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EC number: 269-093-5 | CAS number: 68187-40-6 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77364.
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019-11-06 to 2019-11-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2019-06-18
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MatTek Corporation Protocol: In vitro EpiDermTM Skin Irritation Test (EPI-200-SIT) For use with MatTek Corporation’s Reconstructed Human Epidermal Model EpiDerm (EPI-200-SIT)
- Version / remarks:
- 2017-07-11
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2019-10-23
Test material
- Reference substance name:
- Olivine, cobalt silicate blue
- EC Number:
- 269-093-5
- EC Name:
- Olivine, cobalt silicate blue
- Cas Number:
- 68187-40-6
- Molecular formula:
- Co2SiO4
- IUPAC Name:
- silicon(4+) bis(λ²-cobalt(2+)) tetraoxidandiide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Test item identification: Olivine, cobalt silicate blue (Pigment Blue 73)
- Substance type: inorganic pigment
- Storage condition of test material: Keep dry and container tightly closed. Keep container in an adequately ventilated storage
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: normal, human epidermal keratinocytes
- Cell source:
- other: humans
- Source strain:
- other: not applicable
- Details on animal used as source of test system:
- not applicable
- Justification for test system used:
- This test uses the EpiDerm™ reconstructed human epidermis model (MatTek) which consists of normal human-derived epidermal keratinocytes (NHEK) and therefore represents in vitro the target organ of the species of interest and closely resembles the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis.
- Vehicle:
- other: Dulbecco's Phosphate Buffered Saline (DPBS)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDermTM (EPI-200-SIT; MatTek)
- Tissue lot number: 30837
TEST FOR MTT INTERFERENCE
- To test if a test item directly reduces MTT, 1 ml of a MTT/DMEM solution (1 mg/mL) including 25±2 mg of the test item was incubated for 1 hour (37 ± 1.5°C, 5 ± 0.5% CO2).
- Untreated MTT/DMEM solution (1 mg/mL) was used as negative control.
- After incubation the change of colour was determined by the unaided eye.
TEST FOR COLOUR INTERFERENCE
- to check the colouring potential of the test item 25±2 mg of the test item was added to 300 µl of deionised water and mixed. 330 µl of deionised water was used as control (blank). Both were incubated for 60 min (37 ± 1.5°C, 5 ± 0.5% CO2).
- In parallel, 25±2 mg of the test item was added to 2 mL of isopropanol and mixed. A control (2 mL of isopropanol, blank) was run concurrently. Both were incubated for 1 hour at room temperature.
- After incubation the change of colour was determined by the unaided eye.
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
Since the test item interfered with MTT and reduced it to formazan by itself in the second pre-experiment two additional controls in duplicates run with the main experiment – the freeze-killed tissue controls (killed controls = KC):
- Negative control/ deionised water treated freeze-killed tissues (NC_KC)
- Test item treated freeze-killed tissues (TI_KC)
At the end, the following data correction procedure for viability plus Killed Control tests was performed::
Corrected viability (%) = TI viability – (TI_KC viability – NC_KC viability)
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1.5 °C for 35 minutes followed by incubation at room temperature until the 60-minute treatment period was completed
- Temperature of post-treatment incubation: 37 ± 1.5 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- At the end of the treatment interval the tissues were gently rinsed with PBS several times in order to remove any residual test material and controls.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL (300 µL/well)
- Incubation time: 3 hours ± 5 minutes (37 ± 1.5°C, 5 ± 0.5% CO2)
- After 3 hour ± 5 minutes incubation the tissues were rinsed with PBS and carefully dried with blotting paper. The tissues were transferred into new 24-well plates containing 2 mL of extractant solution (isopropanol) in each well ensuring that the tissues were completely covered. The 24-well plates were sealed to minimise isopropanol evaporation. The formazan salt was extracted within about 3 hours while shaking at room temperature. At the end of the extraction period the inserts were pierced with an injection needle to allow the extract to run into the well from which the insert was taken, and the insert were discarded.
- Per each tissue, 3 x 200 µL aliquots of the formazan solution were transferred into a 96-well, flat bottom, microtiter plate for OD measurement. 200 µL of isopropanol were added to the wells designated as blanks for 96-well plate.
- Measurement: The optical density (OD570nm) was determined spectrophotometrically in duplicates by a microplate reader (Versamax® Molecular Devices). The absorbance values were determined using the software SoftMax Pro Enterprise (version 4.7.1).
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: tissues pass analysis for tissue viability
- Barrier function: tissues pass analysis for tissue functionality
- Morphology: presence of a functional stratum corneum, a viable basal cell layer, and intermediate spinous and granular layers.
- Contamination: absence of bacteria, yeast, and other fungi (long term antibiotic, antimycotic free culture) as well as absence of HIV1-virus, Hepatitis B virus and Hepatitis C virus
Please also refer to the field "Attached background material" below.
NUMBER OF REPLICATE TISSUES:
- Three tissue replicates for test item and controls
PREDICTION MODEL / DECISION CRITERIA
The mean optical density (OD) of the three negative control tissues was calculated after blank correction. This value corresponded 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 is calculated according to the following formula:
Relative viability (%) = [(mean ODtest item / positive control) / ODmean of negative control] * 100
For the test item and the positive control the mean relative viability ± relative standard deviation of the three individual tissues were calculated.
