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EC number: 281-506-0 | CAS number: 83968-28-9
- 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
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) was performed to determine the toxic nature of the test compound C.I. Basic Violet 1 (CAS no 8004 -87 -3) upon repeated exposure to Crl:CD (SD) strain rats. The test chemical was dosed at levels of 0, 1.6, 8 or 40 mg/Kg bw (Actual ingested dose). Male rats were treated for 42 days and female rats were treated from 41 - 48 days (from 14 days before mating to day 4 of lactation). Based on the effects noted at 40 mg/Kg bw, the No Observed Adverse Effect Level (NOAEL) for the test compound C.I. Basic Violet 1 is likely to be 8 mg/Kg bw.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from J check
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- other: Crl:CD (SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Age at study initiation of dosing: 10 weeks old
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5 % Methylcellulose aqueous solution
- Details on oral exposure:
- No data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- - Male: 42 days
- Female: 41 - 48 days (from 14 days before mating to day 4 of lactation) - Frequency of treatment:
- - Female: 41 - 48 days (from 14 days before mating to day 4 of lactation)
- Remarks:
- Doses / Concentrations:
0, 1.6, 8, 40 mg/Kg bw (actual ingested)
Basis: - No. of animals per sex per dose:
- - Male: 7 rats/group (control and high dose groups of main study) + 5 rats/group (control and high dose groups of recovery).
12 rats/group (low and middle dose groups of main study).
- Female: 12 rats/group (all groups of main study) + 5 rats/group (control and high dose groups of recovery). - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: No data
- Cage side observations checked in table [No.?] were included. Mortality
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: No data
BODY WEIGHT: Yes
- Time schedule for examinations: No data
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: No data
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data
URINALYSIS: Yes (Males only)
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table [No.?] were examined. No data
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other No data
OTHER: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- No data available
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Clinical signs:
1.6 mg/Kg bw: Test article-colored feces
8 mg/Kg bw: Test article-colored feces
40 mg/Kg bw:
Found dead or killed in extremis:
Decreased spontaneous activity, Prone position, Bradypnea, Abnormal respiratory tones, Hypothermia, Abnormal gait, Soft stool, Emaciation, Abdominal distention, Dirty around anus, Soiled perineal region, External genital bleeding and test article-colored feces
Survivals:
Soft stool and dirty around anus (Male/Female),
External genital bleeding (Female)
Mortality:
1.6 mg/Kg bw: Male: 0/12, Female: 0/12
8 mg/Kg bw: Male: 0/12, Female: 0/12
40 mg/Kg bw: Male: 4/12 (day 9, day 11 (3 animals)), Female: 5/12 (day 20 (2 animals), gestational day 6, 18, 21)
BODY WEIGHT AND WEIGHT GAIN: Decrease in the body weight and decrease in the body weight gain (Male), Decrease in the body weight gain (Female) was noted in 40 mg/Kg bw dosed animals
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Decrease in the food consumption was noted in 40 mg/Kg bw dosed animals
FOOD EFFICIENCY: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available
