Registration Dossier
Registration Dossier
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EC number: 604-075-6 | CAS number: 138401-24-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 February 1994 to 22 February 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test follows standard guideline. GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- SR 47563
- IUPAC Name:
- SR 47563
- Details on test material:
- - Code name of test material (as cited in study report): SR47563
- Lot/batch No.: 3SNP022
- Certificate of analysis appended
- Chemical name: 2-n.butyl-3-[(2'cyanobiphenyl-4-yl)methyl]1,3-diaza-spiro[4.4]non-en-4-one
- Physical state: white powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: OFA-SD (IOPS Caw)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.6 % methylcellulose
- Doses:
- 0 and 2000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females per dose
- Control animals:
- yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
Mortality :
No mortality was recorded in either male or female rats
Clinical examination :
At 2000 mg/kg on D1, all animals presented ptyalism 15 minutes after treatment (during 15 minutes) and prostation appearing about 1 hour after treatment and lasting all day.
Body weight :
The body weight of treated animals was similar to that of controls.
Pathology :
No macroscopic lesion were observed in either male or female rats.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The dose level of 2000 mg/kg was non lethal to the rat of both sexes (LD50 > 2000 mg/kg). This dose only induced clinical signs (ptyalism and prostration) on day 1.
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