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EC number: 215-237-7 | CAS number: 1314-60-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-05-01 to 2012-05-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study This study is only a dose range finder for a prenatal developmental toxicity study (OECD guideline 414).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- (adopted 2001-01-22)
- Deviations:
- yes
- Remarks:
- since this is only a dose range finder not enough animals and not all parameters of a full study were examined.
- 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)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at day 0 of pregnancy: 8 to 9 weeks
- Weight at day 0 of pregnancy: 200.8 – 221.8 g
- Housing: except during the mating period, the dams were kept singly in MAKROLON cages (type III plus) with a basal surface of approx. 39 cm x 23 cm and a height of approx. 18 cm. Granulated textured wood (Granulat A2, J. Brandenburg, 49424 Goldenstedt/ Arkeburg, Germany) was used as bedding material in the cages.
- Diet (ad libitum): commercial ssniff® R-Z V1324 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany); Food residue was removed and weighed.
- Water (ad libitum): tap water
- Acclimation period: 5 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 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 once daily.
The dose of the test item was adjusted to the animal's body weight daily.
The control animals received the vehicle at a constant volume of 2 mL/kg bw orally once daily in the same way.
The test item-vehicle preparations were freshly prepared every day. - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- not applicable
- Details on mating procedure:
- Sexually mature ('proved') male rats of the same breed served as partners.
- Impregnation procedure: cohoused
- M/F ratio per cage: 1 male and 1 female
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- Day 6 to 19 of pregnancy
- Frequency of treatment:
- once daily
- Duration of test:
- 20 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 300 and 1000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 2 female rats
- 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 dose levels had been selected based on a lack of acute oral toxicity (LD50 > 2000 mg/kg bw), an assumed poor oral availability (<1%), the understanding that pentavalent Sb substances are considered less toxic than trivalent Sb substances which had been tested up to doses of >1000 mg/kg bw/day in rats for 90 days without signs of overt toxicity.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: at least once daily
- Cage side observations checked: any signs of behavioural changes, changes of external appearance or faeces
Further checks were made early in each working day and again in the afternoon to look for dead or moribund animals.
Animals showing signs of abortion or premature delivery were sacrificed on the same day. Foetuses obtained this way were examined for abnormal development whenever possible.
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: on day 0 of gestation (the day of detection of a positive mating sign), followed by daily weighings - always at the same time of theday.
The body weight gain was calculated in intervals (i.e. 0-3, 3-6, 6-9, 9-12, 12-15, 15-18, 18-20). Furthermore the net weight change* from day 6 is given.
* net weight change from day 6 = carcass weight minus day 6 body weight carcass weight = terminal body weight minus uterine weight
FOOD CONSUMPTION AND COMPOUND INTAKE: Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
The quantity of food consumed by each rat was recorded. The absolute food intake per rat (g/rat/day) was calculated using the total amount of food given to and left by each rat in each group on completion of a treatment day.
The relative food consumption (g/kg bw/day) was calculated using the following formula:
Daily food consumption [g/kg bw/day] = total food intake in g/body weight in kg
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: daily monitoring by visual appraisal
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: a dissection with macroscopic examination of the internal organs and placentae of the dams was carried out. In case of macroscopical findings, the affected organs were prepared in 7% buffered formalin for possible future histopathological examinations. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- number and weight of placentae was determined.
- location of foetuses
- number of foetuses (alive and dead) was determined. - Fetal examinations:
- 1) External examinations: Yes, especially for malformations
- sex and viability of foetuses were determined.
- weight of foetuses
2) Soft tissue examinations: Yes: [all per litter / half per litter / #? per litter ] / No / No data
- Skeletal examinations: No
- Head examinations: No - Statistics:
- No statistical analysis was conducted as only 2 animals/group were evaluated.
- Indices:
- Malformation rate per group [%] = (malformed foetuses/foetuses) x 100
Variation rate per group [%] = (foetuses with variations/foetuses) x 100
Pre-implantation loss [%] = (corpora lutea - implantations/corpora lutea)/ x 100
Post-implantation loss [%] = ((implantations - living foetuses)/implantations)/ x 100
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
- no premature deaths were noted in the dams treated orally with 100, 300 or 1000 mg sodium hexahydroxoantimonate/kg bw/day.
- no test item-related changes of behaviour or external appearance were noted in the dams treated orally with 100, 300 or 1000 mg sodium hexahydroxoantimonate/kg bw/day.
- no test item-related influence was noted on the body weight of the dams treated with 100, 300 or 1000 mg sodium hexahydroxoantimonate/kg bw/day.
- no test item-related influence was observed on the food intake of the dams treated with 100, 300 or 1000 mg sodium hexahydroxoantimonate/kg bw/day.
- visual appraisal of the drinking water consumption revealed no differences between the control and the test item-treated rats.
- no test item-related influence was noted on the gravid uterus weight, the carcass weight and the net weight change from day 6 onwards (carcass weight minus day 6 body weight) of the two evaluated dams/group treated with 100, 300 or 1000 mg sodium hexahydroxoantimonate/kg bw/day.
- no test item-related influence on the prenatal fetal development was detected at 100, 300 or 1000 mg sodium hexahydroxoantimonate/kg bw/day with respect to the number of corpora lutea, implantation sites, resorptions and live foetuses or the values calculated for the pre- and post-implantation losses. The differences observed in comparison to the control are without any biological relevance.
- no test item-related findings at necropsy were noted in the female animals treated with 100, 300 or 1000 mg sodium hexahydroxoantimonate/kg bw/day.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
- no dead foetuses were noted at any tested dose level nor in the control group at laparotomy.
- sex distribution of the foetuses in test groups 100, 300 or 1000 mg sodium hexahydroxoantimonate/kg bw/day was comparable with that of the control
foetuses. The differences observed in comparison to the control are without any biological relevance.
- mean placental weights in the test groups 100, 300 or 1000 mg sodium hexahydroxoantimonate/kg bw/day were not influenced by the administration of the test item to the dams as compared to the control groups.
- mean foetal weights were not influenced by the administration of 100, 300 or 1000 mg sodium hexahydroxoantimonate/kg bw/day to the dams as compared to the control group.
- no test item-related differences between the control and the test groups 100, 300 and 1000 mg/kg bw/day concerning external malformations and variations.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- changes in sex ratio
- fetal/pup body weight changes
- external malformations
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL (maternal toxicity) > 1000 mg/kg bw/day
NOAEL (developmental toxicity) > 1000 mg/kg bw/day
Based on the data obtained in this dose-range-finding study, the following dose levels were selected for a prenatal developmental toxicity study of sodium hexahydroxoantimonate in rats (please refer to the Endpoint study record k_Hansen_2013): 100, 300 and 1000 mg/kg bw/day.
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