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Diss Factsheets
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EC number: 939-967-7 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP study. The study was conducted according to a method equivalent to the OECD 408 guideline without major deviations.
- Remarks:
- However, no data on test conditions and preparation of animals were reported. Follow-up of body weight was done weekly, however no individual animal data were reported. No histopathology observations were done. No individual reporting was done.
Data source
Reference
- Reference Type:
- publication
- Title:
- The acute, chronic and topical toxicity of zirconium carbonate.
- Author:
- Harrison, J.W.E., Trabin, B., Martin, E.W.
- Year:
- 1 951
- Bibliographic source:
- Journal of Pharmacology and Experimental Therapeutics 102, 179-184
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- no histopathology was done, detailed data on study set-up and results are lacking
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- [μ-[carbonato(2-)-O:O']]dihydroxydioxodizirconium
- EC Number:
- 260-633-5
- EC Name:
- [μ-[carbonato(2-)-O:O']]dihydroxydioxodizirconium
- Cas Number:
- 57219-64-4
- Molecular formula:
- CH2O7Zr2
- IUPAC Name:
- [({[Hydroxy(Oxo)Zirconio]Oxy}Carbonyl)Oxy]Zirconiumoylol
- Test material form:
- other: paste
- Details on test material:
- - Name of test material (as cited in study report): hydrated zirconium carbonate
- Composition of test material, percentage of components: containing 20.9 % ZrO2
- Molecular formula (if other than submission substance): 3ZrO2.CO2.H2O
- Physical state: water insoluble moist paste
- Analytical purity: no data
- Impurities (identity and concentrations): no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: recently weaned
- Weight at study initiation: 50 g
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): normal diet
- Water (e.g. ad libitum): normal diet
- Acclimation period: no data
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Three groups of 20 rats each were distributed as litter mates and fed during 17 weeks with a mixture of standard rat diet and hydrated zirconium carbonate (HZC) at 0.2%, 2.0% and 20% (w/w).
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 17 weeks
- Frequency of treatment:
- continuously in the diet
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.2 other: % (w/w)
- Remarks:
- Equivalent of 300 to 130 mg/kg bw/day calculated in week 1 and week 15 respectively
Basis: nominal in diet
- Dose / conc.:
- 2 other: % (w/w)
- Remarks:
- Equivalent of 3300 to 1300 mg/kg bw/day calculated week 1 and week 15 respectively
Basis: nominal in diet
- Dose / conc.:
- 20 other: % (w/w)
- Remarks:
- Equivalent of 33900 to 15100 mg/kg bw/day calculated week 1 and week 15 respectively
Basis: nominal in diet
- No. of animals per sex per dose:
- 10 males and 10 females
- Control animals:
- yes, plain diet
- Details on study design:
- Three groups of 20 rats each were distributed as litter mates.
- Positive control:
- No positive control
Examinations
- Observations and examinations performed and frequency:
- Animals observed daily and weighed weekly. Records were kept of the quantities of food and water consumed.
- Sacrifice and pathology:
- Gross pathology of the organs.
- Other examinations:
- - Samples of blood were obtained from 8 animals in each group (4 males/4 females) at the weeks 8 & 16 of the test
- Hemoglobin was determined, erythrocytes and leucocytes were counted, and differential counts were made
- Urine was also examined - Statistics:
- No 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:
- no effects observed
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- no effects observed
- 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:
- - No mortality during the test
- Growth curves were normal and identical to control rats
- No significant differences in the hematologic findings were noted among the various groups examined
- The urine did not differ significantly among the groups in color, reaction, odor, albumin content or microscopic appearance
- For all animals, their fur was smooth, their eyes and noses were clear and their mucous membranes were healthy in appearance
- The heart, lungs, thyroid, thymus, liver, spleen, kidneys, adrenals, stomach, intestines, bladder and genital organs were grossly normal in all animals
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 3 150 - 7 080 mg/kg bw/day (actual dose received)
- Based on:
- other: 20.9% ZrO2 in the test material (HZC)
- Sex:
- male/female
- Basis for effect level:
- other: The NOAEL is based on the daily consumption calculated from equivalent intake levels of ZrO2 and body weights of rats.
Target system / organ toxicity
- Critical effects observed:
- no
Any other information on results incl. tables
Level of HZC in diet: 0%, 0.2%, 2.0% and 20%
Total intake food: 2182 g, 2176 g, 2149 g and 2475 g
Total intake ZrO2: 0 g, 0.9 g, 9.0 g and 103.5 g
Total intake water: 4193 g, 4774 g, 4097 g and 4021 g
Initial weight males: 52-54 g; females: 50-51 g
Weight after 17 weeks males: 340-349 g; females 210-230 g
Weight gain (average) males: 285-295 g; females 160-179 g
Daily consumption of HZC: 0, 0.13-0.30 g/kg, 1.3-3.3 g/kg and 15.1-33.9 g/kg
Applicant's summary and conclusion
- Conclusions:
- Ingestion of equivalent cumulative doses of 0.9 g, 9 g and 103.5 g of ZrO2 in the form of hydrated zirconium carbonate for a period of 17 weeks did not cause any deaths in the 60 rats exposed during the test. This indicates the absence of cumulative toxic effects. After autopsy, no abnormality was observed on heart, lungs, thyroids, thymus, liver, spleen, kidneys, adrenals, stomach, intestines, bladder and genital organs, consequently, it can be concluded that ingestion of HZC (containing 20.9% ZrO2) does not induce harmful effects.
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