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EC number: 947-115-0 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2015-07-07 to 2015-07-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- 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
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of Disodium (sulphonatothio)acetate and sodium chloride
- EC Number:
- 947-115-0
- Molecular formula:
- C2H2Na2O5S2.NaCl
- IUPAC Name:
- Reaction mass of Disodium (sulphonatothio)acetate and sodium chloride
- Test material form:
- liquid
- Details on test material:
- Purity of Test material:
60.9 % Disodium (sulphonatothio)acetate
20.3 % NaCl
4.3 % Na2S2O3
0.6 % NasSO4
5.0 % H2O
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: Sample 14/078 from Mollescal HW, charge 10924344R0
- Expiration date of the lot/batch: April 28, 2019
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Schlachthof Mannheim, Schlachthofstr. 21, 68165 Mannheim, Germany
- Characteristics of donor animals (age): 12 to 60 months
- indication of any existing defects or lesions in ocular tissue samples: No
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 750 µL
- Concentration (if solution): 20 % (w/v)
VEHICLE
- Amount applied: 750 µL - Duration of treatment / exposure:
- 4 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
Corneas free of defects (opacity, scratches, pigmentation etc.) were dissected with a 2 to 3 mm rim of sclera. Isolated corneas were mounted in cornea holders that consists of anterior and posterior chambers. Both chambers were filled to excess with pre-warmed Eagles’s MEM (without phenol red) and then equilibrated in a vertical position at about 32 °C for at least 1 hour.
QUALITY CHECK OF THE ISOLATED CORNEAS
After the equilibration period the medium in both chambers was replaced with fresh prewarmed medium and initial corneal opacity readings were taken for each cornea with an opacitometer. Any corneas that showed macroscopic tissue damage or an opacity value < 542 opacity units were discarded.
NUMBER OF REPLICATES
3 corneas were used per treatment group.
SOLVENT CONTROL USED
De-ionized water
POSITIVE CONTROL USED
Imidazole (CAS No. 288-32-4) 20 % (w/v) solution in deionized water for non-surfactant solid test substances
TREATMENT METHOD: closed chamber
POST-INCUBATION PERIOD: no
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: at least 3 times with Eagle’s MEM (containing phenol red) and once with Eagle’s MEM (without phenol red)
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: was observed visually. Final corneal opacity readings were taken for each cornea with an opacitometer.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader(OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: Evaluation of results were based on the decision criteria used in OECD guideline 437.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- test substance
- Value:
- 0.5
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: Not observed
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Range of historical values: Mean ± SD (Mean-2SD - Mean+2SD)
Historic range NC
Opacity = 11.1 ± 6.9 (-2.7 - 24.9)
Permeability = 0.003 ± 0.001 (0.001 - 0.006)
Historic range PC
Opacity = 76.3 ± 15.1 (46.2 - 106.4)
Permeability = 2.803 ± 0.616 (1.571 - 4.034)
IVIS = 118.3 ± 18.7 (81 - 155.6)
Any other information on results incl. tables
Opacity score of test substance, NC and PC
Cornea No. |
Initial opacity |
Final opacity |
Opacity change |
Corrected opacity change |
Mean |
SD |
|
test substance |
13 |
5.1 |
11.8 |
6.6 |
0 |
0.5 |
0.8 |
14 |
6 |
9 |
3 |
0 |
|||
15 |
4.1 |
12.7 |
8.6 |
1.4 |
|||
NC |
1 |
5.4 |
11.7 |
6.3 |
NA |
7.3 |
3.3 |
2 |
5.1 |
9.8 |
4.6 |
NA |
|||
3 |
4.1 |
15.1 |
10.9 |
NA |
|||
PC |
4 |
3.5 |
107 |
103.4 |
96.1 |
70.2 |
25.4 |
5 |
3.4 |
79.9 |
76.5 |
69.2 |
|||
6 |
3 |
55.6 |
52.6 |
45.4 |
Permeability score of test substance, NC and PC
Cornea No. |
Mean OD490 |
Dilution factor |
Mean corrected OD490* |
Mean |
SD |
|
test substance |
13 |
0.008 |
1 |
0.004 |
0.004 |
0.001 |
14 |
0.009 |
1 |
0.005 |
|||
15 |
0.008 |
1 |
0.003 |
|||
NC |
1 |
0.004 |
1 |
NA |
0.005 |
0.001 |
2 |
0.004 |
1 |
NA |
|||
3 |
0.006 |
1 |
NA |
|||
PC |
4 |
0.699 |
5 |
3.492 |
2.992 |
0.533 |
5 |
0.611 |
5 |
3.052 |
|||
6 |
0.487 |
5 |
2.432 |
In Vitro Irritancy score (IVIS) of the test substance, NC and PC
Cornea No. |
Opacity per cornea |
Permeability per cornea |
IVIS |
|||
Per cornea |
Mean |
SD |
||||
test substance |
13 |
0 |
0.004 |
0.1 |
0.5 |
0.8 |
14 |
0 |
0.005 |
0.1 |
|||
15 |
1.4 |
0.003 |
1.4 |
|||
NC |
1 |
6.3 |
0.004 |
6.3 |
7.3 |
3.3 |
2 |
4.6 |
0.004 |
4.7 |
|||
3 |
10.9 |
0.006 |
11 |
|||
PC |
4 |
96.1 |
3.492 |
148.5 |
115.1 |
33.3 |
5 |
69.2 |
3.052 |
115 |
|||
6 |
45.4 |
2.432 |
81.2 |
|||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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