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EC number: 251-735-0 | CAS number: 33908-66-6
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-05-02 to 2012-05-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study This study is only a dose range finder for a 90 day repeated dose 90-day oral toxicity study in rodents (OECD guideline 408).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- (adopted 1998-09-21)
- Deviations:
- yes
- Remarks:
- since this is only a dose range finder for a Repeated dose 90-day toxicity study not enough animals per dose group were tested and not all parameters were examined in this study, .
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2009-11-12
- Limit test:
- no
Test material
- Reference substance name:
- Sodium hexahydroxoantimonate
- EC Number:
- 251-735-0
- EC Name:
- Sodium hexahydroxoantimonate
- Cas Number:
- 33908-66-6
- Molecular formula:
- NaSb(OH)6
- IUPAC Name:
- sodium hexahydroxoantimonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Sodium hexahydroxoantimonate
- Molecular formula: NaSb(OH)6
- Molecular weight: 246.75 g/mol
- Physical state: white, odourless, crystalline solid inorganic powder
- Storage condition of test material: at room temperature, in tightly closed containers in a well-ventilated place
- Melting point: >600°C
- Boiling point: >600°C
- Water solubility: 594 mg/L at 20°C
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: males: 41 days, females: 41 days
- Weight at study initiation: males: 195.9 – 218.6 g, females: 129.8 – 147.0 g
- Housing: animals were kept singly in MAKROLON cages (type III plus) with a basal surface of approximately 39 cm x 23 cm and a height of approximately 18 cm. Granulated textured wood (Granulate A2, J. Brandenburg, 49424 Goldenstedt, Germany) was used as bedding material for the cages.
- Diet (ad libitum): commercial ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest,Germany); Food residue was removed and weighed.
- Water (ad libitum): drinking water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C (maximum range)
- Humidity: 55% ± 15% (maximum range)
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.8% aqueous hydroxypropylmethylcellulose gel
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test item was suspended in the vehicle to the appropriate concentrations and was administered orally at a constant volume of 2 mL/kg bw to the animals.
The control animals received the vehicle at a constant volume of 2 mL/kg bw orally in the same way.
The application formulations were freshly prepared every day.
The amount of the test item was adjusted to the animal's current body weight
daily. - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- For each test or reference item that is mixed with a vehicle, tests by appropriate analytical methods will be carried out for a 90-day repeated dose toxicity study (please refer to the Endpoint study record k_Hansen_2013_90 days) to determine the concentration, homogeneity and, if needed, stability of the test item in the formulations.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 300 and 1000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 5 males / 5 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale:
The dose levels of 100, 300 and 1000 mg sodium hexahydroxoantimonate/kg bw/day had been selected in agreement with the Sponsor.
The proposed doses had been selected on the basis of a lack of acute oral toxicity (LD50 > 2000 mg/kg b.w.), an assumed poor oral availability (<1%), the understanding that pentavalent Sb substances are considered less toxic than trivalent Sb substances, and the latter had been tested up to doses of >1000 mg/kg
bw/day in rats for 90 days without signs of overt toxicity. - Positive control:
- not applicable
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: at least once daily
- Cage side observations checked: cageside observations included skin/fur, eyes, mucous membranes, respiratory and circulatory systems, somatomotor activity and behaviour patterns.
The animals were checked early in the morning of each working day and again in the afternoon to look for dead or moribund animals.
BODY WEIGHT: Yes
- Time schedule for examinations: at the time of group allocation, on the day of commencement of treatment and weekly thereafter always on the same day of the week throughout the experimental period.
FOOD CONSUMPTION AND COMPOUND INTAKE:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/week: Yes
The quantity of food left by individual animals was recorded on a weekly basis throughout the experimental period. Food intake per rat (g/rat/week) was calculated using the total amount of food given to and left by each rat in each group on completion of a treatment week.
