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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 630-337-4 | CAS number: 39211-00-2
- 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 bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 03 July 1998 (Study Plan completion) to 21 August 1998 (GLP compliance statement)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to the OECD testing guideline and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reference substance 001
- EC Number:
- 604-086-6
- Cas Number:
- 138577-01-2
- Molecular formula:
- Al.Cs.F
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material: Cesium Fluoro Aluminate Complex
- Purity: 99.5%
- Batch: 604/013
- Physical state: White amorphous powder
- Storage condition of test material: At room temperature in the dark
- Expiration date of the lot/batch: 22 May 2001
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver microsomal enzymes were routinely prepared from adult male Wistar rats, which were obtained from Charles River, Sulzfeld, Germany
- Test concentrations with justification for top dose:
- Dose range finding test with tester strain TA100 and WP2uvrA (both with and without S9-mix): 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate.
Mutation assay (with and without S9-mix): 100, 333, 1000, 3330 and 5000 µg/plate - Vehicle / solvent:
- The test substance was suspended in dimethyl sulfoxide (DMSO) of spectroscopic quality (Merck). The stock solution was treated with ultra-sonication to obtain a homogeneous suspension. Test substance concentrations were prepared directly prior to use.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- DMSO (vehicle of the test article)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Saline
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA1535 without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- DMSO (vehicle of the test article)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Saline
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537 without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- DMSO (vehicle of the test article)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Saline
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: daunomycine
- Remarks:
- TA98 without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- DMSO (vehicle of the test article)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- TA100 without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- DMSO (vehicle of the test article)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- WP2uvrA without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- DMSO (vehicle of the test article)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA98, TA100, TA1535 , TA1537 and WP2uvrA with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: none
- Exposure duration: 48h in the dark at 37°C
- Expression time (cells in growth medium): cells were counted just after the exposure
NUMBER OF REPLICATIONS: triplicate
NUMBER OF CELLS EVALUATED: 0.1 mL of fresh bacterial culture (10E9 cells/mL)
DETERMINATION OF CYTOTOXICITY
- Method: To determine the toxicity of cesium fluoro aluminate complex, the reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies were examined.
OTHER EXAMINATIONS:
precipitation of the test substance - Evaluation criteria:
- A test substance is considered to have mutagenic potential, if it induces at least a two-fold increase in the number of revertants with respect to the nunumber induced by the solvent control in any of the tester strains, either with or without metabolic activation. However, any mean plate count of less than 20 is considered to be not significant. The positive response should be reproducible in at least one independently repeated experiment.
- Statistics:
- No statistical analysis was performed.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Slight reduction of background lawn at 5000 µg/plate in the absence of S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING TEST:
Cesium fluoro aluminate complex was tested in tester strain TA100 and WP2uvrA with concentrations of 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate in the absence and presence of S9-mix. This dose range finding test is reported as a part of the first mutation experiment. Precipitation of the test substance on the plates was observed at the start of the incubation period at the concentration of 5000 µg/plate but not at the end of the incubation period. In strain WP2uvrA, no reduction of the bacterial background lawn and no decrease in the number of revertants was observed. In strain TA100, no reduction of the bacterial background lawn was observed and a slight decrease in the number of revertants was observed at the highest dose levels.
MUTATION EXPERIMENT 1 AND 2:
Based on the results of the dose range finding test, cesium fluoro aluminate complex was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix in two mutation experiments. The first experiment was performed with the strains TA1535, TA1537 and TA98 and the second experiment was performed with the strains TA1535, TA1537, TA98, TA100 and WP2uvrA.
Precipitate: Precipitation of the test substance on the plates was observed at the start of the incubation period at the concentration of 5000 µg/plate but not at the end of the incubation period.
Toxicity: The bacterial background lawn was not reduced at all concentrations tested. In tester strain TA100, a slight reduction in the number of revertants was observed at the concentration of 5000 µg/plate in the absence of S9-mix in the second experiment. All other bacterial strains showed no reduction in the number of revertants which was below the minimal value of historical control data range.
Mutagenicity: All bacterial strains showed negative responses over the entire dose range, i.e. no dose-related, two-fold, increase in the number of revertants in two independently repeated experiments.
The negative and strain-specific positive control values were within the laboratory historical background data ranges.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study it is concluded that cesium fluoro aluminate complex is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
- Executive summary:
The mutagenic activity of cesium fluoro aluminate complex was investigated in the Salmonella typhimurium reverse mutation assay and the
Escherichia coli reverse mutation assay according to the OECD Testing Guideline 471 and under GLP.
Cesium fluoro aluminate complex was tested in the Salmonella typhimurium reverse mutation assay with four histidine-requiring strains of Salmonella typhimurium (TA1535 TA1537, TA100 and TA98) and in the Escherichia coli reverse mutation assay with one tryptophan-requiring strain of Escherichia coli (WP2uvrA) in two independent experiments.
Cesium fluoro aluminate complex was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix.
The test substance did not induce a 2-fold and/or dose-related increase in the number of revertant (His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in an independently repeated experiment.
The strain-specific positive control values were at least three times the concurrent vehicle control grop mean indicating that the test conditions were adequate. Based on the results of this study it is concluded that cesium fluoro aluminate complex is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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.