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EC number: 231-832-4 | CAS number: 7758-09-0
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- fertility, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from a study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
- Principles of method if other than guideline:
- According to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Sodium iodide
- EC Number:
- 231-679-3
- EC Name:
- Sodium iodide
- Cas Number:
- 7681-82-5
- Molecular formula:
- INa
- IUPAC Name:
- sodium iodide
- Test material form:
- solid: crystalline
- Details on test material:
- Name: Sodium Iodide (as per study report)
Appearance: White colour crystalline powder
Purity (a.i.): 99.13% w/w
Storage conditions : Room Temperature (20 - 30˚C)
Molecular Weight: 149.89 g/mol
Molecular Formula: Na-I
SMILES: [Na+].[IH-]
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- The Rat is a commonly used species for toxicity studies and is also recommended by the stated regulatory guidelines.
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Inbred animals of animal house facility, of the CRO were used after accuring CPCSEA approval.
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 6-7 weeks
- Weight at study initiation: Males: 206.20 g
Females: 203.60 g
- Fasting period before study: Yes.
- Housing: A total 2-3 rats were housed in each polycarbonate cage (size 37 [cm] x 21 [cm], height 20 [cm]). Cage rotation in every rack was carried weekly once. Sterilized corn-cob produced from pure corn, dried and free from dust, was used as bedding material. It was renewed as often as necessary to keep the animals dry and clean.
- Diet (e.g. ad libitum): A conventional laboratory pellet diet. was offered ad libitum. The copy of composition, microbial and chemical contaminant reports analysed periodically.
- Water (e.g. ad libitum): Aquaguard filtered drinking water in bottles was offered ad libitum. Samples of the drinking water were subjected periodically to bacteriological tests and to chemical contaminant analysis.
- Acclimation period: 7-8 days
DETAILS OF FOOD AND WATER QUALITY: No Data Available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.60 and 23.20°C
- Humidity (%): 40.60 to 66.10%
- Air changes (per hr): 12 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark.
IN-LIFE DATES: From: February 15, 2019
To: April 06, 2019
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- The oral route was selected for the dose administration and recommended by the regulatory guideline.
- Details on mating procedure:
- No Data Available
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The concentration and homogeneity assessment of the dose formulation of Sodium Iodide (CAS No.: 7681-82-5) was performed on Day 01 and Day 22. The results of the analyzed formulation were 3.65, 7.34 and 14.72 mg/ml for Day 01 and 3.65, 7.26 and 14.48 mg/ml for Day 22 for low, mid and high dose respectively. Dose concentration verification were within the acceptance limits of ± 20% of the nominal concentrations for all the dose formulation analysis.
- Duration of treatment / exposure:
- 28 days with 14 days recovery period
- Frequency of treatment:
- Once Daily
- Details on study schedule:
- No Data Available
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- Control Group
- Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- Control Group (Recovery)
- Dose / conc.:
- 37.5 mg/kg bw/day
- Remarks:
- Low Dose Group
- Dose / conc.:
- 75 mg/kg bw/day
- Remarks:
- Mid Dose Group
- Dose / conc.:
- 150 mg/kg bw/day
- Remarks:
- High Dose Group
- Dose / conc.:
- 150 mg/kg bw/day
- Remarks:
- High Dose Group (Recovery)
- No. of animals per sex per dose:
- G1 (Control Group): 5 males and 5 females
G2 (Low Dose Group): 5 males and 5 females
G3 (Mid Dose Group): 5 males and 5 females
G4 (High Dose Group): 5 males and 5 females
G1-R (Control Recovery Group): 5 males and 5 females
G4-R (High Dose Recovery Group): 5 males and 5 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The doses were selected based upon previously performed Dose-Range FInding Study for the test chemical.
- Rationale for animal assignment (if not random): Prior to the first day of dosing, male and female animals were separately randomized into four different test groups, based on the most recent body weight, using validated software.
- Fasting period before blood sampling for clinical biochemistry: Animals were fasted overnight prior to blood collection.
- Rationale for selecting satellite groups: The satellite group was selected as per the requirement of regulatory guideline.
