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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:
- 2008-08-28
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: The Bovine Corneal Opacity and Permeability Assay (BCOP) will be performed according to the INVITTOX (UK) protocol no. 98 "The Bovine Corneal Opacity and Permeability Assayn, dated February 1994.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Bovine Corneal Opacity and Permeability (BCOP) Assay, SOP of Microbiological Associates Ltd., UK, Procedure Details, April 1997.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of the test material (as cited in the study report: FAT 40842/A TE
- Substance type: coloring dye
- Physical state: solid, dark bluish green powder
- Analytical purity: 96%
- Lot/batch No.: Blau DRI 2098 Op 1/07
- Expiration date of the lot/batch: June 30, 2014
- Storage condition of test material: at room temperature at about 20 ºC
Test animals / tissue source
- Species:
- other: in vitro study
- Strain:
- other: in vitro study
- Details on test animals or tissues and environmental conditions:
- not applicable
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- not applicable
- Duration of treatment / exposure:
- 240 ± 5 min.
- Observation period (in vivo):
- not applicable
- Number of animals or in vitro replicates:
- not applicable
Results and discussion
In vivo
Results
- Irritation parameter:
- other: In Vitro Test. See Point "Remarks on Results"
- Basis:
- other: 3 corneas
- Time point:
- other: after 240 min treament
- Score:
- > -2.5 - < -1.6
- Max. score:
- -1.6
- Reversibility:
- other: not applicable
- Remarks on result:
- other: In Vitro Score
Any other information on results incl. tables
Results after 240 Minutes Incubation Time
Test Group |
Opacity value = Difference (t240-t0) of Opacity |
Permeability at 490 nm (OD490) |
In vitroScore |
Meanin vitro Score |
Proposedin vitro Irritation Scale |
||
|
|
Mean |
|
Mean |
|
|
|
Negative Control |
2 |
1.67 |
0.056 |
0.058 |
2.84 |
2.54 |
non |
Negative Control |
2 |
0.070 |
3.05 |
||||
Negative Control |
1 |
0.048 |
1.72 |
||||
Positive Control |
119.33* |
0.820* |
131.63 |
129.35 |
very severe |
||
Positive Control |
120.33* |
1.238* |
138.90 |
||||
Positive Control |
102.33* |
1.011* |
117.50 |
||||
FAT 40842/A TE |
-2.67* |
0.015* |
-2.44 |
-2.2 = 0 |
non |
||
FAT 40842/A TE |
-2.67* |
0.065* |
-1.69 |
||||
FAT 40842/A TE |
-2.67* |
0.013* |
-2.47 |
*corrected values
SCORING
In vitroScore |
Proposedin vitroirritation Scale |
0 - 3 |
Non eye irritant |
3.1 – 25 |
Mild eye irritant |
25.1 – 55 |
Moderate eye irritant |
55.1 – 80 |
Severe eye irritant |
> 80.1 |
Very severe eye irritant |
Validity
Criteria: The test was acceptable if the positive control caused an at least moderate effect.
The positive control (10% (v/v) Benzalconium chloride) showed clear opacity and distinctive permeability of the corneas and therefore, is classified as very severe eye irritant. The in vitro score was calculated as 129.35.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Invitox (UK) protocol no. 98 aand calculated "in vitro" score = 0
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item FAT 40842/A TE is not considered to be an eye irritant.
- Executive summary:
This in vitro study was performed to assess the corneal irritation and damage potential of FAT 40842/A TE by means of the BCOP assay using fresh bovine corneas.
After a first opacity measurement of the fresh bovine corneas (t0), the neat test item FAT 40842/A TE, the positive, and the negative controls were applied to corneas and incubated for 240 minutes at 32 ± 2 °C in cMEM medium, supplemented with 10% FCS. After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneas and opacity was measured again (t240).
After the opacity measurements permeability of the corneas was determined while application of 1 mL of a fluorescein solution for about 90 minutes at 32 ± 2 °C in a horizontal position. The coming out liquid was measured spectrophotometrically.
With the negative control (0.9% NaCl solution) neither an increase of opacity nor permeability of the corneas could be observed.
The positive control (10% (v/v) Benzalconium chloride) showed clear opacity and distinctive permeability of the corneas and therefore, is classified as very severe eye irritant.
The test item FAT 40842/A TE did not cause any opacity or permeability of the corneas compared with the results of the negative control. The calculated in vitro score was 0 and therefore, the test item was classified as non eye irritant.
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item FAT 40842/A TE is not considered to be an eye irritant.
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