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Diss Factsheets
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EC number: 701-315-2 | CAS number: -
- 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:
- 21 April - 27 May 2016
- 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:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,3-diethenyl-1,1,3,3- tetramethyldisiloxane and its platinum(0) complexes
- EC Number:
- 701-315-2
- IUPAC Name:
- 1,3-diethenyl-1,1,3,3- tetramethyldisiloxane and its platinum(0) complexes
- Test material form:
- liquid
- Details on test material:
- - Physical state: Yellow to brown, aromatic liquid
- Storage: At +10°C to +25°C under inert gas, kept in a tightly closed container and stored in a dry place, protected from heat and direct sunlight.
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- other:
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDermTM (EPI-200, Lot no. 23338) MatTek In Vitro Life Science Laboratories, s.r.o, Mlynské Nivy 73, 821 05 Bratislava II, Slovak Republic
- Source strain:
- other: Reconstructed human epidermis model (see details below)
- Details on animal used as source of test system:
- Not applicable
- Justification for test system used:
- The reconstructed human epidermis model system is suitable to test solids, liquids, semi-solids and waxes. The liquids may be aqueous or non-aqueous; solids may be soluble or insoluble in water.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EpiDerm is a three-dimensional reconstructed human epidermis model, comprised of normal, human-derived epidermal keratinocytes, which had been cultured to form a multilayered, highly differentiated model of the human epidermis. It consisted of organised basal, spinous and granular layers, and a multilayered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo.
The principle of the reconstructed human epidermis model test is based on the premise that irritant substances are able to penetrate the stratum corneum by diffusion and are cytotoxic to the cells in the underlying layers. Cell viability was measured by dehydrogenase conversion of the vital dye MTT (3-[4,5- Dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide, Thiazolyl blue), into a blue formazan salt that was quantitatively measured after extraction from tissues. Irritant substances were identified by their ability to decrease cell viability below defined threshold levels (i.e.≤ 50% for UN GHS category 2 irritants).
The EpiDerm™ System was manufactured according to defined quality assurance procedures. All biological components of the epidermis and the culture medium were tested by the manufacturer for viral, bacterial, fungal and mycoplasma contamination. MatTek corporation determines the ET50 value following exposure to Triton X-100 (1%) for each EpiDerm lot. The ET50 must fall within a range established based on a historical database of results. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 μL of undiluted test item were applied to the skin model with a surface area of 0.63 cm2 to uniformly cover the skin surface. Three replicate tissues were employed. At the end of the exposure period, the test item was carefully washed from the skin surface with D-PBS.
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 μL D-PBS was added to each of the three negative control skin units.
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 μL SDS was added to each of the three positive control skin units.
- Concentration (if solution): 5% aqueous solution - Duration of treatment / exposure:
- Exposure for 60 minutes: 35 minutes at 37°C, 5% CO2 and 95% humidity followed by 25 minutes at room temperature.
- Duration of post-treatment incubation (if applicable):
- The post-treatment incubation period of the rinsed tissues in fresh assay medium was 42 hours.
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- Score is a percentage (%) of negative control.
- Run / experiment:
- Mean
- Value:
- 90.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- The mean OD of the NC of 3 tissues was 1.773 and was well within the acceptable range of ≥ 1.0 to ≤ 2.5.
- Positive controls validity:
- valid
- Remarks:
- The viability of cells treated with the PC was 6.0% of the NC and fulfilled the acceptance criterion of ≤ 20%.
- Remarks on result:
- no indication of irritation
- Remarks:
- If the mean relative viability <=50% the test substance is considered to be irritant to skin.
- Other effects / acceptance of results:
- The standard deviation of all triplicates determined was below the limit of acceptance of 18%. Hence, all acceptance criteria required were fulfilled.
Any other information on results incl. tables
No discolorations were noted in the test for colour change under aqueous conditions. Additionally, no change of colour was noted in the test for MTT interference potential. Therefore the test item did not interact with the MTT measurement and no additional test had to be performed.
The summary of the OD results is given below:
Optical density (n=3 tissues) | SD | % OD540 compared to the control | |
Negative control (D-PBS) | 1.773 | 0.0907 | - |
"Karstedt concentrate" | 1.607 | 0.091 | 90.6 |
Positive control (5% SDS) | 0.106 | 0.012 | 6.0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an in vitro EpiDerm assay conducted in accordance with OECD Test Guideline 439 and to GLP, "Karstedt concentrate" was non-cytotoxic and, hence, non-irritant to skin.
- Executive summary:
“Karstedt concentrate” was tested for skin irritation potential in an in vitro EpiDerm assay, using reconstructed human epidermis, conducted in accordance with OECD Test Guideline 439 and to GLP. The mean cell viability following exposure to the test substance was calculated to be greater than 50% (90.6% of the negative controls), and it was therefore considered to be non-cytotoxic and predicted to be non-irritant to skin. The positive and negative controls were considered valid.
Under the conditions of this assay, “Karstedt concentrate” would not be classified as "irritant" according to EU CLP criteria (EC 1272/2008).
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