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EC number: 700-710-7 | CAS number: -
- 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:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- January 1999 to December 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards with acceptable restrictions The highest dose level in this study, 10 mg/kg/day, did not result in toxicity of the parental animals.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- Principles of method if other than guideline:
- Similar to OECD 416
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Nickel sulphate
- EC Number:
- 232-104-9
- EC Name:
- Nickel sulphate
- Cas Number:
- 7786-81-4
- IUPAC Name:
- nickel(2+) sulfate
- Reference substance name:
- Aldrich Chemical Company.
- IUPAC Name:
- Aldrich Chemical Company.
- Details on test material:
- - Name of test material (as cited in study report): Nickel(II) sulphate Hexahydrate; 10101-97-0
- Molecular formula (if other than submission substance): not different than submission substance
- Molecular weight (if other than submission substance): not different than submission substance
- Smiles notation (if other than submission substance): not different than submission substance
- InChl (if other than submission substance): not different than submission substance
- Structural formula attached as image file (if other than submission substance): not different than submission substance
- Physical state: blue green crystalline powder
- Purity: 99%
- Lot no.: 08516TQ
- Other details not reported or not applicable
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, NY, USA
- Age at study initiation: 7 weeks
- Weight at study initiation: 205-257 g (males) and 147-213 g (females)
- Fasting period before study: not reported
- Housing: individually
- Use of restrainers for preventing ingestion (if dermal): yes/no
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26 deg. C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15 per hour
- Photoperiod (hrs dark / hrs light): 12-h light/dark photoperiod.
IN-LIFE DATES: From: February 1, 1999 To: October 15, 1999
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- other: not applicable
- Vehicle:
- other: reverse osmosis deionized water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test substance was dissolved in reverse osmosis deionized water. Control animals received appropriate volumes of water only. The
homogeneity and stability of the test substance in dosing solutions were determined. The concentration of the test substance in dosing solutions
was analytically confirmed at different time intervals during the study period. Groups of 56 test animals of each parental group (28 males/28
females) received the test substance daily by gavage at the following dosage concentrations: 0, 0.1, 0.25, 0.50, and 1.00 mg/ml (equivalent to
dose levels of 0, 1.0, 2.5, 5.0, and 10.0 mg/kg/day). Dose volume was 10 ml/kg, adjusted for body weight. F0 parents and F1 pups selected as the
parental group for the F2 generation received the test substance daily by gavage. F0 parental animals received the test substance (or vehicle for
control group) daily for 10 weeks, starting 70 days prior to mating. F1 offspring selected to produce the F2 generation received the test
substance starting on postpartum day 22 and dosing continued until one day prior to sacrifice.
DIET PREPARATION
- not applicable
VEHICLE
- deionized water - Details on mating procedure:
- - M/F ratio per cage: Animals were caged as mating pairs (1:1) until copulation was confirmed, then transferred to individual cages.
- Proof of pregnancy:The presence of a vaginal plug or sperm was designated as day 0 of gestation.
- Estrous cycle determinations (length and normality) were made daily prior to mating and during cohabitation.
- Dams and pups were caged together during lactation. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analyzed by AAS
- Duration of treatment / exposure:
- Exposure period: F0: before and during mating, pregnancy, and through weaning of F1 offspring. F1: after weaning,
during growth, mating, production and weaning of F2 offspring
Premating exposure period (males): 70 days
Premating exposure period (females): 70 days
Duration of test: 2 generations - Frequency of treatment:
- daily
- Details on study schedule:
- - F1 parental animals not mated until 70 days after selected from the F1 litters.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 1.0, 2.5, 5.0, and 10.0 mg/kg/day
Basis:
nominal conc.
- No. of animals per sex per dose:
- 28 males/28 females per dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Based on the results of 1 generation study, the doses of 0, 1, 2.5, 5.0, and 10 mg/kg-day were selected
- Rationale for animal assignment (if not random): random - Positive control:
- none reported
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly
- During gestation and lactation, F0 and F1 females were examined daily for clinical signs of toxicity.
