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EC number: 806-726-1 | 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
Endpoint summary
Administrative data
Description of key information
In an in-vitro skin corrosion test (artificial three-dimensional model of human skin model) (LPT 2015) the test item was tested at two exposure periods of 3 minutes and 1 hour. It could be shown that the test substance is corrosive to skin. No in-vitro eye irritation study is has to be conducted. A data waiver is claimed.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-08-19 to 2015-09-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- September 26, 2014 reconstructed human epidermis (RHE) test method
- GLP compliance:
- yes (incl. QA statement)
- 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. 21691) MatTek In Vitro Life Science Laboratories, s.r.o, Mlynské Nivy 73, 821 05 Bratislava II, Slovak Republic. - Vehicle:
- water
- Remarks:
- sterile deionised water
- Amount / concentration applied:
- - Test item: 25 mg of test item were applied to the skin model with a surface area of 0.63 cm2 to uniformly cover the skin surface which was
moistened with sterile deionised water to ensure adequate contact with the skin.
- Positive control item was 8 N KOH4, 50 µl
- Negative control was sterile deionised water, 50µl
- At the end of the exposure period, the test item was carefully washed from the skin surface with Dulbecco's phosphate buffered saline - 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
- 25 mg of test item were applied to the skin model with a surface area of 0.63 cm2 to uniformly cover the skin surface
- At the end of the exposure period, the test item was carefully washed from the skin surface with Dulbecco's phosphate buffered saline
- 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 (12 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
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- compared to the control % viability (3 min)
- Value:
- > 50
- Vehicle controls validity:
- not valid
- Negative controls validity:
- valid
- Remarks:
- aqua deion.
- Positive controls validity:
- valid
- Remarks:
- KOH 8N
- Remarks on result:
- other:
- Remarks:
- Remarks: Under the present test conditions the test item tested at two exposure periods of 3 minutes or 1 hour was corrosive to skin in an experiment employing an artificial three-dimensional model of human skin.. (migrated information)
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- compared to the control % viability (1h)
- Value:
- < 15
- Vehicle controls validity:
- not valid
- Negative controls validity:
- valid
- Remarks:
- aqua deion.
- Positive controls validity:
- valid
- Remarks:
- KOH 8N
- Remarks on result:
- other:
- Remarks:
- Remarks: Under the present test conditions the test item tested at two exposure periods of 3 minutes or 1 hour was corrosive to skin in an experiment employing an artificial three-dimensional model of human skin.. (migrated information)
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information
- Conclusions:
- Under the present test conditions the test item tested at two exposure periods of 3 minutes or 1 hour was 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 an experiment with an artificial three-dimensional model of human skin. TheEpiDermTMmodel was employed.
Two tissues were used for each treatment and concurrent control groups. The optical density (OD) was determined by using the MTT (3-[4,5-Dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide, Thiazolyl blue) reduction assay and expressed as relative percentage of viability of the negative control-treated tissues.
Test item was applied topically as liquid test item supplied. 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 113.5% after a 3-minute exposure period and 7.0% after a 1‑hour exposure.
The 3-minute exposure value was above the cut-off percentage cellviability value of 50%, the 1-hour exposure value was less than the cut of percentage cell viability value of 15%. Therefore, the test item was corrosive in this skin model and is predicted to be corrosive to human skin.
The mean optical density (OD) of the negative control of 2 tissues was 1.573 (3‑minute exposure) or 1.507 (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 7.1% (3-minute exposure) and 5.4% (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 corrosive to skin in an experiment employing an artificial three-dimensional model of human skin
Reference
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%.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Only one study available.
Justification for selection of eye irritation endpoint:
According to REACH Annex VII 8.2. column 2 an in vitro eye irritation study does not need to be conducted if the substance is classified as corrosive to skin.
Effects on skin irritation/corrosion: corrosive
Justification for classification or non-classification
Based on the result of the in-vitro skin corrosion study and according to criteria of EC Regulation 1272/2008 the test item is corrosive to skin. Therefore, the test item is classified into Skin Corr. Category 1B and Eye Damage 1 (H314: Causes severe skin burns and eye damage; H318: Causes serious eye damage).
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