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Diss Factsheets
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EC number: - | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-01-23 to 2015-02-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- July 26, 2013 reconstructed human epidermis (RHE) test method
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- other: liquid
- Details on test material:
- Reaction mass of 2,2,4-trimethylhexane-1,6-diylbis{[3-(triethoxysilyl)propyl]carbamate} and 2,4,4-trimethylhexane-1,6-diylbis{[3-(triethoxysilyl)propyl]carbamate} manufactured by Evonik Degussa GmbH. Batch No. IPES-Addukt 7W of 2014-06-23, purity: 95.05.%.
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
Test animals
- Species:
- other: in vitro
- Details on test animals or test system and environmental conditions:
- The following Reconstructed Human Epidermis Model was used:
EpiDermTM (EPI-200-SCT, Lot no. 19622) MatTek In Vitro Life Science Laboratories, s.r.o, Mlynské Nivy 73, 821 05 Bratislava II, Slovak Republic.
Test system
- Vehicle:
- water
- Remarks:
- sterile deionised water
- Amount / concentration applied:
- - test item: 50 μL of test item were applied to the skin model with a surface area of 0.63 cm2.
- Positive control item was 8 N KOH4, 50 µl
- Negative control was sterile deionised water, 50µl - Duration of treatment / exposure:
- 3 minutes and 1 hour
- Details on study design:
- Cell viability measurements
- MTT (3-[4,5-Dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide, Thiazolyl blue; CAS number 298-93-1) reduction, which had been shown to give accurate and reproducible results, was used to measure cell viability
- Each skin sample was placed in an MTT assay solution of 1 mg/mL (37°C incubation temperature, 5% CO2, 95% humidity) for 3 hours
- The precipitated blue formazan product was extracted using the solvent propanol-27, and the concentration of the formazan was measured by
determining the optical density (OD) at a wavelength of 570 nm in a spectrophotometer
- Cell viability measurements were carried out at the end of the exposure period (1st period: 3 min; 2nd period: 60 min). The measurements were
made for each of the two tissues in triplicate.
- Previous checks for interference of the test item with the MTT assay or the tissues were performed. No discoloration or test item
interference with the vital dye was noted
ADMINISTRATION
- EpiDerm tissues were conditioned by pre-incubation (1 hour) for release of transport stress related compounds and debris in the incubator
(37°C, 5% CO2, 95% humidity)
- After pre-incubation tissues were transferred to fresh Maintenance Medium and topically exposed with test item and controls
- 50 μL of test item were applied to the skin model with a surface area of 0.63 cm2 to uniformly cover the skin surface
- Positive control item was 8 N KOH4, 50 µl
- Negative control was sterile deionised water, 50µl
- Two tissues were used per treatment, negative and positive control and exposition time (18 Tissues in total)
- At the end of the exposure period, tissues were rinsed (with Dulbecco's phosphate buffered saline (D-PBS)), blotted and assay medium is
replaced by MTT assay medium (final concentration: 1 mg MTT (3-[4,5-Dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide,
Thiazolyl blue)/mL medium).
- After 3-h incubation, tissues were washed with Dulbecco's phosphate buffered saline (D-PBS), blotted and the blue formazan salt was extracted
with Isopropanol
- Optical density of the formazan extract was determined spectrophotometrically at 570 nm and cell viability was calculated for each tissue as
% of the mean of the negative control tissues
- Skin corrosivity potential of the test materials was classified according to the remaining cell viability obtained after 3 minutes or 1 hour exposure
with the test chemical
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: cut-off percentage cell viability value
- Run / experiment:
- The EpiDerm™ model was employed, 3 minute exposure
- Value:
- 87.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Under the present test conditions test item tested at two exposure periods of 3 minutes (cell viability value =87.5 %) or 1 hour (cell viability value =91.8 %) was non-corrosive to skin.
