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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:
2012

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

Constituent 1
Chemical structure
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

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