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EC number: 931-210-9 | CAS number: 1266534-73-9
- 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:
- 1999-05-05 to 1999-06-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study, tested with EC No. 930-915-9. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 930-915-9
- EC Number:
- 930-915-9
- IUPAC Name:
- 930-915-9
- Details on test material:
- - Name of test material (as cited in study report): Zeostop X
- Related CAS number: 1318-02-1
- Chemical name: silver alumino-silikate
- Analytical purity: approx. 100%
- Lot/batch No.: MR 453 136
- Physical state: white powder
- Composition of test material, percentage of components (surface modified with Ag): Si/Al molarity 1.24
Al2O3: 25.6%
CaO 0.08%
Fe2O3 0.00%
K2O 00.08%
MgO 00.00%
Na2O 11.71%
SiO2 37.33%
Ag2O 02.80%
loss resulting from combustion (900°C)
- Expiry date: May 2000
Constituent 1
Method
- Target gene:
- tk locus
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver post-mitochondrial fraction from rats, induced with Aroclor 1254 (S9)
- Test concentrations with justification for top dose:
- Exp. 1: without S-9: up to 40 µg/mL ; with S-9: up to 160 µg/mL
Exp. 2: without S-9: up to 25 µg/mL ; with S-9: up to 90 µg/mL
The test article was poorly soluble and undissolved material was observed at aIl concentrations tested.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitroquinoline 1-oxide (without S-9) and benzo(a)pyrene (with S-9)
- Details on test system and experimental conditions:
- Tissue culture medium: RPMI 1640
In the cytotoxicity range-finding experiment, 15 doses were tested ranging A from 0.3 to 5000 µg/mL. After the three hours treatment incubation period cultures were visually assessed and seven doses ranging from 2.5 to 156 µg/mL were selected for determination of relative survival. The remaining cultures were discarded. The top doses where cells survived treatment were 20 µg/mL in the absence of S-9 (28.53% relative survival) and 156 µg/mL in the presence of S-9 (17.91 % relative survival).
Accordingly, for the first experiment, eight doses (2.5, 5, 10, 20, 25, 30, 35 and 40 µg/mL) were tested in the absence of S-9 and six doses (10, 20, 40, 80, 120 and 160 µg/mL) were tested in the presence of S-9.
For the second experiment, seven doses (5, 10, 15, 17.5, 20 and 25 µg/mL) were tested without S-9 and eight doses (10, 20, 40, 50, 60, 70, 80 and 90 µg/mL) were tested with S-9.
Negative (vehicle) and positive (4-nitroquinoline 1-oxide (without S-9) and benzo(a)pyrene (with S-9)) control treatments were included in each mutation experiment.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- without S-9: above 20 µg/mL; with S-9: above 80 µg/mL
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Mutant frequencies in negative control cultures fell within normal ranges, and clear increases in mutation were induced by the positive control chemicals 4-nitroquinoline 1-oxide (without S-9) and benzo(a)pyrene (with S-9).
In the absence of S-9, no statistically significant increases in mutant frequency were observed following treatment with Zeostop X at any dose level tested, in experiment 1 or 2. In the presence of S-9, in experiment 1, a small but significant increase (1.4 fold), in mutant frequency (136 mutants per 10E6 viable cells [dose], compared to 94 mutants per 10E6 viable cells [control] was observed at the top dose analysed (80 ug/ml). However, 80 µg/ml was a highly toxic dose (10.03 relative survival and 7% relative total growth) and the increase in mutant frequency was related to a depression in day 2 viability counts rather than marked increase in mutant numbers. Furthermore, in experiment 2, when Zeostop X was tested up to doses of similar toxicity, no statistically significant increases in mutant frequency were observed. The small increase in mutant frequency observed in 80 µg/ml was considered to be due to a change event, probably related to the high toxicity observed at this dose, but of no biological significance. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Relative survival in the cytotoxicity range-finding experiment
Treatment (µg/mL) |
Relative survival without S-9 (%) |
Relative survival with S-9 (%) |
0 |
100 |
100 |
2.5 |
79.18 |
111.95 |
5 |
59.49 |
113.77 |
10 |
63.09 |
173.17 |
20 |
28.53 |
85.40 |
39 |
0 |
107.79 |
78 |
0 |
51.30 |
156 |
0 |
17.91 |
Experiment 1:
The three top doses tested in the absence of S-9 (30, 35 and 40 µg/mL) and the top two doses tested in the presence of S-9 (120 and 160 µg/mL) were considered to be too toxic for selection to determine viability and 5-trifluorothymidine (TFT) resistance.
All other doses were selected. The top doses selected were 25 µg/mL in the absence of S-9 (3.08% relative survival [2% RTG]) and 80 µg/mL the presence of S-9 (10.03% relative survival [7 % RTG]).
Experiment 2:
In the second experiment the dose range was modified slightly to take account of toxicity observed in Experiment 1. The top doses selected to determine TFT resistance in this experiment were 22.5 µg/mL in the absence of S-9 (5.33% relative survival [5% RTG]) and 70 µg/mL in the presence of S-9 (9.25% relative survival [3% RTG]).
When tested up to toxic doses, Zeostop X did not induce mutation at the tk locus of L5178Y mouse lymphoma cells in the two independent experiments, with or without S9 mix.
Under the conditions employed in this study, ZEOSTOP X is not mutagenic in this test system.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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