- Post-exposure recovery period in satellite groups: 2 weeks
- Section schedule rationale (if not random): N/A
- Other: N/A - Positive control:
- No Data Available
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Once Daily, preferably at the same time.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: On treatment Day 1 and weekly thereafter during experimental period.
BODY WEIGHT: Yes
- Time schedule for examinations: At start of treatment and weekly (± 2 days) thereafter, till the end of experimental period.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes, at start of treatment and weekly (± 2 days) thereafter, till the end of experimental period.
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Not specified
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not specified
FOOD EFFICIENCY: Not Specified
- 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: Not specified
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not specified
- Time schedule for examinations: Not Specified
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: During week 4th for main group animals.
- Dose groups that were examined: High dose and control group animals for main group.
HAEMATOLOGY: Yes
- Time schedule for collection of blood: On the termination day, just prior to necropsy.
- Anaesthetic used for blood collection: Not specified
- Animals fasted: Yes
- How many animals: All animals were subjected to blood collection.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: On the termination day, just prior to necropsy.
- Animals fasted: Yes
- How many animals: All animals were subjected to blood collection.
URINALYSIS: Yes
- Time schedule for collection of urine: At the last week of the treatment and recovery periods, all surviving rats of main groups and recovery groups were housed in metabolic cages overnight for collection of urine.
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: Functional Observation Battery/ Neurobehavioral Observation, sensory reactivity to stimuli, assessment of grip strength, hind limb foot splay and motor activity assessment was performed in week 4th for main group animals and in week 6th for recovery group animals.
- Dose groups that were examined: All animals were subjected to Neurobehavioural examinations.
- Battery of functions tested: sensory activity / grip strength / motor activity / other: hind limb foot splay
IMMUNOLOGY: No
- Time schedule for examinations: N/A
- How many animals: N/A
- Dose groups that were examined: N/A
OTHER:
Oestrus Cycle: At termination, the oestrus cycle of all females were determined by taking vaginal smears.
Bone Marrow Smear Examination: Bone marrow smear (from femur) were prepared at the time of necropsy. - Oestrous cyclicity (parental animals):
- At termination, the oestrus cycle of all females were determined by taking vaginal smears.
- Sperm parameters (parental animals):
- No Data Available
- Litter observations:
- No Data Available
- Postmortem examinations (parental animals):
- GROSS PATHOLOGY: Yes, all surviving animals from main group were sacrificed on Day 29 and from recovery group were sacrificed on recovery Day 15. All surviving animals (main and recovery groups) were subjected to necropsy and detailed gross pathology evaluation. Animals were fasted overnight before necropsy. Animals were weighed, euthanized by CO2 asphyxiation and examined externally. All orifices and the cranial, thoracic and visceral cavities were opened and examined macroscopically.
HISTOPATHOLOGY: Yes, full histopathology was carried out on the preserved organs and tissues of all animals in the control and high dose groups. Histopathology was not extended to lower dose groups and recovery group, as there is no test item related lesions observed in control and high dose groups. - Postmortem examinations (offspring):
- No Data Available
- Statistics:
- Raw Data were processed using Statistical Software Sigma Plot 14.0. The mean and Standard Deviation were calculated using the software and all data were summarized in tabular form. All continuous data (body weight, percent change in body weight with respect to day 1, feed consumption, functional observation battery/neurobehavioral observation, foot splay record, grip strength, motor activity, haematology, clinical chemistry, absolute and relative organ weights, etc.) were checked for their normality and for homogeneity, and analysed using one-way ANOVA for comparison of means. Heterogneous data was analysed using Dunnett’s test. In case of recovery groups, means were compared using t-test for homogeneous data and Mann Whitney’s test for heterogeneous data. The significane threshold for all tests (p value) was set at 0.05. Significant differences obtained from the statistical analysis have been indicated at the relevant places in this report.
