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EC number: 275-108-6 | CAS number: 71002-20-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Octasodium 2,2'-[1,4-phenylenebis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino(1-hydroxy-3,6-disulphonatonaphthalene-2,8-diyl)azo]]bisnaphthalene-1,5-disulphonate
- EC Number:
- 275-108-6
- EC Name:
- Octasodium 2,2'-[1,4-phenylenebis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino(1-hydroxy-3,6-disulphonatonaphthalene-2,8-diyl)azo]]bisnaphthalene-1,5-disulphonate
- Cas Number:
- 71002-20-5
- Molecular formula:
- C52H26Cl2N14Na8O26S8
- IUPAC Name:
- octasodium 3-({4-chloro-6-[(4-{[4-chloro-6-({8-[(1E)-2-(1,5-disulfonatonaphthalen-2-yl)diazen-1-yl]-1-hydroxy-3,6-disulfonatonaphthalen-2-yl}amino)-1,3,5-triazin-2-yl]amino}phenyl)amino]-1,3,5-triazin-2-yl}amino)-5-[(1E)-2-(1,5-disulfonatonaphthalen-2-yl)diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Test system: isolated cornea from eyes of slaughtered cattle
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- 750 µl of the test material formulations were applied to the corneas.
- Duration of treatment / exposure:
- 4 hours
- Duration of post- treatment incubation (in vitro):
- 90 min
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- In this test method, eye damaging properties of a test item is assessed by quantitative measurements of changes in corneal opacity and permeability with an opacitometer and a visible light spectrophotometer, respectively. Both measurements are used to calculate an IVIS, which is used to assign an in vitro irritancy hazard classification
category for prediction of the in vivo ocular irritation potential of a test item.
The BCOP test method uses isolated corneas from the eyes of freshly slaughtered cattle. Corneal opacity is measured quantitatively as the amount of light transmission through the cornea. Permeability is measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea, as detected in the medium in the posterior chamber of the corneal holder. Test items are applied to the epithelial surface ofthe cornea by addition to the anterior chamber of the corneal holder.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Mean
- Value:
- 9
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein leakage
- Run / experiment:
- Mean
- Value:
- 0.012
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: IVIS (in vitro irritation score)
- Run / experiment:
- Mean
- Value:
- 9.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
In vivo
- Irritant / corrosive response data:
- Based on OECD TG 437 and the experimental conditions reported the test item is classified as not seriously damaging the eye
Any other information on results incl. tables
Tabular In vitro irritancy score
| Cornea No. | Opacity per cornea | Permeability per cornea | IVIS per cornea | IVIS per group; mean (SD) | |
| Negative control isotonic saline solution | 1 2 3 |
0.7 -0.2 0.4 |
0.009 0.007 0.008 |
0.8 -0.1 0.5 |
0.4 (0.5) |
| Positive Control 20% Imidazole | 4 5 6 |
76.4 77.4 93.3 |
0.980 0.806 0.891 |
91.1 89.5 106.6 |
95.7 (9.5) |
Test item 20 % Bayscript Magenta BB |
10 11 12 |
10.1 4.1 12.8 |
0.020 0.020 -0.003 |
10.4 4.4 12.8 |
9.2 (4.4) |
IVIS < 55: classification as Category 1 is not warranted
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Based on the experimental conditions reported in an OECD TG 437 study the test item is classified as not seriously damaging the eye (no Category 1).
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