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EC number: 605-200-7 | CAS number: 160194-28-5
- 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:
- 2014-06-17 to 2014-06-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study described in this report has been correctly reported and was conducted in compliance with: The Organization for Economic Co-operation and Development (OECD) Principles of Good Laboratory Practice (GLP) (as revised in 1997) ENV/MC/CHEM (98) 17.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes
Test material
- Reference substance name:
- triethyl({[4-(triethylsilyl)but-3-yn-1-yl]oxy})silane
- EC Number:
- 605-200-7
- Cas Number:
- 160194-28-5
- Molecular formula:
- C16H34OSi2
- IUPAC Name:
- triethyl({[4-(triethylsilyl)but-3-yn-1-yl]oxy})silane
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- - Name of test material (as cited in study report): Bis-Tes (dried)
- Molecular formula (if other than submission substance): C16H34OSi2
- Molecular weight (if other than submission substance): 298
- Physical state: Pale yellow liquid
- Storage condition of test material: At room temperature in the dark under nitrogen
- Other:
Constituent 1
Test animals
- Species:
- other: in vitro human skin model
- Details on test animals or test system and environmental conditions:
- Human Skin Model
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 µl
- Concentration (if solution): Undiluted - Duration of treatment / exposure:
- 15 minutes
- Observation period:
- 42 hour
- Number of animals:
- The test was performed on a total of 3 tissues per test substance together with negative and positive controls.
- Details on study design:
- The test is based on the experience that irritant chemicals show cytotoxic effects following short term
exposure to the stratum corneum of the epidermis. The test is designed to predict and classify the skin
irritation potential of a test substance by assessment of its effect on a three dimensional human
epidermis model (1-10).
The test consists of topical application of Bis-Tes (dried) on the skin tissue for 15 minutes. After
exposure the skin tissue is thoroughly rinsed to remove the test substance and transferred to fresh
medium. After a 42 hour incubation period, determination of the cytotoxic (irritancy) effect is
performed.
Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by
formazan production from 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) at the
end of the treatment.
The test was performed on a total of 3 tissues per test substance together with negative and positive
controls. Twenty five µl of the undiluted test substance was added (with a pipette) into 12-well plates
on top of the skin tissues. Three tissues were treated with 25 µl PBS (negative control) and 3 tissues
with 25 µl 5% SDS (positive control) respectively. The positive control was re-spread after 7 minutes
contact time. After the exposure period of 15 minutes at room temperature, the tissues were washed
with phosphate buffered saline to remove residual test substance. After rinsing the cell culture inserts
were each dried carefully and moved to a new well on 2 ml pre-warmed maintenance medium until all
tissues were dosed and rinsed. Subsequently the skin tissues were incubated for 42 hours at 37°C.
After incubation, cell culture inserts were dried carefully to remove excess medium and were
transferred into a 12-wells plate prefilled with 2 ml MTT-medium (0.3 mg/ml). The tissues were
incubated for approximately 3 h at 37°C. After incubation the tissues were placed on blotting paper to
dry the tissues. Total biopsy was made by using a biopsy punch. Epidermis was separated from the
collagen matrix and both parts were placed in prelabeled microtubes and extracted with 500 µl
isopropanol. Tubes were stored refrigerated and protected from light for
68 hours. The amount of extracted formazan was determined spectrophotometrically at 570 nm in
duplicate with the TECAN Infinite® M200 Pro Plate Reader.
Cell viability was calculated for each tissue as a percentage of the mean of the negative control
tissues. Skin irritation potential of the test substance was classified according to remaining cell viability
following exposure of the test substance.
Results and discussion
In vitro
Resultsopen allclose all
- Remarks on result:
- other:
- Irritation / corrosion parameter:
- other: other: mean relative tissue viability
- Value:
- ca. 103
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 15 mins. Remarks: expressed as % . (migrated information)
In vivo
- Irritant / corrosive response data:
- Bis-Tes (dried) is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.
- Other effects:
- Bis-Tes (dried) was checked for possible direct MTT reduction by adding the test substance to MTT
medium. Because no colour change was observed it was concluded that Bis-Tes (dried) did not
interact with MTT.
The positive control had a mean cell viability after 15 minutes exposure of 35%. The absolute mean
OD570 of the negative control tissues was within the laboratory historical control data range.
The standard deviation value of the percentage viability of three tissues treated
identically was less than 8%, indicating that the test system functioned properly.
Any other information on results incl. tables
Mean tissue viability in the in vitro skin irritation test with Bis-Tes (dried)(expressed as % of control)
negative control 100%
Bis-Tes (dried): 103%
Postive control 35%
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- It is concluded that this test is valid and that Bis-Tes (dried) is non-irritant in the in vitro skin
irritation test under the experimental conditions described in this report. - Executive summary:
In vitro skin irritation test with Bis-Tes (dried) using a human skin model.
This report describes the ability of Bis-Tes (dried) to induce skin irritation on a human three
dimensional epidermal model (EPISKIN Small Model (EPISKIN-SMTM)). The possible skin irritation
potential of Bis-Tes (dried) was tested through topical application for 15 minutes.
The study procedures described in this report were based on the most recent OECD and EC
guidelines.
Batch 209-3 of Bis-Tes (dried) was a pale yellow liquid. Bis-Tes (dried) was applied undiluted (25 µl)
directly on top of the skin tissue for 15 minutes. After a 42 hour post-incubation period, determination
of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of
mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the
treatment.
Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The
relative mean tissue viability obtained after 15 minutes treatment with Bis-Tes (dried) compared to the
negative control tissues was 103%. Since the mean relative tissue viability for Bis-Tes (dried) was
above 50% after 15 minutes treatment Bis-Tes (dried) is considered to be non-irritant.
The positive control had a mean cell viability of 35% after 15 minutes exposure. The absolute mean
OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical
control data range. The standard deviation value of the percentage viability of three tissues treated
identically was less than 8%, indicating that the test system functioned properly.
Finally, it is concluded that this test is valid and that Bis-Tes (dried) is non-irritant in the in vitro skin
irritation test under the experimental conditions described in this report.
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