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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 233-662-6 | CAS number: 10294-54-9
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2011-04-13 to 2011-05-19
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliant. An experimental study was performed with a structural analogous read-across substance. Please refer to IUCLID section 13 for read-across justification.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- , adopted 21st July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- Regulation (EC) No 440/2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- cesium hydroxide monohydrate
- EC Number:
- 627-088-9
- Cas Number:
- 35103-79-8
- Molecular formula:
- CsOH * H2O
- IUPAC Name:
- cesium hydroxide monohydrate
- Test material form:
- solid: crystalline
Constituent 1
Method
- Target gene:
- hypoxanthine-guanine phosphoribosyl transferase enzyme locus (hprt) in cultured Chinese hamster cells
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Ham's F12 medium
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (phenobarbital (PB) and β-naphthoflavone (BNF) induced rat liver)
- Test concentrations with justification for top dose:
- Experiment 1, 5-hour treatment period without and with S9 mix:
625, 1250, 2500, 3125, 3750, 4200, 4600*, and 5000* µg/mL
Experiment 2, 20-hour treatment period without S9 mix:
625, 1250, 2500, 3125, 3750, 4000, 4200*, 4600*, and 5000* µg/mL
Experiment 2, 5-hour treatment period with S9 mix:
625, 1250, 2500, 3125, 3750, 4000, 4200, 4600*, and 5000* µg/mL
*These concentrations were very toxic and there was not enough cells start the phenotypic expression period after the treatment. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Ham's F12 medium (cell growth medium)
- Justification for choice of solvent/vehicle: good solubility in aqueous solutions
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: With S9 mix: 7,12-Dimethyl benzanthracene (DMBA); without S9 mix: Ethyl methanesulfonate (EMS)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration:
Experiment 1: 5 h (with and without S9 mix)
Experiment 2: 5 h (with S9 mix), 20 h (without S9 mix)
- Expression time (cells in growth medium): 24 h
- Selection time (if incubation with a selection agent): 8 days
SELECTION AGENT: 6-thioguanine (6 TG)
STAIN: Giemsa
NUMBER OF REPLICATIONS: 2
NUMBER OF EXPERIMENTS: 2
NUMBER OF CELLS EVALUATED: 1E6 cells: 5 plates at 2x1E5 cells/plate
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- The test item would have been considered to be mutagenic in this assay if all the following criteria were met:
- The assay is valid.
- The mutant frequency at one or more doses is significantly greater than that of the relevant control.
- Increase of the mutant frequency is reproducible.
- There is a clear dose-response relationship.
The test item would have been considered to have shown no mutagenic activity if no increases were observed which met the criteria listed above. - Statistics:
- Statistical analysis was done with SPSS PC+ software for the following data:
mutant frequency between the negative (solvent) and the test item or positive control item treated groups.
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: The pH of treatment solutions were dose-associated higher than the concurrent control.
- Effects of osmolality: In osmolality no significant differences between treatment and control groups were observed.
- Evaporation from medium: no evaporation expected
- Water solubility: A clear solution was obtained up to a concentration of 50 mg/mL.
- Precipitation: No precipitation in the medium was noted.
RANGE-FINDING/SCREENING STUDIES:
The dose selection cytotoxicity assay was performed as part of this study to establish an appropriate concentration range for the Main Mutation Assays (Experiments 1 and 2), both in the absence and in the presence of a metabolic activation system (rodent S9 mix). Toxicity was determined by comparing the colony forming ability of the treated groups to the negative (solvent) control and results were noted as percentage of cells in relation to the negative control. The results obtained were used for dose selection of the test item in the Main Mutation Assays.
COMPARISON WITH HISTORICAL CONTROL DATA:
The sensitivity of the tests and the efficacy of the S9 mix were demonstrated by large increases in mutation frequency in the positive control cultures. The mutation frequencies of the positive control cultures were consistent with the historical control data from the previous studies performed at this laboratory.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In Experiment 1 in the absence and in the presence and in Experiment 2 in the presence of metabolic activation the upper examined test item dose level selected was 4200 µg cesium hydroxide monohydrate /mL. In Experiment 2 in the absence of metabolic activation the upper examined test item dose level was 4000 µg cesium hydroxide monohydrate /mL. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test item cesium hydroxide monohydrate was used as read-across substance to determine the genotoxic potential of cesiumsulphate. Cesium hydroxide monohydrate was not mutagenic in an in vitro mammalian cell gene mutation test performed with CHO-K1 (Chinese hamster ovary) cells. Based on these results cesium sulphate is not considered to be mutagenic also. - Executive summary:
The test item cesium hydroxide monohydrate was used as read-across substance to determine the genotoxic potential of cesium sulphate in a HPRT Mammalian Gene Mutation Test in CHO-K1 cells according to OECD guideline 476 and EU method B.17.
The test item was dissolved in Ham's F12 medium and the following concentrations were selected on the basis of cytotoxicity investigations made in a preliminary study (without and with metabolic activation using S9 mix).
Two independent main experiments (both run in duplicate) were performed at the concentrations and treatment intervals given below:
Experiment 1, 5 -hour treatment period without and with S9 mix:
625, 1250, 2500, 3125, 3750, 4200, 4600*, and 5000*µg/mL
Experiment 2, 20 -hour treatment period without S9 mix:
625, 1250, 2500, 3125, 3750, 4000, 4200*, 4600*, and 5000*µg/mL
Experiment 2, 5-hour treatment period with S9 mix:
625, 1250, 2500, 3125, 3750, 4000, 4200, 4600*, and 5000*µg/mL
*These concentrations were very toxic and there was not enough cells start the phenotypic expression period after the treatment.
In Experiment 1, there were no biologically or statistically significant increases in mutation frequency at any concentration tested, either in the absence or in the presence of metabolic activation. There were no statistical differences between treatment and control groups and no dose-response relationships were noted. In Experiment 2, the mutant frequency of the cells did not show significant alterations compared to the concurrent control, when the test item was tested without S9 mix over a prolonged treatment period (20 hours). Furthermore, a five-hour treatment with in the presence of S9 mix did not cause significant increases in mutant frequency, further indicating that the findings in Experiment 1 were within the normal biological variation. As in Experiment 1, in Experiment 2 no statistical differences between treatment and solvent control groups and no dose response relationships were noted. The sensitivity of the tests and the efficacy of the S9 mix were demonstrated by large increases in mutation frequency in the positive control cultures.
The read-across substance tested both without and with metabolic activation (S9 mix), did not induce increases in mutant frequency in this test in Chinese hamster ovary cells.
Cesium hydroxide monohydrate was not mutagenic in this in vitro mammalian cell gene mutation test performed with CHO-K1 cells.
Based on these results cesium sulphate is not considered to be mutagenic also.
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.