- Irritation / corrosion parameter:
- other: cut-off percentage cell viability value
- Run / experiment:
- The EpiDerm™ model was employed, 1 hour exposure
- Value:
- 91.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Under the present test conditions test item tested at two exposure periods of 3 minutes (cell viability value =87.5 %) or 1 hour (cell viability value =91.8 %) was non-corrosive to skin.
Any other information on results incl. tables
Assay acceptability criteria
Assay acceptance criterion 1: Negative control
The absolute OD of the negative control (NC) tissues (treated withsterile deionised water) in the MTT test is an indicator of tissue viability obtained in the testing laboratory after shipping and storing procedures and under specific conditions of use.
The assay meets the acceptance criterion if the mean OD540of the NC tissues is ≥ 0.8 and ≤ 2.8.
Assay acceptance criterion 2: Positive control
A8N KOHwas used as positive control (PC) and tested concurrently with the test chemicals. Concurrent means here the PC has to be tested in each assay.
Tissues treated with the PC, should reflect the ability of the tissues to respond to a corrosive chemical under the conditions of the test method (viability after 1hour exposure: < 15%).
Assay acceptance criterion 3:variability between tissue replicates
Associated and appropriate measures of variability between tissue replicatesshould not exceed 30% (in the range of 20 – 100% viability).
Interpretation of results
The mean OD values obtained for the test item and the positive control were used to calculate percentage viability relative to the negative control, which is arbitrarily set at 100%. The cut-off percentage cell viability value distinguishing corrosive from non-corrosive test items was used to evaluate the results and identify corrosive materials and shown to be appropriate. The prediction of corrosivity associated with theEpiDermTMmodel is:
The test item is considered to be corrosive to skin:
If the viability after 3 minutes exposure was < 50%, or
if the viability after 3
minutes exposure was ≥ 50% and the viability after 1hour
exposure was < 15%.
The test item is considered to be non-corrosive to skin:
If the viability after 3 minutes exposure was ≥ 50% and the viability after 1hour exposure was ≥ 15%.
Applicant's summary and conclusion
- Conclusions:
- Under the present test conditions the test item tested at two exposure periods of 3 minutes or 1 hour was non-corrosive to skin in an experiment employing an artificial three-dimensional model of human skin.
- Executive summary:
The purpose of this study was to assess the corrosive properties of the test item to human skin, in anexperiment with an artificial three-dimensionalmodel of human skin.
TheEpiDermTMmodel was employed.
Two tissues were used for each treatment and concurrent control groups. The optical density (OD) was determined byusing the MTT (3-[4,5-Dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide, Thiazolyl blue) reduction assayand expressed as relative percentage of viability of the negative control-treated tissues.
50 µL test item were applied topically to the model skin surface. Sterile deionised water was used as the negative control. 8N KOH
was used as the positive reference item.The test item and the reference items were applied to the skin model surface at two exposure periods of 3 minutes or 1 hour.
In comparison to the negative controls, the mean viability of cells exposed to the test item was 87.5% after a 3-minute exposure period and 91.8% after a 1‑hour exposure.
The 3-minute and the1-hour exposure values were above the cut-off percentage cellviability values distinguishing corrosive from non-corrosive test items of >50% and >15%, respectively.
Therefore, the test item was non-corrosive in this skin model and is predicted to be non-corrosive to human skin.
The mean optical density (OD) of the negative control of 2 tissues was 1.815 (3‑minute exposure) or 1.827 (1-hour exposure) and
was well within the acceptable range of ≥ 0.8 to ≤ 2.8. The viability of cells treated with the positive reference item 8N KOH were 2.0% (3-minute exposure) and 1.9% (1-hour exposure) of the negative control and, hence well below the 15% cut-off value at the
1-h exposure. The standard deviation of all replicates determined (at 20 - 100% viability) was below the limit of acceptance of 30%. Hence, all acceptance criteria were fulfilled.
Conclusion
Under the present test conditions the test item tested at two exposure periods of 3 minutes or 1 hour was non-corrosive to skin in an experiment employing an artificial three-dimensional model of human skin.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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