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Diss Factsheets
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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The study was performed to the standardised guideline OECD 422 and according to GLP. It has been assigned a reliability score of 2 according to the principles for assessing data quality set out by Klimisch (1997).
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Toxic effects on fertility were determined in a repeat dose oral toxicity screening test (OECD 422), where ammonium zirconium carbonate was administered. Rats received doses up to 1000 mg/kg/day for a period of up to forty-five consecutive days. No adverse effects on reproductive performance were deducible up to the highest dose of 1000mg/kg/day. No treatment-related effects were detected in mating performance or fertility for treated animals of all dose groups compared to controls. Pregnancy was achieved for all females of all dose groups. No reproductive toxic effects at all were observed up to the high dose treatment of 1000mg/kg/day. Therefore the NOAEL was considered to be 1000 mg/kg/day for systemic toxicity.
Short description of key information:
Oral NOEL: 1000 mg/kg/day, OECD 422 combined repeat dose toxicity study with reproduction/development toxicity screening test in rats, conducted to GLP, Marr 2010.
Justification for selection of Effect on fertility via oral route:
The key study (Marr, 2010) was performed on a surrogate substance to the one being registered, potassium zirconium carbonate, and has been provided on the basis of read-across given the substances common ionic components, ZrO2. The study was performed using ammonium zirconium carbonate in a GLP compliant study conducted according to the standardised guidelines OECD 422.
Justification for selection of Effect on fertility via inhalation route:
The data obtained from oral exposure is deemed sufficient to address this endpoint.
Justification for selection of Effect on fertility via dermal route:
The data obtained from oral exposure is deemed sufficient to address this endpoint.
Effects on developmental toxicity
Description of key information
Oral NOEL: 1000 mg/kg/day, OECD 422 combined repeat dose toxicity study with reproduction/development toxicity screening test in rats, conducted to GLP, Marr 2010. This study is read-across from the surrogate substance Ammonium Zirconium Carbonate.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The study was performed to the standardised guideline OECD 422 and according to GLP has been assigned a reliability score of 2 according to the principles for assessing data quality set out by Klimisch (1997).
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
- Quality of whole database:
- The data obtained from oral exposure is deemed sufficient to address this endpoint.
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The assessment of the endpoint developmental toxicity/teratogenicity is based on an available OECD 422 study with the analogue substance ammonium zirconium carbonate.. Rats received doses up to 1000 mg/kg/day for a period of up to forty-five consecutive days.The test item was administered daily during 14 days pre mating, at maximum 14 days mating period in both male and female, during gestation period and up to early lactation for females.Dosing did not result in any treatment-related systemic effects, no adverse effects on reproductive performance and development of offspring up to day 4 of lactation were identified, therefore the no observed effect level (NOEL) for reproductive and development toxicity was considered to be 1000 mg/kg/day .
In accordance with REACH Annex XI a two-generation reproductive toxicity study (as required in section 8.7.3) does not appear scientifically necessary as the substance is of low toxicity (no evidence of toxicity seen in any of the tests available) and no adverse effects on reproductive performance and development of offspring up to day 4 of lactation were identified in a fully compliant OECD 422 study (read-across from the surrogate substance Ammonium Zirconium Carbonate) up to and including the limit dose of 1000 mg/kg bw/day.
Justification for selection of Effect on developmental toxicity: via oral route:
The key study (Marr, 2010) was performed on the surrogate substance Ammonium Zirconium Carbonate, and has been provided on the basis of read-across, given the substance's common ionic components. The study is GLP compliant and was conducted according to the standardised guideline
OECD 422.
Justification for selection of Effect on developmental toxicity: via dermal route:
The data obtained from oral exposure is deemed sufficient to address this endpoint.
Justification for classification or non-classification
Based on data from an OECD 422 study (i.e. Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test) performed with the surrogate substance Ammonium Zirconium Carbonate and in accordance with the criteria set out in Annex I of Regulation No. 1272/2008 the test material does not require classification for toxicity to reproduction. There is no evidence of adverse effects on sexual function and fertility or on development of offspring, caused by exposure. Furthermore, the substance is of low toxicity as demonstrated by a battery of acute toxicity and genotoxicity studies performed with the surrogate substance or the substance registered.
Additional information
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.