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EC number: 939-338-7 | 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 / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline and EU method. GLP study.
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 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction products of imine and acrylate
- Molecular formula:
- Not applicable. UVCB substance
- IUPAC Name:
- Reaction products of imine and acrylate
- Details on test material:
- - Physical state: Clear amber liquid.
- Lot/batch No.: 3017/20461
- Storage condition of test material: in a cool, airy places away from strong alkali, acids, ignition sources, direct sunlight.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Center for Experimental Medicine in Medical University of Silesia in Katowice.
- Age at study initiation: 28-day old
- Housing: Animals were kept in cage with dimensions (length x width x height): 58 x 37 x 21 cm; with plastic bottom and wired lid.
- Diet (e.g. ad libitum): standard granulated "Murigran" fodder, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22 ºC
- Humidity (%): 55 – 80 %
- Air changes (per hr): about 16 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
Test system
- Type of coverage:
- other: in vitro study
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test item was applied evenly to the disc, which was placed inside the tube in volume of 150 μl. - Duration of treatment / exposure:
- Test item and control substances were applied for 2 hours (36% hydrochloric acid) or 24 hours (distilled water and test item) at 21-22°C. Then the test item and control substances were removed by washing off with a jet of tap water at temperature up to 30°C.
- Number of animals:
- Two animals
- Details on study design:
- PREPARATION OF THE SKIN DISCS
The animals were subjected to euthanasia by intraperitoneal administration of morbital in amount of 200 mg/kg b.w. before taking skin discs.
After euthanasia the dorso-lateral skin of each animal was then removed and stripped of excess subcutaneous fat by carefully peeling it away from the skin by using paper towel, and the skin discs were cut out by scalpel. 11 skin discs (2 for quality control procedure, 9 for main testing) with a diameter 20-mm each, were obtained from a single rat skin.
NUMBER OF REPLICATES
Three skin discs, which were obtained from skin of each animal, were used for the test item and control substance (three repetitions).
CONTROLS
The positive (36% hydrochloric acid) and negative (distilled water) controls were used concurrently in each study to ensure adequate performance of the experimental model.
Results and discussion
Any other information on results incl. tables
RESULTS OF ELECTRICAL RESISTANCE (TER) MEASUREMENT
As a quality control procedure, before start of the experiment, the electrical resistance of two skin discs was measured for each animal skin (animal No 1 and No 2). In each case skin discs had resistance values greater than 10 kΩ, so the other skin discs of animals could be used in the experiment.
The mean TER results can be accepted because concurrent positive and negative control values felt within the ranges acceptable for the method (the mean TER results for 36% hydrochloric acid amounted to: 0.83 and 0.75 kΩ; for distilled water amounted to: 20.24 and 21.29 kΩ).
The mean TER results of the skin discs treated with the test item were equal to: 39.61 kΩ (Animal No 1) and 47.49 kΩ (Animal No 2).
The individual values of TER measurements were very diversified and they ranged from 28.47 to 71.23 kΩ which resulted from the deposition of the test item on the treated surface of the skin discs. Directly after termination of 24-hour exposure period and attempt to remove the test item by washing it off with a stream of tap water, the TER values ranged from 103.12 to 132.47 kΩ.
GROSS EVALUATION OF THE TREATED SKIN DISCS
During gross examination of the skin discs from positive control, skin perforation in all cases was stated, whereas in negative control and on the skin discs treated with the test item, no changes on the skin surface were stated. A hard, close-fitting, transparent layer of test item was formed on the surface of each treated skin disc.
RESULTS OF SULFORHODAMINE B CONTENT IN THE DISCS
Concurrent mean disc dye content values of positive and negative control were equal to: for 36% HCl –64.29 μg/disc (Animal No 1) and 70.32 μg/disc (Animal No 2), for distilled water 27.75 μg/disc (Animal No 1) and 29.35 μg/disc (Animal No 2). These values felt within the ranges acceptable for the method.
The mean disc dye content results of the skin discs treated with the test item were equal to 158.49 μg/disc (Animal No 1) and 156.28 μg/disc (Animal No 2). The high content of the dye in the treated skin disc may be result of Sulforhodamine B binding by the layer of the test item covering the discs.
HISTOPATHOLOGICAL EVALUATION OF THE TREATED DISCS
During histopathological examination of the treated discs no pathological changes were stated. Histopathological examination did not confirm the corrosion of test item.
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- On the ground of the study, the test item does not comply with the criteria of the method and therefore based on the results we can not clearly conclude that the test item is corrosive.
- Executive summary:
In vitro skin corrosion: Transcutaneous electrical resistance test (TER) was performed in order to obtain information on health hazard due to superficial influence of the test substance on skin. Skin discs which were used for the experiment, were obtained from 28-day-old animals. As a quality control procedure, before start of the experiment, the electrical resistance of two skin discs was measured from each animal skin. In each case the skin discs showed resistance values greater than 10 kΩ, so the other of the skin discs of animals could be used in the experiment. The undiluted test item was applied uniformly to the epidermal surface of skin disc placed inside a tube. The positive control (36% hydrochloric acid) and negative control (distilled water) were used concurrently in the study. Three skin discs of each animal were used for the test item and three for control materials. Test item and control substances were applied for 2 hours (36% hydrochloric acid) or 24 hours (distilled water and test item) at 21-22°C, and then removed by washing off with a jet of tap water. During 24-hour exposure period the test item upon skin contact took the form of a solid. A hard, close-fitting, transparent layer of test item was formed on the surface of each treated skin disc. In order to remove the test item the discs were soaked in tap water (at about 30 ° C) for 1 hour and shaken every few minutes. Prior to measurement of the electrical resistance, the surface tension of the skin was reduced by adding a sufficient volume of 70% ethanol to cover the epidermis. After few seconds, the ethanol was removed from the tube and the tissue was then hydrated by the addition of 3 mL MgSO4 solution (154 mM). Low-voltage, alternating current LCR Databridge Model 6401 bridge was used to measure the electrical resistance of the skin in kΩ, by placing databridge electrodes on either side of the skin disc. After transcutaneous electrical resistance test (TER), MgSO4 solution was removed from the tube, and the
skin discs were then subjected to gross evaluation in order to reveal possible damage. The dye binding procedure was necessary in this case, since the all TER values for the test item were very diversed.
On the ground of the study, the test item does not comply with the criteria of the method and therefore based on the results we can not clearly conclude that the test item is corrosive.
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