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EC number: 208-904-9 | CAS number: 546-56-5
- 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:
- 2 March 2017 to 24 April 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- 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:
- 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Octaphenylcyclotetrasiloxane
- EC Number:
- 208-904-9
- EC Name:
- Octaphenylcyclotetrasiloxane
- Cas Number:
- 546-56-5
- Molecular formula:
- C48H40O4Si4
- IUPAC Name:
- octaphenyl-1,3,5,7,2,4,6,8-tetraoxatetrasilocane
- Test material form:
- solid
- Details on test material:
- - Density: 1.185 g/cm3
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: 25 µL of sterile DPBS was applied to the epidermal surface in order to improve the contact between the powder and the epidermis. Afterwards, 25 mg (39 mg/cm2) of the test item was applied directly atop the EpiDermTM tissue using an application spoon avoiding compression of the test item. The test item was spread to match size of the tissue by gently shaking the inserts or by using a bulb-headed Pasteur pipette.
- Preliminary purification step (if any): not specified
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: not specified
- Source strain:
- not specified
- 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 epidermal keratinocytes (NHEK) and therefore represents in vitro the target organ of the species of interest and closely mimics the biochemical and physiological properties of the upper parts of the human, i.e. the epidermis.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™
- Tissue batch number(s): 25086
- Production date: not specified
- Shipping date: not specified
- Delivery date: not specified
- Date of initiation of testing: not specified
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 +/- 1 °C, 5.0% CO2
- Temperature of post-treatment incubation (if applicable): 37 +/- 1 °C, 5.0% CO2
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: The tissues were washed by filling and emptying the inserts 15 times with DPBS using a constant stream in about 1.5 cm distance from the tissue surface.
- Observable damage in the tissue due to washing: No damage specified.
- Modifications to validated SOP: Not specified
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 5 mg/mL MTT
- Incubation time: 3 h +/- 5 min at 37 +/- 1 °C, 5.0% CO2, humidified to 95%.
- Spectrophotometer: plate spectrophotometer using isopropanol as a blank.
- Wavelength: 570 nm
- Filter: OD was measured at 570 nm with a filter band pass of maximum ± 30 nm without reference wavelength.
- Filter band width: Not specified
- Linear OD range of spectrophotometer: yes
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: 1.581+/-0.238, acceptance criteria OD (540-570 nm) [1.0-3.0]
- Barrier function: 5.58 h, acceptance criteria ET-50 [4.77-8.72 h]
- Morphology: not specified
- Contamination: No contamination was detected.
- Reproducibility: Not specified.
NUMBER OF REPLICATE TISSUES: Triplicate tissues
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues / killed tissues: killed tissues
- Procedure used to prepare the killed tissues (if applicable): not specified
- N. of replicates : duplicate
- Method of calculation used: NSMTT (non-specific MTT) was then calculated relative to the negative control of living tissues (NK) according to the following formula:
NSMTT [%] = [(ODKT - ODKU)/ODNK] * 100
If the test item is classified as non-irritant and if non-specific MTT reduction is ≤ 30% relative to the negative control of living epidermis, the true MTT metabolic conversion (TODTT) of the test item treated living tissues TM was corrected according to the following formula:
TODTT = ODTM – (ODKT – ODKU)
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: One
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the mean relative tissue viability after 1 hour exposure is less than 50%.
- The test substance is considered to be non-corrosive to skin if the mean relative tissue viability after 1 hour exposure is greater than or equal to 50%.
- Justification for the selection of the cut-off point(s) if different than recommended in TG 431 and 439: not applicable - Control samples:
- yes, concurrent positive control
- other: Negative control: Dulbecco’s phosphate buffered saline (DPBS);
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg + 25 µL DPBS
NEGATIVE CONTROL
- Concentration (if solution): 30 µL DPBS
POSITIVE CONTROL
- Concentration (if solution): 30 µL 5% SDS solution - Duration of treatment / exposure:
- 60 min
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- Triplicate tissues were used.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- No 1 expressed in percentage of negative control
- Value:
- > 50
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: none observed
- Direct-MTT reduction: The test item showed no non-specific reduction of MTT. Therefore, no additional controls were necessary.
- Colour interference with MTT: The test item showed no colouring after mixture with aqua dest. and isopropanol.
DEMONSTRATION OF TECHNICAL PROFICIENCY:
- Mean Absolute OD570 nm Negative control (NC): 2.038, cut off 0.8 ≤ NK ≤ 2.8
- Relative Viability [%] Positive control (PC): 3.5, cut off ≤ 20%
- SD Viability [%]: 0.2 – 4.9, cut off ≤ 18%
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
- Range of historical values if different from the ones specified in the test guideline: not applicable
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the in vitro skin irritation study with octaphenylcyclotetrasiloxane (CAS 546-56-5) using EpiDermTM tissue, the reported mean relative tissue viability (% negative control) was > 50 % (91.4 %) after 60 minutes treatment and 42 hours post-incubation.
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