Registration Dossier
Registration Dossier
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EC number: 700-456-7 | CAS number: 1333490-26-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 22 June 2009-03 August 2009
- Reliability:
- 1 (reliable without restriction)
Data source
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.
- GLP compliance:
- yes
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
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- (Elix, Millipore S.A.S., Molsheim, France
- Doses:
- Dose level (volume) 2000 mg/kg (10 mL/kg) body weight.
Frequency Single dosage, on Day 1. - No. of animals per sex per dose:
- 6 Females (nulliparous and non-pregnant). Each dose group consisted of 3 animals.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
Any other information on results incl. tables
According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.
Based on these results, WAY-189172 does not have to be classified and has no obligatory labeling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007) and the Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Based on these results, WAY-189172 does not have to be classified and has no obligatory labeling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007) and the 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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