The relative food consumption (in g/kg bw/day) was determined using the following formula:
Relative food consumption (g/kg bw/day): (Total food given [g] - Total food left [g])/ (Number of animals days# x Body weight [kg])
#: The term 'animal days' counts one animal day for each animal alive for a whole day; it is assumed that on the day of death an animal does not eat.
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
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
WATER CONSUMPTION AND COMPOUND INTAKE: Yes
- Time schedule for examinations: daily by visual appraisal
DETAILED CLINICAL OBSERVATIONS: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
On test day 29 (one day after the last administration), all animals were sacrificed under ether anaesthesia by cutting the aorta abdominalis, exsanguinated, weighed, dissected and inspected macroscopically.
All superficial tissues were examined visually and by palpation and the cranial roof was removed to allow observation of the brain, pituitary gland and cranial nerves. After ventral midline incision and skin reflection all subcutaneous tissues were examined. The condition of the thoracic viscera was noted with due attention to the thymus, lymph nodes and heart.
The abdominal viscera were examined before and after removal, the urinary bladder was examined externally and by palpation. The gastro-intestinal tract was examined as a whole and the stomach and caecum were incised and examined. The lungs were removed and all pleural surfaces were examined under suitable illumination. The liver and the kidneys were examined. Any abnormalities in the appearance and size of the gonads, adrenal glands, uterus, intra-abdominal lymph nodes and accessory reproductive organs were recorded.
HISTOPATHOLOGY: No - Statistics:
- The test item-treated groups were compared with the control group.
The following statistical method was used:
1) Multiple t-test based on DUNNETT, C. W. New tables for multiple comparisons with a control Biometrics, 482-491 (Sept 1964): Body weight / Food consumption (p ≤ 0.01); the following limit was used: p = 0.01 ≙ t = 3.39 (for 16 degrees of freedom)
These statistical procedures were used for all data.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
None of the animals treated with 100, 300 or 1000 mg sodium hexahydroxoantimonate/ kg bw/day for 28 days died prematurely.
No signs of systemic intolerance were observed in any of the animals treated with 100, 300 or 1000 mg sodium hexahydroxoantimonate/kg bw/day for 28 days. The faeces of control and test item-treated animals were normally formed.
BODY WEIGHT AND WEIGHT GAIN
The body weight and body weight gain were not influenced in the male and female animals treated with 100, 300 or 1000 mg sodium hexahydroxoantimonate/kg bw/day for 28 days compared to the control animals.
FOOD CONSUMPTION AND COMPOUND INTAKE
The food consumption was not influenced in the male and female animals treated with 100, 300 or 1000 mg sodium hexahydroxoantimonate/kg bw/day for 28 days compared with the control group.
WATER CONSUMPTION AND COMPOUND INTAKE
The visual appraisal of the drinking water consumption did not reveal any test item-related influence in any of the dose groups.
GROSS PATHOLOGY
Macroscopic inspection revealed no test item-related changes in the male and female rats treated orally with 100, 300 or 1000 mg sodium hexahydroxoantimonate/kg bw/day for 28 days.
Effect levels
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: The aim of this dose-range-finding study was to select the dose levels for a 90-day repeated dose toxicity study of sodium hexahydroxoantimonate/kg bw/day in rats.
- Remarks on result:
- not measured/tested
- Remarks:
- Effect level not specified (migrated information)
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Oral treatment with 100, 300 or 1000 mg sodium hexahydroxoantimonate/kg bw/day for 28 days did not cause any signs of systemic intolerance. The faeces
were of normal consistency throughout the experimental period. The body weight and the body weight gain were not influenced in the male and female animals at any dose. No test item-related influence was noted on the food and drinking water consumption. Macroscopic examination revealed no test item-related changes.
The following dose levels of sodium hexahydroxoantimonate were suggested for the 90-day repeated dose toxicity study in rats (please refer to Endpoint study record k_Hansen_2013_90 days): 100, 300, and 1000 mg/kg bw/day.
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