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EC number: 692-842-6 | CAS number: 1312296-85-7
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for Testing of Chemicals No. 431, April 13, 2004 (“In vitro Skin Corrosion: Human Skin Model Test”)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for Testing of Chemicals No. 439, July 22, 2010 (“In vitro Skin Irritation: Reconstructed Human Epidermis Test Method”)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - CAS No.: 1312296-85-7
- Purity: 100.4 g/100 g determined by 1H-NMR-analysis.
- Homogeneity: The test substance was homogeneous by visual inspection.
- Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- pH-value: Ca. 5 (undiluted test substance, moistened with water)
- Physical state: Solid
Constituent 1
Test animals
- Species:
- other: not applicable; in vitro test
- Strain:
- other: not applicable; in vitro test
- Details on test animals or test system and environmental conditions:
- TEST SYSTEM
- The test system (target tissue): three dimensional human epidermis model.
The EpiDerm™ model (Epi-200) consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDem™ tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs®, 10 mm ∅) and commercially available as kits (EpiDerm™ 200), containing 24 tissues on shipping agarose.
- Supplier: MatTek Corp., Ashland MA, USA.
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: in vitro test (direct application)
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: in vitro test; 50 µL highly de-ionized water (corrosion test); 30 µL PBS, sterile (irrritation test) were used as negative controls. 50 μL of 8 n potassium hydroxide (corrosion test); 30 μL of 5% SDS (irritation test) were used as positive controls.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): first, 25 μL highly de-ionized water was applied. Thereafter, a bulk volume of 25 μL of the solid test material (about 13 mg) was applied with a sharp spoon and homogeneously distributed with the water. - Duration of treatment / exposure:
- 3 min or 1 h (corrosion test); 1 h (irritation test)
- Observation period:
- until all tissues per application time were dosed (corrosion test); 24 ± 2 h [incubation] + 18 ± 2 h [postincubation] (irritation test)
- Number of animals:
- 2 tissues (corrosion test) or 3 tissues (irritation test) were used per treatment, the test substance, the negative control (NC) and the positive control (PC).
- Details on study design:
- TEST PROCEDURE
- Direct MTT reduction: the test substance was added to the MTT solution, and the mixture was incubated in the dark at about 37°C for 55 to 65 minutes. A negative control (highly de-ionized water) was tested concurrently. If direct MTT reduction occurred, one freeze-killed control tissues per exposure time was treated with, each, the test article and the negative control, in the same way as described below, additionally.
- Pre-incubation of the tissues: 1-1.5 h (corrosion test) or 18 ± 3 h (irritation test) in assay medium at 37°C.
1) Corrosion test
- Pretreatment of the tissues and treatments: after the pre-incubation the tissues were pre-treated with 25 μL highly de-ionized water to wet the tissue surface. Thereafter, a bulk volume of 25 μL of the solid test material was applied with a sharp spoon and homogeneously distributed with the water. Control tissues were concurrently applied with 50 μL of highly de-ionized water (NC) or with 50 μL of 8-n potassium hydroxide (PC).
- Removal of the test substance and post-incubation period: 3 min or 1 hour thereafter, the residual test items were washed out with PBS and rinsed tissues were kept in 24-well plates (holding plates) at room temperature on assay medium until all tissues per application time were dosed and rinsed.
2) Irritation test
- Pretreatment of the tissues and treatments: after the pre-incubation the tissues were pre-treated with 25 μL highly de-ionized water to wet the tissue surface. Thereafter, a bulk volume of 25 μL of the solid test material was applied with a sharp spoon and homogeneously distributed with the water. Control tissues were concurrently applied with 30 μL of PBS (NC) or with 30 μL of 5% SDS (PC). A nylon mesh was placed carefully onto the tissue surface afterwards. The tissues were kept under the laminar flow hood at room temperature for 25 minutes overall and for 35 minutes in the incubator.
- Removal of the test substance and post-incubation period: 1 hour thereafter, the residual test items were washed out with PBS and rinsed tissues were kept in 24-well plates at room temperature on assay medium, incubated for 24 ± 2 h at 37°C, transferred to fresh medium and further incubated at room temperature for 18 ± 2 h (postincubation).
3) Corrosion and irritation tests
- MTT incubation: the assay medium was replaced by MTT solution and the tissues were incubated for 3 hours. The tissues were then washed with PBS to stop the MTT-incubation.
- Determination of optical density: formazan that was metabolically produced by the tissues was extracted by incubation of the tissues in isopropanol at room temperature overnight or for at least 2 hours on a plate shaker. The optical density at a wavelength of 570 nm (OD570) of the extracts was determined spectrophotometrically. Blank values were established of 6 microtiter wells filled with isopropanol for each microtiter plate.
DATA EVALUATION
- Principle: the OD570 values determined for the various tissues are measures of their viability. The quotient of the OD570 of tissues treated with the test material and the mean OD570 values of the NC (percent of control) is used for evaluating whether or not a test material is corrosive or irritant.