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE: Yes
- Time schedule for examinations: weekly
- Oestrous cyclicity (parental animals):
- Daily vaginal smears were collected for a minimum of 3 weeks prior to mating
- Sperm parameters (parental animals):
- Parameters examined in F0 and F1 parental males [sperm count, concentration, motility, and morphology)
- Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: [yes]
- If yes, maximum of [8] pups/litter ([4]/sex/litter as nearly as possible); excess pups were killed and discarded.
PARAMETERS EXAMINED
The following parameters were recorded for each pup during lactation: viability, external examinations, sex determinations, and body weights. F1 and F2 litters were randomly adjusted to 4 males and 4 males on lactation day 4. F1 pups used as the parental animals for the F2 generation were selected between postpartum days 4 and 21. A total of 28 male and 28 female F1 pups were selected. The remaining F1 pups and F2 pups were sacrificed and gross necropsy examinations were performed. Surviving F0 and F1 parental animals were sacrificed and an assessment was made of reproductive performance. - Postmortem examinations (parental animals):
- HISTOPATHOLOGY / ORGAN WEIGHTS:
The following organs from surviving F0 and F1 parental animals were preserved for histopathological examination: adrenal glands, brain, gross
lesions, kidneys, liver, ovaries, pituitary, prostate, right epididymis, testes, seminal vesicles, spleen, uterus, and
vagina. The following organs from surviving F0 and F1 parental animals were weighed and recorded: adrenal glands, brain, epididymides, kidneys,
testes, ovaries, pituitary, prostate, seminal vesicles, spleen, and uterus. - Postmortem examinations (offspring):
- HISTOPATHOLOGY / ORGAN WEIGHTS:
The following organs from surviving F1 parental animals were preserved for histopathological examination: adrenal glands, brain, gross
lesions, kidneys, liver, ovaries, pituitary, prostate, right epididymis, testes, seminal vesicles, spleen, uterus, and
vagina. The following organs from surviving F0 and F1 parental animals were weighed and recorded: adrenal glands, brain, epididymides, kidneys,
testes, ovaries, pituitary, prostate, seminal vesicles, spleen, and uterus. - Statistics:
- One-way analysis of variance (ANOVA) was used to analyze parental and pup body weight, body weight gain, food consumption, organ weights,
length of gestation and estrous cycle, and litter size. If significance was detected, Dunnett's test was performed to compare control and treatment
groups. Copulation and fertility indices, pup sex ratios, numbers of live and dead pups, and pup survival were evaluated by Chi-Square test.
Post-implantation loss was evaluated using the Mann-Whitney U test. The level of significance was 5% (p<0.05). - Reproductive indices:
- Copulation and fertility indices, pup sex ratios, numbers of live and dead pups, and pup survival
- Offspring viability indices:
- Copulation and fertility indices, pup sex ratios, numbers of live and dead pups, and pup survival
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- not examined
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Details on results (P0)
F0 generation: No test substance related mortality of clinical signs of toxicity.
ALL PARAMETERS:
There were no toxicologically meaningful differences in body weight gain or food consumption, copulation and fertility indices, gestation length, implantation and post-implantation loss, or sperm parameters. The numbers of live pups of treated female on lactation day 0 were not significantly different from that control group. Post-implantation loss was higher at 10 mg/kg/day (2.1), but was not statistically different from the control group (0.9). No treatment related changes found at gross necropsy. Statistically significant differences in organ weights included decreased absolute and relative livers weights in males at 10 mg/kg/day, decreased absolute brain weight in females at 2.5 mg/kg/day, and increased relative liver weight in females at 1.0, 2.5, and 10.0 mg/kg/day.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 10 other: mg NiSO4/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: The reproductive NOAEL (2.2 mg Ni/kg BW/day) was based on the absence of any effects on reproduction at the highest expsoure used in the study.
