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EC number: 612-396-8 | CAS number: 61791-19-3
- 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 / corrosion
- Remarks:
- other: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-06-12 to 2012-08-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study is regarded as reliable without restrictions because it was conducted in compliance with GLP regulation and guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- adopted April 13, 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted July 22, 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- of 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Version / remarks:
- of 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 61791-19-3
- Cas Number:
- 61791-19-3
- IUPAC Name:
- 61791-19-3
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- other: in vitro test
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- TEST SYSTEM
- Reconstructed human epidermal model EpiDermTM
- Source: MatTek In Vitro Life Science Laboratories, Bratislava
The EpiSkin SM model has been validated for irritation testing in an international trial and is considered to be suitable for this study.
QUALITY CONTROL:
- EpiSkin SM kits are manufactured according to defined quality assurance procedures (certified ISO 9001). All biological components of the epidermis and the kit culture medium have been tested for the presence of viruses, bacteria and mycoplasma. The quality of the final product is assessed via the MTT cell viability test using the cytotoxic test compound sodium dodecyl sulphate (SDS).
KIT CONTENTS:
- Units: 24 Epi-200 tissues (reconstructed epidermis): surface 0.6 cm² cultured in Millicells ∅ 1 cm
- Wash buffer: Dulbecco's phosphate buffered saline (PBS), w/o Ca 2+, Mg 2+ (MatTek In Vitro Life Science Laboratories, Bratislava and Biochrom, Germany)
- Medium: Dulbecco's modified eagle's medium (DMEM); for the assay and for diluting MTT (MatTek In Vitro Life Science Laboratories, Bratislava /Sigma, Germany)
- Detection agent: 3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide (MTT) (MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia / Sigma,Germany), 1.0 mg / mL assay medium
Test system
- Type of coverage:
- other: Application on the skin model surface
- Preparation of test site:
- other: Human skin model
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Positive and negative control epidermis
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: a sufficient amount to cover evenly all the epidermal surface (30 μL per EpiSkin SM unit) - Observation period:
- MTT test after 42 hours post-incubation
- Number of animals:
- 3 EpiSkin SM for test item incubation
3 EpiSkin SM for positive control
3 EpiSkin SM for negative control - Details on study design:
- Corrosion test:
Performance of the corrosion Study
Pre-incubation (day [-1]):
At least 1 hour but not more than 1.5 hours before test-substance application, tissues were transferred to 6- well plates with 0.9 mL assay medium and preconditioned in the incubator at 37°C. The preincubation medium was replaced with fresh medium immediately before application.
Application:
Two tissues per exposure time (3 minutes at room temperature or 1 hour in the incubator, as a rule) and test group (test material, negative control and positive control; 12 tissues per test) were used. In addition, one killed tissue per exposure time was treated with the test substance and NC, respectively, in order to detect direct MTT reduction. Fifty microliter (50 μL) of the undiluted liquid test substance was applied using a pipette. Control tissues were concurrently applied with 50 μL of de-ionized water (negative control, NC and killed tissue control, KC) or with 50 μL of 8 n potassium hydroxide (positive control, PC) or test substance (killed tissue control, KC).
Rinsing:
The tissues were washed with PBS to remove residual test material 3 minutes or 1 hour after tart of the application treatment. 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.
Post-incubation:
The assay medium was then replaced by MTT solution and tissues were incubated for 3 hours.
After incubation, tissues were washed with PBS and the formazan produced by the tissues was extracted with isopropanol. 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.
Irritation test:
Performance of the irritation Study
Pre-incubation (day [-1]):
On the day of arrival in the laboratory, the tissues were transferred to sterile 6-well plates with 0.9 mL assay medium and preconditioned in the incubator at 37°C. After 1 hour the preincubation medium was replaced with fresh medium and preconditioning continued for 18 ± 3 hours.
Application (day 0):
Three tissues were treated with the test substance, the PC and NC, respectively. Thirty microliter (30 μL) of the undiluted test substance was applied using a pipette. Control tissues were concurrently applied with 30 μL of sterile PBS (negative control, NC) or with 30 μL of 5% SDS (positive control, PC). A nylon mesh was placed carefully onto the tissue surface afterwards.
Exposure (day 0):
The tissues were kept under the laminar flow hood at room temperature for 25 minutes overall and for 35 minutes in the incubator.
Rinsing (day 0):
The tissues were washed with sterile PBS to remove residual test material 1 hour after start of application. Rinsed tissues were blotted on sterile absorbent paper and transferred into new 6-well plates, pre-filled with 0.9 mL fresh medium. When all tissues were rinsed, the surface of each tissue was carefully dried with a sterile cotton swab.
Post-incubation (day 0-2):
Subsequently, the tissues were incubated in the incubator at 37°C for 24 ± 2 hours. After 24 ± 2 hours the tissues were transferred into new 6-well plates pre-filled with 0.9 mL of fresh medium and placed into the incubator for additional 18 ± 2 hours post-incubation period.
MTT test after 42 hours incubation (day 2):
After the postincubation period, the assay medium was replaced by 0.3 mL MTT solution and the tissues were incubated in the incubator for 3 hours. After incubation, the tissues were washed with PBS to stop the MTT-incubation.
Formazan extraction (day 2):
At the end of incubation with MTT a formazan extraction step was undertaken:
The formazan that was metabolically produced by the tissues was extracted by incubation of the tissues in isopropanol. 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.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: viability
- Basis:
- mean
- Time point:
- other: exposure time 3 min
- Remarks on result:
- other: Corrosion: test substance: 97 % Viability compared to untreated control
- Irritation parameter:
- other: viability
- Basis:
- mean
- Time point:
- other: exposure time 3min
- Remarks on result:
- other: Corrosion: positive control: 18 % Viability compared to untreated control
- Irritation parameter:
- other: viability
- Basis:
- mean
- Time point:
- other: exposure time 1 hours
- Remarks on result:
- other: Corrosion: test substance: 97 % Viability compared to untreated control
- Irritation parameter:
- other: viability
- Basis:
- mean
- Time point:
- other: exposure time 1 hour
- Remarks on result:
- other: Corrosion: positve control: 9 % Viability compared to untreated control
- Irritation parameter:
- other: viability
- Basis:
- mean
- Time point:
- other: 42 hours after 55-65 min exposure time
- Remarks on result:
- other: Irritation: test substance: 95 % Viability compared to untreated control
- Irritation parameter:
- other: viability
- Basis:
- mean
- Time point:
- other: 42 hours after 55-65 min exposure time
- Remarks on result:
- other: Irritation: positive control: 2 % Viability compared to untreated control
- Irritant / corrosive response data:
- Based on the observed results and applying the evaluation criteria it was concluded, that Fatty acids, tall-oil, reaction products with ethanolamine, ethoxylated does not show a skin irritation/corrosion potential in the EpiDerm™ skin corrosion/irritation test under the test conditions chosen.
Applicant's summary and conclusion
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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