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EC number: 204-693-2 | CAS number: 124-26-5
- 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
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- 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
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- Nanomaterial pour density
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- 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
RA-S Amides, C16-C18 (even numbered), In vitro Skin Irritation (EU Method B.46: RHE Model Test): not irritating
RA-S CAS 112-84-8, OECD 404, rabbit, 4h semiocclusive: not irritating
RA-S Amides, C16-C18 (even numbered), In vitro Eye Irritation (Reconstructed Human Corneal Epithelium Model): not irritating
RA-S Amides, C16-C18 (even numbered), In vivo Eye Irritation, OECD 405: not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study. Reliability was changed from "1" to "2" according to the ECHA guidance document "Practical guide 6: How to report read-across and categories".
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- Principles of method if other than guideline:
- EPISKIN reconstituted human epidermis model: 15 min treatment followed by 42 hours post-exposure incubation period.
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: reconstituted human epidermis
- Cell source:
- other: adult human-derived epidermal keratinocytes
- Source strain:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 15 min
SCORING SYSTEM: not applicable, measurement of cytotoxicity by colourimetric MTT reduction assay - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 ± 2 mg - Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours post-exposure incubation period
- Number of replicates:
- triplicate tissues
- Vehicle:
- unchanged (no vehicle)
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- Test substance
- Run / experiment:
- mean of 3 runs
- Value:
- 117.4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- Negative control
- Run / experiment:
- mean of 3 runs
- Value:
- 100
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- Positive control
- Run / experiment:
- mean of 3 runs
- Value:
- 7.3
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Other effects / acceptance of results:
- The test material was considered to be Non-Irritant (NI).
- Interpretation of results:
- other: CLP criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study. Reliability was changed from "1" to "2" according to the ECHA guidance document "Practical guide 6: How to report read-across and categories".
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: The Broekman Institute, Someren, The Netherlands
- Age at study initiation: 10, 13 and 17 weeks
- Weight at study initiation: 2303, 2605 and 2853 g
- Housing: Individually in a plastic cage with a perforated floor
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 50-60
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: The right flank served as untreated control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): Moistened with 0.5 mL water
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4h
- Observation period:
- 1, 24, 48 and 72h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: The test substance was spread on 6 cm² patch of Metalline (Lobmann, Germany) and mounted on permeable tape (Micropore, 3M, St. Paul, USA). This was applied to the left flank of each animal, the right flank being covered with the same dressing without test substance. Finally, the animals were wrapped in flexible bandage (Coban, 3M, St. Paul, USA)
REMOVAL OF TEST SUBSTANCE
- Washing: The remaining test substance was removed, using a dry tissue and subsequently a tissue moistened with tap-water.
- Time after start of exposure: 4h
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- The test substance caused only very slight erythema in all three animals, 60 minutes after removal of the dressings.
- Other effects:
- No signs of systemic intoxication were observed in any of the rabbits.
- Interpretation of results:
- other: CLP criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
Referenceopen allclose all
The test material did not directly reduce MTT.
Mean OD540 values and percentage viabilities for the negative control material, positive control material and test material:
Material |
OD540of tissues |
Mean OD540if triplicate tissues |
± SD of OD540 |
Relative individual tissue viability (%) |
Relative mean viability (%) |
± SD of Relative mean viability (%) |
Negative control |
0.784 |
0.834 |
0.045 |
94.0 |
100* |
5.4 |
0.847 |
101.6 |
|||||
0.871 |
104.4 |
|||||
Positive control |
0.069 |
0.061 |
0.016 |
8.3 |
7.3 |
1.9 |
0.071 |
8.5 |
|||||
0.043 |
5.2 |
|||||
Test material |
1.079 |
0.979 |
0.087 |
129.4 |
117.4 |
10.4 |
0.925 |
110.9 |
|||||
0.933 |
111.9 |
* The mean viability of the negative control tissues is set at 100%
The relative mean viability of the test material treated tissues was 119.2% after a 15 -minute exposure, the test material treated tissues appeared blue which was considered indicative of viable tissue.
The relative mean tissue viability for the positive control treated tissues was ≤ 40% relativ to the negative control, and the standard deviation value of the percentage viability was ≤20%. The positive control acceptance criterion was therefore satisfied.
The mean OD540 for the negative control treated tissues was ≥0.6 and the SD value of the percentage viability was ≤20%. The negative control acceptance criterion was therefore satisfied.