Irritant potential of the test item was predicted from the relative mean tissue viabilities compared to the negative control tissues concurrently treated with DPBS. The test item is considered to be irritant to skin in accordance with Regulation EC No. 1272/2008 (UN GHS “Category 2”), if the tissue viability after exposure and post-incubation is less or equal to 50%. Further testing is required to resolve between UN GHS categories 1 and 2 and decide on the final classification of the test substance. The test substance may be considered as non-irritant to skin in accordance with regulation EC 1272/2008 and UN GHS “No Category” if the tissue viability after exposure and post-treatment incubation is more than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: The test item was tested neat. Three tissue replicates were wetted with 25 µL of DPBS prior to application and then 25 mg (39 mg/cm²) of the test item were applied uniformly to the epidermis surface.
VEHICLE
- Amount(s) applied: 25 µL of DPBS
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL DPBS
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL of 5 % SDS solution - Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- approx. 42 hours
- Number of replicates:
- triplicates
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- (mean)
- Value:
- 93.39
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- TEST FOR MTT INTERFERENCE
Optical evaluation of the MTT-reducing capacity of the test item with MTT-reagent showed purple colour. Therefore, an additional test with freeze-killed tissues was necessary for the quantitative correction of the test item viability.
TEST FOR COLOUR INTERFERENCE
The test item did not change colour when mixed with deionised water or isopropanol. No colouring was detectable by unaided eye-assessment. Therefore, an additional test with viable tissues was not necessary.
ACCEPTANCE OF RESULTS:
- the mean OD570 of the tissue replicates treated with the negative control is ≥ 0.8 and ≤ 2.8 (1.953) in accordance with OECD TG 439.
- the viability of the tissue replicates treated with the positive control is ≤ 20% (4.35%) .
- the standard deviation calculated from 3 identically treated replicates is ≤ 18 (0.6 – 8.1).
- Concurrent negative controls (NC) and positive controls (PC) were used in each run to demonstrate that viability (with the NC), barrier function and resulting tissue sensitivity (with the PC) of the tissues were within a defined historical acceptance range.
Please also refer to the field "Any other information on results incl. tables" below.
Any other information on results incl. tables
Results after treatment with Cobalt silicate olivine and the controls
Treatment Group |
Tissue No. |
OD 570 nm |
Mean OD of |
Mean OD of 3 Wells blank corrected |
Mean OD of 3 tissues |
Rel. Viability [%] Tissue |
Standard Deviation |
Mean Rel. Viability [%] |
||
Well 1 |
Well 2 |
Well 3 |
||||||||
Blank |
|
0.040 |
0.041 |
0.053 |
0.044 |
|
||||
Negative Control |
1 |
2.041 |
1.986 |
2.000 |
2.009 |
1.965 |
1.953 |
100.591 |
1.0 |
100.0 |
2 |
2.019 |
1.953 |
1.951 |
1.974 |
1.930 |
98.803 |
||||
3 |
2.063 |
1.995 |
1.970 |
2.009 |
1.965 |
100.606 |
||||
Positive Control |
1 |
0.154 |
0.143 |
0.132 |
0.143 |
0.098 |
0.085 |
5.036 |
0.6 |
4.35 |
2 |
0.124 |
0.122 |
0.121 |
0.122 |
0.078 |
3.988 |
||||
3 |
0.123 |
0.122 |
0.123 |
0.123 |
0.078 |
4.014 |
||||
Test Item |
1 |
1.713 |
1.681 |
1.674 |
1.689 |
1.645 |
1.809 |
84.211 |
8.1 |
93.39* |
2 |
1.918 |
1.843 |
1.841 |
1.867 |
1.823 |
93.317 |
||||
3 |
2.033 |
1.995 |
1.981 |
2.003 |
1.959 |
100.280 |
||||
Blank |
|
0.038 |
0.039 |
0.039 |
0.039 |
|
||||
Negative Control |
1 |
0.115 |
0.113 |
0.113 |
0.114 |
0.075 |
0.072 |
3.835 |
0.2 |
3.69 |
2 |
0.109 |
0.108 |
0.108 |
0.108 |
0.069 |
3.548 |
||||
Test Item Freeze killed Tissues |
1 |
0.097 |
0.096 |
0.097 |
0.097 |
0.058 |
0.057 |
2.963 |
0.1 |
2.90 |
2 |
0.095 |
0.094 |
0.095 |
0.094 |
0.056 |
2.847 |
* Corrected viability (%) = TI viability – (TI_KC viability – NC_KC viability)
Historical Control Data
Positive Control; OD at 570 nm |
Negative Control OD at 570 nm |
|||
Tissue Viability [%] |
3.98 |
Mean OD |
1.69 |
|
Standard Deviation |
1.01 p.p. |
Standard Deviation |
0.19 |
|
Range of Viabilities |
2.24% - 6.19% |
Range of OD* |
1.28 - 2 |
|
Mean OD |
0.07 |
* should be ≥0.8 and ≤ 2.8 (OECD 439/ MatTek) |
||
Standard Deviation |
0.02 |
|||
Range of OD |
0.03 - 0.11 |
|||
Data of 51 sets of controls shared between 197 studies performed from August 2015 until June 2019 |
||||
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, in this study and under the experimental conditions reported, Cobalt silicate olivine is non-irritant to skin and does not require classification and labelling for skin irritation according to UN GHS and EU CLP.
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