Registration Dossier
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: 300-212-6 | CAS number: 93924-19-7 Hollow ceramic spheres formed as a part of the ash in power stations burning pulverized coal. Composed primarily of the oxides of aluminium, iron and silicon and contain carbon dioxide and nitrogen within the sphere.
- 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
- 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:
- 16 Nov 2007 - 11 Jan 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study. In accordance 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:
- 2 008
- Report Date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): Ashes (residues)
- Substance type: technical product
- Physical state: solid
- Significant impurities:
Cr, Cu, Zn - metals with content lower than 0.1 %
As, Pb, Cd, Hg - metals with content lower than 0.01 %
- Composition of test material, percentage of components:
SiO2 (42.12 %), Al2O3 (32.16 %) and Fe2O3 (10.88 %) – main components
TiO2, MnO, MgO, CaO, Na2O, K2O, SO3 – components with content lower than 10 %
- Lot/batch No.: 30.08.2007_ENERGETIKA
- Expiration date of the lot/batch: unlimited
- Stability under test conditions: stable
- Storage condition of test material: labotatory conditions
- Appearance: greyish black powder
Method
- Target gene:
- his operon (S. typhimurium), trp operon (E. coli)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from Delor 106-induced Wistar male rats. Delor 106 is a mixture of PCBs.
- Test concentrations with justification for top dose:
- Toxicity test in tester strain TA 100: 10, 100, 500, 1000, 2500, 5000 µg/plate
1st and 2nd mutagenicity tests: 50, 150, 500, 1500, 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Solubulity tests were performed prior to the main test. The test material is practically insoluble in any of the solvents commonly used and compatible with this mutagenicity test (water, dimethylsulfoxide (DMSO), dimethylformamide (DMFA), ethanol 96%, acetone, cyclohexane). DMSO was chosen due to the homogeneity of the suspensions obtained and its historical use in the testing laboratory.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 0.1 mL DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide (1.5 µg/plate), 4-nitro-o-phenylenediamine (20 µg/plate), 2-aminofluorene (10 µg/plate), 2-aminoanthracene (1 and 2.5 µg/plate), 9-aminoacridine hydrochloride monohydrate (100 µg/plate), N-methyl-N’-nitro-N-nitrosoguanidine (20 µg/plate)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48-72 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency - Evaluation criteria:
- The main criterion for the evaluation of results was the modified two-fold increase rule. According to this rule, a result is considered positive if a reproducible dose-effect and/or a doubling of the Rt/Rc ratio is reached (Rt/Rc: ratio of the number of revertants at the tested dose to the number of revertants in the negative control).
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: no cytotoxicity as determined with tester strain TA 100 without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The effect of Ashes (residues) – Fly Ash on S. typhimurium TA 100 (two experiments).
Note: Rt/Rc: ratio of the number of revertants at the tested dose to the number of revertants in the negative control.
| Without metabolic activation (No. of revertants per plate) | With metabolic activation (No. of revertants per plate) | ||
Doses (µg/plate) | Mean ± SD | Rt/Rc | Mean ± SD | Rt/Rc |
Neg. control | 87±7 | - | 108±3 | - |
DMSO (solvent control) | 90±7 | - | 105±10 | - |
50 | 81±8 | 0.9 | 103±6 | 1.0 |
150 | 95±5 | 1.1 | 100±3 | 1.0 |
500 | 95±8 | 1.1 | 94±6 | 0.9 |
1500 | 100±8 | 1.1 | 93±2 | 0.9 |
5000 | 82±2 | 0.9 | 79±12 | 0.8 |
AS/2 -AF | 476±16 | 5.3 | 527±22 | 5.0 |
|
|
|
|
|
Neg. control | 125±6 | - | 137±4 | - |
DMSO (solvent control) | 114±7 | - | 128±7 | - |
50 | 118±8 | 1.0 | 117±7 | 0.9 |
150 | 114±5 | 1.0 | 130±9 | 1.0 |
500 | 110±0 | 1.0 | 125±3 | 1.0 |
1500 | 108±0 | 1.0 | 129±6 | 1.0 |
5000 | 107±6 | 0.9 | 118±14 | 0.9 |
AS/2 -AF | 560±30 | 4.9 | 998±53 | 7.8 |
The effect of Ashes (residues) – Fly Ash on S. typhimurium TA 1535 (two experiments).
