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EC number: 700-718-0 | 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 22.12.2011 - 06.04.2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Conducted according to OECD Guideline under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline no. 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method (adopted 22 July 2010).
- 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:
- reaction mass of bis(C11-14-alkyl, branched and linear)amine nonadecaoxo hexatungstate
- IUPAC Name:
- reaction mass of bis(C11-14-alkyl, branched and linear)amine nonadecaoxo hexatungstate
- Test material form:
- liquid: viscous
- Details on test material:
- - Molecular formula (if other than submission substance): [R2NH2]2[W6O19];R=C11-C14alkyl (branched and linear) * 4R2NH
- Physical state: Clear yellow viscous liquid (determined at NOTOX)
- Analytical purity: UVCB
- Lot/batch No.: PB-39-131
- Expiration date of the lot/batch: 01 December 2012 (allocated by NOTOX, 1 year after receipt of the test substance)
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
Constituent 1
Test animals
- Species:
- other: adult human-derived epidermal keratinocytes.
- Details on test animals or test system and environmental conditions:
- Not applicable
Test system
- Controls:
- other: Not applicable
- Amount / concentration applied:
- Not applicable
- Duration of treatment / exposure:
- Not applicable
- Observation period:
- Not applicable
- Number of animals:
- Not applicable
- Details on study design:
- Test substance preparation
The test substance has a sticky consistence and was applied using a cotton swab directly on top of the skin tissue. The test substance was spread to match the size of the tissue.
Reference substances
Negative control:
Phosphate buffered saline (PBS, Invitrogen Corporation,, The Netherlands).
Positive control:
5% (aq) Sodium dodecyl sulphate (SDS, Sigma Aldrich, Zwijndrecht, The Netherlands) [CAS Number 151-21-3] in PBS.
Test system
EPISKIN Small Model (TM) (EPISKIN-SM(TM), 0.38 cm2, Batch no.: 12-Ekin-011).
This model is a three-dimensional human epidermis model, which consists of adult human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. The keratinocytes were cultured for 13 days, which results in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
Source: SkinEthic Laboratories, Lyon, France.
Preparation and preincubation
Tissue
On the day of receipt the tissues were transferred to 12-well plates and preincubated with prewarmed Maintenance Medium for 24 hours at 37 degrees Centigrade. Maintenance medium and Assay medium were supplied by Skinethic Laboratories, Nice, France.
Killed tissue (EPISKIN-SM)TM), 0.38 cm2, Lot no.: 12 Ekin-007, received: 14 February, 2012)
Living epidermis was transferred to 12-well plates and incubated with 2 ml Milli-Q for 48 +/- 1 hours. After incubation, killed epidermis was stored at <= 15 degrees Centigrade. Killed tissues were thawed by placing them for 1 hour at room temperature in 12-well plateson 2 ml maintenance medium. Further use of killed tissues was similar to living tissues.
MTT medium
MTT concentrate (Sigma Aldrich, Zwijndrecht, The Netherlands; 3 mg/ml in PBS) diluted (10 x) in Assay medium (final concentration of 0.3 mg/ml).
Environmental conditions
All incubations, with the exception of the test substance incubation of 15 minutes at room temperature, were carried out in a controlled environment, in which optimal conditions were a humid atmosphere of 80 - 100% (actual range 75 - 97%), containing 5.0 +/- 0.5% CO2 in air in the dark at 37.0 ± 1.0 degrees Centigrade (actual range 35.2 - 37.6 degrees Centigrade). Temperature and humidity were continuously monitored throughout the experiment. The CO2 percentage was monitored once on each working day. Temporary deviations from the temperature (in the range of 35.2 - 36.0 degrees Centigrade) and humidity (with a maximum of 5%) occurred that were caused by opening and closing of the incubator door, but the time of these deviations did not exceed 1 hour. Based on laboratory historical data these deviations are considered not to affect the study integrity.
Study design
Test for reduction of MTT by the test substance
The test substance was checked for possible direct MTT reduction before the study was started. To assess the ability of the test substance to reduce MTT, 21 mg of the test substance was added to a 12 well plate filled with 2 ml MTT solution (0.3 mg/ml in PBS). The mixture was incubated for 3 hours at 37 degrees Centigrade. A negative control, sterile Milli-Q water was tested concurrently.
In case the test substance reacts with the MTT medium in addition to the normal procedure, three killed tissues treated with test substance and three killed non-treated tissues must be used for the cytotoxicity evaluation with MTT.
Application/Treatment of the test substance
The test was performed on a total of 3 tissues per test substance together with negative and positive controls. The undiluted test substance was added (using a cotton swab) into 12-well plates on top of the skin tissues. Due to the sticky consistence of the test substance, dead tissue was separated from the collagen matrix and the skin was damaged. Three tissues were treated with 25 microL PBS (negative control) and 3 tissues with 25 microL 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 44 hours at 37 degrees Centigrade.
Cell viability measurement
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 3 h at 37 degrees Centigrade. 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 (Merck, Darmstadt, Germany). Tubes were stored refrigerated and protected from light for 70 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
Results
- Irritation / corrosion parameter:
- other: other: tissue viability
- Value:
- 125
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 15 minutes. Max. score: 100.0. Remarks: scores as percentage relative to negative control (100%). (migrated information)
In vivo
- Irritant / corrosive response data:
- The test substance was checked for possible direct MTT reduction by adding the test substance to MTT medium. Because a colour change was observed it was concluded that the test substance did interact with MTT.
In addition to the normal procedure, three killed tissues treated with test substance and three killed non treated tissues were used for the cytotoxicity evaluation with MTT. The non-specific reduction of MTT by the test substance was 5% of the negative control tissues. The net OD of the treated killed tissues was subtracted from the ODs of the test substance treated viable tissues.
Any other information on results incl. tables
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 the test substance compared to the negative control tissues was 125%. Since the mean relative tissue viability for the test substance was above 50% the test substance is considered to be non-irritant.
The positive control had a mean cell viability after 15 minutes exposure of 5%. 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.
Mean tissue viability with test substance
|
Mean tissue viability (percentage of control) |
Negative control |
100 |
Test substance |
125 |
Positive control |
5 |
Individual OD measurements at 570 nm
|
A (OD570) |
B (OD570) |
C (OD570) |
Negative control OD570measurement 1 OD570measurement 2 |
0.950 0.989 |
0.983 1.010 |
1.012 1.043 |
Test substance on viable tissue OD570measurement 1 OD570measurement 2 |
0.987 1.539 |
1.116 1.346 |
1.264 1.483 |
Test substance on killed tissue OD570measurement 1 OD570measurement 2 |
0.104 0.204 |
0.130 0.127 |
0.116 0.156 |
Non treated killed tissue OD570measurement 1 OD570measurement 2 |
0.073 0.104 |
0.072 0.113 |
0.075 0.085 |
Positive control OD570measurement 1 OD570measurement 2 |
0.087 0.093 |
0.081 0.107 |
0.084 0.099 |
OD = Optical density
Triplicate exposures are indicated by A, B and C.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an OECD 439 study (In Vitro Skin Irritation: Reconstituted Human Epidermis Test Method), conducted according to GLP, reaction mass of bis(C11-14-alkyl, branched and linear)amine nonadecaoxo hexatungstate (the surrogate substance) is a non-irritant (Notox B.V., 2012).
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