Registration Dossier
Registration Dossier
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EC number: 227-114-5 | CAS number: 5661-03-0
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Octahydrocyclopenta[c]pyrrole
- EC Number:
- 227-114-5
- EC Name:
- Octahydrocyclopenta[c]pyrrole
- Cas Number:
- 5661-03-0
- Molecular formula:
- C7H13N
- IUPAC Name:
- octahydrocyclopenta[c]pyrrole
- Test material form:
- gas under pressure: refrigerated liquefied gas
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- formulation prepared daily within 6 hours prior to dosing
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- once daily, 7 days per week, approximately the same time each day.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 mg/kg
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
30 mg/kg
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
130 mg/kg
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
600 mg/kg
Basis:
nominal in water
- No. of animals per sex per dose:
- 5
Examinations
- Observations and examinations performed and frequency:
- Mortality (twice daily), clinical signs (once daily), body weight and feed intake (weekly), clinical pathology (end of study), organ weight, macro- and microscopic examinations.
- Other examinations:
- Functional observations were performed during week 4, between 1 and 3 hours after dosing.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- no mortality ; piloerection and hunched posture at 600 mg/kg/d
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- no mortality ; piloerection and hunched posture at 600 mg/kg/d
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- slightly lower body weight gain at 600 mg/kg/d
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- no relevant effects
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- no relevant effects
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- no relevant effects
- Organ weight findings including organ / body weight ratios:
- no effects observed
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 130 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: clinical signs, body weight effect and forestomach lesions at 600 mg/kg bw/day
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