- Reproductive indices:
- No Data Available
- Offspring viability indices:
- No Data Available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No treatment related clinical signs were noted upto 150.0 mg/kg body weight in either sex.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- No morbidity or mortality were detected in animals of any of the experimental groups throughout the duration of the experiment.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Males: Treatment related mean body weight and body weight gain (percent change in body weight with respect to Day 1) decrease were noted in males at 150.0 mg/kg when compared to concurrent control animals on Day 8, 15, 22 and 28 in all the groups. . Statistically (P<0.05) significant decrease in percent change in body weight with respect to Day 1 was noted in males on Day 8 (-42% at 150.0 mg/kg), on Day 15 (upto -44% at 37.5, 75.0 and 150.0 mg/kg), on Day 22 (upto -34% at 37.5, 75.0 and 150.0 mg/kg) when compared to concurrent control animals. In recovery males statistically (P<0.05) significant decrease in percent change in body weight with respect to Day 1 was noted on Day 8 (-60% at 150.0 mg/kg), Day 15 (-32% at 150.0 mg/kg) and on Day 28 (-28% at 150.0 mg/kg) when compared to concurrent recovery control animals.
Females: No treatment related changes were noted in females in mean body weight and percent change in body weight with respect to Day 1 upto 150.0 mg/kg - Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No treatment related effect on food consumption was noted up to 150.0 mg/kg
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- No ophthalmological abnormalities were detected in the control (G1) and high-dose (G4) groups at week 4 in either sex.
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Statistically significant increase were noted in RBC, Hematocrit and Hemoglobin of males in G3 and G4 groups, while whereas statistically significant decrease in levels of MCH in males of G2 and G3 group, MCHC in G2 males and WBC in females of G4 group. when compared to concurrent control animals. In recovery animals, statistically significant increase were noted in MCV and MCH (Female: G4-R at 150 mg/kg body weight) while statistically significant decrease were noted in RBC and Platelets (Female: G4-R at 150 mg/kg body weight) when compared to concurrent recovery control animals. The observed variations in hematology parameters at the end of treatment and treatment free period, considered as an inconsistence with dose related response in either sex, reversed in recovery group, minimal in nature and it was further not evidenced by histopathological observations.
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Statistically significant increase were noted in Creatinine in males of G2 groups, Glucose in males of G3 and G4 group, Globulin of females in G2 group when compared to concurrent control animals. In recovery animals, statistically significant increase were noted in ALT and Cholesterol in males of high dose recovery group, while statistically significanct decreased was noted in Phosphorus in males of high dose recovery group, when compared to concurrent recovery control animals. The observed variations in biochemical parameters at the end of treatment and treatment free period, considered as an inconsistence with dose related response in either sex, reversed in recovery group, minimal in nature and it was further not evidenced by histopathological observations.
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- No treatment related changes were noted in urine analysis upto 150 mg/kg body weight in either sex of treated and treatment free groups.
- Behaviour (functional findings):
- effects observed, non-treatment-related
- Description (incidence and severity):
- No treatment-related changes were noted in functional observational battery/neurobehavioral observation upto 150.0 mg/kg. Mean foot splay of all dose groups was also found comparable to the control mean. Motor activity measurements revealed statistically significant decreases in Horizontal Count (HC) and in Ambulatory Count (AC) at 150.0 mg/kg in female. This changes were not related to treatment, as it was inconsistent, not dose dependent manner and observed only in single sex.
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No treatment related histopathological findings were observed in vehicle control group and in high dose group animals. Microscopic examination revealed varying degree of different pathological changes in various organs belonging to control and treatment groups as follows:
Liver: focal to multifocal minimal perivascular lymphocytic infiltrate (Male: G4: 2/5; Female: G1: 2/5; G4: 2/5);
Kidneys (Unilateral): focal mild lymphocytic infiltrate (Male: G1: 1/5; Female: G1: 1/5; G4: 1/5) ;
Thyroid: Congenital cyst (Male: G1: 1/5, G4: 2/5; Female: G1:1/5, G4:: 1/5)
Testes(Unilateral): focal minimal to diffuse moderate multinucleated giant cell ( G1: 1/5, G4:1/5);
Epididymis(Unilateral): focal mild sperm stasis ( G4:2/5).
All the other histopathological changes observed during the study were considered as spontaneous and incidental to Wistar Rats - Histopathological findings: neoplastic:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- Bone Marrow smear did not show any adverse effects or deviation as compared to controls.
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Description (incidence and severity):
- No abnormalities detected in the oestrus cycle in any of the treatment group at termination.
