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EC number: 219-694-3 | CAS number: 2498-95-5
- 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
- Study period:
- 2015-05-04 to 2015-09-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2014
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Disodium 2-[4-[[2-cyano-3-[4-[methyl(2-sulphonatoethyl)amino]phenyl]-1-oxoallyl]amino]phenyl]-6-methylbenzothiazole-7-sulphonate
- EC Number:
- 219-694-3
- EC Name:
- Disodium 2-[4-[[2-cyano-3-[4-[methyl(2-sulphonatoethyl)amino]phenyl]-1-oxoallyl]amino]phenyl]-6-methylbenzothiazole-7-sulphonate
- Cas Number:
- 2498-95-5
- Molecular formula:
- C27H24N4O7S3.2Na
- IUPAC Name:
- disodium 2-{4-[(2-cyano-3-{4-[methyl(2-sulfonatoethyl)amino]phenyl}acryloyl)amino]phenyl}-6-methyl-1,3-benzothiazole-7-sulfonate
Constituent 1
Test animals
- Species:
- other: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia containing: 24 Epi-200 tissues (reconstructed epidermis): surface 0.6 cm² cultured in Millicells® 1 cm
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- The EpiDermTM model 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 EpiDermTM tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts and commercially available as kits (EpiDerm™ 200), containing 24 tissues on shipping agarose.
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: No control animals because Human skin model. Negative and positive control were used in this test.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 25 µL - Duration of treatment / exposure:
- 1 hour
- Observation period:
- not applicable
- Number of animals:
- The irritation test was performed with three tissue samples
- Details on study design:
- Treatment
Time: 60 min
Incubator: Within this period the 6-well plates were put into the incubator at 37 °C.
Rinsing: After the end of the treatment interval the inserts were removed with PBS (Dulbecco's Phosphate Buffered Saline)
MTT Assay
A volume of 300 µL of the MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide) solution was added to each well after the post-incubation period and the tissues were incubated.
Incubation period: 3 hours
Time: After the 3 hours incubation period was completed for all tissues and exposure groups, culture inserts were transferred from the holding plates to the MTT plates.
Rinsing: After 3 h incubation, wells were washed with PBS.
Extractant solution: Isopropanol
OD reading: SunriseTM Absorbance Reader, For the determination of the optical density of colored extracts. Measurement using a filter wavelength 570 nm without reference filter.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: relative absorbance (% of negative control)
- Value:
- 89.6
- Remarks on result:
- other:
- Remarks:
- Basis: other: test item, mean value of 3 tissues. Time point: 60 min. Max. score: 100.0. Reversibility: other: not examined. (migrated information)
- Irritation / corrosion parameter:
- other: other: relative absorbance (% of negative control)
- Value:
- 2.8
- Remarks on result:
- other:
- Remarks:
- Basis: other: positive control, mean value of 3 tissues. Time point: 60 min. Max. score: 100.0. Reversibility: other: not examined. (migrated information)
In vivo
- Irritant / corrosive response data:
- In tissues that have been treated with the test substance, a yellow discoloration was noticed after the washing procedure. Due to the ability of the test substance to reduce MTT directly, KC tissues were applied in parallel. The results of the KC tissues indicate an increased MTT reduction (mean viability 4.4 % of NC). Thus for the test substance the final mean viability is given after KC correction. The results of the KC tissues showed high inter-tissue variability. However, taking the highest single value of the test-substance treated KC tissues into account (tissue 2 KC: 12.5% of NC) the final result still corresponds to a viability value well above the cut off for skin irritation (about 82%), thus this deviation is not considered to adversely affect the outcome of this study.
Applicant's summary and conclusion
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