- Calculation of individual and mean optical densities: the individual tissue OD570 is calculated by subtracting the mean blank value of the respective microtiter plate from the respective individual tissue OD570 value. The mean OD570 for a test group of two tissues treated in the same way is calculated.
- Tissue viability: the quantification of tissue viability is presented as the quotient of the mean OD570 divided by the respective OD570 NC value in percent for each exposure time.
ACCEPTANCE CRITERIA
- The absolute OD570 of the NC tissues in the MTT-test is an indicator of tissue viability obtained in the testing laboratory and under specific conditions of the assay. Tissue viability is acceptable if the mean OD570 of the NC is ≥1.0. The mean OD570 of the NC should not exceed 2.5.
- For corrosion test potassium hydroxide as 8-normal ready made solution is used as positive reference; a 3-minute treatment with 8.0 n KOH usually reveals a mean relative tissue viability of ~20%; an assay is acceptable if mean relative tissue viability of the 3 min positive control is ≤30%. For irritation test 5% SDS is used as PC and reflects the sensitivity of the tissues used in the test conditions; a viability of ≤20% is acceptable.
- For every treatment 2 tissues (corrosion test) or 3 tissues (irritation test) were treated in parallel. The inter-tissue variability is considered to be acceptable if the difference of the OD570 values of the two tissues is ≤0.3 (corrosion test) or if the SD of %-viability is ≤20 (irritation test).
EVALUATION CRITERIA:
- In the corrosion test a chemical is considered as "corrosive", if the mean relative tissue viability after 3 min treatment with a test material is decreased below 50%. In addition, those materials with a viability of ≥50% after 3 min treatment are considered as "corrosive" if the mean relative tissue viability after 1 hour treatment with a test material is decreased below 15%.
- In the irritation test a chemical is considered as "irritant", if the mean relative tissue viability with a test material is less than or equal to 50%.
POSITIVE CONTROL
- 8-n potassium hydroxide solution for the corrosion test;
- 5% (w/v) sodium dodecyl sulfate (SDS) in highly de-ionized water, sterile for the irritation test.
HISTORICAL CONTROL DATA
Historical control values of negative and positive controls, gathered over an appropriate time period, were available. These data demonstrate the reproducibility of results and robustness of the procedures. They are used to derive suitable acceptance criteria for the test system.
Results and discussion
In vivo
- Irritant / corrosive response data:
- Based on the observed results and applying the evaluation criteria, the test substance does not show a skin irritation potential in the EpiDerm™ skin corrosion/irritation test under the test conditions chosen.
Any other information on results incl. tables
Table 1: Summary of findings
Test item |
|
Corrosion test (individual values) |
Irritation test ± SD |
|
|
3 min exposure |
1 h exposure |
1 h exposure |
|
Negative control |
Mean OD570 |
1.800 (1.775, 1.825) |
1.768 (1.743, 1.793) |
1.998 (2.046, 1.898, 2.050) |
Mean viability (% of NC) |
100 (98.6, 101.4) |
100 (98.6, 101.4) |
100 ± 4.33 |
|
Test substance |
Mean OD570 |
1.748 (1.710, 1.787) |
1.726 (1.625, 1.828) |
1.903 (1.995, 1.594, 2.120) |
Mean viability (% of NC) |
97 (95.0, 99.3) |
98 (91.9, 103.4) |
95 ± 13.76 |
|
Positive control substance |
Mean OD570 |
0.306 (0.286, 0.326) |
0.115 (0.125, 0.105) |
0.117 (0.116, 0.115, 0.120) |
Mean viability (% of NC) |
17 (15.9, 18.1) |
7 (7.1, 5.9) |
6 ± 0.13 |
|
SD: standard deviation |
- All data were in the range of the historical control data.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- The test item did not show a skin irritation potential in the EpiDerm™ skin corrosion/irritation test under the test conditions chosen.
- Executive summary:
The study was performed according to OECD guidelines 431 & 439 in complinace with GLP.
The potential of the test item to cause dermal corrosion/irritation was assessed by a single topical application of 25 μL bulk volume (about 13 mg) of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm). For the corrosion test two EpiDerm tissue samples were incubated with the test substance for 3 minutes and 1 hour, respectively. The irritation test was performed with three EpiDerm tissue samples, which were incubated with the test substance for 1 hour followed by a 42-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.
The EpiDerm skin corrosivity/irritation test showed the following results:
The test substance is not able to reduce MTT directly.
Corrosion test: The mean viability of the test-substance treated tissues determined after an exposure period of 3 minutes was 97%, and it was 98% after an exposure period of 1 hour.
Irritation test: The mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 95%.
Conclusion: The test item did not show a skin irritation potential in the EpiDerm skin corrosion/irritation test under the test conditions chosen.
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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