Registration Dossier
Registration Dossier
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: 931-257-5 | CAS number: 68131-74-8
- 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

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13.8.2009-14.8.2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- yes
- Remarks:
- This deviation had no impact on the outcome of the study.
- GLP compliance:
- yes
Test material
- Reference substance name:
- FBC Ash
- IUPAC Name:
- FBC Ash
- Details on test material:
- - Name of test material: Fluidized Bed Combustion (FBC) Bottom Ash
- Substance type: technical product
- Physical state: solid
- Appearance: Light grey solid powder with some small black particle
- Chemical structure: Complex product of oxides
- Main components: SiO2 - 27,78%, Fe2O3 - 5,98%, CaO (total) - 35,65%, Na2O - 0,25%, P2O5 - 0,38%, CO2 - 0,5%, CaO (free) - 19,91%, Al2O3 - 11,16%, TiO2 - 2,65%, MgO - 0,44%, K2O - 0,42%, SO3 (sulphate) - 2,84%
- Impurities: Metals: As, Be, Cd, Co, Cr, Cu, Hg, Mo, Ni, Pb, Sb, Se, Tl, V, Zn - sum < 0,1%
- Lot/batch No.: FBC/230309/T2
- Expiration date of the lot/batch: 03/2024
- Stability under test conditions: stable
- Storage: The substance will be stored in PE container at room temperature.
Constituent 1
Test system
- Amount / concentration applied:
- TEST MATERIAL
The test substance (25 mg) was grinded in mortar with pestle. Then it was placed atop the tissue previously moistened with 25 μl of sterile water to improve contact of the tissue surface with the test chemical. The moistened material was spread on the tissue surface.
VEHICLE
Water for injection - Ardeapharma a.s., Lot No. 0101030309 - Duration of treatment / exposure:
- 3 min, 60 min
- Details on study design:
- TEST SYSTEM
The reconstructed human epidermal model EpiDerm™ (EPI-200, MatTek, Ashland, USA) consists of normal human-derived epidermal keratinocytes, which have been cultured to form a multilayered highly differentiated model of the human epidermis.
The EpiDerm™ tissues (surface 0.63 cm²) are cultured on specially prepared cell culture inserts and shipped as kits, containing 24 tissues on shipping agarose together with the necessary amount of culture media.
TEST PROCEDURE
DIRECT MTT REDUCTION:
Some test substances may interfere with the MTT endpoint if it is able to directly reduce MTT. Therefore, before exposure, functional checks for this possibility was performed as follows: 25 mg of the test substance is added to 1 mL MTT medium (red) and incubated in the incubator (37±1°C, 5±1 % CO2, moistured) for 60 min. At the end of the exposure time, the presence and intensity of the staining (if any) is observed. If the solution changes color from red to blue, other steps to correction have to be done.
PROCEDURE:
On the day of receipt, EpiDerm tissues are conditioned by incubation to release transport stress related compounds and debris. After pre-incubation, tissues are topically exposed to the test chemicals for 60 minutes. Three tissues are used per test chemical and for the positive control (PC) and negative control (NC). Tissues are then thoroughly rinsed, blotted to remove the test substances, and transferred to fresh medium.
After a 24 hr incubation period, the medium is replaced by fresh one. Tissues are incubated for another 18 hours. Afterwards, the MTT assay is performed by transferring the tissues to 24-well plates containing MTT medium (1 mg/ml). After a 3 hr MTT incubation, the blue formazan salt formed by cellular mitochondria is extracted with 2.0 ml/tissue of isopropanol and the optical density of the extracted formazan is determined using a spectrophotometer at 570 nm.
OD570 MEASURING:
OD570 is measured on a spectrophotometer Libra S22. Isopropanol serves as a blank.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 1.46
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min
- Value:
- 1.408
Any other information on results incl. tables
STUDY RESULTS
Direct MTT reduction
Before the test itselfdirect MTT reduction was assayed.
After 60 min incubation of the test substance with MTT medium, colour was compared with control solution of MTT medium only. Due to presence of dark suspended test substance colour was not clearly appreciable. After filtration no changes in colouring were observed.
The test substance did not reduce MTT directly.
MTT test
OD570 measuring was performed after overnight extraction.
EVALUATION OF RESULTS
The average viability of affected tissues was 94.6 % of negative control average value after 3 min treatment and 103.2 % after 60 min. These values are higher than critical values (50 and 15% respectively). The substance could be regarded as non-corrosive.
Applicant's summary and conclusion
- Interpretation of results:
- other: non-corrosive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the above-described experimental design, the test substance Fluidized Bed Combustion (FBC) Bottom Ash was non corrosive in In vitro Skin Corrosion Test on EpiDermTM tissues.
- Executive summary:
Test substance Fluidized Bed Combustion (FBC) Bottom Ash was assayed for the in vitro skin corrosion in human epidermal model EpiDermTM. The test was performed according to Method B.40. Skin corrosion (in vitro),Council Regulation (EC) No. 440/2008. Published in O.J. L 142, 2008.
The test substance (25 mg) was grinded in mortar with pestle andplaced atop the tissue previously moistened with 25 μl of sterile water. Length of exposition was 3 and 60 minutes. Nine tissues were used for the experiment in each time, three per test substance (TS), three for positive control (PC) and three for negative control (NC).
After rinsing, tissues were incubated with MTT for three hours and extracted overnight subsequently at room temperature without shaking.OD570 of isopropanol extracts was measured on a spectrophotometer. Relative cell viability was calculated for each tissue as % of the mean viability of the negative control tissues.
In the experiment arrangement given above, the test substance Fluidized Bed Combustion (FBC) Bottom Ash was not corrosive in EpiDermTMmodel.
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.