- Remarks on result:
- other: Generation: all (migrated information)
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
Details on results (F1)
lactation day 0 ranged from 13.6 pups/litter (1.0 mg/kg/day group) to 11.4 pups per litter (10 mg/kg/day group). Post-implantation loss was
slightly higher at 10 mg/kg/day (1.2), but was not statistically different from the control group (0.9). Clinical signs were noted during lactation,
but were not considered to be test-substance related. Clinical signs were of low incidence and sporadically distributed among treatment groups.
Vaginal opening and completion of preputial separation differences were not considered to be treatment related. Vaginal opening of control and 10 mg/kg/day pups occurred by postpartum day 35. Preputial separation of control and male pups in the 10 mg/kg/day group was completed by
postpartum day 46. Gross necropsy observations included atelectasis and absence of milk in the stomach. Other necropsy findings were of low
incidence and sporadically distributed among treatment groups.
Of F1 animals selected to produce the F2 generation, no test substance related mortality of clinical signs of toxicity were noted. Clinical
signs were of low incidence and sporadically distributed among treatment groups and were, therefore, not considered test substance related.
There were no toxicologically meaningful differences in body weight or body weight gains during the growth phase, however, mean body weight
gain was significantly lower in the 1.0 and 5.0 mg/kg/day treatment groups during lactation days 14-21. There were no toxicologically meaningful
differences in food consumption. No statistically significant differences were found in copulation or fertility indices, estrous cycle
determinations, precoital intervals, or gestation lengths. There were no statistically significant differences in mean implantation scar counts,
mean number of live pups on lactation day 0, or mean post-implantation loss. Statistically significant differences in organ weights included
decreased absolute pituitary weight in 1.0 mg/kg/day males, increased relative adrenal weight and decreased relative liver weight in 5.0 and
10.0 mg/kg/day males, and decreased relative liver weight in 2.5 and 10.0 mg/kg/day females. There were no toxicologically meaningful
differences in sperm parameters of 10 mg/kg/day males. No test substance related microscopic histopathological changes were noted.
F2 generation: No test substance related clinical signs of toxicity were noted. There were no statistically significant differences in body weights
during lactation. Gross necropsy observations included atelectasis and absence of milk in the stomach. Other necropsy findings were of low
incidence and sporadically distributed among treatment groups.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
The study was conducted to evaluate the potential effects of nickel sulfate hexahydrate administered to Sprague-Dawley rats in a
two-generation study. Oral (gavage) administration of nickel sulfate hexahydrate at dose levels up to 10 mg/kg/day (2.2 mg Ni/kg) had no
effect on F0 or F1 survival, growth, mating behavior, fertility, gestation, parturition, or lactation. There was no test substance
related mortality or clinical signs of toxicity in F0 and F1 rats or their offspring. Pup viability and growth was not affected. There were
no toxicologically meaningful differences in estrous cycling, sperm parameters, copulation, and fertility indices, precoital intervals,
gestation lengths, gross necropsy findings, or the onset of sexual maturation in F1 rats. Histopathological examinations did not reveal any
test article-related changes in the liver, reproductive organs, or other tissues examined. Statistically significant reductions in absolute
and/or relative liver weights in F0 males at 10 mg/kg/day and in F1 males at 5.0 and 10.0 mg/kg/day were not regarded as toxicologically significant.
Relative liver weight values were less than 10% different from the respective control values.
Applicant's summary and conclusion
- Conclusions:
- Based on these results, 10.0 mg/kg/day is considered a No-Observed-Adverse-Effect Level (NOAEL) for oral administration of nickel sulfate hexahydrate over two generations in rats.
- Executive summary:
ROBUST SUMMARY DEVELOPED BY AN INDEPENDENT REVIEWER.
