Registration Dossier
Registration Dossier
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EC number: 937-756-4 | CAS number: 886588-63-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- 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:
- 7-But-2-ynyl-8-[(R)-3-(1,3-dioxo-1,3-dihydro-isoindol-2-yl)-piperidin-1-yl]-3-methyl-1-(4-methyl-quinazolin-2-ylmethyl)-3,7-dihydro- purine-2,6-dione
- EC Number:
- 937-756-4
- Cas Number:
- 886588-63-2
- Molecular formula:
- C33 H30 N8 O4
- IUPAC Name:
- 7-But-2-ynyl-8-[(R)-3-(1,3-dioxo-1,3-dihydro-isoindol-2-yl)-piperidin-1-yl]-3-methyl-1-(4-methyl-quinazolin-2-ylmethyl)-3,7-dihydro- 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 female at 200mg/kg
3 male and 3 female at 2000mg/kg - Control animals:
- no
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 mortality was observed subsequent to a single oral administration of 200 mg/kg and
2000 mg/kg, respectively rats. - Clinical signs:
- From as early as 0.25 h to 3.5 h post administration at the latest, piloerection was noted at
all doses in rats of both genders. The animals returned to normal during the Day 1 (6.25 h
post administration at the latest) and no further abnormal clinical signs were observed
throughout the entire 14-day observation period. - Body weight:
- No effects on body weight development were noted in males and females
- Gross pathology:
- No necropsy findings were noted 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 occurred in rats subsequent to a single oral administration of CD 749 BS by
gavage at doses of 200 mg/kg and 2000 mg/kg, respectively.
The approximate lethal dose (ALD) for CD 749 BS is above 2000 mg/kg for male and female rats.
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