Conclusion:
The test material was considered to be Non-Irritant (NI).
Based on these results the test substance should be considered as not-irritating to the skin. According to the criteria of the CLP regulation the test substance does not have to be classified as irritating to the skin.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study. Reliability was changed from "1" to "2" according to the ECHA guidance document "Practical guide 6: How to report read-across and categories".
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Only 2 animals tested
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Only 2 animals tested
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd, Hillcrest, Belton, Loughborough, UK
- Age at study initiation: 12 to 20 weeks
- Weight at study initiation: 2.01 and 2.88 kg
- Housing: individually in suspended cages
- Diet: 2030 Teklad Global Rabbit diet (Harlan Teklad, Blackthorn, Bicester, Oxon, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eyes served as controls
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (corrsponding to approximately 51 mg, measured by gently compacting the required volumen into an adapted syringe) - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- No corneal or iridial effects were observed during the relevant observation period of the study. Moderate corneal irritation was only noted in both treated eyes one hour after treatment. Minimal conjunctival irritation was noted at the 24-hour observation. Both treated eyes appeared normal at the 48-hour observation.
Although only 2 animals have been tested the study is fully acceptable for assessment, as even a positive irritation response in a third animal would not lead to a classification according to the criteria of the OECD guidelines for studies performed with 3 animals. Therefore, testing of a third animal would have not increased validity of the study for regulatory purposes and was omitted due to animal welfare reasons. - Other effects:
- Both animals showed expected gain in body weight during the study.
- Interpretation of results:
- other: CLP criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure in accordance with generally accepted scientific standards and described in sufficient detail; performed under GLP.
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- In vitro determination of the eye irritation potential with the SkinEthic Reconstructed Human Corneal Epithelium model.
- GLP compliance:
- yes (incl. QA statement)
- Species:
- human
- Strain:
- other: transformed human keratinocytes of the HCE cell line
- Details on test animals or tissues and environmental conditions:
- not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not applicable, in vitro
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 mg - Duration of treatment / exposure:
- 10 min
- Observation period (in vivo):
- not applicable
- Number of animals or in vitro replicates:
- not applicable, in vitro
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 10 minutes
SCORING SYSTEM: not applicable, colorimetric determination of cell viability in treated tissues relative to control tissues - Irritation parameter:
- mean percent tissue viability
- Remarks:
- Test substance
- Run / experiment:
- mean
- Value:
- 102.9
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The quality criterion required for the acceptance of results in the test was satisfied.
- Interpretation of results:
- other: CLP criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
Referenceopen allclose all
Although only 2 animals were tested the study is fully acceptable for assessment from a regulatory point of view, as even contribution of a third animal demonstrating most severe irritation reactions would have no impact on final classification according to the criteria for eye irritation tests conducted with 3 animals.
The test material was not able to directly reduce MTT.
Assessment of eye irritation potential:
The mean OD540 values and mean viabilities for each treatment group are given in the following table.
Assessment of Eye Irritation Potential – Viability of RHC Tissues:
Material |
Mean Tissue Viability |
Mean OD540 |
Viability (%) |
Negative Control |
1.014 |
0.979 |
100* |
0.943 |
|||
Positive Control |
0.263 |
0.247 |
25.2 |
0.230 |
|||
Test Material |
1.067 |
1.007 |
102.9 |
0.947 |
* The mean viability of the negative control tissues is set at 100%.
The relative mean viability of the test material treated tissues after a 10-minute exposure was 102.9%.
It was considered unnecessary to proceed with tissue histopathology.
The test material and negative control material treated tissues appeared blue which was considered to be indicative of viable tissue. The positive control tissues appeared appeared blue/white which was considered to be indicative of semi-viable tissue.
The quality criterion required for the acceptance of results in the test was satisfied.
Conclusion:
According to the protocol followed the test material was considered to be a Non-Irritant (NI).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No test data for skin and eye irritation is available for stearamide (CAS 124-26-5). Therefore, read-across data from structurally related substances, i.e. Amides, C16-C18 (even numbered) and erucamide (CAS 112-84-5), is included for regulatory purposes. Amides, C16-18 (even numbered) is a UVCB substance which differs from stearamide due to its significant content of palmitamide (C16 fatty acid amide). For decades, stearamide and Amides, C16-C18 (even numbered) have been considered as different purity grades of the same substance and have been marketed as stearamide (CAS 124-26-5). Due to the conventions laid down in the "Guidance for identification and naming of substances under REACH and CLP" these different purity grades now have to be considered as different substances and are subject to separate registrations.
