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EC number: 212-042-9 | CAS number: 754-05-2
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 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:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Version / remarks:
- Feb. 4, 2015
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
Test material
- Reference substance name:
- Trimethylvinylsilane
- EC Number:
- 212-042-9
- EC Name:
- Trimethylvinylsilane
- Cas Number:
- 754-05-2
- Molecular formula:
- C5H12Si
- IUPAC Name:
- trimethylvinylsilane
Constituent 1
- Specific details on test material used for the study:
- purity: 99.59%
In chemico test system
- Details on the study design:
- TEST-SUBSTANCE PREPARATION
- Stock solution: 100 mM
- Vehicle: acetonitrile
- Reason for the vehicle: The test substance is soluble in acetonitrile
CONTROLS
- Reference controls: acetonitrile
- Co-elution control: buffer and test substance without the peptide
- Positive control: cinnamic aldehyde in acetonitrile
PEPTIDES
Synthetic peptides:
- Cysteine- (C-) containing peptide: Ac-RFAACAA
- Lysine- (K-) containing peptide: Ac-RFAAKAA
Stock solution:
- C-containing peptide: 0.667 mM of peptide in pH 7.5 phosphate buffer
- K-containing peptide: 0.667 mM of peptide in pH 10.2 ammonium acetate buffer
Ratios
- C-containing peptide: ratio of 1:10
- K-containing peptide: ratio of 1:50
EXPERIMENTAL PROCEDURE
- Replicates: 3 for each peptide
- Determination remaining non-depleted peptide concentration: HPLC at 220nm: HPLC analysis st
arted 24 to 26 hours after sample preparation and the analysis time was less than 30 hours.
- Calibration samples: samples of a known peptide concentration are measured in parallel
PREPARATIONS SAMPLES
- Calibration sample was prepared from the peptide stock solution (0.667 mM) in acetonitrile in the respective buffer using serial concentrations of 0.534 - 0.017 mM peptide.
- Test-substance samples: samples were incubated at 25°C +/- 2.5°C in the dark for 24 +/- 2 hours and visually investigated for any precipitate that may occur during the exposure period.
- Preparation of vehicle control: in triplicated in the same way as the test-substance samples described above but with acetonitrile instead of the test substance.
- Preparation of co-elution control: in the same way as the test-substance sampled described above but without the peptide, instead buffer was used.
MEASUREMENT PEPTIDE CONCENTRATIONS
- Method: HPLC Agilent 1200 Series
- Wavelength: 220 nm and 258 nm
- Detection: UV Detector
DATA EVALUATION
The concentration of the cysteine an lysine peptide is determined in each sample from absorbance at 220 nm, measuring the area of the appropriate peaks (peak area (PA)) and calculating the concentration of peptide using the linear calibration curves derived from the standard solutions. The percent peptide depletion (PPD) is calculated as:
(1- (Peptide Peak Area in the Replicate Injection/Mean Peptide Peak Area in the Reference Control C))*100
ACCEPTANCE CRITERIA
- the standard calibration curve should have an r2 > 0.99
- the mean PPD value of the three replicates for the positive control is between 60.8% and 100% for the cysteine peptide and the maximum standard deviation (SD) for the positive control replicates is < 14.9%
- the mean PPD value of the three replicates for the positive control is between 40.2% and 69.0% for the lysine peptide and the maximum SD for the positive control replicates is < 11.6%
- the mean peptide concentration of the three reference control A replicatres is 0.50 +/- 0.05 mM
- the coefficient of variation (CV) of nine vehicle controls B and C should be < 15%
EVALUATION RESULTS
Chemical reactivity was determined by mean peptide depletion [%] and was rated as
- high: mean peptide depletion > 42.47
- moderate: mean peptide depletion > 22.62 ≤ 42.47
- low: mean peptide depletion > 6.38 ≤ 22.62
- minimal: mean peptide depletion ≤ 6.38
High, moderate and low reactivity are evaluated as positive.
In case the mean peptide depletion cannot be determined due to invalid K-peptide depletion the evaluation is performed as follows:
- high: mean peptide depletion > 98.24
- moderate: mean peptide depletion > 23.09 ≤ 98.24
- low: mean peptide depletion > 13.89 ≤ 23.09
- minimal: mean peptide depletion ≤ 13.89
High, moderate and low reactivity are evaluated as positive.
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- mean
- Parameter:
- other: Lysine peptide depletion
- Value:
- 0
- Negative controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Run / experiment:
- mean
- Parameter:
- other: Cysteine peptide depletion
- Value:
- 0
- Negative controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: No indication of skin sensitisation potential.
- Executive summary:
The skin sensitisation potential of trimethylvinylsilane was assessed via the in vitro DPRA assessment in accordance with OECD guideline 442C.
The test item exhibited a mean lysine peptide depletion of 0% and a mean cysteine peptide depletion of 0%.
Hence, the DPRA assessment does not indicate for the substance to have a potential for skins sensitisation.
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