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EC number: 630-324-3 | CAS number: 861229-15-4
- 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
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
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- Endpoint summary
- Stability
- Biodegradation
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- 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
oral: The LD50 for acute oral toxicity was 1400 mg/kg bw.
inhalation: The LD50 for acute inhalation toxicity was >4.66 mg/L air (highest attainable concentration)
dermal: The LD50 for acute dermal toxicity was >2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 February 1992 - 9 March 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-1 (Acute Oral Toxicity)
- Version / remarks:
- EPA Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation:Human and Domestic Animals 81-1 Acute oral toxicity study (November 1984)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- batch No.of test material: 5007
- sample No.:1505E
- Expiration date of the lot/batch: March 1993
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 4°C in the dark - Species:
- rat
- Strain:
- other: CD
- Remarks:
- of Sprague-Dawley origin (Hsd/Ola:Sprague-Dawley(CD))
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Olac Ltd., Bicester,Oxon,England
- Age at study initiation: 6 weeks
- Weight at study initiation: 140 to 160 g
- Fasting period before study: yes
- Housing: in groups of 5 rats of the same sex in metal cages with wire mesh floors
- Diet: ad libitum, Standard laboratory diet (Biosure LAD 1)
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23°C
- Humidity (%): mean 58%
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- Preliminary study 800 mg/kg bw
Main study: 1000, 1260, 1600 mg/kg bw - No. of animals per sex per dose:
- Preliminary study: 2/sex/dose
Main study: 5/sex/dose - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
body weight: recorded on Day 1 (prior dosing), 8 and 15 or at death
animals were observed for clinical signs soon after dosing and at frequent intervals for the remainder of Day 1 and subsequent twice a day
- Macroscopic examination; macroscopic appearance of all examined tissues recorded - Statistics:
- The acute median lethal oral dose (LD50) to rats was calculated using the method of Finney [FINNEY, D.J. (1971) Probit Analysis, 3rd ed., Cambridge University Press, Cambridge]. Separate LD50 values for males and females were estimated by undertaking probit analysis on the mortality data from the main study by fitting two parallel lines to the data (males only and females only) using the technique described by Finney [Finney, D.J. (1978) Statistical Method in Biological Assay, 3rd ed., Charles Griffin, London]. A chi-square test was carried out to check that the data did not contain any evidence of non-parallelism.
- Preliminary study:
- The results of the preliminary study indicated that the acute lethal oral dose to rats of MCPP-p 2EHE was greater than 0.8 g/kg bw.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 400 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1.2 - 1.6
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 300 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1.1 - 1.6
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 400 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1.2 - 1.9
- Mortality:
- There were deaths following a single dose of MCPP-P 2-EHE among rats of both sexes dosed at 1260 mg/kg bw and above. Death occurred at intervals from Day 2 until Day 5.
- Clinical signs:
- other: Piloerection was observed in all rats within 5 minutes of dosing and throughout the remainder of Day 1. This sign persisted and was accompanied on Day 1 and/or later intervals by: abnormal body carriage (hunched posture), lethargy, decreased respiratory r
- Gross pathology:
- No macroscopic abnormality was observed for animals killed on Day 15.
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The oral LD50 for MCPP-P 2-EHE was 1400 mg/kg bw.
