Registration Dossier
Registration Dossier
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EC number: 700-456-7 | CAS number: 1333490-26-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 15 July 2009-18 August 2009
- Reliability:
- 1 (reliable without restriction)
Data source
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- 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
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Three groups of five animals were treated with one test substance concentration per group. The highest test substance concentration was selected from the preliminary irritation study. One group of five animals was treated with vehicle.
- No. of animals per dose:
- Group1 animal numbers induction (test substance; % w/w)
1 01 - 05 0 (Acetone/Olive oil)
2 06 - 10 10
3 11 - 15 25
4 16 - 20 50
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: %(w/w) SI Group 2 10% 0.8 Group 3 25% 1.2 Group 4 50% 0.7 Group 1 0% 1.0
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: %(w/w) DPM/group Group 2 10% 208 Group 3 25% 300 Group 4 50% 165 Group 1 0% 249
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information According Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007),
- Conclusions:
- Based on these results WAY-189172 does not have to be classified and has no obligatory labeling requirement for sensitization by skin contact according to the:
- Recommendations made in the test guidelines,
- Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007),
- Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures.
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.
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