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EC number: 700-149-8 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
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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:
- 2008-06-12
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Bovine Corneal Opacity and Permeability Assay (BCOP); SOP of Microbiological Associates Ltd. UK, Procedure Details, April 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - public name of test material:
Reaction mass of 6,13-dichloro-3,10-bis{[2-({[(2-chloroethyl)sulfonyl]alkanoyl}amino)ethyl]-amino}- polycarboheterocyclo 4,11-disulfonic acid, mono and/or disodium salt and 6,13-dichloro-3-{[2-({[(2-chloroethyl)sulfonyl]alkanoyl}amino) ethyl]amino}-10-[(2-{[4-(ethenylsulfonyl)alkanoyl]amino}ethyl)amino] polycarboheterocyclo -4,11-disulfonic acid, mono and/or di sodium salt
- Physical state: solid, dark blue powder
- Analytical purity: approx. 86.6%
- Lot/batch No.: VER 2108 BOP 02/07
- Expiration date of the lot/batch: November 30, 2012
Constituent 1
Test animals / tissue source
- Species:
- other: no animals, in vitro test
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not applicable, in vitro test
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.1g
VEHICLE
no vehicle - Duration of treatment / exposure:
- 240 min (± 5 min)
- Observation period (in vivo):
- not applicable, in vitro test
- Number of animals or in vitro replicates:
- not applicable, in vitro test
- Details on study design:
- Test System: freshly isolated bovine corneas
Number of Conreas per Group: 3
Number of Test Item Group: 1
Number of Negative Control Group: 1
Number of Positive Control Group: 1
Total number of Corneas: 9
After a first opacity measurement of the fresh bovine corneas (t0), the test item FAT 40840/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.
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 240min incubation time
- Score:
- > 42 - < 151
- Max. score:
- 151
- Reversibility:
- other: not applicable
- Remarks on result:
- other: In Vitro Score
Any other information on results incl. tables
Results after 240 min. Incubation time
Test Group | Opacity value = Difference (t240 -t0) of Opacity | Permeability at 490 nm (OD490)* | In vitro Score | Mean in vitro Score | Proposed in vitro Irritation Scale | ||
Mean | Mean | ||||||
Negative control | 2 | 0.0576 | 2.86 | ||||
Negative control | 1 | 1.33 | 0.0512 | 0.056 | 1.77 | 2.17 | Non eye irritant |
Negative control | 1 | 0.0594 | 1.89 | ||||
Positive Control | 92.67 |
2.3085 |
127.29 | ||||
Positive Control | 137.67 |
2.2400 |
171.27 | 164.27 | very severe eye irritant | ||
Positive Control | 159.67 |
2.3058 |
194.25 | ||||
FAT 40841/A TE | 41.67 |
0.0267 |
42.09 | ||||
FAT 40841/A TE | 88.67 |
0.0127 |
88.71 | 93.86 | very severe eye irritant | ||
FAT 40841/A TE | 147.67 | 0.2076 | 150.78 |
In Vitro Score
In vitro score | Proposed in vitro 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 |
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 test material caused opacity and permeability of the corneas compared with the results of the negative control. The calculated in vitro score was 93.86 and therefore, the test item was classified as very severe eye irritant. The test item caused coloring of the cornea which could not be rinsed off even after stringent washing. Therefore the positive effect may be caused by the coloring effect.
Applicant's summary and conclusion
- Interpretation of results:
- other: very severe eye irritant
- Remarks:
- Criteria used for interpretation of results: other: INVITOX (UK) protocol No. 98
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions
reported, the test item test material is considered to be a very severe eye irritant. - Executive summary:
This in vitro study was performed to assess the corneal irritation and damage potential of test material 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 test material, 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 test material caused opacity and permeability of the corneas compared with the results of the negative control. The calculated in vitro score was 93.86 and therefore, the test item was classified as very severe eye irritant. The test item caused coloring of the cornea which could not be rinsed off even after stringent washing. Therefore the positive effect may be caused by the coloring effect.
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item test material is considered to be a very severe eye irritant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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