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EC number: 200-081-4 | CAS number: 51-17-2
- 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
Key value for chemical safety assessment
Effects on fertility
Description of key information
NOAEL was considered to be 53 mg/kg bw for P and F1 generation when pregnant female rat were treated with 1H-benzimidazole orally.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from handbook
- Qualifier:
- according to guideline
- Guideline:
- other: No data
- Principles of method if other than guideline:
- Reproductive toxicity study of 1H-benzimidazole in rats was evaluated.
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material: Benzimidazole
- IUPAC name: 1H-benzimidazole
- Molecular formula: C7H6N2
- Molecular weight: 118.1384 g/mol
- Substance type: Organic
- Physical state: Solid - Species:
- rat
- Strain:
- not specified
- Details on species / strain selection:
- No data
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- No data
- Route of administration:
- not specified
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Details on exposure:
- No data
- Details on mating procedure:
- No data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 5 days (day 8 to day 12)
- Frequency of treatment:
- Daily
- Details on study schedule:
- no data
- Dose / conc.:
- 53 mg/kg bw/day
- Remarks:
- upto
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Details on study design:
- No data
- Positive control:
- No data
- Parental animals: Observations and examinations:
- No data
- Oestrous cyclicity (parental animals):
- No data
- Sperm parameters (parental animals):
- No data
- Litter observations:
- Fetal weight were observed
- Postmortem examinations (parental animals):
- No data
- Postmortem examinations (offspring):
- Gross pathology were examined.
- Statistics:
- No data
- Reproductive indices:
- No data
- Offspring viability indices:
- No data
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- 53 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- reproductive performance
- Remarks on result:
- other: No toxic effect were observed.
- Critical effects observed:
- not specified
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 53 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- gross pathology
- Remarks on result:
- other: No toxic effect were observed
- Critical effects observed:
- not specified
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Reproductive effects observed:
- no
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Conclusions:
- NOAEL was considered to be 53 mg/kg bw for P and F1 generation when pregnant female rat were treated with 1H-benzimidazole orally.
- Executive summary:
In a reproductive toxicity study 1H-benzimidazole was assessed for its possible reprotoxic nature.For this purpose pregnant female rat were treated with 1H-benzimidazole orally upto 53 mg/kg bw on day 8 through 12. The animals were observed for clinical sign, mortality, bodyweight, Food intake, gross and histopathology. The foetus growth and malformation was observed. No significant effects were observed in treated female rats. No effect on fetal growth nor malformation were observed in treated female rats. Therefore, NOAEL was considered to be 53 mg/kg bw for P and F1 generation when pregnant female rat were treated with 1H-benzimidazole orally through 8-12 days of gestation.
Reference
No effect on fetal growth were observed
No effect on fetal body weight were observed in treated rats upto 53 mg/kg bw
Gross pathology:
No malformations were observed in treated rats upto 53 mg/kg bw
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 53 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- data for the target chemical from K2
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In various experimental studies, 1H-benzimidazole (51-17-2)has been investigated for reproductive toxicity to a greater or lesser extent. The studies are mention below
In a reproductive toxicity study 1H-benzimidazole was assessed for its possible reprotoxic nature. For this purpose pregnant female rat were treated with 1H-benzimidazole orally up to 53 mg/kg bw on day 8 through 12. The animals were observed for clinical sign, mortality, bodyweight, Food intake, gross and histopathology. The foetus growth and malformation was observed. No significant effects were observed in treated female rats. No effect on fetal growth no malformation was observed in treated female rats. Therefore, NOAEL was considered to be 53 mg/kg bw for P and F1 generation when pregnant female rat were treated with 1H-benzimidazole orally through 8-12 days of gestation.