Robust Summary for Siglin (2000)
Male and female Sprague-Dawley rats were obtained from Charles River Laboratories, NY, USA, and acclimated to laboratory conditions. Food and
water were provided ad libitum during the study period. Environmental conditions during the study were maintained at a temperature of 18-26
deg. C, a relative humidity of 30-70%, and a 12-h light/dark photoperiod.
Animals were caged as mating pairs (1:1) until copulation was confirmed, then transferred to individual cages. Estrous cycle determinations(length and normality) were made daily prior to mating and during cohabitation. The presence of a vaginal plug or sperm was designated as day 0 of gestation.
Dams and pups were caged together during lactation.
The test substance was dissolved in reverse osmosis deionized water. Control animals received appropriate volumes of water only. Thehomogeneity and stability of the test substance in dosing solutions were determined. The concentration of the test substance in dosing solutions
was analytically confirmed at different time intervals during the study period. Groups of 56 test animals of each parental group (28 males/28 females)
received the test substance daily by gavage at the following dosage concentrations: 0, 0.1, 0.25, 0.50, and 1.00 mg/ml (equivalent to
dose levels of 0, 1.0, 2.5, 5.0, and 10.0 mg/kg/day). Dose volume was 10 ml/kg, adjusted for body weight. F0 parents and F1 pups selected as the
parental group for the F2 generation received the test substance daily by gavage. F0 parental animals received the test substance (or vehicle for
control group) daily for 10 weeks, starting 70 days prior to mating. F1 offspring selected to produce the F2 generation received the test
substance starting on postpartum day 22 and dosing continued until one day prior to sacrifice.
General health checks of F0 and F1 parental animals were made twice daily, and more detailed clinical observations were made weekly. Duringgestation and lactation, F0 and F1 females were examined daily for clinical signs of toxicity.
Individual body weights were measured weekly in F0 and F1 parental animals. Mated females and females that delivered were weighed on days 0,7, 14, and 20 during gestation, and on days 1, 4, 7, 14, and 21 during lactation. Food consumption was recorded weekly, except during
cohabitation and lactation. The following parameters were recorded for each pup during lactation: viability, external examinations, sex
determinations, and body weights. F1 and F2 litters were randomly adjusted to 4 males and 4 males on lactation day 4.
F1 pups used as the parental animals for the F2 generation were selected between postpartum days 4 and 21. A total of 28 male and 28 female F1pups were selected. The remaining F1 pups and F2 pups were sacrificed and gross necropsy examinations were performed. Surviving F0 and F1
parental animals were sacrificed and an assessment was made of reproductive performance. The following organs from surviving F0 and F1
parental animals were preserved for histopathological examination: adrenal glands, brain, gross lesions, kidneys, liver, ovaries, pituitary,
prostate, right epididymis, testes, seminal vesicles, spleen, uterus, and vagina. The following organs from surviving F0 and F1 parental animals
were weighed and recorded: adrenal glands, brain, epididymides, kidneys, testes, ovaries, pituitary, prostate, seminal vesicles, spleen, and
uterus. Sperm was collected from F0 and F1 parental males and examined for sperm count, concentration, motility, and morphology.
One-way analysis of variance (ANOVA) was used to analyze parental and pup body weight, body weight gain, food consumption, organ weights, length ofgestation and estrous cycle, and litter size. If significance was detected, Dunnett's test was performed to compare control and treatment
groups. Copulation and fertility indices, pup sex ratios, numbers of live and dead pups, and pup survival were evaluated by Chi-Square test.
Post-implantation loss was evaluated using the Mann-Whitney U test. The level of significance was 5% (p0.05).
Homogeneity and stability of the test substance in gavage dosing solutions was found to be stable for 24 hours at room temperature and up
to 21 days under refrigeration.
F0 generation:
No test substance related mortality of clinical signs of toxicity. There were no toxicologically meaningful differences in body weight gain orfood consumption, copulation and fertility indices, gestation length, implantation and post-implantation loss, or sperm parameters. The
numbers of live pups of treated female on lactation day 0 were not significantly different from that control group. Post-implantation loss
was higher at 10 mg/kg/day (2.1), but was not statistically different from the control group (0.9).
