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Diss Factsheets
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EC number: 235-730-0 | CAS number: 12627-14-4
- 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 irritation / corrosion
- Remarks:
- other: EpiDerm (in vitro)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 - 27 Sep 2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study according to a draft guideline with acceptable restrictions (limited documentation).
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:
- other: OECD guideline for the testing of chemicals. Draft proposal for a new guideline. In vitro skin irritation: human skin model test, December, 2007
- Deviations:
- yes
- Remarks:
- - Interleukin-1 alpha was not determined
- Principles of method if other than guideline:
- The skin irritancy potenial of lithium silicate was tested by using the human skin model EpiDerm and measurement of cell viability by dehydrogenase conversion of MTT into a blue formazan salt.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany
Test material
- Reference substance name:
- Silicic acid, lithium salt
- EC Number:
- 235-730-0
- EC Name:
- Silicic acid, lithium salt
- Cas Number:
- 12627-14-4
- Molecular formula:
- Li2O*2.8SiO2 - Li2O*6.3SiO2
- IUPAC Name:
- Silicic acid, lithium salt
- Details on test material:
- - Name of test material (as cited in study report): lithium silicate
- Physical state: white powder
- Analytical purity: > 99%
- Batch No.: 009061957
- Expiration date of the batch: 28.05.2010
- Storage condition of test material: at room temperature, 20 ± 5 °C
- Other: Molar Ratio SiO2/Li2O: 4.8 (information provided in the product information sheet for Lithium polysilicate by the data owner)
Constituent 1
Test animals
- Species:
- other: in vitro test: human skin
- Strain:
- other: in vitro test: human skin
- Details on test animals or test system and environmental conditions:
- not applicable
Test system
- Type of coverage:
- other: in vitro test: human skin model test
- Preparation of test site:
- other: in vitro test: human skin model test
- Vehicle:
- other: DPBS buffer
- Controls:
- other: not applicable
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (weight): 25 mg of the neat test item were applied to each of triplicate tissues and wetted with 25 µL DPBS (Dulbecco's Phophate Buffered Saline) buffer.
VEHICLE
- Amount(s) applied (volume): 25 µL DPBS buffer - Duration of treatment / exposure:
- not applicable: see "any other information on materials and methods"
- Observation period:
- not applicable: see "any other information on materials and methods"
- Number of animals:
- not applicable: see "any other information on materials and methods"
- Details on study design:
- not applicable: see "any other information on materials and methods"
Results and discussion
In vivo
- Irritant / corrosive response data:
- Under the experimental conditions, the test item is considered to have no skin irritation potential.
Any other information on results incl. tables
After treatment with the negative control the absorbance values were well within the required acceptability criterion thus showing the quality of the tissues. The positive control induced a decrease in the relative absorbance as compared to the negative control to 15.8% thus ensuring the validity of the test system. After tissue incubation with lithium silicate, the relative absorbance values were increased to 111.5%. This value is well above the threshold for irritancy of 50%. Therefore, the test item is considered to have no skin irritation potential.Results see table 1.
Table 1:
Dose group |
Absorbance 570 nm, tissue 1* |
Absorbance 570 nm, tissue 2* |
Absorbance 570 nm, tissue 3* |
Mean absorbance of 3 tissues |
Mean formazan production [%] |
Negative control |
1.454 |
1.568 |
1.633 |
1.562 |
100% |
Positive control |
0.253 |
0.249 |
0.240 |
0.247 |
15.8% |
Test item |
1.629 |
1.752 |
1.844 |
1.742 |
111.5% |
*Mean of two measurements after blank correction
** relative absorbance [rounded values]: (100 x (absorbance test item)) / (absorbance negative control)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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