Registration Dossier
Registration Dossier
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EC number: 219-694-3 | CAS number: 2498-95-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-04-13 to 2015-10-05
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- 2013
- 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 / tissue source
- Species:
- other: The EpiOcularTM model (OCL-200) is a three-dimensional non-keratinized tissue construct composed of normal human derived epidermal keratinocytes used to model the human corneal epithelium
- Strain:
- other: not applicable
- Details on test animals or tissues and environmental conditions:
- The EpiOcularTM model (OCL-200) is a three-dimensional non-keratinized tissue construct composed of normal human derived epidermal keratinocytes used to model the human corneal epithelium. The EpiOcularTM tissues (surface 0.6 cm²) are cultured on especially prepared cell culture inserts (MILLICELLs, 10 mm ∅) and are commercially available as kits (EpiOcular™ 200), containing 24 tissues on shipping agarose.
Test system
- 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:
- 50 µL of the test item
- Duration of treatment / exposure:
- 6 hours
- Observation period (in vivo):
- not applicable
- Number of animals or in vitro replicates:
- other: 2 EpiOcular tissue samples were incubated with the test substance
- Details on study design:
- Treatment
Time: 6 hours
Rinsing: At the end of the treatment time, the test item was removed by rinsing the tissues 3 times in each of three beakers filled 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.
Incubation period: 3 hours
Extractant solution: Isopropanol
OD reading: The optical density at a wavelength of 570 nm (OD570) of the extracts was determined spectrophotometrically.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: relative absorbance (% of negative control)
- Basis:
- other: test substance, mean of 2 tissues
- Time point:
- other: 6 hours
- Score:
- 78.7
- Max. score:
- 100
- Reversibility:
- other: not examined
- Irritation parameter:
- other: relative absorbance (% of negative control)
- Basis:
- other: positive control, mean of 2 tissues
- Time point:
- other: 6 hours
- Score:
- 29.4
- Max. score:
- 100
- Reversibility:
- other: not examined
- Irritant / corrosive response data:
- In tissues that have been treated with the test substance, a yellowish 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 10.7 % of NC). Thus for the test substance the final mean viability is given after KC correction.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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