Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 234-293-3 | CAS number: 11071-15-1
- 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:
- sub-chronic toxicity: oral
- Type of information:
- other: Bibliographic source
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Effects of Antimony on Rats Following 90-Day Exposure via Drinking Water
- Author:
- R. POON, I. CHU, P. LECAVALIER, V. E. VALLI, W. FOSTER, S. GUPTA and B. THOMAS
- Year:
- 1 998
- Bibliographic source:
- Food and Chemical Toxicology 36
- Reference Type:
- review article or handbook
- Title:
- Review of Subchronic/Chronic Toxicity of Antimony Potassium Tartrate
- Author:
- Barry S. Lynch,Charles C. Capen,Earle R. Nestmann,Gauke Veenstra and James A. Deyo
- Year:
- 1 999
- Bibliographic source:
- Regulatory Toxicology and Pharmacology 30, 9–17
Materials and methods
- Principles of method if other than guideline:
- An appropriate amount of potassium antimony tartrate was dissolved in tap water to make 50-litre batches of drinking water containing 0.5, 5, 50 and 500 ppm
antimony. - GLP compliance:
- not specified
Test material
- Reference substance name:
- Dipotassium bis[μ-[tartrato(4-)-O1,O2:O3,O4]]diantimonate(2-) , stereoisomer
- EC Number:
- 234-293-3
- EC Name:
- Dipotassium bis[μ-[tartrato(4-)-O1,O2:O3,O4]]diantimonate(2-) , stereoisomer
- Cas Number:
- 11071-15-1
- Molecular formula:
- C8H4O12Sb2.2K
- IUPAC Name:
- (2R,3R)-2,3-dihydroxy-butanedioic acid, antimony potassium salt
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The animals were housed individually in stainless-steel mesh cages with free access to food (Purina Chow 5001, Ralston Purina) and water.
The laboratory conditions were maintained as follows: 50 + 10% relative humidity, 22_+ 3°C temperature, and a 12-hr light/dark cycle.
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on oral exposure:
- treatment was initiated by replacing tap water with tap water containing 0.5, 5, 50 and 500 ppm antimony as potassium antimony tartrate. Control groups received tap water as drinking water.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The antimony concentrations were verified by inductive coupled plasma emission spectroscopy (ICP). New batches were prepared
monthly and stored in 50-1itre screw-capped Nalgene ~R' containers and kept at 4°C. The stability of potassium antimony tartrate in drinking water
was confirmed by the ICP method. - Duration of treatment / exposure:
- 90 day exposure
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.5 ppm
- Dose / conc.:
- 5 ppm
- Dose / conc.:
- 50 ppm
- Dose / conc.:
- 500 ppm
- No. of animals per sex per dose:
- 95 male (127 + 10 g) and 95 female (136+ 10g) were randomly divided into 10 groups, with the control and highest dose (500 ppm) groups
each containing 25 animals per sex and the three lower dose groups each containing 15 animals per sex. - Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- Body weight, water consumption and food intake were measured weekly, and clinical
observation was made daily. At the end of the 13-wk treatment period, all but 10 animals per sex inthe control and highest dose groups were terminated.
At the 13th wk, half of the rats were transferred to individual metabolism cages and their urine collected overnight into refrigerated beakers containing 2.0 ml of a preservative. - Sacrifice and pathology:
- HISTOPATHOLOGY:At the termination of the study, a sample of blood was taken. During necropsy, the following tissues and organs were examinated: brain, pituitary, thyroid and trachea, salivary glands, thymus, lung, heart, liver, kidneys, adrenals, spleen, pancreas, oesophagus, gastric cardia, fundus and pylorus, duodenum, jejunum, ileum, caecum, colon, urinary bladder, skin, bone marrow and gonadal tissues.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- no mortality observed
- Description (incidence):
- mild biochemical and haematological changes, and adaptive histological changes in the thyroid, liver, thymus, spleen and pituitary gland.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- At the highest dose, suppression of body weight gain was associated with reduced water intake and was largely reversible, but mild hepatic cirrhosis may represent a progression of the milder liver changes observed at lower doses.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Food consumption in the 500 ppm groups of both sexes was reduced by about 12% by the end of the treatment period, but returned to the control level during the recovery period.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- Highest-dose males and females consumed approximately 35% less water than the controls, but quickly regained the normal rate
of water consumption as soon as tap water replaced the 500 ppm antimony solution during the recovery period. - Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Blood glucose was also a sensitive endpoint with significant decrease detectable in females at 5 ppm.