- Executive summary:
A GLP study according EPA Pesticide Assessment Guidelines, 81-1 acute oral toxicity (Revised Edition November 1984) on rats was performed to assess the acute oral toxicity of MCPP-P 2-EHE. Groups of 10 fasted rats (5 male/5 female) were administered a single oral dose by gavage of the test substance, as supplied, at dose levels of 1000, 1260 and 1600 mg/kg bw. There were deaths among male and female rats dosed at 1260 mg/kg bw and above from Day 2 until Day 5. Clinical signs of reaction to treatment included pilo-erection, abnormal body carriage (hunted posture), abnormal gait (waddling), lethargy, decreased respiratory rate, ptosis, pallor of the extremities, ataxia and prostration. Recovery of surviving rats, as judged by external appearance and behavior, was complete by Day 4 (1260 mg/kg bw), Day 3 or 5 (1000 mg/kg bw) or day 4 to 7 (1600 mg/kg bw). Small bodyweight gains were recorded on Day 8 for one male and one female dosed at 1600 mg/kg bw and one female dosed at 1000 mg/kg bw. All other surviving animals achieved satisfactory bodyweight gains throughout the study. No abnormalities were recorded at macroscopic examination at the end of the study. The LD50 (males/females) was 1400 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 400 mg/kg bw
- Quality of whole database:
- GLP and Guideline study (EPA OPP 81-1)
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 19, 1992 - September 9, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1150 (Acute inhalation toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: EPA FIFRA 81-3
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- GLP compliance:
- yes
- Test type:
- fixed concentration procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- batch No.of test material: 5007
- sample No.:1505E
- Expiration date of the lot/batch: March 1993
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 4°C in the dark - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK
- Age at study initiation: 6 weeks (male) and 8 weeks (female)
- Weight at study initiation: ca. 200 g
- Housing: stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C - 24°C
- Humidity (%): 25% - 65%
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- 2.2 µm
- Geometric standard deviation (GSD):
- 2.31
- Remark on MMAD/GSD:
- The proportion of droplets in the sub-micron size range was 17.8% and lower that EPA specification of 25%. Calculations show, that the 25% level was reached at a particle size of 1.23 µm.
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: aerosol generator; test substance was supplied from syringe driven at a constant rate by a syringe pump
- Exposure chamber volume: chamber with an internal volume of 120 L
- Method of holding animals in test chamber: chamber divided by wire mesh partitions to provide 10 separate animal compartments
- Source and rate of air: flow rate of 0.6 mL/min to give a concentration of 5 mg/L of air
- Temperature in air chamber:mean 23°C measured at the start and then at 30-minute intervals during exposure
TEST ATMOSPHERE
- analytical method used: HPLC
- Samples taken from breathing zone: yes, 5 samples during exposure - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 0 and 4.66 mg/L (highest achieved concentration)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: continuously during exposure and at least twice daily throughout the observation period; daily weighting from start until the end of the experiment
- Other examinations performed: food and water consumption was measured daily; macroscopic examination of all animals, lungs, liver and kidneys examined - Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 4.66 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- One exposed female died overnight following exposure.
- Clinical signs:
- other: CLINICAL SIGNS. During exposure : signs consistent with exposure to an irritant aerosol, including partial closing of the eyes, wetness around the mouth and snout, and exaggerated respiratory movements. During observation period: signs seen in rats includ
- Body weight:
- Reduced bodyweight or reduced rate of bodyweight gain was evident for up to 5 days following exposure. Subsequently, weight gain was similar to that for control rats.
- Gross pathology:
- The lung weight to bodyweight ratio for the rat that died was higher than for the surviving rats.
Macroscopic pathology: the lungs of the rat that died following exposure the substance were congested and the stomach was gas-filled. - Other findings:
- - Organ weights:
The lung weights were within normal limits for the control rats and for the surviving rats exposed to the test substance.. For the rat taht died the lung weight to bodyweight ratio was higher than for the surviving rats.
- Histopathology: The lungs of one rat exposed to the test substance were congested and the stomach was gas-filled. There were no abnormalities in any other rat. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LC50 (4-hour) for MCPP-P 2-EHE is in excess of 4.66 mg/L. This was the highest attainable concentration.
- Executive summary:
In a GLP study according to OECD 403, the acute inhalation toxicity of MCPP-P 2-EHE was assessed by exposing a group of rats to an aerosol produced from the test item. The control group was exposed to air only. The exposure duration was 4 hour in a whole body chamber followed by a 14-days observation period. The concentration of aerosol was measured during the exposure and the particle size distribution was assessed as well.
