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Diss Factsheets
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EC number: - | 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Only two S. typhimurium strains were used: TA 100 (basepair substitution) and TA98 (frameshift).
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:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only two bacteria strains were tested
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- only two bacteria strains were tested
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Zirconium zircon with encapsulated hematite
- Cas Number:
- 68412-79-3
- Molecular formula:
- ZrSiO4*xFe2O3 0,1≤x≤0,5
- IUPAC Name:
- Zirconium zircon with encapsulated hematite
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material: Sicocer F Eisenrosa 2320
- OLD EC name: zirconium iron pink zircon
- NEW EC name: zirconium zircon with encapsulated hematite
- Physical state: solid, pink powder
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: rfa; uvrB; ampicillin resistence (R factor plamid pKM 101); and a modified postreplication DNA repair system, which increases the mutation rate by inducing a defective repair in the DNA
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: rfa; uvrB; ampicillin resistence (R factor plamid pKM 101); and a modified postreplication DNA repair system, which increases the mutation rate by inducing a defective repair in the DNA
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- standard plate test: 0, 20, 100, 500, 2500 and 5000 µg/plate
preincubation test: 0, 20, 100, 500, 2500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Parallel with each experiment with and without S9-mix a solvent control is carried out.
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2.5 µg/plate), dissolved in DMSO
- Remarks:
- with metabolic activation; strains TA 98 and TA 100
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Parallel with each experiment with and without S9-mix a solvent control is carried out.
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitroso-guanidine (5 µg/plate), dissolved in DMSO
- Remarks:
- without metabilic activation; strain TA 100
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Parallel with each experiment with and without S9-mix a solvent control is carried out.
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylendiamine (10 µg/plate), dissolved in DMSO
- Remarks:
- without metabolic activation; strain TA 98
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) and preincubation
DURATION
- Preincubation period: 20 minutes at 37°C (preincubation test only)
- Exposure duration: 48 hours at 37°C in the dark
NUMBER OF REPLICATIONS: 3
EVALUATION
- The frequency of revertant colonies was assessed by counting.
DETERMINATION OF CYTOTOXICITY
- Method: Examination of the background growth.
Titer determination:
- The titer is determined only in the experiments with S9-mix both without test substance (solvent only) and after adding the two highest amounts of substance. The effects of a 10E-6 dilution of the bacteria suspensions on the growth of the bacteria were examined. The frequency of revertant colonies was assessed by counting. - Evaluation criteria:
- A substance to be characterised as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose response relationship
- reproducibility of the results - Statistics:
- not mandatory for this test system
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- In the standard plate test and in the preincubation test, no toxicological significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- The test material was non-toxic under the conditions tested.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- In the standard plate test and in the preincubation test, no toxicological significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- The test material was non-toxic under the conditions tested.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation of the test substance was observed.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- No bacteriotoxic effect (reduced his- background growth) was observed.
Applicant's summary and conclusion
- Conclusions:
- The test substance Sicocer F Eisenrosa 2320 was considered to be non-mutagenic under the conditions of the test.
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