OPHTHALMOSCOPIC EXAMINATION: No data available
HAEMATOLOGY: Increase in the PLT was noted in 40 mg/Kg bw dosed animals
CLINICAL CHEMISTRY:
Killed in extremis:
Increase in the AST and ALT (Male), Increase in the CPK (Male/Female), Increase in the BUN (Male/Female) in 40 mg/Kg bw dosed animals
Survivals:
Decrease in the TP, Increase in the Alb, Decrease in the alpha 1-glb and increase in the A/G (Male), Increase in the BUN (Male), Increase in the BUN (tendency) (Female) in 40 mg/Kg bw dosed animals
URINALYSIS: No adverse effects were noted in any of the dosed grouped animals
NEUROBEHAVIOUR: No data available
ORGAN WEIGHTS: No adverse effects were noted in any of the dosed grouped animals
GROSS PATHOLOGY
1.6 mg/Kg bw: No adverse effects were noted
8 mg/Kg bw: Light violet aqueous content in stomach and cecum (Male 3/12)
40 mg/Kg bw:
Found dead and killed in extremis (Male 4/12, Female 5/12):
Light violet aqueous content and discoloration of mucus membrane in all of the alimentary tract containing oral cavity, subcutaneous tissues and uterus (sporadically noticed in Male and Female), Hydrothorax in thoracic cavity (Male 1/4, Female 2/5), Small thymus (Male 3/4, Female 2/5), Small spleen (Male 1/4, Female 2/5), Edema in thymus (Male 1/4), Reddish urine in gallbladder (Male 1/4), Red discoloration in mucosa of the bladder (Male 1/4), Red discoloration of testis (Male 1/4), Red discoloration of adipose tissue around the testis (Male 1/4), Dilatation of stomach (Female 4/5), Enlargement of adrenal (Female 4/5), Gas retention in stomach (Female 2/5), Dark red viscous retention in vagina (Female 2/5), Dilatation of cecum (Female 1/5), Gas retention in cecum (Female 1/5)
Survivals:
Light violet aqueous content in alimentary tract (Male/Female)
HISTOPATHOLOGY:
40 mg/kg bw:
Found dead or killed in extremis:
Trachea; Desquamation of epithelium and inflammatory cell infiltration of mucosa (Male 1/4, Female 2/5) Glandular stomach; Atrophy of epithelial cell (Male 1/4, Female 1/5) Small/large intestine; Hypertrophy of epithelial cell (sporadically observed in Male and Female) Liver; Hypertrophy of centrilobular hepatocyte (Male 3/4, Female 3/5), Necrosis (Male 1/4, Female 2/5), Vacuolation (Male 1/4) Adrenal; Hypertrophy of zona fasciculata (Male 2/4, Female 5/5) Bone marrow; Deficient erythropoiesis and granulopoiesis (Male 3/4, Female 2/5) Spleen; Atrophy of follicle / marginal zone (Male 2/4, Female 5/5) and periarterial lymphatic sheath (Male 3/4, Female 5/5) Thymus; Atrophy (Male 4/4, Female 3/5) /necrosis of lymphocyte (Male 3/4, Female 4/5) Lymph node; Atrophy of follicle / paracortex (Male 3/4, Female 5/5) Spinal cord / fourth ventricle / testis / urinary bladder; Hemorrhage or hemorrhagic infarction (Male 1/4) Vagina; Hemorrhage (Female 2/5), Mucoid degeneration of mucosa (Female 2/5) Lung; Hemorrhage of alveolus, edema of alveolus and inflammatory cell infiltration (Female 1/5)
Survivals:
Liver; Hypertrophy of centrilobular hepatocyte (Male 2/4) Duodenum; Hypertrophy of epithelial cell (Male 2/4, Female 6/7) Mesenteric lymph node; Sinus histiocytosis (Male 1/4, Female 3/7) - Dose descriptor:
- NOAEL
- Effect level:
- 8 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Male/Female 40 mg/kg/day: Death, Hypertrophy of epithelial cell of intestinal tract, Hypertrophy of centrilobular hepatocyte, Necrosis of centrilobular hepatocyte
- Critical effects observed:
- not specified
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) for the test compound C.I. Basic Violet 1 is found to be 8 mg/Kg bw.