There is an in vitro skin irritation study available for Amides, C16-C18 (even numbered) (Warren, 2010) conducted according to EU Method B.46. This is a validated method that has been accepted by the authorities in the light of animal welfare for the assessment of skin irritating potential. Therefore, it was chosen as key study. The study was performed with the EPISKIN Reconstituted Human Epidermis Model. The human epidermal cultures were topically treated with the test substance for 15 minutes, followed by a 42-hour post-exposure incubation period. Thereafter cell viability in the culture was assessed by means of the colourimetric MTT reduction assay. In this experimental setting the test substance had no adverse effects on cell viability in the human epidermal culture. Therefore, the substance was considered to be non-irritating to the skin in vitro under the conditions of the test.
As additional support for the in vitro data, although not necessary from a regulatory standpoint, read-across data from an in vivo skin irritation test according to OECD Guideline 404, performed in 3 animals with erucamide (CAS 112-84-5), a structurally related substance, is included and chosen as additional key study (Daamen, 1988).
Erucamide is the fatty acid amide resulting from the amidation of erucic acid. Erucic acid is a mono-unsaturated fatty acid with a carbon chain consisting of 22 carbon atoms with a double bond at position 13 (omega-9) of the carbon chain (cis-docos-13-enoic acid). Comparable to stearamide it is not classified in Annex VI of Regulation (EC) No 1272/2008, and does not have to be self-classified according to the available experimental data. Erucic acid is also present in various oils and fats which are part of our diets (20-40% in oils from mustard seeds and up to 50% in original high erucic rapeseed oil, <2% in low erucic acid rapeseed oil; Beare-Rogers, 2001) and will also be broken down into shorter-chain fatty acids in the process of beta-oxidation. One of the most famoust uses is in Lorenzo's oil, a 4:1 mixture of the triglyceride forms of oleic and erucic acid, i.e. an investigational drug used for the treatment of adrenoleukodystrophy, for which an U.S. Patent was established.
In this skin irritation study the animals were exposed for 4 hours under semiocclusive conditions. Only slight erythema 1 hour after removal of the dressing was observed, which was completely reversible within 24 hours, and no signs of systemic toxicity were observed. Based on these results the structurally related substance was considered as not irritating to the skin. Therefore, stearamide (CAS 124-26-5) does not have to be considered as irritating to the skin in vivo, either.
There is data for eye irritation available from an in vitro and an in vivo study performed with Amides, C16-C18 (even numbered).
The in vivo study was conducted in compliance with OECD Guideline 405, although only 2 rabbits were included in the test (Bradshaw, 2010). Nevertheless this study was fully acceptable from a regulatory point of view, as even the contribution of a third animal demonstrating severe irritation reactions would have had no impact on the final classification according to the criteria for eye irritation tests with 3 animals. Therefore, this approach is reasonable considering animal welfare aspects, and the study was chosen as key study. No corneal or iridial effects were observed during the 72-hour observation period of the study. Moderate corneal irritation was noted in the treated eyes of both animals one hour after treatment which had completely reversed until the 24-hour reading. No corneal or iridial effects were observed during the observation period relevant for assessment. Minimal conjunctival irritation in form of erythema and edema was observed at the 24-hour reading; both eyes apperared normal at the 48-hour reading. Due to the lack of any effects after 72 hours the study was terminated then. Considering the mild character and the complete reversibility within 72 hours the test substance was considered to be not irritating to the eyes.
This view is supported by an in vitro study with Amides, C16-18 (even numbered) which had been performed using the SkinEthic Reconstructed Human Corneal Epithelium Model and was chosen as additional key study (Warren, 2010). The cells of the tissue cultures were exposed to the test substance for 10 minutes. Following a 3-hour incubation period with MTT, cell viability was determined using the colourimetric MTT reduction assay. Based on the lack of effects on cell viability the test substance was considered to be a Non-Irritant, as well, in accordance with the in vivo assay. Based on these results the structurally related substance was considered as not irritating to the eyes. Therefore, stearamide (CAS 124-26-5) does not have to be considered as irritating to the eyes, either.
Justification for classification or non-classification
Based on the results from structurally related substances stearamide does not have to be classified as irritating to the skin or the eyes according to the criteria of Regulation (EC) No 1272/2008.
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.
