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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
26 August 2009 - 17 September 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: In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method.
Qualifier:
according to guideline
Guideline:
other: European Community (EC). Commission regulation (EC) No. 761/2009, Part B: Methods for the Determination of Toxicity and other health effects, Guideline B.46 “In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test ". Official Journal of the Eur
Principles of method if other than guideline:
In vitro skin irritation test with WAY-189172 using a human skin model. This report describes the ability of WAY-189172 to induce skin irritation on a human three dimensional epidermal model (EPISKIN Standard model (EPISKIN-SMTM)). The possible skin irritation potential of WAY-189172 was tested through topical application for 15 minutes.
The study procedures described in this report were based on the most recent OECD and EC guidelines.
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 weight: 548.47
Batch: 09-002
Purity: >92% (Contains 6.5% isopropanol as a hemi-solvate
Appearance: Yellowish solid

Test animals

Species:
other: in vitro
Strain:
other: not applicable

Test system

Type of coverage:
other: not applicable
Preparation of test site:
other: not applicable
Vehicle:
water
Controls:
other: not applicable
Duration of treatment / exposure:
not applicable
Observation period:
not applicable
Number of animals:
not applicable

Results and discussion

Any other information on results incl. tables

Finally, it is concluded that this test is valid and that WAY-189172 is non-irritant in the in vitro skin irritation 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 non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.