One female died following exposure and all animals showed signs of constant exposure to an irritant aerosol, including partial closing of the eyes, wetness around the mouth and snout and exaggerated respiratory movements. During the observation period, rats showed abnormal breathing, lethargy, wet fur, matted or oily fur and brown staining around the snout and jaws, but all surviving rats exposed to the test item were normal by day 8 of observation. The body weight was reduced for up to 5 days following exposure to MCPP-P 2-EHE but subsequently, weight gain was similar to that for control rats. Food consumption was reduced for up to one day following exposure and water consumption increased and remained high for several days following exposure to the test item. The lung weight to bodyweight ratios for rats surviving expose were within normal limits.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 4 660 mg/m³ air
- Quality of whole database:
- GLP and Guideline Study (OECD TG 403)
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-2 (Acute Dermal Toxicity)
- Version / remarks:
- EPA Pesticide Assessment Guidelines, Subdivision F. Hazard Evaluation:Human and Domestic Animals 81-2 Acute dermal toxicity study, revised edition November 1984
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- batch No.of test material: 5007
- sample No.:1505E
- Expiration date of the lot/batch: March 1993
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 4°C in the dark - Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: 9 to 14 weeks
- Weight at study initiation: 2.2 to 2.9 kg
- Fasting period before study:
- Housing:
- Diet: ad libitum, Standard Laboratory Diet (SDS Rabbit Diet SQC)
- Water: ad libitum
- Acclimation period: 7days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21°C
- Humidity (%): mean 53%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: hair was clipped one day prior treatment, application on 50 mm x 50 mm area on dorso-lumbar region
- % coverage: 10% of total body surface
- Type of wrap if used: treated area covered promptly with gauze, which was held in place with an impermeable dressing encircled firmly around the trunk
REMOVAL OF TEST SUBSTANCE
- Washing: at the end of exposure; with warm (30-40°C) water and blotted dry with absorbent paper
- Time after start of exposure: 24 hours
A Perspex `Elizabethan´ collar was then fitted to each animal for the remainder of the experimental day to minimize oral ingestion of residual test substance.
TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
. twice daily checked for mortalities
. on Day 1 after dosing and at frequent intervals checked for clinical signs, subsequent twice daily
- bodyweight: recorded on Day 1, 8 and 15, individual bodyweight chances were caluculated weekly.
-macroscopic examination: macroscoupc appearance of all examined tissues was recorded at the end of the experiment
- Dermal responses: Local dermal irritaion at the treatment site was assessed daily using the following numerical system:
No erythema 0
Slight erythrema 1
Well-defined erythema 2
Moderate erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Oedema formation:
No oedema 0
slight oedema 1
Well-defined oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4 - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths following a single dermal application of MCPP-P 2-EHE at 2000 mg/kg bw.
- Clinical signs:
- other: There were no clinical signs of reaction to treatment.
- Gross pathology:
- Terminal examination revealed white foci (up to 3 mm in diameter, extending into the parenchyma or seen on the cut surface of the tissue) on the liver capsular region of all rabbits.
- Other findings:
- Dermal responses:Slight erythema accompanied by slight edema was recorded at the sites of application of MCPP-P 2-EHE on Day 2. These reactions persisted throughout the first week of the study. Irritation had resolved for the majority of animals by Day 9 although reactions continued for one male until Day 12.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 for MCPP-P 2EHE is greater than 2000 mg/kg bw.
