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Diss Factsheets
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EC number: 215-475-1 | CAS number: 1327-36-2
- 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: in vitro / ex vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 28 Jan - 31 Jan 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study of a draft guideline with acceptable restrictions (limited documentation).
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 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 silicic acid, aluminium salt 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, Kaiser-Friedrich-Strasse 7, 55116 Mainz, Germany
Test material
- Reference substance name:
- Silicic acid, aluminum salt
- EC Number:
- 215-628-2
- EC Name:
- Silicic acid, aluminum salt
- Cas Number:
- 1335-30-4
- Details on test material:
- - Name of test material (as cited in study report): silicic acid, aluminium salt
- Physical state: white powder
- Analytical purity: > 99%
- Batch No.: 1000168802
- Expiration date of the batch: Apr 2010
- Storage condition of test material: at room temperature, 20 ± 5 °C
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:
- 60 min
- Observation period:
- incubation time before determination of cell viability: 42 h
- Number of animals:
- not applicable
- Details on study design:
- The Epi-200 -Kit was purchased from MatTek Corporation (Ashland, USA). The tissue consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. The EpiDermTM tissues are cultured on specially prepared cell culture inserts.
EpiDermTM tissues reached LAUS GmbH on September 23, 2009. On the day of receipt, EpiDermTM tissues were transferred to 12-well plates with maintenance medium.
After 18.5 hours incubation of the EpiDermTM tissues, three tissues of the human skin model EpiDermTM were treated with either the test item, the negative (Dulbecco's Phosphate Buffered Saline (DPBS buffer)) or the positive control (5% sodium lauryl sulfate in deionised water) for a total of 60 min. Approx. 25 mg of the test item were applied to each tissue and wetted with 25 µL DPBS buffer. 30 µL of either the negative or the positive control were applied to each tissue. The 6-well plates were placed into the incubator for 35 min at 37 ± 1 °C, 5 ± 0.5% CO2.
After the end of the treatment interval the inserts were removed from the plates using sterile forceps.The tissues were rinsed immediately and transferred into a new 6 -well plate with fresh assay medium. All inserts were dried with sterile cotton tips. The tissues were set in the incubator for 42 hours.
Cell viability was measured by dehydrogenase conversion of MTT [(3,4,5 -dimethyl thiazole 2 -yl) 2,5 -diphenyltetrazoliumbromide], present in cell mitochondria, into a blue formazan salt that is quantitatively measured after extraction from tissues. The percent reduction of cell viability in comparison to untreated negative controls is used to predict skin irriation potential.
The tissues were placed in MTT solution of 1 mg/mL for 3 hours (37 ± 1 °C, 5 ± 0.5% CO2). The precipitated blue formazan product is then extracted using isopropanol. The concentration of formazan was measured by determining the Optical Density (OD) at 570 nm in a plate spectral photometer.
Evaluation of the results
The mean OD of the three negative control tissues was calculated. This value corresponds to 100% tissue viability in the current test. For each individual tissue treated with the test item or the positive control the individual relative tissue viability was calculated according to the following formula:
Relative viability (%)= (OD(test item) x 100) / OD (negative control)
Acceptability of the assay
The absolute OD 570 nm of the negative control tissues in the MTT test is an indicator of tissue viability obtained after the shipping and storing procedure and under specific conditions of the assay. Tissue viability is meeting the acceptance criterion if the mean OD of the three tissues is between 1.0 and 2.5. An assay is meeting the acceptance criterion if mean relative tissue viability of the positive control is ≤ 20% of the negative control and the variation within replicates is below 18%.
Results and discussion
In vivo
- Irritant / corrosive response data:
- 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 9.4% thus ensuring the validity of the test system. After tissue incubation with silicic acid, aluminium salt, the relative absorbance values were increased to 103.4%. This value is well above the threshold for irritancy of 50%. Therefore, the test item is considered to have no skin irritation potential. For detailed results see table 1 in "any other information on results incl. tables".
Any other information on results incl. tables
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 |
2.242 |
2.027 |
1.760 |
2.010 |
100% |
Positive control |
0.183 |
0.192 |
0.192 |
0.189 |
9.4% |
Test item |
2.185 |
2.011 |
2.041 |
2.079 |
103.4% |
*Mean of two replicate wells after blank correction
** relative absorbance [rounded values]: (100 x (absorbance test item)) / (absorbance negative control)
Applicant's summary and conclusion
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.