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Diss Factsheets
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EC number: 272-489-0 | CAS number: 68855-54-9
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 23 March 2010 and 26 March 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed to GLP and internationally accepted guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 431 (In vitro skin corrosion: Human skin model test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Kieselguhr, soda ash flux-calcined
- EC Number:
- 272-489-0
- EC Name:
- Kieselguhr, soda ash flux-calcined
- Cas Number:
- 68855-54-9
- Molecular formula:
- SiO2
- IUPAC Name:
- silanedione
- Details on test material:
- - Name of test material (as cited in study report): Soda-ash flux calcined kieselguhr
- Physical state: Solid
- Purity: 100%
- Lot/batch No.: 211184
- Expiration date of the lot/batch: 31 December 2013
- Storage condition of test material: Room temperature in the dark
Constituent 1
Test animals
- Species:
- other: EPISKIIN™ Reconstituted Human Epidermis model
Test system
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 20 mg
VEHICLE
Test material was used as suppled - Duration of treatment / exposure:
- Duplicate tissues were treated with the test material for exposure periods of 3, 60 and 240 minutes.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: Relative mean viability %
- Value:
- 102.8
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 3 minutes. (migrated information)
- Irritation / corrosion parameter:
- other: other: Relative mean viability %
- Value:
- 111.3
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 60 minutes. (migrated information)
- Irritation / corrosion parameter:
- other: other: Relative tissue viability %
- Value:
- 114.1
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 240 minutes. (migrated information)
Any other information on results incl. tables
Direct MTT reduction
The MTT solution containing the test material did not turn blue/purple. This was taken to indicate the test material did not reduce MTT
Table 1: Mean OD540 values and viabilities for the negative control, positive control material and test material
Material |
Exposure period |
Mean OD540of duplicate tissues |
Relative mean % viability |
Negative control material |
240 minutes |
0.142 |
100* |
Positive control material |
240 minutes |
0.013 |
9.2 |
Test material |
240 minutes |
0.162 |
114.1 |
60 minutes |
0.158 |
111.3 |
|
3 minutes |
0.146 |
102.8 |
* = The mean viability of the negative control tissues is set at 100%
Table 2: Qualitative evaluation of tissue viability (MTT uptake visual evaluation)
Material |
Exposure period |
Tissue 1 |
Tissue 2 |
Negative control material |
240 minutes |
- |
- |
Positive control material |
240 minutes |
++ |
++ |
Test material |
240 minutes |
- |
- |
60 minutes |
- |
- |
|
3 minutes |
- |
- |
- = Blue tissue (viable)
++ = Tissue completely white (dead)
The relative mean tissue viability for the positive control treated tissues was 9.2% relative to the negative control treated tissues following the 240 -minute exposure period. The positive control acceptance criterion was therefore satisfied.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was considered to be non-corrosive to the skin
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.
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