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EC number: 215-180-8 | CAS number: 1310-53-8
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- version 28 July 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Germanium dioxide
- EC Number:
- 215-180-8
- EC Name:
- Germanium dioxide
- Cas Number:
- 1310-53-8
- Molecular formula:
- GeO2
- IUPAC Name:
- Germanium dioxide
- Test material form:
- solid: particulate/powder
- Details on test material:
- Batch number: 968
Description: White Solid (powder)
Purity: 99.9%
Storage conditions: Controlled room temperature (15-25°C, below 70% RH%)
Safety precautions: Routine safety precautions (lab coat, gloves, safety glasses and face mask) for unknown materials were applied to assure personnel health and safety."
Grain size: d50: 14.3 µm
Bulk density: 0.9-1.2 kg/l
Moisture: ≤ 0.5%
Chlorine (Cl): 118 ppm
Aluminium (Al): <0.2 ppm
Calcium (Ca) <0.2 ppm
Iron (Fe) <0.2 ppm
Silicon (Si) <1ppm
solubility >4.5g/l
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- skin obtained from plastic surgery from multiple donors
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKINTM (SM) (Manufacturer: SkinEthic, France
- Tissue batch number(s):16-EKIN-023
- Expiry Date: 13 June 2016
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 25.1-26.8°C
- Temperature of post-treatment incubation (if applicable): 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 1wahsing step: rinsing thoroughly with PBS 1x solution (0.9%)
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 2 mL of 0.3 mg/mL MTT per well
- Incubation time: 3h
- Spectrophotometer: 96-well plate spectrophotometer
- Wavelength: 570nm
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE (see any other info on mat and meth) - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 10mg
VEHICLE
- Amount(s) applied (volume or weight with unit): na; no formulation was required
NEGATIVE CONTROL: PBS
- Concentration (if solution): 50µl
POSITIVE CONTROL: SDS 5%
- Concentration (if solution): 50µl - Duration of treatment / exposure:
- 15 minutes (± 0.5 min)
- Duration of post-treatment incubation (if applicable):
- 42h
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 83.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
The results of the optical density (OD) measured at 570 nm of each sample and the
calculated relative viability % values are presented below:
Table: Optical Density mean (OD) and the calculated relative viability % of the samples
Substance |
Optical Density (OD) |
Viability (% RV) |
|||
|
Measured |
Blank corrected |
|||
Negative Control: |
1 |
0.697 |
0.649 |
90.1 |
|
Phosphate buffered saline |
2 |
0.792 |
0.744 |
103.4 |
|
|
3 |
0.815 |
0.767 |
106.5 |
|
|
mean |
-- |
0.720 |
100.0 |
|
Positive Control: |
1 |
0.082 |
0.034 |
4.8 |
|
5% (w/v) SDS solution |
|
2 |
0.096 |
0.048 |
6.7 |
|
3 |
0.082 |
0.034 |
4.8 |
|
|
mean |
-- |
0.039 |
5.4 |
|
Test Item: |
1 |
0.691 |
0.643 |
89.4 |
|
GERMANIUM DIOXIDE |
2 |
0.612 |
0.564 |
78.3 |
|
|
3 |
0.639 |
0.591 |
82.1 |
|
|
mean |
-- |
0.600 |
83.3 |
Notes:
1. Mean blank value was 0.048.
2. Optical density means the mean value of the duplicate wells for each sample (rounded to three
decimal places).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this in vitro skin irritation test in the EPISKIN model with germanium dioxide the results indicated that the test item is Non Irritant
- Executive summary:
Disks of EPISKINTM(SM) (three units) were treated with the test item and incubated for 15 minutes at room temperature. Exposure of the test item was terminated by rinsing with Phosphate Buffered Saline (PBS). The epidermis units were then incubated at 37°C for 42 hours in an incubator with 5% CO2. The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution atin an incubator with 5% CO2protected from light. The precipitated formazan crystals were then extracted using acidified isopropanol and quantified spectrophotometrically.
PBS and 5% (w/v) Sodium Dodecyl Sulphate (SDS) solution treated epidermis were used as negative and positive controls, respectively (three units /control). Two additional disks were used to provide an estimate of colour contribution (NSCliving) from the test item. For each treated tissue, the viability was expressed as a % relative to the negative control. If the mean relative viability after 15 minutes exposure and 42 hours post incubation is less or equal (≤) to 50% of the negative control, the test item is considered to be irritant to skin.
Following exposure with GERMANIUM DIOXIDE, the mean cell viability was 83.3% compared to the negative control. This is above the threshold of 50%, therefore the test item was considered as being non-irritant to skin. The experiment met the validity criteria, therefore the study was considered to be valid.
In conclusion, in this in vitro EPISKIN model test with GERMANIUM DIOXIDE(Batch number: 968), the results indicate that the test item is non-irritant to skin.
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