- Executive summary:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) was performed to determine the toxic nature of the test compound C.I. Basic Violet 1(CAS no 8004 -87 -3) upon repeated exposure to Crl:CD (SD) strain rats. The test chemical was dosed at levels of 0, 1.6, 8 or 40 mg/Kg bw (Actual ingested dose). Male rats were treated for 42 days and female rats were treated from 41 - 48 days (from 14 days before mating to day 4 of lactation). Based on the effects noted at 40 mg/Kg bw, the No Observed Adverse Effect Level (NOAEL) for the test compound C.I. Basic Violet 1 is likely to be 8 mg/Kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 8 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Data is obtained from K2 source (J check)
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Study obtained from Sax's Handbook of Dangerous Industrial Materials and Dictionary of Substances and their effects
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- inhalation
- Type of inhalation exposure:
- not specified
- Vehicle:
- not specified
- Remarks on MMAD:
- MMAD / GSD: no data
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 100 days
- Frequency of treatment:
- 24 hr/day
- Remarks:
- Doses / Concentrations:
0.3 mg/m³
Basis:
no data - No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Details on results:
- Rats showed significant changes in the central nervous system, blood and liver in the correlation of muscle antagonist chronaxy, a reduced number of erythrocytes and hemaglobin, increased methemoglobin level, reticulocytis, leukopenia, hypoproteinemia, a reduced-SH group content in the serum, and accumulation of pyruvic acid in the liver and serum. Dimethylaniline also increased the coproporphyrin urinary excretion and reduced the adrenal ascorbic acid level.
- Dose descriptor:
- LOAEC
- Effect level:
- 0.3 mg/m³ air
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: lowest observed advser effect
- Critical effects observed:
- not specified
- Conclusions:
- The Lowest observed adverse effect concentration (LOAEC) of N,N-dimethylaniline was found to be 0.3 mg/m³ rats in a 100 day study.
Inhalation of the substance continuously led to anaemia, methaemoglobinaemia, leucopenia and significant pathological changes in the central nervous system. - Executive summary:
Repeated dose inhalation toxicit study was performed using rats for the test compound N, N- dimethylaniline (RA CAS no 121 -69 -7). The Lowest observed adverse effect concentration (LOAEC) of N,N-dimethylaniline was found to be 0.3 mg/m³ rats in a 100 day study. Inhalation of the substance continuously led to anaemia, methaemoglobinaemia, leucopenia and significant pathological changes in the central nervous system.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEC
- 0.3 mg/m³
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- K2 level testing data
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Peer reviewed publications for the alternate cas (8004 -87 -3) and the read across chemicals were used to determine the toxic nature of the test compound (CAS no 83968 -28 -9) upon repeated exposure. The studies are summarized below:
Repeated dose toxicity: Oral
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) was performed (Ministry of Economy, Trade and Industry, Japan, 2016) to determine the toxic nature of the test compound C.I. Basic Violet 1 (CAS no 8004 -87 -3) upon repeated exposure to Crl:CD (SD) strain rats. The test chemical was dosed at levels of 0, 1.6, 8 or 40 mg/Kg bw (Actual ingested dose). Male rats were treated for 42 days and female rats were treated from 41 - 48 days (from 14 days before mating to day 4 of lactation). Based on the effects noted at 40 mg/Kg bw, the No Observed Adverse Effect Level (NOAEL) for the test compound C.I. Basic Violet 1 is likely to be 8 mg/Kg bw.
In a repeated-dose toxicity study (Abdo et al, 2009), 0, 31.25, 62.5, 125, 250 or 500 mg/kg/day of N,N-dimethylaniline (RA CAS no 121 -69 -7) was administered to 10 male and 10 female Fischer 344 rats and B6C3F1 mice per dose via gavage 5 days/week for 90 days. No mortality was observed. Splenomegaly was observed in all treated groups of rats. Hyperplasia of the bone marrow and hematopoiesis in the spleen were observed in all rats in a dose-related manner. In addition, decreased body weight gain was observed in male rats at 250 and 500 mg/kg/day. Dose-related increases in splenomegaly, and extramedullary hematopoiesis and hemosiderosis of the spleen were observed in the mice when given 31.25 mg/kg/day of N, N-dimethylaniline. Splenomegaly was reported as minimal in 4/10 mice, and extramedullary hematopoiesis and hemosiderois were reported as mild in 1/10 mice.Based observations made, the Low Observed Adverse Effect level (LOAEL) was considered to be 31.25 mg/kg/day in Fischer 344 rats and B6C3F1 mice.
