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Diss Factsheets
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EC number: 939-487-8 | 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Study period:
- 9-12 August 1999 (pig skin) and 22-25 September 1999 (human skin)
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Deviations:
- yes
- Remarks:
- (technical difficulties prevented a reliable result from being obtained)
- GLP compliance:
- yes (incl. QA statement)
Test material
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- other: human abdominal skin and pig hind-leg skin
- Strain:
- not specified
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- In vitro test
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 2, 4, 6, 8, 10, 20 and 24 hours
- Doses:
- 10 µl undiluted test material (9.8 mg)/cm2 (or per 0.64 cm2 - study report cites both)
- No. of animals per group:
- In vitro study: 5 human skin and 5 pig skin replicates
- Control animals:
- yes
- Remarks:
- in vitro study: tritiated water and testosterone
- Details on study design:
- In vitro test
- Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin:
- human skin was obtained from one female Caucasian donor of 39 years old after abdominal surgery
- pig skin was obtained from the hind legs of one young female domestic pig (Hollands Landvarken, University of Utrecht) of approx. 30 kg bw directly after sacrifice of the animal
- Ethical approval if human skin: yes
- Type of skin: abdominal (human), hind-leg (pig)
- Preparative technique: briefly, sterile glass rings (internal area 0.64 cm2) were glued to the skin membranes using cyanoacrylate-based glue. Skin membranes were washed 3 times for 15 min in medium supplemented with bactericides and fungicides. The skin membranes were transferred into 6-well plates on a Netwell insert (200 µm mesh), which allows contact of the receptor fluid to the dermal side of the skin, while the stratum coneum remains exposed to the air
- Thickness of skin (in mm): 0.57± 0.03 mm (human); 0.56± 0.03 mm (pig)
- Membrane integrity check: yes
- Storage conditions: on ice
- Justification of species, anatomical site and preparative technique: no data
PRINCIPLES OF ASSAY
- Diffusion cell: 6-well plates
- Receptor fluid: mixture of Dulbecco's Modified Essential Medium and Ham F12 culture medium (2:1) supplemented with Epidermal Growth Factor (10 µg/l), hydrocortisone (400 µg/l, gentamicin (50 mg/l), polyoxyethylene 20 oleyl ether (6%, w/v) and Foetal Calf Serum (10%, v/v)
- Solubility of test substance in receptor fluid: no data
- Static system: yes
- Flow-through system: no
- Test temperature: 32 °C
- Humidity: humidified incubator
- Occlusion: no
- Reference substance(s): water, testosterone
Results and discussion
- Signs and symptoms of toxicity:
- not examined
- Dermal irritation:
- not examined
- Absorption in different matrices:
- - Receptor fluid, receptor chamber, donor chamber (in vitro test system): due to analytical problems, receptor fluid (human skin) was not analysed for the presence of trimethylsilyloxy phenyl silsesquioxane; receptor fluid (pig skin) analysed
- Skin preparation (in vitro test system): due to analytical problems, skin membranes (human and pig skin) were not analysed for the presence of trimethylsilyloxy phenyl silsesquioxane - Total recovery:
- - Total recovery: On cotton swab used to wipe exposure site: 35.1-174.3% (human skin); 30.1 to 107.4% (pig skin)
- Recovery of applied dose acceptable: no
- Results adjusted for incomplete recovery of the applied dose: not applicable
- Limit of detection (LOD): 2 mg/l
- Quantification of values below LOD or LOQ: no
Percutaneous absorption
- Dose:
- 10 µl (9.8 mg)
- Parameter:
- percentage
- Absorption:
- < 0.1 %
- Remarks on result:
- other: 24 hours
- Remarks:
- pig skin: below the limit of detection (2 mg/l extract, 4 µg/l receptor fluid) at all timepoints; no data for human skin due to technical difficulties )
Any other information on results incl. tables
In the study, the analysis of the various samples for the presence of the test material was not successful, mainly due to recurring high background values. Because of these technical difficulties, it was decided to terminate the study.
Applicant's summary and conclusion
- Conclusions:
- In a GLP study, conducted using a protocol similar to OECD test guideline 428, the dermal absorption of trimethylsilyloxy phenyl silsesquioxane was evaluated in vitro in human and pig skin. For pig skin, dermal absorption was <0.1% but, due to technical difficulties, the result should be interpreted with caution. No results were reported for human skin.
- Executive summary:
In a GLP study, conducted using a protocol similar to OECD test guideline 428, the percutaneous absorption of trimethylsilyloxy phenyl silsesquioxane was evaluated in human and pig skin membranes in vitro.
The test material was applied at about 9.8 mg/cm2 and samples of receptor fluid collected periodically over 24 hours. Due to technical difficulties, no reliable analysis of the samples for the presence of the test material was possible and the study was terminated. Some data were generated, which the investigators recommended should be interpreted with caution.
In the pig skin assay, trimethylsilyloxy phenyl silsesquioxane was present at a level below the limit of detection (2 mg/l extract corresponding to 4 µg/ml receptor fluid) at all time points, indicating absorption of <0.1%. Receptor fluid in the human skin assay was not analysed due to technical difficulties.
No reliable results for dermal absorption were obtained from this study.
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.
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