Increased thyroid hormone binding radio was found in the serum of females at 50 and 500 ppm.
Male rats at 500 ppm antimony had decreased red blood cell and platelet counts and slighty increased mean corpuscular volume. - Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Thyroid changes, which were detectable at 0.5 ppm, were the most sensitive endpoints.In the thyroid gland, changes, including decreased follicular size, increased epithelial height, and nuclear vesiculation were observed. Some of these changes such as reduced follicle size in male and female rats and increased epithelial height in female rats, showed reductions in both incidence and severity in the 500 ppm recovery groups but did not return to normal. On the other hand, collapsed follicles, whitch were not observed in the control and treatment groups of both sexes, were present in nine of ten male rats in the 500 ppm recovery group.
It is considered the subtle changes to represent normal physiological variation and not to be of toxicological significance. - Urinalysis findings:
- not specified
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- In the thymus, very mild treatment-related changes were observed in female rats consisting of reduced cortical volume and increased medullary volume. While the males in the 500 ppm treatment group had normal thymus, all 10 males of the recovery group had minimal to mild reduction in cortical volume.
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Females in the 50 ppm dose group had significantly decreased thymus to body weight ratios in comparison to control. Significantly increased
kidney to body weight ratio was observed in the highest dose group of both males and females. - Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- At necropsy one male in the 5 ppm dose group and three males in the highest dose (500 ppm) group had gross haematuria. A male rat in the
highest dose group had a cirrhotic liver and a female rat in the lowest dose group had a nodular, fibrotic, spleen. - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Mild and predominantly reversible histological changes were observed in the thyroid gland and the liver. Lesser changes were found in the thymus, spleen and pituitary gland.
Changes in the thyroid, including reduced follicle size, increased epithelial height and nuclear vesiculation, were detected starting at the lowest dose group of both sexes. Some of these changes showed reductions in both incidence and severity in the 500 ppm recovery groups but did not return to normal. On the other hand, collapsed follicles, which were not observed in the control and treatment groups of both sexes, were present in nine of ten male rats in the 500 ppm recovery group.
In the liver, anisokaryosis was a significant, dose-related change that appoached a moderate degree of severity in all males and females of the highest dose group. This change was still detectable at recovery but with a decreased degree of severity.
MInimal changes in the pituitary consisting of cytoplasmic vacuolation and cytoplasmic inclusions were observed in treated males starting at 0.5 ppm but there was a lack of dose-related increase in incidence or severity. Minimal to mild levels of cytoplasmic inclusions were detected in females starting at 50 ppm. These changes were not seen in the recovery groups of both sexes.
In the thymus, very mild treatment-related changes were observed in female rats. - Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 50 ppm
- Basis for effect level:
- other: histopathologic findings reported and serum clinical chemistry data supports a NOAEL of 50 ppm
Target system / organ toxicity
- Critical effects observed:
- no
- Lowest effective dose / conc.:
- 0.5 ppm
- System:
- haematopoietic
- Organ:
- liver
- pituitary gland
- spleen
- thymus
- thyroid gland
Any other information on results incl. tables
Male treatment | Thyroid hormone binding radio (%) |
0 | 1,38 +/- 0,76 |
0,5 | 14,2 +/- 1,14 |
5 | 13,9 +/- 1,34 |
50 | 13,2 +/- 1,04 |
500 | 15,9 +/- 3,70 |
Recovery | |
0 | ND |
500 | ND |
Female treatment | |
0 | 5,06 +/- 0,85 |
0,5 | 5,46 +/- 0,90 |
5 | 6,06 +/- 1,54 |
50 | 5,85 +/- 1,00 |
500 | 5,90 +/- 1,32 |
Recovery | |
0 | ND |
500 | ND |
Applicant's summary and conclusion
- Conclusions:
- Based on the decreased body weight gain and decreased food and water consumption at the 500 ppm dose level, even though. At this dose level, one animal of each sex was found to have bridging fibrosis of the liver, ampotential sign of liver toxicity. A no-observed-adverse-effect level (NOAEL) is considered to be at 50 ppm antimony in drinking water (equivalent to a calculated intake of 6 mg kg body weight/day).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.