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Diss Factsheets
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EC number: 611-631-1 | CAS number: 58190-57-1
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 11, 2012 - July 13, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test method according to OECD Guideline 439. GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 5-ethyl-2,8-dimethyl-5-{[(propan-2-ylidene)amino]oxy}-4,6-dioxa-3,7-diaza-5-silanona-2,7-diene
- EC Number:
- 611-631-1
- Cas Number:
- 58190-57-1
- Molecular formula:
- C11H23N3O3Si
- IUPAC Name:
- 5-ethyl-2,8-dimethyl-5-{[(propan-2-ylidene)amino]oxy}-4,6-dioxa-3,7-diaza-5-silanona-2,7-diene
- Details on test material:
- - Name of test material (as cited in study report): EAC3
- Physical state: Liquid
- Purity: 92.13%
- Lot/batch No.: 1000061820
- Expiration date of the lot/batch: 11 January 2013
- Storage condition of test material: Controlled Room Temperature (15-25°C, below 70 RH%), Protected from humidity
Constituent 1
Test animals
- Species:
- other: In vitro: Human skin
- Details on test animals or test system and environmental conditions:
- The test system used was EPISKIN-SM, a three-dimensional human epidermis model.
Test system
- Type of coverage:
- other: In-vitro test
- Preparation of test site:
- other: In-vitro test
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: In-vitro test. Negative and positive controls were conducted.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL - Duration of treatment / exposure:
- 15 minutes.
- Observation period:
- After approx. 42 hours.
- Number of animals:
- Not applicable: In-vitro test.
3 replicate wells for the test item and 3 negative controls + 3 positive controls were used - Details on study design:
- PRE-INCUBATION (Day -1):
The assay platewells were filled with a pre-warmed medium (2 mL per well, 37 ºC). The epidermis units were placed, with the media below in contact with the epidermis, into each prepared well and then incubated overnight at 37°C in an incubator with 5% CO2.
APPLICATION AND RINSING (Day 0):
- Test skin units: 50 μL of test item (3 replicates)
- Negative control skin units: 50 μL Phosphate Buffered Saline (PBS) (3 replicates)
- Positive control skin units: 50 μL Sodium Dodecyl Sulphate (SDS) 5% aq. solution (3 replicates)
- For additional control for staining effects of the test item, 50 μL of the test item was applied evenly to the epidermal surface.
The treated plates were incubated for 15 min. exposure time at room temperature (21.7-22.3 ºC). Then, the EPISKIN-SM units were removed and rinsed with PBS 1x solution (0.9%). The units were place into the plate well with fresh pre-warmed maintenance medium (2mL/well) and incubated for 42 h at 37 ºC with 5% CO2.
MTT TEST (Day 2):
The EPISKIN-SM units were transferred into the MTT solution filled wells (2 mL of 0.3 mg/mL MTT per well). The staining control well instead, was transferred to well filled with fresh assay medium. The units were incubated for 3 h at 37 ºC with 5% CO2, protected from light.
FORMAZAN EXTRACTION (Day 2):
The epidermises from each disk were separated with the aid of forceps and both parts (epidermis and collagen matrix) and were placed into a tube of 500 µL acidified isopropanol. The capped tubes were thoroughly mixed by using a vortex mixer and then incubated for 2 hours at room temperature protected from light with gentle agitation (~150 rpm) for formazan extraction.
CELL VIABILITY MEASUREMENT (Day 2):
2×200 μL samples from each tube were placed into the wells of a 96-well plate. The OD (Absorbance / Optical Density) of the samples in a 96-well plate spectrophotometer was read at a wavelength 540 nm, using acidified isopropanol solution blank (6×200 μL). The viability was expressed as a % relative to negative control.
Results and discussion
In vivo
- Irritant / corrosive response data:
- The mean relative viability of test item EAC3 after 15 minutes exposure and 42 hours post incubation period (based on the optical activity measured at 540 nm) was 115% (SD± 8.89). According to EU classification, the substance was determined to be non-irritant since the mean tissue viability % was >50.
Any other information on results incl. tables
CELL VIABILITY:
The results of the optical density (OD) measured at 540 nm of each extract and the calculated % viability of the cells:
Substance |
Optical density (OD) |
Viability (%) |
|
Negative control (PBS) |
1 |
0.797 |
104 |
2 |
0.744 |
97 |
|
3 |
0.753 |
98 |
|
Mean |
0.765 |
100 |
|
Stand. dev. (SD) |
3.79 |
||
Positive control (SDS 5%) |
1 |
0.246 |
32 |
2 |
0.207 |
27 |
|
3 |
0.083 |
11 |
|
Mean |
0.179 |
23 |
|
Stand. dev. (SD) |
10.97 |
||
Test ítem (EAC3) |
1 |
0.856 |
112 |
2 |
0.959 |
125 |
|
3 |
0.823 |
108 |
|
Mean |
0.879 |
115 |
|
Stand. dev. (SD) |
8.89 |
VALIDITY OF THE TEST:
The mean OD value of the three negative control tissues was 0.765.
The positive control result showed a mean of 23% viability.
Each standard deviation value (SD) of the % viability was below 18.
Control OD values were below historically established boundaries.
The SD calculated from individual % tissues viabilities of the three identically test item treated replicates was 8.89.
All validity criteria were within acceptable limits and therefore the study can be considered as valid.
INDICATOR FOR POTENTIAL FALSE VIABILITY:
The test material did not interact with the MTT (based on no colour change observed).
The non specific colour % was calculated as 3.5% (below the threshold of 5.0) and therefore additional data calculation was not necessary.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The mean relative viability of test item EAC3 after 15 minutes exposure and 42 hours post incubation period was 115% (SD± 8.89). According to EU classification, the substance is considered to be non-irritant since the mean tissue viability % was >50.
- Executive summary:
An in-vitro skin irritation test in the EPISKIN model was performed on the substance EAC3 in accordance with OECD Guideline 439 and GLP. Disks of EPISKIN (three units / chemical) were treated with EAC3 and incubated for 15 minutes at room temperature. Exposure of test material was terminated by rinsing with PBS. Epidermis units were then incubated at 37°C for 42 hours in an incubator with 5% CO2. The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution at 37°C in 5% CO2 protected from light. The formazan extract in acidified isopropanol was then spectrophotometrically evaluated for optical density (OD) and quantified. SDS 5% and PBS treated epidermis were used as positive and negative controls respectively. For each treated tissue, optical density (OD) was calculated and the tissue viability was expressed as a % relative to negative control. Following exposure with EAC3, the mean treated skin value was 115% and therefore non-irritant to the skin (>50%). All validity criteria were within acceptable limits and therefore the study can be considered as valid.
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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