Registration Dossier
Registration Dossier
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EC number: 922-028-0 | CAS number: 853029-57-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- 8-bromo-7-(but-2-yn-1-yl)-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]-2,3,6,7-tetrahydro-1H-purine-2,6-dione
- EC Number:
- 922-028-0
- Cas Number:
- 853029-57-9
- Molecular formula:
- C20 H17 Br N6 O2
- IUPAC Name:
- 8-bromo-7-(but-2-yn-1-yl)-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]-2,3,6,7-tetrahydro-1H-purine-2,6-dione
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CrlGlxBrlHan:WI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% aqueous hydroxyethylcellulose
- Doses:
- 200 and 2000 mg/kg
- No. of animals per sex per dose:
- 3 females / 200 mg/kg3 females / 3 males / 2000 mg/kg
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred following a single oral administration of 200 and 2000 mg/kg.
- Clinical signs:
- other: At 2000 mg/kg, piloerection and sedation were seen in rats of both genders from 0.5 h to8.0 h post administration at the latest. They returned to normal during the Day 1 (males atabout 6 h, females at 10 h post administration) and no further abnormal clin
- Gross pathology:
- No gross pathological findings were noted at necropsy in females treated with 200 mg/kg,as well as in rats of both genders subsequent to administration of 2000 mg/kg
Applicant's summary and conclusion
- Interpretation of results:
- other: "not classified" according CLP
- Conclusions:
- Under the conditions of the present study, no mortality was seen in rats subsequent to oral administration of CD 616 BS at doses of 200 mg/kg and 2000 mg/kg, respectively.The approximate lethal dose (ALD) for BI 1356 BS / CD 616 BS is above 2000 mg/kg for male and female rats.
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