Registration Dossier
Registration Dossier
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EC number: 700-455-1 | CAS number: 380843-75-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 July 2009 - 13 August
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- 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.
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile
- EC Number:
- 700-455-1
- Cas Number:
- 380843-75-4
- Molecular formula:
- C26H29Cl2N5O3
- IUPAC Name:
- 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Doses:
- Dose level (volume)
2000 mg/kg (10 mL/kg) body weight.
300 mg/kg (10 mL/kg) body weight.
Frequency Single dosage, on Day 1. - No. of animals per sex per dose:
- 12 Females (nulliparous and non-pregnant). Each dose group consisted of 3 animals.
Young adult animals (approx. 8-9 weeks old) were selected. Body weight variation did not exceed +/- 20% of the sex mean. - Control animals:
- yes
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 300 - <= 2 000 mg/kg bw
- Based on:
- not specified
- Remarks on result:
- other: LD50 cut-off value was considered to be 500 mg/kg body weight.
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information and should be labeled as H302: Harmful if swallowed. Criteria used for interpretation of results: EU
- Conclusions:
- Based on these results:
- according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007), WAY-173606 (CRYSTALLIZED) should be classified as: harmful if swallowed (Category 4) for acute toxicity by the oral route.
- according to the Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures, WAY-173606 (CRYSTALLIZED) should be classified as Category 4 and should be labeled as H302: Harmful if swallowed.
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