In a subacute toxicity study, Sprague-Dawley male and female rats were treated with test chemical in the concentration of 0, 250, 500 and 1000 mg/kg bw orally by gavage for 28 days. All the male and female animals from control and different dose groups up to 1000 mg/kg survived throughout the dosing period of 28 days and the recovery period of 14 days. At the end of the dosing period reduced body weight gain of 14.94% was observed in male animals from 1000 mg/kg dose group. All the male animals from control, 250, 500 and 1000 mg/kg reversal dose groups exhibited normal body weight gain throughout the dosing period of 28 days and the recovery period of 14 days. Female animals from control, 250, 500 and 1000 mg/kg dose groups exhibited normal body weight gain throughout the dosing period of 28 days. Reduced body weight gain of 11.36% was observed in female animals from 1000 mg/kg reversal group. Feed intake of animals from control and different dose groups was found to be comparable throughout the dosing period of 28 days and the recovery period of 14 days. No signs of toxicity were observed in male and female animals from 250 and 500 mg/kg dose groups during the dosing period of 28 days. Detailed clinical observations conducted at weekly interval did not reveal any abnormality in all male and female animals from control and different dose groups during the dosing period of 28 days and the recovery period of 14 days. No statistically significant changes in the values of various Haematological parameters were at the end of the dosing period on day 29. At the end of the recovery period on day 43, statistically significant decrease in the values of Total RBC and HCT at 1000 mg/kg in male. Statistically significant decrease in the values of Hb and HCT at 500 mg/kg and Total RBC at 250 and 500 mg/kg were observed in female rat. At the end of the recovery period on day 43, no statistically significant changes in the values of various parameters in female rats. The decrease in the values of various parameters was marginal and within the normal biological and laboratory limits. Clinical biochemistry analysis at the end of the dosing period on day 29, revealed statistically significant increase in the values of Globulin at 250 mg/kg in male rat. In addition statistically significant decrease was observed in the values of BUN and Urea Nitrogen at 250 mg/kg in male, BUN and Urea Nitrogen at 500 mg/kg in female rat, Alanine Aminotransferase at 250 and 500 mg/kg in female and Alkaline Phosphatase at 250 mg/kg in female rat. At the end of the recovery period on day 43 (Reversal groups) statistically significant increase was observed in the values of Bile Acid at 1000 mg/kg in female and statistically significant decrease was observed in the values of Calcium at 1000 mg/kg in male. The increase/decrease in the values of various parameters was marginal and within the normal biological and laboratory limits. Urine analysis conducted on male animals during 4thand 6thweek of study period (on day 23, 24 and 43), revealed no abnormality attributable to the treatment. Urine analysis conducted on female animals during 4thweek of study period (on day 24 and 26), higher volume of urine was observed in female at 1000 mg/kg dose group. During 6th week of study period (on day 43) revealed no abnormality attributable to the treatment. At termination of dosing on day 29, male animals from 1000 mg/kg dose group revealed increased relative weights of brain. In addition, increased relative weights of liver and kidneys were observed in male at 500 and 1000 mg/kg dose groups when compared with that of controls. Increased relative weights of spleen were observed in male at 250 and 1000 mg/kg as compared to controls. Increased relative weights of thymus were observed in male at 250 mg/kg as compared to controls. No effect on male organ weight sacrificed on day 43 from 1000 mg/kg as comparable to controls. At termination of dosing on day 29, at 1000 mg/kg increased relative weights of liver were observed in female as compared to controls. In addition, increased relative weights of kidneys were observed in female at 500 and 1000 mg/kg as compared to controls. At 500 mg/kg dose decreased relative weights of heart in female rats as compared to controls. Organ weight data of female animals sacrificed on day 43 at 1000 mg/kg increased relative weights of brain, liver, kidneys, spleen and uterus were observed in female as compared to controls. Although significant changes in the values of organ weight of brain, liver, spleen, thymus, heart and uterus were observed in male and female animals at 250 mg/kg and 500 mg/kg dose groups, no related gross pathological and histopathological findings were seen in reproductive organ, hence these findings were considered to be of no toxicological importance. Gross pathological examination did not reveal any abnormality attributable to the treatment. Histopathological examination revealed focal to diffuse, minimal to moderate tubular dilatation in kidneys in male (1/6) and female (6/6) animals from 1000 mg/kg dose group, in male (1/6) and female (6/6) animals from 500 mg/kg dose group and in male (0/6) and female (5/6) animals from 250 mg/kg dose group and in female (1/6) from 1000 mg/kg reversal dose group. Focal to multifocal, minimal mononuclear cells infiltration was observed in kidneys in male (1/6) and female (3/6) animals from 1000 mg/kg dose group and in female animals from 250 mg/kg (2/6) and 500 mg/kg (2/6) dose groups. All histopathological the changes observed in male animals were reversible during the recovery period of 14 days. The histopathological changes observed in female animals were evident in reversal group one animal, during the recovery period of 14 days in reproductive organ. Therefore, No Observed Adverse Effect Level (NOAEL) of test chemical in the Sprague Dawley rat via oral route, over a period of 28 days was found to be 1000 mg/kg body weight for male and female animals.
