Registration Dossier
Registration Dossier
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EC number: 700-455-1 | CAS number: 380843-75-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 July 2009
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: The Ocular Toxicity Working Group (OTWG) of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the National Interagency Centre for the Evaluation of Alternative Toxicological Methods (NICEATM), Background Review D
- Qualifier:
- according to guideline
- Guideline:
- other: In Vitro Techniques in Toxicology Database (INVITTOX) protocol 124. Bovine Opacity and Permeability Assay - SOP of Microbiological Associates Ltd., 1999.
- Qualifier:
- according to guideline
- Guideline:
- other: Gautheron P., Dukic M., Alix D. and Sina J.F., Bovine corneal opacity and permeability test: An in vitro assay of acular irritancy. Fundam Appl Toxicol 18:442-449, 1992.
- Qualifier:
- according to guideline
- Guideline:
- other: Organisation for Economic Co-operation and Development (OECD), OECD Guidelines for Testing of Chemicals; Draft proposal for a new guideline: "Bovine Corneal Opacity and Permeability (BCOP) Test Method for Identifying Ocular Corrosives and Severe Irritants
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile
- EC Number:
- 700-455-1
- Cas Number:
- 380843-75-4
- Molecular formula:
- C26H29Cl2N5O3
- IUPAC Name:
- 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile
- Details on test material:
- Reference substance
Negative control: A negative control, physiological saline (Merck, Darmstadt, Germany) was included to detect non-specific changes in the test system and to provide a baseline for the assay endpoints.
Positive control: The positive control was a 20% (w/v) Imidazole (see § 6.2.3) solution prepared in physiological saline.
Test system
Test System: Bovine eyes were used as soon as possible after slaughter on the same day.
Rationale: In the interest of sound science and animal welfare, a sequential testing strategy is recommended to minimise the need of in vivo testing (1-5). As a consequence a validated and accepted in vitro test for eye irritation should be performed before in vivo tests are conducted. One of the proposed in vitro eye irritation tests is the Bovine Corneal Opacity and Permeability (BCOP) test.
Source: Bovine eyes from young cattle were obtained from the slaughterhouse (Vitelco, 's Hertogenbosch, the Netherlands), where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter.
Transport: Eyes were collected and transported in physiological saline in a suitable container.
Constituent 1
Test animals / tissue source
- Species:
- other: Bovine Corneal
- Strain:
- other: Bovine eyes from young cattle were obtained from the slaughterhouse (Vitelco, 's Hertogenbosch, the Netherlands), where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter.
Test system
- Vehicle:
- physiological saline
- Controls:
- not required
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: In Vitro irritancy score
- Time point:
- other: 240 minutes of treatment
- Score:
- >= 4.2 - 7.3
- Irritation parameter:
- other: mean in vitro irritancy
- Time point:
- other: 240 minutes f treatment
- Score:
- ca. 6.5
- Remarks on result:
- other: Calculated using the negative control mean opacity and mean permeability values.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information mild irritant in the Bovine Corneal Opacity and Permeability Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Finally, it is concluded that this test is valid and that WAY-173606 (crystallized) is a mild irritant in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.
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