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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
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- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
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- 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
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- Nanomaterial aspect ratio / shape
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- Endpoint summary
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- Environmental data
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- 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
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 26 May 2010 and 28 May 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed in accordance with GLP and accepted protocol.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
- Principles of method if other than guideline:
- The purpose of this study was to determine the eye irritation potential of the test material using the SkinEthic Reconstituted Human Corneal model (HCE, SkinEthic Laboratories, Nice, France) after a treatment period of 10 minutes. The test is based on the hypothesis that irritant chemicals are able to penetrate the stratum corneum of the SkinEthic RHC model and are sufficiently cytotoxic to cause cell death in the underlying cell layers
- 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:
- Sponsor's identification: soda-ash flux calcined kieselguhr
CAS Number : 68855-54-9
Description : white powder
Lot number : 211184
Date received : 10 February 2010
Expiry date : 31 December 2013
Storage conditions: room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- other: Reconstituted Corneal Epithelium
Test system
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: Tissues were treated with 30 mg of the test material.
VEHICLE
Test material was used as supplied
CONTROLS:
- Amount applied: 30 µL of Solution A was applied as a negative control and 30 µL of of SDS 1.0% (w/v) as a positive control. Solution A was comprised of Na2HPO4 0.142 g/L, Glucose 1.802 g/L, HEPES 7.149 g/L, KCl 0.224 g/L and NaCl 7.597 g/L. Sodium Dodecyl Sulphate (SDS) was prepared as a 1% w/v solution in sterile distilled water. - Duration of treatment / exposure:
- Cultures were exposed for 10 minutes to the test material.
- Observation period (in vivo):
- Skin cultures were examined after three hours.
- Number of animals or in vitro replicates:
- All test substances were tested in triplicate (including controls)
Results and discussion
In vivo
Results
- Irritation parameter:
- other: relative mean tissue viability
- Basis:
- mean
- Time point:
- other: 10 minutes
- Score:
- 99.1
- Remarks on result:
- other: %
- Irritant / corrosive response data:
- The mean OD540 values and mean viabilities for each treatment group are given in Table 1.
The relative mean viability of the test material treated tissues after a 10 minute exposure was 99.1%.
It was considered unnecessary to proceed with tissue histopathology.
The qualitative evaluation of tissue viability is presented in Table 2.
The test material and negative control material treated tissues appeared blue which was considered to be indicative of viable tissue. The positive control material treated tissues appeared blue/white which was considered to be indicative of semi viable tissue
Any other information on results incl. tables
Table 1: Assessment of Eye Irritation Potential – Viability of RHC Tissues
Material |
Mean Tissue Viability |
Mean OD540 |
Viability (%) |
Negative Control |
1.036 |
1.006 |
100* |
0.975 |
|||
Positive Control |
0.540 |
0.537 |
53.4 |
0.533 |
|||
Test Material |
0.989 |
0.997 |
99.1 |
1.005 |
*= The mean viability of the negative control tissues is set at 100%
Table 2: Qualitative Evaluation of Tissue Viability (MTT uptake visual evaluation)
Material |
Score |
|
Tissue 1 |
Tissue 2 |
|
Negative Control |
- |
- |
Positive Control |
+ |
+ |
Test Material |
- |
- |
MTT Visual Scoring Scheme of SkinEthic Tissues
- = Blue tissue (viable)
+ = Blue/White tissue (semi viable)
++ = Tissue completely white (dead)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- According to the protocol followed the test material was considered to be a Non Irritant The quality criterion required for the acceptance of results in the test was satisfied
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