In a chronic study Male and female CD-1 mice were administered test chemical in diet at levels of 0 (control), 0.031, 0.125 and 0.5% (33.2, 146.3 and 605 mg/kg body weight per day in males and 40.0, 178.8 and 615 mg/kg body weight )for 78 weeks.The animals were observed for clinical sign,mortality,body weight ,food intake, hematology,gross and histopathology There were no significant differences in mortality between the control and treated groups. Mean body weights of high-dose groups showed significant decreases compared with the controls. The bladder weights of male and female mice of the 605 or 615 mg/kg/day group were significantly higher than those of the control mice. Gross findings in treated mice included the renal atrophy, hydronephrosis, calculi in renal pelvis and/or bladder and ovarian atrophy. Microscopic findings in the kidneys of treated mice included the nephrosis, hydronephrosis or hyperplasia of transitional epithelium of renal pelvis or papilla. In the bladder of treated mice, hyperplasia or squamous metaplasia of transitional epithelium and one transitional cell papilloma were observed. Dose-dependent decreases in the
incidence of spontaneous lesion in the male or female reproductive system were recognized. ThereforeNOAEL was considered to be 178 mg/kg/day for female 146.3 mg/kg/day for male respectivley .When test chemical was exposed to the Crj:CD-1 (ICR) male and female mice by oral feed for 78 weeks.
Based on the data available for the target chemical 1H-benzimidazole (51-17-2) does not exhibit reproductive toxic nature and hence is not likely to classify as per the criteria mentioned in CLP regulation.
Effects on developmental toxicity
Description of key information
NOAEL was considered to be 53 mg/kg bw for F1 generation when pregnant female rat were treated with 1H-benzimidazole orally.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from Handbook
- Qualifier:
- according to guideline
- Guideline:
- other: No data
- Principles of method if other than guideline:
- Developmental toxicity study of 1H-benzimidazole in rats
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material: Benzimidazole
- IUPAC name: 1H-benzimidazole
- Molecular formula: C7H6N2
- Molecular weight: 118.1384 g/mol
- Substance type: Organic
- Physical state: Solid - Species:
- rat
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- Sex: Female
- Route of administration:
- oral: unspecified
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Details on exposure:
- No data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Details on mating procedure:
- pregnant female rat were used
- Duration of treatment / exposure:
- 5 days
- Frequency of treatment:
- Daily
- Duration of test:
- day 8 through day 12
- Dose / conc.:
- 53 mg/kg bw/day
- Remarks:
- upto
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Maternal examinations:
- No data
- Ovaries and uterine content:
- No data
- Fetal examinations:
- Fetal weight and gross pathology were examined.
- Statistics:
- No data
- Indices:
- No data
- Historical control data:
- No data
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- not specified
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- not specified
- Dead fetuses:
- not specified
- Changes in pregnancy duration:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not specified - Changes in number of pregnant:
- not specified
- Other effects:
- no effects observed
- Details on maternal toxic effects:
- No effect on fetal growth were observed in trearted rats
- Dose descriptor:
- NOAEL
- Effect level:
- 53 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: No effect on No effect on fetal growth
- Remarks on result:
- other: No toxic effect were observed
- Abnormalities:
- not specified
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed - Reduction in number of live offspring:
- not specified
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- no effects observed
- Skeletal malformations:
- not specified
- Visceral malformations:
- not specified
- Other effects:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 53 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- fetal/pup body weight changes
- external malformations
- Remarks on result:
- other: No toxic effect were observed
- Abnormalities:
- not specified
- Developmental effects observed:
- no
- Treatment related:
- no
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Conclusions:
- NOAEL was considered to be 53 mg/kg bw for F1 generation when pregnant female rat were treated with 1H-benzimidazole orally.
- Executive summary:
In a developmental toxicity study, pregnant female rat were treated with 1H-benzimidazole orally upto 53 mg/kg bw on day 8 through 12. No effect on fetal growth nor malformation were observed in treated female rats. Therefore, NOAEL was considered to be 53 mg/kg bw for F1 generation when pregnant female rat were treated with 1H-benzimidazole orally.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 53 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- data for the target chemical from K2
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Developmental toxicity
In a developmental toxicity study, pregnant female rat were treated with 1H-benzimidazole orally upto 53 mg/kg bw on day 8 through 12. No effect on fetal growth nor malformation were observed in treated female rats. Therefore, NOAEL was considered to be 53 mg/kg bw for F1 generation when pregnant female rat were treated with 1H-benzimidazole orally.
Based on the data available for the target chemical 1H-benzimidazole (51-17-2) does not exhibit teratogenic nature and hence is not likely to classify as per the criteria mentioned in CLP regulation
Justification for classification or non-classification
Thus based on the above annotation for the target chemical 1H-benzimidazole (51-17-2)does not exhibit reproductive toxic nature and hence is not likely to classify as per the criteria mentioned in CLP regulation.
Additional information
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.