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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 938-677-8 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6 February 1992 - 8 April 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: A GLP study performed to standardised guidelines with a sufficient level of detail to assess the quality of the submitted data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Potassium Zirconium Carbonate
- IUPAC Name:
- Potassium Zirconium Carbonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test 1: 6 February-20 February 1992
Five male and 5 female nulliparous and non-pregnant young adult rats of the Sprague-Dawley strain were used. They were 6-8 weeks old and weighed 154-194 g at dosing. They were supplied by Charles River (UK) Limited, Manston Road, Margate, Kent, and arrived at Elphinstone Research Centre on 28 January 1992.
The rats were housed by sex in polypropylene cages with mesh floors suspended over absorbent paper lined trays, with a maximum of 5 animals per cage.
The rats were fed Rat and Mouse No. 1 Maintenance Diet, supplied by Special Diets Services, 1 Stepfield, Witham, Essex, CM8 3AD, but were deprived of food overnight prior to dosing and 4 h post dosing. Tap water was available ad libitum throughout the study. The diet and water are analysed on a regular basis and meet the criteria laid down by IRI.
Mean environmental maximum and minimum temperatures were 21°C and 20°C and mean relative humidity was 37%. A 12 h light/dark cycle was in operation (light hours 0700-1900 h). Mean relative humidity was outwith protocol requirements, however, this is not considered to have affected the integrity of the study.
Test 2: 25 March-8 April 1992
Five male and 5 female nulliparous and non-pregnant young adult rats of the Sprague-Dawley strain were used. They were 6-8 weeks old and weighed 133-178 g at dosing. They were supplied by Harlan Olac Limited, Shaw's Farm, Blackthorn, Bicester, and arrived at IRI on 18 March 1992.
The rats were housed by sex in polypropylene cages with mesh floors suspended over absorbent paper lined trays, with a maximum of
5 animals per cage.
The rats were fed Rat and Mouse No. 1 Maintenance Diet, supplied by Special Diets Services, 1 Stepfield, Witham, Essex, CM8 3AD, but were deprived of food overnight prior to dosing and 4 h post dosing. Tap water was available ad libitum throughout the study. The diet and water are analysed on a regular basis and meet the criteria laid down by IRI.
Mean environmental maximum and minimum temperatures were 21°C and 19°C and mean relative humidity was 39%. At 12 h light/dark cycle was in operation (light hours 0700-1900 h). Mean relative humidity was outwith protocol requirements, however, this is not considered to have affected the integrity of the study.
The rats were allowed an acclimatisation period of 9 days before commencement of the first test and 7 days before commencement of the second test.
The rats were uniquely identified within the study using an ear punch system routinely used at IRI.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- On each day of dosing the test material was freshly prepared in distilled water. The test material was administered orally to 2 groups of 5 male and 5 female rats in a single dose by means of a gavage at dose levels of 5000 mg/kg and 2000 mg/kg. A constant dose volume of 10 ml/kg was employed.
- Doses:
- 5000 mg/kg and 2000 mg/kg
- No. of animals per sex per dose:
- 5 per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: The rats were observed frequently on the day of dosing and once daily for 14 days following dosing.
- Frequency of weighing: They were weighed immediately prior to dosing, 7 days after dosing and at sacrifice at the end of the 14 day observation period.
- Necropsy of survivors performed: Yes, each animal was sacrifice by carbon dioxide asphyxiation and subjected to necropsy.
- Other examinations performed: clinical signs.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 5000 mg/kg: There were 5 deaths (2 males and 3 females) following a single oral dose of the test material at a dose level of 5000 mg/kg.
2000 mg/kg: There was no mortality following a single oral dose of the test material at a dose level of 2000 mg/kg. - Clinical signs:
- other: 5000 mg/kg: Clinical signs, noted 10 minutes - 7 hours after dosing, included ataxia, subdued behaviour, increased salivation, hunched appearance, laboured breathing, hyperventilation, red ocular discharge and prostration. 2000 mg/kg: Clinial signs, note
- Gross pathology:
- 5000 mg/kg: Necropsy findings, noted in 2 males and 2 females, were limited to a distended stomach filled with clear fluid.
2000 mg/kg: No abnormalities were detected at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral toxicity of the test material was determined to be LD₅₀ > 2000 mg/kg in rats. The test material was administered via oral gavage at 2000 and 5000 mg/kg bw to both male and female test animals.
- Executive summary:
The acute oral toxicity potential of the test material was investigated in rats. The vehicle for the dosing solution was distilled water. Two dose levels were investigated, 5000 and 2000 mg/kg.
At a dose level of 5000 mg/kg there were 5 deaths, 2 males and 3 females. Clinical signs, noted 10 minutes - 7 hours after dosing, included ataxia, subdued behaviour, increased salivation, hunched appearance, laboured breathing, hyperventilation, red ocular discharge and prostration. Necropsy findings, noted in premature decedents only, were limited to a distended stomach filled with clear fluid.
At a dose level of 2000 mg/kg there were no deaths. Clinical signs, noted at 0.5 h after dosing, were limited to one male animal which showed increased salivation. No abnormalities were detected at necropsy.
The Median Oral Lethal Dose (LD50) of the test material in rats is greater than 2000 mg/kg.
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.