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EC number: 817-668-1 | CAS number: 667899-24-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- read-across
- Justification for type of information:
- Refer to the section 13 of IUCLID dataset for details on the read across justification. The acute oral toxicity study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Japan, Atsugi breeding center
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 191-214 g
- Fasting period before study: yes
- Housing: 1-3 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 9-16 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.5-24.2°C
- Humidity (%): 48-81%
- Air changes (per h): 8/h
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 6.40%w/v
- Amount of vehicle (if gavage): 0.5 mL/100 g weight
- Justification for choice of vehicle: Stability and uniformity of concentration - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 animals per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 d
- Frequency of observations and weighing: everyday for observation and Days 0, 7, 14 for weighting
- Necropsy of survivors performed: yes - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No motarity
- Clinical signs:
- other: One animal at 300 mg/kg bw suffered from diarrhea after 1 h of dosing. But it recovered after 4 h of dosing. There were no abnormality in other animals.
- Gross pathology:
- There were not any abnormalities for gross pathology at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median dose (LD50) of the substance in the female Crj:CD(SD) IGS rats was determined to be >2000 mg/kg bw.
- Executive summary:
A study was conducted to determine the acute oral toxicity of the read-across substance CAS 7299 -99 -2 in Crj:CD(SD) IGS rats according to OECD Guideline 423. Groups of rats were orally administered the test substance at dose levels of 300 and 2000 mg/kg bw as a solution in corn oil. Clinical signs and bodyweight development were monitored during the study period of 14 d. All animals were subjected to gross necropsy. No mortality was observed in either test group. No clinical signs were observed and there were no treatment-related effects on the body weight. No abnormalities were observed at necropsy. Under the study conditions, the acute oral LD50 of the substance in Crj:CD(SD)IGS rats was determined to be >2000 mg/kg bw (MHLW, 2005).
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- From June 1994 to August 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Read-across
- Justification for type of information:
- The supporting skin irritation study is considered sufficient to fulfil the information requirement.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 4924 - 5154 g
- Sex: Female - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL of the test sample
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Observation time points: 30 - 60 min, 24, 48, 72 and 96 h
- Number of animals:
- Three females
- Details on study design:
- The test sample was applied to a 2.5 cm square area on the shaved left flank of the dorso-lumbar area.
REMOVAL OF TEST SUBSTANCE
- Washing: cleansing with clean warm water
- Time after start of exposure: 4 h (upon removal of the dressing)
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the substance was not considered to be irritating to rabbit skin.
- Executive summary:
A study was conducted to determine the skin irritation potential of the read-across substance CAS 68424 -31 -7 according to a method similar to OECD Guideline 404. Three female New Zealand White albino rabbits were used in the study. Approximately 0.5 mL of the test substance was applied to a 2.5 cm square area on the shaved left flank of the dorso-lumbar region of each animal under a semi-occlusive dressing for 4 h. Upon removal of the dressing, the skin was cleansed with clean warm water. The application sites were assessed for signs of erythema and oedema and scored according to the Draize scale at approximately 30 -60 min, 24, 48, 72 and 96 h after removal of the dressings. Very slight to well-defined erythema and very slight oedema were observed up to 72 h after application and the signs were resolved 96 h after application. Under the study conditions, the substance was not considered to be irritating to rabbit skin (Robinson, 1991).
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From June 1994 to August 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- read-across
- Justification for type of information:
- Refer to the section 13 for details on the read across justification. The skin irritation study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- limited documentation but relevant data given
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- yes
- Duration of treatment / exposure:
- 4 h
- Observation period:
- Time points: 30 - 60 min, 24, 48 and 72 h
- Number of animals:
- 3 females
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The only sign of irritation was a slight transient erythema observed in all three rabbits 30-60 min after patch removal.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the substance was non-irritating to rabbit skin.
- Executive summary:
A study was conducted to determine the skin irritation potential of the read-across substance CAS 7299 -99 -2 in rabbits according to a method similar to OECD Guideline 404. The test substance was applied to the shaved skin of 3 female rabbits under a semi-occlusive patch for 4 h. Upon patch removal, the exposed skin was observed for signs of skin irritation at 30 -60 min, 24, 48 and 72 h. The only sign of irritation was a slight transient erythema observed in all three rabbits 30 -60 min after patch removal. Under the study conditions, the test substance was non-irritating to rabbit skin (Zeneca, 1994).
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 7th April 2004 to 13rd May 2014
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed in 2004, before the requirement for LLNA method was mandated as per the amendment to Annex VII.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: SLC Japan Co., Ltd (3371-8 Koto-cho, Hamamatsu-shi, Shizuoka, Japan)
- Age at study initiation: four weeks old
- Weight at study initiation: 339 g at the time of induction and 486 g at challenge
- Housing:at the time of acquisition 5 per cage in aluminum cages which were installed in an automatically washable rack.