No treatment related changes found at gross necropsy. Statistically significant differences in organ weights included decreased absolute andrelative livers weights in males at 10 mg/kg/day, decreased absolute brain weight in females at 2.5 mg/kg/day, and increased relative liver
weight in females at 1.0, 2.5, and 10.0 mg/kg/day.
F1 generation:
There were no toxicologically meaningful differences in pup viability data or pup body weights during lactation. Mean litter size on lactationday 0 ranged from 13.6 pups/litter (1.0 mg/kg/day group) to 11.4 pups per litter (10 mg/kg/day group). Post-implantation loss was slightly higher
at 10 mg/kg/day (1.2), but was not statistically different from the control group (0.9).
Clinical signs were noted during lactation, but were not considered to be test-substance related. Clinical signs were of low incidence andsporadically distributed among treatment groups. Vaginal opening and completion of preputial separation differences were not considered to be
treatment related. Vaginal opening of control and 10 mg/kg/day pups occurred by postpartum day 35. Preputial separation of control and male
pups in the 10 mg/kg/day group was completed by postpartum day 46. Gross necropsy observations included atelectasis and absence of milk in the stomach.
Other necropsy findings were of low incidence and sporadically distributed among treatment groups.
Of F1 animals selected to produce the F2 generation, no test substance related mortality of clinical signs of toxicity were noted. Clinicalsigns were of low incidence and sporadically distributed among treatment groups and were, therefore, not considered test substance related. There
were no toxicologically meaningful differences in body weight or body weight gains during the growth phase, however, mean body weight gain was
significantly lower in the 1.0 and 5.0 mg/kg/day treatment groups during lactation days 14-21. There were no toxicologically meaningful
differences in food consumption. No statistically significant differences were found in copulation or fertility indices, estrous cycle
determinations, precoital intervals, or gestation lengths. There were no statistically significant differences in mean implantation scar counts,
mean number of live pups on lactation day 0, or mean post-implantation loss. Statistically significant differences in organ weights included
decreased absolute pituitary weight in 1.0 mg/kg/day males, increased relative adrenal weight and decreased relative liver weight in 5.0 and
10.0 mg/kg/day males, and decreased relative liver weight in 2.5 and 10.0 mg/kg/day females. There were no toxicologically meaningful differences
in sperm parameters of 10 mg/kg/day males. No test substance related microscopic histopathological changes were noted.
F2 generation:
No test substance related clinical signs of toxicity were noted. There were no statistically significant differences in body weights duringlactation. Gross necropsy observations included atelectasis and absence of milk in the stomach. Other necropsy findings were of low incidence
and sporadically distributed among treatment groups.
The study was conducted to evaluate the potential effects of nickel sulfate hexahydrate administered to Sprague-Dawley rats in atwo-generation study. Oral (gavage) administration of nickel sulfate hexahydrate at dose levels up to 10 mg/kg/day (2.2 mg Ni/kg) had no
effect on F0 or F1 survival, growth, mating behavior, fertility, gestation, parturition, or lactation. There was no test substance
related mortality or clinical signs of toxicity in F0 and F1 rats or their offspring. Pup viability and growth was not affected. There were
no toxicologically meaningful differences in estrous cycling, sperm parameters, copulation, and fertility indices, precoital intervals,
gestation lengths, gross necropsy findings, or the onset of sexual maturation in F1 rats. Histopathological examinations did not reveal any
test article-related changes in the liver, reproductive organs, or other tissues examined. Statistically significant reductions in absolute
and/or relative liver weights in F0 males at 10 mg/kg/day and in F1 males at 5.0 and 10.0 mg/kg/day were not regarded as toxicologically significant.
Relative liver weight values were less than 10% different from the respective control values.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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