Note: Rt/Rc: ratio of the number of revertants at the tested dose to the number of revertants in the negative control.
| Without metabolic activation (No. of revertants per plate) | With metabolic activation (No. of revertants per plate) | ||
Doses (µg/plate) | Mean ± SD | Rt/Rc | Mean ± SD | Rt/Rc |
Neg. control | 23± | - | 15±1 | - |
DMSO (solvent control) | 20±13 | - | 18±0 | - |
50 | 24±1 | 1.2 | 17±2 | 0.9 |
150 | 24±2 | 1.2 | 22±2 | 1.2 |
500 | 23±3 | 1.1 | 16±1 | 0.9 |
1500 | 21±1 | 1.0 | 15±3 | 0.8 |
5000 | 22±3 | 1.1 | 18±2 | 1.0 |
AS/2-AA | 475±22 | 23.3 | 216±17 | 11.8 |
|
|
|
|
|
Neg. control | 25±1 | - | 21±2 | - |
DMSO (solvent control) | 25±2 | - | 24±3 | - |
50 | 25±5 | 1.0 | 26±2 | 1.1 |
150 | 28±2 | 1.1 | 21±2 | 0.9 |
500 | 25±7 | 1.0 | 21±2 | 0.9 |
1500 | 24±2 | 1.0 | 17±1 | 0.7 |
5000 | 21±2 | 0.8 | 20±6 | 0.8 |
AS/2-AA | 569±13 | 22.7 | 216±2 | 9.1 |
The effect of Ashes (residues) – Fly Ash on S. typhimurium TA 98 (two experiments)
Note: Rt/Rc: ratio of the number of revertants at the tested dose to the number of revertants in the negative control.
| Without metabolic activation (No. of revertants per plate) | With metabolic activation (No. of revertants per plate) | ||
Doses (µg/plate) | Mean ± SD | Rt/Rc | Mean ± SD | Rt/Rc |
Neg. control | 29±4 | - | 32±4 | - |
DMSO (solvent control) | 26±4 | - | 28±1 | - |
50 | 25±1 | 1.0 | 31±2 | 1.1 |
150 | 26±5 | 1.0 | 30±1 | 1.1 |
500 | 27±4 | 1.0 | 28±5 | 1.0 |
1500 | 30±3 | 1.2 | 29±9 | 1.0 |
5000 | 26±3 | 1.0 | 30±3 | 1.1 |
NPD/2-AF | 621±14 | 23.9 | 886±71 | 31.3 |
|
|
|
|
|
Neg. control | 37±3 | - | 36±2 | - |
DMSO (solvent control) | 29±3 | - | 36±3 | - |
50 | 33±3 | 1.1 | 35±1 | 1.0 |
150 | 34±10 | 1.1 | 40±9 | 1.1 |
500 | 28±2 | 0.9 | 32±1 | 0.9 |
1500 | 31±5 | 1.0 | 34±6 | 0.9 |
5000 | 28±1 | 0.9 | 35±3 | 1.0 |
NPD/2-AF | 984±132 | 33.5 | 1037±121 | 28.5 |
The effect of Ashes (residues) – Fly Ash on S. typhimurium TA 1537 (two experiments)
Note: Rt/Rc: ratio of the number of revertants at the tested dose to the number of revertants in the negative control.
