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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 205-362-5 | CAS number: 139-42-4
- 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
Additional information
IN VITRO DATA
Gene mutation in bacteria
The potential of the test material to cause mutagenic effects in bacteria was assessed in accordance with the standardised guidelines OECD 471 and EU Method B.13/14. Furthermore, the test method was designed to be compatible with the guidelines for bacterial mutagenicity testing published by the major Japanese Regulatory Authorities including METI, MHLW and MAFF and the USA, EPA (TSCA) OPPTS harmonised guidelines.
Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and Escherichia coli strain WP2uvrA were treated with the test material, using the plate incorporation and pre-incubation methods, at five dose levels both with and without metabolic activation. The dose levels assessed were 50, 150, 500, 1500 and 5000 µg/plate.
The test material caused no reduction in the growth of the bacterial background lawn at any concentration. No toxicologically significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains.
The vehicle controls gave revertant colony counts within the normal range. The positive controls gave the expected increases in revertants, validating the sensitivity of the assay and the efficacy of the S9-mix.
The test material was considered to be non-mutagenic under the conditions of this test.
In vitro chromosome aberration
The potential of the test material to
induce structural chromosomal aberrations was determined in a study
performed in accordance with the standardised guideline EU Method B.10.
During the study primary lymphocyte cultures were exposed to test
material, in distilled water, at concentrations of 45.6 - 7020 µg/mL or
87.0 - 2500 µg/mL with and without metabolic activation, respectively.
The test material was tested up to precipitating concentrations.
Under the conditions of the study there was no evidence of chromosome
aberration induced over background. Positive controls induced the
appropriate response.
Therefore, the test material is considered to be non-clastogenic in this chromosome aberration test when tested up to precipitating concentrations.
In vitro gene mutation in mammalian cells
The potential of the test material to cause gene mutation or clastogenic effects in mammalian cells was determined in a GLP study which was conducted in accordance with the standardised guideline EU Method B.17. During the study Chinese hamster V79 cells were exposed to test material, in deionised water, at concentrations of 143.8 to 2300 µg/mL in the presence and absence of mammalian metabolic activation. The test material was tested up to precipitating concentrations. Under the conditions of the study there was no evidence of induced mutant colonies over background. The positive controls induced the appropriate response. Therefore, the test material is considered to be non-mutagenic in this HPRT assay.
The in vitro gene mutation assay in bacteria was conducted with the registration substance. It was a GLP study conducted to standardised guidelines. The study was therefore assigned a reliability score of 1 according to the criteria of Klimisch (1997).
The in vitro chromosome aberration assay and the mammalian cell gene mutation assay were conducted with the read across substance cerium carbonate. Since they were both conducted to GLP and in accordance with standardised guidelines, they were each assigned a reliability score of 2. The similar toxicological profiles of cerium carbonate and cerium oxalate, along with the structural similarity, mean that this is considered to be an acceptable read-across approach.
Justification for selection of genetic toxicity endpoint
Three studies have been selected as key in order to address the 3 different genetic toxicity endpoints under REACH. All three studies have been conducted in GLP certified laboratories, in line with recognised OECD guidelines and are considered sufficiently reliable in accordance with Klimisch (1997) to be key studies.
Short description of key information:
Reverse mutation in bacteria exposed to registration substance: Negative (S. typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and E. coli strain WP2uvrA with and without metabolic activation), OECD 471, EU Method B.13/14, Harlan 2012.
In vitro chromosome aberration exposed to read across substance (cerium carbonate): Negative (human lymphocytes with and without metabolic activation), EU Method B.10, RCC-CCR 2006.
In vitro gene mutation in mammalian cells exposed to read across substance (cerium carbonate): Negative (Chinese hamster V79 cells with and without metabolic activation), EU Method B.17, RCC-CCR 2006.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
In accordance with criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for genetic toxicity based on the overall negative response noted in the available genetic toxicity studies.
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.