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EC number: 235-387-7 | CAS number: 12208-13-8
- 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
Description of key information
No test item related changes were observed in a 90-day repeated dose toxicity study via oral route up to the limit dose of 1000 mg/kg bw/day with sodium hexahydroxoantimonate. The no-observed-effect level (NOEL) was above 1000 mg sodium hexahydroxoantimonate/kg b.w./day, p.o. for the male and female rats.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- One key study available (90-day repeated dose toxicity study in rats according to OECD 408, under GLP) which is reliable without restrictions (RL=1). The overall quality of the database is therefore high.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Three oral dose levels of sodium hexahydroxoantimonate were evaluated in a 90-day repeated dose toxicity study in rats. Four groups of 10 male and female animals were treated orally via gavage with dose levels of 0, 100, 300 and 1000 mg/kg bw/d in Methocel once daily. In addition, 5 male and 5 female animals in the high and control group were held as recovery. Animals in the main group were sacrificed on test day 91, animals in the recovery group were sacrificed on test day 119.
None of the rats died prematurely and no test item-related influence was noted on the behaviour or external appearance of the male and female rats. The observational screening, the examination of the fore- and hindlimb grip strength as well as the spontaneous motility did not reveal any test item-related changes. The body weight, body weight gain, food and drinking water consumption, the haematological, biochemical and urinary parameters examined were in the normal range of variation. No test item-related changes were observed at ophthalmological examination. No treatment-related influence was noted on the number of ultrasound resistant spermatids, the number of motile spermatozoa and the sperm morphology of the male rats.
The necropsy as well as the histopathological examination of the organs examined did not reveal any macroscopic or microscopic lesions. The relative and absolute organ weights were in the normal range of variation.
Under the present test conditions the no-observed-effect level (NOEL) was above 1000 mg Sodium hexahydroxoantimonate/kg b.w./day, p.o. for the male and female rats.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Key study
Justification for classification or non-classification
The reference Hansen (2013) is considered as the key study for repeated dose toxicity via oral application and will be used for classification. Rats were dosed at 0, 100, 300 and 1000 mg/kg bw/day orally via gavage. Based on the lack of any adverse effects, the no observed effect level (NOEL) via oral application for sodium hexahydroxoantimonate was established at > 1000 mg/kg bw/day.
The classification criteria according to regulation (EC) 1272/2008 as specific target organ toxicant (STOT) – repeated exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and the no observed effect level (NOEL) via oral application is above the guidance value for a Category 1 classification of 10 mg/kg bw/day and above the guidance value for a Category 2 classification of 100 mg/kg bw/day. For the reasons presented above, no classification for specific target organ toxicant (STOT) – repeated exposure, oral is required.
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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