Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
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
- Report date:
- 2018
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
- Test material form:
- solid
- Details on test material:
- Test item : FAT 40875/A TE
Physical appearance : Dark red powder
Purity as per CoA : 86.4% all organic components
Batch No. : BOP 05-17 (BS-ROE 1550 NIM 25+26+27)
Manufactured date : 20 December 2017
Expiry date : 11 December 2022
pH : 4.3 (aq. soln. 2 %w/w at room-temperature)
Recommended storage condition: Refrigeration (+2 to +8 °C) and protection from light
Constituent 1
- Specific details on test material used for the study:
- Test Item: FAT 40875/A TE
Physical Appearance: Dark red powder
Purity as per Certificate of Analysis (Content): 86.4% all organic components
Batch No.: BOP 05-17 (BS-ROE 1550 NIM 25+26+27)
Manufactured Date: December, 20, 2017
Expiry Date: December 11, 2022
Recommended Storage Condition : Refrigeration (+2 to +8°C)
pH: 4.3 of 2% (w/w) aq. Solution.
Solubility: 499.9 g/l
Test animals / tissue source
- Species:
- other: Bovine eye
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Local abattoir (Slaughter house), Near Frazer town, Bengaluru.
- Storage, temperature and transport conditions of ocular tissue: The bovine eyes were procured from local abattoir and transported in a jar containing Hank’s Balanced Salt Solution (HBSS) and penicillinstreptomycin (100 IU & 100 μg/mL) in an ice box.
- indication of any existing defects or lesions in ocular tissue samples: none
Test system
- Vehicle:
- Hank's balanced salt solution
- Controls:
- yes, concurrent positive control
- Amount / concentration applied:
- 100 mg of test item per cornea
- Duration of treatment / exposure:
- 4 hours
- Duration of post- treatment incubation (in vitro):
- 10 min
- Number of animals or in vitro replicates:
- Triplicate
- Details on study design:
- Pretest examination:
Immediately after receiving the eyes in the lab, all eyes were observed for any evidence of vascularization, pigmentation, opacity or scratches.
Dissection:
Post pretest examination, selected eyes were dissected to isolate the corneas from surrounding tissue and then placed in a container with fresh HBSS (Hank’s Balanced Salt Solution).
Mounting:
The isolated corneas were mounted on the cornea holder. During mounting, it was ensured that the epithelium of the cornea projected into the anterior chamber. The EMEM without phenol red was added in to both the chambers and kept in an incubator (32°C) for 1 hour.
The blank value I0 (lux) was obtained with each of 30 available cornea holders containing medium but without cornea. The mean of the blank value obtained was 502 lux (I0). This value was considered while calculating the initial opacity and final opacity readings.
After pre-test incubation, the EMEM from both the chambers was removed and refilled with the fresh EMEM. The pre-treatment cornea reading (lux) was measured and initial opacity was calculated for all corneas.
The initial opacity was calculated. The corneas which exhibited initial opacity < 7 were considered for further experiment.
NUMBER OF REPLICATES : Three for each test group.
NEGATIVE CONTROL : Distilled water
POSITIVE CONTROL : Imidazole
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 680.328
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- Negative Control: Distilled water
The corneas treated with distilled water exhibited IVIS score of 1.234 hence classified as “No Category”.
Positive Control: Imidazole
The corneas treated with Imidazole exhibited IVIS score of 78.2905 hence classified under “Category 1”.
Test Item: FAT 40875/A TE
The corneas treated with FAT 40875/A TE exhibited IVIS score of 680.3285 hence classified under “Category 1”.
Any other information on results incl. tables
Calculation of In Vitro Irritation Score (IVIS*)
| Treatment group | Mean opacity value | Mean Permeability value | IVIS | Classification |
| Negative control (Distilled water) | 1 | 0.0156 | 1.234 | No category |
| Imidazole | 64.33 | 0.9307 | 78.2905 | Category 1 |
| FAT 40875/A TE | 680 | 0.0219 | 680.3285 | Category 1 |
*IVIS = Mean Opacity value + (15 × Mean Permeability value)
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test item FAT 41047/A TE exhibited an IVIS score of 680.3285. The test item FAT 40875/A TE is predicted to cause serious eye damage.
- Executive summary:
The evaluation of the occular irritancy of “FAT 40875/A TE” was carried out using the Bovine Corneal Opacity and Permeability assay (BCOP) in accordance with OECD TG 437 in a GLP certified laboratory.
100 mg of test substance per cornea, 0.75 mL negative control per cornea and positive control (enough quantity covering the entire corneal surface) respectively were applied undiluted on the corneal surface by means of open chamber method. The control and treated corneas were then subjected to the opacity and permeability measurements.
The negative control (distilled water) was classified as UN GHS "No Category" (IVIS score 1.234) and the positive control (Imidazole) was classified under Category 1 (IVIS score 78.2905).
The test item FAT 40875/A TE exhibited an IVIS score of 680.3285 and was classified under ‘Category 1’ as per UN GHS.
From the results, it can be concluded that the test item FAT 40875/A TE can be predicted to cause serious eye damage to bovine corneal eye.
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