| Without metabolic activation (No. of revertants per plate) | With metabolic activation (No. of revertants per plate) | ||
Doses (µg/plate) | Mean ± SD | Rt/Rc | Mean ± SD | Rt/Rc |
Neg. control | 12±3 | - | 9±1 | - |
DMSO (solvent control) | 13±1 | - | 11±3 | - |
50 | 14±2 | 1.0 | 12±1 | 1.1 |
150 | 9±3 | 0.7 | 14±2 | 1.3 |
500 | 12±2 | 0.9 | 13±4 | 12 |
1500 | 14±2 | 1.1 | 11±1 | 1.0 |
5000 | 8±0 | 0.6 | 10±2 | 0.9 |
9-AAc/2-AA | 1008±30 | 77.5 | 176±25 | 16.5 |
|
|
|
|
|
Neg. control | 18±2 | - | 17±2 | - |
DMSO (solvent control) | 14±1 | - | 16±2 | - |
50 | 14±2 | 1.0 | 16±3 | 1.0 |
150 | 12±1 | 0.9 | 14±4 | 0.9 |
500 | 13±1 | 0.9 | 16±1 | 1.0 |
1500 | 13±3 | 0.9 | 15±1 | 1.0 |
5000 | 11±3 | 0.8 | 12±3 | 0.7 |
9-AAc/2-AA | 958±123 | 68.4 | 169±20 | 10.8 |
The effect of Ashes (residues) – Fly Ash on E. coli WP2 uvrA (two experiments)
Note: Rt/Rc: ratio of the number of revertants at the tested dose to the number of revertants in the negative control.
| Without metabolic activation (No. of revertants per plate) | With metabolic activation (No. of revertants per plate) | ||
Doses (µg/plate) | Mean ± SD | Rt/Rc | Mean ± SD | Rt/Rc |
Neg. control | 30±1 | - | 37±9 | - |
DMSO (solvent control) | 30±0 | - | 30±6 | - |
50 | 25±1 | 0.8 | 28±5 | 0.9 |
150 | 28±6 | 0.9 | 27±1 | 0.9 |
500 | 29±1 | 1.0 | 34±2 | 1.1 |
1500 | 28±3 | 0.9 | 29±2 | 1.0 |
5000 | 32±6 | 1.1 | 32±7 | 1.1 |
MNNG/2-AA | 773±43 | 25.8 | 109±7 | 3.6 |
|
|
|
|
|
Neg. control | 26±5 | - | 30±5 | - |
DMSO (solvent control) | 24±4 | - | 29±4 | - |
50 | 22±5 | 0.9 | 24±2 | 0.8 |
150 | 29±9 | 1.2 | 24±2 | 0.8 |
500 | 30±2 | 1.3 | 22±3 | 0.8 |
1500 | 30±5 | 1.2 | 24±4 | 0.8 |
5000 | 20±0 | 0.8 | 24±3 | 0.8 |
MNNG/2-AA | 716±29 | 29.8 | 102±11 | 3.6 |
AS: sodium azide (1.5 µg/plate; TA 100 and TA 1535 without metabolic activation)
NPD: 4-nitro-o-phenylenediamine (20 µg/plate; TA 98 without metabolic activation)
2-AF: 2-aminofluorene (10 µg/plate; TA 100 and TA 98 with metabolic activation)
2-AA: 2-aminoanthracene (1 µg/plate with TA 1535; 2.5 µg/plate with TA 1537; 25 µg/plate with E. coli; all tests with metabolic activation)
9AAc: 9-aminoacridine hydrochloride monohydrate (100 µg/plate; TA 1537 without metabolic activation)
MNNG: N-methyl-N’nitro-N-nitrosoguanidine (20 µg/plate; E.coli without metabolic activation)
- : not evaluated
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the experimental conditions described, the test substance was nonmutagenic in S. typhimurium strains TA 98, TA 100, TA 1535 and TA 1537 as well as in E. coli strain WP2 uvrA both with and without metabolic activation.
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.

Route: .live2