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Details on results (P0)
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 75 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- food consumption and compound intake
- ophthalmological examination
- haematology
- clinical biochemistry
- urinalysis
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
- reproductive function (oestrous cycle)
- other: No adverse effect during bone marrow smear examinations were observed in both males and females.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Dose descriptor:
- LOAEL
- Effect level:
- 150 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- 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
- Anogenital distance (AGD):
- not specified
- Nipple retention in male pups:
- 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
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Remarks on result:
- not measured/tested
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- no
- Treatment related:
- no
Applicant's summary and conclusion
- Conclusions:
- Based on all the available data, and from the observations and conclusion, the NOAEL and LOAEL for the test chemical, Sodium Iodide (CAS No. 7681-82-5) was found to be 75 mg/kg bw/day and 150 mg/kg bw/day, respectively.
- Executive summary:
A 28 days repeated dose toxicity study was performed using the test chemical, Sodium Iodide (CAS No. 7681-82-5). Wistar rats were used as animals of choice, wherein the test chemical was dosed to the rats for 28 days with 14 days recovery period. A total number of 60 Wistar rats (30 males and 30 females) were randomly allocated to six different dose groups of 5 animals/sex/group. The animals allocated to Group G2, G3 and G4/G4-R received 37.5, 75.0and 150.0mg/kg body weight of Sodium Iodide (CAS No.: 7681-82-5) respectively, whereas the animals of Group G1/G1-R, received vehicle alone [Distilled Water] for 28 consecutive days. Observations comprised of mortality/morbidity, clinical signs, detailed clinical observation, body weight, body weight gain, feed consumption, ophthalmoscopic examination, functional observational battery/neurobehavioral observation, hematology, clinical biochemistry, urinalysis, gross pathology and histopathology (vehicle control group and high dose group). No treatment related mortality/morbidity were noted in either sex up to 150.0 mg/kg body weight. No treatment related clinical signs were noted up to 150.0 mg/kg body weight in either sex. No abnormalities were detected during ophthalmological examination at 150.0 mg/kg body weight in either sex, when compared with control group. Treatment related mean body weight and body weight gain (percent change in body weight with respect to Day 1) decrease were noted in males at 150.0 mg/kg when compared to concurrent control animals on Day 8, 15, 22 and 28 in all the groups. Moreover statistically (P<0.05) significant decreases in mean body weight were noted in males on Day 22 (up to -14% at 37.5, 75.0 and 150.0 mg/kg) and on Day 15 (-15% at 75.0 mg/kg) when compared to concurrent control animals. Statistically (P<0.05) significant decrease in percent change in body weight with respect to Day 1 was noted in males on Day 8 (-42% at 150.0 mg/kg), on Day 15 (up to -44% at 37.5, 75.0 and 150.0 mg/kg), on Day 22 (up to -34% at 37.5, 75.0 and 150.0 mg/kg) when compared to concurrent control animals. In recovery males statistically (P<0.05) significant decrease in percent change in body weight with respect to Day 1 was noted on Day 8 (-60% at 150.0 mg/kg), Day 15 (-32% at 150.0 mg/kg) and on Day 28 (-28% at 150.0 mg/kg) when compared to concurrent recovery control animals. No treatment related changes were noted in feed consumption up to 150.0 mg/kg body weight in either sex. No treatment related changes were noted in functional observational battery/ neurobehavioral observation, foot splay, grip strength and motor activity assessment up to 150.0 mg/kg body weight in either sex. No treatment related changes were noted in hematological and clinical chemistry parameters up to 150.0 mg/kg body weight in either sex. No treatment related changes were noted in urine analysis up to 150.0 mg/kg body weight in either sex. No any abnormalities detected in the oestrus cycle in any of the treatment group at termination. No treatment related gross (external and internal) pathological changes were noted up to 150.0 mg/kg body weight in either sex. No treatment related histopathological examination were noted in any of the tissue/organ at 150.0 mg/kg body weight in either sex. Based on all the above data, and from the observations and conclusion, the NOAEL and LOAEL for the test chemical, Sodium Iodide (CAS No. 7681-82-5) was found to be 75 mg/kg bw/day and 150 mg/kg bw/day, respectively.
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