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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
18 May 2009 - 4 August 2009
Reliability:
1 (reliable without restriction)

Data source

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

Constituent 1
Chemical structure
Reference substance name:
(2E)-2-cyano-N-(2,4-dichloro-5-methoxyphenyl)-3-({4-methoxy-3-[3-(4-methylpiperazin-1-yl)propoxy]phenyl}amino)prop-2-enamide; propan-2-ol
EC Number:
700-456-7
Cas Number:
1333490-26-8
Molecular formula:
C26H31Cl2N5O4 · 1/2(C3H8O1)
IUPAC Name:
(2E)-2-cyano-N-(2,4-dichloro-5-methoxyphenyl)-3-({4-methoxy-3-[3-(4-methylpiperazin-1-yl)propoxy]phenyl}amino)prop-2-enamide; propan-2-ol
Details on test material:
Molecular formula C26H31Cl2N5O4
Molecular weight 548.46
Description Beige-yellow powder (determined at NOTOX)
Batch 09-002
Purity >92%
Composition 6.5% isopropanol as a hemi solvate

Test animals / tissue source

Species:
other: not applicable
Strain:
other: not applicable

Test system

Vehicle:
other: not applicable
Controls:
other: not applicable
Duration of treatment / exposure:
not applicable
Observation period (in vivo):
not applicable
Number of animals or in vitro replicates:
not applicable

Results and discussion

Any other information on results incl. tables

The mean in vitro irritancy score (uncorrected) obtained with the negative control was less than 3.1 indicating that the negative controls did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (20% (w/v) Imidazole) was 112.1 and within the historical positive control data range (Appendix II, Table 6). It was therefore concluded that the test conditions were adequate and that the test system functioned properly. WAY-189172 did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 2.6 after 240 minutes of treatment. Finally, it is concluded that this test is valid and that WAY-189172 is a non irritant in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.

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-189172 is a non irritant in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.