- Executive summary:
A limit test to assess the acute dermal toxicity of MCPP-P 2-EHE on rabbit skin was performed according to EPA Pesticide Assessment Guidelines, 81-2 acute dermal toxicity (Revised Edition November 1984). The test item was applied undiluted on clipped skin of 5 male and 5 female rabbits at a dose level of 2000 mg/kg bw for an observation period of 14 days. There were no deaths and no clinical signs of reaction to treatment and normal body weight gain during the study. Slight erythema and edema was recorded at the sites of application on Day 2. Dermal irritation persisted throughout the first week of the study. Irritation had resolved by Day 8 or 9 for the majority of animals and Day 13 for one animal. Macroscopic examinations revealed white foci on the liver capsular region of all rabbits. The LD50 of MCPP-P 2-EHE was found to be greater than 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP and Guideline study (EPA OPP 81-2)
Additional information
oral
A GLP study according EPA Pesticide Assessment Guidelines, 81 -1 acute oral toxicity (Revised Edition November 1984) on rats was performed to assess the acute oral toxicity of MCPP-P 2-EHE. Groups of 10 fasted rats (5 male/5 female) were administered a single oral dose by gavage of the test substance, as supplied, at dose levels of 1000, 1260 and 1600 mg/kg bw. There were deaths among male and female rats dosed at 1260 mg/kg bw and above from Day 2 until Day 5. Clinical signs of reaction to treatment included pilo-erection, abnormal body carriage (hunted posture), abnormal gait (waddling), lethargy, decreased respiratory rate, ptosis, pallor of the extremities, ataxia and prostration. Recovery of surviving rats, as judged by external appearance and behavior, was complete by Day 4 (1260 mg/kg bw), Day 3 or 5 (1000 mg/kg bw) or Day 4 to 7 (1600 mg/kg bw). Small bodyweight gains were recorded on Day 8 for one male and one female dosed at 1600 mg/kg bw and one female dosed at 1000 mg/kg bw. All other surviving animals achieved satisfactory bodyweight gains throughout the study. No abnormalities were recorded at macroscopic examination at the end of the study. The LD50 (males/females) was 1400 mg/kg bw (MCPP-p Task Force 920497D/JEL 47/AC;1992).
inhalation
In a GLP study according to OECD 403, the acute inhalation toxicity of MCPP-P 2-EHE was assessed by exposing a group of rats to an aerosol produced from the test item. The control group was exposed to air only. The exposure duration was 4 hour in a whole body chamber followed by a 14-days observation period. The concentration of aerosol was measured during the exposure and the particle size distribution was assessed as well. One female died following exposure and all animals showed signs of constant exposure to an irritant aerosol, including partial closing of the eyes, wetness around the mouth and snout and exaggerated respiratory movements. During the observation period, rats showed abnormal breathing, lethargy, wet fur, matted or oily fur and brown staining around the snout and jaws, but all surviving rats exposed to the test item were normal by day 8 of observation. The body weight was reduced for up to 5 days following exposure to MCPP-P 2-EHE but subsequently, weight gain was similar to that for control rats. Food consumption was reduced for up to one day following exposure and water consumption increased and remained high for several days following exposure to the test item. The lung weight to bodyweight ratios for rats surviving expose were within normal limits. The discriminating dose for MCPP-P 2-EHE is in excess of 4.66 mg/L, which was the highest attainable concentration (MCPP-p Task Force JEL 68/930510; 1993).
dermal
A limit test to assess the acute dermal toxicity of MCPP-P 2-EHE on rabbit skin was performed according to EPA Pesticide Assessment Guidelines, 81-2 acute dermal toxicity (Revised Edition November 1984). The test item was applied undiluted on clipped skin of 5 male and 5 female rabbits at a dose level of 2000 mg/kg bw for an observation period of 14 days. There were no deaths and no clinical signs of reaction to treatment and normal body weight gain during the study. Slight erythema and edema was recorded at the sites of application on Day 2. Dermal irritation persisted throughout the first week of the study. Irritation had resolved by Day 8 or 9 for the majority of animals and Day 13 for one animal. Macroscopic examinations revealed white foci on the liver capsular region of all rabbits. The LD50 of MCPP-P 2-EHE was found to be greater than 2000 mg/kg bw (MCPP-p Task Force 920469D/JEL 49/AC; 1992).
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The oral LD50 was 1400 mg/kg bw. As a result the substance is classified for acute oral toxicity (Cat.4, H302:" Harmful if swallowed") under Regulation (EC) No 1272/2008,as amended for the tenth time in Regulation (EU) No 2017/776. Classification for acute dermal and inhalation toxicity is not warranted.
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.