In a repeated-dose toxicity study (USEPA, 2009), Wistar rats (male and female) were administered N,N-diethylaniline via gavage at 0, 10, 50 or 250 mg/kg-bw/day, 7 days/week for 28 days. No mortalities were observed. No changes in body weight, food, and water consumption were reported. Clinical signs of toxicity consisted of increased frequency of respiratory sounds in males at 50 mg/kg-bw/day, and increased frequency of respiratory sounds and salivation in females at 250 mg/kg-bw/day. Hematological effects (decreased red cell counts, decreased hemoglobin concentrations, decreased packed cell volume (PCV) in both sexes and increased mean corpuscular volume (MCV) and mean corpuscular hemoglobin (MCH) in females) were reported at all doses (dose-response not specified). Histological effects were reported for the liver and spleen. In the liver, hemosiderosis of the Kupffer cells at 10 mg/kg-bw/day and extra medullary hematopoeisis at 50 and 250 mg/kg-bw/day were observed. In the spleen, hemosiderosis, extramedullary hematopoiesis and splenic hyperemia were reported at 10 mg/kg-bw/day. Swollen spleens were observed at 50 and 250 mg/kg-bw/day. Increased absolute and relative weights and black pigmentation of the spleen were also reported at 10mg/kg-bw/day. At 50 and 250 mg/kg-bw/day, hyperbilirubinemia, polychromasia were reported, and at 250 mg/kg-bw/day, decreased potassium levels, histopathological findings in the kidneys of both sexes, black pigmentation in the kidneys of females, and increased albumin levels in males were reported. Dose-response and statistical significance were not indicated for any of these observed effects. The Low Observed Adverse Effect level (LOAEL) was considered 10 mg/kg-bw/day (based on hematological and histopathological changes in the spleen and liver consistent with hemolytic anemia).
Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Tes was performed for the test chemical N,N-Dimethylaniline (RA CAS no 121 -69 -7) to evaluate its oral toxic nature upon repeated exposure. The test compund was tested at cocentration of 0, 1, 10 or 100 mg/Kg bw. The male rats were treated for 42 days and females 42 - 46 days (from 14 days before mating to day 4 of lactation). Based upon the observations made, the No Observed Adverse effect level (NOAEL) for the test compound N,N-Dimethylaniline is found to be 1 mg/kg bw in males and < 1 mg/Kg bw in females.
Repeated dose toxicity: Inhalation
Repeated dose inhalation toxicity study (Sax's Handbook of Dangerous Industrial Materials, 2007) was performed using rats for the test compound N, N- dimethylaniline (RA CAS no 121 -69 -7). The Lowest observed adverse effect concentration (LOAEC) of N, N-dimethylaniline was found to be 0.3 mg/m³ rats in a 100 day study. Inhalation of the substance continuously led to anaemia, methaemoglobinaemia, leucopenia and significant pathological changes in the central nervous system.
Repeated dose inhalation toxicity study was performed (Slusar, 1972) using rats for the test compound N, N- dimethylaniline (RA CAS no 121 -69 -7). The Lowest published toxic concentration (TCLo) of N,N-dimethylaniline was found to be 10700 µg/m³ in rats in a 17 week study with intermittent (5 hr) dosage.
Based on the data obtained from the alternate CAS no 8004 -87 -3 and the read across data for the target chemical , the substance Formaldehyde, reaction products with N,N dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides (CAS no 83968 -28 -9) is not likely to show repeated dose toxicity effect by oral and inhalation route and thus cannot be considered for further classification.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The No Observed Adverse Effect Level (NOAEL) for the test compound C.I. Basic Violet (8004-87-3) 1 is likely to be 8 mg/Kg bw.
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
The Lowest observed adverse effect concentration (LOAEC) of N, N-dimethylaniline was found to be 0.3 mg/m³ rats in a 100 day study.
Justification for classification or non-classification
Based on the data obtained from the alternate CAS no 8004 -87 -3 and the read across data for the target chemical , the substance Formaldehyde, reaction products with N,N dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides (CAS no 83968 -28 -9) is not likely to show repeated dose toxicity effect by oral and inhalation route and thus cannot be considered for further classification.
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