viability of the tissues treated with the test substance determined after an exposure period of 1 hour with an about 42-hour post-incubation was 10%.
Based on the results observed and by applying the evaluation criteria, it was concluded that the test substance shows a skin irritation potential in the EpiDerm™ in vitro skin irritation and corrosion test strategy under the test conditions chosen.
Eye irritation:
The objective was to assess the eye irritating potential of the test substance. By using the methods currently available a single in vitro assay is not sufficient to cover the full range of eye irritating potential. Therefore, two in vitro assays were part of this in vitro eye irritation test strategy: The Bovine Corneal Opacity and Permeability Test (BCOP Test) and EpiOcular Eye Irritation Test.
However, in case of the test substance, the results derived with EpiOcular alone were sufficient for a final assessment. Therefore, further testing in BCOP was waived.
The potential of the test substance to cause ocular irritation was assessed by a single topical application of undiluted test substance to a reconstructed three-dimensional, human cornea model (EpiOcular™). Two EpiOcular™ tissues were incubated with the test substance for 30 minutes followed by a 2-hour post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation by using a colorimetric test. The reduction of mitochondrial dehydrogenase activity measured by reduced formazan production after incubation with a
tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the epidermal tissues treated with the test substance is compared to that of negative control tissues. The ratio of the values indicates the relative tissue viability.
The following results were obtained in the EpiOcular™ eye irritation assay:
The test substance is not able to directly reduce MTT. The final mean viability of the tissues treated with the test substance was 93.8%.
Based on the results observed in the EpiOcular Test alone and by applying the evaluation criteria, it was concluded that the test substance does not show an eye irritation potential in the in vitro eye irritation test strategy under the test conditions chosen.
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.