- Diet (e.g. ad libitum): Pellet feed (RC4, Oriental Yeast Co., Ltd)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23±2ºC
- Humidity (%): 50±10%
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 30%
- Route:
- intradermal
- Vehicle:
- other: FCA and physiological saline (1:1 v/v)
- Concentration / amount:
- 0%
- Route:
- intradermal
- Vehicle:
- other: FCA and physiological saline (1:1 v/v)
- Concentration / amount:
- 60%
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0%
- Route:
- other: percutaneous
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Route:
- other: percutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0%
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 50%
- No.:
- #3
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 30%
- No.:
- #4
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 10%
- No.:
- #5
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 5%
- No.:
- #6
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0%
- No. of animals per dose:
- Total 23 animals were allocated as follows: 8 animals to the preliminary study group, 10 to the sensitization group, and 5 to the control group.
- Details on study design:
- 1) Preliminary study:
Formulations for intradermal injection (%): 40, 30, 25, 10, 5, 3, 1, 0.5, 0.3, 0.1, 0.05, 0.03
Formulations for closed application (%): 100, 50, 30, 10, 5, 3
2)Formulations for intradermal induction:
a) Emulsion of FCA and physiological saline at a ration of 1:1 (v/v)
b) 30% test substance solution
c) Emulsion of 60% test substance solution and physiological saline at a ratio of 1:1 (v/v)
d) Liquid paraffin
3) Formulation for percutaneous induction: Sensitization group: 100% test substance solution
Control group: liquid paraffin
4) Formulations for challenge (%): 100, 50, 30, 10, 5, 0 - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the substance did not show skin sensitization potential in guinea pigs.
- Executive summary:
A study was conducted to determine the skin sensitisation potential of the substance according to a method similar to guinea pig maximisation test protocol. 23 animals were used for the study, i.e. 8 for the preliminary study, 10 for the sensitization group, and 5 for the control group. In the induction phase, animals received intradermal injections of (a) emulsion of Freund's Complete Adjuvant (FCA) and physiological saline at a ratio of 1:1, (b) 30% test substance solution (vehicle: liquid paraffin), and (c) emulsion of 60% test substance solution (vehicle: FCA) and physiological saline at a ratio of 1:1. On Day 8 of induction, undiluted test substance was applied under occlusive conditions into each of the treated sites for 48 h. Liquid paraffin was used in the control group in the same manner. The challenge was performed on Day 21 after induction by closed application for 24 h with the test substance at concentrations of 0, 5, 10, 30, 50 and 100%. The skin reactions were observed at 24 and 48 h after application and scores were evaluated. No skin reactions were observed at any of the time points at any concentration. Under the study conditions, the substance did not show skin sensitisation potential in guinea pigs (Hashiyada, 2004).
Sensitization group challenged on Day 21: Summary Table (24 hr closed application, 10 animals)
Formulation | Concentration (%) | Observation time after removal (hr) | Score of erythema | Score of edema | Mean reaction strength |
0 1 2 3 4 | 0 1 2 3 4 | ||||
1 | 100 | 3 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
1 | 100 | 24 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
1 | 100 | 48 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
2 | 50 | 3 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
2 | 50 | 24 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
2 | 50 | 48 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
3 | 30 | 3 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
3 | 30 | 24 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
3 | 30 | 48 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
4 | 10 | 3 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
4 | 10 | 24 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
4 | 10 | 48 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
5 | 5 | 3 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
5 | 5 | 24 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
5 | 5 | 48 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
6 | 100 | 3 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
6 | 100 | 24 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
6 (LP) | 100 | 48 | 10 0 0 0 0 | 10 0 0 0 0 | 0 |
Mean reaction strenght=Scores of erythema and eshar formation +Score of edema/Total number of animals (Vehicle: liquid paraffin (LP))
Control group challenged on Day 21: Summary Table (24 hr closed application, 5 animals)
Formulation | Concentration (%) | Observation time after removal (hr) | Score of erythema | Score of edema | Mean reaction strength |
0 1 2 3 4 | 0 1 2 3 4 | ||||
1 | 100 | 3 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
1 | 100 | 24 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
1 | 100 | 48 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
2 | 50 | 3 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
2 | 50 | 24 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
2 | 50 | 48 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
3 | 30 | 3 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
3 | 30 | 24 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
3 | 30 | 48 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
4 | 10 | 3 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
4 | 10 | 24 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
4 | 10 | 48 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
5 | 5 | 3 | 5 0 0 0 0 | 10 0 0 0 0 | 0 |
5 | 5 | 24 | 5 0 0 0 0 | 10 0 0 0 0 | 0 |
5 | 5 | 48 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
6 | 100 | 3 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
6 | 100 | 24 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
6 (LP) | 100 | 48 | 5 0 0 0 0 | 5 0 0 0 0 | 0 |
Mean reaction strenght=Scores of erythema and eshar formation +Score of edema/Total number of animals (Vehicle: liquid paraffin (LP))
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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.
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