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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
18 August 2009
Reliability:
1 (reliable without restriction)

Data source

Materials and methods

Test guidelineopen allclose all
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
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.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(3-chloropropoxy)-1-methoxy-4-nitrobenzene
EC Number:
618-883-1
Cas Number:
92878-95-0
Molecular formula:
C10H12ClNO4
IUPAC Name:
2-(3-chloropropoxy)-1-methoxy-4-nitrobenzene
Details on test material:
Molecular formula C10H12ClNO4
Molecular weight 245.66
CAS Number 92878-95-0
Description Slightly yellow powder
Batch 18238702
Purity 99.8%
Test substance storage At room temperature protected from light
Stability under storage conditions Stable

Test animals / tissue source

Species:
other: Bovine eyes
Strain:
other: the slaughterhouse (Vitelco, 's Hertogenbosch, the Netherlands)

Test system

Controls:
not required
Duration of treatment / exposure:
240 minutes

Results and discussion

In vivo

Results
Irritation parameter:
cornea opacity score
Basis:
other: eye bovine
Time point:
other: 240
Score:
>= 2.2 - <= 2.6
Max. score:
2.6
Other effects:
The corneas were all clear after the 240 minutes of treatment with WAY-188471. Hence, the in vitro irritancy scores ranged from 2.0 to 2.6 after 240 minutes of treatment with WAY-188471.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Finally, it is concluded that this test is valid and that WAY-188471 is a non irritant in the Bovine
Corneal Opacity and Permeability test under the experimental conditions described in this
report.

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