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EC number: 695-779-2 | CAS number: 80019-35-8
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From August 16, 2018 to April 30, 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,7-Naphthalenedisulfonic acid, 5-(acetylamino)-3-[2-[5-[[4-chloro-6-[[3-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-sulfophenyl]diazenyl]-4-hydroxy-, sodium salt (1:4)
- EC Number:
- 695-779-2
- Cas Number:
- 80019-35-8
- Molecular formula:
- C29H21ClN8O17S5.4Na
- IUPAC Name:
- 2,7-Naphthalenedisulfonic acid, 5-(acetylamino)-3-[2-[5-[[4-chloro-6-[[3-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-sulfophenyl]diazenyl]-4-hydroxy-, sodium salt (1:4)
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- other: stratified human keratino cytes
- Details on test animals or tissues and environmental conditions:
- Description of the test system
The EpiOcular TM tissue model (OCL-200-MatTek Corporation) is composed of stratified human keratinocytes in a three-dimensional structure, reflecting the morphology and function of the human corneal epithelium found in vivo.
Justification for selection of the test system
The EpiOcular TM Eye Irritation Test (EIT), using the MatTek EpiOcular TM tissue model OCL-200, was validated by the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) and Cosmetics Europe between 2008 and 2013. From this validation study and its independent peer review it was concluded that the EpiOcular TM EIT is able to correctly identify chemicals (both substances and mixtures) not requiring classification and labelling for eye irritation or serious eye damage according to UN GHS, and the test method was recommended as scientifically valid for that purpose, as an alternative to Dralze Rabbit Eye Test with excellent correlation - in vivo to in vitro test results.
Characterisation of the test system
MatTek’s EpiOcular TM system consists of normal, human-derived keratinocytes which have been cultured to form a stratified, squamous epithelium similar to that found in the cornea. Cultured on specially prepared cell culture inserts using serum-free culture medium, the cells differentiate to form a multi-layered structure with progressively stratified, but not cornified cells which closely parallel the corneal epithelium. QC results for the specific lot of models received were checked in-house for MatTek acceptance range with the following outcome:
Morphology – PASS
Tissue viability – PASS
Skin barrier function (ET50 value for 0.3% Triton X-100) where ET50 is the time taken for 0.3% Triton X-100 to reduce the viability of the skin model to 50% relative to the negative control) – PASS
Sterility testing showed no contamination during long term antibiotic and antimycotic free culture - PASS
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Duration of treatment / exposure:
- After pre-wetting tissues with 20uL PBS (sterile Dulbecco's Phosphate Buffered Saline) for 30±2 minutes, a single, topical application of approximately 50mg of neat test item using a spatula, or 50uL of reference items was applied to the surface of the Epiocular TM model for 6 hours ± 15 minutes, followed by a 25±2 minutes post-treatment immersion, and 18 hour ± 15 minutes post-treatment incubation, prior to the MTT endpoint; three tissues per condition (n=3).
- Details on study design:
- Preliminary test:
CR SR94 was first checked for its potential for MTT interference and solvent interference (water and isopropanol).
Main test overview:
Day 0: On the day of receipt, EpiOcular TM tissues were pre-incubated overnight at 37°C, 5% CO2, ≥95% RH.
Day 1: Exposure to, and removal of approximately 50 mg of CR SR94 (addition of test item was by spatula) or 50uL of reference item for 6 hours ±15 minutes, followed by a 25±2 minutes post-treatment immersion, and 18 hours ±15 minutes post-treatment incubation.
Day 2: End of MTT viability test, optical density readings at 570 nm without reference filter.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: %viability
- Value:
- 149.334
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Corrected %vialbility
- Value:
- 149.331
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Prior to the study, the required preliminary test confirmed that the test item interfered with the solvent and so colourant controls were performed in parallel.
CR SR94 was classified as No category i.e. not requiring a warning label in the European chemical classification systems for eye irritation or serious eye damage as the viability was above 60%.
Any other information on results incl. tables
Table 1. Viability measurements after 6 hours (±15 minutes) of application and 18 hours (±15 minutes) post-incubation of test and reference items.
Condition | Tissue # | Raw Data | Blank Corrected Data | Mean OD | %Viability | ||
Aliquot 1 | Aliquot 2 | Aliquot 1 | Aliquot 2 | ||||
NC | Tissue 1 | 2.224 | 2.253 | 2.068 | 2.097 | 2.083 | 100.349 |
Tissue 2 | 0.169 | 0.179 | 0.013 | 0.023 | 0.018 | 1.295 | |
Tissue 3 | 2.209 | 2.239 | 2.053 | 2.083 | 2.068 | 99.651 | |
PC | Tissue 1 | 0.876 | 0.832 | 0.720 | 0.676 | 0.698 | 50.234 |
Tissue 2 | 0.623 | 0.624 | 0.467 | 0.468 | 0.468 | 33.645 | |
Tissue 3 | 0.75 | 0.78 | 0.594 | 0.624 | 0.609 | 43.829 | |
TA1 | Tissue 1 | 1.335 | 1.343 | 1.179 | 1.187 | 1.183 | 85.139 |
Tissue 2 | 2.143 | 2.118 | 1.987 | 1.962 | 1.975 | 142.101 | |
Tissue 3 | 2.31 | 2.353 | 2.154 | 2.197 | 2.176 | 156.567 |
Table 2. Mean and SD of viability measurements and of viability percentages after 6 hours (±15 minutes) of application and 18 hours (±15 minutes) post-incubation.
Name | Code | Mean of OD | SD of OD | Mean if viability (%) | Corrected Mean of viability(%) | SD of viability (%) | CV% | Classification |
Sterile water | NC | 2.075 | 0.01 | 100 | N/A | 0.494 | 0.494 | No-Category |
Methyl Acetate | PC | 0.592 | 0.116 | 42.569 | N/A | 8.366 | 19.652 | No Prediction |
CR SR94 | TA1 | 2.075 | 0.142 | 149.334 | 149.331 | 10.229 | 6.85 | No-Category |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A test item is considered as " No Category", i.e. not requiring a warning label in the European chemical classification systems for eye irritation or serious eye damage (UN GHS No Category), if the eye model viability after exposure and post-treatment incubation is >60%. The percentage of viability obtained with CR SR94 was 149.331%, therefore it is classified as No Category.
- Executive summary:
In this study, the eye irritation potential of CR SR94 was assessed in vitro according to OECD Test Guideline 492 (Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage).
After 6 hours ±15 minutes exposure on the surface of EpiOcular TM reconstructed ocular epithelium and 18 hours ±15 mins post-incubation time, the viability of the tissues was assessed and compared to a negative control.
The percentage viability obtained was 149.334% and therefore:
CR SR94 was classified as No Category i.e. not requiring a warning label in the European chemical classification systems for eye irritation or serious eye damage.
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